Apotex Wins the Battle But Loses the NOC War – Until FCA Clears Up the Issue of Judicial Comity in the NOC Quagmire

Published July 20th, 2012

Allergan v. Apotex 2012 FC 767 (Hughes)

Summary – Mr. Justice Hughes (“Hughes”), in the present case (the “Apotex Case”), declined to follow the Federal Court’s earlier findings in Allergan v. Sandoz 2011 FC 1316 (the “Sandoz Case”), that Allergan’s brimonidine/timolol combination for glaucoma was inventive.  However, following a detailed review of the Federal Court of Appeal (“FCA”) jurisprudence on how a second court should evaluate a “repeat NOC case”, Hughes concluded that clarification is required regarding judicial comity (paras. 191-193).  The simple sounding “better evidence or argument test” is actually very difficult to implement in practice.  All that a second court can do is review the first decision (para. 49).  Despite his obviousness finding, Hughes sent the case to the FCA to clarify this procedural point.  From a review of the entire decision, the second court is careful to identify several differences between the first and second case, both in the areas of law and evidence.  On its face, it appears that in fact, Hughes had “better evidence and better argument” before him to justify a departure from judicial comity (paras. 108, 148, 168, 176, 181), although he characterizes it merely as a difference in “quality” (para. 191).

Analysis – The court spent a great deal of time reviewing both the earlier Sandoz Case decided by Mr. Justice Crampton (as he then was) and an earlier US case the “US Case”).  In both cases, Allergan’s patent was upheld.  Arguably, the major difference in the Apotex Case was the expert and factual evidence.  Hughes treated the evidence of Allergan’s key eye expert “with great caution” (paras. 29, 32, 44).  Apotex also filed evidence from an ocular formulation expert which was significant because in essence, Allergan’s main arguments on obviousness were really that a person skilled in the art would not know in advance how to formulate the combination to obtain improved efficacy, stability and less preservative) (para. 108). 

The court dealt with confusion regarding the meaning of “inventive concept”.  After reviewing the origins of inventive concept and explaining its relationship to construction, Hughes concludes it is acceptable to “import” utility into a chemical claim in order to determine the “inventive concept” (para. 141).  Arguably, this is a broad conclusion based on the cases he reviewed and it is expected that this will be an issue for the FCA.  Hughes (unlike Crampton) focussed on the “claim itself” and not the commercial product in evaluating whether “the recipe” for the combination was inventive (paras. 152, 154, 173).  The court accepted Apotex’s formulator evidence that:  (i) no incompatibilities would be expected; (ii) the “principal approach” would be to use the same 2 actives at the same concentrations in the individual products based on one earlier glaucoma timolol combination product; and (iii) Allergan’s preservative was commonly used (paras. 159-161, 165).  “There is always, especially in chemistry, an element of doubt that can only be dispelled by actually doing a test or experiment” (para. 161).  Hughes relied on an earlier UK case that provides a common sense approach to obviousness:  “the doctrine of obviousness exists to prevent a patentee from monopolizing products or activities that a skilled person should feel free to make or perform without worrying about the existence of a patent” (para. 175). 

Hughes criticized the FCA as providing “somewhat contradictory decisions” on comity (para. 193).  Although not clearly explained in the decision, the contradiction appears to arise because standard rules of comity require a departure from a first decision only where there is “strong reason to the contrary … the Court does not mean a stronger or more persuasive argument of Counsel, but a showing that some jurisprudence has been clearly overlooked or is now changed” (para. 66).  In the context of the NOC world, the FCA has said that a second generic should be able to introduce “better evidence or more appropriate legal argument” to avoid comity with a first decision on a particular validity allegation of a first generic (paras. 49, 82).

Apotex has sought an expedited appeal (A-312-12) and Allergan has filed a cross-appeal.

Practice Points – This decision highlights the importance of correctly identifying the person skilled in the art, and selecting the required experts early on in a case.  Hughes was clearly persuaded by the only formulation expert which was put forth by Apotex.  Allergan’s patent was substantively a formulation patent but Allergan failed to file a formulator affidavit.  In addition, the advantages of using limited cross-examination is apparent as additional cross-examination of Allergan’s inventor by Sandoz ended up “ramping up” Allergan’s case to suggest that Allergan’s inventive team had gone on a wild goose chase” (paras. 176, 185).  Arguably, even with this evidence, Hughes would have found the patent obvious. 

Although the Sandoz Case was not appealed to the FCA, had the FCA affirmed the Sandoz Case, one may question whether this would/should have an effect on deference by a second court in the NOC context?  Although not discussed in the decision, the Apotex Case was also originally scheduled to be heard by Mr. Justice Crampton (who was subsequently appointed Chief Justice of the Federal Court).  In practice more recently, the Federal Court may “informally” be doing its part to assist in maximizing resources and avoiding inconsistent results by designating the same judge to a number of cases involving the same patents and different generics.  For example, Madam Justice Heneghan heard both the Pharmascience and Apotex latanoprost NOC cases and Justice Hughes heard both Pharmascience’s amlodipine NOC case and ratiopharm’s action regarding amlodipine). 

The Federal Court also appears to be continuing its trend toward tacitly recognizing the presence of “global litigation”. Hughes reviews the US Case with nearly the same level of detail as he does the Sandoz Case, and then acknowledges that the US Case “is not binding upon me, and I do not treat it as binding in any way.  It is interesting and informative.” (para. 100)