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LEGAL REPORT/INTELLECTUAL PROPERTY A growing sense of unease Broad patent claims raise fears medical research and the development of new treatments may be held back by corporate monopolies. BY KEVIN MARRON development of new treatments could be held back by a corporate monopoly on intellectual property in a promising new field. In a patent application current- A ly 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 demo- graphics, may eventually be used to create tests and treatments targeted to broad patent claim for a groundbreaking stem cell technology has raised fears that med- ical research and the specific patient populations. Although it will likely be many years before this technology is ripe for commercializa- tion, 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 suc- ceeded in inducing IPS cells in a mouse. iPierian, which has collaborated with Yamanaka, holds the U.K. patent. With patent applications in place in sev- eral 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 profes- sor 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 main- tain that the patent approval system is sufficiently rigorous to reject unsub- stantiated and overly broad claims, while there are also opportunities for third parties to challenge contentious patents. "When you're filing a patent appli- cation, your initial claims will often be quite broad and you'll end up nar- rowing 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 nor- mally recognize they can't develop all potential aspects of their inventions and therefore have an interest in char- ging a reasonable royalty to let other people engage in research and develop- ment, says Noel Courage, a partner with Bereskin & Parr LLP in Toronto. Gold says he acknowledges the pat- ent offices in Canada and elsewhere in the world may indeed narrow down the scope of the claims they approve. www.CANADIAN Lawyermag.com JAN UARY 2011 43 JASON SCHNEIDER