Smart & Biggar updates

Federal Court of Appeal remands Remicade new use patent decision on anticipation and obviousness
Smart & Biggar
  • Intellectual Property
  • Canada
  • 30 March 2020

In 2018 the Federal Court found that Kennedy's new use patent for infliximab (Janssen's Remicade) was valid and had been infringed by Hospira's biosimilar Inflectra. However, in January 2020 the Federal Court of Appeal released a decision remitting for reconsideration by the trial judge certain issues relating to the validity of Canadian Patent 2,261,630.

Federal Court of Appeal remands Remicade new use patent decision on anticipation and obviousness
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 25 March 2020

In 2018 the Federal Court found that Kennedy's new use patent for infliximab (Janssen's Remicade) was valid and had been infringed by Hospira's biosimilar Inflectra. However, in January 2020 the Federal Court of Appeal released a decision remitting for reconsideration by the trial judge certain issues relating to the validity of Canadian Patent 2,261,630.

Government introduces Bill C-4 to implement USMCA's required changes
Smart & Biggar
  • Intellectual Property
  • Canada
  • 23 March 2020

Bill C-4 – which addresses some of the changes required under the US-Mexico-Canada Agreement (USMCA) – was recently introduced in the House of Commons. Amendments to the Patent Act were not introduced by Bill C-4 but are expected in the coming years, as Canada must implement the USMCA's required patent term adjustment to compensate for Patent Office delays within four-and-a-half years of the agreement coming into force.

New reports on utilisation of biologics and biosimilars for chronic inflammatory diseases
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 18 March 2020

The Canadian Agency for Drugs and Technologies in Health and the Ontario Drug Policy Research Network (ODPRN) have released reports examining utilisation trends of innovator biologics and biosimilar versions of infliximab and etanercept, as well as the innovator biologic adalimumab, with regard to rheumatic conditions and inflammatory bowel disease in Ontario. This article examines the takeaway messages from the ODPRN report.

True or false: testing limits of comparative advertising
Smart & Biggar
  • Intellectual Property
  • Canada
  • 16 March 2020

Comparative advertising can be a useful tool for marketers. However, there are legal limits to comparative advertising which are set out in federal statutes such as the Competition Act and the Trademark Act. The Federal Court recently explored these limits in a case involving the registered trademark PETSECURE.

Federal Court is back on track: IP holders will continue to benefit from protective orders in IP litigation
Smart & Biggar
  • Intellectual Property
  • Canada
  • 09 March 2020

The Federal Court of Appeal recently reaffirmed the long-established practice of granting protective orders to parties involved in IP litigation before the Federal Court. In doing so, it set aside recent decisions in which the Federal Court refused to issue such an order, including instances where the order was sought with the consent of the parties.

Millennium and Janssen seek leave from Supreme Court in Section 8 bortezomib case
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 04 March 2020

In 2019 the Federal Court of Appeal dismissed Millennium Pharmaceuticals' and Janssen's appeal of a decision granting Teva's claim for compensation under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. Millenium Pharmaceuticals and Janssen have now applied to the Supreme Court of Canada for leave to appeal.

Consultation on draft Patented Medicines Regulations ends and selected presentations published
Smart & Biggar
  • Intellectual Property
  • Canada
  • 02 March 2020

The consultation period for the Patented Medicine Prices Review Board's (PMPRB's) draft guidelines operationalising the amended Patented Medicines Regulations recently ended, after two extensions. Further, the PMPRB has released the presentations from its January 2020 patentee webinar, December 2019 industry forum and December 2019 civil society forum.

Consultation on draft Patented Medicines Regulations ends and selected presentations published
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 26 February 2020

The consultation period for the Patented Medicine Prices Review Board's (PMPRB's) draft guidelines operationalising the amended Patented Medicines Regulations recently ended, after two extensions. Further, the PMPRB has released the presentations from its January 2020 patentee webinar, December 2019 industry forum and December 2019 civil society forum.

PMPRB reports upward trend of high-cost drugs
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 19 February 2020

The Patented Medicine Prices Review Board recently released the Meds Entry Watch 2018, which analyses information about medicines approved by the US Food and Drug Administration, the European Medicines Agency or Health Canada in 2017 and 2018. One of the key findings is the continued upward trend in the entry of high-cost products (eg, orphan drugs and oncology products).

Canadian Institute for Health Information publishes drug spending statistics
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 12 February 2020

The Canadian Institute for Health Information recently published statistics on drug spending, finding that in 2018 approximately 40% of drug spending was spent on 2% of beneficiaries. Of this 2%, three out of five individuals used a drug therapy that cost C$10,000 or more per year (eg, antivirals or biologics for rheumatoid arthritis or Crohn's disease).

Trademarks Office issues new limits on time extensions to respond to office actions
Smart & Biggar
  • Intellectual Property
  • Canada
  • 10 February 2020

Following a recent practice notice, the Trademarks Office will not grant time extensions for office actions issued on or after 17 January 2020 unless exceptional circumstances are demonstrated. The Trademarks Office has also expanded the list of potential exceptional circumstances.

Life sciences intellectual property: 2019 highlights
Smart & Biggar
  • Intellectual Property
  • Canada
  • 03 February 2020

There have been a number of key developments in Canadian life sciences IP and regulatory law over the past 12 months, including significant amendments to the Patented Medicines Regulations, a number of biosimilars developments relating to approvals, pending submissions and naming and the second anniversaries of the certificate of supplementary protection regime and the Patented Medicines (Notice of Compliance) Regulations.

Life sciences intellectual property: 2019 highlights
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 29 January 2020

There have been a number of key developments in Canadian life sciences IP and regulatory law over the past 12 months, including significant amendments to the Patented Medicines Regulations, a number of biosimilars developments relating to approvals, pending submissions and naming and the second anniversaries of the certificate of supplementary protection regime and the Patented Medicines (Notice of Compliance) Regulations.

USMCA amendments: implications for Canadian IP law
Smart & Biggar
  • Intellectual Property
  • Canada
  • 27 January 2020

The United States, Mexico and Canada recently signed the Protocol of Amendment to the Agreement between the United States of America, the United Mexican States and Canada (USMCA). If ratified, the amended USMCA will replace the North American Free Trade Agreement and require a number of changes to Canada's IP laws. Many requirements of the original USMCA have already been met by recent changes in Canadian IP legislation, but more amendments will be required to implement the USMCA.

Federal Court dismisses patent infringement action for delay
Smart & Biggar
  • Intellectual Property
  • Canada
  • 20 January 2020

The Federal Court recently dismissed an action for delay following a status review under Section 382.1 of the Federal Courts Rules where the proceeding remained at the documentary discovery stage with outstanding motions pending more than six years after the action had been commenced. The plaintiff's had alleged infringement of Canadian Patent 2,595,723 in respect of water treatment processes used in Cenovus's steam-assisted gravity drainage oil production facilities.

Amendments to USMCA remove 10-year data protection requirement for biologics
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 15 January 2020

The United States, Mexico and Canada recently signed amendments to the US-Mexico-Canada Agreement (USMCA). The original USMCA was signed on 30 November 2018. The recent amendments have removed a provision, such that Canada can maintain its current data protection laws which provide an eight-year data protection term, with a possible six-month paediatric extension, for all pharmaceutical products, including biologics.

Effectively using experts in IP litigation: theory
Smart & Biggar
  • Intellectual Property
  • Canada
  • 23 December 2019

In IP litigation, expert testimony is common and important. Experts may provide the court with a scientific primer in highly complex cases. Given this, it is important for IP litigators to appreciate the role of experts, understand the test for admissibility and be familiar with all applicable procedural rules. This article focuses on the more theoretical aspects of expert testimony.

Federal Court of Appeal confirms obviousness finding in Section 8 bortezomib action against Teva
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 18 December 2019

In 2018 the Federal Court granted Teva's claim for compensation under Section 8 of the Patented Medicines (Notice of Compliance) Regulations relating to Teva's bortezomib product. According to Justice Locke, Teva would not have infringed Patents 2,203,936 and 2,435,146 because their relevant claims were invalid for obviousness. The Federal Court of Appeal has now upheld the finding of obviousness, dismissing Millennium Pharmaceuticals' and Janssen's appeal.

Federal Court of Appeal confirms obviousness finding in Section 8 bortezomib action against Teva
Smart & Biggar
  • Intellectual Property
  • Canada
  • 16 December 2019

In 2018 the Federal Court granted Teva's claim for compensation under Section 8 of the Patented Medicines (Notice of Compliance) Regulations relating to Teva's bortezomib product. According to Justice Locke, Teva would not have infringed Patents 2,203,936 and 2,435,146 because their relevant claims were invalid for obviousness. The Federal Court of Appeal has now upheld the finding of obviousness, dismissing Millennium Pharmaceuticals' and Janssen's appeal.

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