A. From Collaboration to Monopolization
In 1988, a small group of researchers from the United Kingdom, the United States, Canada, France and the Netherlands joined forces to identify the gene(s) associated with predisposition to early-onset breast cancer.[1] The medical community had observed that certain families have a higher incidence of this disease than the general population, and the researchers sought to locate the “problem areas” of their DNA through a process called “linkage analysis.”[2] They eventually narrowed down the location to regions of DNA on chromosomes 17 and 13, and they subsequently raced to isolate the gene(s) for lab-based study.[3][4]
This work led to the discovery of two genes associated with an increased risk of breast and ovarian cancer – BRCA1 and BRCA2. Normally, these genes help us by producing molecular machines, called proteins, that repair damaged DNA.[5] When certain mutations arise in these genes (i.e. parts of the gene are missing, extra bits are inserted, etc.), the cell’s DNA-repair system is compromised, and there is a corresponding increase in the risk of cancer development.[6]
Women who inherit a harmful BRCA1 or BRCA2 mutation have a 5- to 20-fold increased risk of developing breast or ovarian cancer during their lifetimes.[7] Maximizing access to genetic testing for BRCA1 or BRCA2 mutations affords these women the opportunity to take preventative steps to reduce their risk of cancer and cancer-caused death.[8] Despite its profound importance on public health, the use of isolated BRCA1 and BRCA2 for genetic testing in Canada is currently subject to patent rights held by a Utah-based company called Myriad Genetics.[9] The founders of Myriad, who were part of that initial collaborative effort for BRCA gene discovery, now advocate for the monopolization of said discovery.[10]
The law surrounding gene patents in Canada is currently uncertain. In Monsanto Canada v. Schmeiser, the Supreme Court of Canada (“SCC”) ruled that modified gene sequences from plants constitute patentable subject-matter,[11] but the Court has not had the opportunity to directly address the patentability of naturally occurring human gene sequences. By contrast, the highest courts in the United States and Australia have each dealt with the matter head-on. In 2014, the Children’s Hospital of Eastern Ontario (“CHEO”) challenged the validity of gene patents related to Long QT Syndrome, and all eyes were on a potential elevation to the SCC.[12] However, because the parties eventually settled, the patentability of human gene sequences in Canada remains controversial and, above all, unsettled.
B. Test Cases in the United States and Australia
What might an SCC ruling on human gene patents look like? As a starting point, let’s compare the judicial approaches taken by our next-door neighbour (the United States) and a Commonwealth partner (Australia).
i. SCOTUS Decision
In the 2013 case Association for Molecular Pathology v. Myriad Genetics, the Supreme Court of the United States (“SCOTUS”) held that genes isolated from the human body are “products of nature” and are consequently not patentable.[13] The effect of this decision was to invalidate Myriad’s patents that had previously afforded it exclusive rights to isolate a person’s BRCA1 and BRCA2 genes. The “products of nature” exception is not explicit in the American Patent Act; rather, it is a judicial exception that was read into section 101.[14] This section provides, in relevant part:
“[w]hoever invents or discovers any new and useful…composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”[15]
The Court held that the act of isolating the genes did not create or alter any of the genetic information encoded in BRCA1 and BRCA2, nor did it meaningfully change the structure of the DNA. Thus, in the Court’s view, “[Myriad] found an important and useful gene, but separating that gene from its surrounding genetic material [was] not an act of invention.”[16]
ii. High Court of Australia Decision
Two years later, in D’Arcy v. Myriad Genetics, the High Court of Australia (“HCA”) rendered its decision on the validity of Myriad’s Australian patents on mutant BRCA1.[17] The Court ruled that isolated gene sequences are not patentable for two reasons: first, this subject matter falls outside of the established purposes and concept of “manner of manufacture” in section 18(1)(a) of the Australian Patents Act, and second, patentability would not be consistent with the purposes of the Act itself.[18]
With respect to the first reason, the Court found that “[a]lthough it may be said in a formal sense that the invention as claimed, referring to isolated nucleic acids, embodies a product created by human action, that is not sufficient to support its characterisation as a manner of manufacture.”[19] This is because the substance of the invention was the genetic information encoded in the isolated BRCA1, which “is the same information as that contained in the DNA of the person from which the nucleic acid was isolated.”[20]
With respect to the second reason, the Court held that due to the “very large, indeed unquantified size” of claimed genetic material, there was a significant “risk of a chilling effect upon legitimate innovative activity outside the formal boundaries of the monopoly and [patentability would risk] creating a penumbral de facto monopoly impeding the activities of legitimate improvers and inventors.”[21]
iii. Relevance to Canadian Patent Law
Are the rationales applied in the above cases applicable to Canadian patent law? To summarize, there exists a potential argument based on public policy (the chilling effect described in the HCA case) and a potential argument based on the technical requirements for patentability (the notion that natural products do not constitute patentable subject matter).
It is unlikely that the SCC would rely on a public policy argument to exclude human gene patents from patentability. In Harvard Mouse v. Canada (Commissioner of Patents), the Court held that the Patent Act does not afford the Commissioner of Patents any discretion to refuse a patent on policy grounds.[22] Thus, it is likely that the matter would come down to whether an isolated gene sequence constitutes a “composition of matter” within the meaning of that term in section 2 of the Act.
In Schmeiser, the majority held that a gene constructed through human intervention is patentable,[23] but it did not directly address the question of whether a gene isolated in its natural form would also be patentable. According to the non-binding Manual of Patent Office Practice (“MOPOP”), released by the Canadian Intellectual Property Office (“CIPO”), subsection 27(8) of the Patent Act, which excludes from patentability “mere scientific principles or abstract theorem,” has been interpreted by the courts as excluding natural phenomena from patentability.[24] Given this judicial exception for natural phenomena, the reasoning in the SCOTUS decision is compelling in the Canadian context.
C. Conclusion
Despite the steep consequences for public health and evolving legal landscape in other jurisdictions, human gene patents still subsist in Canada. The settlement involving gene patents for Long QT Syndrome did not resolve legal uncertainty for test providers, researchers, or clinicians,[25] and human gene patents continue to impede cost-effective genetic testing.[26] In the absence of judicial intervention, perhaps it is time for Parliament to step in and provide much needed clarity on this area of the law.
[1] Gert Matthijs et al., “The European BRCA patent oppositions and appeals: coloring inside the lines” (2013) 31:8 Nature Biotechnology 704 at 704.
[2] Peter Devilee et al., “Linkage to markers for the chromosome region 17q12-q21 in 13 Dutch breast cancer kindreds” (1993) 52:4 The American Journal of Human Genetics 730.
[3] Y Miki et al., “A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1” (1994) 266 Science 66.
[4] PA Futreal et al., “BRCA1 mutations in primary breast and ovarian carcinomas” (1994) 266 Science 120.
[5] Ielizaveta Gorodetska, Iryna Kozeretska & Anna Dubrovska, “BRCA Genes: The Role in Genome Stability, Cancer Stemness and Therapy Resistance” (2019) 10:9 Journal of Cancer 2109.
[6] Ibid.
[7] Allison W Kurian et al., “Breast Cancer Risk for Noncarriers of Family-Specific BRCA1 and BRCA2 Mutations: Findings From the Breast Cancer Family Registry” (2011) 29:34 Journal of Clinical Oncology 4505.
[8] Anne Marie McCarthy & Katrina Armstrong, “The Role of Testing for BRCA1 and BRCA2 Mutations in Cancer Prevention” (2014) 174:7 JAMA Internal Medicine 1023.
[9] Kelly Crowe, “Breast cancer gene patents: the Canadian story,” CBC News (18 July 2013).
[10] Matthijs, supra note 1.
[11] Monsanto Canada Inc v Schmeiser, 2004 SCC 34 [Schmeiser].
[12] Katherine L Bonter, Carmela De Luca & Christi J Guerrini, “Gene Patents in Canada: Is There a New Legal Landscape?” (2018) 22 Molecular Diagnosis & Therapy 149.
[13] Association for Molecular Pathology v Myriad Genetics, Inc, 569 US 576 (2013) [Myriad (US)].
[14] Ibid at 11.
[15] 35 USC §101.
[16] Myriad (US), supra note 13 at 12.
[17] D’Arcy v Myriad Genetics Inc, [2015] HCA 35.
[18] Ibid at para 9.
[19] Ibid at para 94.
[20] Ibid at para 89.
[21] Ibid at para 93.
[22] Harvard Mouse v Canada (Commissioner of Patents), 2002 SCC 76.
[23] Schmeiser, supra note 11.
[24] Canadian Intellectual Property Office, Manual of Patent Office Practice (2019) at c 17.03.01, online: <https://manuels-manuals.opic-cipo.gc.ca/w/ic/MOPOP-en>.
[25] Bonter, supra note 12.
[26] Sarah E Ali-Khan & E Richard Gold, “Gene patents still alive and kicking: their impact on provision of genetic testing for long QT syndrome in the Canadian public health-care system” (2017) 19:11 Genetics in Medicine 1253.
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