Law Times

PAGE 10 FOCUS January 30, 2012 • Law Times Biotech patents frequently challenged Many cases have reached the courts given stakes involved BY DARYL-LYNN CARLSON For Law Times T here have been many court challenges over pharma- ceutical patents in Canada that have lawyers watching out for their clients in the biotechnology fi eld. Biotechnology is an area in which companies are focused on developing drugs from ingredients that include living organisms or their derivatives in order to cure an illness. Jane Clark, a partner at Gowling Lafl eur Henderson LLP in Ottawa, says it's very expensive and time consuming to conduct all of the research for a biotech- nology patent. At the same time, patent protection is necessary in order to provide an incentive for the investment of these resources. "On the patent side, it's not a rosy world as, if you have an in- vention for a chronic condition, you may have to show studies over the longer term," says Clark. She points to a matter involv- When it comes to IP in Canada, We're Well Read Ridout & Maybee LLP: Editors of the Canadian Patent Reporter it all starts somewhere www.ridoutmaybee.com ing Eli Lilly and Co. and Teva Canada Ltd. Canada successfully challenged the validity of the patent for the drug Strattera. Th e patent was in- validated for lack of utility since one human clinical trial wasn't enough to demonstrate utility in the longer term. At the same time, there have been several other cases, includ- ing Apotex Inc. v. Sanofi -Synthe- labo Canada Inc. and Novopharm Ltd. v. Eli Lilly and Co., that con- sidered patent validity on the ba- sis of a lack of utility. Th e top court will also hear Teva Canada Ltd. v. Pfi zer Canada Inc., a case that deals with the validity of the Vi- agra patent, in February 2012. "I think it is a diffi cult time in Canada for biotech and pharma- ceutical inventions and we'll see how that develops over the next year," says Clark. As well, litigation over patents can be very expensive, particu- larly for issues such as expert evi- dence on the utility requirements. Eileen McMahon of Torys LLP Untitled-1 1 12-01-23 9:05 AM CANADIAN LAW LIST 2012 YOUR INSTANT CONNECTION TO CANADA'S LEGAL NETWORK Inside you will find: • an up-to-date alphabetical listing of more than 58,000 barristers, solicitors and Quebec notaries, corporate counsel, law firms and judges in Canada; • • contact information for the Supreme Court of Canada, the Federal Court of Canada, Federal Cabinet Ministers, departments, boards, commissions and Crown corporations; legal and government contact information related to each province for the Courts of Appeal, Supreme Courts, County and District Courts, Provincial Courts, law societies, law schools, Legal Aid, and other law- related offices of importance. MORE THAN A PHONE BOOK Hardbound • Published February each year On subscription $149 • L88804-571-26084 One-time purchase $165 • L88804-571 • ISSN 0084-8573 Prices subject to change without notice,to applicable taxes and shipping & handling. Visit carswell.com or call 1.800.387.5164 for a 30-day no-risk evaluation CANADIAN LAW LIST www.lawtimesnews.com CLL - 1/4 pg - 3X.indd 1 1/20/12 10:48 AM in Toronto indicates that litigation related to biotechnology patents is common because the drug sec- tor is a growing and competitive fi eld. "Th ese companies invest sig- nifi cant time, eff ort, and resources into developing drugs. Th e return for them is a period of exclusivity once the drug is approved. If there is any threat to that exclusivity, then litigation is the result." McMahon notes it's largely competitors that will challenge a patent in the drug sector. "Gener- ally in the drug sector, a competi- tor will seek to challenge the pat- ent exclusivity of the drug owner whether the patent relates to a biotech or chemical drug. If there is a chance that the exclusivity will fall, then there's an incentive for a competitor to challenge the exclu- sivity. Th is results in challenges to the patents underlying the exclu- sivity. Th e patents can be attacked on various grounds, including that the inventions claimed in the patents are not new or inventive." Usually, patent owners are well prepared for such challenges, says McMahon. "In fact, for a successful In that case, Teva 'It is a very complex area when a case goes to the courts and it can take a lot of time to deal with,' says Don Cameron. biotech or chemical drug, litiga- tion is generally expected." Many biotechnology compa- nies have established partner- ships with larger pharmaceutical businesses. Th e large companies oſt en handle the marketing of the drugs as well as the litigation re- lated to them. Don Cameron, a partner at Bereskin & Parr LLP in Toronto, affi rms the potential for biotech- nology patents to be subject to court challenges by competitors. Accordingly, countries around the world are developing new policies to reduce the number of matters that end up in the courts. "Predictability has become a key question, so there's a two-sid- ed question regarding if you came up with a drug and it works, you can get a patent if you're certain it works," he says. Cameron notes the last case he had in the courts was 10 years ago. He luckily hasn't had any cli- ents that have faced challenges since then. He points out that expert tes- timony is imperative if the case does go to court. At the same time, according to Cameron, the courts in some cas- es have taken a very long time to deliver a decision due to the com- plexity of matters in the biotech- nology fi eld. He also notes that in Canada, there's a statute that affi rms that a patent for a biotech- nology drug must be proven to be useful, which can further add to the complexity of the case. "In the pharmaceutical and biotechnol- ogy sector, the courts have been wrestling with this," he says. "It is a very complex area when a case goes to the courts and it can take a lot of time to deal with." LT

• Cover