2. EPIP 2 Research Tools in Genetics Sandy Thomas Nuffield Council on Bioethics www.nuffieldbioethics.org www.nuffieldbioethics.org 23 November 2003

3. The ethics of patenting DNA: a discussion paper The role of genetics Biomedicine - drugs, diagnostics Life sciences - model organisms improved understanding Agriculture - crop and animal breeding

4. The ethics of patenting DNA: a discussion paper Role of genetics Goals – to promote the public interest Making available medicines, diagnostics, crop plants Diffusion - diverse paths Balance between incentives for investment – require IP protection Spread of technology – widely accessible

5. The ethics of patenting DNA: a discussion paper Role of genetics Increased level of IP protection in public sector Patenting of biological molecules, animals, plants Trend to patent upstream May restrict technology diffusion Open access: SNPs, PPIRA

6. The ethics of patenting DNA: a discussion paper Progress in genetics Fundamental tension: need to promote sharing of knowledge in research, especially in public sector and developing world and need to promote innovation in health by protecting inventions

7. The ethics of patenting DNA: a discussion paper

10. Genetic information as technology To consider eligibility To consider legal criteria for patentability To consider the public interest

11. The ethics of patenting DNA: a discussion paper Context: DNA Well established that patents play a key role in pharmaceutical innovation IP in biotechnology and genomics has encouraged investment Small companies: assets as IP Still relatively few products on the market

12. The ethics of patenting DNA: a discussion paper Context Two key trends: Protection of investment Protection of information ………..rather than inventions

13. The ethics of patenting DNA: a discussion paper The patent system Goals: Stimulate innovation for the public good To reward people for new and useful ideas and inventions Are these being achieved?

14. The ethics of patenting DNA: a discussion paper Patenting DNA Will patenting DNA promote the public good? Do patents on DNA unfairly reward inventors?

15. The ethics of patenting DNA: a discussion paper Types of information Information about a natural phenomenon –Scientific knowledge –Discovery –Not eligible for patenting A natural phenomenon which is itself information –Genetic information –Encoded in an artificial molecule –Eligible for patenting

16. The ethics of patenting DNA: a discussion paper Eligibility changes as technology evolves New techniques in isolating DNA In silico research Europe vs US  Brings eligibility (and inventiveness) into question

17. The ethics of patenting DNA: a discussion paper Patenting DNA Product patents: on the DNA sequence itself – restricting new applications of information? Use patents: on the use of the sequence – other applications possible?

18. The ethics of patenting DNA: a discussion paper Research tools Scientific findings which have no immediate commercial or therapeutic use Growing category Many patented Case studies: CCR5 and MSP-1

19. The ethics of patenting DNA: a discussion paper Consequences of patents on research tools? Cost of research Practical difficulties Patent owners may withhold licenses “Royalty-stacking” Evidence?

20. The ethics of patenting DNA: a discussion paper Do patents on research tools meet the legal criteria? Novelty Inventiveness/Non-obviousness Utility

21. The ethics of patenting DNA: a discussion paper Malaria vaccines PATH seeking to access IP in relation to antigens to malaria vaccines MSP-1 antigens: 34 patent families, complex: similar and some overlapping Negotiation time consuming, costly, uncertain.

22. The ethics of patenting DNA: a discussion paper CCR5 HGS originally isolated the gene for this receptor and filed for the patent; its 'best guess' of utility: the CCR5 protein product would be a cell- surface receptor Later shown that the CCR5 receptor is the route by which the HIV/AIDS virus enters a host cell

23. The ethics of patenting DNA: a discussion paper CCR5  Is it reasonable that gambles, ie a 'best guess' of utility for a very important cell receptor, be rewarded?  Should the established principle that a patent applies even to an unanticipated utility apply to genes, where the effort of isolation is low?  Freedom to operate

24. The ethics of patenting DNA: a discussion paper Golden rice Rice with Vitamin A Development involved 60+ patents Negotiation of licences: access agreed time consuming, costly MTA more of a problem

25. The ethics of patenting DNA: a discussion paper Utility Claims, which amount to routine discoveries with weakly demonstrated or speculative uses, will seldom deserve the status of patentable inventions The criterion for utility must be rigorously applied so that the grant of a patent more properly reflects the inventor’s contribution.

26. The ethics of patenting DNA: a discussion paper Recommendations Product and use patents should rarely be granted In general, the granting of patents which assert rights over DNA sequences as research tools should be discouraged USPTO utility guidelines

27. The ethics of patenting DNA: a discussion paper ESTs No ‘reach through’ by ESTs to whole genes “We recommend that when rights are asserted in terms intended to cover all sequences that contain the EST that is the subject of the original patent, no patent should be granted.”

28. The ethics of patenting DNA: a discussion paper Existing patents Non-exclusive licensing wherever possible The ‘research exemption’ should be: –given statutory basis in US –clarified in Europe –extended by industry for patented DNA sequences that have a use in research

29. The ethics of patenting DNA: a discussion paper Limiting the scope One gene often produces more than one product If a patent protects all the uses of a sequence, this can give extensive rights, and unjustified rewards Scope of protection should be limited to specific defined uses

30. The ethics of patenting DNA: a discussion paper Recommendations Patents on DNA will become the exception rather than the rule Recommendations are aimed at patent offices, patent lawyers, courts and policy-makers International perspective

31. The ethics of patenting DNA: a discussion paper

32. CIPR Danger of imposing drag on innovation Danger that single product or service will infringe many patents Need for institutions and strategies in development to mitigate such effects Guidance for public sector use of IP

33. The ethics of patenting DNA: a discussion paper Conclusions Grounds for eligibility should be re- examined Rigorous application of patenting criteria –exclude majority of patents claiming sequences as research tools (and diagnostics) Use of research exemption and compulsory licensing to encourage diffusion of technology and applications when in the public interest

34. The ethics of patenting DNA: a discussion paper

35. Diagnostics: BRCA1 Test for faulty gene associated with a disease, based on knowledge of the structure of the gene Both product and use patents can have same effect of powerful monopoly

36. The ethics of patenting DNA: a discussion paper Diagnosis:BRCA1 Myriad has monopoly on the use of the gene; BRCA1 under opposition All diagnostic uses of the gene Broad patents would be dominant over other uses Cannot ‘invent around’ the sequences High cost of tests: $2,400 in UK

37. The ethics of patenting DNA: a discussion paper Diagnostic tests Do patents on diagnostic tests cause adverse effects? - difficulty of ‘inventing around’ - broad patents create a powerful monopoly Are they needed? - to encourage development of new tests - R&D to identify genes for diagnosis

38. The ethics of patenting DNA: a discussion paper Diagnostic tests Use patents? Yes, if specific Product patents? Rarely “ the protection by use patents could provide an effective means of rewarding the inventor while providing an incentive for others to develop alternative tests.” Use of compulsory licensing?

39. The ethics of patenting DNA: a discussion paper Conclusions

40. The ethics of patenting DNA: a discussion paper

41. Patents claiming DNA sequence filed between 1996-1999: by country and sector