Higher costs awards for Federal Court litigation are on the horizon, with the Canadian government consulting on proposed amendments to the costs structure in the Federal Courts Rules (the Rules). The proposed amendments are intended to increase costs awards
Governmental Use of Patented Inventions during a Pandemic: A Global Survey
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
New Federal initiatives to combat pandemic: Patent Act amended to allow limited government use of patented inventions for public health emergencies
On March 25, 2020, the Canadian Government passed into law Bill C-13, An Act respecting certain measures in response to COVID-19, following emergency sittings of Parliament and the Senate. Bill C-13 amends both the Patent Act and the Food
Two generics, one hearing: Federal Court orders common trial on patent validity issues in section 6 actions
The Federal Court has ordered that the trial of two actions brought under the post-CETA Patented Medicines (Notice of Compliance) Regulations (the Regulations), against two separate generics, be heard concurrently, on issues of invalidity. This decision highlights the Federal
First motion for early patent dismissal fails to meet high burden under newly-amended PM(NOC) Regulations
On July 6, 2018, the Federal Court dismissed the first motion brought under section 6.08 of the newly-amended Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court’s public reasons were released July 30, 2018. The moving party, Amgen
CADTH releases updated guidelines for biosimilars
The CADTH Common Drug Review Procedure and Submission Guidelines for Biosimilars (Non-Cancer) and the CADTH pan-Canadian Oncology Drug Review Submission Guidelines for Biosimilars (Cancer) provide an overview of the Common Drug Review procedures and guidance to applicants for biosimilar submissions.
Federal Court of Appeal affirms that the Patent Act’s price control provisions over patented medicines were validly enacted
The Federal Court of Appeal has reaffirmed the constitutionality of the excessive price provisions of the Patent Act that ground the jurisdiction of the Patented Medicine Prices Review Board (PMPRB) over patented medicines.
Background
In 2015, the PMPRB
PMPRB applies unknown test against patentee to make excessive-pricing order outside of the Guidelines
The Patented Medicine Prices Review Board (PMPRB) has issued an excessive-pricing order against Alexion Pharmaceuticals Inc. (Alexion) in respect of SOLIRIS (eculizumab) based on the application of a Lowest International Price Comparison (LIPC) test.
CETA Tracker: Pharmaceutical patent reform to be provisionally implemented in September 2017
As we reported, the Canadian government has approved changes to Canada’s pharmaceutical patent regime, including the introduction of patent term restoration and the replacement of the current summary proceedings under the Patented Medicines (Notice of Compliance) Regulations with full
CETA Tracker: Delays for the implementation of pharmaceutical patent reform
As we reported, the Canadian government has approved changes to Canada’s pharmaceutical patent regime, including the introduction of patent term restoration and the replacement of the current summary proceedings under the Patented Medicines (Notice of Compliance) Regulations with full