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LEGAL REPORT/LIFE SCIENCES & BIOTECH "There are so many patents in various stages of research when developing biotechnology patents that it makes it difficult for companies to know when they're treading on other people's intellectual property." PETER WILCOX, TORYS LLP through the courts to see how things play out so we have a good reference of cases." Anthony Creber, a partner and patent litigator at Gowling Lafleur Henderson LLP in Ottawa, agrees the area of bio- technology can be incredibly complex. He says there have been some new developments in the area of biosimilars as a result of changes implemented by Health Canada. Biosimilars are also referred to as "subsequent entry biolog- ics" (SEBs) in Canada and reference to the innovator product is an integral component of the patent approval. A biosimilar is a relatively large molecule and Canada's patent office has been very selective in whom it grants pat- ents to, he says. "This is definitely an area that in five or 10 years there will be some interesting questions," says Creber. For instance, a biosimilar com- posed of amino acid, "Will it have to have the exact amino acid sequence or will variations be permissible as an approved similar drug? This is what we don't know yet," he says. He says scientists who work in the area "know you can change an amino acid, so if you change some of the amino acids in a non-critical area, do you avoid infringement and is the pat- ent still going to extend to it? As well, if Health Canada starts to permit vari- ances that aren't identical, then we're going to be heading into a round of patent litigation on biosimilars." He says relative to Canada's major trading partners, the new Health Canada regulation regarding biosimi- lars will put a damper on research investment in the country as no com- panies will want to waste their money on developing a new drug with no certainty that it can be patented and He says Canada has been addressing the issue in the context of establishing a framework for SEBs to determining when and how an innovator can "piggy- back" on a similar molecule and then obtain a patent although nothing has been finalized yet. Meanwhile, there was a decision by a U.S. court last March that Cameron says "sent shock waves through the industry" regarding a patent held by Myriad Genetics Inc. related to breast and ovarian cancer wherein the pat- ent was invalidated due to the fact that such patents are not only illegal under American patent laws, but also uncon- stitutional. Myriad was sued by the American Civil Liberties Union. New York Federal District Court protected. "I really think the interplay between the regulatory and patent area will inhibit the desirability to come to market with biotechnology in Canada," he says. Included in the area of biotechnol- ogy patents are those for biologics, which are created from natural, living organisms. Insulin, for example, is a biologic remedy for diabetes. These types of remedies are increasingly common sources of biotechnology products. Don Cameron, of Cameron MacKendrick LLP in Toronto, says there have been several disputes over similar biologics that have made their way to the courts although several major cases, in particular one that is ongoing in the U.S., have clarified the law to some extent. "There's a cloud on the horizon in Canada in terms of a silver lining for litigators as to how our intellectual property rights will protect these biologics while allowing people to make similar products and safely market them," he says. 48 M AY 2011 www. CANADIAN Lawyermag.com Judge Robert Sweet wrote a 152-page decision in Association for Molecular Pathology v. U.S. Patent and Trademark Office that summarized that the patents in question cover parts of the natural world and therefore don't conform to s. 101 of U.S. patent laws, which gov- ern what qualifies as patentable sub- ject matter. The case is headed for the U.S. Court of Appeals for the Federal Circuit, which could release its decision by June. Myriad drugs are also available in Canada and when the lawsuit came to the attention of the provinces, Quebec agreed to pull all of the said drugs off the market, while Ontario responded that it would also sue Myriad. British Columbia responded that it would con- sider taking the drugs off the market, but ultimately didn't. If the appeals court does rule in favour of the ACLU, the outcome should have limited immediate impact on Myriad's business, as the company is still protected from other patents