Thursday, March 14, 2019

Controlled Release Dosage Form Patent Not Invalid on the Facts

Valeant Canada LP/Valeant Canada SEC v Generic Partners Canada Inc 2019 FC 253
Fothergill J
            2,412,671 / NOC

Valeant v Generic Partners is the second case released this week, and the second to raise no interesting issues of law. Valeant’s 671 patent relates to a controlled release dosage form for drugs requiring gastric retention. One known mechanism for controlled release was a polymeric matrix which swells in the stomach so the dose cannot exit into the small intestine [2]. It turns out that some of these forms, particularly those with an elongated shape for easy swallowing, could nonetheless partially exit if the pill became lodged with the long dimension protruding into the pylorus (the opening to the small intestine) [3]. The 671 patent comprises a swellable dosage form with a particular shape that avoids this problem.

In this NOC proceeding, Generic Partners conceded infringement of several claims, and attacked the validity of the 671 patent on the basis of anticipation, obviousness, double patenting and insufficiency. The main attacks were anticipation and obviousness. These both failed on the facts, essentially because nothing in the prior art suggested that shape was a central component of gastric retention [71]-[72], [106]-[108]. Rejection of the double patenting attack followed directly from the conclusion on anticipation [111], and Fothergill J easily dismissed the insufficiency allegation [116].

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