Smart & Biggar/Fetherstonhaugh updates

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.

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
  • 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.

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.

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.

Supreme Court of Canada denies Sobeys leave to appeal in loyalty rewards programme dispute
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 07 November 2018

The Supreme Court of Canada recently denied Sobeys' application for leave to appeal the Alberta Court of Appeal's decision in a dispute regarding the Alberta College of Pharmacists' policy prohibiting pharmacists and pharmacies from offering loyalty rewards programmes or inducements to patients. This decision follows the court's 2016 refusal to grant Sobeys leave to appeal a decision allowing the College of Pharmacists of British Columbia to prohibit "customer incentive programmes".

Federal Court affirms that trademark use for services does not require bricks-and-mortar business in Canada
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 05 November 2018

A recent Federal Court of Canada decision signals that it is maintaining consistency in its broad interpretation of use of a trademark in connection with services and provides comfort for non-Canadian businesses that have no physical presence in Canada. The decisions reverse a longstanding trend by the Trademarks Opposition Board of ignoring ancillary services as being sufficient to constitute use in Canada.

Certificate of supplementary protection regime: first anniversary update
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 31 October 2018

The certificate of supplementary protection (CSP) regime, which recently celebrated its first anniversary, was a long-awaited complement to the existing forms of protection for pharmaceutical products in Canada. As the regime is still new, companies are reminded to consider applying for a potential CSP for any planned new product in Canada early in the lifecycle planning.

Amended PMNOC Regulations: first anniversary update
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 31 October 2018

The amended Patented Medicines (Notice of Compliance) Regulations came into force on 21 September 2017, heralding significant changes to the regulatory landscape for pharmaceutical companies in Canada. Following the first anniversary of the amendments, it is timely to examine the status of actions under the amended regulations, as well as the new procedural rules and guidelines which were introduced in conjunction therewith.

Certificate of supplementary protection regime: first anniversary update
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 29 October 2018

The first anniversary of the certificate of supplementary protection (CSP) regime was 21 September 2018. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the time invested in researching and obtaining regulatory approval in Canada. This article looks back on the previous year, recaps how the regime works and provides an update on the CSPs granted and rejected to date.

CADTH Pharmaceutical Reviews Update published
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 24 October 2018

​The Canadian Agency for Drugs and Technologies in Health (CADTH) has published the CADTH Pharmaceutical Reviews Update. This is a new consolidated publication that will communicate updates to the CADTH's drug review process. Among other things, the first issue of the update invites stakeholder comments on a number of proposals and announces changes to the Pan-Canadian Oncology Drug Review.

National pharmacare advisory council seeks feedback
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 24 October 2018

The Advisory Council on the Implementation of National Pharmacare was launched in July 2018. The council recently invited all Canadians to provide their feedback on national pharmacare in order to "help shape the Council's independent report to the Federal Government, to be presented in spring 2019… which will provide the Government with recommendations and a plan on how to move forward on national pharmacare".

USMCA versus NAFTA: what's changed and what it means for intellectual property in Canada
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 22 October 2018

After more than one year of negotiations, Canada recently reached a new free trade agreement with Mexico and the United States. Among other things, the US-Mexico-Canada Agreement has updated the North American Free Trade Agreement's IP chapter in order to modify the landscape for pharmaceuticals and for patent, copyright and trademark owners. While Canada is already compliant with many of the new agreement's provisions, a number of the changes may have an impact on its IP laws.

Health Canada releases statistical report on PMNOC Regulations and data protection
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 17 October 2018

Health Canada recently released the Therapeutic Products Directorate Statistical Report 2017/2018, which provided an overview of its administration of the Patented Medicines (Notice of Compliance) Regulations and data protection regime. The report includes information regarding trends in listing on the Patent Register and the Register of Innovative Drugs, as well as related court activity.

Health Canada to implement further pre-market transparency initiatives for prescription drugs
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 17 October 2018

Health Canada recently announced that it will move forward with Phase III of its prescription drug product transparency initiatives. As of 1 October 2018, the Health Products and Food Branch will implement five proposals discussed in its April 2018 What We Heard report concerning regulatory decision summaries and information in the Submissions Under Review List.

Health Canada releases statistical report on PMNOC Regulations and data protection
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 15 October 2018

Health Canada recently released the Therapeutic Products Directorate Statistical Report 2017/2018, which provided an overview of its administration of the Patented Medicines (Notice of Compliance) Regulations and data protection regime. Among other things, the report includes information regarding trends in listing on the Patent Register and related court activity.

Teva succeeds in Section 8 bortezomib action
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 10 October 2018

The Federal Court recently granted Teva's claim for compensation under Section 8 of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations for losses suffered while market entry of Teva's bortezomib product was delayed by Janssen's applications under the PMNOC Regulations relating to Patents 2,203,936 and 2,435,146. Teva had succeeded on allegations of obviousness in both proceedings.

Apotex's appeal in judicial review of decision seeking further information from India facilities dismissed
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 10 October 2018

In 2017 the Federal Court dismissed Apotex's application for judicial review of the Therapeutic Products Directorate decision which continued to require Apotex to submit additional information with respect to products manufactured or tested in its facilities in India. The Federal Court of Appeal recently dismissed Apotex's appeal of the Federal Court's decision.

Eli Lilly's Effient combination use patent found obvious
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 03 October 2018

The Federal Court recently dismissed Eli Lilly's application for a prohibition order, finding that Apotex's allegation of obviousness of Patent 2,432,644 (the '644 Patent) was justified. The '644 Patent covered the use of prasugrel (Eli Lilly's Effient) in combination with aspirin for diseases caused by thrombus or embolus. Apotex made a number of attacks on the patent's validity, specifically with regard to patentable subject matter, obviousness and sufficiency and overbreadth.

Federal Court dismisses first motion for early dismissal under amended PMNOC Regulations
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 03 October 2018

The Federal Court recently dismissed the first motion for summary dismissal brought under Section 6.08 of the amended Patented Medicines (Notice of Compliance) Regulations. The underlying action for infringement concerned Amgen Canada's regulatory submission for approval of its biosimilar of Hoffmann-La Roche's Herceptin. Amgen sought to dismiss the action regarding two of the four asserted patents, both of which contained use claims.

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