On December 6, 2011, Justice Boivin of the Federal Court held
that Apotex infringed the patent that claims clopidrogel
bisulfate (sanofi-aventis's PLAVIX)
but that the patent was invalid: Apotex Inc. v.
sanofi-aventis2011 FC 1486, appeal pending.
The same patent ('777) had previously been the subject of
litigation under the Patented Medicines (Notice of Compliance)
Regulations. As reported in the
November 2008 special edition of Rx IP Update, the
Supreme Court of Canada upheld the Order of prohibition preventing
the Minister of Health from issuing a Notice of Compliance
("NOC") to Apotex (2008 SCC 61). Following its loss in the Supreme
Court, Apotex brought an impeachment action, and sanofi-aventis
followed with an infringement action. The December 6 decision
relates to both actions.
The '777 patent discloses and claims the enantiomer
clopidogrel and its bisulfate salt, as well as processes for its
manufacture. An earlier patent ('875) encompassed clopidogrel
bisulfate within its claims and included an example describing the
racemate. The claims also referred to enantiomers.
Starting with the position that the '777 patent is a
selection patent, the Federal Court concluded that the invention of
the '777 patent is a compound that is useful in inhibiting
platelet aggregation, has greater therapeutic effect and less
toxicity than the other compounds of the '875 genus patent,
including the racemate and the opposite enantiomer, has the
advantages of the salts (crystallize easily, not hygroscopic and
sufficiently water-soluble) and the methods for obtaining that
compound. Further, the Federal Court held that the patent made an
explicit promise for the use of the compound in humans.
Invalidity. The Federal Court rejected
Apotex's assertions that the '777 patent was invalid for
overbreadth, insufficiency, lack of novelty and double-patenting.
The Federal Court's decision is consistent with the Supreme
Court's ruling on the latter two grounds.
The Federal Court found the patent invalid on the basis of lack
of utility, both demonstrated or soundly predicted, and
Demonstrated utility. Sanofi-aventis had argued
that the promised utility had been demonstrated as of the Canadian
filing date, at which time a phase 1 clinical study of the compound
was underway. While some of the results of the double-blind study
were known to sanofi-aventis at the date of filing, the study was
not completed until one month later. The Federal Court held that
the early results known by sanofi-aventis were inconclusive on the
issue of the promised utility.
Sound prediction. With regards to sound
prediction, the Federal Court found that sanofi-aventis had a
"track record" studying compounds with similar structures
to clopidogrel bisulfate. As a result of this "track
record," sanofi-aventis established that it had a factual
basis and sound line of reasoning for predicting that clopidogrel
bisulfate could be used in humans. However, the Court found that
the patent did not disclose this "track record," which
the Court held was needed to assist the skilled person to predict
the promised use. As a result, the patent failed the disclosure
branch of the sound prediction test.
Obviousness. In contrast to the Supreme
Court's finding that Apotex's allegation of obviousness was
not justified in that proceeding, the Federal Court held the
invention of the '777 patent "obvious to try." The
Federal Court reasoned that the racemate of clopidogrel was part of
the common general knowledge of the skilled person, that the
skilled person would have been motivated to resolve the enantiomers
of a racemate, and that a particular method of resolving the
enantiomers would have been routine at the time.
Infringement. While in principle moot because
of the finding of invalidity, the Federal Court nonetheless
addressed sanofi-aventis's claim of infringement. The Federal
Court held that Apotex infringed the '777 patent by, among
other acts, importing clopidogrel bisulfate and exporting
Apo-clopidogrel tablets to the United States.
In the U.S., the parties had entered into settlement agreements
regarding the U.S. litigation relating to the U.S. patent claiming
clopidogrel bisulfate. By the agreements, Apotex's liability
for infringement in the U.S. was limited to 50% of its net sales.
Apotex had argued that sanofi-aventis was precluded from recovering
for the U.S. Apo-clopidogrel on the basis of these settlement
agreements. The Federal Court disagreed, finding the agreements did
not consider the '777 patent and were limited to the U.S.
patent and U.S. litigation.
Sanofi-aventis's motion for an interim stay was dismissed. A
number of generic manufacturers have since received NOCs for their
clopidogrel bisulfate products.
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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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