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On August 20, 2018, the Federal Court dismissed Valeant's PMNOC application regarding Ranbaxy's bupropion extended-release tablets and Patent No. 2,524,300.
On August 20, 2018, the Federal Court dismissed Valeant's
PMNOC application regarding Ranbaxy's
bupropion extended-release tablets (Valeant's
WELLBUTRIN XL) and Patent No. 2,524,300. Justice McVeigh held that
Ranbaxy's allegation of non-infringement was justified:
Valeant Canada LP v Ranbaxy Pharmaceuticals Canada Inc.,
2018 FC 847. Justice McVeigh found that
"permeation enhancer" in the amount of "about 20% to
about 40% of the moisture barrier dry weight" is an essential
element, construed "permeation enhancer" to exclude
polyethylene glycol and triethyl citrate, and construed
"about" to mean a range of plus or minus 10%. Therefore,
the amount of permeation enhancer in the Ranbaxy formulation was
outside the scope of the range claimed and Ranbaxy's allegation
of non-infringement was found justified.
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