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Global | Publication | December 2016
Case: Meda AB v Pharmascience Inc, 2016 FC 1362 (T-200-15)
Drug: SUBLINOX® (zolpidem tartrate sublingual orally disintegrating tablets)
Nature of case: Prohibition application pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations)
Successful party: Pharmascience Inc. (Pharmascience)
Date of decision: December 9, 2016
Valeant Canada LP/Valeant Canada S.E.C. markets SUBLINOX® (zolpidem tartrate sublingual orally disintegrating tablets) in Canada for the treatment of insomnia.
Pharmascience sought approval for a generic version of SUBLINOX® and was opposed by Valeant, which asserted Canadian Patent No. 2,629,988 (the 988 Patent) under section 6 of the Regulations. The court found in favour of Valeant on the validity of all but one of the claims in issue, but held that Valeant failed to rebut Pharmascience’s non-infringement allegations. As a result, the court dismissed the application.
The 988 Patent claims rapid-onset sublingual pharmaceutical compositions for treating the acute disorder insomnia, involving ordered mixtures and bio/mucoadhesives, a method for making such compositions, and their use in the manufacture of a medicament. Pharmascience alleged that the patent was invalid for anticipation, inutility, obviousness, and overbreadth and that its proposed generic product, PMS-zolpidem, will not infringe the patent.
The court relied upon the experts for the construction of “bio/mucoadhesive promoting agent” and “ordered mixtures,” both essential elements of all the claims. In reaching its construction, the court rejected Pharmascience’s argument that statements made in the prosecution of a corresponding European patent application regarding the meaning of one of these terms should be taken as an admission against interest in this case. The court held that the file history of the Canadian patent, and any corresponding foreign patent, is inadmissible for purposes of construction or as part of the common general knowledge.
Pharmascience argued that PMS-zolpidem contains neither an ordered mixture nor a bio/mucoadhesive component. Relying upon an analysis that was largely redacted in the public reasons for judgment, the court held that PMS-zolpidem did not contain an ordered mixture.
Meda AB v Pharmascience Inc.,2016 FC 1362
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