In a decision released Friday, the Federal Court of Appeal held that inventive concept is a question of law and application judges should look to determinations of inventive concept made in prior proceedings.
In Apotex v. Allergan, 2012 FCA 308 (PDF) (brimonidine), the Federal Court of Appeal considered the “unusual” appeal from Justice Hughes’ decision granting the prohibition order against Apotex in 2012 FC 767 for brimonidine/Combigan. The Court of Appeal upheld the granting of prohibition of order but on different reasons.
Justice Hughes had found the allegations of obviousness justified based on his determination of the inventive concept but granted the prohibition order because of “serious issues raised as to comity” due to an earlier decision of Chief Justice Crampton involving a different generic but same patent (Allergan v. Sandoz, 2011 FC 1316) where the allegations of obviousness were found not justified with a different determination of the inventive concept. Justice Noël for the Federal Court of Appeal wrote:
[2]… [Justice Hughes] explained that he adopted this unusual course because he wanted to make sure that his concerns about the application of the doctrine of comity in the context of NOC proceedings could be addressed on appeal (reasons, paras. 192 to 194).
The Federal Court of Appeal concluded that it was not open to the judge to grant the prohibition order “to further his desire to clarify the jurisprudence.”
On comity, the Federal Court of Appeal and the application to this case, the Court wrote (references omitted):
[50] Beyond this, the doctrine of comity has no application with respect to findings of fact. A finding that an invention is obvious because the solution proposed was plain to see is one of fact. In contrast, construing a patent in order to identify the inventive concept when it is not readily discernable for the claim itself requires looking at the whole of the patent and gives rise to a question of law. It follows that unless the Federal Court judge could demonstrate that Campton J.’s construction of the patent in order to determine the inventive concept was wrong or that distinct evidence adduced before him compelled him to reach a different conclusion, it would have been preferable for him to adhere to it. [references omitted, emphasis added]
The Federal Court of Appeal therefore reviewed the patent at issue to determine the correct construction of the patent in view of the conflicting lower court decisions. The Court determined that an improved safety profile formed part of the claimed invention (at [74]) and this feature was not shown to be obvious (at [93]). The court therefore concluded that the prohibition order was properly issued, even though for the wrong reasons and dismissed the appeal.
This decision will likely add to the debate on the limited ability of “first persons” to appeal from decisions of the Federal Court dismissing applications under the Patented Medicine (Notice of Compliance) Regulations as well as the importance of inventive concept to determinations of patent validity.
Steve Tanner has posted commentary on the decision and appeals in PM(NOC) applications.
[Update: added link to Steve’s article on the decision.]