Canada, Smart & Biggar/Fetherstonhaugh updates

Healthcare & Life Sciences

Contributed by Smart & Biggar/Fetherstonhaugh
First CSPs issued and application fee increased
  • Canada
  • June 20 2018

Health Canada recently issued the first certificates of supplementary protection (CSPs) against three approvals. In addition, on 1 April 2018 the CSP application fee was increased to C$9,192.

Release of information contained in drug submissions and medical device applications
  • Canada
  • June 20 2018

In December 2017 Heath Canada released proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations, providing for the public release of clinical information contained in drug submissions and medical device applications. Health Canada recently published a draft guidance document addressing the implementation of the proposed amended regulations.

Teva seeks leave in levofloxacin damages assessment
  • Canada
  • June 13 2018

The Federal Court of Appeal recently dismissed Teva's appeal regarding the quantification of damages for its infringement of Janssen's patent for levofloxacin (Levaquin). The Federal Court of Appeal rejected Teva's arguments, finding that the Federal Court had not erred in constructing the hypothetical world and that its factual findings were supported by evidence. On 26 March 2018 Teva applied to the Supreme Court for leave to appeal.

Supreme Court denies leave regarding natural health product licence
  • Canada
  • June 13 2018

The Supreme Court recently dismissed The Winning Combination's leave to appeal. The Federal Court of Appeal had previously set aside the order of mandamus compelling the minister of health to grant a licence to The Winning Combination for its natural health product, Resolve.

Health Canada reports on consultation on proposed approach to cannabis regulation
  • Canada
  • June 06 2018

Bill C-45 – An Act respecting Cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and Other Acts – is currently before the Senate. Rather than pre-publishing draft regulations, the government released regulatory proposals by way of a consultation paper. Health Canada recently announced the release of a report which provides a summary of the comments received on the consultation paper.


Intellectual Property

Contributed by Smart & Biggar/Fetherstonhaugh
Top five reasons to consider patent litigation in Canada
  • Canada
  • June 25 2018

Canada has historically been a much less active jurisdiction for patent litigation compared to the United States, which can be explained in part by the simple fact that the US market is almost 10 times the size of the Canadian market. However, there are a few notable differences in the procedure and substantive law applied in both jurisdictions that have resulted in Canada becoming an increasingly attractive option for high-stakes patent litigation in recent years.

Ontario Court of Appeal dismisses summary judgment appeal in Section 8 case
  • Canada
  • June 25 2018

The Ontario Court of Appeal recently dismissed Abbott and Takeda's appeal of the Ontario Superior Court of Justice's decision to dismiss their motion for summary judgment in an action brought by Apotex under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. The action concerned lansoprazole, the active ingredient in Apo-Lansoprazole. The Ontario Court of Appeal concluded that the motions judge had not erred in finding that Apo-Lansoprazole would have received approval in 2007.

Apotex not entitled to reopen trial on esomeprazole (Nexium) patent validity
  • Canada
  • June 18 2018

The validity of AstraZeneca's NEXIUM patent has finally been decided by the Supreme Court of Canada, with any doubt about the court's intent resolved by its dismissal of Apotex's motion to raise new grounds of patent invalidity. The court also held that AstraZeneca was entitled to a declaration of infringement and ordered the quantification of AstraZeneca's damages or Apotex's profits.

Procedural decisions relating to Herceptin under amended PMNOC Regulations
  • Canada
  • June 18 2018

Two recent decisions addressed procedure under the 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations. In the first case, Prothonotary Aylen ruled that the court lacked jurisdiction to consider a motion under Section 5(3.7) of the regulations to vary confidentiality rules imposed by a party that has served a notice of allegation under Section 5(3.5). In the second case, Aylen dismissed Pfizer's motion to dismiss, adjourn or delay a motion filed by Amgen under Section 6.08.

Teva seeks leave in levofloxacin damages assessment
  • Canada
  • June 04 2018

The Federal Court of Appeal recently dismissed Teva's appeal regarding the quantification of damages for its infringement of Janssen's patent for levofloxacin (Levaquin). The Federal Court of Appeal rejected Teva's arguments, finding that the Federal Court had not erred in constructing the hypothetical world and that its factual findings were supported by evidence. On 26 March 2018 Teva applied to the Supreme Court for leave to appeal.


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