Les Laboratoires Servier et al v Apotex Inc et al, 2015 FC 108 (RoyJ.)
Judgment: February 16, 2015 (confidential judgment and reasons issued January 28, 2015)
Judith Robinson, Bryan Capogrosso, Nikita Stepin for the Applicants, Les Laboratoires Servier and Servier Canada Inc.
Andrew Brodkin, Dino Clarizio and Jaro Mazzola for the Respondent, Apotex Inc.
Result: Application for a prohibition order under the Patented Medicines (Notice of Compliance) Regulations dismissed.
The Federal Court dismissed a prohibition application against Apotex relating to its proposed generic version of gliclazide, marketed by Servier as Diamicron MR®. Servier asserted Canadian Patent No. 2,629,670. The claims in issue related to, among other things, a scored prolonged release tabled containing gliclazide. The Court found Apotex’s allegations of non-infringement and invalidity (obviousness and utility) justified.
The Court first addressed the construction of two disputed claim terms: “identical dissolution profile” (interpreted as requiring identical in vitro dissolution kinetics) and “binder” (interpreted to be different from the claim term cellulose derivative). The Court’s finding that the allegation of non-infringement was justified largely flowed from this construction. With respect to the binder, the Court also allowed Apotex’s evidence relating to a dual purpose compound even though not addressed in Apotex’s Notice of Allegation. The Court held that Apotex was not required to anticipate the dual function of the cellulose derivative theory, especially in view of the definition of binder found in the specification.
The Court found the obviousness allegation justified. The Court identified three different inventive concepts which were reflected in three different claims. The Court considered the specification in order to ascertain the inventive concept, and ultimately construed it in a manner consistent with its construction of the claims. The Court found that the skilled worker would have been able to combine the mosaic of prior art into the claimed invention. Once the decision was made that it would be desirable to have a modified release divisible tablet containing gliclazide, obtaining the precise formulation would have been a matter of routine experimentation and adjustment. The Court found unhelpful evidence from the inventor which lacked particularization and appeared to reflect goals irrelevant to the patent in question.
The Court also found justified the allegation of lack of demonstrated or soundly predicted utility. The Court held that the in vitro dissolution test disclosed in the patent, which was limited to a single tablet, did not demonstrate the promise of the patent. For the same reason, utility was not soundly predicted. The Court also declined to consider two bioequivalence studies relied on by Servier as they had not been referred to in the patent itself.
By: Kiernan A. Murphy, Gowling Lafleur Henderson LLP