On February 16, 2015, Justice Roy dismissed Servier’s application for a prohibition order regarding Apotex’s 60 mg modified release gliclazide tablet (Servier’s DIAMICRON MR): 2015 FC 108. Justice Roy found in Apotex’s favour on infringement and validity (obviousness and utility).
The patent at issue Canadian Patent 2,629,670 relates to a new prolonged-release divisible (scored) tablet formulation containing gliclazide (a known hypoglycemic agent used to treat diabetes), a cellulose derivative and a binder, with the dissolution profile of the undivided tablet being identical to that of a divided tablet.
The parties did not dispute the construction of the claims with respect to gliclazide (the active ingredient) and the cellulose derivative. They did, however, disagree on the construction with respect to the “identical dissolution profile” and the binder. Servier argued that “identical dissolution profile” would be understood by the person skilled in the art to mean “statistically similar in vivo dissolution profile.” Finding “there is nothing in this patent that would signal in vivo dissolution,” the Court held identical in vitro dissolution to be an essential element of the claims. With respect to the binder, the Court agreed with Apotex that the claimed formulation required a binder other than the cellulose derivative used to modify the release of gliclazide.
Apotex’s tablet was held not to infringe the relevant claims as it lacked two essential elements; namely, it did not contain a binder as construed by the Court and in vitro analysis of the tablet demonstrated that the dissolution profiles of Apotex’s complete tablet and a fraction of the tablet were different.
In holding Apotex’s obviousness allegation to be justified, the Court, relying on a prior art “mosaic that does not have that many pieces,” found that modified release formulations were known and a 60 mg gliclazide tablet could be formulated with a cellulose derivative and a binder. The Court noted that “by the claim date, multiple drugs … were both divisible and had modified release properties,” While gliclazide had not previously been formulated as claimed, the Court noted that “there is no evidence to suggest that it was not a suitable candidate for incorporation into such a tablet” and “obtaining the precise formulation would have been a matter of routine experimentation.” The Court found Servier’s evidence of actual course of conduct did not assist.
The Court held the patent to promise “a divisible modified release gliclazide tablet where the whole and subdivided portions of the tablet will exhibit identical in vitro dissolution kinetics.” Justice Roy considered whether, if mistaken, the promise extended to identical in vivo dissolution kinetics. He found such utility had not been demonstrated as, relying on Apotex Inc v Pfizer Canada Inc, 2011 FCA 236 (latanoprost), Servier could not rely on two studies that were not referenced in the patent. Considering the promise to relate to identical in vitro dissolution, Justice Roy held that the single in vitro dissolution test reported in the patent was not sufficient to demonstrate utility across the entire spectrum of the claims. With respect to sound prediction, the Court held that the single in vitro test did not provide an adequate factual basis for predicting across the scope of the claims or to the in vivo dissolution profiles. Further, the Court held that there is “no sound and articulated line of reasoning in the patent bridging the gap between the factual basis and the predicted utility” and most importantly, no proper disclosure in the patent.
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