Blue Genes: The Sad State of Gene Patenting in Canada
Thomas Kurys
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Table of Contents
1.0 Introduction ……………………………………………………………….2.0 What is a Gene? ……………………………………………………………
3.0 Gene Patenting in Canada………………………………………………………
3.1 Patent Law Overview ……………………………………………………..
3.1 Owning Life: A History of Patenting Living Things…………………….
3.2.1 Owning Life Case Law …………………………………………………..
3.3 Patenting Genes: A Closer Look …………………………………………..
3.3.1 Satisfying the Act…………………………………………………………
3.3.1.1 Subject Matter …………………………………………………………..
3.3.1.2 Novelty …………………………………………………………………
3.3.1.3 Utility …………………………………………………………………..
3.3.1.4 Non-Obviousness ………………………………………………………
3.3.2 Gene Patents in Foreign Countries …………………………………….
4.0 Should Genes Be Patented? ……………………………………………….
4.1 Effect on Research ………………………………………………………..
4.1.1 Overview of Biotechnology Research …………………………………..
4.2 Effect on Clinical Work …………………………………………………..
4.2.1 Cancer and Genes: The Myriad Case ………………………………….
4.2.1.1 BRCA Testing in Canada……………………………………………..
4.3 Effect on Commercialization ……………………………………………..
4.4 Ethical Issues ………………………………………………………………..
4.5 A Change to the Gene Patent Regime is Needed …………………………
5.0 Possible Solutions …………………………………………………………..
5.1 Solution 1: Compulsory Licensing ………………………………………..
5.1.1 Other Compulsory Licences for Patents in Canada……………………
5.1.2 Australian Model …………………………………………………………
5.1.3 Possible Model for Gene Patents ………………………………………..
5.1.4 Application to BRCA Testing……………………………………………
5.2 Solution 2: Research Exemption …………………………………………..
5.3 Solution 3: Government Issued Guidelines ………………………………
6.0 Further Consideration: International Relations ………………………….
7.0 Recommended Solution ……………………………………………………
8.0 Conclusion…………………………………………………………………..
9.0 Bibliography………………………………………………………………… / 1
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1.0Introduction
As technology has evolved, so too has the application of the Patent Act.[1]Once meant to deal with inventions that could be modeled with prototypes, the Act is now being used to protect abstract innovations, such as computer programs and genetic material.
In the hands of an inventor, a patent is a very powerful tool. It gives them the exclusive right to make, use and sell their invention in exchange for the public disclosure of their patent. This monopoly provides the incentive to innovate, so that society may benefit from the added new and useful knowledge. However, in the realm of gene patents, left unchecked, this power can be used in many unsavoury ways. For example, patent holders could potentially deny access to life saving technologies, or make them so expensive as to render them unaffordable to all but the very wealthy. Thus, there is a need for a system that continues to stimulate innovation in genetic science while ensuring that the public fully benefits from the technology. This paper recommends that the Act be amended to include a provision that grants Parliament the power to award compulsory licensing to a third party who can demonstrate an overriding public need, as decided by a government administrative body. It is further recommended that the Act be amended to include a research exemption for genetic patents in medical technology.
This paper will proceed in 6 sections. The first part, section 2.0, will provide background information on genetic science. From there, section 3.0 introduces genetic patents by explaining the Canadian patent law system, giving an historical overview of patents on life in general and then looking specifically at how patents on genes fit into this overall system. Section 3.3.2 then briefly compares this system with those in foreign countries.
Once the Canadian gene patent climate has been described, section 4.0 will highlight a number of deficiencies in the way genes are currently patented in Canada and argue that they should remain patentable but that changes to the system are needed. This section sets out the negative and positive effects of gene patents on research, clinical work and commercialization. The controversial patenting of the BRCA genes in breast and ovarian cancer testing by Myriad Genetic Inc. will serve as a case study and illustrate the perils of gene patenting. Furthermore, section 4.4 will explore the main ethical issues of patenting genes. Having identified the main issues, section 5.0 will involve a critical discussion of several possible solutions, including compulsory licensing, research exemptions and government issued guidelines. Next, section 6.0 will consider the impact of any decision on Canada’s international trade relations. Finally, section 7.0 will present the proposed solution, which involves amendments to the Act to include provisions allowing for compulsory licensing and research exemptions in gene patenting, as well a set of guidelines and a government administrative body to evaluate the applications of compulsory licences and to promote awareness of gene patent issues.
This paper explores legal opinions, cases and government reports from Canada and abroad. In taking a critical perspective, itcombines elements of previously recommended alternatives to propose a novel solution to the issue of gene patenting in Canada.
2.0What is a Gene?
Before discussing the legal aspects of gene patenting, it is important to first explain what is being patented. Human cells contain a nucleus, within which are tightly coiled structures called chromosomes. Normally, human cells have 23 pairs of chromosomes: one pair from the mother, the other from the father. Each chromosome has within it hundreds or thousands of genes. Each gene has a specific location and consists of an inherited genetic material called deoxyribonucleic acid (DNA). DNA contains codes that direct the product of proteins, which are used to form the structure of the cell and control the chemical reactions within the cell.[2] The DNA of each gene is characterized by a sequence of bases known as the “genetic code”. DNA can be sequenced when it is removed and isolated from its natural state and clone or amplified.[3] Section 3.3.1.4 will explain the process of isolating and sequencing a gene. Now that genes have been explained, their patentability will be discussed.
3.0Gene Patenting in Canada
In Canada, there is currently no specific legislation dealing with gene patents, thus they are subject to the Act. The following section will provide a general summary of Canadian patent law, followed by a historical synopsis of patenting life and then a description of how genes are currently being patented in Canada.
3.1Patent Law Overview
Patents are issued under the Act and are intended to “stimulate the creation and development of new technologies”.[4] A patent lasts twenty years and gives its holder the exclusive right, privilege and liberty of making, constructing and using the invention and selling it to others to be used,[5] in exchange for complete disclosure of the invention. As Justice Binnie stated in Cadbury Schweppes Inc. v. FBI Foods Ltd.:[6] “The disclosure is the essence of the bargain between the patentee, who obtains a…monopoly on exploiting the invention, and the public, which obtains open access to all of the information necessary to practice the invention.”[7]
Patents are necessary for technology to flourish. They provide an economic incentive to undertake the initial costs of researching and developing. Indeed, without their protection, as soon as a product enters the market,competitors would be able to compete directly without incurring these initial costs.
Patents are issued to applicants if their new technology meets the requirements of patentable subject matter, novelty, utility and non-obviousness.[8] A further explanation of each requirement will be made in section 3.3.1, which discusses the patentability of genes.
There are four main stakeholders in the patent system: the patent holders, the inventor, the users and the public. The patent holders have the exclusive rights to the invention and seek protection in order to develop and market the innovation free of competition.[9] It should be noted that while the inventor is often the owner of the patent, this is not always the case. In certain employment situations, inventions may be the sole property of the employer.[10] Thus, an inventor’s interests will be largely aligned with the interests of the patent holder. The public, though not expressly considered in the Act,[11] benefits from the increase in knowledge to the public domain.[12] This occurs both from publication of the patent and from the addition of the patent to the public domain upon expiration. Similarly, the user of the patent benefits directly from the use of the inventionand further as a member of the public.
3.2Owning Life: A History of Patenting Living Things
The issue of owning life dates back over seventy years, when the American botanist Luther Burbank created new varieties and species of plants for commercial purposes.[13] Since then, rapid advances in technology have occurred, placing genes, stem cells and cloning at the forefront of science. Legislatures have also begun to adapt alongside this evolution. In the United States, the Bayh-Dole Act[14] and the Stevenson-Wyler Act[15]encouraged the patenting of inventions and discoveries for the purpose of promoting new developments in these growing fields.[16] As a direct consequence, there has been a flurry of patents for genetic material.[17] Not surprisingly, this has brought with it a lot of controversy, particularly surrounding the question of “who owns life.”According to author Michael Crichton, “gene patents are now used to halt research, prevent medical testing and keep vital information from you and your doctor”.[18] The following cases exemplify the legal evolution in this area.
3.2.1Owning Life Case Law
In 1980, the United State Supreme Court in Diamond v. Chakrabarty[19] overruled the U.S. Patent and Trademark Office and allowed a patent for the creation of oil-eating bacteria. This marked the first time the issue of patenting organisms other than plants was decided upon.
In the aftermath of the Chakrabarty decision, the issue was brought to the next level with the patentability of Harvard’s famous oncomouse. The question then became: can you patent higher life forms?
On June 21, 1985, the President and Fellows of Harvard College filed a patent application seeking to patent a mouse (the “oncomouse”) that had been genetically altered to increase its susceptibility to cancer, for the purpose of carcinogenic studies.[20] The oncogene was taken from the genetic code of a non-mammal source, typically a virus, and then transported into the chromosome of the mouse using bacterial DNA known as a plasmid.[21] The plasmid was then injected into a fertilized egg, implanted into a female mouse and brought to term. The resulting offspring were tested to ensure that they possessed the oncogene. Those that did were mated with mice that did not have the oncogene.[22] The application sought to patent the method of creating the oncomice, the end product and the offspring. It also sought to patent all non-human mammals.[23] The patent on the mouse itself was not granted in Canada and was the subject matter of the litigation.[24] At the time of the Supreme Court of Canada (SCC) decision, the oncomouse had already been patented in the U.S. and the patent had not even been refused in any country with a patent system comparable to Canada’s.[25] In a 5-4 decision, the SCC ultimately ruled that the transgenic mouse was not patentable subject matter in Canada as it was not an “invention” in the meaning of s2 of the Act.[26] Moreover, Bastarache J concluded that the patenting of higher forms of life raises a host of complex issues and that the courts are not in a position to rule on them.[27]
Two years after Harvard, the SCC was forced to revisit the issue of patenting life in Schmeiser et al. v. Monsanto.[28] In yet another 5-4 decision, the court seemed to make an about-face, ruling that genes and the cells that contain them can be patented. The defendant Monsanto owned a patent for Roundup Ready Canola, which contained genetically modified genes and cells.[29] This product was resistant to the herbicide Roundup, which would kill all other plants.[30] Monsanto issued licences for the use of Roundup. Schmeiser, a farmer, never purchased Roundup Ready Canola nor did he have a licence to plant it, yet in 1998 his fields contained 95-98% Roundup Ready plants.[31] The issue before the court was the patent’s validity. Since all parties agreed that the patent was valid for the gene, the process of insertion and the cell derived from the process, the question was whether the patent covered the plant that is generated from the patented cell.[32] According to the majority “infringement does not require use of the gene or cell in isolation”[33] and there is infringement if the “patented invention is a significant aspect of the defendant's activity”.[34] The court therefore ruled that the patent protection extended to the plant and that Schmeiser’s activity infringed the patent.[35]
The SCC decisions in Harvard and Monsanto appear to be at odds with each and are difficult to reconcile. This showcases some of the general confusion in the area of patenting life. It is this system which has allowed for the patenting of genetic material, which is the primary focus of this paper. With this background in mind, the rest of this paper will explore the legal and ethical issues and consequences of patenting genes, and offer recommendations on ways to improve the regime.
3.3Patenting Genes: A Closer Look
As technology has advanced, it has become possible to sequence genes in organisms and in human beings.[36] From 1981 to 1995 there were over 1,175 gene patents granted worldwide, in 1995 there were 652 patent applications for human DNA[37] and by 2000 there were more than 25,000 DNA-based patents.[38]Further, in the US, revenues doubled between 1993 and 1999 and tripled by 2001.[39]
Given that genes are very different from the traditional understanding of an invention, there has been some confusion as to the application of the Act. Further, even though patents for genes have been issued for over 20 years, patent offices and courts have yet to establish any set of ground rules for patenting DNA sequences.[40] Section 3.3.1 will attempt to explain how genes meet the requirements for a patent in Canada and section 3.3.2 will discuss gene patents in an international context and look briefly at systems in the United States, Europe and Australia.
3.3.1Satisfying the Act
3.3.1.1Subject Matter
The Act states that a patent must disclose a “new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter”.[41]How can genes, which have been around for millions of years, satisfy this requirement? And indeed, genes as they exist in nature cannot be patented.[42] However, once the gene is isolated, its function identified and put into commercial operation, it is no longer a product of nature. It has been transformed into something with real-world utility.[43] Further, in nature, the coding DNA (which is patented) is mixed with non-coding DNA (not patented), making the sequence different from what is patented.[44]
3.3.1.2Novelty
The arguments for and against the novelty requirement mirror those of the subject matter requirement. Since genetic material appears to be a product of nature, how can it be novel? However, as stated above, once isolated and purified, genes are easily distinguishable from their natural counterparts and are therefore “new”.[45]
3.3.1.3Utility
In the case of gene patents, the utility requirement has been less contentious than the other criteria. To satisfy this “utility”, patented sequences have included activity in gene regulation, encoding for therapeutic proteins, diagnostic probes and other activities.[46]
3.3.1.4Non-Obviousness
The final criteria is that the invention must be non-obvious. Under this “inventive step” requirement, the invention must not have been “obvious on the claim date to a person skilled in the art or science to which it pertains”.[47] This is a much more onerous task, since discovering new genes generally incorporates well known scientific techniques.[48]
The inventive step comes from isolating the gene, discovering its function and putting it into commercial use.[49]Traditionally, this begins by identifying the precise biological function of the gene, purifying the protein and sequencing a few of its amino acids. From that, probes are made for all the possible nucleotides that could code for the amino acids. The messenger ribonucleic acid(mRNA) produced from these cells is extracted and transformed into complementary DNA (cDNA). Next, the probes created from the protein sequences are used to “fish out” the coding sequence from the cDNA mixture.[50]
Recent developments in the field have spurred the creation of a new method – one that uses high throughput DNA sequencing. Instead of looking for a gene that encodes a specific biological function, gene sequences can be identified a priori from cDNA.[51]The functionality can be identified from sources such as ‘‘homology analysis,’’ (comparing its structure to the structure of other known sequences) and microarraybased expression analysis.[52] This new process has made it vastly easier and faster to code sequences, to the point where opponents of the patents are calling these “discoveries” and not inventions. However, the difficulty required is irrelevant to the patentability,[53] therefore this does not affect the patentability.
3.3.2Gene Patents in Foreign Countries