(NOC decision appeal) – August 17, 2011

In this decision under the Patented Medicines (Notice of Compliance) Regulations, the Federal Court of Appeal set aside the applications judge’s order prohibiting the issuance of a NOC to Apotex for the medicine latanoprost. The Court of Appeal held that the applications judge had misconstrued the promise of the patent and, consequently, never fully considered whether the promise was soundly predicted.

The Court of Appeal disagreed with the applications judge’s finding that the patent did not promise chronic use of latanoprost for the treatment of glaucoma or ocular hypertension.  The Court found that, on the evidence, glaucoma was a chronic condition that required chronic treatment.  Consequently, it held that the promise of the patent was chronic use of latanoprost for glaucoma and ocular hypertension without causing substantial side effects.

Notably, the Court of Appeal’s finding on the construction of the patent was different from their previous decision in respect of the same patent where they had upheld the application judge’s construction. The Court of Appeal stated that Apotex was not a party to the previous case involving this patent and they were permitted to assert a different construction of the patent based on an issue that was not raised in the earlier case.

The Court of Appeal, having differed from the applications judge with respect to the construction of the promise, went on to consider and reach a difference conclusion with respect to whether the utility had been demonstrated.  The applications judge had held that utility was demonstrated by single dose studies on animals and healthy humans.  However, the Court of Appeal held that these studies were inadequate to demonstrate that latanoprost could be used chronically to treat glaucoma.

In considering whether the promised utility was soundly predicted, the Court of Appeal held that the inventor’s line of reasoning for making the prediction of utility must be disclosed in the language of the patent itself.  The Court refused to consider Pfizer’s assertions that the skilled person would have inferred the sound line of reasoning based on the references listed in the patent or on the prior art as a whole.

Also of interest in this decision was the Court of Appeal’s statement that, while the patent does not have to prove demonstrated utility in the patent disclosure, it must make reference to a study which demonstrates that the patent fulfills its promise.

The full text of the decision can be accessed at: http://www.gowlings.com/knowledgeCentre/enewsletters/pharmacapsules/pdfs/Pfizer Canada Inc v Apotex 2011 FCA 236.pdf