Pharma in brief - Canada: Federal Court finds selection patent invalid for lack of utility [ZYPREXA® (olanzapine)]

November 2011 Author: Daniel Daniele

Contacts

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: November 10, 2011

Summary

In October 2009, the Federal Court dismissed Lilly’s action for infringement of Canadian Patent No. 2,041,113 (“113 Patent) primarily on the basis that Lilly was not entitled to a second patent for olanzapine (Eli Lilly Canada Inc. v. Novopharm Limited, 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 concluded that the ‘113 selection 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.  On November 10, 2011, the Federal Court found that Novopharm established that the patent’s promise had not been demonstrated and could not have been soundly predicted on the basis of the evidence available to the inventors at the filing date (1991).  Accordingly, the selection patent was found to be invalid and Lilly’s action for infringement was dismissed.

Promise of the Patent

The trial judge held that a selection patent must contain an explicit promise of a substantial advantage and that this advantage may lie in a single beneficial property or in a number of lesser ones.  In construing a selection patent, it is “helpful to recall the utility described in the genus patent”.  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 patent.

The trial judge found that the promise of the ‘113 patent is "[o]lanzapine is substantially better 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. This promise expresses a substantial advantage for olanzapine over the other [compounds in the Genus Patent], which had never actually been used to treat schizophrenia.  The individual advantages asserted in the [Selection] Patent (other than in relation to cholesterol) form the foundation for the overall promise of the patent."

The trial judge held that the same “promise” applied to all the claims, regardless of whether they were compound or use claims.  

Demonstrated Utility

The trial judge held 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.  He found that the evidence available to Lilly in April 1991 did not demonstrate that olanzapine could meet the promise of the ‘113 patent, namely, that it would provide markedly superior clinical treatment of schizophrenia with a better side effects profile than other known antipsychotics.  While there were early positive signals about olanzapine’s efficacy and safety, the trial judge held that there was simply not enough evidence at the time of filing to demonstrate those characteristics.

Sound Prediction

Since the trial judge held that Lilly had not demonstrated the promised utility of the ‘113 patent at the filing date, the Court went on to consider whether there was a sound prediction.  The trial judge applied the three-part test from Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153, which requires the party to show: (1) a factual basis for the prediction; (2) an articulable and sound line of reasoning linking the facts and the desired result; and (3) sufficient disclosure.

The trial judge held that based on all of the evidence available at the time of filing, the inventors could not draw a prima facie reasonable inference to the promised utility of the ‘113 patent.  Accordingly, there was no articulable and sound line of reasoning connecting the factual information about olanzapine at the filing date and the ‘113’s promise as construed.  In particular, the Court held that the chronic nature of the condition to be treated by a patented compound must be taken into account when determining whether the patent’s promise has been demonstrated or can be soundly predicted.  The trial judge noted that “[w]hile the ‘113 patent contains some information about the testing of olanzapine, it does not set out a line of reasoning to support its alleged clinical superiority in the treatment of schizophrenia and better side effects profile.”  

The Court held that in the context of a selection patent, the invention is the discovery of a substantial advantage over the genus compounds.  The trial judge was not satisfied that Lilly found any special qualities of olanzapine that would justify a “fresh monopoly”. In sum, O’Reilly J. concluded that there was no sound prediction and accordingly, held the ‘113 patent to be invalid.

Sufficient Disclosure

The Court held that to meet the requirements of s. 27(3) of the Patent Act, a selection patent must set out clearly what is better and different about the selected compound as compared to the genus from which it is derived.  The patent must give enough detail that a person skilled in the art would know the advantages of the selected compound.  In the case of an invention based on an alleged sound prediction of utility, there is no requirement to set out the factual basis and line of reasoning supporting that prediction.  The trial judge was satisfied that Lilly met the disclosure requirements, as the ‘113 patent describes the compound of the invention (olanzapine), its advantages, how to make it, and the range within which it can be dosed.

Link to decision:

Eli Lilly Canada Inc. et al. v. Novopharm Ltd., 2011 FC 1288

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