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Health Canada liable for damages to Apotex for misfeasance in public office and negligence in review of Apo-Trazodone submission
On November 18, 2014, the Federal Court found the Minister of Health liable in tort for its failure to abide by a settlement agreement with Apotex, which significantly delayed the approval of Apotex's generic trazodone product: Apotex Inc v Canada (Minister of Health), 2014 FC 1087. However, the Court held that the Minister was not liable for the full delay period, as Apotex ought to have mitigated its damages. Further, the Court found that Apotex's action for breach of the settlement agreement was barred by a limitations period.
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Proposed amendments to the Patented Medicines (Notice of Compliance) Regulations to address strict matching test for listing a patent for a single compound against a fixed-dose combination product
Industry Canada's Forward Regulatory Plan for 2014-2016 provides information on regulatory proposals that Industry Canada expects to bring forward over the next two years. One such initiative proposes amendments to the PM(NOC) Regulations regarding the requirements for listing patents naming a single compound against fixed-dose combination products.
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Proposed amendments to Schedule 1 of the Patent Act (drugs eligible for export under Canada's Access to Medicines Regime (CAMR))
Industry Canada has indicated that it proposes to add three HIV/AIDS therapies to Schedule 1 of the Patent Act. Schedule 1 is the list of drugs eligible for export under CAMR.
A Canadian generic pharmaceutical manufacturer has requested that three therapies, which include efavirenz, emtricitabine and tenofovir disoproxil, be added to Schedule 1. The notice indicates that the amendments are intended to ensure that (i) Schedule 1 remains current with the evolving public health needs of developing countries and (ii) the Commissioner of Patents is in a position to authorize the export of the three therapies if a generic manufacturer applies for an export licence under CAMR.
Industry Canada has indicated that the public will have the opportunity to comment when the proposed amendment is published in the Canada Gazette, Part 1.
Regulatory Initiative: Amendments to Schedule 1 of the Patent Act — Forward Regulatory Plan 2014-2016.
Quebec introduces legislation concerning listing agreements and pharmaceutical rebates
On November 26, 2014, Quebec’s Minister of Finance introduced Bill No. 28, An Act mainly to implement certain provisions of the Budget Speech of June 4, 2014 and return to a balanced budget in 2015-2016. An aspect of the Bill pertains to pharmaceutical rebates and listing agreements, amendments that would permit Quebec’s Minister of Health and Social Services to negotiate listing agreements with manufacturers before a medication is added to the basic prescription drug insurance plan (see sections 172-173, 176-177 and 179). If passed, this legislation will also provide the framework for Quebec to participate in the pan-Canadian Pharmaceutical Alliance negotiations.
Teva denied leave to appeal re: availability of punitive and exemplary damages under section 8 of the PM(NOC) Regulations
As reported in the September 2014 edition of Rx IP Update, Teva had sought leave to appeal a decision of the Federal Court of Appeal that affirmed that punitive and exemplary damages are not available in a section 8 action. On November 13, 2014, the Supreme Court dismissed Teva’s application for leave.
Teva Canada Limited v Pfizer Canada Inc,
SCC Case No. 36019.
Federal Court of Appeal decision — 2014 FCA 138.
Federal Court decision — 2014 FC 69.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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gliclazide modified release (DIAMICRON MR)
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Applicants:
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Les Laboratoires Servier and Servier Canada Inc
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Respondents:
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Actavis Pharma Company and the Minister of Health
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Date Commenced:
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October 23, 2014
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Court File No.:
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T-2169-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,629,670. Actavis alleges non-infringement and invalidity.
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Medicine:
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brimonidine tartrate (ALPHAGAN)
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Applicants:
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Allergan Inc and Allergan, Inc
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Respondents:
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Alcon Canada Inc and the Minister of Health
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Date Commenced:
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November 14, 2014
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Court File No.:
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T-2358-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,225,626. Alcon alleges non-infringement and invalidity.
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Medicine:
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pantoprazole magnesium (TECTA)
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Applicant:
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Takeda Canada Inc and Takeda GmbH
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Respondents:
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The Minister of Health and Teva Canada Limited
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Date Commenced:
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November 28, 2014
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Court File No.:
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T-2440-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,341,031. Teva alleges non-infringement (certain claims only) and invalidity.
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Other proceedings
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Medicine:
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N/A
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Applicants:
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Apotex Inc, Apotex Pharmachem India PVT Ltd, Apotex Research Private Limited
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Respondents:
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Minister of Health and Attorney General of Canada
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Date Commenced:
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October 29, 2014
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Court File No.:
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T-2223-14
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Comment:
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Application for judicial review of a decision of the Minister of Health to issue and implement an import ban to prevent the importation of drug products into Canada from Apotex Pharmachem India Pvt Ltd and Apotex Research Private Limited.
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Medicine:
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rasagiline (AZILECT, Apo-Rasagiline)
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Applicant:
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Apotex Inc
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Respondents:
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Minister of Health and Attorney General of Canada
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Date Commenced:
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November 24, 2014
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Court File No.:
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T-2411-14
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Comment:
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Application for judicial review of a decision of the Minister of Health to refuse to issue a Notice of Compliance for Apo-Rasagiline tablets. The basis for the refusal stems from the import ban on drug products from Apotex Pharmachem India Pvt Ltd and Apotex Research Private Limited.
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Medicine:
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N/A
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Plaintiff:
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Children's Hospital of Eastern Ontario
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Defendant:
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University of Utah Research Foundation, Genzyme Genetics, Yale University
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Date Commenced:
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November 3, 2014
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Court File No.:
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T-2249-14
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Comment:
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As reported previously, action seeking a declaration that the Plaintiff does not infringe Patents Nos. 2,240,737; 2,336,236; 2,337,491; 2,369,812; and 2,416,545 by the processes proposed to be used to diagnose and/or assess the risk of Long QT syndromes in human patients and a declaration that the Isolated Nucleic Acid Claims and Testing Method Claims in the above patents are invalid.
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Medicine:
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sildenafil (VIAGRA, Apo-sildenafil)
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Plaintiffs:
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Apotex Inc
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Defendants:
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Pfizer Ireland Pharmaceuticals and Pfizer Canada Inc
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Date Commenced:
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October 27, 2014
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Court File No.:
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CV-14-514915
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Comment:
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Action for: (a) treble damages pursuant to section 4 of the Ontario and U.K. Statutes of Monopolies, (b) section 8 damages under the PM(NOC) Regulations, (c) disgorgement of revenues or profits from the sale of VIAGRA attributable to the higher prices charged by Pfizer as a consequence of: the issuance / enforcement of Patent No 2,163,446 and/or the delay attributable to the invocation by the Defendants of the PM(NOC) Regulations, and (d) damages or an accounting of profits under the Trade-marks Act.
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