Canadian Lawyer

January 2011

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LEGAL REPORT/INTELLECTUAL PROPERTY However, he says, there is a tendency for patent offices to grant broader pat- ents in dealing with a new area. This has happened before, he says, in the case of patents issued in the early 1990s to Myriad Genetics Inc., a biotech com- pany based in Salt Lake City, Utah, for the BRCA1 and BRCA2 genes, associ- ated with a hereditary vulnerability to breast cancer that were isolated in order to develop targeted tests for people with a family history of the disease. Myriad subsequently became embroiled in a tussle with several Canadian provinces after the company issued cease-and- desist orders to health services that were administering BRCA tests. Myriad eventually backed away from a con- frontation and did not take any steps to prevent the provinces from continuing with the tests. However, the biotech industry in the United States and many small Canadian biotech companies that depend on obtaining U.S. patents in order to com- pete in the North American market, are currently in turmoil following a lower court ruling, currently under appeal, in the case of Association for Molecular Pathology v. United States Patent and Trademark Office, in which Myriad's gene patents were ruled invalid. The case was brought by individual cancer patients, various medical organizations, and public interest groups represented by lawyers from the American Civil Liberties Union and the Public Patent Foundation. Gold maintains the case reflects "a growing sense of unease on the rapid expansion of patentable subject matter without much limitation." The issues Gold and others have raised with respect to iPierian reflect a broader concern that there is no gov- ernment or other policy-making body examining the issues involved in stem cell patents (or for that matter any other new technology) so the agenda is being set by CIPO and the courts on the basis of legislation that has not been revised substantially since the 1990s and addresses only the narrow issues involved in patent law. Furthermore, Gold notes the Federal Court stated that CIPO has limited policy-making powers in a ruling that overturned the agency's decision to deny Amazon.com's patent application for its "one-click" business process. "There's no one looking at the big picture," says Gold. "There's an inter- nal logic to patent law and it swings back and forth. Sometimes, they give invent- ors a lot of power and sometimes they realize they've gone too far and hold back. But there's no one saying, 'What's the overall pattern? What's the right bal- ance for Canada in this field?'" In the meantime, Courage and Nador both observe the new stem cell technol- ogy does not raise any significant new issues in patent law and there are poli- cies and precedents in place for dealing with them under normal patent approval processes or in any subsequent court challenges. "Whether society wants to deal with this technology differently from others — that's a question that's bigger than me," adds Nador. 44 JAN UARY 2011 www. CANADIAN Lawye rmag.com Untitled-2 1 12/13/10 10:14:23 AM

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