Canadian Lawyer

w w w . C A N A D I A N L a w y e r m a g . c o m A u g u s t 2 0 1 4 51 LEgaL rEport/InTelleCTual pRopeRTy Has Canada really gone off its meds with 'promise of the patent?' by jennifer brown y ou might say it's a battle that's been brewing for more than a decade — one that pits internation- al mega pharmaceutical forces against Canada's scrappy patent law that some say holds "utility" in a different light than the rest of the world. In January, the Supreme Court of Canada granted leave to appeal a decision of the Federal Court of Appeal in Sanofi- Aventis v Apotex Inc., noted for its analysis of two of the most heavily litigated aspects of patent law: the "obvious to try" test and the "promise of the patent." The hear- ing of the appeal at the SCC is slated for November 2014 and will bring forward a long history of litigation surrounding the Sanofi-Aventis blood thinner Plavix (clopi- dogrel bisulfate). This appeal is of interest to the Canadian pharmaceutical market, in particular, mainly in the hope that it will bring clarity to the law of promised utility — the so-called "promise doctrine." "I think the courts are getting off into the woods and trying to figure out techni- calities like what is the promise and is there a promise or statement of advantages that may work?" says Noel Courage, a part- ner with Bereskin & Parr LLP in Toronto. "What has people upset internationally is the utility standard here has gone higher than other countries." Generics will say that's a good thing — we should be holding people to what they say — but the brand companies' point of view is they are filing at an early stage and need to cast a broad net. But ultimately, Courage says the big companies like Eli Lilly are spending the money, developing the drugs, proving they treat patients, and bringing the drugs to market and need the patent to make back the hundreds of millions of dollars they've spent in devel- opment. It's putting the big brands in a situation of uncertainty as to whether their patent is going to stand up. "You're getting some patents upheld and some invalidated. We're getting a lot of inconsistent deci- sions," says Courage. "The courts wander off and look at: are they promising it may treat the disease or just promising it may one day treat the disease so the whole thing is creating unpredictability — is there a promise in there — if you say it's less toxic is that a promise or an advantage?" However some say there's just been a "cherry-picking" of a few cases where brand-name pharmaceutical companies were unsuccessful, largely for factual rea- sons. "There's history here," says Ildiko Mehes, vice president and general counsel with generic drug company Teva North America. "This is a wonderful branding campaign by companies who have been unhappy with some of the results in their matt daley Broken promises

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