Latest updates

Final regulations addressing public release of clinical information now in force
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 24 April 2019

The final Regulations Amending the Food and Drug Regulations and Regulations Amending the Medical Devices Regulations recently came into force. Their objective is to provide public access to clinical information submitted to Health Canada for drugs for human use and medical device applications. As a result of the regulations, Health Canada published (among other things) a guidance document to help explain aspects of the new regulations, such as the procedures to prepare information for release.

Federal Court finds invalidity allegations relating to patent for metformin formulations unjustified
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 22 April 2019

Valeant Canada's application for an order prohibiting the minister of health from issuing a notice of compliance to Generic Partners for its generic version of Valeant's Glumetza, a metformin formulation, was recently granted. With respect to anticipation and double patenting, the court found that the prior art document on which Generic Partners had relied for both allegations did not disclose all three of the size, shape and time elements of the claimed formulations.

Court of Appeal dismisses appeal of judgment awarding Apotex damages
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 17 April 2019

In December 2017 Apotex was awarded more than C$11 million in damages and pre-judgment interest for losses resulting from delays in the US Food and Drug Administration's approval of its amoxicillin-clavulanic acid and levodopa-carbidopa products, which had been caused by contractual breaches and negligence on the part of MDS Pharma Services (MDS). However, the Ontario Court of Appeal recently dismissed MDS's appeal and Apotex's cross-appeal of that judgment.

Apotex seeks leave from Supreme Court of Canada in cefaclor damages action
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 17 April 2019

The Federal Court of Appeal recently allowed in part Apotex's appeal of a decision awarding Eli Lilly more than C$100 million for Apotex's infringement of eight process patents relating to the antibiotic cefaclor. The court rejected Apotex's argument that a non-infringing alternative would have been available to Apotex during the relevant period. The case was remitted to the Federal Court for reconsideration on the issue of prejudgment interest; Apotex has applied to the Supreme Court of Canada for leave to appeal.

Save money: renew all trademark registrations now
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 15 April 2019

The new trademark law will take effect on 17 June 2019. Among the changes is a new fee-per-class structure, under which the government renewal fee will be C$400 for the first class and C$125 for each additional class. Brand owners can potentially realise huge savings if they take steps to renew all of their existing Canadian trademark registrations before the new law takes effect.

Apotex seeks leave from Supreme Court of Canada in cefaclor damages action
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 15 April 2019

The Federal Court of Appeal recently allowed in part Apotex's appeal of a decision awarding Eli Lilly more than C$100 million for Apotex's infringement of eight process patents relating to the antibiotic cefaclor. The court rejected Apotex's argument that a non-infringing alternative would have been available to Apotex during the relevant period. The case was remitted to the Federal Court for reconsideration on the issue of prejudgment interest; Apotex has applied to the Supreme Court of Canada for leave to appeal.

Costco Pharmacies receives C$7.25 million penalty for accepting drug rebates
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 10 April 2019

The Ontario Ministry of Health and Long-Term Care recently announced that CWC Pharmacies (Ontario) Ltd (Costco Pharmacies), a subsidiary of Costco, has been ordered to pay an administrative monetary penalty of C$7.25 million for accepting payments from certain generic manufacturers which had violated the prohibition on drug rebates.

Proposed changes to OHIP+ programme
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 03 April 2019

The OHIP+ programme was implemented by the Province of Ontario to provide free prescription drug coverage for all children and youths (ie, individuals aged 24 and under), regardless of family income or whether they have private insurance. However, under proposed amendments to Ontario Regulation 201/96 made under the Ontario Drug Benefit Act, only children and youths without private insurance will continue to receive coverage through the OHIP+ programme.

Health Canada publishes guidance document on post-market drug benefit-risk assessments
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 27 March 2019

Health Canada recently published its "Overview of the format and content for post-market drug benefit-risk assessment in Canada – guidance document". The objective of the guidance document is to assist market authorisation holders in developing a post-market benefit-risk assessment for a marketed drug when requested.

Health Canada releases further information alongside Action Plan on Medical Devices
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 27 March 2019

Further to its Action Plan on Medical Devices, Health Canada has released, among other documents, a notice announcing an upcoming meeting of its Scientific Advisory Committee on Medical Devices used in the Cardiovascular System and draft guidance to better define regulatory compliance requirements for emerging technologies.

Save money: file your multi-class applications now
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 25 March 2019

Canadian trademark law will be overhauled on 17 June 2019, with many significant changes – both procedural and substantive – coming into effect. This article discusses the important strategies to consider before these changes take effect, including tips that could save time and money now and in future.

Orders of prohibition relating to polymorphic form patent for Pristiq upheld on appeal
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 20 March 2019

In a pair of decisions, the Federal Court granted orders prohibiting Apotex and Teva from marketing their generic o-desmethyl-venlafaxine succinate products. The Federal Court of Appeal recently dismissed both Apotex's and Teva's appeals. Among other things, Apotex and Teva argued that the application judge had misapplied the test for obviousness and that the application judge had erred in considering several aspects of the inventors' course of conduct.

Health Canada announces decision on naming of biologic drugs
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 20 March 2019

Following its stakeholder consultations and analysis of issues relating to the name of biologic drugs, including biosimilars, Health Canada recently announced its Policy Statement on the Naming of Biologic Drugs. To implement the naming convention, Health Canada will, among other things, communicate with stakeholders on the importance of recording both brand and non-proprietary names throughout the medication use process.

Orders of prohibition relating to polymorphic form patent for Pristiq upheld on appeal
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 18 March 2019

In a pair of decisions, the Federal Court granted orders prohibiting Apotex and Teva from marketing their generic o-desmethyl-venlafaxine succinate products until the expiration of Patent 2,436,668. Both Apotex and Teva appealed the decisions, claiming – among other things – that the application judge had misapplied the test for obviousness and erred in considering several aspects of the inventors' course of conduct. However, the Federal Court of Appeal recently dismissed both parties' appeals.

2018 round-up: notable trademark case law
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 04 March 2019

A number of trademark cases were heard by the Canadian courts in 2018, including a decision on a motion for summary judgment brought by Duracell, a decision on whether Imperial Tobacco Canada Limited's trademarks were confusing in light of new survey evidence filed on appeal and a decision on whether retail store services require a brick-and-mortar establishment or direct delivery of products to Canada to constitute use of a trademark in Canada.

Trademarks in Canada: a year of change and global harmony
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 04 March 2019

Canada's trademarks profession had an exciting 2018. The long-awaited changes to the Trademarks Act were announced, many of which will bring Canada into line with the rest of the world. In addition, further unexpected legislative developments were announced, which will significantly affect trademark protection.

Apotex seeks leave to appeal ramipril pleadings amendment decision
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 27 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.

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

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.

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