Are Human Genes Patentable? (Pt II – Gene Patentability in Canada)

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.

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

Litigating for health care reform in Canada: How new legal challenges aim to extend Chaoulli’s scope // Speaker bio: Antonia Maioni

Posted By Rosel Kim – Feb. 20, 2014
On February 22nd, 2014, the McGill Journal of Law and Health’s annual colloquium will be revisiting the divisive Chaoulli decision and analyzing the impact it has had nine years after its release.  The colloquium, “Litigating for health care reform in Canada: How new legal challenges aim to extend Chaoulli’s scope” will examine legal decisions from Alberta and British Columbia that indicate Chaoulli’s influence is spreading to other provinces. Here is the biography of one of our speakers, Antonia Maioni.
Antonia Maioni is Director of the Institute for the Study of Canada at McGill University, where she also holds the positions of Associate Professor of Political Science and William Dawson Scholar. She studied at St. Mary’s University and Université Laval, and earned an M.A. from Carleton University’s Norman Paterson School of International Affairs and a Ph.D. in political science from Northwestern University. She has taught at the University of Ottawa, and has held visiting appointments at Columbia’s Mailman School of Public Health, Harvard’s Center for European Studies, the North American Studies Program at Duke University, and the Robert Schuman Centre of the European University Institute.
Professor Maioni has published widely in the fields of Canadian and comparative politics, with a particular focus on public policy. Her most recent research projects were funded by the Social Sciences and Humanities Research Council of Canada, the Canadian Institutes for Health Research, and the Max Bell Foundation. She currently teaches in the Department of Political Science and Canadian Studies at McGill University, and is a member of the International Masters in Health Leadership team in the Desautels Faculty of Management.
A frequent media commentator on Canadian and Quebec politics and public policy,in both English and French, Professor Maioni has been a political analyst with CTV News since 2008. She was named CIBC Scholar- in-Residence for the Conference Board of Canada and McGill’s Top Newsmaker in 2006. She is a mentor in the Action Canada program for young leaders, the Sauvé Scholars and the Canadian Merit Scholars programs. She sits on the boards of the McCord Museum of Canadian History, the Sacred Heart School of Montreal and the Canadian Health Services Research Foundation, and is a former member of the Institute for Research on Public Policy and the Management Board of the Banff Forum.

Litigating for health care reform in Canada: How new legal challenges aim to extend Chaoulli’s scope // Speaker bio: Alana Klein

Posted By Rosel Kim – Feb. 19, 2014
On February 22nd, 2014, the McGill Journal of Law and Health’s annual colloquium will be revisiting the divisive Chaoulli decision and analyzing the impact it has had nine years after its release.  The colloquium, “Litigating for health care reform in Canada: How new legal challenges aim to extend Chaoulli’s scope” will examine legal decisions from Alberta and British Columbia that indicate Chaoulli’s influence is spreading to other provinces. Here is the biography of one of our speakers, Alana Klein.


Assistant Professor Alana Klein teaches and researches in health law, criminal law, and human rights. The position of marginalized groups and individuals in decentralized and privatized systems and the role of accountability requirements in governance and decision-making are primary preoccupations in her research.
Prior to joining the Faculty, she was a senior policy analyst with the Canadian HIV/AIDS Legal Network, where she worked on HIV/AIDS and immigration, legal and other barriers to harm-reduction programs for people who use illegal drugs, and law reform to promote the rights of women and girls in the context of HIV/AIDS in sub-Saharan Africa.

She has taught at Columbia Law School and Columbia University and has interned with the International Refugee Program at the Lawyers Committee for Human Rights (now Human Rights First) and with the Palestinian Ministry of Economy and Trade. In 2002-2003, she was a law clerk to former Supreme Court of Canada justice Louise Arbour and she was appointed to the Ontario Human Rights Commission in 2006.

Education

J.S.D. (Columbia) 2011
LL.M. (Columbia) 2005
B.C.L., LL.B. (McGill) 2002
B.A. (Concordia) 1997

Employment

Assistant professor, McGill University, Faculty of Law (2008- )
Boulton Fellow, McGill University, Faculty of Law (2007-2008)
Senior Policy Analyst, Canadian HIV/AIDS Legal Network (2006-2007)
Associate in Law, Columbia Law School (2003-2005)
Law clerk to Hon. Louise Arbour, Supreme Court of Canada (2002-2003)
Member of the Law Society of Upper Canada

Areas of Interest

Canadian and comparative constitutional law, human rights law, international law, criminal law

Publications

Journal articles

A. Klein, “Criminal Law, Public Health, and Governance of HIV Exposure and Transmission” (2009) 13 Int’l J. Hum. Rts. 251.

A. Klein, “Gladue in Quebec” (2009) 54 Crim. L. Q. 506.

A. Klein, “Judging as Nudging: New Governance Approaches for the Enforcement of Constitutional Social and Economic Rights” (2008) 39 Colum. Hum. Rts. L. Rev. 351.

Research reports

A. Klein, Sticking Points: Barriers to Access to Needle and Syringe Programs in Canada. (Toronto: Canadian HIV/AIDS Legal Network, 2007).

A. Klein, Immigration and HIV/AIDS: Final Report. (Montreal: Canadian HIV/AIDS Legal Network, 2001).

Litigating for health care reform in Canada: How new legal challenges aim to extend Chaoulli’s scope // Speaker bio: John Carpay

Posted By Rosel Kim – Feb. 18, 2014
On February 22nd, 2014, the McGill Journal of Law and Health’s annual colloquium will be revisiting the divisive Chaoulli decision and analyzing the impact it has had nine years after its release.  The colloquium, “Litigating for health care reform in Canada: How new legal challenges aim to extend Chaoulli’s scope” will examine legal decisions from Alberta and British Columbia that indicate Chaoulli’s influence is spreading to other provinces. Here is the biography of one of our speakers, John Carpay.
John Carpay has been a voice for freedom in Canada’s courtrooms since 2001, when his then-employer, the Canadian Taxpayers Federation, intervened in Benoit v. Canada. In the Benoit case, the Canadian Taxpayers Federation argued that race, ancestry, descent, and ethnicity should not be grounds for the unequal taxation of Canadians. John also championed racial equality before the Supreme Court of Canada in R. v. Kapp, representing the intervener Japanese Canadian Fishermen’s Association. He defended freedom of expression before the Saskatchewan Court of Appeal in Whatcott v. Saskatchewan Human Rights Commission, and before the Alberta Court of Queen’s Bench in Lund v. Boissoin. John’s involvement in Kingstreet Investments v. New Brunswick led to a victory for taxpayers and for democratic accountability, with the Supreme Court of Canada recognizing the principle of “no taxation without representation.” In Wilson v. University of Calgary (currently before the Alberta Court of Queen’s Bench) John advocates for the right of tuition-paying students to express their opinions on campus in the face of the university’s censorship demands. The court action of Allen v. Alberta seeks to empower citizens with the right to access health care outside of the unaccountable government monopoly with its long and painful waiting lists.  John Carpay serves on the Board of Advisors of iJustice, an initiative of the Centre for Civil Society, India.
Preston Manning presented John Carpay with the Pyramid Award for Ideas and Public Policy in recognition of John’s success in building up and managing a non-profit organization to defend the constitutional freedoms of Canadians.
Originally from the Netherlands, John grew up in Williams Lake, B.C. He earned his B.A. in Political Science at Laval University in Quebec City, and his LL.B. from the University of Calgary. He is fluent in English, French, and Dutch.
John served the Canadian Taxpayers Federation as Alberta Director from 2001 to 2005, advocating for lower taxes, less waste, and accountable government. During that time,Alberta Venture magazine named him as one of Alberta’s 50 most influential people. The Edmonton Sun described him as the “unofficial leader of the opposition.”
John’s many columns have been published in newspapers across Canada, and are posted at www.taxpayer.com and www.johncarpay.ca.
John, his wife Barbra, and their four children reside in Calgary.
To RSVP or to receive more information about the colloquium, please contact: mjlh.colloquium@gmail.com.

Litigating for health care reform in Canada: How new legal challenges aim to extend Chaoulli’s scope

Posted By Silvia Neagu – Feb. 17, 2014

On February 22nd, 2014, the McGill Journal of Law and Health’s annual colloquium will be revisiting the divisive Chaoulli decision and analyzing the impact it has had nine years after its release.  The colloquium, “Litigating for health care reform in Canada: How new legal challenges aim to extend Chaoulli’s scope” will examine legal decisions from Alberta and British Columbia that indicate Chaoulli’s influence is spreading to other provinces.  While legally Chaoulli’s ratio only applies to Quebec, the issues at the heart of the case – two-tier health systems, access to health care and a resource-strained system –remain relevant.  The decision begs the question of whether the decision was the first sign of a larger problem in Canadian health system.

The facts in Chaoulli

Mr. George Zeliotis had had several hip surgeries within Quebec’s public health system and had spoken out against the delays he experienced.  Dr. Jacques Chaoulli was a physician who provided residential medical services and wanted to get a license to operate a private hospital.  The two brought an application for a declaratory judgment stating that s. 15 of the Health Insurance Act and s. 11 of the Hospital Insurance Act, which prohibited patients from purchasing private health insurance for services covered by public health care, violated s. 1 of the Quebec Charter and s. 7 of the Canadian Charter, which protect one’s right to life, liberty and security of the person.  The Actsdid not prohibit the existence of private health care facilities, but only the coverage of their services by insurance plans.  The plaintiffs argued that given the long waiting times in the public system, the absolute ban on insurance for private health care violated their constitutional rights.

Both the Superior Court of Quebec and the Quebec Court of Appeal agreed that the interference with the applicants’ rights were consistent with the principles of fundamental justice under s. 7 of the Canadian Charter.

The judgment

Writing the majority reasoning, Deschamps J found that the provisions violated the applicants’ rights under s. 1 of the Quebec Charter and did not address the Canadian Charter violation in her reasoning.  While McLachlin CJ, Major and Bastarache JJ agreed with Deschamps’ reasoning with respect to the Quebec Charter, the three judges also addressed s. 7 of the Canadian Charter.

Binnie, Lebel & Fish JJ were in dissent, having found that the violations were in accordance with the principles of fundamental justice and the violation of s. 1 of the Quebec Charter was saved under s. 9.1.

s. 1 of the Quebec Charter: the Right to life and personal inviolability

Deschamps J began her judgment by describing the health system in the following way: “[t]he public health care system, once a source of national pride, has become the subject of frequent and sometimes bitter criticism.”[1]

She went on to find that the waiting lists, combined with the absolute ban on private insurance, infringed patients’ right to life and personal inviolability.  Their rights were infringed since the ban increased patients’ risk of death, the risk that the injuries were irreparable and left patients in pain and with their quality of life affected.[2]  The judgment called the existence of waiting times in Quebec as an “implicit form of rationing.”[3] Deschamps J also found that the violations were not justified under s. 9.1 of the Quebec Charter, since the prohibition on private insurance did not minimally impair patients’ rights.  Interestingly, Deschamps J asserted that evidence from the rest of Canada and other OECD countries did not support the view that an absolute ban was not necessary to protect the integrity of the public plan.[4]

s. 7 of the Canadian Charter: The Right to life and security of the person

McLachlin CJ’s judgment recognized that  “access to a waiting list is not access to health care”[5]and that “delays in the public system are widespread and have serious, sometimes grave, consequences.”[6]  Therefore, she found that the right to life was engaged because delays could result in death, while the right to security of the person was engaged because of the possibility of psychological and physical suffering caused by the delays. Justice McLachlin wrote that the absolute prohibition on insurance created a situation where only the extremely rich could avoid the harms caused by the waiting lists because they could purchase private health services without using insurance:

“We conclude, based on the evidence, that prohibiting health insurance that would permit ordinary Canadians to access health care, in circumstances where the government is failing to deliver health care in a reasonable manner, thereby increasing the risk of complications and death, interferes with life and security of the person as protected by s. 7 of the Charter.”

McLachlin CJ found the provisions to be arbitrary and therefore not in accordance with the principles of fundamental justice because “the evidence on the experience of other western democracies refutes the government’s theoretical contention that a prohibition on private insurance is linked to maintaining quality public health care.”[7]  She went on to find that the interference was not saved under s.1 of the Charter.

Conclusion

While the Chaoulli decision was seen as an attack on medicare, it was the catalyst to some positive developments for it too.  The Quebec government pledged to cover radio-oncology, cancer surgery and advanced cardiac care in a private clinic if patients had to wait more than three months.  It also allowed hip, knee and cataract surgeries to be covered by private insurance and pledged to pay for private care if the wait was more than 6 months. [8]  Hence, the government actually adopted the Court’s ruling but only with regard to those three treatments. The federal government also earmarked more money for wait time reduction for the provinces and Ontario introduced a plan to reduce wait times.[9]

 

To RSVP or to receive more information about the colloquium, please contact: mjlh.colloquium@gmail.com

[1] Chaoulli v Quebec (Attorney General) [2005] 1 SCR 791 at para 2.

[2] Ibid at para 42.

[3] Ibid at para 39.

[4] Ibid at para 84.

[5] Ibid at para 123.

[6] Ibid at para 112.

[7] Ibid at para 149.

[8] Colleen M Flood, “Chaoulli’s Legacy for the Future of Canadian Health Care Policy”, Osgoode Hall LJ (2006) 44.

[9] Ibid.