Human Gene Patents: Recent Developments

For the Canadian Biotechnology Advisory Committee

August 2002

By E. Richard Gold
Bell Chair in e-Governance
Faculty of Law
McGill University

Abstract

Canadian, European and US policy makers have recently had to address the health policy implications of granting patents over human genes. The source of this need was the granting in Canada, Europe and the United States of patents covering various aspects of the BRCA1 gene and diagnostic tests in respect of that gene. This concern arose against a general background policy of encouraging the patenting of the products of biotechnology research, as illustrated by Europe's passage of a directive on biotechnology patents. Following on the controversy over BRCA1, European legislators have been more reluctant to implement the directive's rules regarding the patentability of human genes. Health administrators in Canada have also urged that some limitations be placed on gene patents in order to ensure continued access to important diagnostic tests.

One of the problem areas identified in both the interim and final CBAC reports on the patenting of higher life forms was that of patents on human gene. This issue was canvassed in my December 2000 paper for CBAC entitled “Patents in Genes.” In that report, I discussed the patentability of genes and some of the ethical issues that had thus far been identified in relation to those patents. The issue of gene patents was also raised in the CBAC Consultation Document for the Patenting of Higher Life Forms project. There was even some discussion of the issue during the multi-stakeholder consultations held across the country by CBAC in 2001. Nevertheless, as the issue was tangential to the central question of the patentability of plants and animals, CBAC made no specific recommendations on gene patents in its final report. It did state, however, that the issue was of importance for health care and needed resolution.

CBAC's caution toward gene patents in the final report is easily justified given developments in the area of gene patents in the past year. This paper sets out the major developments in this area in Canada and elsewhere. I first discuss developments in Europe and in the United States before examining events in Canada. In the final section, I look at reports of international bodies, research institutes and academics.

Europe

With the passage of Directive 98/44 on the legal protection of biotechnological inventions in July 1998 (calling for implementation by the end of July 2000), Europe seemed on the verge of settling the matter of biotechnology patents in general and gene patents in particular. Although some Member States were hesitant, the Directive came into force. Soon after its implementation in 2000, four Member States (joined later by a fifth) incorporated it into national law. In addition, the European Patent Office (EPO) amended its regulations to effectively bring the Directive within the European Patent Convention.

Despite appearances, the issue of gene patents was far from settled. The Netherlands launched a challenge against the Directive before the European Court of Justice, joined by Italy. (The court dismissed this challenge in October 2001.) Ten Member States continued to stall in implementing the Directive for a variety of reasons not least of which was opposition to the notion of patenting human genes.

As murky as the situation was in Europe, the grant by the EPO of a set of patents to Myriad Genetics over the BRCA1/2 genes beginning in January 2001 upset any consensus that had theretofore developed. In reaction to these patents the European Parliament passed a resolution on October 4, 2001 expressing dismay at the grant of these patents and reiterating its view that human genes are unpatentable in their natural environment (European Parliament, Resolution on the patenting of BRCA1 and BRCA2 ('breast cancer') genes, adopted on 4 October 2001, B5-0633, 0641, 0651 and 0663/2001).

The French government, in particular, fought against the Myriad patents. Although France had been one of the promoters of the Directive, the government had already encountered opposition to the Directive provisions dealing with human genes. The grant of patents to Myriad led the French government to encourage the Institut Curie and other research institutes in France to file oppositions against the patents. In October 2001, the Institut Curie and others filed the first of their oppositions. The formal grounds for attack centred on lack of inventive step and failure to appropriately describe the invention. At the political level, the Institut Curie raised the dangers of granting a monopoly over the provision of all genetic tests in regard to BRCA1/2, especially since the Institut Curie had developed an alternative test (that fell within the very broad language of the patent claim) that it claimed was superior to that used by Myriad.

France took a further step against gene patents in the winter of 2002. The government introduced legislation to implement all aspects of the Directive except those relating to human genes. This it left aside because of the political opposition to human gene patents. Interestingly, the proposed legislation included a widening of France's compulsory licensing rules. Previously, diagnostic tests had not been included in the section of the French Code of Industrial Property dealing with those licences. The proposed legislation widened this provision by permitting the Minister of Health to issue a “licence d'office” in respect of diagnostic inventions.

Even though the proposed legislation did not deal with human gene patents and did include a widening of compulsory licensing rules, the government encountered firm opposition to its legislation. The legislation has not progressed and the government indicated that it might go forward with the compulsory licensing provisions (for which there was support) separately from the provisions dealing with the Directive.

At the same time as the French government was moving forward with legislation to implement the Directive, the National Assembly passed a provision that expressly contradicted the Directive. I n January 2002, the National Assembly passed an amendment to a bill before it to specifically provide that no patent can be issued on a human gene (Article 12bis, Project de loi relatif à la bioethique, Texte adopté n° 763).

While France was struggling with its legislation, Germany was also trying to find a way to deal with fears about patents over human genes. While Germany has not yet announced how it plans to proceed in this area, one proposal gaining support is that the German patent office adopt a rule that it would generally refuse to grant patents claiming genes per se; instead, it would grant a patent on using a gene for particular and identified purposes. The patent office would be able to grant patents over genes that have been significantly modified or that are completely artificial.

The result of all the discussion in Europe is that, for all intents and purposes, human genes are patentable in Europe. This is because the vast majority of patent applications are made to the EPO and not to national patent offices. Since the EPO follows the Directive, the fact that individual countries do not, hardly matters. Even France's provision that genes cannot be patented will not lead to the invalidity of the patent issued by the EPO. On the other hand, national legislation dealing with compulsory licensing or enforcement of patents does apply to patents issued by the EPO. Thus, if France successfully modifies its compulsory licensing provisions, even patents issued by the EPO (such as those to Myriad) will be subject to compulsory licensing in France.

United States

In the United States, two Members of the House of Representatives introduced legislation that would amend US patent law to provide that a patent holder cannot bring an action for infringement against a health care provider or associated health entity for providing a genetic diagnostic test (Genomic Research and Diagnostic Accessibility Act of 2002, H.R. 3967, 107^th Cong., 2d Sess. (2002)). The bill would only affect those patents issued after the amendment was adopted, thus considerably reducing its practical effect. Nevertheless, the bill illustrated the level of concern over gene patents even in the United States.

Canada

The Canadian Intellectual Property Office (CIPO) awarded Myriad Genetics the first of its BRCA1/2 patents in October 2000. This largely went unnoticed until Myriad's lawyers began sending out cease and desist letters to provincial health authorities. For example, Ontario received a letter from Myriad on May 31, 2001, requesting it to stop providing genetic testing services in respect of BRCA1/2.

The reaction from Ontario was swift and forceful. During the summer of 2001, then-premier Harris called for the federal government to intervene to prevent gene patenting. At a premiers' conference, he promised that Ontario would provide a study of the issue and report back in January 2002.

The Ontario Ministry of Health and Long-Term Care actively took hold of the file, pursuing a two-tier strategy. First, the Ministry prepared its defence against Myriad, taking the position that Ontario was not infringing on any valid patent. Second, the Ministry began examining policy in the general area of patent law and gene -based inventions. In December 2001, the Minister of Health held a Genetics and Gene Patenting Roundtable to which it invited experts from academia, clinicians, and government representatives (including a representative of the French Ministry of Research). At this Roundtable, the Minister stated that there was a need to modify patent law to address its impact on access to medical care.

At about the same time as Ontario was developing its position, the House of Commons Standing Committee on Health issued its report entitled “Assisted Human Reproduction: Building Families.” In this report, the Committee stated that human genes ought not to be patentable. (It should be noted, however, that the committee was proceeding on the incorrect assumption that no such patents had been granted.)

Following on the Ontario Roundtable, Ontario's internal research, and outside advice, Ontario released its report “Genetics, Testing and Gene Patenting: Charting New Territory in Healthcare” at the Vancouver premiers conference on January 25, 2002. Instead of restricting itself to the case of Myriad's patents, the report took a much more holistic view of the entire issue of genetic testing. The report recognized that genetic testing raises many important challenges for the health care system, of which the patenting of genes is only one. The report set out a plan that was unanimously accepted by the premiers in January. At the heart of that plan was the establishment of a crossjurisdictional co-ordinating body that would bring together the federal, provincial and territorial governments to address the wide variety of issues that genetic testing presents. These include the establishment of laboratory and other standards, co-ordinating decision-making with respect to including genetic testing services within health care systems, privacy of genetic information, human and financial resource planning, public engagement, professional training, and, not least, patent reform. In terms of the question of gene patenting, Ontario suggested that patent law be reformed to ensure that patients have access to new health technology. The report proposed several options for reform, including clarifying the research exemption, changing the na ture of the methods of medical treatment exclusion, the introduction of an 'ordre public or morality' clause and differentiating between patents over physical molecules and those restricting access to information contained in particular DNA sequences.

Following on the adoption of the Ontario proposals, the Co-ordinating Meeting on Genetics and Health held its first meeting in Montreal in June 2002. Its work continues.

International and Academic

There have been many international initiatives dealing with genes and patents in the last decade. Most notable among these are UNESCO's Universal Declaration on the Human Genome and Human Rights in 1997, the HUGO Ethics Committee Statement on Benefit Sharing (April 2000) and the HUGO Intellectual Property Rights Committee statement on Patenting of DNA Sequences (April 2000 and January 1995).

Of the more recent discussions of gene patenting, the OECD Expert Workshop on Genetic Inventions, Intellectual Property Rights and Licensing Practices, held in Berlin in January 2002, and the Nuffield Council on Bioethics' discussion paper, The Ethics of Patenting DNA, are most notable. The OECD brought together experts from government, academia, and industry to discuss the current state of affairs regarding gene patenting and methods to address concerns over access to innovation. The meeting was heavily weighted in favour of industry and professional participants. It concluded that, while there appear to be some concerns over the scope of research exemptions and over access to genetic diagnostic tests, the patent system as a whole seems to be working well. Whatever problems do exist (with respect to sharing information and “reachthrough” patent claims) can be adequately dealt with by private initiative or by patent offices. This view was not unanimous among speakers and less so among Member States. The OECD is currently working on a draft report elaborating on the conclusions reached.

The Nuffield Council's report was very recently released (July 23, 2002). Unlike the OECD Workshop, the conclusions drawn were much more critical of the patent system. The Council concluded that gene patents ought to be the exception and not the rule. According to the Council, most discoveries of genes no longer meet the level of inventiveness required by patent law. In addition, the Council stated that no patent ought to be issued over general methods of genetic diagnosis, although particular means ought to continue to be patentable. The Council also recommended against the patenting of DNA sequences as research tools by applying the industrial application standard more vigorously. The Council encouraged public and private sector patent holders to enter into multiple non-exclusive licences with respect to gene-based inventions rather than exclusive arrangements. Like CBAC, the Ontario government and the OECD, the Council asked for clarification of the research exemption. The Council argued that, as the use of a gene in gene therapy was obvious once the gene was identified, product patents on genes should not be issued in this domain. The Council also called for patent offices to engage in an ethics review.

A number of academic papers have dealt specifically with the issue of gene patents. One interesting article, addressing the issue of access to genetic diagnostic tests, was published in February 2002 in Nature. In an article by Jon F. Merz, Antigone G. Kriss, Debra G.B. Leonard, and Mildred K. Cho entitled “Diagnostic testing fails the test: The pitfalls of patents are illustrated by the case of haemochromatosis” (2002) 415 Nature 577 the authors noted that human gene patents do not seem necessary to encourage the development of diagnostic procedures. (It should be noted that the study did not address the issue of whether patents were needed to actually identify disease genes.) In addition, the authors found that patents actually had a negative impact on the development of and access to diagnostic tests because many clinics stopped developing tests and stopped delivering tests once a patent had been granted.

Conclusion

In the past year to year and a half, concerns over the patenting of human genes has moved from the academic to the practical. While people have long been concerned about the commercialization of human genes, it is the advent of genetic testing services that has focussed the attention of health care providers and international bodies. Instead of general fears over the effects of gene patenting, there is beginning to develop a consensus that the patent system as it exists today needs adjustment. Some, like the OECD experts, believe that that adjustment can take place within patent offices and through private sector initiatives. The growing majority view however, is that legislative action is necessary.