Law Times

Law Times • augusT 23, 2010 An online resource 1.800.263.3269 Focus On Biotechnology patents face challenges A HEALTH/LIFE SCIENCES LAW U.S. ruling turns heads BY DARYL-LYNN CARLSON For Law Times recent decision by a U.S. District Court in New York has lawyers south of the border and in Can- ada concerned about the implications for the future of some types of patents in the biotechnology fi eld. Th e case, Association for Molecular Pa- thology v. United States Patent and Trade- mark Offi ce, challenged whether genes could be subject to a proprietary patent regarding a breast cancer susceptibil- ity gene discovered by a company called Myriad Genetics Inc. Th e court determined that a claim to a gene sequence didn't qualify for a patent under a U.S. prohibition on patents for anything deemed as a product of nature. It determined in its decision that "the widespread use of gene sequence infor- mation as the foundation for biomedical research means that resolution of these is- sues will have far-reaching implications, not only for gene-based health care and the health of millions of women facing the spectre of breast cancer, but also for the future course of biomedical research." Th e court continued: "Th e novel cir- cumstances presented by this action against the [patent offi ce], the absence of any remedy provided in the Patent Act, and the important constitutional rights the plaintiff s seek to vindicate establish subject matter jurisdiction over the plain- tiff s' claim against the [patent offi ce]." Graeme Boocock, a technical adviser and patent agent trainee at Borden Lad- ner Gervais LLP's Ottawa offi ce, says the decision could stymie a signifi cant sector of research in the biotechnology fi eld. "Th ere has to be some way to protect genetic-based technologies," says Boo- cock, who completed his doctoral research at the Hospital for Sick Children, where he was part of the team that discovered the gene that mutates in Shwachman- Diamond syndrome. "I think there really has to be some incentive out there for the private sector to pursue this type of research, and uni- versities have a lot to lose if this decision is upheld because universities carry out a lot of gene-patenting research." He says that so far in Canada, there have been very few cases or related de- cisions in the fi eld of gene-patent chal- lenges, so the U.S. ruling could aff ect any future developments here. "Even though there are no cases pend- ing in Canada, the Canadian courts will sometimes look south of the border for guidance," he acknowledges. As a result of the U.S. decision, screen- ing in Canada based on Myriad Genetics' technology was subject to a cease-and-de- sist order, although only the province of British Columbia complied temporarily. In a paper Boocock authored entitled, "A World Without Gene Patents? Examin- ing the Implications of the Decision," he writes: "Today, it is estimated that up to 20 per cent of human genes are claimed as intellectual property in the United States. However, genes can only be patented with some attached commercial utility." 'There has to be some way to protect genetic- based technologies,' says Graeme Boocock. He continues: "Patent practice also does not permit claims to genes in their natural form; humans do not infringe patents sim- ply on account of their cellular make up. However, the U.S. and Canadian patent offi ces have readily accepted patent claims directed to genes in an 'isolated' state. "Whether or not one approves of Myriad's conduct or the district court's reasoning, two facts are undeniable. First, Myriad contributed something of great medical signifi cance to the realm of hu- man knowledge when it identifi ed and publicly disclosed breast cancer-linked mutations" in the genes. "Second, knowledge pertaining to dis- ease association is not equivalent to the discovery of a gene sequence as it occurs in nature. To be clear, information about a gene's link to disease cannot be deter- mined from a sequence in the absence of lengthy and costly experimentation to map and pinpoint mutations within the three billion DNA building blocks which make up the genome." Boocock says the latter point "is often con- fused because Myriad's patents encompass Recruiting? Post your position on GREAT RATES. GREAT REACH. GREAT RESULTS. Contact Sandy Shutt at sshutt@clbmedia.ca for details. www.lawtimesnews.com Untitled-2 1 8/19/10 5:21:42 PM both claims to the isolated" gene sequences as well as to specifi c disease-associated muta- tions. Myriad is appealing the decision, al- though Boocock suggests the courts are perhaps not the best forum to determine gene-patent issues. "Th e public may be better served by clarifi cation of the uncertain state of not-for-profi t use of patented inventions or by a regulatory pricing for diagnostic tests akin to that which exists for patented medicines," he concludes in his paper. "Th ese are but two options which come closer to addressing the heart of the issue without the negative consequences of a general prohibition on gene patenting." Yet in Canada, the current environ- ment doesn't necessarily facilitate such innovation; rather, trailblazers are simply met with a lot of red tape. Jill Daley, an intellectual property law- yer in the pharmaceutical and biotechnol- ogy fi elds at Ogilvy Renault LLP in To- ronto, says that once a patented medicine comes to market in Canada, there are 19 diff erent processes for manufacturers to follow in order to obtain pricing and re- imbursement on the various federal, pro- vincial, and territorial public drug plans. At the federal level, prices must be ap- proved by the Patented Medicine Prices Review Board, which was established in 1987 but has been exercising its jurisdic- tion more frequently in the past few years. "We've seen a tremendous increase in ac- tivity by the board," says Daley, who often works with it on behalf of clients. "Th ere has also been quite a bit of activity in the past few years in the Federal Court." She notes that for the fi rst time, the Supreme Court of Canada is scheduled to hear a matter dealing with the jurisdiction of the board in November. In the case, Celgene Corp. v. Attorney General of Canada, the board is exert- ing its jurisdiction over sales made by an American corporation under Health Canada's special access program, which See Concern, page 11 PAGE 9

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