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The May / June 2020

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SPCs – what happens after Brexit?

CTC Legal Media

USPTOappealstrategies 4

Instructing experts Page 19

Innovationpartnerships

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Darren Smyth and Gareth Probert of EIP look at where Brexit leaves Supplementary Protection Certificates in the UK

Law firmRANKINGS

SOUTH AMERICA

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CTC Legal Media THE PATENT LAWYER

THE PATENT LAWYERIssue 48EditorMatt [email protected]

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TheMay / June 2020



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Darren Smyth and Gareth Probert of EIP look

at where Brexit leaves Supplementary Protection

Certificates in the UK

Law firmRANKINGS

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Welcome to this, our May/June 2020 Issue of The Patent Lawyer.Having focused last issue on the IP issues raised by the currentpandemic, now seems a good time to remind ourselves of

some of the other key issues facing patent lawyers across the globe.Brexit continues to loom large, of course – overshadowed by the global

situation, but of critical importance, nonetheless. Of continued interest ishow the UK’s exit from the EU might impact Supplementary ProtectionCertificates in the UK, and Darren Smyth & Gareth Probert, Partners at EIP,

are on hand to look at where the UK’sdecision to exit the EU leaves SPCs and theenhanced protection they offer topharmaceutical and agrochemical productsas they make their often tortuous waythrough regulatory authorization.

We look too at Brexit’s potential impacton Innovation Partnerships, looking to the future with Malcolm Dowden and Moga Moodley of Womble Bond Dickinsonto discuss how such partnerships could berevitalized.

Elsewhere, William Smith and NoelCourage of Bereskin & Parr look at the

key strategic considerations when deciding whether to appeal in theUSPTO, Josh Gerben, founder of Gerben Law, details the different types ofpatents available to US inventors and outlines how to apply for them, andSaiful Khan, partner at Potter Clarkson, takes us through the recent WIPOconsultation on AI IP policy.

All this, plus articles on FibroGen v Akebia, the recent KnowIt 2020 event,RNAi patent searches, and much, much more.

I hope you enjoy the issue.

Matt SeexEditor

Editor’swelcome

Mission statementThe Patent Lawyer educates and informs professionals working in the industry bydisseminating and expanding knowledge globally. It features articles written by peopleat the top of their fields of expertise, which contain not just the facts but analysis andopinion. Important judgments are examined in case studies and topical issues arereviewed in longer feature articles. All of this and the top news stories are brought toyour desk via the printed magazine or the website www.patentlawyermagazine.com

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We look too at Brexit’spotential

impact onInnovation

Partnerships

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[email protected]+44 (0) 207 186 1800

www.ipcentrum.com

LAUNCH SEQUENCE

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G2 CR SEPARATION

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P1 CLIENT ONBOARDINGG2 PR SEPARATION

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has cleared the tower“Continually push further and without being limited by convention, to prove that the ‘truly special’ can be done, regardless of whether it is absolutely necessary to do so. Without a drive towards such things, the world would solely be functional.”

The imminent launch of IPC Renew, by IP Centrum, marks the final few weeks of the renewals industry as we’ve all known it to date.

After five years of the most intense service development programme imaginable, we are proud to finally introduce to the world’s greatest IP formalities professionals, the future of renewals.

Follow the launch: @ipcentrum

Sign up for early access: www.ipcentrum.com/renewals

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37 Patent rights in the midstof COVID-19Sérgio Braz, Industrial Property Agent and foundingPartner at Braz & Associates, looks at the impact thecurrent global pandemic is having on the IPlandscape in Mozambique.

40 Patent types explained:utility, design, and plantJosh Gerben, founder of Gerben Law Firm, PLLC,explains the three different types of patents available toinventors in the US, and outlines how to apply for them.

42 Biotech patentharmonization – a PolishperspectiveAleksandra Sołyga-Żurek, European patent attorney,and Katarzyna Jedynak, patent attorney trainee, bothof Patpol, look at recent moves to harmonize Polishbiotech patent protections with EU law.

46 WIPO consultation showsthere will be no automaticsolutions on AI IP policyFollowing on from WIPO’s public consultation on AI and IP policy, written submissions are now available online. To understand how policy in this area might evolve from here, Saiful Khan, partner andpatent attorney at Potter Clarkson, looks at key pointsin the feedback from some of the most integralpolicy-shaping organizations.

49 The challenges posed by nanotechnologypatentsMargarita Guerrero and Manuel Lopez, Associates at

Uhthoff, Gomez-Vega & Uhthoff, discuss the patent

implications of this groundbreaking technology.

52 Rankings: South AmericaTen of the best law firms from each of the top South

American jurisdictions, including Argentina, Brazil, and

Venezuela.

58 Directory of servicesAn A to Z list of the international law firms who

provide IP related services.

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4 THE PATENT LAWYER CTC Legal Media

Contents22 Why do "innovation

partnerships" fail?Malcolm Dowden and Moga Moodley of Womble

Bond Dickinson (UK) LLP discuss how innovation

partnerships could be revitalized, particularly in light

of the challenges posed by Brexit.

24 KnowIt 2020 – Editor’sReportMatt Seex, Editor of The Patent Lawyer, looks back at a

thought-provoking and entertaining three-day live-

stream event.

28 Patentability of AI-relatedinvention patentapplications in ChinaJiuliang LIU, partner and senior patent attorney at

Beijing Sanyou IP Agency Ltd, discusses AI-related

amendments to the Guidelines for Patent Examination

in China.

32 Demystifying RNAi patentsearches to supportstronger claimsPeter Blasi and Anne Marie Clark of CAS IP Services

discuss avoiding pitfalls in patentability and freedom

to operate searches.

6 Meet the Editorial BoardMeet our Editorial Board members who help

determine the direction of this magazine.

7 NewsRenewed calls for a unified EU patent system, USPTO

invites comments on prioritizing COVID-19 applications,

and Spin Master awarded highest-ever patent

infringement damages for foreign plaintiff in China.

10 COVER STORYSupplementary ProtectionCertificates in the UK –what happens after Brexit?Darren Smyth and Gareth Probert, Partners at EIP, look at where the UK’s decision to exit the EU leaves SPCs.

May/June 2020

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14 Strategic considerationswhen deciding whether toappeal in the USPTOWilliam Smith and Noel Courage of Bereskin & Parr

discuss how to decide if your applicant’s case is

ready for appeal, and if that would be the best

strategy decision.

19 FibroGen v Akebia – doLord Justice Arnold’srecent comments signify achange in approach toinstruction of experts?Matthew Raynor of Bristows LLP examines Lord

Justice Arnold’s recent comments in FibroGen v

Akebia regarding the Medimmune approach to the

instruction of experts in UK patent cases.

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Renewed calls for a unifiedEU patent system

USPTO may prioritize COVID-19 applications

DESPITE, OR MAYBE because of recent high-profile blows tothe planned implementation of such a system, EU InternalMarket Commissioner Thierry Breton has once again calledupon Member States to move forward with a unified EU patent.

Breton’s call comes at a time when the future of Europe’sUnified Patent Court (UPC) itself seems increasingly in doubt.The British Government has already confirmed that it will notbe seeking membership of the Court following Brexit, and notlong after that, Germany’s intended involvement was deemed“unconstitutional” by the country’s Federal Constitutional Courton the grounds that the UPC agreement was not passed by theBundestag with the necessary two-thirds majority required,leaving any claimed ratification at odds with German Basic Law.

The UPC was intended to provide “one-stop” enforcement ofEuropean Patents, underpinned by a unified EU Patent thatwould be more efficient and cheaper to obtain for industries andinnovators across the EU. The broad nature of such a patentwas agreed between the European Council and the EuropeanParliament back in 2012, but various setbacks and disagreementshave meant that implementation of the system across the EUremains, at best, patchy, with the continued lack of a centralizedEU patent court being seen by many as a critical issue.

Apparently undeterred by such setbacks, in a recent meetingof the European Parliament’s Legal Affairs committee Bretonsaid that one of his priorities following the COVID pandemicwould be the proper implantation of a “single European patentsystem”.

He said: “The EU has a solid framework for intellectualproperty, but the current system has to become much moreeffective. It’s too fragmented and too expensive. And it has tobe adapted to the challenges of the digital age and theenvironment. It’s a question of developing solutions that allowtechnologies to be shared. It’s a question of competitiveness.”

Of course, it remains to be seen whether Breton’s statementwill have any impact on the ongoing impasse surrounding theUPC and the unified EU patent more broadly.

THE UNITED STATES Patent andTrademark Office (USPTO) has asked forcomments on its proposal to fast-trackpatent applications relating to COVID-19– a so-called Prioritized Examination PilotProgram (PEPP).

In a statement released on its website,the USPTO says that it is “implementing a pilot program to provide prioritizedexamination of certain patent applications.To qualify, the claim(s) of an applicationmust cover a product or process relatedto COVID-19, and such product or processmust be subject to an applicable FDAapproval for COVID-19 use.

“Under this pilot program, the USPTO

will grant qualified requests for prioritizedexamination without payment of certainfees associated with prioritized examinationfor applicants that qualify for small ormicro entity status. The goal of prioritizedexamination is to provide a final dispositionwithin 12 months, on average, from thedate the prioritized status has been granted.Furthermore, the USPTO believes it canachieve final disposition in six months ifapplicants provide more timely responsesto notices and actions from the USPTO,as compared to those required byprioritized examination.”

Interested parties have until 13 July 2020to comment on the USPTO’s proposal, with

the USPTO adding that it “will acceptrequests for prioritized examinationbeginning [13 July] until such time as theUSPTO has accepted a total of 500 requests.

The USPTO may extend the pilotprogram (with or without modifications) orterminate it depending on the workloadand resources needed to administer theprogram, feedback from the public, andthe effectiveness of the program. If thepilot program is extended or terminated,the USPTO will notify the public.”

Standard operating procedure for theUSPTO, in common with other such bodiesacross the world, is to consider patentapplications in order of filing date.

News

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MEET THE EDITORIAL BOARD

Ken Adamo – IP Attorney USAKen has extensive trial experience as leadcounsel before state and federal courts and theUS International Trade Commission.

Daniela Ampollini – Trevisian & Cuonzo,ItalyDaniela is a partner of Trevisan & Cuonzo. She advises clients in IP matters in the Italianjurisdiction, with a focus on patent litigation.

Dr Saiful Khan – Potter ClarksonSaiful is a Partner and Board Member at PotterClarkson who practises in both the Electronics & Computing Group and the Design &Engineering Group.

Enrique A. Diaz – Goodrich RiquelmeEnrique is head of the Industrial and IntellectualProperty Department. He currently manages theprosecution of over 3500 trademarks and morethan 1000 patents per year.

Osamu Yamamoto – Yuasa & Hara, JapanOsamu Yamamoto is a patent attorney, and amanaging partner of Yuasa and Hara. Hespecializes in patents in the fields ofbiotechnology & pharmaceuticals.

Pravin Anand – Anand & Anand, IndiaPravin Anand, managing partner of Anand andAnand, is an advocate and a patent andtrademark attorney.

Eric Su – HongFangLaw, ChinaEric Su is founding partner at HongFangLaw and studied law at the East China University ofPolitics and Law and chemical engineering at the North University of China.

Noel Courage – Partner, Bereskin & Parr LLPNoel Courage is a partner and patent attorney at Bereskin & Parr LLP, working in its Torontooffice. His practice focuses on patenting andlicensing of life sciences inventions.

Sergio Olivares Jr. – Olivares, MexicoSergio Olivares leads the multi-award winningpatent practice at the law firm Olivares and iswidely recognized as one of Mexico’s leadingpatent attorneys.

Stefan Schohe – Boehmert & BoehmertStefan is partner at Boehmert & Boehmert. Hemainly works in the fields of IT and physics, with a focus on litigious issues.

Malcolm Dowden – Legal Director, Womble Bond DickinsonMalcolm is the author of the EU/UK chapter inthe American Bar Association's The Law ofArtificial Intelligence and Smart Machines.

Caitlin Heard – Partner, CMSCaitlin’s principal area of expertise is multi-jurisdictional patent litigation. She hasacted on a number of high-profile disputesacross a range of technical areas.

Valery Medvedev – Gorodissky & Partners,RussiaValery is the Managing Partner and in charge ofthe largest IP practice in Russia. He is a Russianand Eurasian Patent Attorney.

Vitor Fidalgo – Inventa International Vítor Palmela Fidalgo is a Trademark and Patent Attorney, specialized in all IP matters andis the IP Director at Inventa International.

Eugene Goryunov – Partner, Haynes and BooneEugene Goryunov is a partner in the IntellectualProperty Practice Group in the Chicago office ofHaynes and Boone and an experienced triallawyer.

Piotr Dynowski LL.M. – Bird & BirdPiotr is Partner, co-head of the IP, and head ofTMT practice at the Warsaw office. He is one ofthe leading IP and patent litigation lawyers inPoland.

Maria Zamkova – Fenix Legal KB, SwedenMaria has a Master of Industrial Design and is a patent and trademark attorney. She is anexpert in European Patents.

Simon de Banke – Founder & CEO, IP CentrumSimon de Banke is founder and CEO of the high-tech-focused IP Services disruptor IPCentrum.

Dr. Claudia Tapia – Ericsson, GermanyClaudia is Director of IPR Policy & LegalAcademic Research at Ericsson. She is Chair of4iP Council and vice chair of the Patent andTechnology Licensing of LESI.

Mark Durrant – Director of Marketing andCommunications, Marconi GroupMark spent thirteen years at Nokia, mostrecently as Director of Communications for NokiaTechnologies, He is now Director of Marketingand Communications at Marconi Group.

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Spin Master awarded highest-everpatent infringement damages forforeign plaintiff in ChinaLEADING GLOBAL children’s entertainment company, Spin Master,has won a major victory in a long-running patent dispute againstone of the most prominent toy producers in China, resulting inthe largest damages ever awarded to a foreign patent owner.

In a first instance judgment, the Suzhou Intermediate Peoples’Court found the defendant, Guangzhou Lingdong Creative CultureTechnology, had infringed Spin Master’s patents covering itsglobally popular Bakugan toy line.

The Court awarded Spin Master damages of RMB 15.5million(US$2.2million) – the largest ever for a foreign plaintiff accordingto public data for patent infringement cases in China.

Spin Master claimed that Lindong’s products infringed severalaspects of Spin Master’s Bakugan patent, including its rollableshape, interior structure, and magnetic properties.

Notably, the ruling came after Chinese prosecutors had declinedto file formal charges against the infringers, forcing Spin Masterto bring the first successful private criminal prosecution in ChineseIP history. Three individuals were sentenced to three years’imprisonment and the companies were fined.

Spin Master was advised throughout both cases by Chineselaw firm Lusheng, part of the Rouse network. Douglas Clark,

Global Head of Dispute Resolution with Rouse, commented:“We’re delighted for Spin Master. The high damages awarded,

and successful private prosecution are both extremely rare andsend a clear message to IP rights holders globally and to potentialinfringers in China that infringement of IP rights will not betolerated.

“If ever there is a time when the courts in China might err onthe side of local protectionism you would be forgiven for thinkingit is now, just as the economy recovers from Covid-19. The factthat they have ruled so emphatically in favor of protecting thelegitimate rights of the IP owner is a clear and bold statement.”

Chris Harrs, Executive Vice-President at Spin Master, added:“We are very pleased with the outcome and are thankful toLusheng and Rouse for their guidance throughout both litigations.Spin Master will continue to steadfastly protect and enforce itsintellectual property rights in all jurisdictions globally.”

The rulings represent another key breakthrough in China’scontinued crackdown on IP infringement. Over the past decade,China has made significant strides in developing and enforcinga robust IP rights regime, bringing its domestic IP landscape inline with developed systems in the US and Europe.


NEWS


Innovation surge neededto address climate change,says WIPO reportA WIPO REPORT has highlighted the fact that innovation inenvironmentally friendly technologies as measured by internationalpatent applications barely rose in 2019, prompting a call fromWIPO Director General Francis Gurry for a green tech surge tofight climate change.

For its "World IP Day 2020: Innovate for a Green Future" report,the WIPO analyzed international patent filings via its PatentCooperation Treaty (PCT) in four categories of green energytechnologies. These covered:• alternative energy production, notably renewable energy

technologies;• energy conservation technologies;• green transportation; and• nuclear power generation.

The report found that PCT applications – one measure ofinnovative activity – containing at least one IPC green energycode, grew to 16,940 applications in 2019, a 1.3 percent increasefrom 2018. This lags a peak of 17,880 in 2016 and represents justover 6% of the total number of PCT applications filed in 2019.

Further, the report highlighted the fact that overall greeninnovation growth has been hindered by a drop in alternativeenergy technologies, which fell 18% since 2013.

Commenting, Mr Gurry said: “Climate change has far-reachingeffects for all of us and innovation in green tech sectors will be keyto successfully addressing this global challenge. Policymakers,businesses, academic institutions, inventors around the world:Let’s all work together to create a green-tech innovation surgethat meets the requirements of our times.” A WIPO report hashighlighted the fact that innovation in environmentally friendlytechnologies as measured by international patent applicationsbarely rose in 2019, prompting a call from WIPO Director GeneralFrancis Gurry for a green tech surge to fight climate change.

For its "World IP Day 2020: Innovate for a Green Future" report,the WIPO analyzed international patent filings via its PatentCooperation Treaty (PCT) in four categories of green energytechnologies. These covered:• alternative energy production, notably renewable energy

technologies;• energy conservation technologies;• green transportation; and• nuclear power generation.

The report found that PCT applications – one measure ofinnovative activity – containing at least one IPC green energycode, grew to 16,940 applications in 2019, a 1.3 percent increasefrom 2018. This lags a peak of 17,880 in 2016 and represents justover 6% of the total number of PCT applications filed in 2019.

Further, the report highlighted the fact that overall greeninnovation growth has been hindered by a drop in alternativeenergy technologies, which fell 18% since 2013.

Commenting, Mr Gurry said: “Climate change has far-reachingeffects for all of us and innovation in green tech sectors will be keyto successfully addressing this global challenge. Policymakers,businesses, academic institutions, inventors around the world:Let’s all work together to create a green-tech innovation surgethat meets the requirements of our times.”


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extremely valuable products, and so everypossible related legal issue is intensely litigated,it is also due to the lack of clarity of the keyprovisions of the SPC Regulations.

For example, Article 3(a) of Regulation (EC) No469/2009 requires that “the product is protectedby a basic patent in force”. But how is this to beinterpreted when the “product” is a combinationproduct, and the “basic patent” relates mainly toonly one component of the combination, andthe other component is mentioned only brieflyor indirectly in the claims, or in the descriptiononly, or not at all? One approach would be the“infringement test” – if the product wouldinfringe the patent, then it is “protected by abasic patent in force”. We rather favor this test,but it has been rejected both by the UK Courtsand the ECJ. In the UK, Mr Justice (now LordJustice) Arnold has indicated a preference forthe “inventive advance” test – if the inventiveconcept or technical contribution embodied inthe patent relates to the combination, then Art3(a) is satisfied; if (as in most of the cases whichhave been litigated so far) the inventive conceptrelates to only one component of the combination,then Art 3(a) is not satisfied.

The ECJ has endorsed neither of these twotests. In the case of combination products, itruled in Daiichi C-6/11 (one of the “MedevaQuintet” of cases) that an SPC cannot be grantedrelating to “active ingredients which are notidentified in the wording of the claims of thebasic patent”. But this ducked the question ofwhat “identified” means. It did not help that inthe Medeva C322/10 itself, the term “specified”was used instead of “identified”. Clarity as to themeaning of identified/specified was hoped for,but not provided, in HGS/Lilly C-493-12, whichruled that the requirement is that the claims ofthe patent, “interpreted inter alia in the light ofthe description of the invention, … relate,implicitly but necessarily and specifically, to theactive ingredient in question”. What is to beunderstood by “necessarily and specifically” as amodifier for “implicitly” is a question borderingon the theological.

The argument for the “inventive advance” testwas set out in the decision of Arnold J in Teva vGilead [2017] EWHC 13 (Pat), in which he referredto the ECJ the question “What are the criteria for

deciding whether ‘the product is protected by abasic patent in force’ in Article 3(a) of the SPCRegulation?” The answer forthcoming from theECJ continued to fail to elucidate – the rulingstated “the combination of those activeingredients must necessarily, in the light of thedescription and drawings of that patent, fallunder the invention covered by that patent” and“each of those active ingredients must bespecifically identifiable, in the light of all theinformation disclosed by that patent.”

It is clear from repeated referrals of similarquestions to ECJ that UK judges are frustratedby repeated lack of clear answers from the EU

The UKGovernmenthas statedthat it willnot extendthetransitionperiod.

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RésumésDarren SmythDarren is a Partner and Head of EIP’s Elements practice group. Withover 20 years of experience in private practice. Darren has wide-rangingIP expertise, including patents, supplementary protection certificatesand registered designs.

Gareth ProbertGareth is highly skilled in contentious IP having represented clients inmore than 250 Opposition and Appeal hearings at all levels of the EPO.For the last 10 years, Gareth has held senior positions at two leading IPfirms including Head of MedTech.


Supplementary protection certificates(SPCs) occupy a unique position amongstintellectual property rights. The legal basis

for granting them lies in a number of EU Regulations(469/2009 in respect of pharmaceutical andveterinary products, and 1610/96 in respect ofplant protection products), but they are appliedfor, examined, and granted nationally by theintellectual property office of each EU memberstate. SPCs provide a further period of protectionof up to five years after the expiry of an underlyingpatent where a pharmaceutical, veterinary oragrochemical product is subject to receivingregulatory authorization, to compensate (at leastin part) for the time when the patent could notbe exploited because of the need to obtainregulatory authorization.

SPC practice after BrexitDuring the present transition period, EU lawcontinues to apply unchanged. The transition periodis scheduled to expire on 31 December 2020.While it can be extended by up to two years, anysuch extension must be agreed before 1 July 2020.The UK Government has stated that it will notextend the transition period. Nevertheless, theUK policy on this could change. It is advisable toplan on the basis that the transition period will

expire on 31 December 2020, but in July this willbe known with reasonable certainty.

After the end of the transition period, EURegulations, including those relating to SPCs,continue in effect in the UK as “retained EU law”(pursuant to Section 3 of the European Union(Withdrawal) Act 2018), and so the legal basis forthe continued validity of existing SPCs, as wellas the granting of new ones, will remain. Thenecessary amendments for the EU texts to applyas UK law have already been made in thePatents (Amendment) (EU Exit) Regulations 2019.Accordingly, the UK IPO will continue to examineand grant applications exactly as before. Interms of the mechanics of securing an SPC forthe UK, virtually nothing will change.

Of course, while the retained EU law is thestarting point for SPC legislation in the UK, thereis nothing to stop the UK developing the lawfurther – the freedom to do so is arguably thewhole point of leaving the EU. However, atpresent there are no indications of any intent tochange the statutory law.

SPC case law after BrexitThe interpretation of the law is, however, adifferent matter. Whilst cast in deceptivelysimple terms, the SPC Regulations are, in reality,rather unclear, and are ambiguous as to theirinterpretation in all but the simplest cases. SPCshave been the subject of a large number ofreferrals to the European Court of Justice (ECJ).While this is in part because SPCs often protect

Supplementary ProtectionCertificates in the UK –what happens after Brexit?

Darren Smyth and Gareth Probert, Partners at EIP, look at where the UK’sdecision to exit the EU leaves SPCs.

Darren Smyth

Gareth Probert

SPCs


[email protected]@eip.com

SPCs


court. The interpretation of Article 3(a) is onlyone issue among many. For example, theNeurim C-130/11 decision introduced a newlevel of uncertainty into the provision of Article3(c) “the product has not already been the subjectof a certificate”. This may have benefitted Neurim,but now leaves the scope of Article 3(c) unclear.

The European Union (Withdrawal) Act 2018provides in section 6 that a court at appellatelevel or above is not bound by retained EU caselaw (pre-Brexit decisions of the ECJ) and candepart from it on the same criteria as departingfrom its own case law. This therefore opens upthe possibility of the existing SPC laws beinginterpreted in a clearer manner in the UK infuture. This would not be expected to be in theform of a sudden change, but rather as amanaged divergence taking place over time.

Where might the case law head?SPCs for medical devices?One area where the UK may decide to divergefrom the EU relates to medical devices whichincorporate a drug. Currently, such drug/deviceproducts are subject to regulatory approval either as a medicinal product (under Directive2001/83/EC), or as a medical device (underDirective 93/42/EC, which is being progressivelyreplaced by the Medical Device Regulation). Theroute depends on the function and therapeuticeffect of the drug and device product. If thedevice incorporates a substance which has anaction ancillary to that of the device, then theproduct is regulated as a medical device ratherthan a medicinal product.

The ECJ has previously ruled that BostonScientific’s TAXUS coronary stent (which elutedthe drug paclitaxel in situ to prevent restenosis)was not eligible for SPC protection as it hadbeen authorized under Directive 93/42/EC as amedical device, rather than under Directive2001/83/EC as a medicinal product. Boston hadargued that SPC protection should be allowedas the drug component of the stent hadundergone an equivalent procedure to themedicinal product regulation process.

Arguably, manufacturers of drug/devicecombinations should be allowed to obtain SPCprotection as compensation for the time neededto obtain regulatory approval of these products.In future, the UK may be persuaded to divergefrom the previous rulings of the ECJ and allowSPC protection in order to encourage innovationin these healthcare products.

Implementation of theinfringement test?As mentioned above, the criteria for whether aproduct is “protected by a patent” under EUjurisprudence remain unclear after many referrals

to the ECJ. The only meaning that “protected”can have that refers to an established concept inpatent law is whether the product wouldconstitute an infringement of the patent – i.e. the“infringement test”. While the infringement testhas not found favour in the UK, this is arguablyonly because UK courts were trying to followprior ECJ decisions that made it clear thatinfringement alone was not sufficient,“something more” was required (as stated byArnold J in Teva v Gilead). If not obliged to followthe dicta of the ECJ, to the extent that they caneven be interpreted, it might be possible for UKcourts to start again from first principles andconsider the merits of the infringement test. Thiswould greatly simplify SPC law, to the benefitboth of the rights holders and those seeking toavoid infringement.

The SPC Waiver LawIn May 2019 the EU adopted Regulation 469/2009introducing the so-called “SPC Waiver”. In essencethis provides that an SPC is not infringed bymanufacture within an EU member state of productfor export outside the EU. It also allows stockpilingof product within the EU up to six months beforethe SPC expires, so that the product can bemarketed within the EU immediately upon expiry.As this Regulation came after the Patents(Amendment) (EU Exit) Regulations 2019, thereis currently no provision for the EU Regulation tooperate in the UK as retained EU law after theend of the transition period.

This is an area where the UK may wish tolegislate to take an approach different from theEU. The EU law favors generic manufacturersand enables them to get to market more quicklyand is designed to make the EU more attractiveas a location for production facilities for genericproducts. While it is possible that the UK maywish to mirror this approach, it is also possible thatthe UK may instead decide to pursue a coursethat is more favorable to originator companies.The UK IPO ran a consultation on how the EU lawshould be modified for the UK in July/August2019, and the resulting legislation is now beingconsidered. The form of this legislation is nowawaited. Current indications are that the EUapproach will be followed so that the UK law willclosely match the current EU Regulation.

Conclusion Overall, it will be largely business as usual forSPCs in the UK after Brexit, despite the complexinterplay between EU and national law thatunderpins the SPC system. Some developmentsin case law and in relation to the SPC waiversystem may be expected.

SPCs havebeen thesubject of a largenumber ofreferrals totheEuropeanCourt ofJustice.

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B. Pre-appeal considerationsNot every patent application eligible for anappeal under the statute and rules is necessarilyready for an appeal. To determine whether anappeal to the PTAB is the best route to follow, anumber of factors need to be evaluated. Also, inmaking this decision, use of modern patentprosecution data analytics that set forth theexaminer’s track record during prosecution andat the PTAB should be considered.

i. Appealable or petitionable issueA rough rule of thumb is that a rejection ofclaims is to be appealed to the PTAB whileobjections and procedural requirements aresubject to petition.

Common situations where a practitioner findsit necessary to file a petition to overturn anexaminer’s action include when an examinermakes a restriction requirement final or refusesto enter an amendment or an affidavit after a

RésumésWilliam SmithWilliam is a former Administrative PatentJudge at the USPTO.

Noel Courage Noel is a Canadian patent attorney andUS patent agent.

It ispossible foran applicantto feel like it is on atreadmill.

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Patent prosecution in the USPTO tends toproceed to final Office Action morequickly than in other jurisdictions, such as

the European Patent Office and the CanadianPatent Office. In the US, additional rounds ofargument can be bought by paying a fee andfiling a request for continued examination or acontinuation application. In that type of system,it is possible for an applicant to feel like it is on atreadmill, where the miles and fees accumulatewithout forward progress.

Applicants are often reluctant to give up claimscope, so patent attorneys regularly providecounsel on appropriate compromise. Othertimes, some USPTO examiners may be hesitantto indicate allowable subject matter where theyshould do so. A case may also raise difficult legalor technical issues. Where the applicant isrealistically entitled to a patent, but not makingprogress, it may be helpful to seek guidancefrom the Patent Trial and Appeal Board (PTAB)to change the examiner’s mind. Every applicantwhose claims have been twice rejected mayappeal the examiner's decision to the PTAB.

The Board and its internalworkflowTo appeal, the applicant first files a notice ofappeal and fee. Within two months from thedate of the filing of the notice of appeal, theapplicant must file an appeal brief.

Appeals are usually heard by a merits panelof at least three members of the Board. Typically,the panel will consist of Administrative PatentJudges (APJ). Panels are typically assigned on arandom basis, but an attempt is made to matchAPJs’ technical background with the technologyunder review in the appeal. However, there is noguarantee that the APJs assigned to the panelwill have any particular knowledge about the

involved technology. This should be kept in mindif you write an Appeal Brief.

The pre-appeal briefIf there is a clear deficiency in the prima faciecase in support of a rejection, then the pre-appealprocess is worth considering. Any applicant whohas filed a notice of appeal has the opportunityto concurrently file a pre-appeal brief (maximumfive pages). The pre-appeal brief provides anopportunity for matters on appeal to be reviewedby your examiner along with two other examiners.The pre-appeal process is completed prior tothe deadline for filing of an appeal brief. Thegoals of the pre-appeal process are (1) to identifyany clearly improper rejections based on factualerrors, and (2) to identify the omission orpresence of essential elements to establish aprima facie rejection.

This can be a helpful process if there is a clearlegal or factual deficiency in the rejections. Theconventional appeal process is more appropriatewhere there is an issue regarding aninterpretation of the claims or prior art teachings.A shortcoming, from an applicant’s point of view,is that if the pre-appeal brief is deemed notpersuasive, the case is sent for full appealwithout consultation with the applicant’s patentattorney and without providing further reasons.

Pre-appeal considerationsA. Which cases will likely need an appealCases involving the following issues mostcommonly require an appeal:• Subject matter eligibility (§ 101) such as

business methods, software-enabledprocesses and diagnostic methods.

• Significant legal issues involvingdeclarations (eg. 37 CFR § 1.131 and § 132).

• Obviousness issues (§ 103).

Strategic considerationswhen deciding whetherto appeal in the USPTO

William Smith of Adam R. Stephenson Ltd and Noel Courage of Bereskin & Parr discuss how to decide if your applicant’s case is ready for appeal, and if that would be the best strategy decision.

William Smith

Noel Courage

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perilous to RCE or refile the application with claimamendments unless there is a clear need toamend or present evidence. Doing so withoutsome assurance that this will be convincing tothe examiner could create needless estoppels.Thus, guidance from the PTAB in all likelihoodwill be needed before an examiner removes arejection.

Also, in advising a client on how to proceed,the timeliness of receiving a Board decision mustbe considered. The majority of cases receivedat the Board at this time that are in proper formare being decided within one to two years of theDocket Notice being mailed. Board statistics asto pendency and outcome are available at theBoard’s web page at the USPTO web site. Thus,the applicant should carefully consider whetheran appeal is the better path to pursue ratherthan file a continuation or RCE. With the appeal,you will receive an appeal conference and, ifneeded, a decision by the Board. Even if your caseis reopened after the appeal conference, youwill have moved the case forward because ofthe appeal conferee’s input. It is not clear thatmost examiners realistically review the extantrejections anew in a continuation or RCE asthere is no input from an appeal conferee at thatstage. Also, a Board reversal will result in patent

term adjustment. If the appeal does not go inthe applicant’s favor, there is the option toappeal to court or to reopen prosecution withthe examiner by filing a continuation application.

SummaryAppeals are a very useful tool to move forwarda case that is caught on the prosecution treadmill.If an applicant has made good use of examinerinterviews and written responses to rebut theexaminer’s case, then the appeal process mayprovide the most efficient next step to obtain apatent.

Appeals are a veryuseful toolto moveforward acase that is caught on theprosecutiontreadmill.

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ContactWilliam Smith, Registered Patent Attorney,Adam R. Stephenson, Ltd.Scottsdale, Arizona(480) 264-6075 [email protected]

Noel Courage, Partner, Bereskin & Parr LLPToronto416 957 [email protected]

5 http://www.uspto.gov/

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USPTO APPEALS


final rejection. Another situation that is subjectto petition, not appeal, is when the examinermakes a premature final rejection. A petitionablematter cannot be argued in an Appeal Brief.

ii. Claim scopeThe state of the overall record including thescope of the claims needs to be considered priorto seeking review of the examiner’s adversedecision. The first step should be a thoroughreview of the existing claims, to come to anunderstanding how they will be construedunder the legal standard appropriate for claimspending before the USPTO.

It may come as a surprise how broadly a claimwill be read by a patent examiner and/or a PTABmerits panel. Claims are given their broadestreasonable interpretation (“BRI”) consistent withthe specification1. This is a different standardthan the “plain and ordinary standard” used by District Courts when construing claims inlitigation2. Don’t lock in on the examiner’sobjections when considering claims. A significantnumber of patent applications contain rejectionswhere the examiner has not construed all of theclaims properly or in detail. It behooves thepractitioner to take a step back and determinejust how broad the claims are under the BRIstandard. Once a Notice of Appeal has beenfiled, the opportunity to amend the claims islimited.

The fact that appellants can point to definitionsor usages that conform to their interpretationdoes not make the PTO's definition unreasonablewhen the PTO can point to other sources thatsupport its interpretation3. While Morris statesthat a claim will be interpreted in view ofwhatever enlightenment there may be in thespecification, the PTO will be looking first at thewords in the claims and second for expressdefinitions in the specification. The PTO isunlikely to give a claim a nuanced meaningbased upon other disclosure in the specification.Since an argument based upon a nuancedmeaning will in all likelihood create a prosecutionhistory estoppel on the issue, it is best to workwith the examiner, starting early in prosecution,to arrive at claim language that meets everyone’sneeds. Examiner interviews can be invaluable toresolve impasses4. If the examiner provides aclaim construction you disagree with, your taskis two-fold, whether the case is at a pre-appealstage or on appeal. First, you must explain whythe examiner’s construction is unreasonableand, second, provide your own constructionbased upon the principles set forth in Morris.

iii. EvidenceIf it is determined that the claims are of thecorrect scope, a review of the record should be

undertaken to ensure all evidence to be reliedupon in the appeal has been properly enteredand considered by the examiner as theopportunity to present additional evidence oncethe Notice of Appeal has been filed is also limited.Silence on the part of the examiner does not mean the evidence has been entered.Consideration of the entered evidence by theexaminer must also be apparent on the record.Review the electronic record at the PTO andmake sure all evidence is showing. If evidenceis acknowledged by the examiner but notdiscussed in any meaningful way, applicantshould insist by way of response that theexaminer set forth on the record a reasonedexplanation why the evidence is not persuasive.Cases forwarded to the PTAB where theexaminer is silent in regard to record evidencewill, in most cases, result in a remand with theaccompanying delay in the merits decision.

iv. References of recordPrior to deciding that an appeal is the appropriateaction to take, each reference of record, whetherrelied upon by the examiner or not, should beconsidered in light of at least each claim to beseparately argued. Relevant prior art is often ofrecord but has not been relied upon by theexaminer. A substantial number of remands andnew grounds of rejection entered by meritspanels are based upon prior art of record notrelied upon by the examiner.

v. Non-English language documentsAlso be aware that, if the examiner has reliedupon a document in a language other thanEnglish, the examiner is required to obtain a fulltext translation of the document prior to thecase being forwarded to the Board. A completetranslation of any document that the attorney orthe examiner rely upon should be obtained assoon as practicable, so the relevant facts are ofrecord. The same considerations apply toabstracts of a document being relied upon asevidence by either the examiner or counsel.Most times, the full text or fully translateddocument makes the examiner’s case significantlystronger or weaker. If the more complete set offacts had been considered earlier in the case, anappeal may not have been needed.

vi. Appeal, RCE, or abandonSometimes it is difficult to evaluate the truestrength of the examiner’s position becauseexaminers (particularly new examiners) may notclearly articulate the basis of a rejection. Despiteinterviewing the examiner and/or the supervisor, aclear understanding of the rejection may not bepossible. It is difficult to advise a client to abandonthe application under these circumstances. It is

Silence onthe part of theexaminerdoes notmean theevidencehas beenentered.

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1 This standard applied by the

USPTO has recently been

upheld for both prosecution

and for most inter partes

review in Cuozzo Speed

Technologies, LLC v. Lee.

(2016) 136 S. Ct. 2131 (USSC). 2 Phillips v. AWH Corp., 415 F.3d

1303 (Fed. Cir. 2005). The

Phillips standard is also used

by the ITC. Robert H. Resis

and Benjamin Koopferstock.

“Supreme Court Confirms

Broadest Reasonable

Interpretation Allowed in

Inter Partes Review and

Limits Review of Institution

Decisions.” ABA Landslide,

Vol. 9, No. 3,

January/February 2017.3 In re Morris, 127 F.3d 1048, 10

(Fed. Cir. 1997) at 1056-57.4 Consider the potential

benefit of processes that

may provide an additional

interview opportunity, such

as the After Final

Consideration Pilot, currently

extended through

September 20, 2020.


mailto:william%40iptech.law?subject=

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Matthew Raynor of Bristows LLP examines Lord Justice Arnold’s recentcomments in FibroGen v Akebia regarding the Medimmune approach to theinstruction of experts in UK patent cases.

On 20 April 2020, Arnold LJ (sitting as aHigh Court judge) handed down acomprehensive 640 paragraph judgment

in FibroGen v Akebia [2020] EWHC 866 (Pat). Aswell as dealing with a multitude of case-specificissues, the judgment also contains a number ofmore general practice points (and warnings)which are likely to be of interest to UK patentpractitioners.

First, the judge re-iterated the warning hegave in Medimmune v Novartis [2011] EWHC 1669(Pat) that lawyers should ensure their experts Matthew Raynor

RésuméMatthew RaynorMatthew specializes in intellectualproperty litigation with a particular focus on patent litigation in the techsector. He has handled cases in thetelecommunications, computer hardwareand software, virtual reality, inertialnavigation, and LED lighting sectors,including SEP litigation and FRANDissues, licensing strategy, freedom tooperate advice and patent validityanalysis. Matthew has a physics degreeand finds his scientific backgroundinvaluable for understanding thecomplex technical issues that underliemany intellectual property disputes.

FibroGen v Akebia – doLord Justice Arnold’srecent comments signifya change in approach toinstruction of experts?

Bristows_TPL48_v3:Layout 1 24/6/20 13:26 Page 19

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(and non-infringement) arguments wererejected by the judge in their entirety.

There are more examples in the case law ofexperts being criticized for using hindsight byvirtue of the manner in which they are instructed- see for example Starsight Inc v Virgin Media[2014] EWHC 828 (Pat) at [131] and AmericanScience v Rapiscan [2016] EWHC 756 (Pat) at[109] to [111]. By contrast, in Rovi v Virgin Media[2014] EWHC 1559 (Pat), Mann J did not considerthe fact that Virgin’s expert had been shown thepatent before the prior art to be a relevantcriticism on the facts of the case, the judgeobserving that “I am not sure what he would havebeen able to contribute had he been shown theprior art with no real context against which toconsider it”.

Interested readers can review a report of aseminar hosted by LSE in March 20181 at whichthis issue was further debated. Of note wasArnold J’s opinion that the courts are highlydependent on high quality expert evidence andthat parties should therefore want to amelioratepotential weaknesses such as hindsight bias asmuch as possible. Birss J suggested a note ofcaution however that if blinding is to be used,double blinding may be needed (i.e. the expertmust not know which side they are instructedby), the judges may also need to be blinded,and the difference in skill between the expertand the skilled person may need to beconsidered.

Although it is clear from the case law thatnon-adherence to the Medimmune approach is not necessarily fatal, the fundamentalimportance of expert evidence in UK patentproceedings means that parties have felt to datethat they are potentially taking a risk if they donot follow the dance steps when it might laterbe said that they could have done so.

The decision in FibroGenIn FibroGen, the defendants’ expert, Prof Haase,was accused of using hindsight in reaching hisconclusion that the claims were obvious becausehe had been shown the PCT application for thepatent before the prior art. The defendants justifiedtheir approach on the basis that obviousnesswas not in issue when Prof Haase was firstapproached and Prof Haase needed the PCTapplication in order to identify the skilled teamto which the patent is addressed.

In addressing this criticism, Arnold LJcommented that the submission illustrates whyit can be advantageous to instruct expertwitnesses using the sequential unmaskingapproach, and re-iterated his view that it wasdesirable to minimize hindsight on the part ofthe expert where possible. However, he alsoconfirmed that there was “no rule or principle

that experts must be instructed sequentially” andthat “there are often real practical problems indoing so”. He then gave examples of suchproblems, including:- how does one identify the skilled person in

order to establish the common generalknowledge without showing the expert thepatent?

- how does the expert put his pre-existingknowledge out of his head whenconsidering the prior art? What happens ifnew prior art is subsequently introduced? He noted that even if an expert is instructed

in sequence, it is often difficult for them to recallwhat they knew when, unless it is clearlydocumented.

In this case, Arnold LJ noted that because ProfHaase had prior knowledge of the subjectmatter of the invention, it would not have beenpossible to instruct him in a way which was freefrom hindsight. He therefore did not criticize themanner in which he was instructed but acceptedthat it should be taken into account in assessmentof his evidence. Ultimately, the defendants’obviousness attack failed although this did notappear to turn expressly on the manner in whichProf Haase had been instructed.

Where does this leavepractitioners?The FibroGen decision is helpful to practitionersin that it confirms the Medimmune approach isnot a rule that must always be followed andrecognizes the inherent difficulties in the approach.However it still leaves open the question ofwhether all other things being equal, the courtwill prefer expert evidence which has beenobtained following the Medimmune approach(or at least, be in a position to use such adisparity of approach as support for a findingleaning one way or the other). Practitioners areunder increasing pressure from the courts tokeep costs proportionate, and from clients tokeep costs to a minimum. In circumstances wherethe stakes are high, the judge’s comments inFibroGen may perhaps still leave them with adifficult decision to resolve.

TheMedimmuneapproachhas becomegenerallyacceptedpractice.

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ContactBristows LLP100 Victoria Embankment, London EC4Y [email protected]

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disclose their own relevant publications and,where appropriate, explain them in their report.The expert’s CV should also be included.

He also re-iterated the warning he gave inMSD v Shionogi [2016] EWHC 2989 (Pat) regardingpersonal attacks on witnesses during cross-examination, as in this case, counsel had allegedlycontinued to berate the witness for a page of thetranscript regarding whether some papers referredto in his report had been supplied to him by hisinstructing lawyers, in circumstances where theexpert had already provided a response, andwithout any basis to doubt his previousresponse.

It was, however, the judge’s comments on“sequential unmasking”, which grabbed thisreader’s attention; the process of instructing anexpert in a particular order to minimize hindsightbias – first asking about the common generalknowledge, next showing the expert the priorart and asking questions such as what stepswould be obvious in light of that art, and onlythen showing them the patent in suit. This practicewas first commended by Mr Justice Arnold (ashe then was) in Medimmune v Novartis and issometimes referred to as the “Medimmuneapproach”.

Practitioners will be familiar with the practicaldifficulties of the Medimmune approach. Discussingthe common general knowledge and the priorart (and obvious developments therefrom), andonly then the patent, and documenting the expert’sviews at each stage, is a very time consumingand expensive process, especially where it isnecessary to speak to a number of potentialexperts to find someone appropriate to supportthe case. The staged approach is also only as“sterile” as the explanation of the problem whichthe expert is being asked to solve from thecommon general knowledge; phrasing thatquestion without suggesting an avenue whichleads to the patent is in itself not easy.

There is, therefore, a lively debate as to thebenefits and disadvantages of the Medimmuneapproach. In the absence of a clear judicialconsensus, and with large sums of money atstake and the arguments often finely balanced,the Medimmune approach has becomegenerally accepted practice amongst patentpractitioners, who simply cannot afford to takethe risk that their expert’s evidence is ultimatelygiven less weight as a result of the way in whichthey were instructed.

In this recent decision, Arnold LJ takes theopportunity to clarify his views on instruction ofexperts. In particular, he confirms there is no rulethat experts should be instructed using theMedimmune approach and acknowledges thatthere are often real practical problems in doingso. The question for practitioners is, though, do

the comments go far enough to make it safe forparties to abandon the rather cumbersomeexercise generally?

BackgroundThe Medimmune approach became generallyaccepted practice following Mr Justice Arnold’scomments in Medimmune v Novartis, handeddown in July 2011. In that case, he said thatinstructing the expert in sequence was “… thecorrect way for those instructing [the expert] toproceed...” and commented that it wasunfortunate that the expert’s report was notdrafted in a manner which reflected the opinionshe expressed at each stage of the assessment.These comments are the reason why manyexpert reports today are laid out in an orderwhich reflects the Medimmune approach.

In HTC v Gemalto [2013] EWHC 1876 (Pat)handed down in July 2013, Mr Justice Birssappeared to take a somewhat different view. Hesuggested the Medimmune approach was not aconcrete rule, although it had been useful in theparticular context of that case. What matteredwas the reasons for the expert’s opinion and notthe opinion itself, as the expert is not arepresentative of the skilled person and theirreport is not a test to see what the skilled personwould do before being handed the patent(otherwise the parties may have to disclose theresults of similar tests they had carried out withother experts, which would add enormous costand complexity to patents cases). He alsorecognized that many lawyers are highly skilledin presenting information to an expert which,consciously or subconsciously, has the effect ofleading the expert to the conclusion sought,which is capable of giving a false impression.

Whilst the court’s view in Gemalto providedhelpful guidance that the Medimmune approachwas not mandatory, the potentially devastatingconsequences of not following the Medimmuneapproach were highlighted in HTC v Nokia [2013]EWHC 3247 (Pat) - where HTC’s expert evidencewas strongly criticized because of the way theexpert was instructed. In paragraph [5] of thejudgment, the judge noted:

“Furthermore, it became apparent that he hadbeen instructed in a manner which wascalculated to induce hindsight. Initially he wasprovided with the Patent and some prior art. Tobegin with, he focused on the Patent and wrotea critique of it which he accepted accentuatedthe negative over the positive. Only subsequentlydid he focus on the prior art, but even then heunderstood from his instructions that he wasonly to consider parts of Itakura. As a result, heonly considered the document as a whole acouple of weeks before trial...”

It is perhaps unsurprising that HTC’s invalidity

There is norule thatexpertsshould beinstructedusing theMedimmuneapproach.

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with the possibility of termination at the end ofeach stage of the project would focus attentionon the full range of legal mechanisms availableto ensure a fair and viable return on investment(whether through money or "sweat equity"). As inany commercial joint venture, the best time todiscuss, define and agree a fair exit strategy foreach party is at the beginning of the process,while relationships are fresh and cordial. Jointventures tend to fail, either at the outset or whentensions subsequently emerge, where thedifficult questions relating to exit strategies areeither not addressed or are fudged.

Brexit – an opportunity to revisit and revitalise innovationpartnerships?With the UK officially out of the EU but remainingwithin the transition period at least until 31 December 2020, and in light of the currentCOVID-19 pandemic, there is a window ofopportunity to revisit these EU-derived rulesand reignite the drive for innovation in the UK. Ifbleak projections of a global recession postCOVID-19 are realised, then there would be astrong incentive to fuel and support up start-upsand to incentivise innovation. Using public fundsto invest in these innovative solutions could be integral to the rebuilding of the economy.Rethinking the rules on innovation partnerships,so that they might fulfil their potential as anengine of growth, might be a crucial contributionto that process.

Viable exit strategies might be purely contractual,or in some cases might involve approachessuch as joint applications and co-ownership ofpatents or other intellectual property rights.Licensing might also provide a viable basis forcollaboration. While there might be strongresistance (often cost-based) to the front-loadingof negotiations to negotiate and put in placeagreed forms of licence, revenue or profit sharearrangements to cover future commercialisation,those early steps can in practice make thedifference between success and failure. Forexample, private or academic sector participantsmight agree to grant licences to the contractingauthorities, enabling them to use the partners'intellectual property as a key component of subsequent stages. Expressly negotiatedprovisions will then act as safeguards for boththe partners and the contracting authority.Partners will have security in knowing that theystill own their intellectual property andcontracting authorities will have security inknowing that their funds will be used for thepurposes they intended.

An alternative would be for the public sectorparty to issue licences for a limited time period.If the private sector body do not make use of the

licence during that time period and it expires,they will have to purchase the licence from thepublic sector body.

The options mentioned above used alongsideearlier negotiations and ensuring exit strategiesare fully planned out must all be hemmed intothe rules of innovation partnerships. If Brexit doesgive the opportunity for the rules to be revisited,this should be done with the key targets ofinnovation partnerships in mind:

• Increasing competitiveness • Diversifying the range of innovation

projects• Bridging the gap between the private and

public sectorNew and emerging technologies might

themselves be enlisted to assist in the processof tracking and fairly rewarding contributionsmade at each stage of development, and by arange of stakeholders. For example, blockchainand distributed ledger technologies derivedfrom or related to the architecture of Bitcoin andother cryptocurrencies are being used totokenise and track other forms of property,custody, or value. Related technologies such as"smart", "data-driven", or "connected" contractsare also being applied to trigger payments toreflect contributions or entitlement to value. Inparticular, blockchain permits the creation ofhighly secure and "tamper-evident" records ofvalue to be created and made available tostakeholders, with "smart" contracts permittingthe distribution of value at any scale from "micro"payments representing small fractions of apenny or cent to the settlement of high valuefinancial sector transactions. Application ofthose technologies in the context of pay-per-click targeted advertisements or the tracking ofmusic videos and other online content throughpeer to peer systems surely point the waytowards a viable application in the context ofinnovation partnerships.

Tight restrictions have driven away private andpublic bodies from using innovation partnerships.Arguably, expressly addressing the vexed questionof exit strategies, and recognising the value-tracking potential of blockchain, distributedledger and related technologies wouldreinvigorate the model, opening up new pathsand solutions to the problem of post COVID-19economic recovery.

Using publicfunds toinvest intheseinnovativesolutionscould beintegral to therebuildingof theeconomy.

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ContactWomble Bond Dickinson (UK) LLP [email protected] 02380 208 428

[email protected]

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RésumésMalcolm DowdenMalcolm is a Legal Director attransatlantic law firm Womble BondDickinson, and is the author of theEU/UK chapter in the American BarAssociation's new book The Law ofArtificial Intelligence and Smart Machines.

Moga MoodleyMoga Moodley is a paralegal at WombleBond Dickinson and co-author of “Whydo ‘innovation partnerships’ fail?”.

Caninnovationpartnershipsbe made towork?

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In 2017, Transatlantic law firm Womble BondDickinson published Close Encounters: thepower of collaborative innovation. That initial

report focused on the organizational and culturalchallenges facing large commercial organizationswhen seeking to innovate, including the frequenttensions between corporate decision-making,agile development and risk-taking. Internalprojects often failed as they fell into the abyssof committees, while attempts to buy innovationthrough the acquisition of start-ups or universityspin-out companies often stifled or crushed thetarget's culture of innovation. Research anddiscussions following publication of the initialreport disclosed similar structural and culturalissues affecting government and public sectorbodies, for example in relation to "smart city"projects, and focused attention on the low take-upand poor success rate of "innovation partnerships"in the five years since their introduction. Thepressing need for economic recovery in light ofthe COVID-19 crisis adds urgency to thequestion: what are the barriers to success, andcan innovation partnerships be made to work?

What are innovation partnerships?Innovation Partnerships were introduced intopublic procurement law by the publication of

Directive 2014/24/EU. Their objective was todiversify public procurement methods and to permit the application of public funds andmarket-scale purchasing power to drive thedevelopment, commercialisation and scaling-up of new technologies and applications.Specifically, Article 31 of the Directive states thatthe "process can be used when no market solutionsexist and when research and development (R&D)is required to provide a solution to meet anagency's needs".

Innovation partnerships are a potentiallypowerful tool, but in practice success has beenlimited by their structural makeup. Innovationpartnerships are required to define and map outspecific stages, with precise deliverables and deadlines. Crucially, the structure permitscontracting authorities to terminate private andacademic sector participants' contracts at theend of each stage of development. Referred toas “necessary market-pull” in Recital 49 of thedirective, termination is meant to "incentivise thedevelopment of an innovation solution withoutforeclosing the market". In practice, the risk oftermination, and of the associated requirementsthat enable the contracting authority to proceedto subsequent stages of development, possiblywith rival developers, creates a material risk forprivate sector participants. One result is that, inan attempt to create some level of security,public, private and academic sector parties tendto argue for retention of full intellectual propertyrights during and after the innovation partnershipprocess. Inevitably, negotiations tend to breakdown at this point as consensus is rarely reachedon the appropriate allocation of ownership anduse rights.

Properly structured, Innovation Partnershipscould be an effective way of increasing innovation.They provide a legitimate route through whichpublic funds and purchasing power might beused to facilitate and promote innovation thatwould otherwise remain merely conceptual orunderfunded. Early and constructive engagement

Why do "innovationpartnerships" fail?

Malcolm Dowden and Moga Moodley of Womble Bond Dickinson (UK) LLPdiscuss how innovation partnerships could be revitalized, particularly in lightof the challenges posed by Brexit and any post-COVID economic recovery.

Malcolm Dowden

Moga Moodley

INNOVATION PARTNERSHIPS

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the total number of patents held in the USoverall, over 90% are held by men.

Heather Metcalf, Chief Research Officer of theAssociation for Women in Science, spoke aboutsystemic bias and how this becomes embeddedin our workplace thinking. She also examinedthe complex range of reasons why so manyfemale STEM graduates take jobs elsewhere,and highlighted the fact that direct harassment,such as that directed towards LGBTQ people,remains depressingly widespread.

Lindsey Zuloaga, Director of Data Science atHireVue, talked about systemic bias and abouthow algorithms, regardless of whether they havebeen programmed with the best of intentions,so often discriminate against minorities becausethey have not been "trained" using sufficientlydiverse data – arguably an entirely predictableresult of an overwhelming majority of softwareprogrammers being white men.

A highlight of Day Two was the discussion “Willtrademarks survive the rise of the machines?”. Theanswer, according to Lou Perry, Partner at FaegreDrinker Biddle & Reath LLP, is “yes, but it willcertainly be an interesting journey”. Under debatewas whether the concept of a trademark as abrand identifier really means all that much in anage when products are so often selected for usby Amazon algorithms et al based on customerprofiling data and purchase histories. In the 21stcentury, would it not make more sense toconsider whether potentially infringing products

might cause confusion not just for us flesh-and-blood consumers, but also for AIs? After all,reasoned Michael K. Friedland, Partner atKnobbe Martens, US trademark law does notspecify that an actual “person” might bedeceived by an infringing product, although thediscussion conceded that the relevant case lawdoes indeed take this as a given. That said, therehave already been some important decisions onthis topic, and while it seems that, for example,Amazon product searches that direct aconsumer away from one trademarked brand toanother do not, in themselves, infringe upon anytrademark, the risk that online retailers may endfulfil orders with counterfeit products remainsvery real.

The issue of risk, this time of copyrightinfringement, was further discussed in “AI isbeing trained using human creative output. Is thatfair?” which looked at copyright's role in theFourth Industrial Revolution where the training ofAI to do anything from driving cars to providingsearch tools that scan the contents of millionsof books necessarily involves the ingestion bythat AI of vast quantities of copyrighted material.Lauryn Guttenplan, Deputy General Counsel atthe Smithsonian Institution, Eleanor M. Lackman,Partner at Mitchell Silberberg & Knupp LLP, andNick Aries, Partner at Bird & Bird LLP, askedwhether such input is protected by fair use(where such a doctrine even exists) and whetherthe output, such as a car-driving AI, was similarly

There is, no doubt, a certainattraction in keepingtradesecrets.

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KnowIt 2020became an onlinelive-streamevent.

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In May, The Patent Lawyer was proud to be,with our sister titles, official media partner toKnowIt, a new annual event which aims to

“define intellectual output in a digital world andusher in the Fourth Industrial Revolution” via aprogram of discussions and seminars, attended,hosted, and presented by IP industry leaders, in-house counsel, creators, and many others.

The original plan was for the event to havebeen held in Las Vegas, but, of course, the currentglobal pandemic made this impossible. Instead,KnowIt 2020 became an online live-streamevent, although, as anybody who has spent anytime in Las Vegas can attest, spending time inthe world’s gambling capital, where it’s all too easyto completely lose track of time whilst drinkingto excess, is perhaps not all that different to lifeunder imposed lockdown...

Undeterred by this shift in presentation, KnowItbegan by asking one of the big questions of themoment: “Is intellectual property ready for primetime in the Fourth Industrial Revolution?”

Laura A. Coruzzi, Senior Vice President of IP atREGENXBIO Inc, argued that the continual erosionof the US patent system over the past 30 yearshas undermined innovation, citing specifically theexample of the US Supreme Court’s decision inMyriad Genetics that naturally-occurring humangenes cannot be patent-eligible.

Decisions such as these have, argued Laura,undermined diagnostic infrastructure and put theUS significantly behind the rest of the world,meaning that, sadly, the US has not been asprepared for the COVID-19 outbreak as it oughtto have been.

Agreeing, David J. Kappos, Partner at Cravath,Swaine & Moore LLP, said that when the USgovernment appeared to suggest that it couldtake ownership of any IP arising from vaccinedevelopment, it merely served to further dissuadebiopharma from investing in such research.

Along with David Nimmer of Irell & Manella LLP,Laura and David discussed how some companiesrely upon trade secrets rather than seek patentprotection. The presentation “The Allure of TradeSecrets” discussed this area further, looking atthe pros and cons of going down the “tradesecrets route”. There is, no doubt, a certainattraction in keeping trade secrets; they are, bydefinition, confidential, there are no statutorytime limits to consider, legal costs are reduced,and there is no lengthy application process. Onthe other hand, patents enjoy greater legalprotection in the event of infringement, there islittle a company can do to stop competitorsreverse-engineering its tech if patent protectionis lacking, and, of course, there is the ever-present risk of employees jumping ship andtaking valuable trade secrets with them. Beingable to prove harm in terms of financial andreputational impact in the event of a theft isclearly a key consideration, and Kim R. Jessum,Chief IP Counsel U.S. and Associate GeneralCounsel & Secretary at Heraeus Incorporated,Sheryl Falk, Partner and Co-Lead of Winston’sGlobal Privacy & Data Security at Winston &Strawn LLP, Serge D. Jorgensen, Founding Partnerand CTO of Sylint, and Carl A. Kukkonen, III,Partner at Jones Day, discussed this in detail,emphasizing in particular the critical need tomaintain proper documentation and data security.What emerged, again, is that there is considerabledisquiet regarding the US patent system’s abilityto adequately support innovation and protect IP.

The gender disparity in IP, particularly when itcomes to patent applications from the STEMfields, is something we have looked at in ThePatent Lawyer. Discussion “Closing the GenderGap” dissected the complex interplay of factorsbehind a status quo that sees women gaininghalf of all engineering and science degreesawarded in the US, and yet, when it comes to

KnowIt 2020 –Editor’s report

Matt Seex, Editor of The Patent Lawyer, looks back at a thought-provokingand entertaining three-day live-stream event.

Matt Seex

KNOWIT 2020


For more than 50 years GLP has been offering a complete range ofservices for a structured protection of intellectual property.

Our Clients range from artisans to some of the Top Companies on theForbes 500 list, for whom we provide initial consultancy and support in

lawsuits – both as plaintiff and defendant – throughout the world.

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The commitment of the Group has led toGLP being a top-level European player.

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KNOWIT 2020


protected. The intended purpose of the outputtedresult - whether that result is “transformative” - iskey, although the situation in jurisdictions suchas the EU, where there is no fair use doctrine, ismore complicated.

The third and final day of KnowIt 2020 saw adiscussion on “IP & Comics”, which provided acomprehensive look at the changing face ofcomics distribution over the decades, the impactof digital distribution on the industry, and howmedia licensing, especially for TV and film, hascarried so many well-known characters toimmense worldwide success over the last fewyears. Marc H. Greenberg, Founding Director ofthe IP Law Program at Golden Gate University,and Michael L. Lovitz, Partner at Lovitz IP LawPC, provided some fascinating insight, althoughthis commentator for one was saddened to think

YouTube of its unmanned test rockets explodingin mid-flight) as a means by which true innovationin 21st century space travel can be achieved. Itwas a great way to round off the three-day event.

Of course, the aforementioned discussions werebut a few highlights. From discussing the impactof current patent and copyright case law, to in-depth takes on AI, cybersecurity, privacy, andethics, KnowIt seemed to have every base covered.

All in all, this was an excellent event, and onewhich promises to make an even greater impactin 2021, when, hopefully, attendees and mediapartners alike can meet in person. Wheneverand wherever next year’s event takes place, ThePatent Lawyer hopes to see you there.

RetiredNASAastronautGarrettReismanspoke abouthis amazingexperiencesin space.

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ContactMatt Seex, Editor, The Patent [email protected]

of this still much-underratedartform being seen as a mere“loss leader” for the more lucrativebusiness of movie licensing and merchsales.

KnowIt 2020 went out in style with asupremely entertaining and humbling talk byretired NASA astronaut, and current SeniorAdvisor at Space X, Garrett Reisman, who spokecompellingly about his amazing experiences inspace, the questions people always ask him(which generally boil down to “what was it like?”)and the way in which Space X is celebrating riskand failure (going so far as to post videos on


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AI


invention patent application, either in thephase of drafting the Description/claimsor in the phase of responding to the OA.The definition of the application scenarioswill play a very important role in solvingthe issue of eligibility.

(3) To pay attention to the correlationbetween technical features and non-technical features

In the phase of drafting the Description/claims and the phase of responding to theOA, attention shall be paid to thecorrelation between technical features(e.g., parameters in the applicationscenarios) and non-technical features(algorithms). The correlation between thetechnical features and the non-technicalfeatures is the premise for the examiner to consider the two types of features as awhole. In other words, even if an AI-relatedclaim includes both the technical featuresand the non-technical features, the wholetechnical solution does not reflect thecorrelation between the two types offeatures, and there is still a risk that theclaim is not considered as eligible.

2. Sufficient Disclosure (A26. 3)Since the improvement point of an AI-relatedinvention usually lies in algorithms or software,while an algorithm or software can be appliedto different scenarios, an AI-related inventionshall describe how it is embodied in a specificapplication scenario in addition to the overallapplication scenarios at the initial drafting phaseof the Description. Otherwise, if the Descriptiononly gives less-specific algorithms and genericapplication scenarios, and persons skilled in theart cannot embody or obtain a deterministicresult based on the technical solution recordedin the Description, it will be deemed as the so-called “black box operation”. In case of thissituation, the problem of ‘insufficient disclosure’will be encountered in examination process.

In order to avoid the above problem, thefollowing points shall be focused on during thedrafting phase of the Description:

2.1 Specific application scenariosIf the final purpose of executing the computerprogram is to solve the problem of specificscenario applications, such as improving the userexperience (saving transaction cost, saving time/space distance), improving management platformefficiency (increasing consumption demand,creating a new service mode), etc. , on the onehand, it is necessary to clearly and explicitlystate what better specific scenario applicationeffect the invention can achieve in the Summary

of the Description, and on the other hand, it shalldescribe in detail the specific implementationscapable of obtaining advantageous effectsunder the specific scenario applications in theembodiments.

The specific scenario application must bebased on a certain technical problem, and thetechnical features adopted to solve the technicalproblem shall be interrelated and work togetherwith the algorithm features adopted to solve theproblem of the specific scenario application tocomplete the whole process of the solution,instead of solving the corresponding problemsindividually and being pieced into one solution.

In other words, the technical field, the problemto be solved, the solution, the technical effect,the embodiment, etc. in the Description mustclearly define the problem and effect of thespecific scenario application.

2.2 Essential technical parametersThe core of the invention patent applicationrelated to the AI technology is the solutionrecorded in the Description. The hardware andsoftware environments of the computer recordedin the Description must be sufficient to implementthe algorithm features in the solution. TheDescription shall clearly and completely describethe solution adopted by the invention to solveits technical problem or the problem of the specificscenario application. The solution shall specifythe technical means adopted to solve the aboveproblems, or the mixed means containing boththe technical features and the algorithmfeatures that are interrelated and work togetherwith the technical features.

Specifically, the necessary technicalparameters mentioned here shall include:

(1) The computer hardware and itsconnection.

(2) The complete steps of the computeralgorithm.

(3) The data required by the algorithm(e.g. training data and sampling data).

RésuméJiuliang LIU Jiuliang LIU is a partner and senior patent attorney at Beijing Sanyou IPAgency Ltd., a full-service IP law firm founded in 1986 in Beijing, P.R.China. He specializes in patent prosecution, invalidation, reexamination,administrative and infringement litigation in the field of semiconductor,telecommunication, electronics, and computer systems, etc. Mr LIUworks with organizations with sophisticated technologies across thesemiconductor and wireless communications industries, immerseshimself in their products, business goals, industry, and competitivelandscape. He leverages innovative technologies during every step ofthe patent lifecycle to deliver high quality services in a consistent,timely, and cost-effective manner.

Theproblem ofinsufficientdisclosureis differentfrom otherdefects.

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If a claimincludesbothalgorithmfeatures andtechnicalfeatures, thepossibilityof patentright grantshall not beexcluded.

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In response to the needs of innovators tofurther clarify the examination rules for patentapplications in new industry conditions and new

fields concerning AI, the National IntellectualProperty Administration of China issued anAnnouncement No. 343 on 31 December 2019,which makes more explicit provision for theexamination of invention patent applicationsconcerning AI, “Internet+”, big data, block chains, etc.

In terms of the drafting of such applicationsand the response to the Office Action (OA) thereof,the three issues of major concern are eligibility,sufficient disclosure, and novelty.

1. Patent eligibility 1.1 Relevant provisions of eligibilityThe innovation points of most AI related inventionslie in the improvement of algorithms or software,which decides that the AI-related claims aremostly composed of technical features andnon-technical features (algorithm features). Inthe examination process, if an AI-related claimincludes only non-technical features (algorithmfeatures) while lacking technical features, oralthough it includes both technical features andnon-technical features, a correlation there betweenis absent, the claim may face the challenge ofthe eligibility issue.

In the Chinese Patent Law, the provisionsrelated to the eligibility of the AI patents mainlyinclude whether the features of one claim arethe rules and methods for mental activities(A25.1) and whether those features constitute atechnical solution (A2.2). In accordance with therevised Guidelines for Patent Examination, theexaminer will firstly determine whether the claimsatisfies A25.1, and further determine whetherA2.2 is met after determining that A25.1 issatisfied.

According to A25.1, if a claim includes onlyfeatures related to algorithms and rules for mental

activities, instead of any technical feature, it willprobably be excluded from the subject matterof patent protection (exclusion clause). On theother hand, if a claim includes both algorithmfeatures and technical features, and the claim asa whole is not a rule or method for mentalactivities, the possibility of patent right grantshall not be excluded according to A25.1.

The key point of A2.2 lies in the technicality ofthe solution. The amended Guidelines for PatentExamination explicitly stipulates for A2.2 that “allthe features recorded in one claim shall beconsidered as a whole. If the claim records thattechnical means utilizing natural laws areadopted for the technical problem to be solved,and thus a technical effect conforming to thenatural laws is obtained, the solution defined inthe claim belongs to the technical solutionstipulated in Article 2, paragraph 2 of the ChinesePatent Law”.

1.2 How to avoid the issue of eligibility(1) To avoid claims merely of algorithmsIt shall be ensured that an AI-related claimincludes both non-technical features(algorithms) and technical features, which isa basic premise to meet A25.1. Generallyspeaking, mere algorithms will be probablyexcluded from the subject matter ofprotection in the examination phase.

(2) To reflect application scenarios ofnon-technical features (algorithms)

Since the improvement point of an AI-related invention usually lies in theimprovement of algorithms or software,while an algorithm or software can beapplied to different scenarios to solvedifferent problems, the description of theapplication scenarios is very important toemphasize the technicality of an AI-related

Patentability of AI-relatedinvention patentapplications in China

Jiuliang LIU, partner and senior patent attorney at Beijing Sanyou IP AgencyLtd, discusses AI-related amendments to the Guidelines for PatentExamination in China.

Jiuliang LIU

AI


Beijing Sanyou FP.indd 1 01/06/2020 11:36

ContactBeijing Sanyou Intellectual PropertyAgency Ltd.16th Fl. Block A, Corporate Square,No.35 Jinrong Street, Beijing, 100033ChinaTel: 86-10-88091921,88091922Fax: [email protected]

AI


(4) The correlation between theparameters in the algorithm and variousdata in the application scenario.

If the above two points can be done in thedrafting phase of the Description, the problemof insufficient disclosure will be largely avoided.

The problem of insufficient disclosure is differentfrom other defects (e.g., novelty, inventiveness,and eligibility). Once the problem of insufficientdisclosure is challenged in the examinationprocess, the amendment to the applicationdocument (especially the amendment to thetechnical solution in the Description) is very limiteddue to the strict amendment requirement of theChinese Patent Law. At that time, the applicantwill face an embarrassing situation that thedefect of insufficient disclosure cannot beovercome by the amendment.

3. Novelty & inventiveness (A22.2 & 22.3)

As mentioned above, an AI-related claim usuallyincludes both technical features and non-technicalfeatures (algorithms). The examination requirementson novelty and inventiveness of the AI-relatedinvention can be roughly summarized into thefollowing two points.

3.1 Overall judgmentFor a solution that includes both technical featuresand non-technical features, during the noveltyjudgement, the non-technical features that areinterrelated and work together with the technicalfeatures shall be combined with the technicalfeatures as a whole to judge whether the claimedinvention has novelty relative to a referencedocument.

The algorithm features or business rules andthe method features, which functionally supportand interact with the technical features, shall beconsidered as a whole with the technical features.

The stipulation further emphasizes the overallconsideration of the technical features and thenon-technical features, which indicates thecontribution of the non-technical features tosolving the technical problem is accepted in theexamination process.

Therefore, in the drafting and OA handlingphases, the applicant/attorney shall pay attentionto the integrity between the technical featuresand the non-technical features (algorithms)under the specific application scenario, andclearly emphasize the technical effect broughtby the overall technical solution in the draftingphase, which will be conducive to overcomingthe defects of lacking novelty/inventiveness.

3.2 Correlation effectDuring the judgment of inventiveness, thecorrelation between the technical features and

the non-technical features is taken intoconsideration. This is also a consideration of thecorrelation between the AI algorithm and thespecific application scenario. The technicalproblem (technical contribution) solved after thecorrelation between the AI algorithm (non-technical features) and the technical elements(technical features) in the specific applicationscenario will help to improve the persuasivepower of the argument in the examinationprocess of inventiveness.

From this perspective, at the drafting phase,the applicant/attorney shall pay attention todescribe the correlation between the AI algorithmand technical elements in the specific applicationscenario (e.g., the correlation between the technicalparameters in the specific application scenarioand the parameters in the AI algorithm), and thetechnical problem (achieved technical effect)directly solved after the correlation.

4. SummaryEligibilityAttention shall be paid to the technicality of asolution and a correlation between non-technicalfeatures and technical features.

Sufficient disclosureAttention shall be paid to a specific applicationscenario of the non-technical features (algorithmfeatures) and the disclosure of essential technicalparameters.

Novelty and inventivenessWhether in the drafting phase or in the OAhandling phase, attention shall be paid to theadaption of the principles of the overall judgmentand correlation between the technical featuresand the non-technical features.

An AI-relatedclaimusuallyincludesbothtechnicalfeatures and non-technicalfeatures.

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siRNA, sometimes known as short interferingRNA or silencing RNA, is a class of double-strandedRNA, typically 20-25 base pairs in length, similarto miRNA. Typically, siRNA duplexes have 21-ntsense and 21-nt antisense strands, paired with a 2-nt 3' overhang as seen in Figure 2. Intherapeutic siRNAs, 2'-deoxynucleotides in the 3'overhangs are used instead of ribonucleotidessince they are cheaper to synthesize and probablymore nuclease resistant.

RNAi Drug DiscoveryThere are 52 clinical trials on RNAi-based drugsspanning multiple therapeutic areas in progress.Successful drugs must be safe and effectivewith relatively convenient dosing. For therapeutics,siRNA development challenges include off-target transcript silencing (causing safetyconcerns), delivery to target cells, and degradationby nucleases causing the drug to be degradedbefore achieving a therapeutic dose. Chemicalmodification and bioconjugation can helpovercome these problems.

The US Food and Drug Administration recentlyapproved two siRNA drugs: Onpattro (Patisiran)and Givlaari (Givosiran). Both drugs were developedby Alnylam Pharmaceutical and are shownbelow in Figures 5 and 6. Patisiran is a chemicallymodified, double-stranded small interferingribonucleic acid (siRNA), formulated as a lipidcomplex for delivery to hepatocytes and is usedfor the treatment of transthyretin-mediatedamyloidosis. Patisiran specifically binds to agenetically conserved sequence in the 3’untranslated region (3’UTR) of mutant and wild-type transthyretin (TTR) messenger RNA(mRNA).

Source: US Patent Application No. 20050144669

Figure 1. miRNA hairpin structure binding a target sequence.

Figure 2 Structure of siRNA

Figure 4: Top 10 companies filing RNAi-related patent publications since 1991

Source: US Patent No. 9260470

siRNAs are 21-23 nucleotide double stranded RNA

(dsRNA) duplexes with symmetric 2-3 nucleotide 3’

overhangs and 5’ phosphate and 3’ hydroxyl groups

Growth in RNAi Patent PublicationsSince the discovery of RNAi, there has been steadygrowth in the volume of worldwide patentpublications that disclose its different forms. Thefollowing two figures show the number of worldwidepatent publications and the companies with themost RNAi-related patent publications since 1991.

Figure 3: Number of worldwide RNAi-related patent publications by year

(Source: CAS content collection)

Note: Due to the elapsed time between patent application and publication, the last

two years of data are incomplete.

(Source: CAS content collection).

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RésuméAnne Marie ClarkAnne Marie is a Senior Searcher on theCAS IP Services team. Her particularsubject expertise is small molecules,sequences, and formulations, and she isskilled in patent searching, analysis andlandscaping, and competitivebenchmarking.

Peter BlasiPeter leads business development forthe CAS IP Services team, introducingclients to the value of CAS IP Servicesand bringing them together withseasoned search professionals to meettheir information needs.


With the approval of two smallinterfering RNA (siRNA) biopharma-ceuticals and 52 clinical trials spanning

multiple therapeutic areas in progress, the valueand complexity of the patent landscape aroundRNA interference (RNAi) is increasing. Challengeswith searching siRNA include non-standardizedterminology, drug delivery that is claimedseparately from the molecules, and the limitationsof familiar biosequence search methodologies.Due to these challenges, RNAi searches requirespecialized expertise in search techniques andinformation sources where those techniquesshould be implemented.

This article examines how RNAi inventions are claimed and described in the specification,which information sources ensure the mostcomprehensive retrieval, and the best search

techniques to use. These examples and techniquesaim to demystify the process for finding relevantpatent and non-patent literature related toefficiently retrieving these sequences.

RNA interference discovery and mechanismIn 1998, Andrew Fire and Craig Mello discoveredRNA interference (RNAi), sometimes called Post-Transcriptional Gene Silencing (PTGS), for whichthey received the Nobel Prize in 2006. Smallinterfering RNAs (siRNAs) selectively silence theexpression of a target gene by degrading itsmRNA. The silenced gene is specified by thesmall RNA component, which recognizes thetarget by base pairing.

RNAi allows a brand-new class of drugs.Sequence-specific gene silencing can eliminatethe root cause of a disease, and can halt orreverse the disease progression, rather thanslowing it or only treating the symptoms. Thereare two common types of RNAi molecules:micro RNA (miRNA) and small interfering RNA(siRNA). Both are non-coding RNAs, as they donot code for a protein. miRNA are small RNAmolecules which silence genes by binding totarget messenger RNAS (mRNAs). Mechanismsinclude:

1) Cleavage of the mRNA strand into two pieces,

2) Destabilization of the mRNA throughshortening of its poly(A) tail, and

3) Less efficient translation of the mRNAinto proteins by ribosomes.

Since their discovery in 1993, miRNA have beenfound in all eukaryotic cells conserved acrossthe species. miRNAs are small non-coding RNAmolecules (containing about 22 nucleotides) andoften have hairpin structures as seen in Figure 1.

Demystifying RNAifor stronger patentsearches

Peter Blasi and Anne Marie Clark of CAS IP Services discuss avoiding pitfallsin patentability and freedom to operate searches.

Peter Blasi

Anne Marie Clark

RNAi


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Search Techniques to RetrieveRNAi ReferencesA comprehensive search for RNAi prior art shouldinclude both a sequence search and a text search,because of the inconsistencies of how RNAi-related inventions are claimed. There are a varietyof different human-curated and algorithmically-curated databases with information for bothsequences and text. A typical workflow for apatent search is: start with sequences withhuman-curated sequence databases such as CAS BIOSEQUENCESTM first, then searchalgorithmically-curated sequence databases.After the sequence search, search text terms inhuman-curated databases, such as CAplusSM,and then finally search full-text patent databases.An siRNA search should start by searching theunmodified base sequence in a biosequencedatabase.

Some common methodologies for sequencesearches include:

• Exact sequence - retrieves sequenceswith exact match, and same length.

• Subsequence - retrieves sequenceswhere the query sequence may beembedded.

• Motif search - retrieves sequences with.repeats, alternatives, spacers, etc.

• BLAST (Basic Local Alignment SearchTool) - searches sequence similarity(generally expressed as % of sequenceidentity, or %ID).

siRNA and miRNA sequences are usually firstsearched using a motif allowing specific variablesor exact search where 100% matches are found.

The following questions should be consideredby the searcher and attorney:

• Should overhanging nucleotides betrimmed from the strategy? Theoverhanging nucleotides can bereplaced with bioconjugates or modifiednucleotides.

• Will the strategy retrieve chemicalmodifications or bioconjugates?

• Will the bioconjugate molecule besearched separately?

Conducting an RNAi sequence search usinghuman-curated databases can yield preciseresults. When searching text, the strategy shouldinclude such human-curated databases likeCAplus which offer the increased power andprecision of controlled vocabulary as well asfull-text patent databases. When developing asearch strategy, consider multiple ways the siRNAcan be described such as modified dsRNA,oligonucleotides, oligomers, RNA interference,RNAi. For chemical modifications, the modificationpattern, not just a specific sequence, can beclaimed and should be searched. Claims canalso be target-focused rather than substance-focused; so, that aspect may also be searched.To ensure the most reliable results, RNAi searchesshould cover different features, uses, andcharacteristics of the siRNA/miRNA.

ConclusionA high-quality, professional search performedusing multiple information sources and searchtechniques specific to RNAi is extremely valuableto support drafting the strongest possible RNAiclaims. A search performed by a reliableprofessional with database and strategy knowledgeis the key first-step to assist attorneys who areadvising their clients on patentability andfreedom-to-operate.

Theseexamplesandtechniquesaim todemystifythe process.

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ContactCAS IP ServicesTel: 866-360-0814www.scienceip.orgwww.cas.org

Table 3: Abbreviations of Nucleotide Monomers Used in Nucleic Acid Sequence

Representation

Table 4: Sequences With Chemical Modifications


RNAi


How RNAi is Represented in PatentsRNAi is claimed in a variety of ways within patents. siRNA orRNAi terminology is not always used, and chemical modificationscan be described a variety of ways which means that there is nosingle strategy that can be used to efficiently retrieve thisinformation from different databases. For example, US PatentNo. 8,334,373 does not use the term siRNA or claim specificsequences. It uses double-stranded ribonucleic acid terminologyand claims chemical modifications as sequence motifs makingboth retrieval and analysis challenging. Claim 1 is shown below.

In US Patent No. 9,101,643, lipid-formulated compositionsand methods for inhibiting expression of transthyretin (ttr) areclaimed, and analysis of the full patent document is requiredto determine the scope of the claims, as shown below.

However, as seen in Figure 8 and Table 2, neither the claimnor the sequence listing describes the chemical modifications.The chemical modifications are described in Tables 3 and 4,making analysis challenging.

Figure 5: Chemical Structure of Patisiran

(Source: US Food and Drug Administration)

Givosiran is an aminolevulinate synthase 1-directed small interfering

RNA (siRNA), covalently linked to a ligand containing three

N-acetylgalactosamine (GalNAc) residues to enable delivery of the siRNA

to hepatocytes. Givosiran is used to treat acute hepatic porphyria and it is

both chemically modified and bioconjugated.

(Source: US Food and Drug Administration)

Abbreviations: Af = adenine 2'-F ribonucleoside;

Cf = cytosine 2'-F ribonucleoside; Uf = uracil 2'-F ribonucleoside; Am =

adenine 2'-OMe ribonucleoside; Cm = cytosine 2'-OMe ribonucleoside;

Gf=guanine 2'F ribonucleoside; Gm = guanine 2'-OMe ribonucleoside;

Um = uracil 2'-OMe ribonucleoside;

L96 = triantennary GalNAc (N-acetylgalactosamine)

Figure 6: Chemical Structure of Givosiran

Figure 7 Claim in Patent No. 8,334,373

Table 1: Summary of the Invention in the '373 Patent

Figure 8: Claim 1 from '643 Patent

Table 2: SEQ ID No. 1009


http://www.scienceip.org

http://www.cas.org

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RésuméSérgio Braz Sérgio is a leading intellectual propertypractitioner with 19 years’ experience insearching and clearing trademarks, filing,prosecuting, enforcement, and disputeresolutions. As a founder partner at Braz& Associados, Lda, Mozambique’s only IPboutique firm, Sérgio is responsible forlarge IP portfolios from various industriesand his expertise extends to all topicsrelated to patents, industrial designs,utility models, and domain names. Healso counsels and assists foreigncompanies and associates to obtain IPprotection in Mozambique.

On the news from RDP-Africa radio station,broadcasted on 10 April 2020, at 12h00in Maputo, a specific report caught my

attention. It alluded that in Spain a carmanufacturer had developed a ventilator basedon the functioning of windshield wiper motors.It further stated that the ventilators would bemade available to health services in Spain withthe aim of combating COVID-19. The inventorshad decided not to register the invention, so thatsuch invention should not fall under theirIntellectual Property Rights; thus allowing thecountries that need it most (especially in Africaand Latin America) to manufacture their ownventilators based on this invention1 .

We are faced with an extraordinary form ofaltruism. In contrary to the people and companieswho seek to take advantage in the currentsituation by increasing the production and pricesof food, products, and essential protectionequipment used in the combating of thispandemic, these inventors made their inventionaccessible and free of charge.

This and other situations really motivated me,and I thought it could be useful to revisit whatour current patent legislation provides for caseswhereby inventions are created and used incombating pandemics or other dangers whichrepresent a threat to public health.

National legislation Under the national legislation, every nationalinventor enjoys the legal protection for theirrights duly provided for in the article 74 of the

Industrial Property Code (IPC). In effect, the currentlegal provision stipulates in paragraph 1 that“Without prejudice to any other provisions ofthis chapter, the patent holder enjoys the followingexclusive rights relating to the invention: a) Exploit the patented invention; b) Grant orassign of the patent; c) Conclude licenseagreements for the exploitation of the invention;made; d) Opposing the improper us of the patent”.

What this means is that, alongside the right touse or explore, the patent holder also enjoys theright to conclude different types of contractswith potential interested parties, as well asexercising his right to prevent such a patentbeing used by third parties without his permission.

Patent rights in themidst of COVID-19

Sérgio Braz, Industrial Property Agent and founding Partner at Braz & Associates, looks at the impact the current global pandemic is having on the IP landscape in Mozambique.

Sérgio Braz

1 An audio extract of the

news can be found at

https://www.rtp.pt/play/

p5442/e466418/noticiarios

-rdp-africa. For more

updates or development

on the subject, please see

https://www.seat.pt/

empresa-seat/noticias-

auto/novidades-seat/

a-seat-inicia-a-producao-

de-ventiladores-de-

emergencia-nas-suas-

instalacoes-de-martorell.

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http://www.inta.org

http://www.rtp.pt/play/p5442/e466418/noticiarios-rdp-africa

http://www.seat.pt/empresa-seat/noticias-auto/novidades-seat/a-seat-inicia-a-producao-de-ventiladores-de-emergencia-nas-suas-instalacoes-de-martorell.html

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“other uses without authorization of the rightholder”, the agreement establishes that memberstates may authorize the use of the invention bythird parties, provided that the respective nationallaws make provision for such. It also requires thatthe use by third parties must be communicatedto the right holder, but such communication isnot required "in cases of emergency or othercircumstances of extreme urgency or in casesof non-commercial public use”5 .

As you might easily attest to, our IPC is in linewith current international legislation in so far asthe matter under scrutiny here is concerned. Norcould it be otherwise, because Mozambiquehas joined and accepted these Agreements,thus being included in its national legal system.

The social function of the intellectual property The legal provisions discussed above are

intrinsically linked to ensure the authorized useof patents by third parties and this is regardedas being an integral part of the doctrine knownas the Principle of the Social Function of theIntellectual Property. This doctrine derives froman understanding that notwithstanding IP Rightsin general, and the right of IP rights holders toenjoy the protection and exclusive right of theiruse, these rights should in essence, wheneverneeded, play a social role as a way of helpingcountries to meet their social developmentgoals. In a nutshell, intellectual property mustbe subject to the imperatives of national interestwhenever needed. In other words, every singleholder of an IP right has a duty towards hiscommunity; that is, his property should be servingthe community whenever there are justifiedreasons for so doing.

VARELLA, Marcelo (1996) cited by CARVALHO,Thiago and THOMÉ, Karim (2015) emphasizedthat “the social function is a limit found by thelaw-makers in order to outline the property, incompliance to the principle of the supremacyof the public interest above the private interest”.

From this legal premise, it is clear that thesocial function of property is not a restriction onthe property itself, but on itsmisuse. According to BARBOSA,

Denis (2003) "the social function would be alltranscendence of the selfish interest". Thismeans that the holder of the right should give uphis personal interests and accept that such personalinterests should serve the community at large.

For instance, in Mozambique this principle isin line with the very nature of the State as clearlydefined in the ambits of the Constitution of theRepublic, thus establishing in article 1 that“Mozambique Republic is an independent,sovereign, democratic and social justice state”.As result of this definition, there is an alignmentof the entire organization and the action of thestate to reach this goal6.

Concluding remarksWith Mozambique being regarded an undevelopedcountry, lacking in technological advancement,people do not consider the hypothesis that, inthe near future, a great invention of national orinternational impact will emerge. In fact, an in-depth reading of the Industrial Property Bulletinpublished monthly by the IPI clearly reinforcesthis perception, because the inventions so farregistered by our inventors are commonlyregarded as “small patents” and of low impactnationwide, simply because they are not welldeveloped inventions, even though they weremade to address and meet the basic needs andchallenges faced by communities.

Notwithstanding this, one cannot discredit orignore the human ingenuity which at any giventime can lead to the invention of something witha national impact and repercussion, be it forcombating a pandemic, or finding a solution toeradicating a chronic problem such as hungeror malnutrition; these should not be overlookedas they remain challenges that affect a largepercentage of Mozambicans. Or perhaps we willsee an invention to solve an eventualtechnological “blackout” in the national financialsystem, among several other situations. In sucha case, it would be necessary to carefullyanalyze the situation to assess how best any

interests in the invention and the needs of thecommunity could be reconciled.

This meansthat theholder of the rightshouldaccept thatsuchpersonalinterestsshouldserve thecommunityat large.

”

“

ContactBraz & AssociatesTel: +258 21 321 792M: +258 82 3200 [email protected]

5 Clause (b) of the article 31

of the TRIPS Agreement. 6 See article 11 on the

Fundamental Objectives,

article 96 on the Economic

Policy and article 101 on

the Coordination of

Economic Activity.


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Failure to do so is legally regarded as a breachof the exclusive rights of the patent, provided forand duly punished in accordance to theprovision contained in the article 214 of the IPC.

However, there are exceptions to this rule, inthat it can be motivated by certain situations, forinstance the outbreak of pandemics, such as theone that is currently devastating the entire world.Mandatory License is the legal mechanism whichprovides for the said exception, duly stipulatedin the article 92 of the IPC. This mechanism isaccessed or activated whenever there arejustified reasons of public interest, namely whenthe invention is crucial for combating publichealth issues. The relevant Ministry, in this casethe Ministry of Health authorizes the exploitationof the invention, upon request addressed toIndustrial Property Institute (IPI)2.

For extreme situations such as nationalemergency, the compulsory license is applicable,and the requesting is therefore not required. TheGovernment, through the relevant Ministry,simply authorizes the use of the invention for aslong as necessary, provided it is aimed tocontain the pandemic. This is in reference to thePrinciple of Proportionality which according toBARBOSA, Denis (2003), its application requiresthat “… the principle of proportionality isapplicable whenever we are confronted withtwo constitutional requirements – the protectionof property and that of social interest.

It is emphasized that the collective interestwill only prevail to the exact extent, and nofurther action will be needed to satisfy thatinterest. In essence, this means that the actualcompulsory license, in accordance to theconstitutional parameters, cannot exceed theextension, duration and indispensable formwith the excuse of serving the relevant publicinterest, or to repress the abuse of the patent

or that of the economic power”3.Let us assume, for example, a Mozambican

national invented something that would help inthe fight against COVID-19, and during the periodof time in which the Government declared astate of emergency, the government could resortto the mandatory license as to limit the exclusiverights of the patent holder and, thus authorizethe exploitation of the invention by third parties.However, it is still important to state that theinterests of the inventor will always be takencare of. In effect, under the terms of paragraph 6 ofarticle 92 of the IPC, "the patent holder receivesan adequate remuneration, paid by the beneficiary,adjusted to each specific case, taking intocognizance the economic value of the patent".In the case of the discovery of the pandemiccure, the remuneration should not be paid byeach person who benefited from such cure, itshould be paid by the Government.

International legislationThe protection of intellectual copyrights has asits regulating cornerstone the Paris Convention of20 March 1883 whose sole mandate is to protectthe industrial property of which Mozambique isa signatory member state4.

The Convention gives the newly joined memberstates of the Union the prerogative to include intheir national legislation provisions on mandatorylicensing, as a way to “prevent abuses thatcould result from the exercise of the exclusiveright conferred by the patent, as, for example,the lack of exploitation”. As can be seen, theenumeration is exemplary, therefore an extensiveinterpretation of this standard must be made,and it should include situations such as the stateof national emergency, threats, or danger topublic health, among other things.

A similar provision is also found in the Trade-Related Aspects of Intellectual Property RightsAgreement (TRIPS). This agreement remains byfar the broadest international instrument enactedfor the protection of intellectual property and isbinding on all the member states of the World TradeOrganization. In its article 31, with the heading

We are facedwith anextraordinaryform ofaltruism.

”

“

2 Article 92, no 1 to 3, from

the IPC. 3 In: BARBOSA, Denis (2003)

The New Regulation for

Compulsory License for

Public Interest. Article

published in the issues of

Gazeta Mercantil of 17th,

18th and 19th of November

2003 and is available at

http://denisbarbosa.addr.c

om/trabalhospi.htm,

consulted on the 14th and

15th of April 2020.4 Mozambique joined the

Union through Resolution

no.21/97, of 12th of August.no

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http://www.baipa.co.mz

PATENT TYP

ES


A utilitypatent is themostcommon ofthe threepatenttypes.

”

“required to submit clear and detailed drawingsto the USPTO, often showing the invention fromall or multiple angles. In some limited cases,black and white photographs may be used inplace of drawings, but only if photographs arethe only practicable medium for illustrating theinvention. Design patents have a term of 15 yearsfrom the date of issuance, and no maintenancefees are necessary.

Plant patents The USPTO grants plant patents to inventorsthat have invented and reproduced a new varietyof plant. The new variety must be “asexually”reproduced, which means not grown from aseed but created through another process, likegrafting, budding, or rooting of cuttings. Theplant must also be unique and not found in thewild. As just an example, the tree that wascreated by researchers at the University ofMinnesota to grow the popular Honeycrisp applewas covered by a (now expired) plant patent,U.S. Patent No. PP7197.

Plant patents are not as common as utility anddesign patents, and account for only a smallportion of patents issued by the USPTO each year.Because of the extensive examination processrequired for a plant patent, it can take 2 years ormore to gain approval from the USPTO. Similarto a utility patent, a plant patent will last for 20years calculated from the earliest filing date.

Apply for a patent at the USPTO As an inventor who has invested both time andmoney developing your product, you understandthe importance of protecting that invention.Oftentimes, the best way to protect what youhave created is through a patent applicationfiled with the USPTO. Keep in mind that yourinvention may qualify for both utility and designpatent applications, assuming it has uniquefunctional and ornamental characteristics. As anexample, different aspects of a new vacuumcleaner may potentially qualify for both a utilitypatent application and a design patent application,such that the operation of a unique brush headmay fall within a utility patent application,whereas its streamlined handle design may fallwithin a design patent application.

As the owner of a US patent, you will have thelegal right to stop or exclude others frommaking, using, or selling the invention in theUnited States, or importing the invention into theUnited States. You may also want to considerfiling similar patent applications in other, foreigncountries, particularly if you plan to sell ormanufacture the invention outside of the UnitedStates. You can do so by filing a patentapplication directly within each country, or, forpurposes of a utility patent application, you can

submit an international patent application viathe Patent Cooperation Treaty or PCT. Currentlythere are over 100 member countries of the PCT,although the final decision to approve or rejectthe patent application is still made by eachindividual country.

In any case, keep in mind that a foreign utilitypatent application, including a PCT application,must be submitted within 12 months of yourearliest priority date, e.g., your USPTO filing,whereas a foreign design patent applicationmust be filed within 6 months of the earliestpriority date.

Work with an experienced IP attorney You should work with an experienced patentattorney to complete the patent applicationprocess and to assist with the various detailedlegal decisions that will likely need to be madealong the way.

For example, a patentability search is often arecommended first step in the patent applicationprocess that can uncover potential prior art patentreferences that may impact the patentability ofyour invention. An experienced patent attorneycan assist with the patentability search andadvise you on the results thereof. For instance, ifa patent reference disclosing a similar inventionis found, you can work with your patent attorneyin an effort to craft a patent application that maybe able to focus on the aspects of your inventionthat are truly unique.

Furthermore, as your patent application isexamined by the USPTO, you will likely need tomake some amendments to the claims andpresent legal arguments in response to officeactions issued by the assigned USPTO patentexaminer. Work with an experienced patentattorney to ensure that this process is doneproperly and in a timely manner.

Whether you are looking to obtain a utilitypatent to protect the function of your invention,a design patent for its unique look, or a plantpatent for a newly invented plant, begin theprocess as soon as possible to ensure yourunique idea is protected.

ContactGerben Law Firm, PLLChttps://www.gerbenlaw.com/https://twitter.com/joshgerbenhttps://www.linkedin.com/in/joshuagerben

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PATENT TYPES


Apatent is a type of intellectual propertythat gives an owner the right to excludeothers from making, using, or selling

the invention in the United States or importingthe invention into the United States, for a limitedperiod of time. The United States Patent andTrademark Office, or USPTO, issues three typesof patents: • Utility patents, which generally cover how an

invention functions or how an invention ismade.

• Design patents, which cover the ornamental,non-functional features of an invention.

• Plant patents, which cover certain newlydiscovered plants.

Utility patents A utility patent is the most common of the threepatent types. In fact, utility patents account formore than 90 percent of patent applications filedwith the USPTO each year. The USPTO only issuesutility patents for inventions that are both new andnot obvious as compared to existing or knownproducts, patents or publications, for example.

To qualify for a utility patent, the inventionmust fall within at least one of the followingstatutory categories: • Process • Machine

• Manufacture• Composition of matter • Any new and useful improvement thereof

When filing a utility patent application, inventorshave two options, at least initially -- a provisionalpatent application or a non-provisional patentapplication. A provisional patent application willnot be examined by the USPTO, and therefore willnot issue as a utility patent, unless a correspondingnon-provisional patent application is timely filed,i.e., within one year of the provisional filing date.Provisional patent applications often serve thepurposes of a being a placeholder, for example,while you fine tune your invention or raisecapital. Importantly, while your provisionalpatent application is on file, you can claim“patent pending” status for the inventiondisclosed in the application.

Once a non-provisional application is filed, theUSPTO will assign a patent examiner to yourcase who will conduct a search and examinationof the application. The patent applicationprocess is often lengthy, and your patentapplication can remain pending for up to 2 or 3years. If a utility patent is ultimately issued by theUSPTO, it will carry a term of 20 years from theearliest filing date, with maintenance fees dueat 3.5 years, 7.5 years and 11.5 years from thedate of issuance.

Design patents Design patents cover the ornamental or non-functional aesthetic features of aninvention, or otherwise, the look or shape of theinvention. As an example, the non-functionalshape of a computer mouse may be the subjectof a design patent application, so long as thatshape is new and nonobvious.

Design patents are often easier to obtain thanutility patents, although the application processis still detailed and sometimes just as lengthy.There is no standardized form for a designpatent application, although applicants are

RésuméJosh Gerben Josh is the founder of Gerben Law Firm,PLLC, a full-service intellectual propertyboutique offering trademark, copyright,and patent services. Since 2008, Gerbenhas secured over 5,000 trademarks forclients and has been featured in a widerange of local and national news outlets,including NPR, The Washington Post, TheWall Street Journal, Fox News and more.

The patentapplicationprocess isoftenlengthy.

”

“

Patent types explained:utility, design, and plant

The canny entrepreneur should have a solid understanding of theimportance of IP. Here, Josh Gerben, founder of Gerben Law Firm, PLLC,explains the three different types of patents available to inventors in the US,and outlines how to apply for them.

Josh Gerben

Gerben_TPL48_v1:Layout 1 24/6/20 12:26 Page 40

http://www.gerbenlaw.com

http://www.twitter.com/joshgerben

http://www.linkedin.com/in/joshuagerben

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for each page exceeding 20. If the sequencelisting is a part of the description, then itinfluences the page fee and costs may visiblyincrease. The page count does also have animpact on other official fees, such as fee for thepriority document or publication fee.

A sequence listing may be in practice filed asa separate file using online filing. There are noofficial guidelines as to whether such aseparately filed listing, if not included in thepage fee, will be considered as part of thedescription as filed (and e.g. published anddisclosed to the public after the 18 monthsperiod). Due to this, it is generally recommendedto include the sequences for the calculation ofpage fee, and optionally later request a refund.

It is worth noting on the side that the sameissue occurs in case of a validation of aEuropean Patent in Poland, if the B1 publicationincludes a sequence listing. The Polish translationof the whole patent text has to be provided,including the sequences (as otherwise it wouldnot be published in Polish, while it is thepublished Polish text which is considered theauthentic text according to article 70(3) EPC).The publication fee depends on the number ofpages above 10 and as such is usually muchhigher when the sequence listing is included.

If the invention relates to a biological material,often a deposit is necessary for sufficientdisclosure. Poland is a contracting party to theBudapest Treaty and recognizes deposits filedin any of the International Depositary Authorities(IDAs) according to this treaty. There are threedepositary authorities in Poland, which arerecognized by the PPO (deposits for bacteria,yeasts, filamentous fungi, and bacteriophagesare possible). One of these institutions however(Narodowy Instytut Leków) is NOT a BudapestTreaty IDA and will not be recognized in othercountries. A deposit of other type (e.g. an animalcell culture) has to be deposited abroad and anydocuments from a depositary authority will haveto be completely translated to Polish.

If the invention relates to a nucleic acid oramino acid sequence, the industrial applicabilityand function of the sequence have to beexplained in the description (as before the EPO),but the function of the sequence has to beexplicitly mentioned in an independent claim.This cannot be omitted or simply implied; thefunction of the sequence has to be preciselydefined and will have to be a technical featurein the claim.

It is important to note that the PPO does nothave a counterpart of the EPO’s guidelines and theExaminers are, to the extent of their examinationof an application, independent and bound onlyby the relevant acts of law. There will also beonly one Examiner searching and examining a

patent application. Due to this, specifics mayvary between Examiners, although there aresome visible trends as discussed below.

Functional definitions in the claims are veryoften objected to. In principle, a feature definedin functional terms such that a person skilled inthe art would have no trouble understandingwhat is required (such as a “filling agent” in aclaimed formulation) should be accepted, butthis may strongly depend on the particularinvention and on the Examiner. Functionaldefinitions in case of biological molecules suchas proteins, receptors, antibodies etc. will usuallynot be accepted.

Support for the invention as claimed in theapplication as filed is an especially importantaspect in drafting applications in all fields, but it may become especially significant inbiotechnology, biology in medicine. Strong anddiverse support in the exemplary embodimentsin the description will be crucial for obtainingpatent protection in these fields in Poland.Especially in biotech and medicine, it is notunusual for the PPO to require limitation of thescope of protection merely to the embodimentsactually shown in the examples.

For example, this issue may occur when anapplication claims a group of compounds definedby a Markush formula and presents examples ofseveral molecules with experimental data showingan effect for some or even only one of them. ThePPO may decide that there is no evidence in theapplication as filed that the invention works asintended for the whole scope. This is sometimesphrased as an objection against insufficientdisclosure or lack of industrial applicability, whichmay sometimes be confusing, but the mostcommon problem lies not adequate experimentalsupport. In such cases, the PPO will usually requirelimiting the scope of the claims, sometimeseven to the experimental example only. Submitting

RésumésAleksandra Sołyga-Żurek Ph. D.Aleksandra specializes in patent applications in the fields of biology,biotechnology, pharmacy and chemistry, prior art, and freedom-to-operate searches, as well as proceedings before the Patent Office. She is a graduate of Warsaw University and holds a Ph.D. in molecularbiology and genetics.

Katarzyna Jedynak Ph. D.Katarzyna specializes in verifying validation texts of European patentsand preparing the documentation of patents for validation. Among her other responsibilities are searches in patent literature databases,preparation of correspondence with the Patent Office and law firms, and preparing patent applications in the fields of biology,biotechnology, pharmacy and chemistry. She graduated from Warsaw University and in 2015 completed her doctoral studies.

Inbiologicalor medicalfields, a singleworkingexample isvery rarelyenough.

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Convincingthe PPOmight not beeasy.

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Recent times are certainly anything butboring. In May, the Enlarged Board ofAppeal at the EPO completely changed

its stance on the patentability of plants obtainedby a biological process. COVID-19 causedinterruptions in administrative periods before IPoffices, and since the actions of local authoritiesvaried, the calculation of resultant deadlines indifferent European countries will be complex.Even before that, IP laws were amended in manycountries, including quite significant changes, asin France or later Poland. And by the beginningof this year, the UK left the European Union.

This last event has an impact on EU trademarksand registered community designs. For now,until the end of 2020, these rights will continueto extend to the UK. Comparable UK rights willbe created at the end of the transition period.

In the world of patents, however, not thatmuch has changed. The UK is still a ContractingState to the European Patent Convention. Europeanpatent attorneys based in the UK continue to beable to represent applicants before the EPO. Nevertheless, it may be expected that thenavigation of IP laws will become morecomplicated in the years to come, as the onething that is almost certain to be affected by UKdeparture is harmonization of laws, includingthe ones relevant to IP.

This problem is certainly not new, and patentattorneys are used to the fact that IP requirementsvary between countries. In fact, even thoughharmonization is the key concept in the EU,some differences keep persisting between theMember States. This issue is too extensive to bediscussed thoroughly here and hence we will try toconcentrate on one technical field (biotechnology)and an example of Poland, which alreadyamended its IP laws several times, partially tobring them closer with EU laws and the EPC.

The so-called Biotech Directive (Directive98/44/EC of the European Parliament and of theCouncil of 6 July 1998 on the legal protection ofbiotechnological inventions) has, to some extent,harmonized the requirements and possibilities ofobtaining patent protection for biotechnologicalinventions in EU countries. Poland joined theEuropean Union in 2004 and earlier introducedthe appropriate regulations in its IP law. The Acton Industrial Property Law of 30 June 2000 (IPL)was updated several times, with considerationalso towards the TRIPS agreement, the BudapestTreaty, and the EPC. Chapter 9 of the IPL sectionconcerning patents and utility models isdirected entirely to the protection of inventionsin the field of biotechnology and the wording ofmajority of respective regulations is based directlyon the Biotech Directive. All of this, however, stilldoes not mean that an undertaking to obtainlegal protection for a biotechnological inventionwill provide the same results in Poland as inother EU or EPC countries. There are still a lot ofpractical differences and pitfalls that have to befactored in, when a procedure before the PolishPatent Office (PPO) is anticipated (directly or as anational phase of a PCT application).

First of all, if the specification mentions anynucleic acid or amino acid sequences, a sequencelisting compliant with the ST.25 standard shouldbe provided in a form that will allow furtherelectronical processing of the data. Thisrequirement by itself is not unusual. However, itis not completely clear whether the sequencelisting should actually be considered as a partof the description in the patent application, asthe PPO requires that the sequence listing is infact placed in the final part of the description(“Inventor’s guide”, ed. Andrzej Pyrża, PPOpublication, 2017, p. 169, par. 1). Simultaneously,the filing fee before the PPO includes a page fee

Biotech patentharmonization – aPolish perspective

Aleksandra Sołyga-Żurek, European patent attorney, and Katarzyna Jedynak,patent attorney trainee, both of Patpol, look at recent moves to harmonizePolish biotech patent protections with EU law.

Aleksandra Sołyga-Żurek

Katarzyna Jedynak

HARMONIZATION


PAT P O L . P L

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T +48 22 546 91 00 E [email protected]

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additional experimental data, although allowed,may not always be considered enough, as it isrequired that the scope of protection be fullyderivable from the application as filed. Thus, ifthis problem occurs before the PPO, it may besometimes difficult to address.

Another case is an invention relating to a useof a microbiological strain, which was shown tohave a desired metabolic activity and thereforeis deemed useful in an industrial method. Simplyshowing experimental data that the strain doeshave the desired activity in vitro may not beenough. Showing its use in the process it isintended for, may prove to be necessary. If theuse or method is due to a genetic constructintroduced to the microorganism, and there is asingle example of transforming a microorganismand experimental data showing it having theintended effect, this may be considered enoughsupport just for the exact strain as illustrated.Even though it might be clear that suchconstruct would work in related strains orspecies, convincing the PPO might not be easy.

Therefore, it cannot be stressed enough that inthe Polish patent procedure the key is providingas many and as varied examples as possibleand to do this on the filing date. In biological or medical fields, a single working example isvery rarely enough. This may sometimes betroublesome as biological experiments take time,while the applicants simultaneously wish to securetheir rights by filing suitably early. As a result, inPoland, obtaining a broad scope in this field mayin practice often be harder than before the EPO.

The procedure for granting SPCs, i.e.Supplementary Protection Certificates, forpharmaceutical and plant protection products isan aspect that deserves special attention. SPCsare regulated by EU and along with theappropriate rulings of the Court of Justice of theEuropean Union (CJEU) this is directly applicableto all EU countries. Despite this, there are stilldifferences. In case of an SPC, a patent office alwayshas to balance the benefit of the applicant onone hand and the welfare of the citizens on theother. The way this balance is understood may,however, vary. In Poland, it should be expectedthat obtaining an SPC will not be easy. Theprocedure will be quite long (several years) andwill usually involve a complex exchange of officialletters between the PPO and the applicant(which may raise costs). Probably one of themost important aspects however, is that when aCJEU ruling is cited in the procedure, the PPOvery meticulously analyzes the specific facts of thecase and reasons that led to the judgement andwill be strict in evaluating whether it is relevantat all. The Examiner will have to be convincedthat the case before them is similar enough orthat there are no additional aspects deviating

from the situation as analyzed by the CJEU. Inother words, the position developed by theCJEU may not always directly and immediatelytranslate into practice before the PPO.

As shown briefly in the examples above, evenin an EU country, wherein significant effort wasput into harmonization, both laws and practicemay markedly differ from other Member States.With these variations between individual EUcountries and the EPC, the unclear future of theUnified Patent Court, which may or may notcome into existence (but probably without theUK) and then divide EU states into the onesparticipating and those not, and the UK possiblydrifting further away (possibly bringing its IP lawcloser to US?) the IP law landscape will keepchanging. This seems unavoidable, and onething is certain – to all this we will have to adapt.

The key isproviding as many and asvariedexamples as possible.

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mailto:patpol%40patpol.pl?subject=

http://www.patpol.pl



AI A

ND

IP


of any AI system. When claimed as such (i.e.,without any implementation that can confertechnical character upon them), mathematicalmethods are excluded from patentability.

There is a risk that a narrow interpretation of what constitutes a patentable specifictechnical implementation might exclude some significant advances in AI technologyfrom patentability. (CIPA)

The EUThe written submissions of the European Union(EU) includes general comments and specificobservations on the impact of AI on patents,copyright, data, designs and capacity building.

Acknowledging that “The interplay between AI,data and the different intellectual property rightsdeserves a discussion at international level.”, theEU view WIPO’s draft issues paper as presenting“a good opportunity to initiate such a discussion.This could in the future serve as a kick-start to acoordinated global approach addressing thechallenges that AI presents to the intellectualproperty system”.

On patents, the EU considered the legalrequirements of inventorship and disclosure,requirements that face challenges in respect ofAI inventors, as discussed above, and “black-box” AI where the inner workings are unclear:

With respect to patents, we propose that the[next WIPO issues] paper includes self-standing issues on AI and patentinfringements, the concept of person skilled inthe art as well as patentability of inventionsassisted by AI as computer-assistedinventions. The inventorship/ownership issueshould include fundamental questionsconcerning identification of AI-generated orAI-assisted inventions by the IP Offices, thepossibility of naming a legal person asinventor and the possible consequences tosociety of according inventorship rights to AI.

Concerning the issue of disclosure, wepropose to raise additional questions on black box AI inventions and artificial neuralnetworks. The patent policy considerationsshould cover the possible need for a newhierarchy of social policies to address theissues of preserving the patent system and of encouraging innovation in AI.

The UKIPO and the USPTOAlthough the UK Intellectual Property Office andthe United States Patent and Trademark Officedo not go into detailed discussion of WIPO’s draftissues paper in their written submissions, theynevertheless recognize its value in providing aplatform for discussion:

The UK is pleased to see the inclusion ofquestions which seek to address the risk ofnew technological advancements increasingthe digital divide on both domestic andinternational levels. It is important thatdiscussions are mindful of the potentialimpact of Al development on thetechnological landscape in both developedand developing nations. We would also be interested in exploring howthe IP framework could harness the power ofAl in order to positively impact on consumers,the public, and wider society. We believe that

RésuméSaiful KhanSaiful is a partner and patent attorney at Potter Clarkson. With extensiveexperience of prosecuting patent applications before numerous patentoffices, he has represented his clients at hearings before the EPO inBerlin, The Hague and Munich. Saiful has also taken part in interviewswith USPTO examiners and his work has been used in successful globalpatent licensing and litigation discussions. In addition, he has conductedopinion work and has represented the interests of leading global patentholders in face-to-face patent assertion discussions.

The linebetween AIas a “tool”and AI as aninventor isblurring.

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Potter Clarkson_TPL48_v2:Layout 1 24/6/20 12:53 Page 47

Over 250writtensubmissionswere filed in responseto WIPO’scall forcomments.

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From December 2019 to February 2020, theWorld Intellectual Property Office (WIPO)called for comments on its draft issues paper

on artificial intelligence (AI) and intellectualproperty (IP) policy. Comments were sought inrelation to several areas of the IP system: patents,copyright, data, designs and accountability forIP administrative decisions taken using AI.

Over 250 written submissions were filed inresponse to WIPO’s call for comments, all ofwhich are now available on the WIPO website.

Parties ranging from individuals to corporationsand national governments responded to WIPO’scall for comments, indicating widespread interestin, and backing for, continued conversation onhow AI intersects with the IP system.

CIPAThe written submissions of the Chartered Instituteof Patent Attorneys (CIPA) includes, in part,comments on AI inventorship and the substantiverequirements of patentability.

At a general level, CIPA “does not currentlysupport the creation of a sui generis system for AIgenerated inventions”. Within CIPA, however, theissue of AI inventorship has different points of view:

CIPA does not have a single view onwhether the law (as presently applied in theUK) should be changed such that an AIsystem can be named as inventor on apatent application. There are many who thinkthis would be acceptable if the contributionmade by the AI system is such that, if ahuman had made the contribution, thehuman would be recognized as inventor.Others however think patent applicationsshould continue to require at least onehuman inventor.

The question of whether an AI system can benamed as inventor on a patent application isbeing tested by the Artificial Inventor Project. Todate, patent applications filed by this project–patent applications in which an AI machinecalled “DABUS” has been designated as soleinventor – have been refused pending appeal inthe UK and Europe due to non-compliance withthe requirement that only natural persons maybe designated as inventor.

In relation to the substantive requirements ofpatentability, in response to WIPO’s question“Should the law exclude from patent eligibilityinventions that are autonomously generated byan AI application?” CIPA answered that they are“not currently advocating any change to the lawon exclusions from patentability”. Related to this,on the question of whether AI should havespecific examination provisions (e.g., in a manneranalogous to computer-implemented inventions),CIPA replied:

The core criteria of novelty, inventive step,technical subject matter/contribution,sufficiency and clarity remain appropriate and do not need to be amended. It may beappropriate to develop guidelines or similaron how these criteria are best applied to AI-assisted inventions.Dedicated guidance on the examination of

AI-based inventions already exists in somejurisdictions. We anticipate that other patentoffices will follow suit as AI continues to developin new and existing technology areas.

An important recognition by CIPA, no doubt of others too, is that patent law in its existingstate may not necessarily accommodate everyadvance in AI. This likely reflects the fact thatmathematical methods form the building blocks

WIPO consultation showsthere will be no automaticsolutions on AI IP policy

Following on from WIPO’s public consultation on AI and IP policy, writtensubmissions are now available online. To understand how policy in this area might evolve from here, Saiful Khan, partner and patent attorney at Potter Clarkson, looks at key points in the feedback from some of themost integral policy-shaping organizations.

Saiful Khan

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Patents usually make it possible tomeasure the results of the incorporationof new technologies in society. In the case

of nanotechnology, it has given rise to a hugenumber of potentially innovative ideas. However,as in many other cases, technology advancesfaster than the legal framework that covers it.

The US National Institute for Human GenomeResearch defines nanotechnology as a sciencewhere various elements are manipulated at theatomic scale in order to solve difficult problemsto solve on larger scales. This developing sciencehas useful applications in different areas of scientificinterest, for example: in the environment to facilitatewater desalination or soil decontamination, inrenewable energies to improve its productionand storage, in medicine for the development ofdrug nanotransporters to specific unreachableparts of the body, etc.

According to Conacyt (National Council ofScience and Technology), Mexico ranks secondin Latin America in the ranking of the countries withthe largest initiatives, research projects, infra-structure, and the number of nanotechnologypublications. Various reports indicate that morethan 56 institutions and 159 national laboratoriesare dedicated solely to the research anddissemination of this science. The growth inproductivity, development, and investment inthis field forces the industrial property area toask questions regarding the registration of thesenew technologies. Like any other science thatwas once in development and challenged theparadigms of industrial property to make changesto its laws and processes, the nanotechnologyregistry is already beginning to raise questionsto industrial property.

According to the World Industrial PropertyOrganization (WIPO), one of the most importantquestions has to do with the size of the technologythat will be registered. For example, if there is a

very similar technique at larger levels, such asthe atomic level, would it be valid to record thenanometric technique? If not, how would scientificinstitutions protect their nanometric technologiesthat differ in efficiency and results with processes?existing at larger levels? Another importantaspect to consider is whether the current terms,such as “nanoscale”, that are used in patents arethe specific ones to distinguish one technologyfrom another.

Nanotechnology is probably forcing us to bemore specific in the use and registration of these

RésumésMargarita GuerreroMargarita is an Associate at Uhthoff,Gomez-Vega & Uhthoff with more than 12 years of experience in intellectualproperty matters. She holds a ChemicalEngineering Degree and has particularexpertise in Chemistry and Pharmacy.Margarita is an active member of theMexican Association for the Protection ofIndustrial Property (AMPPI).

Manuel Lopez Manuel advises IT clients on design andpatent matters. Dr Lopez has more than 14years’ experience in IP matters, includingdesign and patent drafting and PPH filing,and has particular expertise in advancedtechnology, including nanotechnology,electronics, telecommunicationsequipment, e-commerce, and computerservices. Dr Lopez is a member of theMexican Association for Industrial PropertyProtection (AMPPI) (for which he frequentlylectures) and the American IntellectualProperty Law Association (AIPLA).

Mexicorankssecond in LatinAmerica.

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The challenges posedby nanotechnologypatents

Margarita Guerrero and Manuel Lopez, Associates at Uhthoff, Gomez-Vega &Uhthoff, discuss the patent implications of this groundbreaking technology.

Margarita Guerrero

Manuel Lopez

Uhthoff_TPL48_v2:Layout 1 24/6/20 13:06 Page 49

AI AND IP


it would be of value to consider how the IPenvironment could best encourage investmentin Al to solve some of the key challengesfacing society today. (UKIPO) We welcome IP offices and stakeholdersaround the world engaging in a discussion of the challenges and opportunities that AI technologies pose not only for their patentsystems, but also for other IP disciplines aswell. (USPTO)As a general comment in relation to patents,

the UKIPO queried the definition of the term “Alassisted inventions”:

Issue 2 on patentable subject matter uses theterm "Al assisted inventions". It would be usefulfor a definition to be provided as it is notentirely clear what this term means.As the Artificial Inventor Project is attempting

to prove, AI systems are in the process ofmoving beyond their use as a part of a solutionfor solving a technical problem towards entitiesthat can autonomously generate such solutions.In other words, the line between AI as a “tool”and AI as an inventor within the framework ofpatent law is blurring. If patent law is to changein response to AI, the exact meaning of termssuch as "Al assisted inventions" will requirecareful consideration.

Next stepsThe WIPO is due to feedback with a new issuespaper, taking into account the feedback, at avirtual meeting in July.

Complementary acts can be expected soon.For example, the USPTO’s recent request forcomments on intellectual property protectionfor AI innovation will lead to report later this year,as indicated in their written submissions.Elsewhere, the IP5 group of patent offices areaiming to develop a scoping document for AIand merging technologies by June.

It is clear from the feedback outlined aboveand the many forums in which this subject isbeing discussed that there are still morequestions than answers. Many innovators in thisspace may become increasingly frustrated atthe lack of concrete action and, given the hugepotential in this area, it is imperative that thecurrent conversation leads to concretedecisions and action.

Patent law inits existingstate may notnecessarilyaccommodateeveryadvance in AI.

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ContactPotter [email protected]


TheMay / June 2020



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Darren Smyth and Gareth Probert of EIP look at where Brexit leaves Supplementary Protection Certificates in the UK

Law firmRANKINGS

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A subscription to The Patent Lawyermagazine will ensure that you andyour colleagues have detailedinformation on all the most importantdevelopments within theinternational patent law industry.

The Patent Lawyer magazine isdedicated only to the patent industryand is written by patent experts forpatent professionals worldwide.

A subscription includes a hard copyand an electronic copy which can beread easily on your smartphone ortablet.

Subscribe now!

Tel: +44 (0)20 7112 8862 Fax to: +44 (0)20 7084 0365 E-mail: [email protected]


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processing and defending patent applicationsfrom this technological branch, it is advisable totreat and negotiate the respective objections ofthe examiners before the Mexican Institute ofIndustrial Property (IMPI), always striving toachieve multidisciplinary interviews with all theexaminers, thus achieving, convening andbringing together examiners from various areasof technical knowledge, in order to achieve acomprehensive and clear understanding of theentire invention in question, which will help toaddress the objections issued from varioustechnological fronts, thus achieving an agilegrant and that includes the main novel andinventive characteristics of the correspondingpatent application.

One of the tasks for the future, for all actorsinvolved in and related to nanotechnology, willbe to encourage and foster sustained andcontinuous innovation in nanotechnology,ensuring that the associated intellectual propertysystem grants certain, consistent and broadfreedom to innovators. so that they can workand develop new nanotechnological applications,avoiding at all costs any problem, technical orlegal, that affects the incentives for thedisclosure of patents, investment in them and atthe same time creating a legal environment thathelps the holders to promote litigation casesthat weigh and cover all the technical aspectsassociated with each case.

The cycle of science revolution occurs whenestablished and evidence-based paradigmsbegin to be challenged and refuted by newtechnologies. Later, science goes through astage of uncertainty in which scientists andexperts in the field seek the new paradigm toguide their research and discoveries. In the end,

the revolution is consolidated when newparadigms are found and adopted by scientists.In the same way, industrial property seems tohave entered this cycle of revolution in science.While it is true that industrial property lawscannot be fully rebutted, uncertainty is alreadybeginning to be found in the way of processing,evaluating, and handling applications and patentsrelated to nanotechnology. Following the courseof the cycle, it would be prudent to wait for thenew modifications that the intellectual propertyorganizations will make to their respective lawsin order to give stability to the experts of the fieldin the way of processing and patenting thenanotechnology techniques.

Thetechnicaland legalvariablesthat helpensure a goodprobabilityof grantingshould beconsidered.

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ContactUhthoff, Gomez-Vega & UhthoffHamburgo 260, Col. Juarez, CP 06600,Mexico City, Mexicowww.uhthoff.com.mx

Manuel [email protected]: +52 55 5533 5060 ext. 1211

Margarita [email protected]: +52 55 5533 5060 ext.1125 -1177


NANOTECHNOLOGY


processes, otherwise the claims of a patentapplication could be confusing and vague forthe creators of these technologies. While it istrue that nanotechnology is a new field andtherefore it can be argued that there is not asufficient state of the art to comply with the legalframework of industrial property, WIPO is alreadyworking to see what arrangements are in placefor the current legislation on patents can helpaddress these new challenges. It is of utmostimportance for the industrial property sector toanticipate these challenges that come withnanotechnology and its registration, to avoiddifficult legal conflicts.

That being said, not only the definition"nanoscale" brings ambiguity, words like"nanotechnology" and "nano-agglomerates" alsobring with them a certain level of uncertainty asmany corporations in the industrial propertysector use them differently, making it impossibleto create uniformity. and consensus regardingthe use of these words. According to WIPO, this“lack of standard definitions” can have asignificant impact on the classification of patentsand on the monitoring of its evolution. In worsecases, this inconsistency may cast doubt on thepatentability of technologies, since if we considerthat one of the patentability criteria is that ofinventive step, which establishes that theinvention must not be evident from the state ofthe art for an expert in the matter, the criteriacould not be valid since it could be argued thatthe terms such as “on a nanometric scale” aresufficiently ambiguous so that the person skilledin the art can interpret it without uncertainty andtherefore validly rule whether the inventive stepis fulfilled or not.

To avoid these potential problems, the UnitedStates Patent and Trademark Office (USPTO), theEuropean Patent Office (EPO), and the JapanPatent Office (JPO), which are the main officesthat register nanotechnology patents currently,they have decided that any invention ofnanotechnology must operate on a scale lessthan 100 nanometers. Thus, patent applicationssubmitting measurements with differentnanometer arrangements are excluded. Thisconsensus of the most important worldwide patentoffices in this matter makes it possible to giveuniformity and structure to the nanotechnologypatent applications registry.

As mentioned at the beginning of the article,nanotechnology has various applications acrossvery different fields. This feature of the field isbeneficial because for the diversity of processesthat it can help; however, it can be a problem forindustrial property experts. Typically, patentapplications are assigned to experts in the fieldto determine their patentability by evaluatingthe invention. However, this is not feasible in the

field of nanotechnology due to the wide rangeof areas that its inventions can cover. WIPO states that it is unlikely that a single expertcan adequately assess whether or not theapplication meets the patentability criteria.

Beyond the fact that patent offices need tospend more monetary and human resources toevaluate such applications for the simple factthat more experts in the field will be required toreview the patentability of an application, theproblem of multidisciplinary can make that therisk of improperly evaluating the “pertinent stateof the art” or “inventive step” increases, since theapplication evaluators may not be exactly expertsin the matter; for example, pharmacology expertsmay evaluate nanotechnology applications thathave to do with distributing drugs in specificparts of the body, however, experts may notnecessarily have the necessary experience torigorously evaluate a pharmacological inventionrelated to nanotechnology. This problem can beaggravated later when patents that do not meetthe standard are granted and later canceled incourt.

Problems with nanotechnology in the field ofindustrial property increase when nanotechnologyinventions contain similar formulations of previouslydisclosed and patented structures, compounds,and materials. The most controversial exampleof this problem was the BASF case against OricaAustralia, where it was disputed that previouslyregistered BASF polymer nanoparticles of morethan 111 nanometers nullified the novelty ofparticles less than 100 nanometers that Orica wastrying to patent. The EPO, however, determinedthat the Orica particles were novel since theypresented improved properties such as thebrightness of their surface. This difference wasconsidered sufficient to validate its novelty. Thiscase invites us to reflect on the complications ofdeciding whether or not a patent application isnovel to nanoscales. Firstly, the difference in sizeof the different techniques has never beenenough to say that they are both novel. Then, wemust remember that in the history of intellectualproperty, the slightest coincidence with previoustechniques may be enough to nullify the “novelty”character of an application. Considering theseimplications, we can see how nanotechnologyis already beginning to challenge the criteriaestablished in industrial property.

When drafting the claims of a patent relatedto nanotechnology, the technical and legalvariables that help ensure a good probability ofgranting should be considered, especiallytaking into account that different Patent Officesworldwide interpret the principles that governthe law of patents in different ways, which canaffect the patentability of an invention.

Specifically, and in the case of Mexico, when

Technologyadvancesfaster thanthe legalframeworkthat coversit.

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YOUR IP EXPERTS IN BRAZILDELIVERING RESULTS

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TPL48 rankings - South America:Layout 1 24/6/20 15:53 Page 53


SOUTH AMERICAN RANKINGS 2020

Throughout the next few pages, you will view a comprehensivelist of the 10 most well-respected law firms from SouthAmerica, in alphabetical country and company order. Our focused list is derived from a multifaceted methodology,which uses months of industry research and feedback from our readers, clients, and esteemed connections around theworld. All firms are ranked top 10 in their jurisdiction but aredisplayed alphabetically to avoid bias.

Berken IPEstudio ChaloupkaG BreuerHausheer Belgrano & FernandezMarval O’Farrell & MairalNoetinger & ArmandoObligado & CiaO’Conor & PowerPalacio & AsociadosRichelet & Richelet

Argentina

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Bolivia

Leaders in Intellectual Property in Latin America, we provide the support for our clients to achieve the best protection and

Intellectual Property, since 1900. Our team is formed by lawyers, IP agents and attorneys with technical background ready to provide multidisciplinary advice and innovative solutions.

SOLUTIONS FOR A WORLDWHERE IDEAS ARE VALUABLE

Montevideo, Uruguay+598 2626 - 2304

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Brasília, Brazil+55 61 3433 - 6694

WE ARE DANNEMANN SIEMSEN


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Baker McKenzieBrigard & CastroCastellanos & CoCavelier AbogadosClarke Modet & CoDentons Cardenas & CardenasLloreda Camacho & CoOlarte Moure & AsociadosTriana Uribe & MichelsenVera Abogados Asociados

Colombia

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Bermeo & BermeoBustamante & BustamanteFabara AbogadosFalconi Puig AbogadosJulio C Guerrero BPaz HorowitzPérez Bustamante & PonceRomero Corral AbogadosQuevedo & PonceTobar ZVS

Ecuador

Av.12 De Octubre N26-97 Y Lincoln Edificio Torre 1492, Oficina 1505 Quito, Ecuador

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Albagli Zaliasnik SpAAlessandriBeuchat, Barros & PfennigerCareyClarke Modet & CoClaro y CiaEstudio VillasecaJohansson & LangloisSargent & KrahnSilva

Chile

Rankings: UK & Europe

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Paseo de la Reforma 265, M2Col. y Del. Cuauhtemoc, 06500 Mexico, D.F.Tel. (5255) 5533 0040, Fax. (5255) 5207 3150

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Peru

Rankings: UK & Europe

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SPACE TO FILL

Antequera Parilli & RodríguezBaker McKenzieBentata AbogadosBolet & TerreroClarke Modet & CoDe Sola Pate & BrownECV & AsociadosHoet Peláez Castillo & DuqueMarquez Henriquez Ortin & ValedonMoreau González & Asociados

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Patent and trademark prosecution and litigation.45 years of professional practice in all areas of IP practice representing clients from several countries.

Address: Manuel Almenara 265, Lima 18, Peru

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To enter your firm in the Directory of Services section please email [email protected]

Directory of Services

United Trademark & PatentServicesInternational Intellectual Property Attorneysspecialising in Trademarks, Patents, Designs,Copyrights, Domain Name Registration, Litigation &Enforcement services.

Address: 85 The Mall Road, Lahore 54000, PakistanTel: +92 42 36285588, +92 42 36285590,

+92 42 36285581, +92 42 36285584Fax: +92 42 36285585, +92 42 36285586,

+92 42 36285587Website: www.utmps.com & www.unitedip.comEmail: [email protected]: Yawar Irfan Khan, Hasan Irfan Khan

PAKISTAN

Bharucha & Co.Established in 1948, Bharucha & Co. is one of theleading Intellectual Property law firms in Pakistanproviding full range of IP services including allaspects of patents, trademarks, designs, copyright,domain names, licensing, franchising and litigation.The firm is ranked among the leading law firms inAsia by most of the prestigious legal referral guides.

Address: F-7/1, Block 8, K.D.A Scheme 5,Kehkashan Clifton, Karachi, Pakistan.

Tel: +92-21-3537 9544Fax: +92-21-3537 9557-58Website: www.bharuchaco.comEmail: [email protected]: Mohammad Fazil Bharucha, Abdul Aziz

PAKISTAN

PHILIPPINES

Romulo Mabanta BuenaventuraSayoc & de Los Angeles Founded in 1902, the firm is now 114 years old. Afull-service IP firm, it has pioneered in IntellectualProperty law practice, and some of its key casesdecided by the Philippine Supreme Court have beenfeatured in Philippine Reports, formerly the repositoryof the decisions of the Philippine Supreme Court, andnow in the Supreme Court Reports Annotated(SCRA).

Address: 21st Floor, Philamlife Tower, 8767 Paseode Roxas, Makati City 1226 Philippines

Tel/Fax: (632) 5559555; (632) 8134558;(632) 8103110

Website: [email protected]: [email protected]: Rogelio Nicandro; Joaquin V. Sayoc

RUSSIA

Vakhnina and PartnersOne of the leading IP firms in Russia. Advising ourclients on all aspects of IP in Russia, Ukraine,ex-USSR countries and Baltic States. Using our owntrademark search engine. Services: Patents,trademarks, designs, utility models, copyright,litigation and enforcement. Members of Russian PAAssociation, INTA, AIPPI, LESI, ECTA, PTMG, GIPC.

Address: Bld. 6, Preobrazhenskaya Pl., Moscow,107061, Russia

Tel: +7-495-231-4840Fax: +7-495-231-4841Website: www.vakhnina.comEmail: [email protected]: Dr. Tatyana VAKHNINA

Dr. Alexey VAKHNIN

SojuzpatentSojuzpatent is the oldest leading IP law firm on theterritory of the former USSR, with seven offices inRussia, and associates in all the neighboringcountries. We employ more than 150 people,including 50+ patent attorneys and litigation lawyers,to achieve seamless prosecution and successfullitigation. We offer everything you may need forprotecting your IP in the whole region.

Address: Myasnitskaya St., 13, Bldg. 5, Moscow,101000, Russia

Tel: +7 495 221 88 80/81Fax: +7 495 221 88 85/86Website: www.sojuzpatent.com Email: [email protected] Contact: Svetlana Felitsina, Managing Partner

Tatiana Petrova, Head of TrademarkDepartment

RUSSIA

NIGERIA

Aluko & Oyebode We are a full-service law firm focusing on patentprosecution rated for Patent Contentious by ManagingIntellectual Property. The Firm was named Law Firm ofthe Year 2015 and Intellectual Property & TechnologyTeam of the Year 2017 by Law Digest Africa Awards.The Firm was also named the Law Firm of the Year2016 and Intellectual Property Team of the Year 2017by ESQ Nigerian Legal Awards. We will continue toadvise clients on patent strategy in Nigeria, Ghana,OAPI and ARIPO.

Address: 1 Murtala Muhammed Drive, Ikoyi,Lagos, Nigeria

Tel: +234 1 462 8360 / +234 806 680 3387Website: www.aluko-oyebode.com Email: [email protected]

[email protected]: Uche Nwokocha, Partner

MEXICO CITY

TOVAR & CRUZ IP-LAWYERS, S.C.We are a specialized legal firm providing intellectualproperty and business law services. Founded in 2009.The purpose is that our clients not only feel safe,besides satisfied since their business needs have beenresolved, so, our professional success is also based onproviding prompt response and high quality,personalized service. “Whatever you need in Mexico,we can legally find the most affordable way”

Tel: 525556611278Website: www.tciplaw.mx Email: [email protected]

[email protected]@tciplaw.mx

Contact: Elsa Cruz, Martin Tovar

Deep & Far Attorneys-at-lawDeep & Far attorneys-at-law deal with all phases oflaws with a focus on IPRs, and represent someinternational giants, e.g. InterDigital, MPS, SchottGlas, Toyo Ink, Motorola, Cypress. The patentattorneys and patent engineers in Deep & Farnormally are generally graduated from the top fiveuniversities in this country. More informationregarding this firm could be found from the websiteabove-identified.

Address: 13 Fl., 27 Sec. 3, Chung San N. Rd.,Taipei 104, Taiwan

Tel/Fax: 886-2-25856688/886-2-25989900Website: www.deepnfar.com.tw Email: [email protected]: C.F. Tsai, Yu-Li Tsai

TAIWAN, ROC

Fenix LegalFenix Legal, a cost-efficient, fast and professionalPatent and Law firm, specialized in intellectualproperty in Europe, Sweden and Scandinavia. Ourconsultants are well known, experienced lawyers,European patent, trademark and design attorneys,business consultants, authorized mediators andbranding experts. We offer all services in the IP fieldincluding trademarks, patents, designs, disputeresolution, mediation, copyright, domain names, IPDue Diligence and business agreements.

Tel: +46 8 463 50 16Fax: +46 8 463 10 10Website: www.fenixlegal.euEmail: [email protected]: Ms Maria Zamkova

Mr Petter Rindforth

SWEDEN

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MEXICO

Goodrich Riquelme AsociadosOur staff of attorneys, engineers and computerspecialists help adapt foreign patent specifications andclaims to Mexican law, secure patent inventions andtrademark registrations and maintain them by handlingthe necessary renewals. Our computer system, whichis linked to the Mexican Patent and TrademarkDepartment, permits us to provide our clients with atimely notice of their intellectual property matters. Wealso prepare and register license agreements.

Address: Paseo de la Reforma 265, M2, Col. Y Del.Cuauhtemoc, 06500 Mexico, D.F.

Tel: (5255) 5533 0040Fax: (5255) 5207 3150Website: www.goodrichriquelme.comEmail: [email protected]: Enrique Diaz Email: ediaz@ goodrichriquelme.com

IPSOLIPSOL is a key service line focused on the planning,registration and management of trademark, patentand other IP rights portfolios, offering solutions thatenable to maximize the protection of your IP assets inMacau and worldwide.

Address: Avenida da Praia Grande, 759, 5° andar, Macau

Tel: (853) 2837 2623Fax: (853) 2837 2613Website: www.ipsol.com.moEmail: [email protected]: Emalita Rocha

MACAU

CHINA

ANSEN Patent Law OfficeEstablished in 1999, is a Chinese intelltual propertylaw firm located in Beijing, China, with goodreputation in professional service, competitive priceand high quality management. ANSEN is specializingin providing both domestic and international clientsprofessional service in the fields of the patent,trademark, copyright as well as IP litigation in China.Our attorneys and engineers have had extensiveexperience in technical fields of new material,mechanical, electrical & electronics, communication,computer science, food, biotechnology and agricultureengineering etc.

Tel: +86 10 82837725/6Website: www.citicip.comEmail: [email protected]: Xiaojuan Zhang and Lin XU

GUATEMALA

LexincorpA leading Central American law firm with 7 officeslocated in the major cities throughout the region.LEXINCORP has specialized in providing legaladvisory to our domestic and international clientelefor more than 40 years. Our regional practice hasevolved to integrate processes, services, knowledge,business, values and solutions to provide the highestquality results operated as a single, fully integratedCentral American firm with over 80 lawyers.

Address: 9a Avenida 14-78 zona 10, Guatemala,Guatemala, C. A.

Tel/Fax: (502) 2246 3000 / (502) 2333 5980Website: www.lexincorp.comEmail: [email protected]

[email protected] Contact: Mr Gonzalo Menéndez G., Ms Gina Roca

LUXEMBOURG

Patent 42Patent 42 is a law firm acting in Industrial Property.Our job is to help and assist companies andentrepreneurs in protecting and defending theirinvestments in innovation and creation.If innovation is first of all a state of mind, it is also a necessity and a source of development and growthfor your company. Investments carried out to developnew products or new activities deserve to beprotected.seeking to protect valuable originalcreations.

Address: 34, rue DicksL-4081 Esch-sur-AlzetteLuxembourg

Tel: +352 691 999 350Fax: +352 24 61 10 10Email: [email protected]

INDIA

Mehta & Mehta Associates Mehta & Mehta Associates (Gurgaon, INDIA) is a full-service boutique IP Law Firm, providing Filing,Prosecution and Litigation services in respect ofPatents (in different fields of science and engineering),Trade Marks, Designs and Copyright. The Firm assistsboth national and international clientele, from differentgeographical locations and backgrounds for all IPrelated contentious and non-contentious matters.

Address: Mehta & Mehta Associates, Mehta House,B-474, Sushant Lok-1, Sector-27,Gurgaon-122002, NCR, India

Tel: +91-124-410 8474, 410 8475Fax: +91-124-410 8476 Website: www.mehtaip.comEmail: [email protected]: Dr. Ramesh Kr. Mehta, Founder

Ankush Mehta, Principal Attorney

INDIA

HONDURAS

BUFETE MEJIA & ASOCIADOSA full-service Intellectual Property law firm covering:Honduras and Central America offering a convenientand cost-effective regional service. The firm servicesinclude filing, prosecution, maintenance, enforcementand defense of all types of intellectual property.Furthermore, the firm has strong litigation andarbitration capabilities and is known for handlingcomplex litigation matters as well as infringement and anti-counterfeiting actions before all Courts,Administrative Offices and Customs authorities.

Tel: +504 25507744 / +1 (914) 4125719Fax: +1 (718) 7322118Website: www.bufetemejia.comEmail: [email protected]: Ricardo Anibal Mejia Mejia

& Blanca Rebeca Mejia Lozano

Excellon IPEXCELON IP is a full-service Intellectual PropertySolutions Provider, guiding clients ranging from early-stage start-ups to MNCs across severalindustries in protecting their intellectual property inIndia and across the globe. Established with ourintellectual capital in the field of IP rights, we are a one-stop escape for all IP related matters.We have blend of experience including technical as well as IP laws and that makes us different. We believe in customer centric approach and alwayscommitted to provide customized solution suitable for client requirement and need.

Tel: +91 951233 2604Website: https://excelonip.com/Email: [email protected] Contact: Sanjaykumar Patel

(Founder- Principal IP Attorney)

India


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To list your firm in this section,please email

[email protected]

Pakharenko & PartnersPakharenko & Partners provides full IP service coveragein Ukraine, CIS countries and Baltic states and hasoffices in Kyiv and London. We pride ourselves on anexclusive expertise and experience in the fields of IPlaw, anti-counterfeiting and anti-piracy, pharmaceuticallaw, competition law, advertising and media law,corporate law, litigation and dispute resolution.

Address: P.O.Box 78, 03150 Kyiv, UkraineVisiting: Business Centre 'Olimpiysky',

72 Chervonoarmiyska Str., Kyiv 03150,Ukraine

Tel/Fax: +380(44) 593 96 93+380(44) 451 40 48

Website: www.pakharenko.comEmail: [email protected]: Antonina Pakharenko-Anderson

Alexander Pakharenko

UKRAINE

Young & ThompsonYoung & Thompson, established in 1903, is a fullservice intellectual property law firm focusing on U.S.patent and trademark prosecution of the highest qualitywhile maintaining costs at a moderate level. Young &Thompson has been recognized as an industry leaderfor innovation in new technologies and procedures,being among the first law firms adopting a paperlessworkplace, and co-developed an automated solution forcreating and executing all workflows.

Address: 209 Madison Street, Suite 500,Alexandria, VA 22314

Tel: 703-521-2297Fax: 703-685-0573Website: www.young-thompson.comEmail: [email protected]: Andrew Patch

UNITED STATES VIETNAM

Pham & AssociatesEstablished in 1991, staffed by 110 professionalsincluding 14 lawyers and 34 IP attorneys,Pham & Associates is one of the largest legalpractices in Vietnam specialized in IP. The firm isone of the biggest filers of patents, trademarks andindustrial designs each year and has been renownedfor appeals, oppositions, court actions and handlingIP infringements. The firm also advises clients in all aspects of copyright law.

Tel: +84 24 3824 4852Fax: +84 24 3824 4853Website: www.pham.com.vnEmail: [email protected]: Pham Vu Khanh Toan, Managing Partner

General DirectorTran Dzung Tien, Senior IP Consultant

TURKEY

Destek PatentWe are a multinational legal practice that hasprovided full range Intellectual Property servicesincluding trademarks, patents, designs, plant varietyprotection and more since 1983. With more than200 qualified in-house staff, including 50 patent andtrademark attorneys, we are able to assist domesticand international clients worldwide.

Address: Eclipse Business D Blok No:5, ISTANBULTel: +90 212 329 00 00Website: www.destekpatent.comEmail: [email protected]: Claudia Kaya

([email protected])Murat Bürkev([email protected])Simay Akba([email protected])

VIETNAM

ELITE LAW FIRMELITE LAW FIRM, with a team having solid expertise ina broad range of Intellectual Property, providesprofessional and highest quality in IP matter in Vietnamas well as many countries around the world such asLaos, Cambodia, Myanmar, Thailand… Optimizingclient’s benefits is our top goal. We commit to obtain IPrights for our diverse cilents by expeditious solutionsand in the most effective way.

Address: 255 Hoang Van Thai Street, Thanh Xuan District, Hanoi, Vietnam

Tel: (84-24) 37373051Fax: (84-24) 37373056Website: lawfirmelite.comEmail: [email protected]: Mr. Nguyen Tran Tuyen – Managing Partner/

Patent and Trademark Attorney

SIPI Law AssociatesSIPI Law Associates is a boutique commercial lawpractice in Uganda, with a bias to Intellectual PropertyLaw. Our IP advisory services cover all transactionalaspects of Patents, Trademarks, Copyright, Industrialdesigns, Trade Secrets and licensing aspects. The firmphilosophy is based on providing first class legal servicesbased on the integrity of our staff, giving our clientssound legal and timely advice, as well as holding ourclients’ information in the utmost confidentiality.

Address: PO BOX 4180, KAMPALA, UGANDAVisiting: Jocasa House, Third Floor, Unit 5 Plot

14 Nakasero Road.Tel/fax: +256 393 272921/ +256 414

235391 / +256 752 403 763Website: www.sipilawuganda.comEmail: [email protected]: Paul Asiimwe; Dinnah Kyasimiire

Uganda


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