Law Times

Law timeS • September 24, 2012 Drugs, food practices among major issues with Europe FOCUS IP key in EU trade talks N BY KENNETH JACKSON For Law Times are expected to wrap up by the end of the year, but according to many in the industry, the deal has faced roadblocks on the question of pharmaceutical pat- ent reform. The European Union wants egotiations for a free- trade agreement be- tween Canada and the European Union relates to the fact that companies can spend years of their patent protection period try- ing to get their drug to market. "If you have an in- The second issue extensions proposed by the EU could raise Cana- dians' drug costs by $2.8 billion a year." Drugs are the second Canada to fall in line with the protection it provides big phar- maceutical companies. That's the reported sticking point so far in the negotiations for a Can- ada-EU trade agreement, says Patrick Kierans, a senior partner at Norton Rose Canada LLP. Kierans says he expects Can- ada to harmonize its rules but notes there's a lot at stake. There are a number of areas at issue, according to Kierans, who's head of pharmaceuticals and life sciences at Norton Rose. First is the lack of an appeal vention for a mouse trap, you can have it on the market within weeks, months — not a very long time," says Kierans. "A drug — from the time you ac- tually invent the mole- cule to the time you file for patent protection — can take 10 years." There's ment, testing, clinical trials, and filing for regulatory approvals with the authorities. Both Europe and the United States have pat- ent term protection. Canada doesn't. "Canada is a net develop- system in Canada for innovators if they lose a patent challenge against a generic drug company. "There's a procedure for the in- major health-care cost for the provinces, ac- cording to the NDP. It's also an expense that's rising every year. "The CETA forum, or any other trade agree- ment, is not the appro- priate place for this de- bate to take place," said Davies, the NDP trade critic. "Patent legislation Patrick Kierans believes Canada will likely give the European Union what it wants. novators to enforce their patents and it's an odd system. If the ge- neric can convince the court the patent is shaky in some way, the generic gets on the market imme- diately. There's precious little the innovator can do," says Kierans, who notes it can cost a company hundreds of millions of dollars to determine if it even wants a patent for a potential drug. On the other hand, if the ge- neric loses its challenge of the patent, it has the right to appeal. "It's just a crazy system," says Kierans. "It's evolved and the judges have developed their in- terpretation of Canadian law." According to Kierans, the technology importer, at least in this field," says Kierans. "If you are a net technology importer, then there's a natural tendency to not want to pay foreigners for access to their technology. If we were a net technology exporter, we would want our nationals treated very well in other coun- tries. — dollars and cents. What it does do is it ignores your trad- ing partners and puts you out of step with them. Frankly, it doesn't really encourage the de- velopment of Canada's industry here because Canada is not seen as a particularly friendly place to invest hundreds and hundreds of millions of dollars." The third part is also about It's an economic thing patent system is supposed to encourage investors and inno- vators to put time and money into risky innovations, not just in the pharmaceutical industry but other sectors as well. "There's been an effort to harmonize the standard of pro- tection that innovation is go- ing to have in different parts of the world," he says. "That's the first thing the European Union wants fixed. It shouldn't only be limited to generics. That's al- most a motherhood and apple- pie kind of thing." brings a new drug to the mar- ket aſter going through all of the approvals, spending the money, and undertaking clinical trials, the laws won't allow a generic competitor to copy the drug for a period of eight to 10 years. Canada offers six to eight will likely do what the Europe- ans ask. "It will want a trade deal with Europe . . . and Europe is very keen to bring it up to snuff," he says. Clarification A Law Times article on Sept. 17 entitled "A lawyer's call for a fairer, more transparent law society" contained an editing error. The article suggested the proceedings au- thorization committee may edit a licensee's submissions after a disciplinary investigation is complete. In fact, there's no guarantee the committee will receive those submissions, edited or not, as they first go through the Law Society of Upper Canada's professional regulation department. Untitled-2 1 www.lawtimesnews.com 1/26/11 3:59:49 PM issue is becoming a political one as the NDP is calling on the gov- ernment to remove provisions it believes could mean billions of dollars in additional health-care costs. "Changing the patent regime In terms of patent reform, the for pharmaceuticals is a com- plicated issue with deep conse- quences for Canadians, provin- cial health-care programs, and Canadian employers," said NDP MP Don Davies in an Aug. 24 press release. "Studies project the patent Steve Verheul, according to Geist, has said the matter is too hot an issue for the negotiators to determine. The truth of the matter is the talks have remained under wraps and it's hard to pinpoint mately boil down to a political decision made by Prime Minis- ter Stephen Harper, according to Michael Geist, a blogger and University of Ottawa law profes- sor who has written about the EU trade talks. Canada's lead negotiator gaining chip in these ne- gotiations." The issue could ulti- and prescription medi- cine costs are stand- alone issues that need to be fully studied and debated in public, not behind closed doors in trade policy talks, and not traded off as a bar- stake in the trade talks than just drugs when it comes to intellec- tual property. There's also food, says Sara Zborovski of Gilbert's LLP, a patent and trademark firm in Toronto. That issue involves intellec- exactly what's at stake. But the general consensus is that patent protection is the roadblock in completing the trade talks. However, there's more at only allow GIs to extend to wines and spirits," says Zborovski. "The EU is very in favour of tual property matters related to geographic indications. "Currently in Canada, we GIs and they issued about 6,000 GIs that cover a wide range of products, including meats, cheeses, fruits, and veggies. The European Union has a vested interest and are pushing very strongly to get Canada to re- spects its GIs. They are putting a very high priority on that aspect. "When you are looking at the PAGE 9 impact on Canada, consider Kraſt parmesan cheese, for example. Say parmesan has a GI that in- dicates the cheese comes from a specific region in Europe. Kraſt has a product called Kraſt parme- san cheese. If Canada accepts the EU's demand in respect to GIs, Kraſt will no longer be able to call its product parmesan." If that happens, Zborovski says Canadian food companies will have to relabel and rebrand their products, something that could be expensive for both busi- nesses and consumers. LT the dollars and cents. In Europe, if a company years. Europe wants that bumped up, says Kierans. But Kierans believes Canada

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