Topic: Life sciences and healthcare

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Health Canada issues new Interim Order to prevent bulk exportation of prescription drugs from Canada

On November 27, 2020, the Minister of Health (the Minister) issued the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) (the Interim Order), pursuant to s. 30.1(1) of the Food and Drugs Act.

Summary

The current Interim Order is a response to international frameworks which allow for bulk importation of drugs from Canada, which the Minister believes could cause Canadian drug shortages. For example, the US Food and Drug Administration (FDA) published a rule entitled Importation of Prescription Drugs (the US Importation Rule) which permits US pharmacists or wholesalers to bulk import certain … Continue Reading

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

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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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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PMPRB launches consultation on revised Draft Guidelines

On June 19, 2020, the Patented Medicine Prices Review Board (PMPRB) launched its consultation on revised Draft Guidelines to implement the amended Patented Medicines Regulations. The revised Guidelines outline new price tests for existing and new patented medicines, as well as a revised risk-based system for reporting and investigations. They will be available for public comment until July 20, 2020.

Background

Amendments to the Patented Medicines Regulations are scheduled to come into force on January 1, 2021. These amendments are intended to lower the prices of patented medicines in Canada. They include: (1) new factors for … Continue Reading

Federal Court determines that infringement action under PM(NOC) Regulations is not moot where trial proceeds after patent expiry

On May 22, 2020, the Federal Court granted a motion seeking an order that the issue of infringement in an action brought pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations (Regulations) would not be moot notwithstanding that the trial was set to proceed after the expiry of the relevant patent.

Background

Sandoz served a Notice of Allegation on AstraZeneca alleging non-infringement, invalidity and ineligibility for listing of AstraZeneca’s patent for saxagliptin tablets (marketed as ONGLYZA), being Canadian Patent No. 2,402,894 (894 Patent). AstraZeneca commenced an action against Sandoz seeking a declaration that … Continue Reading

PMPRB update: Amendments delayed, new Guidelines consultation announced, and judicial review heard

This week has seen a number of developments relating to the Patented Medicine Prices Review Board (PMPRB), including a six-month delay to the implementation of amendments to the Patented Medicines Regulations and renewed consultation by the Board on revised Draft Guidelines to implement those amendments. Meanwhile, the Federal Court is now considering a judicial review of those amendments.

Amendments to the Patented Medicines Regulations delayed

The federal government has delayed the implementation of the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements), which are now scheduled to come into force on January 1, Continue Reading

Two PM(NOC) Actions Dismissed After Common Trial on Validity of Treatment Regimen Patent

The Federal Court has dismissed two infringement actions brought against defendants under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations), following a common trial on the validity of Canadian Patent No. 2,562,277 (277 Patent). The Court found that all the asserted claims – to uses for treating multiple sclerosis (MS) – were obvious and that some were anticipated. This is the third decision on the merits of an action under the Regulations since they were amended in September 2017. We previously reported on the first and second trial judgments.

The actions. Continue Reading

Health Canada amends regulations to permit distribution of OTC and NHP samples to general public

Health Canada has finalized amendments to the Food and Drug Regulations (FDR) and Natural Health Product Regulations (NHPR) to allow for the distribution of samples of non-prescription drugs (NPDs, or “over-the-counter” (OTC) drugs) and natural health products (NHPs) to a larger scope of healthcare professionals as well as the general public. Previously, the distribution of these products was limited to physicians, dentists, veterinary surgeons and pharmacists. The regulatory amendments were made as part of Canada’s obligations under the Canada–United States–Mexico Agreement (CUSMA) and the passing of the CUSMA Continue Reading

Update: Expanded Federal Funding for Research and Innovation

As we reported in March, the Federal Government pledged $275 million to research relating to COVID-19. On April 23, 2020, an additional $1.1 billion in funding was announced and includes funding for:

  • Research and Data:
    • $114.9 million for research to accelerate the development, testing, and implementation of medical and social countermeasures to COVID-19. This will be provided through the Canadian Institutes of Health Research.
    • $40 million for the Canadian COVID-19 Genomics Network for COVID-19 viral and host genome sequencing research.
    • $10 million to improve data monitoring coordination of pandemic-related data across the country.
  • Vaccine Development:
    • $600 million to support
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First trial judgment under new PMNOC Regulations declares claims to biologic drug invalid

The Federal Court has released its first trial judgment in an action brought under the new Patented Medicines (Notice of Compliance) Regulations. In Amgen Inc v Pfizer Canada ULC, 2020 FC 522, the Court dismissed Amgen’s action and declared certain claims in Canadian Patent No. 1,341,537 (537 Patent) invalid for obviousness. The action related to Pfizer’s filgrastim biosimilar.

Under the new Regulations, which came into force in September 2017, a full action determines the question of whether the marketing of a generic or biosimilar drug would infringe any valid claims of any patents listed … 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 products.

The Guidance Document, entitled Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs (the Guidance Document), is effective as of April 1, 2020.  It identifies information that will support requirements mandated under the PLL Regulations, and points to other FAQs, … Continue Reading

Health Canada issues Interim Order to address shortages of health products

Health Canada has published an Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (the Interim Order). This Interim Order allows Health Canada and the Canadian Food Inspection Agency to address critical supply issues in an expedited manner when shortages occur. It was signed by the Minister on March 30, 2020.

The Interim Order allows the Minister to permit the exceptional importation and sale of: (1) drugs, including biocide drugs (such as hand sanitizers and disinfectants) but not natural health products (NHPs); (2) medical devices; and (3) foods for … Continue Reading

Quebec maintains drug evaluation activities for listing purposes and launches clinical trials

In this post, the Pharma in Brief team reports on two recent developments in the Quebec regulatory landscape related to the COVID-19 crisis.

Adjustments to submission procedure for applications for listing of innovative drugs and blood products on formulary

On April 6, 2020, Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS) issued a notice to drug manufacturers and blood system product manufacturers describing temporary measures implemented recently to avoid processing backlogs for applications for listing on Quebec’s formulary during the COVID-19 crisis. As of March 30, 2020, manufacturers of innovative drugs or blood products can … Continue Reading

Federal Court issues first decision on patent term restoration – Minister’s decision denying certificate of supplementary protection (CSP) is unreasonable

On April 7, 2020, the Federal Court issued a decision in Canada’s first judicial review under the Patent Act and new Certificate of Supplementary Protection Regulations (CSP Regulations). It is the first decision issued under this regime, and also one of the first decisions to apply the Supreme Court of Canada’s new standard of review framework set out in Canada (Minister of Citizenship and Immigration) v Vavilov, 2019 SCC 65 (Vavilov).

The judicial review application was brought by GlaxoSmithKline Biologicals S.A. (GSK) in respect of an August 3, 2018 decision (Decision) … Continue Reading

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