Federal Court of Appeal Upholds First Trial Judgment under New PM(NOC) Regulations

The Federal Court of Appeal has upheld the first trial judgment under the new Patented Medicines (Notice of Compliance) Regulations. In Amgen Inc v Pfizer Canada ULC, 2020 FCA 188, the Court dismissed Amgen’s appeal from the Federal Court’s decision declaring certain claims in Amgen’s Canadian Patent No. 1,341,537 (537 Patent) invalid for obviousness. The action related to Pfizer’s filgrastim biosimilar drug.

Appeal decision

The Court of Appeal found that the Trial Judge applied the correct approach to obviousness, noting that it requires a flexible approach and must be applied in context to the facts … Continue Reading

NOC issued after Federal Court overturns Minister’s decision on effective date of consent letter under the PM(NOC) Regulations

On October 29, 2020, the Federal Court ordered the Minister of Health to immediately issue a notice of compliance (NOC) for a biosimilar drug following a dispute about the effective date of a consent letter under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court held the Minister acted unreasonably in refusing to issue the NOC given the nature of the consent provided.

Background

Fresenius Kabi Canada Ltd. (Fresenius Kabi) seeks to market its adalimumab product, IDACIO, in Canada. IDACIO is a biosimilar of AbbVie Biotechnology Ltd.’s (AbbVie) HUMIRA. AbbVie owns … Continue Reading

Finality, finally:  Adir and Servier Canada Inc. confirm their perindopril win

The 14 year perindopril litigation in Canada is over, with Adir and Servier Canada Inc. (collectively “Servier”) emerging victorious against Apotex Inc. and Apotex Pharmachem Inc. (collectively “Apotex”). The end was marked by the Supreme Court of Canada’s dismissal of Apotex’s application for leave to appeal a decision requiring it to disgorge its profits associated with infringement of Servier’s patent.

Judith Robinson and Joanne Chriqui of Norton Rose Fulbright Canada are proud to have successfully represented Servier at all levels of this hotly contested litigation.

The first chapter was a 2008 trial judgment upholding the validity … Continue Reading

Federal Court issues new consolidated guidelines on complex proceedings

On October 22, 2020, the Federal Court (FC) issued new Case and Trial Management Guidelines for Complex Proceedings (the FC Guidelines). These new consolidated FC Guidelines address many of the topics raised in the following earlier FC Notices to the Profession:

  1. Case management: Increased Proportionality in Complex Litigation before the Federal Court (June 24, 2015);
  2. Trial Management Guidelines (April 2017);
  3. Intellectual Property (experimental testing) (May 12, 2016); and
  4. Guidelines for Actions under the Amended PMNOC Regulations (September 21, 2017).

The FC Guidelines are divided in two sections: the first is a general section … 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 (EDR) (for drugs for veterinary use).

To recap, previously a practitioner requesting a drug under the SAP was required to submit supporting data concerning the use, safety, and efficacy of the drug with each request. This supporting … Continue Reading

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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