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Pharmaceutical Litigation | 19 whose sales are significant enough to justify the expense by the generics of fighting the patent." The pipeline is not as full as it used to be, he says, "since the sales of many of the products that remain under patent aren't as significant as those of the blockbuster drugs, the kind that sell hundreds of millions of dollars a year, that have already been litigated. In comparison, if a drug sells $10 million a year in Canada and the generic is going to make $2 million a year selling it, then it's hard to justify spending $2 million litigating it." Gaikis travels a lot in Europe where the pharma company executives he meets with "all seem to have heard that not only is Canada very litigious, but things are not going well for pharmaceutical patent owners in litigation. So not only is there uncertainty, but it's uncertainty combined with 'our chances are not good in Canada to have our patent survive a legal challenge.' So that kind of a general image and understanding means that if you're calling the shots at a large company in terms of where you are going to invest, then Canada is not going to be high on your list." Still, domestically and globally, companies of both stripes and their lawyers are watching nascent litigation over "biologics" that may have the potential to spell a new wave of  litigation. "Typically, the drugs we take are relatively simple chemical compounds, the products over which the battles historically take place," says Cameron. "The new generation of pharmaceuticals called biologics, the product of bio-technology, very complicated products made by organisms, are turning into big dollar products in the pharmaceutical area, so we're in the early stages of the generics taking a run at some of these biologics patents. We're also starting to see in the industry that companies are trying to get as much protection as they can for these products in anticipation of the litigation that is around the corner." But here again there's disagreement. "It remains to be seen whether biologics are going to be as fertile an area of litigation as other pharmaceuticals have been because of the complexity and the difficulty in developing generic equivalents," says Stainsby. Still, there's one area where there seems to be some sense of agreement among lawyers on both sides of the divide: the war between brand pharma and the generics, says Gaikis, "is one of the most active and high-profile areas of intellectual property litigation in Canada." "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." – Donald Cameron, Bereskin & Parr LLP Bev Cline is a freelance business and legal-affairs writer and editor in Toronto. LEXPERT®Ranked Lawyers Hendy, AdE, George R. Osler, Hoskin & Harcourt LLP (514) 904-8119 ghendy@osler.com Mr. Hendy's corporate/ commercial litigation practice includes pension fund litigation, unfair competition, product liability, class actions, fraud, shareholder disputes, oppression remedies, fiduciary duties, unjust dismissal and contracts. Hodgson, James A. Norton Rose Fulbright Canada LLP (416) 216-2989 jim.hodgson@ nortonrosefulbright.com Mr. Hodgson practises commercial, corporate and civil litigation. He focuses on shareholders' rights, securities litigation, class actions, construction, product liability and professional liability. Past President, Advocates' Society, Fellow ACTL. Hogue, AdE, Marie-Josée Heenan Blaikie LLP (514) 846-2201 mhogue@heenan.ca Ms. Hogue, an ACTL Fellow, focuses on commercial and professional liability litigation, including shareholder disputes, securities, contracts and manufacturers' liability. She is recognized as a leading litigator in numerous peer surveys. Holsten, R. Jay Houston, Donald B. Howard, Peter F.C. Torys LLP McCarthy Tétrault LLP Stikeman Elliott LLP (416) 865-7523 jholsten@torys.com (416) 601-7506 dhouston@mccarthy.ca (416) 869-5613 phoward@stikeman.com Chair of Torys' Competition and Antitrust Practice, Mr. Holsten has developed particular expertise in the Canadian financial services sector and has been involved in most of the significant M&A transactions in the sector over the past 15 years. Mr. Houston's competition litigation practice includes defending criminal prosecutions, civil cases before the Competition Tribunal and private actions including class actions. He also gives transactional advice and makes submissions to regulators. Mr. Howard's domestic and international practice focuses on securities, corporate, class actions and white-collar criminal litigation, and embraces shareholder, insolvency, M&A and banking issues. He appears before courts, tribunals and ADR forums.

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