As 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a growing consensus that laws surrounding the acquisition of patents for biotechnology developments are based on out-of-date precedents and antiquated formulas compared to the how far the field has advanced in terms of research; in fact, most of Canada’s patent laws have not been updated since the 1900s.

Three key decisions rendered by the Canadian Intellectual PropertyOffice’s PatentAppeal Board illustrate why domestic laws have fallen behind, says Thuy Nguyen, a biochemist and patent agent with Smart & Biggar Fetherstonaugh’s Ottawa office.

For example, she says, an application submitted by Yeda Research and Development Company Limited (No. 2,017,025, 2007) to register a protein inhibitor that could serve to diminish tumor growth, included the description of a partial sequence describing its discovery.But the Patent Appeal Board, based on the fact the description 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 application 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 researchers filed the application, they were trying to be the first to patent their innovation following the research they’d invested and also believed they had provided an adequate description of the process they had discovered to date to demonstrate to the board that they could characterize 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 determining what kind of experimental data you actually need,” she says, adding, “It’s always important to file as early as possible. But how soon is soon?”

In the second case,Wistar Institute applied for a patent (No. 616,029 2007) for a monoclonal antibody. Over the past decade, antibodies have become commonplace—even available to order over the Internet—and Wistar’s patent set out to describe the innovative means by which it has enabled a monoclonal antibody to fuse to a cancerous tumor.

But relying on an earlier decision in which the Canadian Intellectual Property Office rejected a patent application by the company, Institut Pasteur way back in 1987 (subsequently 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 asserts. “In the U.S. and in Europe and most countries I know of, if you have detected the antigen, it’s a natural extension of the invention.”

She says Wistar’s rejection illustrates Canada is relying on dated precedents. “Technology 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 antibodies are one of the major market drugs out there.”

Similarly, the appeal board affirmed a patent Nguyen referred to as No. 610,944, initially rejected by the application board, because the applicant demonstrated means to create a monoclonal antibody, which further 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 issue,” she says. “Even Canadians 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, a report released earlier this month that took seven years of study concludes that in the context of biotechnology, the world’s IP system is indeed breaking down.

The report, titled Toward a New Era of Intellectual Property; From Confrontation toNegotiation and touted as a landmark study, documents a number of examples where the failure to expand traditional knowledge has broken down while the biotechnology community remains guarded and competitive.

“The old IP approach of the biotechnology community has failed to deliver on its potential to address disease and hunger in both developing and industrialized nations,” says Richard Gold, a professor of IP at McGill University and chair 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 programs being carried out in Ontario and British Columbia. The company sent cease and desist letters to the provinces’ health ministers and while B.C. complied, Ontario did not, resulting in a public feud that saw U.S. Senator Orin Hatch and 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 worldwide so that knowledge gets to those who need it most.”

The above article was written by Toronto freelancer Daryl-Lynn Carlson (dlcarlson@sympatico.ca). It first appeared in the September 22, 2008 issue of Law Times, published 40 times a year by Law Times Inc., Aurora, ON, www.lawtimesnews.com. It was reprinted with permission.