In a patent application currently before the Canadian Intellectual Property Office, iPierian Inc., a San Francisco-based biopharmaceutical company, has made a total of 132 claims involving innovations that the company sees as heralding a new era in drug discovery. Instead of isolating human stem cells from embryos — a process that is fraught with ethical and legal challenges — induced pluripotent stem (IPS) cell technology derives stem cells from human tissues and organs, most commonly the skin of individual patients.
It’s a technology that opens the door to new discoveries in personalized medicine, since stem cells derived from patients with the same diseases, with similar medical histories and demographics, may eventually be used to create tests and treatments targeted to specific patient populations. Although it will likely be many years before this technology is ripe for commercialization, iPierian is confidently predicting that it “will revolutionize the nature of drug discovery . . . by putting patients at the very forefront of the drug discovery process.”
Patents for IPS cell technology have already been granted in Japan and the United Kingdom, in both cases taking advantage of a fast-track patent process. The Japanese patent was granted to Kyoto University, based on the work of Shinya Yamanaka, whose lab first succeeded in inducing IPS cells in a mouse. iPierian, which has collaborated with Yamanaka, holds the U.K. patent. With patent applications in place in several jurisdictions around the world, Canadian patent applications have been filed by several academic and research institutions in Japan and the U.S., as well as iPierian and one other U.S.-based company.
Richard Gold, an associate professor at the McGill University Faculty of Law, is concerned that iPierian’s claims are “exceedingly broad” and, if granted as currently drafted, “would give them a monopoly not only on the particular technique they’ve developed but any subsequent technique later developed by anybody else.”
It’s a concern that’s dismissed by many practising IP lawyers who maintain that the patent approval system is sufficiently rigorous to reject unsubstantiated and overly broad claims, while there are also opportunities for third parties to challenge contentious patents.
“When you’re filing a patent application, your initial claims will often be quite broad and you’ll end up narrowing them later as it goes through the patent review process,” says Anita Nador, a partner in the Toronto office of McCarthy Tétrault LLP. Even where there may be a concern about overly broad claims, the patent holders normally recognize they can’t develop all potential aspects of their inventions and therefore have an interest in charging a reasonable royalty to let other people engage in research and development, says Noel Courage, a partner with Bereskin & Parr LLP in Toronto.
Gold says he acknowledges the patent offices in Canada and elsewhere in the world may indeed narrow down the scope of the claims they approve. However, he says, there is a tendency for patent offices to grant broader patents in dealing with a new area. This has happened before, he says, in the case of patents issued in the early 1990s to Myriad Genetics Inc., a biotech company based in Salt Lake City, Utah, for the BRCA1 and BRCA2 genes, associated with a hereditary vulnerability to breast cancer that were isolated in order to develop targeted tests for people with a family history of the disease. Myriad subsequently became embroiled in a tussle with several Canadian provinces after the company issued cease-and-desist orders to health services that were administering BRCA tests. Myriad eventually backed away from a confrontation and did not take any steps to prevent the provinces from continuing with the tests.
However, the biotech industry in the United States and many small Canadian biotech companies that depend on obtaining U.S. patents in order to compete in the North American market, are currently in turmoil following a lower court ruling, currently under appeal, in the case of Association for Molecular Pathology v. United States Patent and Trademark Office, in which Myriad’s gene patents were ruled invalid. The case was brought by individual cancer patients, various medical organizations, and public interest groups represented by lawyers from the American Civil Liberties Union and the Public Patent Foundation. Gold maintains the case reflects “a growing sense of unease on the rapid expansion of patentable subject matter without much limitation.”
The issues Gold and others have raised with respect to iPierian reflect a broader concern that there is no government or other policy-making body examining the issues involved in stem cell patents (or for that matter any other new technology) so the agenda is being set by CIPO and the courts on the basis of legislation that has not been revised substantially since the 1990s and addresses only the narrow issues involved in patent law. Furthermore, Gold notes the Federal Court stated that CIPO has limited policy-making powers in a ruling that overturned the agency’s decision to deny Amazon.com’s patent application for its “one-click” business process. “There’s no one looking at the big picture,” says Gold. “There’s an internal logic to patent law and it swings back and forth. Sometimes, they give inventors a lot of power and sometimes they realize they’ve gone too far and hold back. But there’s no one saying, ‘What’s the overall pattern? What’s the right balance for Canada in this field?’”
In the meantime, Courage and Nador both observe the new stem cell technology does not raise any significant new issues in patent law and there are policies and precedents in place for dealing with them under normal patent approval processes or in any subsequent court challenges. “Whether society wants to deal with this technology differently from others — that’s a question that’s bigger than me,” adds Nador.