Canadian Lawyer InHouse

11 CANAdIANLAwyERMAG.COM/INhOUSE october 2014 by David Heller & christopher Langan Intellectual Property U nder the Patent Act, an invention must be useful to be patentable. While in Canada the inventor does not need to describe the utility of the invention in the patent, where the patent makes a promise of util- ity, utility is measured against that promise. If the in- ventor does not make an explicit promise of a specific result, the threshold to find utility will be low; a "mere scintilla" of utility will suffice. Under the "promise doc- trine" a patent, which would otherwise be valid, can be invalid if it promises more than the invention delivers. As a result, discerning whether the specification has a promise of a specific result can have significant impact on the validity of a patent. The recent Federal Court of Appeal decision of Apotex Inc. v. Sanofi-Aventis Canada Inc., for which the Supreme Court has granted leave to appeal, advocates for a degree of constraint when deter- mining whether a patent contains a promise. In Sanofi, the court held that it must look to the pat- ent to determine whether it contains an explicit promise that the invention will achieve a specific result. Since there is no obligation on the part of the inventor to dis- close the utility of his invention in the patent, not every patent contains an explicit promise of a specific result. The idea of a promise doctrine is the subject of a NAFTA challenge by Eli Lilly. Central to Lilly's ar- gument is that two of Lilly's patents were invalidated on the ground they were not useful, notwithstanding their approval by Health Canada and their commer- cial success. Lilly alleges that the promise doctrine is inconsistent with NAFTA as it imposes a significantly higher burden on the patentee than the standard of utility mandated by NAFTA. Specifically, Lilly alleges that Canada's failure to abide by its NAFTA obligations has resulted in the unlawful expropriation of its pat- ent rights. Lilly argues that the promise doctrine has caused a dramatic and unprecedented shift in Canada's utility standard and is inconsistent with the utility stan- dard embodied in NAFTA. Lilly pointed out that one of the patents was challenged and upheld in 18 coun- tries throughout the world and Canada was the only jurisdiction to invalidate on the basis of inutility. Canada, in response, has argued that the promise doctrine was endorsed by the Supreme Court as early as 1981 in Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., while NAFTA came into force in 1994. There is no requirement to make a promise, but a promise may be made for a variety of reasons, including where a new and non-obvious use of a known compound is the essence of the invention or in selection patents where a sub-species of the genus has a surprising and non-obvi- ous advantage. Canada further notes that NAFTA does not provide direction as to how the core patent concepts of "new," "inventive," and "industrial application" are to be interpreted and applied in particular patent cases. The Sanofi decision appears to have pushed back on certain elements of the promise doctrine that Lilly complains of in its NAFTA challenge. Lilly alleges the courts read into the patents an "implied promise" that the drugs would work in the longer term based on the chronic nature of the conditions being treated. In Sanofi, the Court of Appeal finds that the trial judge erred in finding a promise on the basis of inferences, in the absence of clear and unambiguous language. Sanofi thus draws a distinction between the potential use of an invention and an explicit promise to achieve a specific result and finds that a goal is not necessarily a promise. As noted by Canada in its statement of defence, domestic patent law continues to evolve, including the promise doctrine. One possible way forward is to limit the promise doc- trine in a manner similar to the Federal Court's recent treatment of the heightened requirements for a "sound prediction" of utility. In a July 2014 Apotex v. Astra- Zeneca decision, Justice Rennie concluded the patentee should only face a higher burden for disclosed utility in "new use for known compound" type patents. The ra- tionale was that, for these "new use" patents, the entire invention resided in the new utility, hence there should be a higher standard for showing utility. The appeal of AstraZeneca to the Federal Court of Appeal, the Sanofi appeal to the Supreme Court of Can- ada, and Lilly's NAFTA challenge will continue the evolution of these doctrines. IH David Heller is a partner and Christopher Langan, an associate with Ridout & Maybee LLP. Promises that can kill patents eli Lilly's NAFtA challenge will continue the evolution of the doctrine.

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