Smart & Biggar/Fetherstonhaugh updates

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.

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.

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
  • 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.

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.

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.

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.

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.

Apotex not permitted to plead promise-based invalidity grounds in Section 8 lansoprazole action
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 21 November 2018

The Ontario Superior Court of Justice recently dismissed Apotex's motion to plead promise-based invalidity grounds in a Section 8 lansoprazole action. The motion had arisen in the context of a Section 8 action in which Apotex claimed damages for delay in the issuance of its notice of compliance for its generic lansoprazole product (Takeda's Prevacid) due to prohibition applications commenced by Abbott and Takeda.

Amgen not precluded from asserting patent under current PMNOC Regulations
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 21 November 2018

The Federal Court of Canada has refused Pfizer's motion to dismiss an action under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations between Amgen and Pfizer. Pfizer sought to dismiss the action, asserting that it was redundant, scandalous, frivolous, vexatious or otherwise an abuse of process. Pfizer based its argument on a decision under the old PMNOC Regulations in which the court had found that Apotex's allegation of invalidity was justified.

Apotex not permitted to plead promise-based invalidity grounds in Section 8 lansoprazole action
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 19 November 2018

The Ontario Superior Court of Justice recently dismissed Apotex's motion to plead promise-based invalidity grounds in a Section 8 lansoprazole action. Apotex claimed damages for delay in the issuance of its notice of compliance for its generic lansoprazole product due to prohibition applications commenced by Abbott and Takeda. Abbott and Takeda had pleaded patent infringement as a defence and brought a counterclaim for patent infringement. Apotex in turn challenged the validity of Takeda's patents.

New Bill C-86 introduces many more changes to IP laws
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 19 November 2018

The government recently introduced Bill C-86. The changes introduced by the bill are in addition to the many amendments to the Trademarks Act and Patent Act yet to be brought into force. These changes represent continuing efforts by the government to update and modernise Canada's IP legislation and ensure that it is compliant with Canada's international obligations.

Interim order permits import of FDA-approved drug to address Canadian shortage of EpiPens
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 14 November 2018

The minister of health recently made an order permitting the immediate import and sale of epinephrine auto-injectors for use in emergency treatment of life-threatening allergic reactions to address the shortage of EpiPen products. This is the first time that an interim order under Section 30.1(2)(a) of the Food and Drugs Act has been used to address the shortage of an approved product.

Prohibition denied for Ranbaxy's bupropion extended-release tablets
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 14 November 2018

The Federal Court recently dismissed Valeant's application under the Patented Medicines (Notice of Compliance) Regulations regarding Ranbaxy's bupropion extended-release tablets. The court found that the amount of permeation enhancer in the Ranbaxy formulation was outside the scope of the range claimed. As such, Ranbaxy's allegation of non-infringement was found to be justified.

Amgen not precluded from asserting patent under current PMNOC Regulations
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 12 November 2018

The Federal Court of Canada has refused Pfizer's motion to dismiss an action under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations between Amgen and Pfizer. Pfizer sought to dismiss the action, asserting that it was redundant, scandalous, frivolous, vexatious or otherwise an abuse of process. Pfizer based its argument on a decision under the old PMNOC Regulations in which the court had found that Apotex's allegation of invalidity was justified.

Prohibition denied for Ranbaxy's bupropion extended-release tablets
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 12 November 2018

The Federal Court recently dismissed Valeant's application under the Patented Medicines (Notice of Compliance) Regulations regarding Ranbaxy's bupropion extended-release tablets. The court found that the amount of permeation enhancer in the Ranbaxy formulation was outside the scope of the range claimed. As such, Ranbaxy's allegation of non-infringement was found to be justified.

Recent PMPRB reports
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 07 November 2018

The Patented Medicine Prices Review Board (PMPRB) recently released its fourth edition CompassRX report, which was prepared as part of the National Prescription Drug Utilisation Information System and examines public drug plan expenditures in Canada. The PMPRB also released the 2017 Supplement to the Market Intelligence Report, Biologic Response Modifier Agents 2015 and its 2017 Annual Report.

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