The Federal Court granted leave to the United States of America (USA), in its capacity as co-owner of a patent, to file its own pleading in an action under s 6(1) of the Patented Medicines (Notice of Compliance)
PMPRB extends consultation on new Draft Guidelines implementing amendments to the Patented Medicines Regulations
The Patented Medicine Prices Review aboard (PMPRB) has extended the deadline for written submissions on new Draft Guidelines until January 31, 2020. Originally, the consultation was scheduled to run until January 20, 2020.
Background
PMPRB launches 60-day consultation on new Draft Guidelines following amendments to the Patented Medicines Regulations
Today, the PMPRB launched a consultation on Draft Guidelines intended to implement recent amendments to the Patented Medicines Regulations. The PMPRB also released a Q&A-style Consultation Backgrounder. Interested parties have 60 days, until January 20, 2020, to make
Federal Court of Appeal applies holistic approach to the “palpable and overriding error” standard of review
The Federal Court of Appeal has provided a detailed review of the proper approach to identifying palpable and overriding errors of fact or mixed fact and law in an appeal concerning the obviousness of two patents. The Court of Appeal
Federal Court relies on foreign prosecution history in first application of file wrapper estoppel
In CanMar Foods Ltd. v TA Foods Ltd., 2019 FC 1233, the Federal Court interpreted and applied the new file wrapper estoppel provision, section 53.1 of the Patent Act, RSC 1985, c P-4, for the first time.
Government releases final amendments to the PMPRB’s Patented Medicines Regulations to lower the prices of patented medicines
The Government is moving forward with changes to the PMPRB intended to lower the prices of patented medicines in Canada in order to lay the foundation for National Pharmacare. The changes are set out in final amendments to the Patented
Federal Court of Appeal agrees that the PMPRB incorrectly applied the patent-pertaining analysis
The Federal Court of Appeal has provided new guidance on the proper approach to the “patent pertaining” analysis used by the Patented Medicine Prices Review Board (PMPRB or Board), including on the identification of the medicine and the
Competition Bureau publishes Final IP Enforcement Guidelines
On March 13, the Competition Bureau published a revised version of its IP Enforcement Guidelines (IPEGs). The IPEGs clarify the Bureau’s approach to conducting investigations of alleged anti-competitive activities that involve IP, including settlement of pharmaceutical patent litigation
Federal Court of Appeal upholds Health Canada’s requirement for additional information on testing data integrity
The Federal Court of Appeal (FCA) has dismissed Apotex’s appeal arising from its application to end Health Canada’s requirement for additional information establishing the integrity of data from Indian drug manufacturing facilities. The FCA found that the Federal
Federal Court upholds patent validity and grants prohibition order against generic lisdexamfetamine in pre-CETA PM(NOC) application
The Federal Court dismissed Apotex’s action to invalidate the claims of Canadian Patent No. 2,527,646 (the 646 Patent), which was consolidated with Shire’s application to prohibit the Minister of Health from issuing a Notice of Compliance for Apotex’s generic