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23 May 2018
On February 21 2018 Justice O'Reilly granted Collegium Pharmaceutical's motion to strike Purdue Pharma's statement of claim for infringement of a patent relating to oxycodone salt (Purdue's OxyNEO).(1) The court overturned the prothonotary's dismissal of the motion, finding that the facts alleged nothing beyond the regulatory use exemption and that the imminence branch of the test for a quia timet action had not been met; Purdue's allegations merely suggested that Collegium was attempting to meet Canadian regulatory requirements, and did not contemplate when Collegium might obtain a notice of compliance.
Purdue's action was brought in parallel with an application under the pre-amended Patented Medicine (Notice of Compliance) (PMNOC) Regulations. The amended PMNOC Regulations (for further details please see "Publication of final regulations on patent linkage and term restoration relating to CETA") will now effectively allow for quia timet actions by permitting a patent owner who receives a notice of allegation to bring an action for infringement of patents not covered by the notice of allegation, but which could be infringed by the generic drug.
For further information on this topic please contact Abigail Smith at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar website can be accessed at www.smart-biggar.ca.
(1) Purdue Pharma v Collegium Pharmaceutical, 2018 FC 199.
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