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Court grants prohibition order despite obviousness finding; cites uncertainty in comity law as basis

brimonidine tartrate + timolol maleate

On June 18, 2012, the Federal Court of Canada issued a Judgment and Reasons for Judgment in a prohibition proceeding between Allergan and Apotex involving Allergan’s brimonidine + timolol combination product (COMBIGAN) and Canadian Patent No. 2,440,764. This is not the first time the ‘764 patent has been involved in litigation under the Patented Medicines (Notice of Compliance) Regulations.  In November 2011Justice Crampton held that Sandoz’s allegations in respect of the same ‘764 patent were not justified and granted a Prohibition Order preventing the Minister of Health from approving Sandoz’s ANDS until the expiry of the ‘764 patent in 2023 (2012 FC 1316).

On the evidence before him in the Apotex matter, Justice Hughes concluded that Apotex’s allegation of obviousness was justified but nevertheless granted a prohibition order against Apotex, stating as follows:

CONCLUSIONS AS TO OBVIOUSNESS

[189] As is apparent, I would find on the evidence before me that Apotex’s allegations as to obviousness are justified. In this regard, my findings are in line with the decision of O’Reilly J of this Court in Merck & Co Inc v Canada (Minister of Health), 2010 FC 1042, where he held that a similar patent directed to the earlier combination product COSOPT was obvious, and with the decision of Justice Floyd of the High Court of Justice, Chancery Division, Patents Court of England and Wales in Teva UK Limited v Merck & Co Inc, supra, where he held the European COSOPT patent to be obvious.

[190] That is, however, not the end of the matter.

[191] I must consider the question of comity. Is the evidence and argument before me “different” from or “better” than the evidence and argument before Crampton J in Sandoz? There is no real way to measure “different” or “better”. The evidence and argument is of the same kind. In some cases evidence and argument is more one of quality to the best that can be discerned from the record that I have, and this Court not having the record as to what was before Crampton J.

[192] If I were to dismiss this application on the basis that Allergan did not discharge its burden ofproving that Apotex’s allegations as to obviousness were not justified; then, within a matter of hours – if not days – the Minister would give Apotex a Notice of Compliance, and the issue as to whether the Court should grant a prohibition order would be moot. The Court of Appeal, in all likelihood, would not hear an appeal.

[193] I believe that there have been serious issues raised as to comity. The somewhat contradictory decisions of the Court of Appeal should be considered by that Court and clear instruction given as to how, in an NOC context, previous decisions of a Court on the same issues respecting the same patent, should be considered.

[194] The only practical way to get the matter before the Court of Appeal is for me to grant the Order for prohibition in the likely expectation that Apotex will appeal.

[195] In the circumstances, I will not award costs to any party.

A copy of the Reasons for Judgement and Judgment may be found here.