TOWARD A NEW ERA FOR INTELLECTUAL PROPERTY: FROM CONFRONTATION TO NEGOTIATION

1. TOWARD A NEW ERA FOR INTELLECTUAL PROPERTY:FROM CONFRONTATION TO NEGOTIATION Tania Bubela School of Public Health, University of Alberta, Canada Richard Gold Faculty of Law, McGill University, Canada INTERNATIONAL EXPERT GROUP ON BIOTECHNOLOGY, INNOVATION AND INTELLECTUAL PROPERTY

2. Old IP • An Era of New IP based on collaboration • Lessons from Case Studies • Indigenous Knowledge • Conclusions • The Innovation Partnership Plan

3. For better or for worse, biotechnology is at the centre of current debates about health care, the environment, food and development. • For a decade, there have been clear signs that the present way we deal with intellectual property is breaking down. OLD IP

4. Our team recognized the need for a new era in IP, in which the biotechnology industry will need to become more open and collaborative. • We recognized that the stories we told ourselves about the primacy and necessity of patents and other IP rights are wrong, and that there are universal barriers to collaboration. • Many were born of a lack of trust among negotiating parties. Recognizing the Problem

5. A lack of infrastructure threatens the ability of LMICs to participate in biotechnological innovation. • No one actor has the knowledge or capacity to carry out innovation and to distribute new products and services to those who need and want them. • Sharing and collaboration are key to future biotechnological innovations. • While there are certainly products that are on the market today because of IP, there are certainly others that were never developed or never delivered because of it. FINDINGS

6. At the heart of the move from Old IP to New IP is an emphasis on collaborations and partnerships instead of hoarding and distrust. • Collaboration requires breaking out of the ruts in our thinking that have plagued Old IP. • We need more and better collaborations. The move from Old IP to New IP

7. Pay attention to all the components of innovation, such as health and environmental regulations, the judicial system, tax rules and marketplace regulation, and not simply IP. • Work with industry to support the creation of independent trust builders to mediate disputes, encourage dialogue and to engage indigenous and local communities in policy development. • Develop Public-Private Partnerships to conduct early stage research including through the sharing of health related data while protecting privacy. • Support the development and dissemination of novel business models that feature collaboration. Recommendations - Government

8. Collect standardized patent-related information, including license data as they are doing in Japan. • Assist developing countries and NGOs in finding out which patents exist in order to enable licensing. Recommendations – Patent Offices

9. Establish an independent, non-profit technology assessment organization to evaluate new biotechnology products from developing countries. • Participate actively in the creation of Public-Private Partnerships and other collaborative mechanisms. • Be transparent about their patent holdings. • Develop new business models that promote partnerships and collaborations. Recommendations - Industry

10. Develop clear principles relating to the use and dissemination of their intellectual property and promote greater access and broad licensing. • Develop measures of the success of their transfer of technology based on social returns rather than on the number of patents they hold. • Enter into collaborations between developed and developing countries to ensure that developing country doctoral and post-doctoral students have opportunities to study and work at home. Recommendations - Universities

11. Indigenous communities concerned about protecting TK from inappropriate use. • Bio-piracy vs. Bio-prospecting. • Has lead to calls for an international regime to recognize indigenous rights over TK and other expressions of culture. • Legal entitlement to a share in benefits from commercialization/use of TK. • Enhances biological and cultural diversity • Till recently, international discussion focussed on property rights. TK Case Study: The Problem

12. No one definition of TK. • IPRs are time limited. • Require disclosure into public domain. • Much TK inalienable. • May be inappropriate to use TK outside cultural context. • Communally held, may be diffuse. • May be difficult to identify all communities holding TK or organisations/individuals with whom to negotiate access rights. The Problem with Intellectual Property Rights for TK

13. Culturally and biologically diverse country. • Legal and administrative framework for ABS based on property rights. • Problems with administration and overlapping property rights claims. • The legal framework is not necessarily balanced against other national interests in a developing country such as establishing an endogenous research base and bio-innovation industry founded on Brazil’s rich biodiversity. • Legal framework being reconsidered. Lessons from National Case Studies: BRAZIL

14. Also rich in cultural and biological diversity. • ABS laws implemented 2006 and constitutional protection of indigenous peoples and recognition of customary laws. Lessons from National Case Studies: KENYA

15. Interests of indigenous peoples require enforcement of laws, not just existence of laws crafted by IP lawyers. • Need laws crafted in consultation with indigenous communities and with their interests in mind. • Need reverse capacity building process for policy and law makers about TK and the customary laws and values that govern its development and use. • Appropriately balanced laws essential for environmental and natural resource co-management. KENYA: RESULT

16. Vast geographic area • Sparsely populated • Rich in natural resources • Undergoing rapid change due to resource development • Impacted by climate change • Significant proportion of the population First Nation/Inuit • History of injustice, discrimination and exploitation • Many social problems NORTHERN CANADA

17. Ability to maintain TK and protect its role in structuring community relationships is important interest. • Most of Northern Canada now covered by modern Land Claims or Self-Government Treaties. • Grants of autonomy to structure affairs in natural resource management, education, parts of health, social services and natural resource management. NORTHERN CANADA

18. Co-management boards use western science and indigenous knowledge systems, e.g., MVEIRB • New scientific collaborations and funding structures based on needs of indigenous peoples • Problem is lack of capacity for governance etc. And resources NORTHERN CANADA

19. TK is as varied as the cultures within which it originates and flourishes. No single set of laws can meet the interests of all indigenous peoples in promoting and protecting their TK. • Promoting autonomy and land rights rather than property is the key. • An appropriate balance needs to be struck between national economic interests and the needs of the communities to which TK owes its existence. CONCLUSIONS

20. International discourse is shifting away from property rights to misappropriation or unfair dealings with TK. • Recognition of the need for flexibility in addressing the differing interests of indigenous communities. Hopeful Signs

21. Aligning metrics with mission for biomedical publicly funded research • Distribution of Plant-Derived Vaccines • Myriad Genetics • Design and implementation of Canada’s compulsory licensing laws for access by developing countries to essential medicines • UNITAID essential medicines patent pool Other Case Studies

22. An independent, not-for-profit consultancy firm based in Montreal, Canada that draws on the research of the International Expert Group. • Work ranges from policy analysis to coordinating legal services. • TIP helps decision-makers develop and implement IP policies which foster innovation, improve access to new products and support scientific infrastructure. • TIP advises public and private entities, conducts its own policy-oriented research, offers executive training and works as a trust builder in order to find common ground among stakeholders with divergent interests. The Innovation Partnershipwww.theinnovationpartnership.org

23. We thank SSHRC for its innovative funding programme that allowed this multi-year, international and multi-stakeholder study to take place. I also would like to thank CIHR, the NIH, Canadian Stem Cell Network, and Genome Canada that have supported components of this project. Acknowledgements