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Patents and your health.

Intellectual property issues are of growing importance in the health care field. Legislators, judges, researchers and the public are currently grappling with complex questions regarding the appropriate boundaries of patent law, particularly in regard to patents on genes and higher life forms. Patents are a form of intellectual property protection that grant an inventor a monopoly over an invention for a specific period of time. In other words, the inventor acquires the exclusive privilege to make and use the invention and sell it to others. Inventions that are new, useful, and non-obvious are patentable under Canada's Patent Act. Because years of work and millions of dollars often go into research, it is only fair to grant patents so inventors have time to gain some return on their investment. By providing this protection, patents encourage scientific research and innovation.

However, recent advances in genetic research and technology have created challenging issues in the field of intellectual property law. Will patents on genetic tests limit access to health care services and drive up health care costs? Should genetically-altered animals be considered patentable inventions? How will the Canadian legal environment affect our growing biotechnology industry and our international competitiveness? These complex questions have recently made headlines in Canada in regard to patent claims over genes associated with breast cancer and genetically modified mice used for cancer research.

Genetic Testing for Hereditary Breast Cancer

Over the past two years, controversy has brewed in Canada regarding the impact of patents on access to genetic testing for breast cancer. Approximately 5 to 10% of breast cancer cases are hereditary, meaning that women with specific genetic mutations are at high risk of developing the disease. Two genes, known as BRCA 1 and BRCA 2, are associated

with breast (and ovarian) cancer. An American company, Myriad Genetics Inc., developed a testing procedure to detect the mutations and currently holds patents in Canada that cover the genetic sequencing process that identifies mutations in the genes that are associated with cancer.

In 2001, Myriad sought to enforce its patents in Canada and demanded that provinces, including Alberta, Ontario and British Columbia, cease doing their own testing and obtain tests only through a Myriad-approved lab. Myriad charges close to $4000 for each test, compared to the cost of around $1000 in Canada. Alberta and Ontario both ignored Myriad's threat of legal action, but British Columbia ceased offering testing as a publicly-funded service, stating it was too expensive to pay for testing through Myriad. This decision left women in BC with the option of foregoing testing or paying for it themselves if they could afford to do so. (The BC Cancer Agency eventually attempted to sidestep the patent dispute by sending samples to Ontario for testing as part of a research program.) In February 2003, BC reversed its position and again began covering the cost of testing. Although the decisions of provincial governments to disregard Myriad's patent claim have been lauded by some, this action leaves open the continuing prospect of legal disputes.

The Myriad example raises significant concerns about the impact of patents on access to, and cost of, health care services, particularly predictive genetic tests. It is anticipated that tests for genetic predisposition to a number of common conditions-including heart disease, various types of cancer, and diabetes--will become available over the next ten years. Provincial governments throughout Canada will, then, face difficult decisions about what tests ought to be publicly-funded as benefits under provincial health insurance plans. If tests covered by patents are more expensive, governments may decide not to fund these tests, to the potential detriment of some individuals who cannot afford to purchase the service privately.

In its recent report, the Romanow Commission on the Future of Health Care in Canada expressed some concern over the impact of patents on health care costs and access (especially in relation to pharmaceuticals) and specifically recommended the federal government review patent legislation in regard to the issue of gene patenting. Clearly, our intellectual property regime must offer sufficient protection and incentives for firms to conduct research, but this goal must be balanced with the need to ensure affordable access to health care services such as genetic tests that give some individuals important information about their disease risks.

The Case of the "Oncomouse"

In December 2002, the Supreme Court of Canada released its decision in Harvard College v. Canada (Commissioner of Patents), a case that considered whether a transgenic mouse could be patented. Researchers at Harvard University developed a process to breed a cancer-promoting gene into mice to make them susceptible to cancer. The resulting oncomice are useful for cancer research and Harvard sought Canadian patents both for the process used to create the mice, as well as the mice themselves. Five members of the Supreme Court of Canada ruled the oncomouse did not constitute an invention under the Canadian Patent Act and could not be patented, with the remaining four members reaching the opposite conclusion. This contentious case has sent waves throughout the legal and biotechnology communities, both in Canada and abroad.

The majority of the Court stated that the process of inserting a cancer-promoting gene into a mouse embryo is a patentable process but the living mouse is not. While lower life forms (such as oil-degrading bacteria) are patentable in Canada, the majority of the Court ruled that higher life forms are not inventions. The justices stated that our existing patent legislation was not drafted to address the intricate issues that arise in relation to patenting complex living organisms. For example, some argue that allowing patents on higher life forms will lead down a slippery slope to the commodification of human tissues and organs. The majority of the Supreme Court noted that it cannot resolve such concerns, and Canadians and their elected representatives in Parliament must engage in debate about these issues.

The dissenting judges stated that the Patent Act does not distinguish between lower and higher life forms and ruled that the onco-mouse constitutes an invention that may be patented. In their view, if a genetically altered, fertilized mouse egg is an invention, so, too, is the resulting mouse. The fact that processes of nature are involved in the development of a living mouse from a fertilized cell does not preclude the mouse from being patentable. Many patented inventions, such as pharmaceuticals, only have their desired effect when introduced into a human body through natural processes such as digestion and blood circulation. The minority ruling also noted the Patent Act does not contain authority to refuse a patent based on concerns about morality.

Interestingly, the onco-mouse has been patented in numerous European countries and in the United States; in fact, there was no evidence before the Supreme Court that a patent on the oncomouse has been denied in any other jurisdiction in which it was sought. Thus Canada is alone among industrialized nations in denying such a patent and many commentators speculate that biotechnology companies will move from Canada to jurisdictions with more favourable intellectual property laws. However, this outcome is not inevitable. While genetically altered animals may not be patentable in Canada, nothing currently precludes such research in this country and Canadian biotech firms may still apply for patent protection in other countries. In any event, the oncomouse case has highlighted fundamental questions about the patentability of higher life forms and the Supreme Court of Canada has signalled the federal government to take action in reviewing and modernizing our patent laws so we are equipped to deal with inventions--however they may be defined--emerging from the biotechnological revolution.

Nola M. Ries, LL.M., is a Research Associate with the University of Alberta Health Law Institute and Stacey E. Grubb, B.Sc., is a third-year law student at the University of Alberta in Edmonton, Alberta.
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Title Annotation:Special Report on Intellectual Property
Author:Ries, Nola M.; Grubb, Stacey E.
Geographic Code:1USA
Date:Dec 1, 2003
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