A somewhat confusing victory for Allergan Inc. was won on June 18th, as the Honourable Justice Hughes upheld their patent on COMBIGAN despite the fact that their invention was ruled to be obvious. The Honourable Justice Hughes ruled in favour of Allergan by prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to competitor Apotex for a rival generic product.
COMBIGAN is a topical ophthalmic product used to treat intraocular pressure for people suffering from chronic glaucoma and has been patented (hereafter “’764 patent”) by Allergan since April 2003 (granted October 2005). A generic version, developed by Apotex (known as APO-BRIMONIDINE-TIMOP), could only receive a NOC from the Minister of Health before April 2023 if Apotex could invalidate the ‘764 patent. A finding by Justice Hughes that the ‘764 patent was obvious (and therefore invalid) conflicted with the final order prohibiting Apotex from obtaining the NOC for their product.
The ruling, according to Justice Hughes, was made in order to preserve comity. There was a previous decision in the federal court where a different generic competitor (Sandoz) also attempted to invalidate the ‘764 patent on the basis of obviousness, and lost. Justice Crampton, in making that decision, relied on expert testimony to come to the conclusion that the ‘764 patent was not obvious. In the current decision, Justice Hughes, relying on different expert witnesses who represented Apotex and slightly different testimony by Allergan’s expert, decided that the ‘764 patent was obvious. Justice Hughes recognized the similarity between the two cases and the fact that both judges were relying on similar evidence to reach their conclusions.
“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” (at 191).
In order to acknowledge this difficulty in the law, Justice Hughes was forced to admit that he might not be in the best position to rule on the obviousness of the ‘764 patent and left the matter for an appellate court. “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” said Justice Hughes, which explains his order for prohibition. At the same time however, Justice Hughes stated his own conclusion that the ‘764 patent was obvious in order to demonstrate to an appeal court that he had reached a separate and opposite conclusion to that of Justice Crampton. Given the fact that both judges were relying heavily on expert testimony, Justice Hughes correctly identified the real possibility of conflicting judgments within the same level of court, despite having nearly identical facts and arguments.
When it comes to patent law, judges rely on being able to access expert witnesses that can explain the current state of the art and whether or not a current patent was obvious to those skilled in the art. Judges simply do not have the technical skill for coming to their own conclusions about obviousness. Therefore, these findings of obviousness are mainly based on the expert evidence that is before a judge. It follows that, given different evidence of a similar kind, judges from the same level of court might reasonably disagree on the findings of obviousness depending solely on the type of expert evidence they hear. Justice Hughes finds that result unacceptable and therefore deferred the matter to a higher court.
By making the judgment that he did, Justice Hughes has created an opportunity for a higher level court to make the final decision regarding obviousness, while at the same time expressing his own opinion on the evidence and giving deference to comity. Since he prohibited Apotex from obtaining the necessary NOC for their product, he anticipates an appeal might give Apotex the result he feels they deserve, and also allow the court to offer guidance regarding similar NOC proceedings. It was a practical if somewhat confusing way to address the problems in this case and I commend him for it.
Adam Stevenson is a JD Candidate at Western University faculty of law
2 Responses
I have great difficulty understanding this decision. There are three reasons why this decision is problematic. First, the sole purpose of an NOC proceeding is to determine whether the Minister of Health can grant regulatory approval to a generic. The purpose does not include resolving other issues that are of interest to the court. The Court found Apotex’s obviousness allegation justified and should have dismissed Allergan’s application. Secondly, the cases the Court refers to when discussing comity state that courts must respect prior decisions of the same court on matters of law. The issue in this case and the “rule” the court set out, paragraph 82, dealt with differences in evidence and facts that were before the court. Finally, the Federal Court of Appeal has already dealt with the issue of two generic companies litigating the same patent on the same allegations. In Apotex v Janssen-Ortho the Court of Appeal stated that if one generic is unsuccessful it is not an abuse of process for a second generic to litigate the same allegation (2009 FCA 212). The Court stated that in the second proceeding the judge is “required to assess the evidence put before him by both parties independently of the findings” made in the prior decision. It would appear the Court of Appeal has already provided clear guidance on this issue and I’m sure Apotex was not alone in feeling baffled by the courts decision to allow Allergen’s application despite finding the patent obvious.
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