Sarah Pennington

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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

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

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

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

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

Food and Drug Regulations amended: COVID-19 drugs and vaccines transitioned out of interim order framework

The Food and Drug Regulations (FDR) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance (NOC) under the FDR. Certain provisions of the amendments came into force on March 18, 2021, while others will come into force on … Continue reading

Health Canada consults on proposed guidelines for the use of electronic media in prescription drug labelling

Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. The intent of the draft guidance document is to describe Health Canada’s expectations for manufacturers who distribute prescription drug information through an electronic means, such as a website or mobile … Continue reading

Federal Court of Appeal upholds one of the last prohibition orders under the old PM(NOC) Regulations

The Federal Court of Appeal has affirmed one of the last judgments granting a prohibition order under subsection 6(1) of the pre-September 2017 Patented Medicines (Notice of Compliance) Regulations (the PM(NOC) Regulations). The Court of Appeal upheld the prohibition order despite a decision in a subsequent action under the amended PM(NOC) Regulations finding that the … Continue reading

Bill C-213, An Act to enact the Canada Pharmacare Act: rejected by Parliament

On February 24, 2021, Parliament voted down Bill C-213, which would have enacted the Canada Pharmacare Act. The Private Member’s Bill was first introduced a year ago, re-introduced in September 2020 after Parliament’s prorogation, and defeated at Second Reading. The Canada Pharmacare Act set out a series of criteria and conditions that would have been … Continue reading

Divided success in PM(NOC) actions regarding glatiramer acetate

The Federal Court has decided two infringement actions concerning glatiramer acetate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations of anticipation based upon “speculative” prior art and rejected an argument that there was insufficient disclosure to satisfy the test for sound prediction. However, the Court found one of … Continue reading

Health Canada finalizes regulations relating to sale of unapproved drugs for emergency treatment under the Special Access Program

Regulatory amendments to the Food and Drug Regulations (FDR) and the Natural Health Products Regulations (NHPR) were published in Canada Gazette (Part II) on October 14, 2020. We previously reported on these changes, which seek to reduce the administrative burden associated with the Special Access Program (SAP) (for human drugs) and the Emergency Drug Release … Continue reading

New Interim Order to address COVID-19-related drug shortages in Canada

On October 16, 2020, the Minister of Health (the Minister) signed the Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to Covid-19 (the IO), which introduces new tools for the Minister to address actual or potential drug shortages caused, or exacerbated, by COVID-19.  The scope of the IO excludes shortages of veterinary … Continue reading

National Pharmacare Update

On September 23, 2020, the government identified national pharmacare, a national program to fund prescription drugs in Canada, as a continued priority in the Speech from the Throne (the Speech) to open the Second Session of the 43rd Parliament of Canada. As we reported, the federal government previously announced funding for the implementation of certain … Continue reading

Health Canada collaborates with international partners to address pandemic

Health Canada recently published a notice to industry detailing its collaborations with international partners during the COVID-19 pandemic. These cooperative efforts aim to ensure that Canadians’ health product needs are being met quickly and effectively during the outbreak, and that Canada’s policies and regulatory strategies are consistent with those in force around the world. Collaboration … Continue reading

Health Canada releases Guidance Document addressing the Plain Language Labelling Regulations requirements for non-prescription drug products

Health Canada recently published a new Guidance Document that provides information on how Health Canada interprets and applies the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) (colloquially known as the Plain Language Labelling Regulations or PLL Regulations) for non-prescription (i.e. over-the-counter or OTC) drug … Continue reading

Apotex held to induce infringement in one of the last applications under the old PM(NOC) Regulations

The Federal Court has granted an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for a generic version of ZYTIGA (abiraterone acetate). It held that the use of the combination of abiraterone acetate and prednisone claimed by Janssen Inc.’s patent was patentable subject matter, and that the patent’s … Continue reading
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