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Intellectual property – Patents – Medicines – Infringement – Whether the creation by the Federal Court of Appeal of a new non-statutory test for “utility”, the so-called “Promise Doctrine”, is a matter of public importance.

In 1991, the Applicants (collectively, “Eli Lilly”) applied for the ‘113 patent for a medicine, olanzapine, and the patent was granted in 1998. Olanzapine was included in an earlier Eli Lilly genus patent, the ‘687 patent, that covered 15 trillion compounds, all with a similar chemical structure. Olanzapine fell within a group of “most preferred compounds” of the ‘687 patent although it was not specifically named. The ‘687 patent stated that the utility of the compounds was their potential use for treatment of diseases of the central nervous system, including schizophrenia. Novopharm Limited (“Novopharm”) sought to bring its generic version of olanzapine to market. In 2007, in proceedings under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, the applications judge refused to issue an order prohibiting the Minister from granting Novopharm a notice of compliance. Soon afterward, Novopharm obtained a notice of compliance. Eli Lilly’s appeal was held to be moot and it then commenced an action for patent infringement under the Patent Act, R.S.C. 1985, c. P-4. The trial judge dismissed the infringement action, finding that the ‘113 patent was an invalid selection patent as it did not represent an invention over and above the compounds of the ‘687 patent. He further found that it was invalid for non-utility, insufficiency, anticipation and double patenting. On appeal, the trial judge was held to have erred in his approach to selection patents. The ‘113 patent was held not to be invalid for anticipation, double patenting or obviousness. The issues of utility and sufficiency were referred back to the trial judge as the court found the record was inadequate for appellate review.