Pharmacapsules @ Gowlings November 15, 2011 - Volume 10, Number 7

Edited by Jennifer L. Wilkie and Isabel Raasch

Recent Pharma Decisions:

Eli Lilly Canada Inc. et al v. Novopharm Limited, November 10, 2011, 2011 FC 1288, olanzapine (reconsideration by trial judge):

This decision relates the reconsideration of an earlier decision regarding Eli Lilly's action against Novopharm for infringement of Lilly's patent to the compound olanzapine. In the initial judgement, Justice O'Reilly determined that the olanzapine patent was invalid on the basis that the utility of olanzapine was not soundly predicted, that the description of the invention set out in the patent was not sufficient and that therefore the patent was not a valid selection patent. Lilly then appealed that decision and the Federal Court of Appeal determined that the trial judge had erred in applying the law with respect to utility and sufficiency and returned the matter to the trial judge for reconsideration. In particular, the Court of Appeal found that the trial judge erred in considering whether the olanzapine patent was a "valid selection patent", as that is not a stand-alone ground to attack a patent, rather than evaluating the validity of the patent on the basis of the requirements for utility and sufficiency as set out in the Patent Act. Hence, the Court of Appeal returned the question of what was the promised utility of the olanzapine patent (as opposed to what were the stated advantages) and whether that promised utility was demonstrated, or soundly predicted by way of a prima facie reasonable inference, as of the filing date.

After reconsideration the trial judge again found that the patent was invalid, this time for lack of sound prediction alone, and dismissed the action for infringement. On the question of sufficiency, Justice O'Reilly found that the patent met the sufficiency requirements under the Patent Act.

In analyzing the issue of sound prediction, Justice O'Reilly held that, for a selection patent, the stated utility could not be simply that which was promised in the genus patent and must be greater than the promised utility of the genus patent. Against this background, and based on the patent specification and the expert evidence, Justice O'Reilly held that the promise of the olanzapine patent was the treatment of schizophrenia in the clinic in a markedly superior fashion, with a better side-effect profile than other antipsychotics. Justice O'Reilly then applied the promise to both the claims to the compound olanzapine and the...