Smart & Biggar/Fetherstonhaugh updates

Health Canada requests feedback on company names added to Generic Submissions Under Review List
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Abbott and Takeda plead third party's patent would be infringed by non-infringing alternative
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Contrasts and distinctions: 2018 Canadian patent law developments
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Life sciences intellectual property: 2018 highlights
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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?
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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.

Health Canada publishes revisions to guidance document on notifying Health Canada of foreign actions
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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 prejudgment interest issue
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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.

Federal Court of Appeal overturns cefaclor damages decision on pre-judgment interest issue
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Five important changes to Patent Act now in effect
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 07 January 2019

The Budget Implementation Act 2018, which recently received royal assent, introduced important changes to the Patent Act that will affect the scope of protection available under Canadian patents. Effective immediately, the amendments concern licensing commitments in respect of standard-essential patents, prosecution histories in claim construction, the experimental use of patented inventions, the scope of prior user rights and written demand requirements.

New Patent Rules: 12 notable changes and tips
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 24 December 2018

The government recently released its proposed new Patent Rules in the Canada Gazette. This is one of the last steps necessary for implementing the significant changes to Canada's patent law which are expected to come into force in 2019. Many of the changes intend to implement the Patent Law Treaty and help to minimise the risk of loss of rights, while others will reduce the rights of patent applicants and patentees.

Divided success in Sandoz's motion to strike monetary remedies and other novel claims
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Court allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 19 December 2018

The Ontario Court of Appeal recently overturned a motion judge's decision denying Sanofi and Schering leave to amend their defences to plead the Supreme Court of Canada's decision in AstraZeneca Canada Inc v Apotex Inc. The present action is one of several novel claims by Apotex seeking damages pursuant to the Ontario Statute of Monopolies and the UK Statute of Monopolies.

Divided success in Sandoz's motion to strike monetary remedies and other novel claims
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 17 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.

Court allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 17 December 2018

The Ontario Court of Appeal recently overturned a motion judge's decision denying Sanofi and Schering leave to amend their defences to plead the Supreme Court of Canada's decision in AstraZeneca Canada Inc v Apotex Inc. The present action is one of several novel claims by Apotex seeking damages pursuant to the Ontario Statute of Monopolies and the UK Statute of Monopolies.

The date is set – new trademark law will be in force June 2019
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 03 December 2018

After years of uncertainty, a date has been set for the implementation of Canada's new trademark law, which will come into force on 17 June 2019. The law will bring about significant changes, including the simplification of trademark applications, the elimination of the government registration fee for new applications and the introduction of fees per class.

Anti-dilution remedy not limited to registered trademarks
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 03 December 2018

Section 22 of the Trademarks Act, depreciation of a registered trademark's goodwill, is a potentially powerful yet generally underused weapon for dealing with damaging comparative advertising campaigns. Dilution-type claims to prevent comparative ads displaying a registered trademark are particularly complex as they require that the advertising actually 'use' the registered mark within the meaning of the Trademarks Act.

We have lift off: Canada's new industrial design regime launched
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 26 November 2018

Numerous and substantial amendments were recently made to the Industrial Design Act and the Industrial Design Rules. The amendments will modernise Canada's industrial design law and harmonise it with other jurisdictions. Among other changes, applicants may now file a divisional application for any design that is originally disclosed – not merely claimed – in a parent application as filed and choose whether to provide a description of the design or statement of limitation.

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