Gene Patenting in Canada From the oncomouse to cancer gene testing and beyond
BY JAMES J. RUSTHOVEN
AND THE OF THE
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
18 GeNeWatch
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
BIOTECHNOLOGY REFERENCE GROUP CANADIAN COUNCIL OF CHURCHES
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 naturallyoccurring 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
april-May 2011