Smart & Biggar/Fetherstonhaugh updates

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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