Case: Teva Canada Limited v Novartis
Pharmaceuticals Canada Inc, 2016 FCA 230 (Court File No.
A-404-15), aff'g 2015 FC 770
Drug: EXJADE® (deferasirox)
Nature of case: Appeal from a prohibition
proceeding under Section 6 of the Patented Medicines (Notice of
Compliance) Regulations in which the prohibition order was
Successful party: Novartis Pharmaceuticals
Date of decision: September 15, 2016
The Federal Court of Appeal dismissed Teva's appeal of a
decision of the Federal Court granting a prohibition order against
Teva in respect of its generic version of EXJADE®
(deferasirox). Utility was the only issue on appeal. Teva did not
dispute the legal principles applied by Justice O'Reilly
(TrialJudge), and the FCA held
that he had not misapplied these principles to the facts.
Norvartis's patent covers two classes of compounds: formula
I and formula II. Formula II is a subset of formula I. The patent
differentiates between the two classes, as formula I includes some
previously known compounds whereas the compounds of formula II are
all said to be new.
reported, Novartis obtained a prohibition order against Teva at
the Federal Court. On appeal, Teva argued the Trial Judge erred in
finding different promises for formula I and formula II compounds.
Teva also asserted that the Trial Judge erred by applying the
doctrine of claim differentiation to construe the promise and by
relying on the patent's abstract in construing the promise.
Promises must be made in a clear and unambiguous way
The FCA reiterated that the "promise" doctrine will
hold an invention to an elevated standard of utility "only
where a clear and unambiguous promise has been made" and that
where validity is challenged on the basis of an unfulfilled
promise, the patent will be construed in favour of the patentee if
it can reasonably be read by the skilled person as excluding the
This is the second recent confirmation from the FCA on this
point (see our report on Nova Chemicals Corporation v The Dow
Chemical Company, 2016 FCA 216
The "promise" doctrine has been the subject of much
recent litigation, and as we
reported, the Supreme Court of Canada will hear the appeal from
AstraZeneca Canada Inc v Apotex Inc, 2015
FCA 158 on November 8, 2016. In that case, the FCA dealt
extensively with the standard of utility including the
"promise" doctrine, and the appeal should provide
guidance on a much-debated issue.
Different claims can have different utilities
The FCA confirmed that different claims can have different
utilities for the same compound and held that the Trial Judge's
construction of the promise of the patent was consistent with the
differentiation between the formula I compounds and the formula II
compounds in the disclosure and the claims.
The abstract should not be considered when construing the
promise of the patent
The FCA agreed that the Trial Judge ought not to have considered
the abstract when construing the promise of the patent. However,
his error was not material as he supported his construction with
appropriate references to the patent.
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On June 30, 2016, the Minister of Justice and Attorney General of Canada, the Minister of Public Safety and Emergency Preparedness, and the Minister of Health announced the creation of a nine-member Task Force on Cannabis Legalization and Regulation (the "Task Force").
Pharma in Brief reported on many legal and regulatory developments of interest to the pharmaceutical industry in 2016. Looking back on 2016 as the new year begins, we have compiled our list of the past year's top headlines below. These include, in no particular order, key developments that affect the pharmaceutical industry and we will continue to monitor in 2017.
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