Canada, Smart & Biggar/Fetherstonhaugh updates

Healthcare & Life Sciences

Contributed by Smart & Biggar/Fetherstonhaugh
Apotex's appeal in judicial review of decision seeking further information from India facilities dismissed
  • 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
  • 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
  • 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
  • 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.

Health Canada news: September 2018
  • 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.


Intellectual Property

Contributed by Smart & Biggar/Fetherstonhaugh
Health Canada releases statistical report on PMNOC Regulations and data protection
  • 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
  • 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.

Federal Court dismisses first motion for early dismissal under amended PMNOC Regulations
  • 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
  • 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.

No store, no problem: broad interpretation of 'use' advantageous for foreign retail trademark owners
  • 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.


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