Law Times

Law Times • march 21, 2016 Page 3 www.lawtimesnews.com NEWS AVAILABLE RISK-FREE FOR 30 DAYS Order Online: www.carswell.com Call Toll-Free: 1-800-387-5164 In Toronto: 416-609-3800 Over the past two decades, allegations of misfeasance have expanded from areas of administrative decision-making into the realms of fi nancial regulation and law enforcement. Misfeasance has been aimed at controversial policy decisions perceived to be politically motivated, and government handling of cases that seek to balance individual rights with national security. No other book so thoroughly addresses the case law and the general trends in recent decisions than Misfeasance in a Public Offi ce. This new publication not only sets out the various elements of a claim with reference to a range of cases from across the Commonwealth, but also provides historical analysis and theoretical justifi cation. The extensive commentary includes leading modern cases and dozens of Canadian lower court decisions that illustrate important principles relating to the tort, its relationship to other claims, its overlap with the Canadian Charter of Rights and Freedoms and available remedies. Order # 987052-65203 $105 Softcover approx. 240 pages March 2016 978-0-7798-7052-3 Shipping and handling are extra. Price(s) subject to change without notice and subject to applicable taxes. 00235ZT-A54989 Know more about the misfeasance tort for abuse of power cases New Publication Misfeasance in a Public Offi ce Erika Chamberlain, LL.B., Ph.D. 'Groundbreaking' settlement with patent owner BY JENNIFER BROWN For Law Times A recent settlement reached in Fed- eral Court means the Children's Hospital of Eastern Ontario and all public hospitals in Canada can license a genetic test for a potentially deadly heart rhythm condition on a not-for-profit basis. On March 9, lawyers for CHEO struck a deal with the American owners of gene patents that ensures Canadian public sec- tor hospitals and laboratories the right to test for Long QT syndrome for patients in this country. CHEO has been granted a licence by the patent owner, Transgenomic, Inc., to use the genes for non-profit diagnostic testing. e patent owners also agreed to grant licences to other non-profits. "e intent was to get some certainty on gene patents, which we don't have, but the result I think can be used not just in the Long QT context," says Sana Halwani, partner with Gilbert's LLP, who says the settlement is "groundbreaking." Halwani worked on the CHEO case pro bono for more than two years along with Nathanial Lipkus, partner with Osler Hoskin & Harcourt LLP, who was also at Gilbert's until six months ago. "As far as we know, this type of licence we put together with Trangenomic is the first one of its kind struck between a public en- tity and private entity in this way," she says. In 2014, CHEO launched the Federal Court challenge against the owners of five gene patents related to the potentially deadly Long QT syndrome. "We thought if we started a case where there was a genuine access barrier, not like the ones in the U.S. and Australia, which were human rights cases, if we brought a case that put access at the forefront, it would help to create a pathway forward," says Lipkus. "When we learned this Long QT test had been denied because a patent letter had been sent by the patent holder to the Ontario government, that seemed to be a situation that could merit some action." Previously, individuals who needed the test at CHEO could get it under limited circumstances if the government approved it on a patient-by-patient basis. Samples were sent to a U.S. lab and it would be done at a cost of about $4,000, paid for by OHIP. e Long QT test is the third most common genetic test referred to labs out- side of Canada. In 2012, there were more than 700 tests sent out of the country. "When the hospital was running tests where they could have otherwise included the Long QT genes, they were forced to ei- ther not sequence them or ignore them or filter out the results associated with Long QT," says Lipkus. "So if that was the expla- nation for a patient's disease, they would not be able to know or advise the patient. From a health care practitioner's perspec- tive, that was a non-starter." It is hoped the CHEO deal also sets a precedent that will address the issue of gene patents more broadly in the Canadi- an health-care system. Lipkus says the On- tario government is already taking steps to apply the result in the context of Long QT and taken a "strong interest" in the struc- ture of the agreement and how broadly it can be adapted to other technologies where patents have come into play. "People we've spoken with at Health Canada are delighted because they're grap- pling with whole exome/whole genome sequencing where you literally sequence a patient's genes and even one patent on one mutation could be enough to thwart the power of the test, so they've been happy with the result and looking at how it might affect them," he says. Halwani says she is hopeful people will see the settlement and if there are other roadblocks in the gene patent world in Canada or abroad, they will look to this licence model. "e hope here is that we've created a moral push to do it in the context of a pub- lic health-care system that offers testing on a not-for-profit basis and we hope compa- nies will see the right way forward and the government will step in if more roadblocks are thrown up in the form of gene patents on other tests," she says. As CHEO could not authorize spending patient care money on the litigation itself or judicial costs, Halwani says the situation demanded the result be arrived at via settle- ment as opposed to prolonged litigation. "at was the line that had to be drawn," she says. "We're hopeful this will create a precedent in that way. Would I have liked a decision on the gene patent issue at the core of the case? Of course, that was the intent at the beginning, but from a client perspective and CHEO wanting to bring specific care to its patients, it is a very big win for them and in the broader context we think this type of a licence will create the precedent." Halwani and Lipkus also teamed up with Richard Gold, professor and associate dean at McGill University's Faculty of Law and department of human genetics who provided input on experts and the policy side of the case. "e problem in Canada is if you're a commercial enterprise your normal reac- tion is to say 'I don't think these patents are very valid so I'm going to enter the market and if they sue me then I will defend it,' but as a public hospital you can't do that," he says. Despite what is being heralded as a win for patients, the case settled without de- termination of the subject matter patent- eligibility of genes. "As far as patent eligibility it's still wide open," says Noel Courage, partner with Bereskin & Parr LLP. "e win is on this specific patent in that they have a licence to use it. What they've done, which is innova- tive, is to get broader access so that other people who want to do non-profit testing can get a licence as well." He says there is short-sightedness in the "militancy" of the opposition to gene patents and it's a question of finding the right balance. "To just say no one should have any pat- ents around diagnostics is too extreme," he says. LT Sana Halwani says the intent of a recent pro bono effort was to achieve some certainty on gene patents.

• Cover