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
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)
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
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
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