We previously reported that amendments to the Patented Medicines Notice of Compliance Regulations (PM(NOC) Regulations) came into force on September 21, 2017. The Amendments replace summary applications with “fast-track” full actions resulting in final determinations of patent validity and infringement while keeping the 24-month statutory stay. The Amendments apply to notices of allegation served on innovators (called the “first person”) on or after September 21, 2017.

To date, four actions, all relating to trastuzumab (HERCEPTIN®) marketed by Hoffmann-La Roche Limited, have been commenced under the amended PM(NOC) Regulations:

1.      Genentech, Inc and Hoffmann-La Roche Limited v Amgen Canada Inc (T-1921-17), commenced on December 11, 2017 and scheduled to be heard beginning on August 12, 2019; and

2-4.   Genentech, Inc and Hoffmann-La Roche Limited v Celltrion Healthcare Co Ltd (T-1969-17, T-1970-17 and T-1971-17), all commenced on December 18, 2017 and scheduled to be heard beginning on September 9, 2019.

Summary By: Junyi Chen

E-TIPS® ISSUE

18 01 24

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