In a rather lengthy 271 page judgement, the Federal Court of
Canada held that Sanofi-Aventis ("Sanofi") patent
1,336,777 ('777) for clopidogrel bisulfate (Plavix®) is
infringed by Apotex, but is invalid on the basis of lack of
utility1. Noticeably, the same patent had previously
been the subject of a complex litigation under the Patented
Medicines (Notice of Compliance) Regulations and had then been
found both infringed and valid in a landmark decision by the
Supreme Court of Canada2. After its loss in the Supreme
Court, Apotex brought an impeachment action against Sanofi, after
which Sanofi filed an infringement action. The decision rendered by
the Federal Court on December 6, 2011 relates to both actions. The
key issue in the determination of invalidity of the '777 patent
in the present case was the lack of demonstrated, or soundly
predicted, utility, an issue which was not addressed in the NOC
By way of context, the '777 patent discloses and claims
clopidogrel, its bisulfate salt and processes for its manufacture.
The compound is the single enantiomer of a previously disclosed
racemate used as an anticoagulant drug in humans. The '777
patent describes various tests on clopidogrel, which demonstrated
the compound had a better therapeutic index than the racemic
mixture and a better tolerability, including ex vivo
measurements of inhibition of platelet aggregation and in
vivo measurements of toxicity and tolerability conducted in
rats. Although not mentioned in the patent, human clinical trials
were ongoing at the time the patent application was filed.
In its analysis, the Court ascertained the promise of the patent
and opined that the '777 patent makes an explicit promise for
use of the compound in humans. Because the Court was not persuaded
that the utility in humans had been demonstrated, the Court
analyzed whether the promise for use in humans was soundly
After considering the science and contextual history of the
development and testing of the patented compound, the Federal Court
acknowledged that Sanofi had a factual basis and sound line of
reasoning for predicting that clopidogrel bisulfate could be used
in humans. However, the Court concluded that the underlying factual
basis and line of reasoning that grounded the inventor's
alleged prediction were not disclosed and, as a result, the patent
failed the third branch of the sound prediction test.
This decision is one of a series of at least four fairly recent
decisions in which patents for drugs were found invalid for lack of
utility3 4 5. This calls into question the validity of
many pharmaceutical patents given the very high thresholds for
utility in Canada compared to other jurisdictions. Indeed, the
recent decisions from the Federal Court and the Court of Appeal
seem to suggest that clinical trial data may be required for new
drugs directed to humans. The Supreme Court of Canada may address
this high threshold in Teva v. Pfizer, which will be heard
in the spring of 2012.
These recent decisions highlight the importance for Applicants
to include in their patent application any supporting data they may
have on hand to ensure that the utility requirement is met. The
language used in the application should also be considered
carefully to ensure the patent is not bound to a higher promised
utility that what may be supported.
1 Sanofi-Synthelabo Canada Inc v.
Apotex Inc. 2011 FC 1486, appeal pending.
2 Apotex. v. Sanofi-Synthelabo Canada
Inc., 2008 SCC 61.
3 Eli Lilly Canada et al.v. Novapharm
Ltd, 2011, FC 1288, relating to the drug Olanzapine
4 Sanofi-Aventis Canada Inc. v. Apotex
Inc., 2011 FCA 300, relating to the drug ramipril
5 Apotex Inc. v. Pfizer Canada Inc.,
2011 FCA 236, relating to the drug latanoprost
A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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