TIP Group Conference 2014, Day 3: Gene Patents in the Courts

Disclaimer: Views expressed are solely those of Nathaniel Lipkus and Sheldon Hamilton, and do not represent the opinions or positions of Gilbert’s LLP or Smart & Biggar.

On March 5, 2014, the third day of the 15th Annual Technology and Intellectual Property Group Conference, attendees had the opportunity to hear two prominent Canadian IP litigators, Mr. Nathaniel Lipkus and Mr. Sheldon Hamilton, discuss a contentious current issue in patent law: the patentability of life forms.

Mr. Lipkus is a litigator at Gilbert’s LLP who has represented clients before the Federal Court of Canada, the Federal Court of Appeal, and the Ontario Superior Court. His presentation focused on the 2013 US case Association for Molecular Pathology v. Myriad Genetics (Myriad). In Myriad, the US Supreme Court invalidated Myriad’s claims on two genes that predict susceptibility to breast cancer. As Mr. Lipkus explained, the Court concluded that DNA is not patentable subject matter; rather, it constitutes a law of nature. Laws of nature are discovered, not invented, and no matter how groundbreaking, innovative, or brilliant such a discovery is, it cannot be patented.

Although Mr. Lipkus described the case as a “big win” for the ACLU (whose lawyers assisted the Association for Molecular Pathology), he noted that Myriad is still enforcing patent claims related to testing for the genes in question: it has launched over a dozen lawsuits since the ruling in Myriad, and most defendants have reached settlements that include ceasing to provide the tests in North America. 

Mr. Lipkus further noted that the question of the patentability of human genes has yet to come before the Supreme Court of Canada (SCC), although gene patents have been granted in Canada. Former Supreme Court Justice Binnie has however described the Patent Act as a crude tool, ill-suited to dealing with cases involving human gene patents.

Mr. Hamilton is a leading patent litigator from Smart & Biggar with particular expertise in pharmaceutical litigation, who has appeared as counsel at both the trial and appellate levels. He spoke about whether life forms are patentable subject matter. He began with a discussion of plants, and in particular the 1989 Canadian case Pioneer Hi- Bred Ltd. v Canada, in which the SCC considered whether a new variety of soybean created by cross-breeding constituted patentable subject matter. Although the patent sought was ultimately rejected on other grounds, the Court expressed concern that the alleged “invention” might in fact be a law of nature. This led the Canadian government to pass the Plant Breeder’s Rights Act, providing protection to the work of plant breeders outside the patent system.

Mr. Hamilton’s presentation focused on 2002’s Harvard College v Canada (Harvard College), the famous “Harvard mouse” case. In Harvard College, the SCC ruled that higher life forms are not patentable subject matter since they do not fall within the wording of the definition of “invention” in the Patent Act – although Mr. Hamilton noted that ethical considerations clearly weighed in the decision. He also pointed out that this was not a unanimous ruling, and highlighted the dissenting opinion’s focus on incentives to innovation, reminder that the Patent Office allows patents on human genes, and questioning of the drawing of a distinction between higher and lower life forms. 

Both the majority and dissent in Harvard College said the issue of patentability of higher life forms ought to be dealt with by Parliament. The majority pointed to the Plant Breeder’s Rights Act as suggesting the Patent Act was not intended to cover higher life forms, and said that it should be up to Parliament, not the courts, to devise a similar approach to other higher life forms. The dissent, on the other hand, said it should be up to Parliament, not courts, to decide if certain subject matter should be excluded from the Patent Act on ethical grounds.

Following these presentations, the audience engaged in a discussion of the patentability of life forms and the role of ethics in patent law. Of note was the discussion regarding the SCC case, Monsanto Canada Inc. v. Schmeiser (Monsanto), which followed Harvard College two years later. While Monsanto did not overturn the decision in Harvard College, life forms can now be patented in Canada indirectly. Instead of claiming a whole life form, the applicant instead claims the cells of that the life form. By having a claim over said cells, the applicant indirectly has a claim over the whole life form, given that the life form consists of said cells. The discussion also revolved around the change in the Supreme Court in between these two cases. Justices L’Heureux-Dube and Gonthier left while Justices Fish and Dechamps joined. When only the justices who ruled on both Harvard College and Monsanto are considered, with the exception of Justice Arbour, the majority in Harvard College was the dissent in Monsanto while the dissent in Harvard College was the majority in Monsanto. As such, the audience discussed how the different Justices’ ethical beliefs may have influenced these two decisions.

While Harvard College and Monsanto aimed to clarify the question of patentability of life forms in Canada, the field is still ripe with differentiations that are often difficult for both the biotechnology industry and legal profession to assess. Given that the biotechnology industry is a significant source of revenue and employment in Canada, and given the increasing complexity of the ethical questions involved, the Supreme Court will undoubtedly have to address the patentability question in the future.