Pharma in Brief: The 2022 Year in Review

Does 2022 already seem like a blur? The Pharma in Brief team is here for you with a summary of some of 2022’s most significant legal and regulatory developments in the Canadian pharmaceutical space. We also flag what to watch out for in 2023.    The most significant legislative changes concerned the Patent Act and … Continue reading

Health Canada consulting on wide-ranging regulatory amendments for drugs and medical devices

Health Canada has launched a consultation on proposed amendments to the Food and Drug Regulations and Medical Devices Regulations (the Regulatory Amendments). Consultation on the Regulatory Amendments, which have been published in the Canada Gazette, Part 1, is open until March 27, 2023. The Regulatory Amendments build upon the regulatory flexibilities introduced in the Interim … Continue reading

Federal Court of Appeal overturns judicial review decision in data protection dispute

The Federal Court of Appeal (FCA) has overturned a decision of the Federal Court (FC) that found the Minister of Health’s (Minister) analysis of the data protection provisions of the Food and Drug Regulations unreasonable. The FCA restored the Minister’s decision granting an NOC to Médunik Canada (Médunik) for its amifampridine product, RUZURGI. Background Catalyst … Continue reading

Ontario introduces biosimilar transition policy

On December 20, 2022, the government of Ontario announced a new policy to expand the use of biosimilar drugs in the province. Patients receiving coverage under the Ontario Drug Benefit (ODB) program for eight originator biologic drugs will be required to transition to the biosimilar version by December 29, 2023.  During the transition period from … Continue reading

Federal Court of Appeal issues decision in industry challenge to the PMPRB Patented Medicines Regulations

On December 5, 2022, the Federal Court of Appeal (FCA) upheld the validity of changes to the list of countries used for international reference pricing by the Patented Medicine Prices Review Board (PMPRB). This new schedule of countries, known as the PMPRB11, removes the United States and Switzerland while adding six lower-price jurisdictions.[i] The FCA … Continue reading

PMPRB issues excessive price order on rare disease drug

The Patented Medicine Prices Review Board (PMPRB) has issued a decision that Procysbi (cysteamine bitartrate) is being sold at an “excessive” price. The PMPRB ordered the manufacturer, Horizon Pharma PLC (Horizon), to reduce its price and pay excess revenues to the Crown. In its decision, the Board applied the Guidelines to determine the price ceiling … Continue reading

24-month stay extended under the PM(NOC) Regulations for late pleadings amendment

In a recent pleadings amendment motion under the Patented Medicines (Notice of Compliance) Regulations (the Regulations), the Federal Court gave the generic a choice: either (a) abandon proposed new grounds of invalidity or (b) accept that the scheduled trial date will be adjourned, with a commensurate extension of the 24-month statutory stay preventing approval of … Continue reading

Generic not required to address Patent Register when reference innovator drug is no longer marketed in Canada

On August 17, 2022, the Federal Court dismissed applications for judicial review regarding the product-specificity requirements for addressing patents listed on the Patent Register under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). Background This case concerns biosimilar presentations of an AbbVie Corporation and AbbVie Biotechnology Ltd. (collectively, AbbVie) product, HUMIRA (adalimumab), sought to … Continue reading

PMPRB round-up: report on current reforms

In this post, we summarize the current status of reforms to the Patented Medicine Prices Review Board (PMPRB). These reforms commenced with August 2019 amendments to the Patented Medicines Regulations (the Amendments) and accompanying changes to the Board’s Guidelines. Background of the proposed reforms The Amendments were intended to lower the prices of patented medicines … Continue reading

ONCA Confirms Generics Limited to Section 8 Damages in the Face of an Innovator’s Legitimate Exercise of Rights under the PM(NOC) Regulations

On August 16, 2022, the Ontario Court of Appeal (ONCA) released its decision in Apotex Inc. v. Eli Lilly Canada Inc., 2022 ONCA 587.  The ONCA denied Apotex’s appeal of a lower court summary judgement decision that dismissed Apotex’s novel claims under the UK and Ontario Statutes of Monopolies, the Trademarks Act, and at common law (see … Continue reading
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