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17 December 2012
On November 23 2012, in Apotex Inc v Allergan Inc, the Federal Court of Appeal dismissed Apotex's appeal of the Federal Court decision (1) granting an order prohibiting the minister from issuing a notice of compliance to Apotex for its ophthalmic drug combining brimonidine and timolol (Allergan's COMBIGAN). In doing so, the Federal Court of Appeal re-analysed Apotex's allegation of obviousness and commented on the doctrine of judicial comity. (2)
The appeal arose in an unusual way. The Federal Court had found that Apotex's allegation of obviousness was justified (2012 FC 767). (3) Despite this finding, the Federal Court issued the prohibition order specifically to allow the Federal Court of Appeal to address apparent "serious issues raised as to comity", which arose because of a prior decision of the Federal Court holding that Sandoz's allegation of obviousness was not justified (Allergan Inc v Minister (Health), 2011 FC 1316, (4) (Sandoz decision)).
The Federal Court of Appeal held that by issuing a formal judgment that was contrary to the conclusion that he reached on the merits, the Federal Court judge had "failed in his task". The Federal Court of Appeal did not agree that any serious issues of comity were raised in the Apotex proceeding. The court explained that the doctrine of comity promotes certainty in the law and seeks to prevent the same legal issue from being decided differently by members of the same court. Judicial comity applies only to determinations of law as, in theory, there can be only one correct answer to a question of law. A departure is authorised where a judge is convinced that the prior decision is wrong and the departure is necessary, and where cogent reasons can be articulated for doing so.
The Federal Court of Appeal held that construing a patent to identify the inventive concept when it is not readily discernible from the claim itself requires looking at the whole of the patent and gives rise to a question of law. In the court's view, the Federal Court judge was wrong to have construed the inventive concept differently from what had been found in Sandoz, as he had identified no error in the prior construction; nor did he rely on distinct evidence to explain why he chose to construe the patent differently.
Faced with two conflicting and equally authoritative decisions on the construction of the patent, the Federal Court of Appeal undertook the task of determining which construction was correct. The court agreed with Allergan and the Federal Court's Sandoz decision that the inventive concept, on the basis of the whole of the patent disclosure including the clinical study disclosed in Example II, included an improved safety profile associated with the drug combination. In doing so, the Federal Court of Appeal held that the Federal Court judge had taken too narrow a view of the inventive concept when he restricted it to what was stated in one paragraph of the patent in isolation of the rest of the disclosure. The court reiterated that claim construction must be conducted in light of the patent as a whole.
The Federal Court of Appeal then proceeded with the remaining steps of the obviousness analysis, rather than remitting the matter back to the Federal Court judge. The court found that the difference between the state of the art and the inventive concept of the patent – in particular, the improved safety profile of the drug combination – would not have been obvious to a skilled person. As such, the court dismissed the appeal and stated that "although the prohibition order was issued by the Federal Court for the wrong reason, it was nevertheless properly issued".
(1) Federal Court decision – see http://decisions.fct-cf.gc.ca/en/2012/2012fc767/2012fc767.html.
(2) Federal Court of Appeal decision – see decisions.fca-caf.gc.ca/en/2012/2012fca308/2012fca308.html.
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