Canada, Smart & Biggar/Fetherstonhaugh updates

Healthcare & Life Sciences

Contributed by Smart & Biggar/Fetherstonhaugh
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.

List of generic submissions under review now available
  • Canada
  • 16 January 2019

Health Canada recently advised that it would implement certain proposals for its prescription drug product transparency initiatives. In particular, Health Canada will start providing regulatory decision summaries for the approval of drugs which are approved on the basis of abbreviated new drug submissions. Among others things, Health Canada now provides a new, separate Generic Submissions Under Review List, which includes a list of the generic submissions under review by medicinal ingredient.

Divided success in Sandoz's motion to strike monetary remedies and other novel claims
  • Canada
  • 19 December 2018

A Federal Court order has issued on a motion to strike that was brought by Sandoz in four actions relating to the infringement of rituximab patents. The court declined to strike out the claims for damages and an accounting of profits on the basis that, at law, such remedies are unavailable in such an action. The court's treatment of the novel claims by Roche may be of interest to litigants under the current scheme of the Patented Medicines (Notice of Compliance) Regulations.


Intellectual Property

Contributed by Smart & Biggar/Fetherstonhaugh
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.

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.

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.

What's in a name? Has Canada made it more difficult to register name and surname marks?
  • Canada
  • 28 January 2019

The Canadian Intellectual Property Office recently revised its practice notice regarding name and surname objections. Previously, examiners had to locate a minimum of 25 listings in Canadian phone directories before a name and surname objection could be raised. The revised practice notice indicates that "to better reflect the purpose of paragraph 12(1)(a)", effective immediately, examiners are no longer required to find a minimum number of listings before an objection under this section can be raised.

Federal Court of Appeal overturns cefaclor damages decision on prejudgment interest issue
  • Canada
  • 21 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.


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