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COPYRIGHT 2005 Health Law Institute
I Introduction
The past 25 years have witnessed a growing interaction between healthcare and intellectual property rights. This growth has been due to both new genetic technologies and the expanding scope of intellectual property protection. The interaction does not come without costs, however, and intellectual property rights are increasingly pointed to as a culprit in access to health care. Disputes over Myriad Genetics' patents over breast cancer genes have brought attention to this issue and it is instructive to examine how Canadian courts might react to a demand for funding for a patented genetic test in light of existing law.
Following this introduction, the article begins with a brief overview of the main provisions of patent law. Next, section III explores health care and access to patented technologies via a case study of Myriad Genetics and its patents on genes and genetic tests related to breast cancer. The role of how the cost for the test might affect access to existing and future treatments is explored in more detail through an analysis of relevant international and Canadian law. In particular, the section focuses on how Canadian courts, in light of the current case law, might consider the high cost of a patented genetic test when assessing medical necessity and justifications for discrimination under a section 1 Charter analysis. Finally, section V offers some concluding remarks.
II Introduction to Patent Law
A brief explanation of patent law helps to lay the framework for the discussion that follows. Patents are used to grant inventors exclusive rights to their inventions. Under the Canadian Patent Act (1), "'invention' means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement" thereof. (2) Section 28.3 of the Act also requires that an invention be non-obvious in order to receive a patent. Finally, mere discoveries and products of nature are not inventions as they lack the requisite novelty. (3)
A patent entitles an inventor to a twenty-year monopoly to prevent others from making, using or selling the invention. (4) It is this monopoly period that frequently, serves as a justification for patent law.
The difficulty comes because of the idea that information goods are not only non-rival (uses do not interfere with each other) they are also assumed to be non-excludable (it is impossible, or at least hard, to stop one unit of the good from satisfying an infinite number of users at zero marginal cost.) Pirates will copy the song, the mousetrap, the drug formula. The rest of the argument is well known. Lacking an ability to exclude, creators will be unable to charge for their creations; there will be inadequate incentives to create. Thus the law must step in and create a limited monopoly called an intellectual property right. (5)
The incentive provided by the monopoly is seen as particularly important in the medical field where large investments are needed to investigate new drugs and pay for the clinical trials necessary to bring a product to market.
These standards are not exclusive to Canada. The Uruguay Round of negotiations under the General Agreement on Tariffs and Trade created the Agreement on Trade-Related Aspects of Intellectual Property Rights (6) (TRIPS) which sets certain international standards for patent law. In particular, Article 27(1) of the TRIPS Agreement embodies novelty, non-obviousness and utility as the standard for obtaining a patent.
III Case Study: Myriad Genetics
Myriad Genetics is a Utah-based company with patents on two of the genes linked to breast cancer as well as on tests and diagnostic kits for detecting mutations in these genes. (7) Several Canadian provinces funded their own tests for detecting mutations in the breast cancer genes until Myriad sent them cease-and-desist orders in the spring of 2001 claiming that the provinces were infringing Myriad's patents. (8) Myriad wants Canadians' DNA samples to be sent to its laboratory for testing but the price charged by Myriad is significantly higher than the price the provinces had been paying. How did this happen?
A. History of Myriad's Patents
1. Myriad's Patents in Canada
In the 1990s, Myriad succeeded in identifying, locating and isolating two genes, known as BRCA 1 and BRCA 2, that are linked to breast cancer. (9) Mutations of these genes are factors in 5-10% of breast cancer cases. (10) Myriad obtained patents in the U.S., Canada and Europe on both these genes as well as methods of their use, including screening for mutations.
Intuitively, genes would appear to be products of nature and thus not fall within the definition of invention described in section II, above. The courts and patent offices, however, have drawn a very fine line that allows genes in a certain form to constitute an invention. Genes as they exist in nature as part of the larger genome of an organism are not considered patentable but a gene isolated by human intervention is sufficient to constitute novelty. (11)
After obtaining the patents, Myriad largely refused to issue licenses for other facilities to conduct the screening test. (12) Instead, the company required DNA samples be sent to its facilities in Salt Lake City where it would perform the test at a cost of approximately US$2,500. (13) Myriad argued that this was for quality control purposes--it wanted to ensure that the tests were performed accurately. (14) It also, however, raises issues of access and affordability.
At the time of the cease-and-desist letters in May of 2001, eight Canadian provinces covered the costs of the tests for the breast cancer genetic mutations in their provincial health insurance plans and funded their own facilities to perform the test. (15) The screening test used by these facilities was different from the one claimed by Myriad in its patent. In Ontario and British Columbia, at least, the cost was also a lot cheaper.
The cease-and-desist orders sent by Myriad to the provincial health care authorities stated that the provincial screening tests infringed Myriad's patents by using the patented genes. (16) The fact that the test used by the provinces was different from the one claimed by Myriad in its patents was not relevant because ultimately any screening test required use of the patented genes. The letters required all DNA samples be sent to Myriad's facilities for testing. (17) If they did not comply, the provinces faced the risk of patent infringement litigation. Of the eight provinces, British Columbia initially suspended its funding for the test, then withdrew funding altogether, and has since resumed funding for a different test; Alberta and Manitoba quietly continued as they had been doing; Saskatchewan, Newfoundland and Nova Scotia sent their samples to Ontario so depended on the latter's decision; and Quebec complied with the order and began sending its samples to Utah. (18) In September 2001, Ontario announced that it would not comply with the order, that it would continue to fund its own tests and that it did not believe it was infringing Myriad's patents. Subsequently, Ontario adopted a new test that is cheaper and more accurate than the one it had been using previously. (19) There has been no response from Myriad to date.
Ontario is in a difficult position because it has already been ordered to fund the genetic test for breast cancer. In the late 1990s, the test was still considered experimental in Canada. Canadian women only had access to it if they participated in research studies, and these studies could take up to two years to return with the test results. Myriad' s results, on the other hand, were available within a few weeks. (20) An Ontario woman named Fiona Webster had a family history of breast cancer and she wanted to know if she was at risk as well. At 39, she did not feel she could wait two years to know the test results. The Ontario Health Insurance Plan (OHIP) was willing to pay approximately $20,000 for Webster to have a bilateral mastectomy and breast reconstruction surgery but was not willing to pay for Myriad's test. (21) Webster appealed the OHIP decision to the Ontario Health Services Appeal Board. It ruled that the government must pay for the Myriad test if individuals can show a compelling case history. (22) As it turned out, Webster did not have a mutation in her genes so the surgery would have been unnecessary. (23) As will be discussed below, any province that refuses to fund a genetic test could leave itself open to similar litigation.
2. Myriad's Patents" in Europe
Before moving on to discuss the issues of access raised by Myriad's patents and gene patents in general, an examination of the situation in Europe is worthwhile. In Europe, unlike in North America, third parties have nine months to file an opposition to a patent once it has been issued. (24) While an opposition is ongoing, the patentee of the impugned patent cannot enforce its rights. (25) In Canada and the U.S., on the other hand, patents can be re-examined by the respective patent offices in light of new prior art. (26) This usually results in amendments to the patent claims rather than the patent being invalidated. Otherwise, the validity of patents must be challenged through litigation, a very costly and time-consuming process. (27)
As mentioned, Myriad has patents on the BRCA 1 and 2 genes as well as on methods of using these genes in Europe as in North America. The Institut Curie, the Institut Gustave Roussy, and the Assistance Publique-Hopitaux de Paris, with the explicit backing of the French government, and along with numerous other European organizations have launched opposition proceedings against four of these patents. (28) Like the Canadian...
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