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Federal Court finds olanzapine selection patent invalid for inutility

As reported in the August 2010 issue of Rx IP Update, the Federal Court of Appeal set aside a decision of the Federal Court finding Eli Lilly's patent for the compound olanzapine (ZYPREXA) invalid: Eli Lilly Canada Inc. v. Novopharm Limited 2010 FCA 197, rev'g 2009 FC 1018. The Court of Appeal held that the Trial Judge erred by using the conditions for a valid selection patent as an independent basis upon which to attack the validity of a patent and remitted the matter to the Trial Judge to consider the utility and sufficiency of disclosure grounds of alleged invalidity. Upon reconsideration, on November 10, 2011, Justice O'Reilly held that the patent was invalid as the promised utility had not been demonstrated and could not have been soundly predicted: Eli Lilly Canada Inc. v. Novopharm Limited, 2011 FC 1288.

Promise of the selection patent. Justice O'Reilly interpreted the Court of Appeal's finding as requiring that a selection patent contain an explicit promise of a substantial advantage, which may lie in a single beneficial property or be made up of a number of lesser ones. He also noted that the promise of a selection patent must be greater than that of the genus patent, and it is not enough for a selected compound to achieve what was promised in the genus patent. Therefore, Justice O'Reilly dismissed Lilly's submission that the selection patent promised that olanzapine was a relatively safe and effective anti-psychotic, the same utility as the genus patent and held that the promise is "[o]lanzapine is substantially better ('marked superiority') in the clinical treatment of schizophrenia (and related conditions) than other known antipsychotics, with a better side-effects profile, and a high level of activity at low doses."

Demonstrated utility. Justice O'Reilly noted that "where a patented compound is claimed to be safe and effective in the treatment of a chronic condition, utility will be demonstrated if the patent discloses studies showing that the patented compound, when administered over a long term, meets that promise." Justice O'Reilly held that the evidence available to Lilly at the Canadian filing date was not sufficient to demonstrate that olanzapine met the promise that "it would provide markedly superior clinical treatment of schizophrenia with a better side effects profile than other known antipsychotics" when administered over a long term, despite early positive signals about olanzapine's efficacy and safety.

Sound prediction of utility. Justice O'Reilly accepted the Court of Appeal's finding that a sufficient factual basis existed for a sound prediction and considered whether the information available to the inventors supported a prima facie reasonable inference of the patent's promise. While Justice O'Reilly was satisfied that the information in Lilly's possession as of the Canadian filing date could support certain reasonable inferences about olanzapine's properties, he found that "one could not reasonably infer from the available evidence that olanzapine would treat schizophrenia patients in the clinic in a markedly superior way" and "with fewer side-effects, than other known antipsychotic drugs." Therefore, he held that the inventors could not draw a prima facie reasonable inference to the promise of the selection patent. He concluded that "Lilly had not found any special qualities of olanzapine that would justify a fresh monopoly."

Sufficiency. Justice O'Reilly concluded that Novopharm's sufficiency attacks failed because the patent "describes the compound of the invention, its advantages, how to make it, and the range within which it can be dosed."

Junyi Chen, Toronto


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