Update: Sandoz discontinued its appeal and Pharmascience’s appeal was dismissed.
On January 12, 2021, the Federal Court issued its public decision in four patent infringement actions pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations brought by Bristol-Myers Squibb (BMS) against Pharmascience and Sandoz (the Defendants) regarding apixaban (BMS’s ELIQUIS): BMS v Pharmascience and Sandoz, 2021 FC 1. Justice Zinn found both Canadian Patent Nos. 2,461,202 (202 patent) and 2,791,171 (171 patent) valid. The Defendants did not advance a non-infringement defence for either patent, other than the argument that the patents will not be infringed because they are invalid, and accordingly Zinn J declared that both patents were infringed.
The 202 patent claims the compound apixaban and the use of apixaban in a mammal in the treatment or prevention of thromboembolic disorders, including ischemic sudden death, transient ischemic attack or stroke, deep vein thrombosis and pulmonary embolism. The Court rejected each of the Defendants’ validity attacks, namely insufficiency, inutility, anticipation, obviousness, double patenting, overbreadth, and insufficiency and inutility of a selection patent. BMS and the Defendants disagreed on whether, in assessing sufficiency of disclosure, the Court should consider the patent application as it existed at the date of publication, or rather the patent as issued. The Court determined that the latter interpretation was correct and articulated the test for sufficiency as: whether the skilled person at the date of publication is able to work the invention claimed in the patent as issued.
With respect to the allegation of inutility, the Court found that BMS had demonstrated the effectiveness of apixaban in treating thromboembolic disorders in mammals prior to the filing date, based on studies in animals that were models of thrombosis. The Defendants further alleged that an earlier genus patent (330 patent) invalidated the 202 patent on the grounds of anticipation, obviousness and obviousness-type double patenting. The anticipation allegation was rejected with the Court finding that, although apixaban fell within the scope of at least one claim of the 330 patent, the skilled person would not be able to identify apixaban among the large genus of compounds or make apixaban, as the 330 patent lacked such instructions. Similarly, the Court found that it would not be obvious to the skilled person that “apixaban was included in the 330 Patent and even if it were, it would not be obvious that it was an effective FXa inhibitor useful in treating thromboembolic disorders”. With respect to double patenting, the Court concluded that there was an inventive step between the claims of the 330 and 202 patents in discovering that apixaban could be used as an effective treatment of thromboembolic disorders. Lastly, the Court noted in obiter that a failure to meet the three conditions described in Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61 regarding selection patents does not in itself invalidate the patent; rather, validity is subject to the usual requirements for any patent. In any event, the Court found that the 202 patent did meet the conditions of a selection patent by disclosing the special advantage that apixaban is useful in treating thromboembolic disorders.
The asserted claims of the 171 patent claim a tablet formulation of apixaban made observing thresholds for minimum dissolution rate and maximum particle size, which ensure that the tablets provide consistent, solution-like exposures. The Court concluded the invention was neither obvious nor obvious to try in part because there were significant differences between the state of the art concerning BCS Class III drugs like apixaban, and the findings of the inventors, which were also contrary to the common general knowledge. The Court also rejected the Defendant’s allegations of insufficiency and overbreadth, ambiguity and inutility and declared the 171 patent to be valid.
The Defendants may appeal, as of right.
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