On January 30, 2014, the Supreme Court of Canada granted Apotex Inc. leave to appeal a decision of the Federal Court of Appeal which overturned a Federal Court’s decision invalidating the patent that claims clopidogrel bisulphate (sanofi-aventis’ PLAVIX): SCC Case No. 35562, case summary.

The Supreme Court of Canada is expected to address issues regarding the assessment of the promised utility of a patent, if any, providing guidance on an issue that has been central to a number of pharmaceutical patent decisions in the last number of years.

By granting leave to Apotex, the Supreme Court will consider the validity of the PLAVIX patent (the “777 Patent”) for the second time.

The 777 patent discloses and claims an enantiomer clopidogrel and its bisulfate salt, as well as processes for its manufacture. An earlier patent (875 Patent) encompassed clopidogrel bisulfate within its claims and included an example describing the racemate. PLAVIX, with clopidogrel bisulfate as the active ingredient, is used to inhibit platelet aggregation activity in the blood.

The 777 Patent had previously been the subject of litigation under the Patented Medicines (Notice of Compliance) Regulations. The Supreme Court upheld the Order of prohibition preventing the Minister of Health from issuing a notice of compliance to Apotex with respect to the 777 Patent (2008 SCC 61; reported in the November 2008 special edition of Rx IP Update). In that decision, the Supreme Court addressed the doctrine of selection patents and rejected Apotex’s contention that the 777 Patent was invalid on the bases of anticipation, obviousness and double patenting.

Following its loss in the Supreme Court, Apotex commenced an impeachment action, and sanofi-aventis commenced its own infringement action against Apotex based on, among other things, export to the U.S. The two actions were consolidated (collectively, the “impeachment action”) and resulted in the Federal Court of Appeal decision that will be reviewed by the Supreme Court.

In the impeachment action, Justice Boivin of the Federal Court invalidated the 777 Patent on the basis of lack of utility and obviousness (2011 FC 1486; reported in the January 2012 edition of Rx IP Update). While in principle moot, Justice Boivin addressed sanofi-aventis’ infringement claim. He held that Apotex infringed the 777 Patent and rejected Apotex’s 2-year limitation period defence on the basis that Apotex’s infringement was not limited to a single province. sanofi-aventis appealed to the Federal Court of Appeal.

The Court of Appeal reversed Justice Boivin’s findings of lack of utility and obviousness (2013 FCA 186; reported in the August 12, 2013 edition of Rx IP Update). Regarding utility, the majority of the Federal Court of Appeal stated that not every patent contains an explicit promise of a specific result, since there is no obligation on the part of the inventor to disclose the utility of the invention in the patent. The majority held that the Trial Judge erred in reading in a promise for use in humans “on the basis of inferences, in the absence of language at least as clear and unambiguous as that used to establish the advantages of the selection over the compounds of the genus patent.” As the 777 patent described a compound having advantages over the compounds of the 875 patent and those advantages were clearly disclosed in the patent specification and the Trial Judge found that those advantages were demonstrated at the time of the patent application, the patent was not invalid for lack of utility. The Court of Appeal also upheld the Trial Judge’s rejection of Apotex’s arguments regarding the limitation period.

A hearing is expected later this year.