Federal Court finds Minister of Health’s refusal to grant CSP based on the “Timely Submission Requirement” unreasonable

SUMMARY The Federal Court has granted Merck Canada Inc.’s (Merck) application for judicial review of a decision of the Minister of Health (Minister) denying a Certificate of Supplementary Protection (CSP) for Canadian Patent No. 2,670,892 (892 Patent) and the drug BELSOMRA (suvorexant). BACKGROUND A CSP provides patent-like rights and is intended to compensate patentees for … Continue reading

Canada seeks leave to appeal to the Supreme Court in PMPRB excessive-pricing case

The Attorney General of Canada has sought leave to appeal to the Supreme Court in an excessive-pricing case regarding the drug SOLIRIS. As we reported, Alexion Pharmaceuticals Inc. was successful before the Federal Court of Appeal in an application for judicial review of a 2017 PMPRB decision finding that Alexion had sold SOLIRIS at an … Continue reading

ONSC dismisses Apotex’s second monopolies action

The Ontario Superior Court of Justice has released the second decision in a series of summary judgment motions relating to Apotex’s claims against innovative drug companies under various causes of action pursued above and beyond the section 8 damages regime in the Patented Medicines (Notice of Compliance) Regulations. In Apotex Inc. v. Pfizer Ireland Pharmaceuticals, … Continue reading

Health Canada reports on a national strategy for rare disease drugs

Health Canada has published a report on its public consultation on building a national strategy to address access to drugs for rare diseases. This report follows the Government of Canada’s commitment to create a national strategy for drugs for rare diseases based on recommendations made by the Advisory Council on the Implementation of National Pharmacare. … Continue reading

Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations (FDR) and the Medical Devices Regulations in the spring of 2022. The proposed amendments are intended to modernize the Canadian therapeutic product regulatory system at every stage of products’ lifecycles from authorization to post-market. … Continue reading

PMPRB excessive price decision quashed by Federal Court of Appeal

The Federal Court of Appeal has quashed an excessive-price decision of the Patented Medicine Prices Review Board (PMPRB) in a proceeding concerning the drug SOLIRIS. The matter has been remitted to the PMPRB for redetermination. Procedural background The PMPRB issued a decision in 2017 finding that Alexion Pharmaceuticals Inc. sold SOLIRIS (eculizumab) at an excessive … Continue reading

CADTH convenes Advisory Panel on a pan-Canadian prescription drug list

CADTH has convened a pan-Canadian Advisory Panel on a Framework for a Prescription Drug List (the Panel). The Panel will provide recommendations on developing a potential pan-Canadian prescription drug list (or formulary). Stakeholder consultations are scheduled to take place in the fall and winter of 2021, leading to a final public report setting out the … Continue reading

PMPRB Guidelines update: consultation on changes re delayed implementation

The Patented Medicine Prices Review Board (PMPRB) has launched a consultation on proposed changes to its new Guidelines (the New Guidelines). These changes include revisions to the price tests for some medicines marketed prior to the anticipated coming-into-force date of the New Guidelines. The PMPRB has indicated that these changes are intended to account for … Continue reading

Certain COVID-19 medical devices no longer hold urgent public health need status under Interim Order No. 2

Health Canada has issued a notice explaining a policy change to the review of applications for COVID-19 medical devices. As of July 16, 2021, Health Canada is no longer accepting applications for certain categories of medical devices under Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO … Continue reading

Consultation on proposed amendments to Patent Rules

The Government of Canada has proposed a series of amendments to the Patent Rules intended to keep Canada compliant with its obligations under the Canada-United States-Mexico Agreement (CUSMA) and the Patent Cooperation Treaty (PCT). As part of the proposal, the Canada Gazette published a Regulatory Impact Analysis Statement on July 3, 2021, summarizing the changes and their anticipated impact. Interested persons have … Continue reading
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