Lexpert Special Editions

Pharmaceutical Litigation | 17 & Parr LLP in Toronto, "it has to be new, useful and inventive. For the longest time, 'useful' just meant it worked. Utility was never a big deal; the case law always said a scintilla of utility is enough. But there's been a shift over the past five years when the utility standards effectively were raised by the court to the level where if your invention doesn't do everything you promised, your whole patent is invalid, even though your invention has some amount of utility." Another evolving issue, says Cameron, "is the extent to which – or when – you can get a patent for something you've never made, but are confident will work. Often only one drug is tested and proven to work, but pharma companies try to patent that drug and many others that are chemically similar, and which have never been tested. In the last decade, the courts have said that if you are predicting that something will work, you must set out in the patent the data you have to support your prediction and the theory behind your prediction. And if you didn't do that many years ago when you applied for your patent, then your patent doesn't satisfy the new standard of 'sound prediction.' Since they never anticipated this requirement, many patents lack these." As a result, says Cameron, "this has triggered a lot of litigation and there have "IT'S NOT SO MUCH ABOUT THE LAW, BUT RATHER THE SMALL NUMBER OF BRANDED PHARMACEUTICALS REMAINING UNDER PATENT PROTECTION WHOSE SALES ARE SIGNIFICANT ENOUGH TO JUSTIFY THE EXPENSE BY THE GENERICS OF FIGHTING THE PATENT." been a number of patents that have been declared invalid as a result of the patents not having the data and the theory of prediction as to why it will work built into the patent." Jonathan Stainsby, partner and head of the intellectual property litigation team at Heenan Blaikie LLP in Toronto, sees through a totally different lens. "The whole suggestion of unpredictability in Canadian patent law arising from the socalled 'promise doctrine,' or otherwise for that matter, is a red herring," says Stainsby, who represents generic drug companies. "It's all a matter of looking at the patent and seeing what the patentee has said the invention will do; part of what judges do in patent law, and every other area of law, is read and interpret documents and decide what in fact they say. [Judges are] not doing it any differently than they are in contracts, insurance, actual statutes and regulations. I think this is a manufactured issue that was raised in order to try to change the law in some way that would benefit brand pharma." "Promise of the patent to my mind makes a lot of sense," says Carol Hitchman, partner and head of the IP Group at Gardiner Roberts LLP in Toronto, who works for the generic drug companies. "We don't have file wrapper estoppel as they do in the US, where as a pat- –Jonathan Stainsby, Heenan Blaikie LLP LEXPERT®Ranked Lawyers Fuerst, Linda L. Gaikis, Gunars A. Garland, Steven B. Gascon, Denis Gelowitz, Mark A. Lenczner Slaght Royce Smith Griffin LLP Smart & Biggar/ Fetherstonhaugh Smart & Biggar/ Fetherstonhaugh Norton Rose Fulbright Canada LLP Osler, Hoskin & Harcourt LLP (416) 865-3091 lfuerst@litigate.com (416) 593-5514 ggaikis@smart-biggar.ca (613) 232-2486 sbgarland@smart-biggar.ca (416) 862-4743 mgelowitz@osler.com Ms. Fuerst's litigation practice covers a range of commercial matters, focusing on securities litigation, class actions and regulatory issues. She has appeared before all levels of court in Ontario, provincial securities commissions and IIROC. Mr. Gaikis specializes in pharmaceutical and biological patent litigation at trial and appeal, primarily for patentees, in the Federal and Supreme Courts. He is a licensed pharmacist as well as a patent and trade-mark agent. Mr. Garland specializes in IP litigation of all types including: patent, trade-mark, copyright, industrial designs, trade secrets & competition law. He has appeared before the Federal & Supreme Courts as senior counsel in patent & trade-mark matters. (514) 847-4435 denis.gascon@ nortonrosefulbright.com Mr. Gascon advises on competition and international trade law, including Canadian and multijurisdictional mergers, criminal cartels and conspiracies, distribution strategies and pricing practices, compliance programs and trade remedies. Mr. Gelowitz's civil and securities litigation, appellate and international arbitration practice in various provinces across Canada embraces M&A, D&O, governance, oppression, defamation, product liability, mining and class-action matters. Glendinning, Deborah A. Osler, Hoskin & Harcourt LLP (416) 862-4714 dglendinning@osler.com Ms. Glendinning specializes in defending multi-jurisdictional complex class actions and commercial matters and providing businesscritical strategic litigation advice, primarily in the areas of product liability, banking and financial services.

• Cover