Research Ethics, Property Rights & Innovation in the Biosciences

1. Research Ethics, Property Rights & Innovation in the Biosciences Aurora Plomer, BA, MA, LLB, PhD Professor of Law & Bioethics Director of SIBLE University of Sheffield A.Plomer@sheffield.ac.uk

2. Core Assumptions of the Patent System • “Intellectual Property is a critical component of our present and future success in the global economy.” • “The ideal IP system creates incentives for innovation, without unduly limiting access for consumers and follow on innovators. It must strike the right balance in a rapidly changing world so that innovators can see further by standing on the shoulders of giants.” (Gower Report, 2006)

3. Ethical Rationale of IP • Reward inventors for their work Natural Right to Property Locke (1690)/Nozick (1974) • Incentive for investment & innovation Utilitarian maximization of social welfare

4. (Un)Ethical Patents Unjust Patents • Unjust rewards: i.e. patents on ‘discoveries’ rather than ‘inventions’, subject matter of the patent lacks novelty/inventive step/utility • Blocking patents Patents on Unethical Inventions • The subject matter of the patent - the invention- is unethical per se (i.e. letter bombs).

5. What is patentable? • 1. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. • 2. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. • 3. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application. (UK Patents Act (1977) Regulations 2000, implementing EU Directive Biotechnological Inventions (1998)

6. Moral Exclusions Article 6(1)/Article 53(a) Inventions shall be considered un patentable where their commercial exploitation would be contrary to ordre public or morality … Article 6(2)/Rule 23(d) (c) uses of human embryos for industrial or commercial purposes EU Directive on Biotechnological Inventions (1998)

7. The WARF Patent • US Patents 780 and 806 contain broad, reach-through claims on purified preparations of primate and pluripotent ES cells and methods of isolating them. The USPTO review board refused to invalidate the patents on the basis of prior art & obviousness. • The European patent was rejected on moral grounds by the EPO. WARF’s appeal is awaiting judgment of Enlarged Board of Appeal. • Stem Cell Patents Report (2006) argues that the EU Directive does not preclude the grant of patents on hESC derivatives.

8. Displaced Moral Discourse? • The ‘moral’ question which is the focus of attention at the EPO properly belongs to social debates on the morality of research within the distinct moral and legal cultures of each European State. • Patent offices lack the competence or legitimacy to settle questions on research involving morally contested technologies. • The focus on the ethics of hESC patents is obscuring the ethical, social, economic and legal issues relating to the hESC patents already granted by national patent offices in Europe.

9. Patents have only national/territorial validity • A patent granted by the EPO may be revoked or invalidated by national jurisdictions. • Applicants may concurrently file applications at the EPO and at national patent offices. • National patent offices retain the right to grant national patents.

10. UK Stem Cell Patents • The UK patent office has granted a number of foundational patents on hESCs (Plomer, Taymor & Scott, Cell Stem Cell (2008) • The existence of the patents is not widely known, neither is their potential scope and reach (IP Workshop, UK Stem Cell National Network, Inaugural Conference, Edinburgh, April 2008). • Some of these patents are very broad and cover a wide range of research taking place in the UK (Plomer & Denning, Patents on Cardiomyocytes, forthcoming) • Scientists working within the patents are infringing. • There is no clear ‘research exemption’ defence in English law (Gower, 2006).

11. Distribution UK grants per patentees country of residence Total Number = 72

12. Total Number = 26

13. Some Patents under the Radar • GB2415781B2 • Genes that are up- or down-regulated during differentiation of human embryonic stem cells • GB2412379B2 • Hematopoietic cells from human embryonic stem cells • GB2393734B2 • Cells of the cardiomyocyte lineage produced from human pluripotent stem cells • GB2379447B2 • Neural progenitor cell populations

15. Could GB Patent 393734 B have been averted? The scientific community has the power to influence patent scrutiny pre-grant Following publication of a patent application 21.-(1) …. any other person may make observations in writing to the comptroller on the question whether the invention is a patentable invention, stating reasons for the observations, and the comptroller shall consider the observations in accordance with rules. (UK Patents Act 1977)

16. Conclusion:What can/should the scientific community do? • Assist in the identification and evaluation of systemic institutional and structural weaknesses in training, patent awareness and access to patent data. • Encourage/forster culture of patent awareness and engagement with the patent system. • Participate in social debates about the ethical, legal and social impact of advances in the biosciences on the patent system and vice-versa.