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. …