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

Federal Courts Extend Suspension Periods to June 15

The Federal Court of Appeal (FCA) and the Federal Court (FC) have extended their Suspension Periods to June 15, 2020.

Federal Court of Appeal

On May 28, 2020, the FCA issued a Notice to the Parties and the Profession extending the Suspension Period to June 15, 2020.

Federal Court

On May 29, 2020, the FC issued an updated Practice Direction and Order (FC Update), also extending the Suspension Period to June 15, 2020. Pursuant to the FC Update:

  • the Suspension Period is still subject to the five exceptions listed in the FC’s Practice Direction
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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

Federal Court supports virtual trials for intellectual property actions

The Federal Court of Canada has embraced virtual hearings as the best solution to the prolonged Covid-19 shutdown. While acknowledging some litigants’ concerns pertaining to procedural fairness and information security in recent rulings, the Court is more concerned that justice delayed can become justice denied.

Videoconferencing will not impede the Court’s ability to assess the credibility of witnesses

The unprecedented suspensions following Covid-19 saw some litigants facing lengthy suspensions mid-way through trial. In Rovi Guides, Inc. v Videotron Ltd., one party argued that it would be unfair to require some witnesses to testify remotely after other witnesses had testified … Continue Reading

Dosing regimen patent found valid and infringed in the second decision under the new PM(NOC) Regulations

In the second trial judgment under the new Patented Medicine (Notice of Compliance) Regulations, the Federal Court (FC) found for the Plaintiffs, Janssen Inc. and Janssen Pharmaceutica N.V., and enjoined Teva Canada Limited (Teva) from making, constructing, using or selling paliperidone palmitate (paliperidone) in accordance with its abbreviated new drug submission. The Court rejected Teva’s argument that the claimed dosing regimens were obvious, as well as its arguments against direct infringement of certain of the claims.

Background

Paliperidone is marketed in Canada as INVEGA SUSTENNA and is used to treat schizophrenia and related … Continue Reading

FCA gives guidance for common PM(NOC) trials involving multiple actions

The Federal Court of Appeal has reversed the Federal Court’s decision to add two additional generic defendants (Taro Pharmaceuticals Inc. and Sandoz Canada Inc.) to an upcoming common trial under the Patented Medicines (Notice of Compliance) Regulations. The common trial will determine patent validity issues in Bayer Inc.’s actions against Teva Canada limited and Apotex Inc. concerning generic versions of XARELTO® (rivaroxaban).

Background

This is an appeal by Teva and Apotex from a decision of the Federal Court allowing Taro and Sandoz to join Teva and Apotex in a trial of common validity issues. As we reported, the … Continue Reading

Suspension Periods extended at the FCA and CIPO

This week, the Federal Court of Appeal (FCA) extended its Suspension Period and the Canadian Intellectual Property Office (CIPO) extended its deadlines, both until the end of May.

Federal Court of Appeal

As we reported, the FCA has issued a number of Notices to the Parties and the Profession concerning the conduct of litigation during the pandemic, including a Suspension Period and various exceptions under which cases may proceed.

On May 12, 2020, the FCA published its most recent Notice to the Parties and Profession (FCA Update). The FCA Update announces that the … 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 with International Regulators

 

International Coalition of Medicines Regulatory Authorities (ICMRA)

Health Canada is a member of the ICMRA, an entity made up of 29 regulatory authorities and with the World Health Organization (WHO) as an observer. ICMRA members work together … 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

Federal Court extends Suspension Period and expands use of virtual hearings

On April 29, 2020, the Federal Court (FC) published a Practice Direction and Order (FC Update) extending its Suspension Period until May 29, 2020 and adjourning hearings until June 29, 2020—subject to certain exceptions. During this time, the Court has made provisions to hold certain hearings by phone or Zoom videoconference.

The FC Update is an amendment to its previous Updated Practice Direction and Order dated April 4, 2020, which we discuss here and otherwise remains in force.

Extension of Suspension Period & other measures

The FC Update introduces three main changes to procedural timelines:… Continue Reading

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