Posted By Jey Kumarasamy – Mar. 21, 2014

Current situation

In Canada, the Canadian Intellectual Property Office has treated isolated genes and cDNA as patentable material. For example, Myriad Genetics still holds Canadian patents to BRCA1 and BRCA2. However, the validity of patents on isolated genes has never been challenged in a Canadian court, and the existing jurisprudence concerning gene-related patents seems to be inconsistent. For instance, in Harvard College v Canada, the Supreme Court of Canada (SCC) held that higher life forms are not patentable. Two years later, in Schmeiser v Monsanto, the SCC held that protection of a patented genetically-modified plant cell could extend to the entire plant, despite that a plant is a higher life form.

Consequently, the confusion over gene patents, particularly for investors and laboratories, places Canadians in a disadvantaged position. Investors may be reluctant to invest in genetic biotechnology research when there may be no profit. Additionally, laboratories and hospitals may be reluctant to innovate and apply tests related to patented genes, in fear of facing a potential patent lawsuit. If Canada wants to facilitate the growth of biotechnological innovation, then the parameters for gene patents must be clarified.

Possible legal solutions

In the US, Europe, and Australia, the patentability of human genes has been determined through test cases (e.g., AMP v Myriad Genetics). A test case’s purpose is to set a precedent for other cases involving a similar legal issue. A similar undertaking in Canada would be a possible solution. It remains to be seen, whether the US Supreme Court ruling on gene patents will influence Canadian courts.

Alternatively, the federal government could choose to clarify the validity of gene patents by updating patent laws. However, so far Parliament has been reluctant to do so. In 2005, a report commissioned by the Canadian Biotechnology Advisory Committee concluded that Canada should continue to allow human gene patents, in order to conform to international standards, and to not appear unfriendly towards biotechnology research. But the recent US Supreme Court decision that isolated genes cannot be patented indicates that the international position on human gene patentability is highly fragmented.

Concerns

As in the US, several organizations in Canada have expressed concern over permitting patents on genes. For example, the Canadian Cancer Society takes the following position:

“We also believe that these patents will have a negative impact on research as patents can hinder collaboration among researchers and can add to the cost of research.”

In 2001, the Parliamentary Standing Committee on Health recommended that human gene patents be banned:

“We are deeply disturbed that the Patent Act does not specifically disallow patenting with respect to human genes, DNA sequences and cell lines.”

In contrast, in 2002, the President of BIOTECanada, a national association of biotechnology researchers, responded negatively to the Harvard College v. Canada decision:

“Today’s decision destroys our Canadian infrastructure of knowledge and innovation, creates an even greater brain drain, and we will lose our place at the world table in influencing how and where society accepts this technology.”

Conclusions

Biotechnology is a rapidly growing industry in Canada, in which gene patents continue to play a significant role. Therefore, in light of the US Supreme Court’s decision in AMP v Myriad Genetics, there is a serious need for clarification on the patentability of human genes in Canada.

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[Part I of the series discussed the US Supreme Court’s decision in AMP v Myriad Genetics and its impact on biotechnology]