Smart & Biggar/Fetherstonhaugh updates

Release of information contained in drug submissions and medical device applications
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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 Health Canada recently published a draft guidance document addressing the implementation of the proposed amended regulations.

First CSPs issued and application fee increased
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Procedural decisions relating to Herceptin under amended PMNOC Regulations
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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.

Apotex not entitled to reopen trial on esomeprazole (Nexium) patent validity
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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.

Supreme Court denies leave regarding natural health product licence
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Teva seeks leave in levofloxacin damages assessment
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Apotex fails to establish that it would have obtained non-infringing product from foreign suppliers
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • June 06 2018

Servier and its related company ADIR were recently successful in another chapter of the patent litigation concerning perindopril when the Federal Court again dismissed the non-infringing alternative defence of Apotex Inc and Apotex Pharmachem Inc (collectively, Apotex). The court found that Apotex would not have called on foreign third parties to manufacture perindopril to supply its affiliates in the United Kingdom and Australia and thus reaffirmed the quantum of profits from its original judgment.

Health Canada reports on consultation on proposed approach to cannabis regulation
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Teva seeks leave in levofloxacin damages assessment
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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.

First CSPs issued and application fee increased
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • June 04 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.

Proposed national pharmacare programme and prescription and generic drug pricing modifications
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • May 30 2018

Unlike many Organisation for Economic Cooperation and Development member countries, Canada has no national pharmacare programme (ie, a single system of public insurance coverage for prescription drugs). However, the Standing Committee on Health recently released a report advocating the establishment of such a programme as an insured service under the Health Act. The report also made a number of recommendations, including with respect to drug pricing.

CADTH releases 2018-2021 strategic plan
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • May 30 2018

The Canadian Agency for Drugs and Technologies in Health (CADTH) recently announced the release and published a brief overview of its strategic plan for 2018 to 2021. According to the plan, the CADTH – a health technology assessment agency – plans to transition to a health technology management agency.

Apotex fails to establish that it would have obtained non-infringing product from foreign suppliers
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • May 28 2018

Servier and its related company ADIR were recently successful in another chapter of the patent litigation concerning perindopril when the Federal Court again dismissed the non-infringing alternative defence of Apotex Inc and Apotex Pharmachem Inc (collectively, Apotex). The court found that Apotex would not have called on foreign third parties to manufacture perindopril to supply its affiliates in the United Kingdom and Australia and thus reaffirmed the quantum of profits from its original judgment.

New patent term extension framework
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • May 28 2018

The amendments to the Patent Act and the enactment of the Certificate of Supplementary Protection (CSP) Regulations flowing from the Canada-EU Comprehensive Economic and Trade Agreement introduced a new framework in Canada for the issuance of CSPs. CSPs provide an additional patent-like protection term and are intended to partly compensate innovators for the time required to research and obtain regulatory approval in Canada.

Federal Court grants motion to strike plaintiff's quia timet pleading in oxycodone infringement action
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • May 23 2018

In a recent case, the Federal Court granted the plaintiff's motion to strike a rival pharmaceutical company's statement of claim for infringement of a patent relating to oxycodone salt. The court overturned the prothonotary's dismissal of the motion, finding that the facts alleged nothing beyond the regulatory use exemption and that the imminence branch of the test for a quia timet action had not been met.

Costco pharmacy directors fined for professional misconduct
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • May 23 2018

The discipline committee of the Ontario College of Pharmacists recently found that two directors of Costco pharmacies had committed acts of professional misconduct by soliciting C$1,266,000 in payments relating to advertising which would reasonably be regarded as rebates for the purchase of interchangeable drug products.

Federal Court grants motion to strike plaintiff's quia timet pleading in oxycodone infringement action
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • May 21 2018

In a recent case, the Federal Court granted the plaintiff's motion to strike a rival pharmaceutical company's statement of claim for infringement of a patent relating to oxycodone salt. The court overturned the prothonotary's dismissal of the motion, finding that the facts alleged nothing beyond the regulatory use exemption and that the imminence branch of the test for a quia timet action had not been met.

Colour it mine: protecting colour trademarks
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • May 21 2018

A number of changes will soon be made to Canadian trademark law, which will make it possible to protect a colour per se as a trademark (as opposed to a colour applied to a product with a particular shape). Rights holders seeking to protect colours as trademarks in Canada may therefore benefit from the new regime. However, overcoming objections based on functionality or establishing distinctiveness may present significant new hurdles to the registration of such marks.

CADTH Common Drug Review accepting submissions up to six months before market approval
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • May 16 2018

The Canadian Agency for Drugs and Technologies in Health has announced that the Common Drug Review Programme will now accept drug submissions up to six months before a drug manufacturer's anticipated receipt of a notice of compliance (NOC) or NOC with conditions from Health Canada.

Consultation on proposed regulations under Health Sector Payment Transparency Act 2017
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • May 16 2018

The Ontario legislature recently passed the Strengthening Quality and Accountability for Patients Act 2017, which enacts or amends 10 statutes, including the Health Sector Payment Transparency Act 2017. When in force, the transparency act will require the disclosure of financial relationships between pharmaceutical or medical device manufacturers (among other payors) and healthcare professionals (among other recipients).

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