The Supreme Court of Canada denied leave to appeal today from the Federal Court of Appeal ("FCA") decision in Allergan Inc. et al ats. Apotex Inc., 2012 FCA 308. This Patented Medicines Notice of Compliance ("PM(NOC)") proceeding concerned the construction of the “inventive concept” underlying patent claims for a combination of two known drugs into a single formulation for the topical treatment of glaucoma.
In the Federal Court (2012 FC 767), Justice Hughes had found that the “inventive concept” of Allergan’s patent claims was that the claimed combination of ingredients in particular quantities achieved the promises of the patent, as set out explicitly in paragraph 1 of the patent, including improved patient compliance, increased stability and increased efficacy. Based on his construction of the “inventive concept” Justice Hughes found the claims to be obvious. He nevertheless went on to issue the requested prohibition order so that the NOC would not issue and the FCA would have an opportunity to consider the issue of judicial comity as it relates to the construction of patents. The comity issue arose because in an earlier PM(NOC) proceeding brought by Allergan against Sandoz with respect to the same patent, Justice Crampton had found that the “inventive concept” of the patent included an improved safety profile that was observed during the clinical trials discussed in the patent, and had concluded that the patent was not obvious. Justice Crampton came to his decision based in part on Allergan’s expert evidence that the skilled person would have considered the improved safety profile to be part of the invention.
The FCA held that it was an error for Justice Hughes to have granted the prohibition order for the purpose of allowing the FCA to clarify the comity issue. The FCA did nevertheless note that whereas comity has no application with respect to findings of fact, such as a finding that an invention is obvious because the solution was plain to see; it does apply to construing the whole of a patent in order to identify the inventive concept, which is a question of law. Therefore, unless Justice Hughes could demonstrate that Justice Crampton's determination of the patent's inventive concept was wrong, or had evidence before him to justify a different result, it would have been better to follow Justice Crampton.
The FCA ultimately concluded that: Justice Hughes had misconstrued the patent; the improved safety profile was part of the inventive concept, and the allegation of invalidity was not justified. In the result, the Court upheld the prohibition order.