Canada, Smart & Biggar/Fetherstonhaugh updates

Healthcare & Life Sciences

Contributed by Smart & Biggar/Fetherstonhaugh
Abbott and Takeda plead third party's patent would be infringed by non-infringing alternative
  • Canada
  • 20 February 2019

On the eve of a Section 8 trial, the Ontario Superior Court granted Abbott and Takeda leave to amend their pleadings to assert that Apotex's alleged non-infringing alternative was unlawful as it would have infringed a third party's patent. The court found that Apotex had not established that it would be prejudiced by the amendment, as any delay to the trial could be compensated by costs and an adjournment if appropriate.

Health Canada requests feedback on company names added to Generic Submissions Under Review List
  • Canada
  • 20 February 2019

Health Canada recently requested feedback on the possible impact on and use to stakeholders if the Generic Submissions Under Review List is updated to include sponsor names (ie, the company that filed the generic submission). Sponsors are included in the Submissions Under Review List for new drug submissions (which includes biosimilars) accepted into review on or after 1 October 2018.

Life sciences intellectual property: 2018 highlights
  • Canada
  • 06 February 2019

There have been a number of key developments in Canadian life sciences IP and regulatory law over the past 12 months, including a consultation on the different approaches to the naming of biological drugs. Among other developments, four biosimilars were approved, the Canadian Agency for Drugs and Technologies in Health announced revisions to its biosimilar and administrative review process and significant proposed amendments to the Patent Rules were released.

Health Canada publishes revisions to guidance document on notifying Health Canada of foreign actions
  • Canada
  • 23 January 2019

Health Canada recently updated its Notifying Health Canada of Foreign Actions – Guidance Document for Industry, including by providing a link to an online reporting form. This update comes after the foreign risk reporting requirement provisions of the Food and Drug Regulations came into force in October 2018.

Federal Court of Appeal overturns cefaclor damages decision on pre-judgment interest issue
  • Canada
  • 16 January 2019

The Federal Court of Appeal recently allowed in part Apotex's appeal of a decision awarding Eli Lilly over C$100 million for Apotex's infringement of eight process patents relating to the antibiotic cefaclor. The court remitted the decision to the Federal Court for reconsideration solely on the issue of interest.


Intellectual Property

Contributed by Smart & Biggar/Fetherstonhaugh
Abbott and Takeda plead that third party's patent would be infringed by non-infringing alternative
  • Canada
  • 25 February 2019

On the eve of a Section 8 trial, the Ontario Superior Court granted Abbott and Takeda leave to amend their pleadings to assert that Apotex's alleged non-infringing alternative was unlawful as it would have infringed a third party's patent. The court found that Apotex had not established that it would be prejudiced by the amendment, as any delay to the trial could be compensated by costs and an adjournment if appropriate.

Apotex seeks leave to appeal ramipril pleadings amendment decision
  • Canada
  • 25 February 2019

The Ontario Court of Appeal granted Sanofi and Schering leave to amend their defences to plead the Supreme Court of Canada's decision in AstraZeneca Canada Inc v Apotex Inc. In the underlying action, Apotex relied on the invalidity decision in Sanofi-Aventis Canada v Apotex Inc as a central element of its novel claims under the Ontario Statute of Monopolies, the UK Statute of Monopolies and the Trademarks Act. Apotex recently applied for leave to appeal to the Supreme Court of Canada.

2018 round-up: notable patent cases
  • Canada
  • 11 February 2019

A number of patent decisions were taken by the Canadian courts in 2018, including one concerning a relatively rare interlocutory injunction and several others decided on the merits. Damages totalling C$7,915,000 were awarded in one case based on lost profits and reasonable royalties, as well as compound interest, but the justice refused to award punitive damages. Several of the decisions remain under appeal.

Contrasts and distinctions: 2018 Canadian patent law developments
  • Canada
  • 11 February 2019

Canada saw a range of disparate patent law developments in 2018, including the renegotiation of the North American Free Trade Agreement. Separate from this, the second federal budget bill for 2018 introduced a series of amendments to the Patent Act, which concern diverse matters such as licensing commitments on standard-essential patents and the role of the prosecution history in claim construction.

Life sciences intellectual property: 2018 highlights
  • Canada
  • 04 February 2019

There have been a number of key developments in Canadian life sciences IP and regulatory law over the past 12 months, including a consultation on the different approaches to the naming of biological drugs. Among other developments, four biosimilars were approved, the Canadian Agency for Drugs and Technologies in Health announced revisions to its biosimilar and administrative review process and significant proposed amendments to the Patent Rules were released.


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