2.patentoppos2.ition 2008

8/13/2019 2.Patentoppos2.Ition 2008

1/5

Oppositions in India Feature

The patent oppositionsystem in India

14 IP in the life sciences industries 2008 www.iam-magazine.com

The Indian patent system was revolutionisedon 1st January 2005, when the doors werefinally opened to product patents for food,chemicals and pharmaceuticals. However,while the new patent regime offers a wealth of new opportunities to innovator companies, ithas also been dogged by increasing backlogs,delays in grant and the constant risk thatpatents are open to challenge at any stage.

While the wrongful grant of a patentcreates a wrongful monopoly, undue delay inthe grant of a patent is an unfair situationthat causes loss to the innovator. A balancebetween the interests of patent applicants

and the need to prevent bad patents istherefore essential to ensure a steady prosecution process and encourage R&D;but such a balance has not been achieved inIndia. This article examines the Indianopposition procedure and its implications.

BackgroundOpposition prior to the grant of a patent hasalways been possible. The Patents Act 1970allowed for opposition by an interested party within a specified timeframe. However,statistics from this period indicate that onlya handful of oppositions were filed under the1970 Act. As the deadline for compliancewith the Agreement on Trade-Related Aspectsof Intellectual Property Rights (TRIPs)loomed, there was concern in the Indianpharmaceutical industry that once the productpatent regime took off in 2005 there would bean increase in the number of frivolous patentsgranted, particularly within the pharmaceuticalsector. This meant that, when suggestingrevisions to the Patent Act, the governmentand policy makers had to strike a balancebetween ensuring compliance with TRIPs andrespecting the concerns of the Indianpharmaceutical industry.

It took 29 years to make the firstamendments to the Patents Act. The PatentAmendment Ordinance 2004 provided forpre-grant representation and alsointroduced post-grant opposition. Pre-grantrepresentation under the Ordinance waslimited to the grounds of patentability (ie,novelty, inventive step and industrialapplication), as well as wrongful/non-disclosure of the source and geographicalorigin of biological material used in theinvention and anticipation of the inventionfrom knowledge available within a local orindigenous community in India or elsewhere.However, the representation could be madeby any person. The grounds for post-grantopposition, on the other hand, were muchbroader than those for pre-grant

representation.The main drawback of the post-grant

opposition process is that this remedy isavailable only through the courts, makingredressal a lengthy process and, in the caseof bad patents, allowing the patent holder toenjoy a wrongful monopoly. This is of particular concern in India, given theprotracted nature of the judicial process.This shortcoming was addressed in 2005,when fully fledged pre-grant oppositionreplaced pre-grant representation. Therefore,a dual opposition system now prevails,allowing both pre and post-grant oppositionof a patent in order to prevent the grant of bad patents.

The grounds for both pre and post-grantopposition are identical and there is nothingto preclude a pre-grant opponent fromsubsequently filing a post-grant opposition.However, despite the similarities, there arealso several procedural differences betweenthe two types of opposition. First, any person can file a pre-grant opposition,whereas only an interested person can filea post-grant opposition. Second, Section25(1) of the Act does not explicitly allow thepatent applicant the opportunity to be heard

By Archana Shanker and Neeti Wilson ,Anand and Anand


2/5IP in the life sciences industries 2008

Oppositions in India

www.iam-magazine.com

in a pre-grant opposition. Third, there is noremedy against an order of the Controller ina pre-grant opposition, except to file a writ

petition under the Indian Constitution.Finally, the lengthy administrative delays inthe grant of patents result in an open-endedtimeframe to file pre-grant oppositions, thuscompounding the plight of patent applicants.

Pre-grant oppositionSince the Gleevec case, pre-grant oppositionin India has come under close internationalscrutiny. Proponents of the pre-grant systemmaintain that the initial examinationconducted by the Patent Office may behampered by a lack of information, and thatthe pre-grant opposition can remedy this by bringing little-known information to theattention of the Controller. However, theopposition of patents at the pre-grant stagedelays the prosecution and consequent grantof the patent, to the applicants cost. Pre-grant representation, as proposed in the2004 Ordinance, would thus be a betteroption to assist in the accretion of information of which the patent examinerwould otherwise be unaware. This argumentin support of pre-grant opposition also castsdoubt on the capabilities of the Indian PatentOffice to conduct a thorough substantiveexamination itself. However, any such doubtsshould be laid to rest by 2009, when the

Indian Patent Office will be granted thestatus of international searching authority under the Patent Cooperation Treaty. ShouldIndia therefore be setting an internaldeadline to abolish the pre-grant oppositionsystem in favour of invalidation proceedings,as in most countries, so as to prevent apatent from being repeatedly attacked underduplicative administrative and judicialopposition systems, and relieve patentees of the undue burdens of increased costs anddelays. India would do well to emulatesystems as in Japan, China and Korea,which seem to be operating successfully.

Beyond 2005Since 2005, a total of 250 pre and post-grant oppositions have been filed at theIndian Patent Office. While in the 2004-2005financial year the number of oppositions filedstood at just 86, by the following year thisfigure had almost doubled to 155. Reportsdating from March 2007 indicate that of thepre-grant oppositions filed to date, two havebeen rejected, 10 have been upheld and theremainder are pending.

An analysis of the industries in whichpre-grant oppositions have been filed

reveals that the pharmaceutical sectorfeatures heavily. Some relevant cases areoutlined below:

Domestic drug manufacturer USV Ltdfiled a pre-grant opposition against USpharmaceuticals giant Eli Lilly & Cospatent application IN/PCT/2000/00119for Forteo, its osteoporosis drug. Afterhearings which lasted a year, the KolkataPatent Office rejected the application ongrounds that included prior knowledgeand failure to establish enhancement of known efficacy.

The Indian Network for People Living withHIV/AIDS filed a pre-grant oppositionagainst Glaxos patent application872/CAL/98 for abacavir hemisulfatesalt. Glaxo subsequently withdrew theapplication and hence the opposition wasnot decided. Another interesting caseinvolved GlaxoSmithKline (GSK), which inOctober 2007 withdrew its patentapplication for Trizivir, a fixed-dosecombination of lamivudine, zidovudineand abacavir sulfate. GSK, which has apatent for this combination drug in theUnited States and other countries, hadapplied to the Kolkata Patent Office for apatent in 2000, but Cipla had objectedto the application and filed a pre-grantopposition in 2006.

Indian companies Natco Pharma and GM

Pharmaceuticals filed pre-grantoppositions against AstraZenecas patentapplication 841/DEL/96 for Iressa, abranded formulation of the lung cancerdrug known in generic terms as gifitinib.The main grounds for the opposition werelack of inventive step and prior knowledge.After hearings which lasted more than ayear, the New Delhi Patent Office rejectedAstraZenecas patent application, citingknown prior use of the drug.

Panacea Biotec Ltd filed a pre-grantopposition against Stoplik Services IndiaPvt Ltds patent application for animesulide preparation.

US-based non-governmental organisation(NGO) I-MAK and Cipla have filed a pre-grant opposition at the Mumbai PatentOffice against Abbott Laboratories Ltdspatent application for its heat stableform of HIV drug combinationlopinavir/ritonavir (Kaletra).

Pre-grant oppositions filed by the IndianNetwork for People Living with HIV/AIDSand Tamil Nadu Networking Peopleagainst Roches valganciclovir drug havebeen rejected by the Chennai PatentOffice. However, the Lawyers Collective


3/5



has objected to the grant and Cipla hasalso decided to file post-grant oppositionagainst the patent.

Interestingly, as is illustrated by theabove examples, most pre-grant oppositionsare filed by generic drug companies or NGOsagainst innovator pharmaceutical companies.It is difficult to dispel the notion that majorblockbuster drugs are not a deserving targetof such oppositions, which delay the grant of important patents.

Section 3(d) of the Patents ActOpposition proceedings are not the only way in which to prevent the grant of bad patents.The Patents Act includes standards thatexceed the basic requirements of patentability (ie, novelty, inventive step andindustrial application). In addition to providingthat energy-related inventions are notpatentable, the Patent Act 2005 contains along list of things which do not constituteinventions under the Act. The mostcontentious point of the list is Section 3(d),which provides that the mere discovery of anew form of a known substance, which doesnot result in the enhancement of the knownefficacy of that substance, is not patentable.This is the most questionable requirement of the Patents Act, as it sets higher standardsfor assessing the criteria of non-obviousness

and inventive step. Further, the Act does notregard the mere discovery of a new property or new use of a known substance as aninvention. Also, mere use of a knownprocess, machine or apparatus is notconsidered an invention under the Act, unlesssuch known process results in a new productor employs at least one new reactant.

The Act fur ther clarifies that salts, esters,ethers, polymorphs, metabolites, pure form,particle size, isomers, mixtures of isomers,complexes, combinations and otherderivatives of known substances shall beconsidered to be the same substance unlessthey differ significantly in properties withregard to ef ficacy. Once again, no definitionof efficacy is provided, which leaves roomfor interpretation. However, on a plain readingof Section 3(d), it is clear that a significantdifference in efficacy is not required for aninvention to qualify for patent protection. Asmay be interpreted from the explanation,Section 3(d) requires a significant differencein properties to result in an efficaciousproduct. Further, an interpretation of the termefficacy should not be restricted topharmacological and therapeutic efficacy, asnowhere does the Act define the term in such

a limited manner. The statute does notdiscriminate between pharmaceutical andnon-pharmaceutical inventions. This provision

extends to chemical compounds,intermediates for pharmaceutical products,agro-chemicals, food-based chemicals etc,all of which cannot imaginably be requiredto establish therapeutic efficacy in order toqualify for a patent. Even in respect of pharmaceutical products, efficacy can includetherapeutic efficacy and/or non-therapeuticefficacy, such as improved thermodynamicstability, improved processing, solubility characteristics, enhanced patient compliance,economic efficacy and reduced microbialdrug resistance.

It remains to be seen how this provisionwill be interpreted by the Indian Patent Officeand the courts. One trend that seems to beemerging from the pre-grant oppositions filedthus far is that the term efficacy is beinginterpreted only to mean therapeuticefficacy. Therefore, this provision of the Actought to be applied and interpreted very carefully, with a view to encouragingincremental innovations and preventing theevergreening of patents.

Post-grant opposition systemThe new post-grant opposition system underthe Patents Act 2005 has yet to take centrestage. The Indian Patent Offices annual

report for 2005-2006 indicates that just sixpost-grant oppositions were filed that year,although the numbers have since picked up:a preliminary search of the Indian PatentOffice Journal from 2005 onwards showsthat more than 50 post-grant oppositionshave been filed in the past three years.The trend of filing post-grant oppositiondoes not seem to be confined to thepharmaceutical industry, but it is alwayspossible that pharma-related post-grantopposition filings may yet come to dominate.

One such example is the Pegasys episode. Roche was among the firstpharmaceutical companies to obtain aproduct patent in India, in this case forpegylated interferon alpha 2a (Pegasys:Patent 198952). A post-grant oppositionhas already been filed against this patentby Wockhardt and by NGO Sankalp.

It appears there is also a possibility of further post-grant opposition filings by CPAAand Cipla against Roches patents forHerceptin and Tarceva respectively.

Revocation of patentsAgain, the opposition procedure is not thesole route by which a third party can attack


4/5IP in the life sciences industries 2008


www.iam-magazine.com

a patent before the Indian Patent Office:under the Patents Act a patent may also bechallenged at any point during its lifetime by

means of revocation proceedings brought ongrounds similar to those for pre and post-grant proceedings. Revocation proceedingsmay be initiated at any time after grant even within one year of grant, which is thewindow specified by Section 25(2) of the Actfor filing post-grant opposition. Thus, anopponent can essentially attack a patent viatwo different routes simultaneously.

Litigation: an emerging weaponBesides the Indian Patent Office, the othertwo forums in which a patents validity may be challenged directly are the IntellectualProperty Appellate Board (IPAB) and the HighCourts. As IPAB was only recently set up, on2nd April 2007, it has not yet contributedsignificantly towards patent case law.However, the High Courts have developedthis considerably: they now hear almost fivetimes more patent cases as they did adecade ago.

Wockhardts application for its drugNadoxin (nadifloxacin) (308/MUM/1175) isone such example of how patent litigation isshaping up in India. Wockhardt was grantedexclusive marketing rights (EMR) for Nadoxinand filed an infringement action against HeteroDrugs at the Madras High Court. In response,

Hetero filed a writ petition challenging theconstitutional validity of the grant of EMR andsought an order restraining Wockhardt fromtaking any action based on the EMR, as wellas seeking revocation of the EMR granted.Hetero prevailed at first instance, but thedecision was reversed on appeal before theDivision Bench of the Madras High Court. Thematter was brought before the Supreme Court,which modified the High Court injunction,restricting it to the manufacture of nadifloxacincream 1% only. The twist in the tale camewhen the patent application was refused by the Indian Patent Office under Section 3(d)and on grounds of anticipation.

In another famous case, a pre-grantopposition was filed against Novartisspatent application for Gleevec(1602/DEL/1998) on similar grounds:namely anticipation and Section 3(d). TheIndian Patent Office rejected the patentapplication in January 2006, despite asubmission citing 30% increasedbioavailability of the claimed product overprior art as efficacy. Novartis responded by filing two writ petitions: one challenging therejection of the application and the otherchallenging the constitutional validity of

Section 3(d) of the Indian Patents Act.The first petition has been referred to

IPAB. The hearing is still pending due to

controversy over who the technical memberof the Board would be. Respondent 1 (UOI,DIPP) has proposed to hear the case withoutthe technical member and Novartis hasagreed to this proposal. However, Natcoobjected to this solution before the SupremeCourt. The Supreme Court recently held thatIPAB cannot hear Novartis s patent rejectionchallenge without a technical member.

The second petition, attacking the validity of Section 3(d) of the Indian Patents Act forimposing additional patentability requirements as laid down by TRIPs, wasrejected by the Madras High Court, primarily on the following grounds: The dispute settlement mechanism

under the Patent Cooperation Treaty (provided under Article 64 of TRIPs) isthe appropriate forum for deciding onissues relating to TRIPs compliance.

There is no ambiguity or vagueness inthe expressions incorporated in theamended Section 3(d) and theexplanation attached thereto.

The High Court further held that no lawcan be declared illegal because there is apossibility of its misuse, and that theLegislature has a duty to safeguard the

economic interest of the country.Meanwhile, in January 2008 Roche filed

a patent infringement suit against Cipla withregard to its patented anti-cancer drugTarceva. Natco had previously filed a pre-grant opposition against the Tarceva mailboxapplication, which was subsequently rejectedby the Delhi Patent Office. The Tarcevaepisode illustrates the increasing frequency with which parties are approaching thecourts for relief.

Patent litigation is thus taking off in Indiaand pharma companies are the forerunnersof this trend, whether as plaintiffs ordefendants. The validity and enforcement of patents are thus emerging issues with whichthe Indian courts must contend.

OutlookThe new two-stage patent opposition processhas fuelled fears among innovatorcompanies, particularly in thepharmaceutical industry. Patent applicantsare now vulnerable to multiple pre-grantoppositions filed by competitors, or even by a single competitor. Moreover, there isnothing to stop a party which has filed a pre-grant opposition from subsequently filing an


5/5



opposition once the patent has beengranted. As a result, continuous andrepeated opposition proceedings may be

launched against the same patentapplication. The resulting delays are a majorcause of concern for the patent applicant, asthe patent term begins to run from the dateof filing of the application. This wave of opposition proceedings is also exacerbatingthe backlog of patent prosecutions at theIndian Patent Office. Given that revocationand litigation are also available options tochallenge a patent, the delay in grant may beregarded as bias against the patentee.

If the Indian Patent Office isnonetheless determined to prevent thegranting of bad patents, it is worth

revisiting the 2004 Ordinance, whichprovided for pre-grant representationrather than the disruptive oppositionproceeding. Retention of post-grantopposition presents no problems, as thisproceeding suits the interests of bothpatent applicant and opponent. TheGovernment must thus address theoverriding need to boost the momentum of R&D efforts for the benefit of both society and patent holders alike.

Archana Shanker has been with Anand and Anand since 1995.Her areas of practice include drafting patent applications, infringement opinions and validity analyses; handling patent prosecutions and oppositions, from filing through to hearing; drafting patent applications for international filings; and representing clients before the US,European and Japanese Patent Offices.

Ms Shanker also handles complex patent litigation issues before various judicial and quasi-judicial forums in India, and advises clients on patent strategies and regulatory affairs. She conducts regular workshops on patent matters specific to clients' requirements.

Archana Shanker Senior partner patents Email: [email protected] Tel: +91 120 4059300

Anand and Anand India www.anandandanand.com

Neeti Wilson is a senior associate in the patent department of Anand and Anand, New Delhi. She is registered as a patent agent at the Indian Patent Office and holds a PhD in molecular biology from TERI- School of Advanced Studies, New Delhi. She has also completed a course on patent law at Nalsar University of Law, Hyderabad. Prior to

joining Anand and Anand, Ms Wilson was a research associate in TERI,New Delhi and published research papers in international journals.She was also associated with the TIFAC Patent Facilitating Centre.Her main areas of practice are drafting and prosecution, patent mining,biotechnology, plant variety protection, biodiversity and life sciences.

Neeti Wilson Senior associate Email: [email protected] Tel: +91 120 4059300

Anand and Anand India www.anandandanand.com

2.patentoppos2.ition 2008

Documents