Federal Court Dismisses Prohibition Application Relating To The
On February 14, 2014,
the Federal Court dismissed an application by Alcon Canada Inc
(Alcon) which sought an order prohibiting the issuance of a Notice
of Compliance to Cobalt Pharmaceuticals Company (Cobalt) for its
generic version of the drug PATADAY® prior to the
expiry of Canadian Patent No
2,447,924 (924 Patent). Alcon had previously discontinued that
part of the proceeding related to Canadian Patent No 2,195,094.
(Deeth Williams Wall LLP represented Cobalt).
Cobalt alleged that the 924 Patent was invalid on several
grounds including obviousness, lack of demonstrated utility/lack of
sound prediction, ambiguity, overbreadth and insufficiency. Justice
Gleason found that the allegations of lack of utility/sound
prediction and overbreadth were justified.
After construing the claims and determining the inventive
concept, Justice Gleason held that the 924 Patent promised that
polyvinylpyrrolidine (PVP), at sufficient concentrations, improves
the physical stability of olopatadine solutions. Specifically,
claim 2 promised that PVP having an average molecular weight of
5000 to 1600K, and at sufficient concentrations, will enhance the
physical stability of 0.18 - 0.22% olopatadine. The Court held that
though the concentrations of PVP were not specified in Claim 2,
construed in light of the disclosure, it promised effectiveness at
concentrations between 0.1 – 3%. Claim 7 promised that PVP
having an average molecular weight of 5000 to 1600K, and at
concentrations of 1.5 – 2%, will enhance the physical
stability of 0.17 – 0.62% olopatadine solutions.
Each of the claims also explicitly noted certain substances that
were excluded from the claimed formulations ("excluded
substances"). The Court considered whether these excluded
substances were promised to not enhance physical stability. Alcon
submitted that this formed part of the inventive concept but not
the promise of the patent. The Court held that it was
"incongruous" to argue that this element made the
invention inventive, yet was not promised.
After a detailed analysis of the experimental data reported in
the 924 Patent and the expert testimony, Justice Gleason held that
experimental results disclosed in the '924 Patent did not
demonstrate or soundly predict that the use of PVP across the whole
range of molecular weights claimed would enhance the physical
stability of the olopatadine solutions as promised. The Court noted
the lack of evidence regarding how many points along the claimed
molecular weight range need to be tested in order to demonstrate
utility across the whole range. The testimony of Alcon's expert
was also found wanting in that the expert provided "no
discernable scientific basis for the prediction of utility across
the entire claimed range." To the contrary, Alcon's expert
opined that physical stability is a random and unpredictable
For similar reasons, the Court held that the 924 Patent was
overly broad for promising more than it could demonstrate or
soundly predict. As a result, the Court dismissed Alcon's
application and Cobalt received its Notice of Compliance.
Accordingly, no appeal lies from this decision.
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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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