On 20 August 2018, the Federal Court dismissed Valeant's application under the Patented Medicines (Notice of Compliance) Regulations regarding Ranbaxy's bupropion extended-release tablets (Valeant's Wellbutrin XL) and Patent 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). 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 to be justified.

For further information on this topic please contact Tierney GB Deluzio at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.

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