Prior informed consent to patent applications by donors

of human genetic material

NCCR, BerneMarch 28, 2007

antony.taubman@wipo.int

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Journal articles(Westlaw)

●Genetic material– any material of plant, animal, microbial or

other origin containing functional units of heredity

●Genetic resources– genetic material of actual or potential value

●But who values? And whose values? When?

the genetic paradox

●Genetic materials:– a common biological root– great majority of genes are shared – common mechanism for reproduction and

transmission of traits, coding for proteins– but forms the basis – the very expression

- of diversity– and are perceived, exploited and

regulated by distinct regimes

●Human genetic resources ●Animal genetic resources●Plant genetic resources for food and

agriculture●Biodiversity-related genetic

resources●Space law?

● Human genetic resources

● Animal genetic

resources

● Plant genetic resources for food and agriculture

● Biodiversity-related genetic resources

● UNESCO, WHO, UNHRC

● FAO

● FAO – International Treaty

● CBDcovers ‘other’ genetic material, but not human genetic resources(COP Decision II/11)

THE RICE WITH HUMAN GENESby Sean Poulter -

The first GM food crop containing human genes is set to be approved for commercial production. The laboratory-created rice produces some of the human proteins found in breast milk and saliva. Its U.S. developers say they could be used to treat children with diarrhoea, a major killer in the Third World. The rice is a major step in so-called Frankenstein Foods, the first mingling of human-origin genes and those from plants. But the U.S. Department of Agriculture has already signalled it plans to allow commercial cultivation.

HUMAN GENES IN MY FOOD? YES, PLEASE

Horror of horrors! "Human genes in your food! Rice crops to be genetically modified with human DNA" screams the front page of today's Daily Mail.

If this disturbing news made you swallow in shock, you just got a dose of the products of two of the human genes in question. One is lysozyme, an enzyme that kills some bacteria by breaking down their cell walls. The other is lactoferrin, an iron-binding protein that helps us absorb the metal while starving bacteria of it. It also attacks viruses and bacteria in several other ways.

Both molecules are found in our saliva, tears and other secretions, including breast milk. You also consume somewhat different animal versions of these proteins with just about every meal - eggs are rich in lysozyme, for instance, while cow's milk contains both proteins.

Thanks to their antimicrobial and other benefits, some health food companies already sell lysozyme and lactoferrin supplements. But it's babies who need these proteins most - human milk is rich in lysozyme and lactoferrin. Infant formula contains neither, which may be one of the reasons why breastfeeding is so much healthier. Hence the interest in adding lysozyme and lactoferrin to formula and related products such as the rehydration fluids given to young children with diarrhoea.

Comparative genomics studies of mammalian genomes suggest that approximately 5% of the human genome has been conserved by evolution since the divergence of those species approximately 200 million years ago,

the polyvalence of genetic materials

Genetic information

Collectiveidentity

Collectiveinheritance

Functionaltool

Physical sample

Genetic material

ways of seeing

the polyvalence of genetic materials

‘Pre-competitive’information

(HUGO)

Social utility/public welfare

Value ofcollective identity

Knowledgeof genome as a public

good

Scientific potential

Commercialpotential

Value of personal integrity and human dignity

Genetic material

ways of valuing:‘actual or potential value’

the polyvalence of genetic materials

Ownership ofknowledge

Collective personality

right

Communityresource/

common heritage‘kind of national property

‘

Control overex situ use

Contractlaw

Law of civil liability

Ownershipof a

chattel

Genetic material

ideas of property, access & control

the polyvalence of genetic materials

Privacy of genetic information

Prior informedconsent as

a right

Right to health

Right to property

Right to collective identity

Moral & material interests as author of scientific

production

Communityresource/

common heritage‘kind of national property

‘

Access to scientific advances

Genetic material

human rights

perspectivesinnovation

solidarity

morality

equity

dignity

UNESCO Universal Declaration on Bioethics and Human Rights

human beings … an integral part of the biosphere

●Art 3: Human dignity to be fully respected

●Art 8: privacy of personal information●Art 15: sharing benefits from scientific

research and its applications (including access to quality health care)

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human

Subjects

8. Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. … Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research and for those for whom the research is combined with care.

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human

Subjects

22.In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the subject has understood the information, the physician should then obtain the subject's freely-given informed consent …

United Nations Declaration on the Rights of Indigenous

Peoples, adopted by the Human Rights Council (June 29, 2006)

●‘‘provide effective mechanisms for prevention of, and redress for . . . any action which has the aim or effect of depriving [indigenous peoples] of their integrity as distinct peoples, or of their cultural values or ethnic identities’’.

General Comment on Art.15(1)(c) of the International Covenant on Economic, Social and

Cultural Rights

●collective interests of indigenous peoples relating to their productions, which are often expressions of their cultural heritage and traditional knowledge

●measures to recognize, register and protect the individual or collective authorship of indigenous peoples under national intellectual property rights regimes

●prevention of ‘‘the unauthorized use of scientific, literary and artistic productions of indigenous peoples by third parties’’.

The right of everyone to the enjoyment of the highest attainable standard of physical and mental health

● Medical care in the event of sickness, as well as the prevention, treatment and control of diseases, are central features of the right to the highest attainable standard of health.

● These features depend upon access to medicines. Thus, access to medicines forms an indispensable part of the right to the highest attainable standard of health.

● Numerous court cases, as well as resolutions of the Commission on Human Rights, confirm that access to essential medicines is a fundamental element of the right to health.

● Some of the cases also confirm that access to essential medicines issues are closely connected to other human rights, such as the right to life.

– Report of the Special Rapporteur – UNGA, September 13, 2006, A/61/338

Leveraging the ‘right to health’

INDONESIA TO RESUME SHARING H5N1 AVIAN INFLUENZA VIRUS SAMPLES FOLLOWING A WHO MEETING IN JAKARTA

● 27 MARCH 2007 | JAKARTA -- WHO welcomes the news from the Minister of Health of Indonesia, who announced at a joint news conference today that the country would resume sharing of H5N1 avian influenza virus samples “immediately”. This commitment by the Government of Indonesia follows a two-day meeting organized by WHO in Jakarta on 26-27 March 2007.

● Indonesia’s Minister of Health, Siti Fadilah Supari, has focused global attention on the fact that developing countries have supplied H5N1 virus to WHO Collaborating Centres for analysis and preparation for vaccine production, but that the resulting vaccines produced by commercial companies are likely to be unavailable to developing countries such as Indonesia. She called this system “unfair.”

● At the same time, withholding viruses from WHO Collaborating Centres poses a threat to global public health security and the ongoing risk assessment for influenza, conducted by WHO Collaborating Centres.

When news of the Hagahai and Solomons patents serviced (sic), it seemed incomprehensible that a foreign government could patent DNA cells collected from Pacific indigenous people without the informed consent of the individuals, their communities or even their national governments.

The Pacific patents were eventually challenged by the governments of Papua New Guinea and the Solomon Islands, but the US government rejected their concerns taking the view that the source of the DNA (and by implication the process in which they were collected) was of no consequence.

?

Consent? Consent?

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Series1

C12N 5/00 Undifferentiated human, animal or plant cells

PCT applications by year of publication

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C12N-5/08 - Human cells or tissues  - year of PCT publication

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JP

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FR

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AU

DK

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EP

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C12N-5/08 - Human cells or tissues PCT – nationality of principal applicant

what linkage with patent system?

Nature of claim over genetic material

Impact on patent system

Property right Title in patent? (Moore) Conversion? (Moore)Unjust enrichment?

Consent… to research

Inequitable conduct?Obligation to disclose PIC?

Consent… to commercialize/

seek patent

Fraudulent concealment(Greenberg)Breach of contractInequitable conduct?Obligation to disclose PIC?

what linkage with patent system?

Nature of claim over genetic material

Impact on patent system

Bioethics/ human dignity

Unpatentable as contrary to morality?

Collective ownership/ entitlement to

equitable benefits

Right of equitable benefitsObligation to disclose

Commons … to commercialize/

seek patent

Fraudulent concealment(Greenberg)Breach of contractInequitable conduct?

Nature of mechanism

Subject matter Linkage with invention

Legal basis Nature of obligation

Consequences of failure

Implementation

Acknowledgement of inventorship

Traditional knowledge

Part or entirety of the claimed inventive concept

Entitlement to apply derived from actual inventor(s);Paris Convention obligation to identify inventor

If TK holder contributes to claimed inventive concept, requirement to disclose identity.Possible requirement to identify TK holder as co-applicant/co-owner, or as sole applicant/owner.

Application may be refused

Office may request further information in the event prima facie doubt exists re identity of inventorAdministrative or judicial proceedings for opposition, revocation or full/partial transfer of patent to TK holder

Declaration of TK as relevant prior art

Traditional knowledge that meets legal criteria for prior art[and that is known to applicant]

Relevant to the patentability of the claimed invention (e.g. novelty and inventiveness/ non‑obviousness

Patentability of invention includes novelty and inventive step (or non-obviousness).Obligation to inform office of known relevant information.

Applicant is obliged to disclose all known prior art relevant to patentability of claimed invention, including traditional knowledge.

‘Fraud on the office’ or similar offence; sanctions for inequitable behaviour;Failure to disclose known TK may render patent unenforceable.

Failure to disclose may become apparent during examination or enforcement of patent, or in opposition or revocation proceedings

Definition of prior art

Traditional knowledge

TK explicitly designated as prior art that vitiates novelty and/or non-obviousness

Clarification of existing law of patentable inventions

Invention must be novel and non-obvious

Claims may be narrowed, refused or revoked.

Relevant to examination, opposition or revocation proceedings.

Definition of patentable invention

Traditional knowledge and/or GBMR

Invention cannot consist of existing TK or certain GBMR

Law defining scope of patentable subject matter

Claimed invention must fall within permitted subject matter

Claims may be narrowed, refused or revoked.

Relevant to examination, opposition or revocation proceedings.

Nature of mechanism``

Subject matter Linkage with invention

Legal basis Nature of obligation

Consequences of failure

Implementation

Specific disclosure of TK or GBMR, or related ABS-compliance measure

(i) TK(ii) TK associated with GR(iii) genetic resources(iv) biological resources and/or(v) biological materialWhere(i) source/origin of TK/GR is already known to applicant; or(ii) applicant can determine its source/origin through reasonable effort; or(iii) TK/GR is not subject to any such qualification]TK/GR may be in public domain [or may be hitherto undisclosed]

Invention(i) directly based on TK/GBMR(ii) [essentially] derived from TK or GBMR(iii) uses biological material(iv) makes immediate use of GR (depends on its specific properties)(v) resulted from research using GBMR or TK, which were - essential/necessary - incidental - necessary to deriving the invention(vi) partly or entirely comprises TK/GBMRor there is an obligation or responsibility under ABS law, regulation, permit, licence or agreement relating to TK or GBMR that covers(i) the research or related activities that lead to the invention, or(ii) the attainment of the invention, or(iii) the act of filing for patent on the invention.

Compliance with ABS laws in the country of origin, with the terms of an ABS licence or permit, or with specific contractual obligations to provider of GBMR or TK.Ownership rights established on the basis of an ABS law or specific ABS agreement.Expanded application of patent law disclosure principles.Principles governing equitable behaviour and the equitable basis of an entitlement to apply for, be granted or enforce a patent.

Patent applicant is obliged to:(i) disclose the origin or source of the GBMR or TK(ii) provide a declaration, evidence or certification of prior informed consent relating to access(iii) provide a declaration, evidence or certification of an agreement to share benefits, or of actual sharing of benefits and/or(iv) ensure TK or GMBR used in invention are legitimately sources(v) ensure applicant has derived proper title from the inventor and third party interests (e.g. provider of TK or GBMR) are reflected in identification of applicant.

(i) Application considered incomplete upon filing without required declaration or documentation(ii) Application rejected during formality examination (with/without procedure for rectifying)(iii) Application rejected during substantive examination (with/without procedure for rectifying)(iv) Patent not granted or sealed until/unless required material is provided(v) Patent opposed or revoked if required material is lacking. (vi) Patent ownership transferred in whole/in part to beneficiary of ABS law or agreement.(vii) Patent is not enforceable on basis of equity.

(i) routine step during formal/substantive examination(ii) grounds for opposition, revocation, or unenforceability of patent(iii) basis for claim of assignment or transfer of patent in whole or part to ABS beneficiary.

Nature of mechanism

Subject matter Linkage with invention

Legal basis Nature of obligation

Consequences of failure

Implementation

Obligation outside patent law to disclose details of access/use, or to cede/share ownership

GBMR and/or TK provided under an ABS or related law, or within the terms of a specific ABS agreement.

Defined by obligations under the ABS or related law, or the specific ABS agreement.

ABS or related law in country of originContract obligation in country of origin, to be recognized in patenting country.

Obligation to disclose TK or GBMRObligation to include ABS beneficiary as applicant or co-applicant

Breach of obligation under law or contractTransfer of ownership in whole or part.

Counterclaim during patent enforcementChallenge by interested party

Deposit of microorganisms or biological material

Microorganisms, or biological material

Relevant to patent procedure (e.g. invention cannot be fully disclosed or enabled without access to microorganism or biological material)

Obligation to disclose invention under basic patent law principles cannot be fulfilled without deposit of actual sample.Budapest Treaty arrangements for international recognition of deposit.

Disclosure of actual sample;Provision of certification regarding deposit to patent authorities.

Patent may be found inadequately disclosed, resulting in

Certification provided during patent procedure.

Broadening disclosure obligations

Proposed Article 29bis: Disclosure of Origin of Biological Resources and/or Associated Traditional Knowledge

1. For the purposes of establishing a mutually supportive relationship between this Agreement and the Convention on Biological Diversity, in implementing their obligations, Members shall have regard to the objectives and principles of this Agreement and the objectives of the Convention on Biological Diversity.

2. Where the subject matter of a patent application concerns, is derived from or developed with biological resources and/or associated traditional knowledge, Members shall require applicants to disclose the country providing the resources and/or associated traditional knowledge, from whom in the providing country they were obtained, and, as known after reasonable inquiry, the country of origin. Members shall also require that applicants provide information including evidence of compliance with the applicable legal requirements in the providing country for prior informed consent for access and fair and equitable benefit-sharing arising from the commercial or other utilization of such resources and/or associated traditional knowledge.

3. Members shall require applicants or patentees to supplement and to correct the information including evidence provided under paragraph 2 of this Article in light of new information of which they become aware.

4. Members shall publish the information disclosed in accordance with paragraphs 2 and 3 of this Article jointly with the application or grant, whichever is made first. Where an applicant or patentee provides further information required under paragraph 3 after publication, the additional information shall also be published without undue delay.

5. Members shall put in place effective enforcement procedures so as to ensure compliance with the obligations set out in paragraphs 2 and 3 of this Article. In particular, Members shall ensure that administrative and/or judicial authorities have the authority to prevent the further processing of an application or the grant of a patent and to revoke, subject to the provisions of Article 32 of this Agreement, or render unenforceable a patent when the applicant has, knowingly or with reasonable grounds to know, failed to comply with the obligations in paragraphs 2 and 3 of this Article or provided false or fraudulent information.

IP/C/W/474, 5 July 2006: Communication from Brazil, China, Colombia, Cuba, India, Pakistan, Peru, South Africa, Thailand and Tanzania

●Where the subject matter of a patent application concerns, is derived from or developed with biological resources and/or associated TK,

●Members shall require applicants to disclose the country providing the resources and/or associated TK, from whom in the providing country they were obtained, and, as known after reasonable inquiry, the country of origin.

●Members shall also require that applicants provide information including evidence of compliance with the applicable legal requirements in the providing country for prior informed consent for access and fair and equitable benefit-sharing arising from the commercial or other utilization of such resources and/or associated traditional knowledge.

Egypt – patent law

●Where the invention involves biological, plant or animal product, or traditional medicinal, agricultural, industrial or handicraft knowledge, cultural or environmental heritage, the inventor should have acquired the sources in a legitimate manner.

Andean Community Decision 486

●The Member Countries shall ensure that the protection granted to intellectual property elements shall be accorded while safeguarding and respecting their biological and genetic heritage, together with the traditional knowledge of their indigenous, African American, or local communities. As a result, the granting of patents on inventions that have been developed on the basis of material obtained from that heritage or that knowledge shall be subordinated to the acquisition of that material in accordance with international, Andean Community, and national law.

Andean Community Decision 391● The Member Countries shall not acknowledge rights,

including intellectual property rights, over genetic resources, by-products or synthesized products and associated intangible components, that were obtained or developed through an access activity that does not comply with the provisions of this Decision. Furthermore, the Member Country affected may request nullification and bring such actions as are appropriate in countries that have conferred rights or granted protective title documents.

● The Competent National Offices on Intellectual Property shall require the applicant to give the registration number of the access contract and supply a copy of it as a prerequisite for granting the respective right, when they are certain or there are reasonable indications that the products or processes whose protection is being requested have been obtained or developed on the basis of genetic resources or their by-products which originated in one of the Member Countries.

India – patent law2002 +2005 amendments

Grounds of opposition and refusal include:

that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention;

South Africa

China – draft law

● For an invention-creation, the completion of which depends on acquisition and exploitation of genetic resources, but the acquisition and exploitation of said genetic resources are contrary to relevant laws and regulations of the State, no patent right shall be granted.

● (Article 25, A2, Amended Patent Law, Draft)

● For an invention-creation, the completion of which depends on acquisition and exploitation of genetic resources, the applicant shall indicate the source of said genetic resources in the description. (Article 26, Amended Patent Law, Draft)

The patent system & human genetic resources

●How do conventional patent principles apply?– invention must be new and non-obvious,

having regard to prior art– title to patent comes from (all) inventors– must disclose all that is necessary to carry

out the invention as claimed– in some jurisdictions:

• Specific disclosure requirements for genetic resources

• requirement to disclose all known prior art• fraud on the patent office / ‘clean hands’• recognition of equitable interests

Clarifying the issues...●Where there are claims of misappropriation of

TK, or of genetic resources, is this due to:– Obtaining illegitimate patents?– Or unauthorised use of the TK or genetic resources?

●A safeguard against obtaining patent rights (defensive publication) may precipitate the unauthorised use…

●Existence of a patent may be the symptom of an underlying problem– a patent document brings to light unauthorized use or

commercialisation, possible in breach of access laws or of contracts or licenses

– Recalling the public policy interest in patent transparency

Access & equitable benefit-sharing: what links to the

patent system?●Two essential scenarios put forward:

– Direct patenting of source material• a patent (or application) directly claims as an invention

genetic resources (or associated traditional knowledge) obtained from a separate source

– Patenting inventions derived from source material• a patent (or application) claims an invention that is somehow

derived from or somehow uses genetic resources or TK - this link expressed in several ways

● Has the GR/TK been legitimately accessed?● Is the patent consistent with equitable benefit-sharing? ● How can the patent system promote and advance

equitable benefit-sharing? Is this a matter of law or practice?

● Legal: what obligations arise (or should arise) from the circumstances of access and the nature of use of genetic resources (and associated TK)?

● How does (or should) this affect:– the entitlement to apply for and be granted a

patent (should the applicant receive a patent?)– the patentability of the invention as such (does

the invention merit protection?)– other interests and entitlements (e.g. equitable

or ownership interests, expectation to benefit)– other obligations (e.g. obligation to report on

patenting activity, obligation to disclose invention, circumstances of inventorship etc.)

Access & equitable benefit-sharing: what links to the

patent system?

●‘Disclosure requirements:’ – various existing mechanisms,

national/regional legislative initiatives,and international proposals

– create or confirm a legal linkage betweenGR or TK used and the claimed invention

– beyond disclosure per se (provision of information), have variously been linked to:• invention: patentability of invention as such•applicant: entitlement to apply or be granted a

patent•ownership: who should be owner of patent•enforcement: can’t enforce patent obtained

inequitably

Access & equitable benefit-sharing: what links to the

patent system?

Practical issues for the patent system concerning genetic

resources...●Concerns about patents granted on inventions based on genetic resources or TK:– are the patents invalid?

• Not novel; obvious• Inventorship not properly reflected

– were the genetic resources illicitly accessed?• A breach of contract or access agreement?• A breach of national laws - trespass, unauthorised

export of biological samples, breach of bioprospecting laws, breach of confidence

• how can/should patent system respond?

– are there ethical (non-legal) issues?

– For an invention ‘based on’ genetic resources:• what was the relationship between the patented

invention and the genetic resource?– is access to the genetic resources necessary to carry

out the invention? Is identification of the actual source significant in itself (e.g. the resource is not generally available)?

• is access subject to agreement with the owners/custodians/access providers of genetic resources, or subject to national laws?

– What should be done to remedy breach of this agreement or of the laws?

– Is the access provider eligible for share in the ownership of the patent?

– Or should the patent be

WIPO fora and GR/patent issues

● Intergovernmental Committee on IP and Genetic Resources, TK & Folklore– considers legal issues (technical study)– oversees capacity-building initiatives

●Standing Committee on Patent Law– proposed text for Article 2 of draft Substantive Patent

Law Treaty– reference to issue of disclosure at last meeting

●Working Group on PCT Reform– Swiss proposal for amendment of PCT Regulations to

allow for disclosure mechanisms

●Ad hoc process on patent disclosure for GR