PMPRB Update: Final Guidelines Released

On Friday, October 23, the Patented Medicine Prices Review Board (PMPRB) released final Guidelines that are intended to take effect on January 1, 2021, together with the scheduled coming-into-force of amendments to the Patented Medicines Regulations (the Amendments).

According to the PMPRB:

The Guidelines provide information on the PMPRB’s general approach to the price review process and investigations. They supersede all previous guidance documents, policy communiqués and written or verbal statements of any kind by the PMPRB regarding the administration of the price review process and investigations, including all previous versions of the PMPRB’s Compendium of Guidelines,

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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 or natural health products.

This IO is the 4th Interim Order to be issued by Health Canada in the context of COVID-19.  The other COVID-19-related Interim Orders are:

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Overview of IP Law In Canada – The Intellectual Property Review, 9th Edition

The recently published Ninth Edition of the Intellectual Property Review (the Review) includes a chapter detailing the various forms of IP protection available in Canada, and highlights important changes in Canadian IP law over the past year. The chapter was authored by members of the Pharma in Brief team.

The chapter also provides an overview of patent law, protection of IP in respect of pharmaceuticals including under the PM(NOC) Regulations, data protection and patent term restoration. Canada is one of 16 countries featured in the Review, with chapters also available on the US and UK.

Links:

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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 recommendations from the Advisory Council on the Implementation of National Pharmacare, including the creation of: (1) the Canadian Drug Agency; (2) a national formulary; and (3) a national strategy for high-cost drugs for rare diseases.

The Speech reaffirms that national pharmacare remains an … Continue Reading

New Interim Order to expedite the approval of COVID-19 drugs and vaccines

On September 16, 2020, the Minister of Health signed an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the Interim Order) which provides new regulatory pathways to expedite the approval of COVID-19 drugs and vaccines that have not yet been approved for sale in Canada. It also allows for addition of new indications related to COVID-19 that are not included in a currently-marketed product’s authorization.

Expedited Approval

The Interim Order establishes alternative pathways to the standard regulatory review process which helps expedite the authorization of eligible products.

  • Manufacturers will be permitted
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Federal Courts update guidance on COVID-19

The Federal Court of Appeal (FCA) provided updated guidance for resuming hearings starting September 1, 2020 and clarified the effect of the federal Time Limits and Other Periods Act (COVID-19) on timelines for commencing and conducting litigation in the FCA. Both the FCA and the Federal Court confirmed that all Practice Directions, judgments, orders and directions from both courts remain in full force and effect.

Resumption of in-person hearings

On September 1, 2020, the FCA issued a Notice to the Parties and Profession (Notice) confirming that three types of hearings will be held during the Court’s … Continue Reading

Data protection upheld for subsequently approved combination drugs containing new chemical entities: Federal Court finds Minister of Health’s decision to deny generic ANDS filing is reasonable

Summary

On July 24, 2020, the Federal Court dismissed an application for judicial review brought by Natco Pharma (Canada) Inc. (Natco) in respect of a July 26, 2019 decision (Decision) by the Minister of Health (Minister).  The Decision refused to accept Natco’s ANDS filing using Gilead Sciences Canada Inc.’s (Gilead) product DESCOVY as the Canadian Reference Product.  DESCOVY contains a combination of tenofovir alafenamide (TAF) hemifumarate and emtricitabine.  The Minister determined that TAF is a new chemical entity first approved in another Gilead drug product GENVOYA.  GENVOYA is a designated … Continue Reading

Federal Court finds Minister’s CSP decision unreasonable on patent eligibility for fixed-dose combination drug product

On July 10, 2020, the Federal Court issued a decision in a judicial review under the Certificate of Supplementary Protection Regulations (CSP Regulations). The application was brought by ViiV Healthcare ULC (ViiV) regarding a decision by the Minister of Health (Minister) refusing to issue a CSP in respect of Canadian Patent No. 2,606,282 (282 Patent) and the drug JULUCA® (Decision).

The Federal Court determined that the Decision was unreasonable, including for failing to interpret the CSP regime in a manner consistent with the Canada-European Union Comprehensive Economic and Trade … Continue Reading

PMPRB takes jurisdiction over medicine (again) following Federal Court of Appeal remand

The Patented Medicine Prices Review Board (PMPRB or Board) has found that a patent can pertain to a medicine based on clinical similarities to the invention—even if the patent does not actually encompass the medicine.

Background

This case concerns Canadian Patent No. 2,478,237 (the 237 Patent), which relates to the use of adapalene to treat dermatological disorders. The patentee, Galderma Canada Inc. (Galderma), markets two adapalene products in Canada:

  • Differin®, which contains 0.1% adapalene (DIFFERIN).
  • Differin XPTM, which contains a higher concentration of adapalene: 0.3% (DIFFERIN XP).
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Federal Court lifts Suspension Period

On June 25, 2020, the Federal Court (FC) issued its latest Practice Direction and Order (FC Update) regarding Court operations during the pandemic, announcing that its Suspension Period will no longer be in force anywhere in Canada as of June 30, 2020. The FC Update also establishes guidelines for the transition toward more regular operations

Background

The FC Update is the fifth Practice Direction and Order issued by the FC in response to the Covid-19 pandemic. For ease of reference, the FC has published a consolidated version of these five notices, including those provisions of each … Continue Reading

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