On June 18, 2012, the Federal Court issued an Order prohibiting the Minister of Health from issuing a notice of compliance to Apotex for its proposed ophthalmic drug containing brimonidine and timolol, which was compared to Allergan Inc.'s COMBIGAN (Allergan Inc v Minister (Health) and Apotex Inc, 2012 FC 767). Justice Hughes of the Federal Court allowed the application for reasons of comity, despite finding that Apotex's allegation of obviousness was justified.
Justice Hughes held, "comity comes into consideration when a Court is faced with a decision of the same Court which deals with the same legal issues or factual circumstances. There is a general view that the subsequent Court should respect the decision of the earlier Court unless it is manifestly wrong or the jurisprudence has changed." The issue of comity arises because Allergan v Apotex is the second prohibition application under the Patented Medicines (Notice of Compliance) Regulations ("Regulations") relating to Allergan's Canadian Patent No. 2,440,764 ("’764 patent"). In a prior proceeding, Allergan Inc v Minister (Health) and Sandoz Inc, 2011 FC 1316, Justice Crampton held that Sandoz's allegation of obviousness regarding the ’764 patent was not justified, and granted the Order of prohibition.
Justice Hughes reviewed the jurisprudence regarding multiple prohibition applications pursuant to the Regulations relating to the same patent. Jurisprudence has established that if a patentee is not successful in a prohibition application against one generic, it is an abuse of process for the patentee to subsequently relitigate the same issues against another generic (sanofi-aventis Canada Inc v Novopharm Inc, 2007 FCA 163). However, if a patentee is successful against one generic, it is not an abuse of process for a subsequent, different generic to serve a notice of allegation and relitigate the same issues (Janssen-Ortho Inc v Apotex Inc, 2009 FCA 212). Justice Hughes stated that a Court, when faced with an earlier decision in which the patentee was successful in challenging an invalidity allegation, must:
- "do the best it can from the reasons of the Court in the earlier proceeding to discern what the evidence and argument was;
- compare that evidence and argument with that in the proceedings at hand;
- determine if there are meaningful differences between the evidence and argument in the earlier case and present case;
- give respect to the earlier decision but, if there are determinative differences in the evidence, the Court must make its own decision; and
- if the previous decision contains a critical error of law or if the law has changed the Court must make its own decision as to the law."
Justice Hughes then proceeded to consider Apotex's allegation of obviousness of the ’764 patent, which claims the use of an ophthalmic pharmaceutical composition of particular quantities of brimonidine and timolol and a particular preservative, for the treatment of glaucoma or ocular hypertension. While referring to and considering the decision of Justice Crampton in Allergan v Sandoz, Justice Hughes performed his own interpretation of the ’764 patent and analysis of the evidence before him. Justice Hughes's interpretation of the inventive concept differed from that of Justice Crampton. Justice Hughes further drew different conclusions regarding the considerations of whether the differences between the prior art and the inventive concept would have been obvious to the skilled person, and ultimately drew the conclusion that Apotex's allegation of obviousness was justified.
While this was a sufficient basis to dismiss the application, Justice Hughes then considered the issue of comity, and held that "there have been serious issues raised as to comity." He concluded that the "only practical way to get the matter before the Court of Appeal is for [the Federal Court] to grant the Order for prohibition in the likely expectation that Apotex will appeal."
While an appeal has not yet been filed, it is expected that Apotex will appeal the decision.
Allergan Inc et al v Minister (Health) and Apotex Inc, June 18, 2012.
Federal Court decision – 2012 FC 767.
Addendum: Apotex filed an appeal on June 29, 2012 (Court File No. A-312-12).
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