Kristin Wall

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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

Federal Court of Appeal upholds decision invalidating claims to multiple sclerosis treatment regimen

The Federal Court of Appeal (FCA) has dismissed appeals concerning two actions brought under the Patented Medicines (Notice of Compliance) Regulations (Regulations), confirming the Federal Court (FC) holding that claims to uses of the molecule fampridine were invalid. The FCA’s decision provides guidance on claims construction and analyzing obviousness, while pointedly refusing to endorse the FC’s … Continue reading

FCA upholds selection patent protecting apixaban and rejects that a second patented invention was obvious to try

The Federal Court of Appeal (FCA) has dismissed an appeal concerning four actions related to the molecule apixaban under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The Federal Court (FC) found the patents at issue to be valid. Background Bristol-Myers Squibb Canada Co. (BMS) markets ELIQUIS® (apixaban) in Canada for the treatment of thrombosis. … Continue reading

2022 Guide to Canada’s Pharmaceutical Intellectual Property Regime

Our 2022 Guide to Canada’s Pharmaceutical Intellectual Property Regime is a convenient all-in-one reference to the important legal and regulatory regimes governing pharmaceuticals in Canada. The Guide provides a detailed review of the key regimes, including: Data protection market exclusivity; The Patented Medicines (Notice of Compliance) Regulations (PMNOC), linking generic market access to patent rights; … Continue reading

Federal Court finds generic would induce infringement of combination therapy patent

The Federal Court has allowed a second infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court found that the defendant would induce infringement of claims relating to combination treatment if it were allowed to market its macitentan product. Background Janssen Inc. markets OPSUMIT® (macitentan) to treat patients … Continue reading

Government of Canada invests in clinical trial development in Canada through the Clinical Trials Fund

On June 22, 2022, the Canadian Institutes of Health Research (CIHR) announced the launch of the Clinical Trials Fund (CTF), which will inject funding into Canada’s clinical trials environment. The government’s goals include reinforcing Canada’s clinical trials infrastructure so as to improve the health and safety of all Canadians while also ensuring that Canada is … Continue reading

Federal Court finds a combination therapy patent valid and infringed

The Federal Court has allowed an infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations that the asserted patent claims were invalid for obviousness, lack of utility, overbreadth, and insufficiency of disclosure. Background Janssen Inc. (Janssen) markets OPSUMIT® in Canada for the treatment of pulmonary arterial … Continue reading

Overview of IP Law in Canada – The Intellectual Property Review, 11th Edition

The recently published Eleventh Edition of the Intellectual Property Review (the Review) includes a Canadian chapter. Readers are invited to learn more on the various forms of IP protection available in Canada, and highlights of important changes in Canadian IP law over the past year. The chapter was authored by members of the Pharma in Brief team. The chapter … Continue reading

Federal Court sends NOC dispute concerning data protection provisions back to the Minister for a second redetermination

The Federal Court (FC) has granted an application for judicial review involving the data protection provisions in section C.08.004.1 of the Food and Drug Regulations in a case involving new drug submissions (NDSs) for two different amifampridine products. This is the second time that the FC has set aside a decision to issue a notice … Continue reading

New interim order continues expedited authorization pathway for COVID-19 medical devices

The Minister of Health has issued a new interim order regarding expedited authorizations for COVID-19-related medical devices. Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 3) maintains all of the flexibilities of its predecessor, including the consideration of urgent public health needs (UPHN). … Continue reading

Federal Court finds patent valid, but rejects infringement claims in a PM(NOC) action regarding risedronate

The Federal Court has decided an infringement action concerning risedronate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations of anticipation based on prior art, as well as arguments that the asserted claims were invalid due to lack of demonstrated utility, insufficiency of disclosure, and/or overbreadth. However, the Court … Continue reading

CADTH advisory panel consults on framework for pan-Canadian formulary

In a recently published discussion paper, an Advisory Panel (the Panel) convened by the Canadian Agency for Drugs and Technologies in Health (CADTH) presents a proposed framework for a potential pan-Canadian formulary. The Panel is asking for feedback on the framework with an online questionnaire.  The feedback will inform a stakeholder session in spring 2022 … Continue reading

FCA upholds patent validity, rejects argument that a soundly predicted invention must be obvious

The Federal Court of Appeal (FCA) has affirmed a decision of the Federal Court (FC) finding that a patent concerning glatiramer acetate (GA) is valid and would be infringed under the Patented Medicines (Notice of Compliance) Regulations. Background As we previously reported, the FC decision concerned allegations by Teva Canada Innovation and Teva Canada Limited … Continue reading

Pharma in Brief: The 2021 Year in Review

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021. Introduction In 2021, governments advanced major policy initiatives aimed at the COVID-19 pandemic and broader health priorities. These policy initiatives included reforms to the Patented Medicine Prices Review Board (PMPRB), the Patented Medicines … Continue reading

PMPRB Update: further-delayed implementation of Patented Medicines Regulations amendments and new Guidelines

Changes to the Patented Medicine Prices Review Board (PMPRB) regime, contained in pending amendments to the Patented Medicines Regulations, have been delayed until July 1, 2022. These amendments form the basis for new PMPRB Guidelines. The PMPRB has updated its website to indicate that the new Guidelines will be in place as of the coming-into-force … Continue reading

PMPRB will not proceed with proposed July 15, 2021 changes to its new Guidelines

The Patented Medicine Prices Review Board (PMPRB) has announced that it will not proceed with changes to its new Guidelines that were proposed in a July 15, 2021 Notice and Comment. As we reported, these changes would have affected the definition of “Gap” medicine, references to the PMPRB11 basket of comparator countries, and the price … Continue reading

Federal Court of Appeal provides guidance on disclosure exemptions in ATI requests

The Federal Court of Appeal (FCA) has set aside a decision of the Federal Court (FC), which had invalidated Health Canada’s decision to disclose records in response to a request (ATI Request) made pursuant to the Access to Information Act (the Act). The FCA remitted the matter to the FC for redetermination. Procedural Background As … Continue reading

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

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
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