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Wrongly issued COMBIGAN prohibition order upheld for different reasons

brimonidine tartrate + timolol maleate

On November 23, 2012, the Federal Court of Appeal dismissed Apotex’s appeal of Justice Hughes’ Judgment granting a prohibition Order in respect of Apotex’s proposed brimonidine + timolol fixed combination product and notwithstanding having found that Apotex’s allegation of obviousness  of Canadian Patent No. 2,440,764 was justified (see our previous post here).  In finding Apotex’s allegation of obviousness justified, Justice Hughes had adopted a different inventive concept than Justice Crampton had in an earlier prohibition application involving the 764 Patent and Sandoz.  As acknowledged by the Court of Appeal, the circumstances of Apotex’s appeal were unusual:

[2] The appeal comes to this Court in an unusual way. Although the Federal Court judge held that Apotex’s allegation of invalidity on grounds of obviousness was justified and that the prerequisite for the issuance of the prohibition order sought by Allergan had therefore not been established, he nevertheless issued it. In so doing, he adhered to the judgment given by his colleague Crampton J. (as he then was) in another NOC proceeding involving the same patent (Allergan Inc. v. Canada (Health) and Sandoz Canada Inc., 2011 FC 1316 (Sandoz)), even though he expressly disagreed with the reasons and the conclusion reached in that case. He 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). 

Comity

The Court of appeal held that the Justice Hughes had erred in granting the appeal in order that Federal Court could clarify how previous decision of a Court on the same issues respecting the same Patent should be considered:

[49]           It is apparent from the foregoing that it was not open to the Federal Court judge to issue a prohibition order for the purpose of having his concerns about the use of the doctrine of comity and the notion of abuse of process addressed by this Court on appeal. As noted earlier, the parties were entitled to have their dispute settled on the merits and the Federal Court judge by issuing a formal judgment that was contrary to the conclusions that he reached on the merits, failed in his task.

Inventive Concept

The only claim at issue in the appeal was claim 22, which depends on claims 6, 3, and 1.  The relevant claims read:

1. An ophthalmic topical pharmaceutical composition for the treatment of glaucoma or ocular hypertension comprising an effective amount of brimonidine and an effective amount of timolol in a pharmaceutically acceptable carrier therefor.

3. A composition according to Claim 1, wherein the amount of brimonidine is 0.2 percent by weight and the amount of the timolol is 0.5 percent by weight.

6. A composition according to claim 3 further comprising from 0.001% by weight to less than 0.01% by weight of benzalkonium chloride.

22. Topical use of a therapeutically effective amount of a composition according to claim 6 in an affected eye for treating glaucoma.

Unlike Justice Crampton on the Sandoz matter, Justice Hughes did not read the improved safety profile of the fixed combination, including the elimination of the “afternoon trough” when brimonidine dosed alone twice daily is less effective, as part of the inventive concept.  The Federal Court held that Justice Hughes had erred in concluding that the inventive concept was limited to a fixed combination that is safe:

[72] Apotex has not been able to provide any justification for the Federal Court judge’s narrow reading of the patent. In holding that the inventive concept is restricted to what is stated in paragraph 1 of the patent, the Federal Court judge read this paragraph in isolation. Claim construction must be conducted in light of the patent as a whole.

….

[74] In my respectful view, a purposive and complete reading of the ’764 patent leads to the conclusion that the improved safety profile forms part of the claimed invention.

Having determined that Justice Hughes had erred in his interpretation of the inventive concept of the 764 Patent, The Court of appeal concluded that it would be more efficient for the Court of Appeal to determine the issue of obviousness on the paper record before it.  Unlike Justice Hughes, who had found one of Allergan’s experts to be evasive and less than forthright on many occasions, the Court of Appeal found this expert’s evidence on the improved safety profile of the fixed combination to be uncontradicted, well explained and supported by the scientific literature.  Holding that there was nothing routine about the extensive, multicentered, double masked randomized trial disclosed in the 764 Patent, the Court concluded that Apotex had failed to show that the improved safety of the combination to be obvious and accordingly dismissed Apotex’s appeal.

A copy of the Court of Appeal’s Reason for Judgment may be found here