Configuración del idioma para los mensajes de voz (si el módulo

The STS scholar Parthasarathy showed that genetic medicine has developed in different ways in the last part of the twentieth century and that the divide largely hinges on “different health-care systems and approaches to commercialization in biomedical research and technology”.⁹⁵⁶ She focused her analysis on genetic testing for breast and ovarian cancer, comparing how the architecture of genetic testing⁹⁵⁷ was built and devised in two national contexts, the United States and United Kingdom, which are dissimilar as to the provision of health care and the approach to university-industry relationships. In particular, she pointed out that, in the United States, genetic medicine grew in the context of a private health care system, in which the government was attempting, but not succeeding, to provide universal coverage through Medicare and Medicaid programs, aiming at offering health insurance to the poor and elderly. However, approximately 40 million people, at the time still, had inadequate or no insurance at all.⁹⁵⁸

The same kind of matters should be taken into account in order to explain how Myriad Genetics’ patents have been challenged in Canada, but not before a patent court.

956 Parthasarathy (n 888) 27.

957 ibid 57-114.

958 ibid 27.

182 In Canada, Myriad was granted four patents related to the BRCA1 and 2 genes and their testing by the Canadian Intellectual Property Office. On 10 October 2000, CIPO granted patents No. 2,196,797 and 2,196,790, which covered the BRCA1 gene and its mutations, and, on 3 April 2001, patent No. 2,196,795 on the diagnostic test.⁹⁵⁹ Moreover, on 3 April 2001, the company was granted patent No. 2,239,733 on the BRCA2 gene sequences.⁹⁶⁰

Although the Oncomousejudgment by the Supreme Court of Canada, in 2002, clarified that higher life forms fell outside the definition of patentable invention, when the CIPO granted these patents to Myriad, it simply complied with a long-standing practice of granting patents on DNA sequences, which had never been questioned. CIPO issued quite broad patents to the company, but did not expect that they would spark social, institutional and political turmoil across the country in the next decade.

Myriad Genetics (Myriad) designed a strategic business model centred on gaining IPRs on the BRCA1 and 2 gene sequences (wild-type and mutated sequences) and the diagnostic methods to compare across several jurisdictions.⁹⁶¹

In Canada, MDS Laboratories, a private Canadian-based diagnostic testing laboratory, was exclusively licensed as the sole provider of single mutation testing on 9 March 2000 and in the same year it began, together with Myriad, to offer its genetic testing services to provincial government officials who managed diagnostic centres.⁹⁶² At the time, however, genetic tests for BRCA1 and 2 genetic mutations were already offered, on a research basis, by several Canadian provinces to residents with a family history of multiple breast and ovarian cancer cases.⁹⁶³

As Gold and Carbone pointed out, these provincial government officials and the federal ministers of health, who are in charge of allocating the provincial budget on health care services, “soon realized that Myriad’s commercialization model – of requiring patent samples to be collected, sent outside the country, and analysed using a methodology determined by Myriad and not health care authorities – not only represented a higher cost (three times the cost of the test already in use in Ontario) but also more importantly, a challenge to the way the province provided services”.⁹⁶⁴ Moreover, they were aware that any kind of settlement

959 Canadian patents CA 2,196,790, CA 2,196,795, and CA 2,196,797; E Richard Gold and Julia Carbone,

‘Myriad Genetics: In the Eye of the Policy Storm’ (2010 Supplement) 12(4) Genetics in Medicine, S39, S43.

960 Canadian patent CA 2,239,373; Gold and Carbone (n 862) S43.

961 Matthew Rimmer, Intellectual Property and Biotechnology: Biological Inventions (Edward Elgar 2008) v, 188.

962 Gold and Carbone (n 959) S50.

963 ibid.

964 ibid.

183 that they would agree upon with Myriad would establish the framework for future genetic services offered by provinces.⁹⁶⁵

The issue of accessibility of genetic tests, together with the sustainability of the new genetic medicine for the Canadian health care system, has been at the forefront of the national narrative over Myriad’s IPRs over the BRCA1 and 2 genes and their related diagnostic products.

Canada, since the 1980s,⁹⁶⁶ has set up a policy of biotechnology in order to foster one of the major industries in the country and the patent eligibility of DNA sequences have never been questioned by CIPO. However, these patents related to diagnostic genetic tests have prompted a political counter-narrative, according to which they would hinder the national health care system and affect the right to health of Canadian citizens.

The policy debate over Myriad’s genetic tests took place, from the early to mid-1990s, in which provincial governments and, in particular Ontario and Saskatchewan, curbed health care expenditures and closed several hospitals.⁹⁶⁷ These controversial choices evoked criticism from citizens, who called for major financial support to health care system. As a result, several commissions and advisory committees were established to set out recommendations on how to devise the future of Medicare in Canada.⁹⁶⁸

Gold and Carbone illustrated that, in 2000, MDS Laboratories and Myriad approached Ontario province’s government officials (Ontario has the largest health care budget in Canada) and, by the end of the year, Ontario’s Health Ministry’s policy unit began a consultation with scientists and laboratory directors in order to address the concerns regarding their diagnostic services.⁹⁶⁹ Since MDS and Myriad did not obtain any reply from the laboratory branches of Ontario’s Ministry of Health after several months, in spring 2001 Myriad started to send cease-and-desist letters to Alberta, Quebec, Ontario and British Columbia, four provinces which were offering and carrying out BRCA1 and 2 gene testing, asking to comply with its IPRs by 18 June 2001.⁹⁷⁰

Ontario’s Health Minister, Tony Clement, significantly, pinpointed that “predictive breast and ovarian cancer tests should be available to women who require them” and that neither the

965 ibid S51.

966 Under the National Biotechnology Strategy, named since 1998 Canadian Biotechnology Strategy, the preferred “product” frame for biotechnology has largely supported CIPO’s long-standing practice of allowing the patentability of DNA sequences.

967 Gregory P Marchildon, ‘Canadian Medicare: Why History Matters’ in Gregory P Marchildon (ed), Making Medicare: New Perspectives on the History of Medicare in Canada (University of Toronto Press 2012) 3.

968 ibid.

969 Gold and Carbone (n 959) S51.

970 ibid.

184 payments to hospitals for providing these services nor the services offered by the hospitals themselves constituted infringements of Myriad’s patent claims.⁹⁷¹

It has been noticed that in his firm rejection of Myriad’s claims, Ontario’s Health Minister

“was opening up the question of the validity of Myriad’s Canadian patents”.⁹⁷² Furthermore, Ontario’s government officials were shifting the debate over genetic testing from the provincial level to the federal one, as Industry Canada deals with biotechnology policy and is in charge of the Patent Act.⁹⁷³

The debate triggered by Myriad’s claims and business model was framed in terms of access to genetic mutation tests for patients and sustainability⁹⁷⁴ of genetic medicine for the Canadian health care system. As Bryn William-Jones observed, the Canadian health care system, in the 1990s, was falling short in providing “comprehensive and timely genetic testing and counselling for hereditary breast and ovarian cancer” and Ontario was one of the provinces which were attempting to expand the number of laboratories providing this kind of testing.⁹⁷⁵

Moreover, the standard of care, as far as genetic testing was concerned, was notably below the United States’ one, since Canadian hospitals were able to offer testing for only 120 genetic diseases, while in U.S. more than 600 tests were available.⁹⁷⁶

Facing a strong reaction from Myriad and the threat of trade sanctions from the U.S.

Ambassador to Canada, Clement took the position that the federal government should consider revising the Patent Act with regard to the patentability of genes.⁹⁷⁷

He organised, in December 2001, a wide roundtable in Toronto to debate genetic testing and, in January 2002, the Ministry of Health and Long-Term care published a report entitled Genetic Testing and Gene Patenting: Charting New Territories in Health Care,⁹⁷⁸ in which they called for the assessment of new health technologies and suggested that the government

971 ibid.

972 ibid.

973 Ibid.

974 Vandna Bhatia and Michael Orsini, ‘Narrating Sustainability in Canadian Health Care reform Discourse’

(2016) 50(3) Social Policy and Administration 297.

975 Bryn William-Jones, ‘History of a Gene Patent: Tracing the Development and Application of Commercial BRCA Testing’ (2002) 10 Health Law Journal 123, 141.

976 Richard Gold, Timothy A Caulfield and Peter N Ray, ‘Gene Patents and the Standard of Care’ (2002) 167(3) JAMC 256, 257.

977 Gold and Carbone (n 959) S51.

978 Ontario Ministry of Health and Long-Term Care, Genetic Testing and Gene Patenting: Charting New Territories in Health Care (Ontario Ministry of Health and Long-Term Care 2002).

185 had to limit the negative impact of gene patents over the health care system.⁹⁷⁹ The Report was backed by all Canadian provincial leaders.

In the meanwhile, Industry Canada’s Patent Policy Directorate did not consider any of the concerns over gene patents and did not put forward any clear proposal to solve the controversy.⁹⁸⁰

After 7 years, Myriad, finally, renounced to enforce its IPRs in Canada against provinces and the federal government and decided to invest more in the U.S. as a more profitable market.⁹⁸¹ Also the CIPO did not contemplate issuing new guidelines for the examination of patent claims covering DNA sequences. At present, the Canadian Intellectual Property Office’s practice manual, at ch 17.02.04 clarifies that “biomolecules are chemical compounds, and claims to nucleic acids, polypeptides, proteins and peptides are therefore directed to statutory matter”.⁹⁸² It is still, therefore, embracing an understanding and definition of genes and DNA sequences as chemical compounds and, as such, patentable inventions, even though this view has been challenged in later patent cases.⁹⁸³

However, this patent case that was never debated before a court has produced a shift in the way of imagining the benefits of IPRs over biotech products for Canadian society, making clear that they could also hinder the protection of the right to health.