The Federal Court of Appeal’s recent decision in Allergan, Inc. et al v. Apotex Inc. et al is the most significant decision on the question of obviousness to be rendered following the Supreme Court of Canada’s landmark decision in Apotex Inc. v. Sanofi-Synthelabo Canada Inc. The Federal Court of Appeal’s decision is particularly significant for two reasons:
- The Court clarified when recourse to the specification is appropriate to construe the inventive concept of a claim; and
- The Court held that the determination of the inventive concept is a question of law.
Recourse to Specification
In Allergan the Federal Court of Appeal held conclusively that, where the inventive concept of a claim is not readily discernible from the claim itself, recourse is to be made to the specification.
In the years following the release of Sanofi, certain generics (e.g. Sandoz) had argued that recourse is only to be made to the specification where (i) the patent was a selection patent; or (ii) the claim was to a bare chemical compound.
Indeed, the trial judge in Allergan may be read to have suggested that the U.K. position (taken from Pozzoli) does not support recourse to the specification (see paras. 136-141) except in the case of a selection patent or the case of a bare chemical compound.
In Allergan neither of those proposed exceptions applied. No party asserted that the patent at issue was a selection patent, and the claim at issue was to an ophthalmic topical pharmaceutical composition (which is not to a bare chemical compound), yet the Court of Appeal clearly construed the inventive concept (absent from the claims) by reading the patent as a whole.
Accordingly, in Allergan the Court of Appeal has clearly affirmed Justice Crampton’s conclusion that the inventive concept need not be derived solely from the claims or even referred to in them. This is consistent with prior appellate jurisprudence on this point (see, for example, Laboratoires Servier v. Apotex Inc. (2009), 75 C.P.R. (4th) 443 (“Servier”) at para. 58 (F.C.A.)).
To the extent that parties have sought to take a narrow reading of Sanofi, that reading is now no longer tenable.
Question of Law
The Federal Court of Appeal also held that construing the inventive concept of the claims is a question of law. This decision may be significant to parties seeking to appeal a negative finding on the question of obviousness where the Court rejected its proposed construction of the inventive concept.
In PM(NOC) applications this finding may most often be beneficial to generics seeking to overturn a finding that their allegation that a claimed invention was obvious was not justified. Absent legislative change, generics will be more likely to find themselves in the role of appellant than innovators.