Law Times

Law Times • sepTember 26, 2016 Page 11 www.lawtimesnews.com Governments urged to support non-commercial use Hospitals should push for use of gene patents, prof says BY MICHAEL MCKIERNAN For Law Times A law professor who helped secure public health access to a ge- netic test for a heart condition has urged Canadian governments to throw their weight behind the landmark agreement and make gene pat- ents irrelevant to health care in this country. Under a settlement reached in March, U.S.-based Transge- nomic Inc. granted licences to the Children's Hospital of East- ern Ontario and any other pub- lic hospital that wants to use its patented genes on a non-profit basis for diagnostic testing to detect Long QT syndrome, a potentially fatal heart rhythm condition. Richard Gold, a professor in law and medicine at McGill University who advised the CHEO legal team on policy issues during the case, says the agreement was designed to provide a precedent under s. 19 of Canada's Patent Act, which allows for public, non- commercial use of patented inventions by government. In the case of future disagree- ments over gene patents, Gold says, public hospitals should push for similar agreements to the one achieved by CHEO. Should patent holders refuse, governments at all levels should demonstrate a willingness to step in and force the issue using their s. 19 powers, adds Gold. A strong governmental en- dorsement of the CHEO ap- proach, as well as a set of guide- lines for future s. 19 applications, would effectively remove the threat of lawsuits by gene patent holders against Canadian hos- pitals or public laboratories, ac- cording to Gold. "Now it's really a question of political will at the federal and provincial level," he says. "We're doing what we can, but in the end it's up to the provin- cial health ministries, the Min- istry of Innovation, Science and Economic Development and the Canadian Intellectual Property Office to decide what will hap- pen in practice and move this out of the legal realm and into the policy realm where it be- longs." Nathaniel Lipkus, a part- ner in the intellectual property practice group at Osler Hoskin and Harcourt LLP who acted as counsel to CHEO, says he hopes the settlement provides a tem- plate for public access to subse- quent gene patents. "Right now, we're focused on trying to leverage the agreement as much as we can for policy purposes. I think it's being taken quite seriously as a model," he says. "It respects the public health system, and preserves the abil- ity for patent holders to explore commercial opportunities in the private sector." CHEO launched its action back in 2014 against the own- ers of five gene patents related to the Long QT syndrome after the hospital had trouble getting the test for the condition done in Canada due to concerns about infringement on the patents. Instead, patients in need of the testing had their samples sent to licensed clinics south of the border for a cost of more than $4,000 a go, paid by the Ontario Health Insurance Plan. According to CHEO presi- dent and CEO Alex Munter, who hailed the settlement as a "tremendous win for families," the agreement will cut the price of Long QT testing in half. "As these tests can now be performed in Canada, families across the country will have bet- ter, quicker access to the answers and the care they need. This agreement sets a precedent and will save lives," Munter said in a statement. "Freer access to testing will allow geneticists, as well as other physicians and researchers to re- alize the full potential of genom- ic medicine, which promises to unlock many medical mysteries, and tailor medical decisions and treatments to a patient's specific genetic profile," added Dr. Gail Graham, the hospital's chief of genetics. CHEO's lawsuit originally claimed that the patents at is- sue were invalid and void, and while the hospital made no concessions about their valid- ity as part of the settlement, critics have lamented a missed opportunity to achieve some certainty on the question. Even the lawyers involved admit they would have liked to get a final word from the courts on the patentability of human genetic material. "As a lawyer and someone in- terested in the law and broader legal principles, of course you would like a bit more certainty," says Sana Halwani, a partner at Toronto IP boutique Gilbert's LLP and Lipkus' co-counsel in the case. "But I'm very pleased with how things turned out for CHEO. It was a big win for them and their patients." Gold says legal clarity was among the aims at the outset of the case, but that the limited na- ture of the resources at CHEO's disposal favoured a quicker, more pragmatic solution; the entire legal team acted on a pro bono basis. "Even assuming you win in court, it's going to take five or six years at best, versus this set- tlement that was immediately available. "You have to ask yourself if the costs and fundraising are worth doing that," Gold says. According to Lipkus, the ap- proach taken by CHEO differed from groups making similar le- gal challenges to gene patents in other countries. "In the U.S. and Australia, they were framed as human rights cases; almost as a crusade against gene patents, but neither we nor the hospital were inter- ested in that," he says. "We just wanted to make sure that this test and the next generation of genetic tests are going to be available publicly." In any case, Ryan Evans, a Toronto lawyer with Dimock Stratton LLP, says the U.S. litiga- tion offers a cautionary tale for those pinning their hopes on the courts to make straightforward rulings on patentability. In 2013, the U.S. Supreme Court ruled in Association for Molecular Pathology v. Myriad, a case involving gene patents related to diagnos- tic tests for mutations on two genes strongly associated with increased risks for breast and ovarian cancer. The decision distinguished between naturally occurring isolated DNA, finding it was not patentable, and complementary DNA, a synthetic version with some information stripped out, which it found patentable. "Both sides were able to kind of claim victory," Evans says. According to Gold, the dis- tinction has made it easy for pat- ent holders to find ways around the prohibition on isolated DNA patents. "We've seen smart people drafting patents that circumvent the policy underlying the deci- sion, while staying within what they think the law is. There's a lot of muddling, because people don't really know what the law is," he says. LT FOCUS Untitled-8 1 2016-09-20 3:02 PM Richard Gold says public hospitals should push for similar agreements to the one achieved by the Children's Hospital of Eastern Ontario. Photo: Lysanne Larose We just wanted to make sure that this test and the next generation of genetic tests are going to be available publicly. Nathaniel Lipkus

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