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Issue link: https://digital.canadianlawyermag.com/i/50884
Since most diagnostic methods do not include an "administering" step, the conclusion on the "determining" step is very significant. In particular, the CAFC noted the determining step involved a transformation as the levels could not be determined by mere inspection. Complicating the landscape is the recent decision by the District Court of New York in Association for Molecular Pathology v. USPTO (Myriad). The case has been appealed and its outcome will have implications not only to diagnostic method claims but also to basic composition claims in biotechnology. In particular, Myriad Genetics Inc.'s patents had claims to isolated DNA encoding two breast cancer genes as well as to methods of detecting the gene mutations. The District Court held that claims to isolated DNA are not "markedly different" from native DNA and purification of a product of nature cannot transform it into patentable subject matter. This was the first time a court found claims to isolated genes to be unpatentable on that basis. It further held that the diagnostic method claims failed the machine-or-transformation test. The Myriad claims use terms such as "analyzing" and "comparing" for identifying the presence of the mutations. Importantly, Myriad is not binding on the United States Patent and Trademark Office unless it is affirmed by the CAFC. Since the CAFC held that Prometheus passed the machine-or-transformation test, it is hoped it will uphold the patentability of the Prometheus claims although there are those who think this case could be used to show that the test is not definitive. For Classen and Myriad (diagnostic claims), we expect the CAFC to affirm the machine-or-transformation test is not satisfied and hopefully provide further guidance on what other factors need to be considered. Until the courts provide more guidance on the patentability of diagnostic claims, we recommend avoiding terms like "analyze" or "compare" and using terms such as "determining," "assaying," "measuring," etc., which arguably amount to more than mere inspection. Further, we recommend including dependent claims that further define the methods (such as specific probes, primers, etc.) to further differentiate the method from ntitled-3 1 a mere abstract idea. With respect to composition claims, any alterations from naturally occurring substances should be emphasized and claimed, for example, any unnatural modifications, portions of sequences not normally found in nature (with a specific functionality), differential glycosylation, gene fusions, etc. Thus, biotechnology stakeholders must wait in limbo for the decision in Classen and Prometheus as well as the appeal decision in Myriad for further guidance on the patentability of claims to diagnostic methods and isolated genes. It is hoped that the CAFC will affirm the patentability of such claims to provide incentive for inventors, owners, and investors to continue to pursue biotechnology research. IH Micheline Gravelle is a partner and the leader of the biotechnology and pharma- ceutical practice group at Bereskin & Parr LLP in Toronto, and Melanie Szweras is an associate in the same group. Research Solutions It Thinks. A truly intelligent approach to patent research — LexisNexis® TotalPatent™ with Semantic Search At last, semantic brains AND Boolean search technology working together in a single patent research resource. TotalPatent™ can help ensure you don't miss a thing in your critical prior art searches. Only TotalPatent: 50 million search- able patent PDFs, including full-text patents from an industry-leading 27 global patent authorities. totalpatent@lexisnexis.ca 1-800-855-5174 Register today for a free trial. LexisNexis and the Knowledge Burst logo are registered trademarks of Reed Elsevier Properties Inc., used under licence. TotalPatent is a trademark of LexisNexis, a division of Reed Elsevier Inc. Other products or services may be trademarks or registered trademarks of their respective companies. © 2010 LexisNexis Canada Inc. All rights reserved. INHOUSE OCTOBER 2010 • 11 8/26/10 10:50:32 AM