Prior informed consent to patent applications by donors of human genetic material

1. Prior informed consent to patent applications by donors of human genetic material NCCR, Berne March 28, 2007 antony.taubman@wipo.int

3. 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?

4. 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

5. Human genetic resources • Animal genetic resources • Plant genetic resources for food and agriculture • Biodiversity-related genetic resources • Space law?

6. 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)

7. THE RICE WITH HUMAN GENES by 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.

8. 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.

9. 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,

10. the polyvalence of genetic materials ways of seeing

11. the polyvalence of genetic materials ways of valuing:‘actual or potential value’

12. the polyvalence of genetic materials

13. morality equity dignity the polyvalence of genetic materials

14. 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)

15. 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.

16. 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 …

17. United Nations Declaration on the Rights of IndigenousPeoples, 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’’.

18. 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’’.

19. 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

20. 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.

21. 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.

22. Consent? Consent? ?

23. C12N 5/00 Undifferentiated human, animal or plant cells PCT applications by year of publication

24. 41% 16% C12N-5/08 - Human cells or tissues - year of PCT publication

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

26. what linkage with patent system?

27. what linkage with patent system?

31. 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

32. 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.

33. 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.

34. 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.

35. 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.

36. 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;

37. South Africa

38. 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)

39. 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

40. 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

41. 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?

42. Access & equitable benefit-sharing: what links to the patent system? • 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.)

43. 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

44. 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?

45. 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

46. 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