Rx IP Update - March 2019

Smart & BiggarIN THIS ISSUE:

Federal Court finds invalidity allegations relating to patent for metformin formulations not justified

Health Canada News

Final regulations addressing the public release of clinical information now in force

Health Canada and CADTH launch new initiative to provide early parallel scientific advice

Health Canada launches e-Learning Tool for understanding premarket regulatory requirements for medical devices

National Pharmacare update

Quebec Court of Appeal overturns Minister's decision to delist REMICADE from Quebec's List of Medications

Supreme Court of Canada denies Apotex leave to appeal Federal Court of Appeal’s rejection of judicial review of Health Canada decision regarding India facilities

Competition Bureau publishes final updated Intellectual Property Enforcement Guidelines

PMPRB publishes 2017 Meds Entry Watch

New Court Proceedings

Federal Court finds invalidity allegations relating to patent for metformin formulations not justified

By Abigail Smith

On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of Health from issuing a notice of compliance to Generic Partners for its generic version of Valeant’s GLUMETZA, a metformin formulation: Valeant Canada v Generic Partners Canada2019 FC 253.

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Health Canada News

Final regulations addressing the public release of clinical information now in force

By Katie Lee

On March 4, 2019, the final Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information) and Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information) (collectively, the “Regulations”) came into force. The Regulations had been pre-published for comment (in substantially the same form) on December 9, 2017 (see article here).

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Health Canada and CADTH launch new initiative to provide early parallel scientific advice

By Tierney GB Deluzio

On February 28, 2019, Health Canada released a Notice to Industry announcing the Early Parallel Scientific Advice initiative. Currently, Health Canada and the Canadian Agency for Drugs and Technologies in Health (CADTH) offer separate processes for drug sponsors seeking early advice on evidence related to market authorization and reimbursement in Canada. Through this new initiative, drug sponsors can obtain advice from Health Canada and CADTH in parallel.

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Health Canada launches e-Learning Tool for understanding premarket regulatory requirements for medical devices

By Katie Lee

On March 19, 2019, Health Canada published a Notice, announcing the launch of its e-Learning tool: Understanding How Medical Devices are Regulated in Canada – Premarket Regulation. According to the Notice, the tool will offer an overview of Health Canada’s premarket regulatory requirements for medical devices and provide targeted guidance to enable greater consistency in the understanding, interpretation and application of the Food and Drugs Act, the Medical Devices Regulations and their related policies and guidelines.

National Pharmacare update

By Brandon Heard

As previously reported, the 2018 Federal Budget announced the creation of an Advisory Council on the Implementation of National Pharmacare. On March 6, 2019, the Advisory Council delivered an interim report, with three initial recommendations:

  • Creating a national drug agency to oversee national pharmacare;
  • Developing a comprehensive, evidence-based list of prescribed drugs - a national formulary - to harmonize coverage across Canada; and
  • Investing in data on prescription drugs and information technology systems.

The Advisory Council indicated that the final report should be issued in the coming months.

On March 19, 2019, the Federal government delivered the 2019 Federal Budget, which reflects these recommendations. In particular, the government plans to create a new Canadian Drug Agency, a national formulary, and a national strategy for high-cost drugs for rare diseases “to help Canadians get better access to the effective treatments they need…. an important first step in expanding drug coverage through federal support.” While the mandate for the Canadian Drug Agency is still in development, it will “be able to provide impartial and independent advice so that drug evaluation and price negotiation could be carried out by a single, coordinated entity.”

Quebec Court of Appeal overturns Minister's decision to delist REMICADE from Quebec's List of Medications

By Tierney GB Deluzio

This appeal arose in the context of a February 15, 2017 decision of the Minister of Health and Social Services (the "Minister") to halt coverage of Janssen's REMICADE (with certain exceptions, including patients who had previously been receiving REMICADE), and to require that Quebec only pay for the less expensive biosimilar version of infliximab. On January 16, 2019, the Quebec Court of Appeal found the Minister's decision to delist REMICADE from Quebec's Liste des médicaments (the "List") (the Quebec equivalent to a formulary) to be invalid and ordered the Minister to reinstate the drug on the List: Janssen Inc c Ministre de la Santé et des Services sociaux, 2019 QCCA 39. In allowing the appeal, the Court did not comment on the merits of delisting REMICADE, instead holding that (1) the Minister's decisions to list or delist individual drugs are administrative and not regulatory in nature; and (2) a decision to delist a drug may require the Minister to respect certain minimum standards of procedural fairness. The Court concluded that the Minister had violated procedural fairness and should have given Janssen formal notice and an opportunity to respond before making the change. On February 11, 2019, the Minister published an amendment to the List, reinstating full coverage of REMICADE.

Supreme Court of Canada denies Apotex leave to appeal Federal Court of Appeal’s rejection of judicial review of Health Canada decision regarding India facilities

By Urszula Wojtyra

As previously reported, the Federal Court of Appeal (FCA) dismissed Apotex’s appeal of a judicial review decision of the Therapeutic Products Directorate (TPD) which required Apotex to submit additional information concerning products manufactured or tested in Apotex’s facilities in India. The FCA found that the Federal Court made no reviewable error in its conclusion that the TPD’s decision was not improperly motivated. On February 22, 2019, the Supreme Court dismissed Apotex’s application for leave to appeal (docket No. 38336).

Competition Bureau publishes final updated Intellectual Property Enforcement Guidelines

By Urszula Wojtyra

On March 13, 2019, the Competition Bureau (“Bureau”) published the final version of its updated Intellectual Property Enforcement Guidelines (IPEGs). The previous version of the IPEGs was released in April 2016 (our previous commentary is found here and here). As noted by the Bureau when it launched its consultation on the draft updated IPEGs “[t]he updates are modest and will not substantially change the Bureau’s approach in enforcing the Competition Act with respect to matters involving intellectual property.” Indeed, the majority of the changes to the IPEGs reflect the 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations, and in particular the termination of dual litigation.

PMPRB publishes 2017 Meds Entry Watch

By Katie Lee

On February 19, 2019, the Patented Medicine Prices Review Board (PMPRB) announced the publication of the 2017 edition of Meds Entry Watch. According to the notice, this publication provides information on new medicines entering Canadian and international markets. The 2017 edition examines the availability, sales, uptake, pricing, and treatment costs of new medicines approved by the US Food and Drug Administration, the European Medicines Agency, and/or Health Canada in 2016 and 2017, as well as trends, going back to 2009. This edition also includes an analysis of biosimilars approved between 2006 and 2017.

New Court Proceedings

For complete details about these proceedings, click here.

PMNOC Actions

daptomycin (CUBICIN): Cubist and Sunovion v Accord

rivaroxaban (XARELTO): Bayer v Taro

Other Proceedings

dolutegravir/rilpivirine tablets (JULUCA): ViiV v The Minister of Health

pegfilgrastim (NEULASTA, FULPHILA): Amgen v BGP

Selected Rankings

Canadian IP Impact Case of the Year 
AstraZeneca v Apotex (NEXIUM)
LMG Life Sciences

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Canada’s Intellectual Property Litigation Firm of the Year
Benchmark Canada

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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