On January 28, 2014, the Federal Court issued a decision under the Patented Medicines (Notice of Compliance) Regulations involving the patent for the drug celecoxib, which is marketed by Pfizer Canada under the brand name Celebrex®. Justice Harrington found that Mylan Pharmaceuticals’ allegation that the invention failed to meet a “promise” of reduced side-effects in humans was not justified. In fact, the Court found that the celecoxib patent made no such promise. Thus, the Court issued an Order prohibiting the Minister of Health from issuing regulatory approval to Mylan until after expiry of the patent (i.e. November 14, 2014).

Celecoxib is a member of the NSAID class of compounds (non-steroidal anti-inflammatory drugs). There was no issue between the parties that celecoxib is, in fact, a useful drug to treat inflammation. However, Mylan alleged that the patent promised that celecoxib produces fewer side-effects in humans than other NSAIDs. While Mylan did not dispute that fewer side-effects were soundly predicted, it alleged that it is now known that celecoxib does not meet this promise.

In finding that the celecoxib patent made no promise of reduced side-effects in humans, the Court relied on the language of the claims, which did not include a reference to reduced side-effects. In addition, the Court also noted that the disclosure used permissive language regarding reduced side-effects.

The Court also referred to a line of cases, including the Federal Court of Appeal’s decision regarding the patent for clopidogrel bisulfate (Plavix®) (2013 FCA 186), which had reiterated the need for any “promise” to be explicit. In this regard, the Court rejected Mylan’s argument that the Court of Appeal’s decision in Eurocopter v Bell Helicopter Textron Canada Limitée (2013 FCA 219) held otherwise.

Justice Harrington also echoed Justice Gauthier’s concurring reasons in the Plavix® decision, in which she noted that statements in the disclosure are not necessarily made to “promise” a particular utility. The Court commented that, while the patentee may not have been confident enough to claim reduced side-effects in humans based on the rat testing, the disclosure of these results may have prevented others from patenting a new use on the grounds that such use was anticipated by the patent.

Finally, the Court rejected Mylan’s argument that it was an abuse of process for Pfizer to argue that the patent did not promise reduced side-effects, when Pfizer had agreed in an earlier court proceeding (involving a different generic) that the utility included this benefit. The Court held that a concession made by a first person in one proceeding under the Regulations is not an admission binding upon it in another. In addition, the Court noted that the “lesser side-effects” that Pfizer had admitted were part of the invention’s utility in the earlier proceeding were not lesser side-effects in humans, but in rats. 

Click here for the Federal Court decision.