With input from the Biotechnology Reference Group of the Canadian Council of Churches
The recent decision by United States District Court Judge Robert Sweet to invalidate seven patents on the BRCA breast cancer genes held by Myriad Genetics is a monumental decision (though the decision is being appealed as expected).1 Coupled with the subsequent U.S. Justice Department amicus brief arguing against the patenting of naturally-occurring genetic material,2 these events have triggered advocacy groups from other countries such as Australia to consider its own legal action to restrict DNA patentability laws and policies.3 The pendulum now may be swinging away from internationally-accepted, broadly interpreted and applied gene patenting practices toward tighter rulings against the patenting of naturally-occurring genetic material.4 In this changing climate, we offer a perspective on the current state of gene patenting in Canada.
The case of the Harvard oncomouse put Canada front and centre in gene patenting law and policy-making. United States patent approval for exclusivity rights to the oncomouse was granted in 1988. After eight years of governmental and legal reflection and decisions, at the end of 2002 the Supreme Court of Canada (SCC) denied the patent on genetically-modified (GM), entire non-human mammals including the oncomouse by the narrowest of margins.5 The five judge majority argued that a mouse does not qualify as a "manufacture" or "composition of matter," the terms used in patent law for patentable materials.
However, only a year and a half later, in the case of Schmeiser vs Monsanto, the SCC ruled by the same narrow 5-4 margin that a patent protecting commercial rights to GM cells in canola plants also could impart de facto exclusive rights over the entire plant.6 The majority argument hinged on the concept that patent infringement could be construed involving a whole organism if a commercial or business activity involving an organism with a patented gene or cell necessarily involves using that patented part. This decision seems to conflict with the earlier oncomouse decision against patent protection of the entire mouse.
These cases reflect an as-yet-unresolved debate and societal tension regarding biological, ethical, economic, and political aspects of human interventions involving life forms in Canada. Arguments have sometimes alluded to extra-legal effects on capital investment and international economic competitiveness, at times at the expense of sound legal reasoning.7 It should be noted that in both cases, the SCC rejected the broad, carte blanche type of whole organism patenting granted in the United States. However, as a result of the Schmeiser vs Monsanto decision, the legal status of whole organism patenting in Canada lacks clarity on the basis of such inconsistent case judgments by the highest court of the land.
In the meantime, the momentum to commercialize genomic research continues unabated in Canada and elsewhere. Our knowledge of the full complement of genes of a growing number of whole organisms is growing rapidly and whole genomes are now being reconstructed through synthetic biology techniques. Research melds with commercial ventures through increasing university/industry collaborations. Despite these developments, there remains no practical guidance for researchers and policy-makers on the ethical implications of privatization and commercialization of bioresearch beyond the general ethical framework of the Tri-Council Policy Statement.8 In recent qualitative studies, researchers have expressed more concern over increasing secrecy, publication delays, and increasing numbers of material transfer contracts than over patenting, commercialization, and conflicts of interest.9,10
Societal Imperatives: Healthcare Access versus Private Commercialization of Healthcare Resources
In Canada, the narrow margin of SCC decisions of the above cases may not only reflect discordant legal views on patenting life forms but also ongoing societal differences of worldviews over the relationship of humankind with the natural order. In the past, The Canadian Council of Churches and the Evangelical Fellowship of Canada have argued that higher life forms should not be patentable on the grounds that humankind has a God-given responsibility to care for the created order.11 In this worldview, privatization and commercialization of life forms threatens that overarching mandate. The recent paradigm-changing decision to strike down the Myriad patents on naturally-occurring breast cancer-associated genes suggests that such a view may be regaining support at the highest government and societal levels in the US (as suggested by the amicus brief noted above), the country that granted the broadest patent protection for the oncomouse patent.
Notwithstanding the seemingly contradictory judgments by the SCC over whole organism patenting, the recent drama played out over the Myriad patents has somewhat ironically positioned Canada as an advocate against "natural" single gene patenting. Unlike the oncomouse and GM canola cases, however, the Myriad case impacts on public healthcare access to necessary diagnostic testing, bringing a new and more ominous societal danger to the concerns over 'anti-commons' issues in Canada.12 It also brings into sharper focus the societal and political forces that drive arguments for the various positions. Legally, in the judgment of Industry Canada's Patent Office Directorate, Myriad Genetics did not violate Canada's patent or competition laws.13 Industry Canada even challenged the government of Ontario to provide evidence that gene patents deterred research as well as evidence that it could not obtain a compulsory license to override Myriad's patent monopoly on BRCA gene testing.14
Politically, both Myriad's case and that of provincial and federal governments suffered from miscommunications and misjudgments.15 Federal and provincial governments debated over who should solve the gene patenting problem, ministries could not agree on the problem or its solution, and provinces varied in their decisions to comply with or resist Myriad's exclusivity claims. Analysts argued that much of the government response and tactics were fuelled by negative press against Myriad's bullying tactics16 and its attempted displacement of the public system's pre-existing gene testing program that included patient counseling.17 Studies identifying public concern about the potential for gene patenting to limit healthcare accessibility to poorer citizens bolstered government refusal to bow to corporate intimidation.18 Thus, government action against single gene patenting may be driven more by perceived direct threats to the publicly-owned and operated healthcare system than to any government change toward a broader moral view of the dangers of patenting life forms.
Has Anything Changed?
At the time of the oncomouse Supreme Court decision, the Biotechnology Reference Group of the Canadian Council of Churches created a discussion guide of short essays (Life: Patent Pending) that highlights a number of fundamental concerns over the patentability of whole organisms that are mentioned above.19 Also mentioned is an element of whole organism patent protection that is often overlooked: patent protection coverage for the offspring of such whole organisms over the life of the patent. The introduction to the discussion guide includes an appeal to the Canadian Parliament to develop laws that directly face the question of whole organism patentability.
Have the Harvard oncomouse decision and the subsequent landmark cases resulted in any concrete changes to gene patent law or practice in Canada? After years of intergovernmental jurisdictional and political wrangling, the Patent Policy Directorate and Health Canada finally agreed to consult directly with Canadians through the independent Canadian Biotechnology Advisory Committee (CBAC). Regrettably, nearly all of its recommendations have been ignored; CBAC was disbanded a few years ago, its mandate taken up by the Science, Technology, and Innovation Council of Industry Canada. After more than seven years the federal government continues to simply ignore patents while provinces are confident that they sent a clear signal that commercialization of necessary healthcare resources will not work in the Canada. This strategy may have recently deterred one recent Canadian licensee of another patented gene from attempting to enforce its exclusivity rights. Instead, the company has sold kits to public laboratories.
The failure to heed the exhortation to provide guidance for future investors in Canadian genetic bioresearch through legal changes has left the problem in continued legal as well as moral limbo. Admittedly, the problem is a politically difficult challenge to Canadian governments. Any attempt to tighten and clarify patent laws requires political wisdom through a clear picture of the multiple societal values, interests, and risks. Some analysts have argued for better societal and moral guidance through a new research framework that replaces commercialization with the broader perspective that considers implementation of research knowledge including the full breadth of societal implications.20 Others have proposed an independent governance entity that would oversee commercialization through patent pools and open source strategies that would facilitate access to patented inventions. Such initiatives would aim to restore public trust through better integration of diverse public voices and the consideration of broader social and ethical issues.21
For its part, The Canadian Council of Churches continues to oppose patenting of life forms and commercial exploitation, promotes open exchange of research ideas for the common good of humankind and the created order around us, and supports the formal integration of public voices that consider the full impact of genetic technologies on the various aspects of societal life in Canada. The Council lauds individual legal decisions that go against international currents that Canadian governments deem socially and morally dubious or wrong. But it also continues to urge the establishment of proactive legal and moral guidance that reflects the diverse moral sensitivities of Canadian society and gives direction to the improved overall health of Canadian society. Life is given as a gift from God, for us to both enjoy and to respect.
Members of the Biotechnology Reference Group include: James Rusthoven (chair), Moira McQueen, Stephen Allen, Anne Mitchell, Erin Green, Richard Crossman, James E. Read, Paul Fayter, George Tattrie, Mark Boulos, Isaac Kawuki Mukasa, Emanuel Kolyvas, Peter Noteboom, and Mary Marrocco.
1. Schwartz, J. and Pollack, A. Judge Invalidates Human Gene Patent. New York Times, March, 29, 2010.
2. Pollack, A. U. S. Says Genes Should Not Be Eligible for Patents. New York Times, October 29, 2010.
3. Ray, T. Australian Patient Groups Follow ACLU/PUBPAT Path in Challenging Gene Patenting. GeneWebNews, Pharmacogenomics Reporter, June 15, 2010 (http://www.genomeweb.com/dxpgx/australian-patient-groups-follow-aclupubpat-path-challenging-gene-patenting). Last accessed 7 February 2011.
4. Kesselheim, A. S. and Mello, M. M. Gene Patenting - Is the Pendulum Swinging Back? New England Journal of Medicine 2010; 362:1855-1858.
5. Harv1.ard College v Canada 2002.
6. Percy Schmeiser and Schmeiser Enterprises v Monsanto Canada and Monsanto Inc 2004.
7. Prudham, S. The Fictions of Autonomous Invention: Accumulation of Dispossession, Commodification, and Life Patents in Canada. Antipode 2007; 39(3): 417, 418.
8. Joly, Y., Caulfield, T., Knoppers, B., and Harmsen, E. The Commercialization of Genomic Research in Canada. Healthcare Policy 2010; 6(2): 26.
9. Murdoch, C.J. and Caulfield, T. Commercialization, Patenting and Genomics: Researcher Perspectives. Genome Medicine 2009; 1(2): 22.
10. Silverstein, T., Joly, Y., Harmsen, E., and Knoppers, B.M. The Commercialization of Genomic Academic Research: Conflicting Interests. In: B.M Knoppers and E.R. Gold, eds., Biotechnology, Ethics, and Intellectual Property. Markham, ON: LexisNexis, Canada, 2009, 131-163.
11. Biotechnology Reference Group, Canadian Council of Churches. Life: Patent Pending. A Discussion Guide on Biotechnology and the Oncomouse. Available on the Canadian Council of Churches website: http://www.councilofchurches.ca/en/Biotechnology/biotechnology-resources.cfm. Last accessed 8 Feb 2011.
12. The 'anti-commons' problem refers to the view that the increasing number of private rights over basic biomedical information compromises biomedical research due to the high transaction cost. See Heller, M. A. and Eisenberg, R. S. Can Patents Deter Innovation? The Anticommons in Biomedical Research. Science 1998; 280: 698-701.
13. Gold, E.R. and Carbone, J. Detailed Legal Analysis of Gene Patents, Competition and Privacy Law. Appendix B from the Working Document: Myriad Genetics In the Eye of the Policy Storm, 2008 (http://www.theinnovationpartnership.org/data/ieg/documents/cases/TIP_Myriad_Legal.pdf). Last accessed 7 February 2011.
14. Gold, E.R. and Carbone, J. Myriad Genetics: In the Eye of the Policy Storm. Genetics in Medicine 2010; 12(4): S53.
15. Ibid, S52.
16. Caulfield, T., Bubela, T., and Murdoch, C.J. Myriad and the Mass Media: The Covering of a Gene Patent Controversy. Genetics in Medicine 2007;9(12): 850-855.
17. Gold and Carbone 2010, S50.
18. Caulfield, T., Einsiedel, E., Merz, J.F., and Nicol, D. Trust, Patents, and Public Perceptions: The Governance of Controversial Biotechnology Research. Nature Biotechnology 2006;24(11): 1352-1354.
19. Biotechnology Reference Group, Canadian Council of Churches. Life: Patent Pending.
20. Gold and Carbone 2010, S54.
21. Joly 2010, 30, 31.