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

“New NAFTA” to take effect July 1, 2020: USA completes domestic ratification of CUSMA

Canada, the United States, and Mexico have each completed the domestic processes necessary to bring the Canada-United States-Mexico Agreement (CUSMA, also known as USMCA or New NAFTA) into effect. CUSMA will come into force on July 1, 2020, the first day of the third month after it was ratified by each member country. The United States was the final member country to complete its domestic ratification process, giving notice to Canada and Mexico on April 24, 2020. Canada and Mexico had provided notice on April 2 and 4, 2020, respectively.

Next step: Uniform Regulations

The CUSMA member countries … 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
Continue Reading

Governmental Use of Patented Inventions during a Pandemic: A Global Survey

Key Contacts: Jordana Sanft (Toronto), Jeffrey Lewis (New York), Jenny Shum (New York), Clemens Rubel (Munich), Seiko Hidaka (London), Justin Davidson (Hong Kong SAR), Jackie O’Brien (Sydney)

Around the globe, pharmaceutical and medical device companies are helping in the fight of the COVID-19 pandemic. Many of these companies may have patents pertaining to technology that could be used for the benefit of the broader public during this time of crisis, such as patents on ventilators, diagnostic tests, pharmaceuticals or personal protective equipment. Governments around the globe have mechanisms in place that can mandate the use of patented inventions during a … Continue Reading

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