WIPO Life Sciences symposium IP and Bioethics A

WIPO: Life Sciences symposium: IP and Bioethics A framework for looking at IP and Bioethics September 2007 A. S. Taubman Global IP Issues Division, WIPO

bioethics? l as against ethics, moral issues writ large? – l is it about outcomes? – – l a moral judgement as to right and wrong? who decides, and on what basis? is it about a way of making policy choices? – l what is distinctive about life sciences? consultation, consent, a broader framework? is it a judgement on behaviour? – what kinds of research activities, ways of doing business do we favour?

IP and bioethics: law or ethics? l IP systems largely a creature of statute – – – l ‘Natural rights’ basis for [some] IP laws and principles – l Law vs. ethics: what is ethical aspect of lawmaking guided by public policy? Ethically neutral? Or policy space for ethical considerations? Law vs. morality: question of patentability of morally questionable technologies Article 15. 1(c) ICESCR, Art 27. 2 UDHR but strong utilitarian flavour to IP law and policy, increasingly emphasized in current debate on IP as a tool of public policy – Article 7, TRIPS

distinguish… l ethical aspects of a technology as such l ethical aspects of national authorities granting IP l ethical aspects of an individual seeking exclusive IP l ethical aspects of the forms of exercising IP rights

distinguish… l ethical aspects of a technology as such – e. g. the ethics of stem cell research l ethical aspects of national authorities granting IP l ethical aspects of an individual seeking exclusive IP l ethical aspects of the forms of exercising IP rights

distinguish… l ethical aspects of a technology as such l ethical aspects of national authorities granting IP – e. g. ethics of a patent office granting patents on life forms l ethical aspects of an individual seeking exclusive IP l ethical aspects of the forms of exercising IP rights

distinguish… l ethical aspects of a technology as such l ethical aspects of national authorities granting IP l ethical aspects of an individual seeking exclusive IP – l e. g. ethics of a public funded agency patenting research) ethical aspects of the forms of exercising IP rights

distinguish… l ethical aspects of a technology as such l ethical aspects of national authorities granting IP l ethical aspects of an individual seeking exclusive IP l ethical aspects of the forms of exercising IP rights – e. g. ethics of licensing patents key medical technologies).

distinguish… l ethical aspects of a technology as such – l ethical aspects of national authorities granting IP – l e. g. ethics of a patent office granting patents on life forms ethical aspects of an individual seeking exclusive IP – l e. g. the ethics of stem cell research e. g. ethics of a public funded agency patenting research) ethical aspects of the forms of exercising IP rights – e. g. ethics of licensing patents key medical technologies).

Some distinctions l Ethics and IP law and practice – – l In the sense of guidance for right behaviour e. g. When is consent regarding seeking IP an ethical question? Morality and IP law and practice – – In the sense of determining innate right & wrong e. g. substantive references to ‘morality’ in IP laws l l l Exclude patent protection for technologies the exploitation of which would be contrary to morality Trademarks contrary to morality ‘Moral rights’ in copyright and related rights

l l International law: States may exclude from protection inventions on morality grounds (Article 27. 2, WTO TRIPS Agreement). States agree to leave space for morality considerations to apply at the domestic level: – – They then have the option to create a specific morality exception within their own national patent laws. In exercising such an exception, a decision maker working within the national system may be required to undertake a specific ethical judgment about a particular technology.

distinguish… l ethical aspects of a technology as such – l ethical aspects of national authorities granting IP – l e. g. ethics of a patent office granting patents on life forms ethical aspects of an individual seeking exclusive IP – l e. g. the ethics of stem cell research e. g. ethics of a public funded agency patenting research) ethical aspects of the forms of exercising IP rights – e. g. ethics of licensing patents key medical technologies).

the BRCA gene patent

IP and bioethics: some themes l l l Transparency Consent Benefit sharing Crossover between law and morality Accommodating different value systems

Transparency in the patent system Transparency as the basis for ethical scrutiny of relevant technologies Patent information systems used to monitor: l trends and background in key technologies l state of the art in key technologies l research and patenting activities of firms/institutes/individuals But need for improved use/access of patent information, and value-added information products to guide policymaking

International patent applications on human, animal or plant cell lines by year of publication (Source: Patentscope)

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NOVEL BIODEGRADABLE AGRICULTURAL AND PHARMACEUTICAL FORMULATIONS BASED ON COW URINE, NEEM AND OTHER HERBS, EFFECTIVE AS PEST REPELLENT, PLANT IMMUNO-STIMULANT, PLANT GROWTH PROMOTING AND ANTI-FUNGAL AGENT. Application 1104/MUM/2002 published 2005 -01 -28, filed 2002 -12 -09 A process fo production of sustained release formulation based on active fraction of cow urine with herbs which is useful as pest repellant, plant immunostimulant and plant growth promoting agent is described. The characteristic features are: - 1) There is combination of fraction of cow urine with extracts of some active herbs. 2) Dried mixture is palletized with the help of suitable binders. 3) The pellets are coated wit suitable polymers to controlled/desired release rate. 4) The product is biodegradable, ecofriendly and polyfunctional. Applicant DORLE AVINASH KESHAV & 16 OTHERS 42, RAMNAGAR, PIROJSHANAGAR, NAGPUR: 440 010, MAHARASHTRA, INDIA. Inventor AS ABOVE. International Info Classification:

United States Patent 6, 410, 059 Khanuja , et al. June 25, 2002 Pharmaceutical composition containing cow urine distillate and an antibiotic A pharmaceutical composition comprising an antibiotic and cow urine distillate in an amount effective to enhance antimicrobial effect of the antibiotic is disclosed. The antibiotic can be an antifungal agent. The antibiotic can be a quinolone or a fluoroquinolone. The antifungal agent can be azoles, clotrimazole, mystatin or amphotericin. Inventors: Khanuja; Suman Preet Singh (Lucknow, IN), Kumar; Sushil (Lucknow, IN), Shasany; Ajit Kumar (Lucknow, IN), Arya; Jai Shankar (Lucknow, IN), Darokar; Mahendra Pandurang (Lucknow, IN), Singh; Monika (Lucknow, IN), Sinha; Prachi (Lucknow, IN), Awasthi; Soumya (Lucknow, IN), Gupta; Subhash Chandra (Lucknow, IN), Gupta; Vivek Kumar (Lucknow, IN), Gupta; Madan Mohan (Lucknow, IN), Verma; Ram Kishore (Lucknow, IN), Agarwal; Sweta (Lucknow, IN), Mansinghka; Sunil Balkrishna (Nagpur, IN), Dawle; Suresh Haribhau (Nagpur, IN) Assignee: Council of Scientific and Industrial Research (New Delhi, IN) Citations: U. S. 6231849 May 2001 Schiller, Japan 3039865 May 2000

Traditional chinese medicine

inclusion and consultation NGO accreditation to the IGC Where accredited organizations are active 1 organization 2 to 5 organizations more than 5 organizations

Traditional knowledge and IP “indigenous peoples have rarely placed anything in the so called ‘‘public domain’’, a term without meaning to us. . . the public domain is a construct of the IP system and does not take into account domains established by customary indigenous laws” - Saami Council

Traditional knowledge and IP l l misuse of TK can cause severe physical or spiritual harm to the individual caretakers of the knowledge or their entire tribe from their failure to ensure that the Creator’s gifts were properly used, even if misuse was used by others outside of the tribe, or by tribal members who were outside of the control of customary authority. For this reason. . . misappropriation and misuse [is] not simply a violation of ‘‘moral rights’’ leading to a collective offense, but a matter of cultural survival for many indigenous peoples. – Tulalip Tribes

IP and the sharing of benefits l UNBHR: equitable access to medical, scientific and technological developments as well as the greatest possible flow and the rapid sharing of knowledge concerning those developments and the sharing of benefits, with particular attention to the needs of developing countries;

IP in research agreements UNBHR: When negotiating a research agreement, terms for collaboration and agreement on the benefits of research should be established with equal participation by those party to the negotiation. (art 21. 4)

IP and bioethics in the innovation process l l research policy and planning the research phase the acquisition of IP rights the use of new technology, and exercise IP of rights

reviewing IP and bioethics issues throughout the technology development pipeline Ideally: each stage guided by an overarching conception of workable, equitable and effective arrangements for innovation in the public interest, consistent with legitimate private interests -- the ethical basis of good public policymaking?

a concluding example l many have called for an ‘open source’ approach to biotechnology l what are the bioethics-IP implications?

“should” l protection of IP “should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations. ” WTO TRIPS Agreement, art. 7

but what is the nature of that ‘should’? l “should” - as – – – l l ethical (deontological), ethical (utilitarian), legal (obligatory) aspirational, or predictive? within legal text, guide to broader interpretation within policy context, guide to policymaker – an heuristic?

l l what message to life science policymakers? if one should encourage or adopt ‘open source’ innovation in the life sciences – – l l prudential – it is good for you, it serves your objective interests; ethical: any ‘right thinking person’ would do so; social utilitarian: – it yields overall welfare outcomes; legal – you must do it, whether or not it is in your real or perceived interests. Each has been made for ‘open source’ approaches to life sciences innovation. How does the nature of the ‘should’ depend on who and where you are?

two layers of ‘should’ l essence of IP policymaking is setting what legally defined exclusivities over knowledge resources will advance innovation, fair competition and public welfare, and how those exclusivities should be shaped and governed. – l some ‘open source’ ideas hard-wired at the legislative level (or can be) individual holders of exclusive rights are also presented with a range of obligations – ethical and legal - and motivations. – when and how is there a convergence of the overall architecture of the IP system, the interests and behaviour of players within that system, and the kinds of modes characterized as open source in the life sciences?

some approaches to IP and bioethics… l l bioethics within the law of patents: the scope for judgements about morality in assessments on patentability bioethics considerations in consultations on policymaking bioethics as a guide to practice in medical research and in business bioethics and fundamental rights and responsibilities