Latest updates

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.

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.

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.

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.

Teva succeeds in Section 8 bortezomib action
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 01 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.

Health Canada news: September 2018
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 26 September 2018

There have been a number of recent Health Canada developments. For example, in June 2018 the Advisory Council on the Implementation of National Pharmacare was launched, together with the release of a discussion paper and the opening of a public consultation. In addition, Health Canada recently published notice of revised guidance documents on post-notice of compliance changes and its Drug and Medical Device Highlights 2017 report.

Tobacco companies cannot compel production of health records
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 26 September 2018

The province of British Columbia recently brought an action against Philip Morris International and other tobacco manufacturers to recover healthcare costs relating to the treatment of diseases caused or contributed to by exposure to a tobacco product pursuant to the Tobacco Damages and Healthcare Costs Recovery Act. The Supreme Court of Canada held that British Columbia could not be compelled to produce a collection of anonymised healthcare databases that it intended to use to prove causation and damage.

Federal Court dismisses first motion for early dismissal under amended PMNOC Regulations
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 24 September 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.

Eli Lilly's Effient combination use patent found obvious
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 24 September 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.

Alexion denied leave to appeal in case challenging constitutionality of PMPRB's remedial powers
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 19 September 2018

The Supreme Court of Canada recently dismissed Alexion Pharmaceuticals' application for leave to appeal the Federal Court of Appeal decision in Alexion Pharmaceuticals Inc v Canada (Attorney General). The Federal Court of Appeal had dismissed Alexion's challenge of the constitutionality of certain Patent Act provisions relating to the Patented Medicine Prices Review Board's remedial powers.

CADTH releases new guidelines
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 19 September 2018

The Canadian Agency for Drugs and Technologies in Health (CADTH) recently published the Procedure and Submission Guidelines for the CADTH Common Drug Review, which consolidate two previously separate guidelines and include a number of revisions to the submission requirements. These changes will be enforced for all submissions and resubmissions received on or after 27 July 2018.

No store, no problem: broad interpretation of 'use' advantageous for foreign retail trademark owners
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 17 September 2018

Non-Canadian retailers can breathe a sigh of relief thanks to a recent Federal Court decision which reaffirms its position that providing retail store services does not require a bricks-and-mortar establishment or direct delivery of products to Canada to constitute 'use' of a trademark in Canada. The decision also reverses the Trademarks Opposition Board's longstanding trend of ignoring ancillary services as being sufficient to constitute 'use' in Canada.

Patented Medicine Prices Review Board's multi-stakeholder steering committee holds first meeting
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 12 September 2018

The Patented Medicine Prices Review Board (PMPRB) has been consulting on its proposed reform of the federal price review process and associated guidelines. As part of this reform, the steering committee held its first meeting on 25 June 2018 to "discuss aspects of the new regime and assist the PMPRB in synthesizing stakeholder views on key technical and operational modalities of new draft Guidelines that would give effect to these changes".

Patented Medicine Prices Review Board releases annual report on drug market entry
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 12 September 2018

The Patented Medicine Prices Review Board recently announced the publication of the second annual edition of Meds Entry Watch 2016. The report provides a review of long-term trends in new active substances approved by Health Canada, among others, between 2009 and 2015. It also describes the availability, pricing and sales of such new active substances in 2015 and 2016 and provides a preliminary analysis of their effect on the market as of the fourth quarter of 2016.

Alexion denied leave to appeal in case challenging constitutionality of PMPRB's remedial powers
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 10 September 2018

The Supreme Court of Canada recently dismissed Alexion Pharmaceuticals' application for leave to appeal the Federal Court of Appeal decision in Alexion Pharmaceuticals Inc v Canada (Attorney General). The Federal Court of Appeal had dismissed Alexion's challenge of the constitutionality of certain Patent Act provisions relating to the Patented Medicine Prices Review Board's remedial powers.

Shire's VYVANSE patent valid, prohibition order issued
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 05 September 2018

The Federal Court has granted Shire's application under the pre-amended Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the minister of health from issuing a notice of compliance to Apotex for its lisdexamfetamine product (Shire's Vyvanse) until the expiry of Canadian Patent 2,527,646. The application had been consolidated with Apotex's action seeking a declaration of invalidity and non-infringement and was decided on the basis of the evidence adduced in that action.

First judicial consideration of Vanessa's Law: Health Canada must disclose requested clinical trial data
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 05 September 2018

In the first case calling upon a court to interpret and apply the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), the Federal Court ordered Health Canada to release requested complete copies of all sections of all clinical study reports and all electronic datasets from the clinical trials, including participant level datasets, for Gardasil, Gardasil 9, Cervaris, Tamiflu and Relenza.

Shire's VYVANSE patent valid, prohibition order issued
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 03 September 2018

The Federal Court has granted Shire's application under the pre-amended Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the minister of health from issuing a notice of compliance to Apotex for its lisdexamfetamine product (Shire's Vyvanse) until the expiry of Canadian Patent 2,527,646. The application had been consolidated with Apotex's action seeking a declaration of invalidity and non-infringement and was decided on the basis of the evidence adduced in that action.

Health Canada publishes guidance documents that address reporting of adverse reactions
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 15 August 2018

Health Canada recently published the Reporting Adverse Reactions to Marketed Health Products guidance document, which provides assistance on reporting adverse reactions to marketed health products. Further, it published Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products, which addresses the format and content of annual summary reports and issue-related summary reports, as well as procedures for their submission to Health Canada.

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