The first court action under the newly amended Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) was commenced on December 11, 2017. Genentech, Inc. and Hoffmann-La Roche Limited v Amgen Canada Inc. (T-1921-17) addresses allegations of infringement with respect to Canadian Patent Nos. 2,376,596; 2,596,133; 2,407,556 and 2,540,547 and a biosimilar new drug submission for trastuzumab. Trastuzumab is marketed by Hoffmann-La Roche Limited under the brand name PrHERCEPTIN®.
Norton Rose Fulbright Canada LLP is representing the innovator plaintiffs.
As we reported, the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act (CETA Act) and accompanying regulations came into force on September 21, 2017. The CETA amendments provide key reforms to the Patent Act affecting the pharmaceutical industry, including a new pharmaceutical patent litigation regime under the PM(NOC) Regulations. Proceedings previously conducted as summary applications will now proceed as actions while the confines of the 24-month statutory stay remain unchanged.
The new PM(NOC) Regulations apply to matters where a notice of allegation is served on or after September 21, 2017.
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