Canada: Federal Court Of Appeal Holds That Selection Patent Is Invalid For Lack Of Utility [ZYPREXA® (Olanzapine)]

Case: Eli Lilly Canada Inc. et al. v. Novopharm Ltd.

Drug: Olanzapine (ZYPREXA®)

Nature of case: Patent Infringement

Successful party: Novopharm Ltd.

Date of decision: September 10, 2012

Summary

The Federal Court of Appeal recently heard Lilly's appeal from the dismissal of its action for infringement of Canadian Patent No. 2,041,113 ("'113 Patent"). The sole issue for consideration by the Court was whether the utility the Federal Court found to be promised for the selection invention claimed in the '113 Patent had been demonstrated or could be soundly predicted at the patent filing date. The appeal was dismissed from the bench without substantive reasons.

The '113 Patent claims olanzapine as a selection from a previous patent owned by Lilly. The validity of the '113 Patent has been the subject of both PM(NOC) proceedings and patent infringement actions spanning several years. Lilly's first action for patent infringement was dismissed in October 2009 (2009 FC 1018). In July 2010, the Federal Court of Appeal allowed Lilly's appeal and found that the trial judge had erred in his approach to selection patents (2010 FCA 197). The Court of Appeal concluded that the '113 Patent was not invalid for anticipation, double patenting or obviousness. However, the issues of utility and sufficiency were sent back to the Federal Court for re-determination (2011 FC 1288).

The Federal Court's decision

On the re-determination, the Federal Court construed the '113 Patent as promising that "olanzapine 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." The Court held that the promise of a selection patent must be greater than that of the genus patent. It is not enough for a selected compound to achieve what was promised in the genus.

The Federal Court opined 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". Since schizophrenia is a chronic condition, the trial judge considered whether, at the time of filing of the '113 patent, there was enough evidence available to Lilly showing that olanzapine would meet its promise when administered over the long term.

The evidence before the Court on the issue of olanzapine's utility was overwhelming. Nearly eight years before the filing of the '113 Patent, Lilly had conducted extensive animal pharmacological and toxicity testing and decided to advance olanzapine to clinical development. By the filing date of the Patent, Lilly had already begun human clinical trials on patients suffering from schizophrenia. The preliminary results of these clinical studies, as well as a number of observations regarding olanzapine's side effects profile, were disclosed in the '113 Patent.

Notwithstanding Lilly's preclinical studies involving in vitro assays and tests in animals, as well as its clinical studies in human patients, the Court found that the evidence available to Lilly in April 1991 did not demonstrate that olanzapine met the promise of the '113 Patent. The Court also held that there was no sound prediction of utility, as the factual basis disclosed in the '113 Patent did not support a prima facie reasonable inference that would have allowed Lilly to soundly predict that olanzapine would meet its promise.

The Court held that there was no evidence that olanzapine was superior to any other compounds in the genus patent, other than with respect to two compounds mentioned in the '113 Patent. However, because the comparisons did not relate to the class as a whole, the Court held that it had no evidence that any advantage was peculiar to olanzapine. The Court did not go so far as requiring that every member of the genus patent be tested in order to demonstrate a special advantage in the selected member, but left unspecified what degree of comparisons would suffice.

Observations

The Federal Court's decision follows a recent trend in the Canadian jurisprudence in which the level of utility required for a patent claim depends on the "promise" of the patent. This doctrine of the "promise of the patent" is a judicially created doctrine that does not find support in the Patent Act.

The "promise of the patent" leads to uncertainty, as it invites the Court to parse the disclosure of a patent in order to determine what the patent is promising as a whole, rather than focusing on what the inventors claim as their invention. Since the evidence required to demonstrate or soundly predict the promised utility will depend on a court's construction of the promise, it is difficult for patentees to evaluate the level of disclosure required to support a valid claim.

Also of concern was the lower Court's apparent acceptance that only adequately powered clinical trials in humans could support the asserted advantages of olanzapine. This approach is contrary to dicta in the Supreme Court of Canada. It would effectively create an additional hurdle to obtain patents and delay patent filings and publication of useful advances in medicine, not to mention the potential for anticipatory disclosure during clinical trials. Such a delay would undermine the global first to file and absolute novelty policies adopted by Canada and designed to encourage the earliest possible disclosure of innovation. Is Canada to be an outlier in this regard?

Link to decision

Eli Lilly Canada Inc. v. Novopharm Ltd., 2012 FCA 232

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