Law Times

Law times • SEPTEMBER 22, 2008 FOCUS Patent system behind the times Biotech industry being stymied BY DARYL-LYNN CARLSON For Law Times A s the science community does its part to move ahead with finding cures for common yet deadly diseases, the legal side of supporting these innovations, both in Canada and worldwide, seems to have much catching up to do. There's a growing consensus that laws surrounding the ac- quisition of patents for biotech- nology developments are based on out-of-date precedents and antiquated formulas com- pared to how far the field has advanced in terms of research; in fact, most of Canada's pat- ent laws have not been updated since the 1900s. Three key decisions rendered by the Canadian Intellectual Prop- erty Office's patent appeal board illustrate why domestic laws have fallen behind, says Thuy Nguyen, a biochemist and patent agent with Smart & Biggar/Fetherston- haugh's Ottawa office. For example, she says, an ap- plication submitted by Yeda Re- search and Development Co. Ltd. (patent application no. 2,017,025, 2007) to register a protein inhibitor that could serve to diminish tumor growth, in- cluded the description of a partial sequence describing its discovery. But the patent appeal board, based on the fact the descrip- tion was incomplete, rejected the patent outright. "In this case the applicant did have some information about the product, but not complete information," says Nguyen. "So the board makes the decision that while the ap- plication describes exhaustively how to make the product, but doesn't describe it in detail, it's not good enough." She says at the time the re- searchers filed the application, they were trying to be the first to patent their innovation follow- ing the research they'd invested, and also believed they had pro- vided an adequate description of the process they had discovered to date to demonstrate to the board that they could character- ize their protein finding enough to obtain the patent. "But the board says that's not enough. So that limits the scope of certain claims in determin- ing what kind of experimental data you actually need," she says, while adding, "It's always important to file as early as pos- sible. But how soon is soon?" In the second case, Wistar Institute applied for a patent (patent application no. 616,029, 2007) for a monoclonal anti- body. Over the past decade, antibodies have become com- monplace — even available to order over the internet — and Wistar's patent set out to de- scribe the innovative means by which it has enabled a mono- clonal antibody to fuse to a cancerous tumor. But relying on an earlier de- cision in which the Canadian Intellectual Property Office re- jected a patent application by the company, Institut Pasteur way back in 1987 (subsequent- ly denied at appeal in 1995), the patent board again declined Wistar's application. The board based its decision on the fact that Wistar didn't achieve the production of a monoclonal antibody, only its means to fusing to its target. "Everybody in the industry knows what antibodies look like and the only thing that distinguishes an antibody from another is how it binds to its target," says Nguyen. "The really interesting thing is the patent office in Canada on the subject matter of antibodies is way out in left field compared to all other countries," she as- serts. "In the U.S. and in Eu- rope and most countries I know of, if you have detected the an- tigen, it's a natural extension of the invention." She says Wistar's rejection exemplifies its dated approach. Nguyen points out that in the U.S., where most Canadian companies turn to acquire their initial patent, it's only necessary to demonstrate the antigen to which a monoclonal antibody would bind; not the structure or mapping of the antibody itself. "It's a peculiar Canadian is- sue," she says. "Even Canadi- ans don't patent in Canada in the biotech industry. But if we want a lively industry and want to promote the industry we need to keep a balance." Looking beyond Canada, 'Technology changes. What's true in 1987 sure isn't now because you can order it online,' says Thuy Nguyen. on dated precedents. "Tech- nology changes. What's true in 1987 sure isn't now because you can order it online," she says. "We've made all kinds of efforts to try to understand why the patent office is taking this bizarre position but to no avail, they're sticking to their guns saying, 'You need to make an antibody before you can claim it.' It's unfortunate because an- tibodies are one of the major market drugs out there." Similarly, the appeal board af- Bereskin_LT_Dec5_05.qxd 11/29/05 11:18 AM Page 1 illustrates Canada is relying firmed a patent Nguyen referred to as No. 610,944, initially re- jected by the application board, because the applicant demon- strated means to create a mono- clonal antibody, which further a report released earlier this month that took seven years of study concludes that in the context of biotechnology, the world's intellectual property sys- tem is indeed breaking down. The report, titled "Toward a New Era of Intellectual Property; From Confrontation to Negotia- tion," and touted as a landmark study, documents a number of examples where the failure to expand traditional knowledge has broken down while the bio- technology community remains guarded and competitive. The study includes discus- sions with policy makers, in- dustry representatives, scien- tists and academics around the world, and features a series of case studies. "The old IP approach of the biotechnology community has failed to deliver on its po- tential to address disease and hunger in both developing and industrialized nations," says Richard Gold, a professor of intellectual property at McGill University and chairman of the international expert group that produced the report. Amongst the cases included to illustrate systemic breakdowns is the attempt by Myriad Genetics, based in Salt Lake City, to assert its patent in genetic breast and ovarian cancer screening test pro- grams being carried out in On- tario and British Columbia. The company sent cease and desist letters to the prov- inces' health ministers, and while B.C. complied, Ontario did not, resulting in a public feud that saw U.S. Senator Orin Hatch and former U.S. ambassador to Canada Paul Cellucci jumping in to the fray on Myriad's behalf. In summing up the report's findings, Gold adds, "The end of our old way of doing business does not mean we don't need a system for protecting intellectual knowledge. We need an IP system that will support collaborations among researchers and partners in industry and academia world- wide so that knowledge gets to those who need it most." The report includes a series of recommendations to facili- tate more seamless biotechnol- ogy development, including re- lated regulatory, legal, and even tax rules that tend to hamper its accessibility. LT PAGE 11 intellectual property RANGE & DEPTH One of Canada's leading intellectual property law firms, Bereskin & Parr combines proven expertise with a dedication to service that has earned lasting trust from many of the world's most original thinkers. www.bereskinparr.com TORONTO MISSISS A UG A WA TE RLOO MONTRÉ A L CANADIAN LEGAL NEWSWIRE it's fresh, it's free, it's weekly e-news! www.lawtimesnews.com Sign up today at www.lawtimesnews.com FROM THE EDITORS OF LAW TIMES AND CANADIAN LAWYER

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