As we reported, Canada implemented a single-track pharmaceutical patent litigation regime through amendments to the Patented Medicines (Notice of Compliance) Regulations (the Regulations) on September 21, 2017. Below, we provide an update on new actions and decisions under the amended Regulations.
New actions under the amended Regulations
Nearly seven months after the amended Regulations came into force, litigation is gathering steam. As we reported, the first action under the new regime was commenced by Norton Rose Fulbright Canada LLP on behalf of Genentech, Inc. and Hoffmann-La Roche Limited (collectively, Genentech) in respect of trastuzumab biosimilars on December 11, 2017. This was followed by three more trastuzumab-related actions in late December 2017.
Since the beginning of 2018, ten more actions have been commenced, for a total of fourteen actions currently ongoing:
- Genentech, Inc. et al. v Amgen Canada Inc., Court File No. T-1921-17 (trastuzumab)
- Genentech, Inc. et al. v Celltrion Healthcare Co., Ltd., Court Files No. T-1969-17, T-1970-17, and T-1971-17 (trastuzumab)
- Bristol-Myers Squibb Canada Co. et al. v Apotex Inc., Court Files No. T-350-18 and T-351-18 (apixaban)
- Janssen Inc. et al. v Teva Canada Limited, Court File No. T-353-18 (paliperidone)
- Hoffmann-La Roche Limited et al. v Pfizer Canada Inc., Court Files No. T-401-18 and T-402-18 (trastuzumab)
- Allergan et al. v Tillots Pharma AG, Court File No. T-503-18 (mesalamine)
- Shire LLC et al. v Apotex Inc., Court File No. T-641-18 (lisdexamfetamine)
- Bayer Inc. v. Jamp Pharma Corp., Court File No. T-666-18 (vardenafil)
- Eli Lilly et al v Apotex Inc., Court File No. T-724-18 (teriparatide)
- Amgen Inc. et al v. Pfizer Canada Inc., T-741-18 (filgrastim)
In order to manage the significantly increased number of deadlines in actions under the amended Regulations compared to applications under the former regime, the Court has applied its “Guidelines for Actions under the Amended PMNOC Regulations”, reported here. This includes early scheduling of the steps leading up to trial using a checklist developed by the Court, early assignment of trial judges, and early booking of trial dates to occur within 21 months of the statement of claim being filed.
Two motions have been decided under the amended Regulations. The court dismissed a motion to vary unilaterally imposed confidentiality rules as premature. The court also dismissed a motion to stay a 6.08 motion until after discovery.
- Genentech Inc. v Pfizer Canada Inc., 2018 FC 233
- Genentech, Inc. v Amgen Canada Inc., 2018 FC 303
- Patented Medicines (Notice of Compliance) Regulations, SOR/93-133
- Guidelines for Actions under the Amended PMNOC Regulations