Dec
26

In Novo Nordisk Canada Inc. v. Cobalt Pharmaceuticals Inc., the Federal Court (“FC”) dismissed Novo Nordisk Canada Inc.’s (“Novo”) application for an order to prohibit the Minister of Health (“Minister”) from issuing a Notice of Compliance to Cobalt Pharmaceuticals Inc. (“Cobalt”) until the expiration of Canadian Patent No. 2,111,851 (“the ’851 patent”) for a compound named repaglinide useful for type 2 diabetes treatment. The FC concluded that one of Cobalt’s allegations of invalidity is justified.

Cobalt pointed out that the process of developing repaglinide had already been rewarded with the issuance of several patents, two of, including Canadian Patent Nos. 1,225,398 (“the ’398 patent”) that already claimed “racemic repaglinide” and its enantiomers.

An allegation of anticipation usually requires a court to determine whether the claimed invention has already been disclosed to the public in such a way as to enable it to be put into practice. The FC found there was no disclosure in either the ’398 patent or the priority ’331 patent application defining in clear terms the special pharmacokinetic advantages allegedly possessed by repaglinide. Simply claiming the “racemic repaglinide” and its enantiomers did not mean that those properties were disclosed in the prior patents. As a result, the allegation of anticipation was struck down.

With regard to the issue of obviousness, the FC assessed whether the ’398 patent and ’331 patent, together with the general knowledge that a person skilled in pharmacokinetic and pharmacodynamic study would have, made the invention claimed in the ‘851 patent more-or-less self evident. The FC found the prior art did alert the person skilled in the art of considerably more than the mere possibilitythat testing the enantiomers of the “racemic repaglinide” for their pharmacokinetic properties was something that might be worth trying. The fact that testing of enatiomers for their pharmacokinetic properties had become a routine part of the industry practice made the FC conclude that repaglinide’s pharmacokinetic properties would inevitably have been discovered as a result of this routine testing. As a consequence, the FC found Cobalt’s allegation of obviousness was justified for the purposes of its NOC application.

You can leave a response, or trackback from your own site.

Leave a Reply

Categories

Subscription Options

Subscribe via RSS

Previous Posts