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Federal Court dismisses Servier’s application for order of prohibition regarding salt patent for perindopril arginine

On May 8, 2019, Justice Roy dismissed Servier’s application for a prohibition order under the pre-amended Patented Medicines (Notice of Compliance) Regulations for Canadian Patent No. 2,423,825 (825 Patent) and perindopril arginine/amlodipine product (Servier’s VIACORAM): Les Laboratoires Servier v Apotex Inc, 2019 FC 616. Apotex had alleged that the patent was invalid for obviousness, overbreadth, inutility and insufficiency. The 825 Patent claimed the arginine salt of perindopril and its hydrates.

The Federal Court held that the allegations of inutility and insufficiency were not justified. However, Justice Roy dismissed the application, finding that Apotex’s allegations of obviousness and overbreadth were justified. With respect to overbreadth, the Court construed the claims to include all forms of arginine and its hydrates, whereas (1) the inventors had only ever made the perindopril salt with the naturally occurring form, L-arginine; and (2) the inventors did not have reason to believe that a hydrate of perindopril arginine could form. Based on these findings, Justice Roy found that the Servier had not discharged its burden of disproving the allegation that the claims were broader than the invention. With respect to obviousness, the Court found that arginine salts were known, and that a skilled person would have known that a structured salt screen conducted to search for a solution to the stability issues of the known salt, perindopril erbumine, would have been available by the filing date.