Healthcare & Life Sciences, Smart & Biggar/Fetherstonhaugh updates

Canada

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

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.

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.

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.


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