The Federal Court of Appeal has upheld the first trial judgment under the new Patented Medicines (Notice of Compliance) Regulations. In Amgen Inc v Pfizer Canada ULC, 2020 FCA 188, the Court dismissed Amgen’s appeal from the Federal Court’s decision declaring certain claims in Amgen’s Canadian Patent No. 1,341,537 (537 Patent) invalid for obviousness. The … Continue reading
On October 29, 2020, the Federal Court ordered the Minister of Health to immediately issue a notice of compliance (NOC) for a biosimilar drug following a dispute about the effective date of a consent letter under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court held the Minister acted unreasonably in refusing to … Continue reading
The 14 year perindopril litigation in Canada is over, with Adir and Servier Canada Inc. (collectively “Servier”) emerging victorious against Apotex Inc. and Apotex Pharmachem Inc. (collectively “Apotex”). The end was marked by the Supreme Court of Canada’s dismissal of Apotex’s application for leave to appeal a decision requiring it to disgorge its profits associated … Continue reading
On October 22, 2020, the Federal Court (FC) issued new Case and Trial Management Guidelines for Complex Proceedings (the FC Guidelines). These new consolidated FC Guidelines address many of the topics raised in the following earlier FC Notices to the Profession: Case management: Increased Proportionality in Complex Litigation before the Federal Court (June 24, 2015); … Continue reading
On Friday, October 23, the Patented Medicine Prices Review Board (PMPRB) released final Guidelines that are intended to take effect on January 1, 2021, together with the scheduled coming-into-force of amendments to the Patented Medicines Regulations (the Amendments). According to the PMPRB: The Guidelines provide information on the PMPRB’s general approach to the price review … Continue reading
The recently published Ninth Edition of the Intellectual Property Review (the Review) includes a chapter detailing the various forms of IP protection available in Canada, and highlights important changes in Canadian IP law over the past year. The chapter was authored by members of the Pharma in Brief team. The chapter also provides an overview … Continue reading
On July 10, 2020, the Federal Court issued a decision in a judicial review under the Certificate of Supplementary Protection Regulations (CSP Regulations). The application was brought by ViiV Healthcare ULC (ViiV) regarding a decision by the Minister of Health (Minister) refusing to issue a CSP in respect of Canadian Patent No. 2,606,282 (282 Patent) … Continue reading
The Patented Medicine Prices Review Board (PMPRB or Board) has found that a patent can pertain to a medicine based on clinical similarities to the invention—even if the patent does not actually encompass the medicine. Background This case concerns Canadian Patent No. 2,478,237 (the 237 Patent), which relates to the use of adapalene to treat … Continue reading
On June 25, 2020, the Federal Court (FC) issued its latest Practice Direction and Order (FC Update) regarding Court operations during the pandemic, announcing that its Suspension Period will no longer be in force anywhere in Canada as of June 30, 2020. The FC Update also establishes guidelines for the transition toward more regular operations … Continue reading
On June 19, 2020, the Patented Medicine Prices Review Board (PMPRB) launched its consultation on revised Draft Guidelines to implement the amended Patented Medicines Regulations. The revised Guidelines outline new price tests for existing and new patented medicines, as well as a revised risk-based system for reporting and investigations. They will be available for public … Continue reading
On May 22, 2020, the Federal Court granted a motion seeking an order that the issue of infringement in an action brought pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations (Regulations) would not be moot notwithstanding that the trial was set to proceed after the expiry of the relevant patent. Background … Continue reading
This week has seen a number of developments relating to the Patented Medicine Prices Review Board (PMPRB), including a six-month delay to the implementation of amendments to the Patented Medicines Regulations and renewed consultation by the Board on revised Draft Guidelines to implement those amendments. Meanwhile, the Federal Court is now considering a judicial review … Continue reading
The Federal Court has dismissed two infringement actions brought against defendants under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations), following a common trial on the validity of Canadian Patent No. 2,562,277 (277 Patent). The Court found that all the asserted claims – to uses for treating multiple sclerosis (MS) – were … Continue reading
The Federal Court of Canada has embraced virtual hearings as the best solution to the prolonged Covid-19 shutdown. While acknowledging some litigants’ concerns pertaining to procedural fairness and information security in recent rulings, the Court is more concerned that justice delayed can become justice denied. Videoconferencing will not impede the Court’s ability to assess the … Continue reading
In the second trial judgment under the new Patented Medicine (Notice of Compliance) Regulations, the Federal Court (FC) found for the Plaintiffs, Janssen Inc. and Janssen Pharmaceutica N.V., and enjoined Teva Canada Limited (Teva) from making, constructing, using or selling paliperidone palmitate (paliperidone) in accordance with its abbreviated new drug submission. The Court rejected Teva’s … Continue reading
The Federal Court of Appeal has reversed the Federal Court’s decision to add two additional generic defendants (Taro Pharmaceuticals Inc. and Sandoz Canada Inc.) to an upcoming common trial under the Patented Medicines (Notice of Compliance) Regulations. The common trial will determine patent validity issues in Bayer Inc.’s actions against Teva Canada limited and Apotex … Continue reading
This week, the Federal Court of Appeal (FCA) extended its Suspension Period and the Canadian Intellectual Property Office (CIPO) extended its deadlines, both until the end of May. Federal Court of Appeal As we reported, the FCA has issued a number of Notices to the Parties and the Profession concerning the conduct of litigation during … Continue reading
On April 29, 2020, the Federal Court (FC) published a Practice Direction and Order (FC Update) extending its Suspension Period until May 29, 2020 and adjourning hearings until June 29, 2020—subject to certain exceptions. During this time, the Court has made provisions to hold certain hearings by phone or Zoom videoconference. The FC Update is … Continue reading
Key Contacts: Jeffrey Lewis (New York), Jenny Shum (New York), Clemens Rubel (Munich), Seiko Hidaka (London), Justin Davidson (Hong Kong SAR), Jackie O’Brien (Sydney) Around the globe, pharmaceutical and medical device companies are helping in the fight of the COVID-19 pandemic. Many of these companies may have patents pertaining to technology that could be used … Continue reading
The Federal Court of Appeal (FCA) has decided that the Federal Court’s Notice to the Profession regarding experimental testing (the Notice) does not apply to testing conducted in advance of litigation. As a result, parties wishing to lead evidence of pre-litigation testing at trial are not required to obtain leave of the Court. Background This … Continue reading
The Federal Court has released its first trial judgment in an action brought under the new Patented Medicines (Notice of Compliance) Regulations. In Amgen Inc v Pfizer Canada ULC, 2020 FC 522, the Court dismissed Amgen’s action and declared certain claims in Canadian Patent No. 1,341,537 (537 Patent) invalid for obviousness. The action related to … Continue reading
On April 15, 2020, the Federal Court of Appeal (FCA) published an updated Notice to the Parties and the Profession (FCA Update). As we previously reported, the FCA suspended the running of time under the Federal Courts Rules (the Rules) to May 15, 2020 (the Suspension Period). The FCA Update advises that circumstances permit the … Continue reading
On April 7, 2020, the Federal Court issued a decision in Canada’s first judicial review under the Patent Act and new Certificate of Supplementary Protection Regulations (CSP Regulations). It is the first decision issued under this regime, and also one of the first decisions to apply the Supreme Court of Canada’s new standard of review … Continue reading
Canada has completed domestic ratification of the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA or new NAFTA). As we reported, Canada introduced Bill C-4 to implement CUSMA on January 29, 2020 and it received royal assent as the Canada-United States-Mexico Agreement Implementation Act (CUSMA Implementation Act) on March 13, 2020. No coming-into-force date … Continue reading