Broad genus patent falls, but single-species patent upheld

Novartis Pharmaceuticals Canada Inc. v. Teva Canada Limited, 2013 FC 283

Drug: zolendronic acid I.V.

The Federal Court found Teva’s allegations of invalidity were not justified for Novartis’ narrow compound patent, while the allegations against Boehringer’s broader genus patent were justified. As a result of the split decision, the application for prohibition was successful. Teva had alleged that both patents at issue were invalid for being obvious, lacking utility and insufficiency, and the species patent was also alleged to be overbroad.

These two patents had previously been the subject of conflict proceedings under the old Patent Act. Although both of the original applications contained many compounds, the conflict proceeding resulted in Boerhringer keeping the broad genus claims and Novartis kept the narrow claim to zolendronate. This factual backdrop became critical for determining whether the species patent was sufficiently disclosed. Although the issued species patent only claimed a single compound, the initial filing contained additional genus and species claims. Those claims had been narrowed to a single compound only as a result of the conflict proceeding. Therefore, the Court would have invalidated the patent if sufficiency were evaluated upon the broad claims as filed. However, the relevant date of sufficiency was found to be the date of publication, or the day the patent is issued for an old Patent Act patent, and therefore the patent was sufficiently disclosed.

The genus patent was found to be insufficient for the same reason that it lacked utility. Only one of the possible compounds in the genus claim asserted by the patentee had been tested. That one tested compound was found not capable of establishing all the compounds claimed had utility. Indeed, “the state of the art was at the empirical stage where compounds would have to be assessed individually.” The species patent did not suffer from this problem. It was directed to a single compound that had been made and tested before the Canadian application was filed and it was to be useful for the stated purpose.

The Court did not find that either invention was obvious, as it was not “self-evident” that what is claimed ought to work, and that “research ought to be rewarded, not discouraged”.