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Teva awarded section 8 damages regarding ratiopharm-venlafaxine
On April 3, 2014, the Federal Court released a decision on the merits under section 8 of the Patented Medicines (Notice of Compliance) Regulations ("PMNOC Regulations") in respect of venlafaxine hydrochloride (Wyeth's EFFEXOR XR). In Teva Canada Limited v Pfizer Canada Inc, 2014 FC 248, Justice Zinn determined certain issues, which provided direction from which the parties could arrive at the quantum of Teva's compensation.
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Supreme Court of Canada matters
Leave to appeal re: olanzapine dismissed. As reported in the March 2014 edition of Rx IP Update, Apotex sought leave to appeal a Federal Court of Appeal decision declining to: (i) set aside a prohibition Order (which had been affirmed on appeal) and (ii) dismiss the application seeking the prohibition Order regarding the patent claiming olanzapine (Eli Lilly's ZYPREXA). Apotex brought the motion on the basis of a declaration of invalidity of the patent at issue, released subsequent to issuance of the Order of prohibition. Apotex's leave to appeal was dismissed.
Apotex Inc v Eli Lilly Canada Inc, SCC Case No. 35714.
Federal Court of Appeal decision — 2013 FCA 282.
Federal Court decision — 2010 FC 952.
Health Canada news
Plain Language Initiative. On April 4, 2014, Health Canada released revisions to the Guidance Document for Product Monographs as part of its Plain Language Labelling Initiative. Modifications were made to Part III, now entitled Patient Medication Information. The requirements implemented by these revisions will be subject to a phased implementation beginning June 1, 2014.
Notice.
Guidance Document – Product Monograph.
Frequently Asked Questions – Plain Language Revisions to the Product Monograph, Patient Medication Information (formerly Consumer Information).
Guidance Document on the Application for a Certificate of a Pharmaceutical Product. The Health Products and Food Branch Inspectorate released an updated Guidance Document on the Application for a Certificate of a Pharmaceutical Product on April 1, 2014. This document clarifies the requirements to be met for the issuance of a Certificate of a Pharmaceutical Product (CPP) and describes the procedure for the request of a CPP.
Guidance Document on the Application for a Certificate of a Pharmaceutical Product.
Competition Bureau news
As reported previously, on April 2, 2014, the Competition Bureau released a draft update of its Intellectual Property Enforcement Guidelines ("IPEGs"). On the same day, the Bureau and CIPO announced that they had signed a Memorandum of Understanding (MOU) calling for closer cooperation between the two agencies.
The Update to the IPEGs is intended to reflect amendments made to the Competition Act in March 2009 and March 2010 and to bring the IPEGs in line with other Bureau enforcement guidelines released since 2000. The update does not represent a significant departure with respect to how the Bureau approaches the interface between competition policy and intellectual property rights, and the circumstances in which the Bureau may apply the Competition Act to conduct involving intellectual property rights remain substantially the same.
The Memorandum of Understanding is stated to be intended to assist the Bureau and CIPO in carrying out their important and complementary roles in promoting an efficient marketplace economy.
Competition Bureau Seeks Input on the Updated Intellectual Property Enforcement Guidelines.
Draft update of Intellectual Property Enforcement Guidelines.
CIPO and the Competition Bureau Sign Memorandum to Enhance Inter-Agency Cooperation.
CADTH news
Priority Review Process for Common Drug Review Submissions. Following consultation with stakeholders, Canadian Agency for Drugs and Technologies in Health (CADTH) has adopted a revised priority review process for its Common Drug Review (CDR). The following are key aspects of the revised procedure: a priority review may be requested for either or both clinical and economic reasons; a priority review may be requested for submissions filed on a pre-NOC or post-NOC basis; and manufacturers requesting a priority review will be required to complete a priority review application template.
The revised CDR Priority Review Process is in effect for all CDR submissions and resubmissions filed with CADTH after May 7, 2014. For submissions and resubmissions that are queued or undergoing screening on or before May 7, 2014, CADTH will provide manufacturers with a one-time opportunity to request a priority review for their submissions or resubmissions.
CDR Update — Revised CDR Procedure and Submission Guidelines for Priority Review.
CDR Priority Review Procedure and Submission Guidelines.
Patented Medicine Prices Review Board news
New NEWSletter released. The PMPRB released the April 2014 issue of its NEWSletter. The NEWSletter publishes, inter alia, final requirements for Human Drug Advisory Panel (HDAP) submissions, a project update on online filing of Form 2, CPI-based price-adjustment factors for 2015, and the hearing panel's approval of a Voluntary Compliance Undertaking (VCU) in the Teva Canada Innovation G.P-S.E.N.C. copaxone matter.
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
Federal Court allows application for prohibition Order re: celecoxib. Justice Harrington allowed Pfizer and G.D. Searle's application for an Order of prohibition regarding celecoxib (Pfizer's CELEBREX) against Apotex. Justice Harrington recently granted a prohibition order regarding celecoxib in a separate proceeding with Mylan, reported in the March 2014 issue of Rx IP Update. Apotex asserted invalidity of Canadian Patent No. 2,177,576 on the basis of lack of utility in treating inflammation and associated pain and in reducing harmful side-effects, and lack of proper disclosure. Apotex also alleged it was an abuse of process for Pfizer to argue that reduced harmful side-effects were not part of the invention, as it had previously conceded this point in a proceeding against Novopharm (see the May 2007 edition of Rx IP Update). Justice Harrington held that none of Apotex's allegations were justified. Apotex has appealed.
Pfizer Canada Inc v Apotex Inc, April 15, 2014.
Federal Court decision — 2014 FC 314.
Other decisions
Sanofi-aventis added as a party to Hospira's application for judicial review regarding data protection. Hospira filed a New Drug Submission (NDS) for a drug containing "Chemical Entity A" as the active ingredient in 2006. The Minister had previously rejected the submission for reasons unrelated to this application, and Hospira successfully applied for judicial review of that decision, as reported in the May 2010 and January 2011 editions of Rx IP Update.
Hospira brought a further application to judicially review the Minister's decision, challenging the Minister's interpretation and application of the data protection provision of the Food and Drugs Regulations. Hospira asserts that the data protection provision does not apply to its NDS because it was filed before the innovator's drug was listed on the Register of Innovative Products and in any event, it did not directly or indirectly compare its product to the innovator's drug. Hospira's notice of application did not name the innovator nor the drug, again identified as "Chemical Entity A."
On the basis of sanofi-aventis' belief that "Chemical Entity A" is oxaliplatin, and sanofi-aventis' ELOXATIN containing oxaliplatin was listed on the Register of Innovative Drugs on June 15, 2007, sanofi-aventis brought a motion to be added as a party. Although Hospira did not admit (and the Court did not determine) that "Chemical Entity A" is oxaliplatin, for the purposes of the decision, the Court assumed that it is.
The Court held, "It is beyond question that the order sought will directly prejudice Sanofi, as it will remove the protection and its right to the exclusion of Hospira's product from the market, both of which were intended for Sanofi's direct benefit." The Court therefore held that the "innovator whose product is listed on the Register of Innovative Drugs as corresponding to "Chemical Entity A" is a person directly affected by the order sought" by Hospira, and ordered that Hospira add the innovator as a party to the application. Sanofi-aventis Canada was subsequently named as a respondent. Hospira has appealed.
Hospira Healthcare Corporation v the Minister of Health, February 26, 2014.
Federal Court decision — 2014 FC 179.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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oxycodone (OXYCONTIN; OXYNEO)
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Applicant:
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Actavis Pharma Company (formerly Cobalt Pharmaceuticals Company)
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Respondents:
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The Minister of Health and the Attorney General of Canada
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Date Commenced:
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March 26, 2014
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Court File No.:
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T-742-14
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Comment:
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Application for an Order quashing the Minister's decision which found Cobalt's Supplemental Abbreviated New Drug Submission (SANDS) No. 166129 triggered the application of section 5(2) of the PMNOC Regulations and for a declaration that Cobalt is not required to address Patents Nos. 2,595,954 and 2,661,573 in relation to SANDS 166129.
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Medicine:
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Unidentified
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Applicant:
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Bayer Inc
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Respondents:
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The Minister of Health
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Date Commenced:
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March 26, 2014
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Court File No.:
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T-743-14
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Comment:
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Application for judicial review of a decision of the Minister to disclose third party information belonging to the applicant pursuant to a request under the Access to Information Act.
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Medicine:
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tadalafil (CIALIS)
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Applicant:
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Eli Lilly Canada Inc
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Respondents:
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Teva Canada Limited and the Minister of Health
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Respondent/Patentee:
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ICOS Corporation
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Date Commenced:
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April 4, 2014
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Court File No.:
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T-847-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,181,377. Teva alleges non-infringement (certain claims only), and invalidity.
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Medicine:
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tadalafil (CIALIS)
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Applicant:
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Eli Lilly Canada Inc
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Respondents:
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Teva Canada Limited and the Minister of Health
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Respondent/Patentee:
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ICOS Corporation
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Date Commenced:
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April 4, 2014
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Court File No.:
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T-848-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,371,684. Teva alleges non-infringement and invalidity.
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Medicine:
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tadalafil (CIALIS)
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Applicant:
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Eli Lilly Canada Inc
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Respondents:
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Teva Canada Limited and the Minister of Health
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Respondent/Patentee:
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ICOS Corporation
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Date Commenced:
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April 4, 2014
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Court File No.:
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T-849-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,379,948. Teva pleads non-infringement (certain claims only), and invalidity.
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Medicine:
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tadalafil (CIALIS)
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Applicant:
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Eli Lilly Canada Inc
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Respondents:
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Teva Canada Limited and the Minister of Health
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Respondent/Patentee:
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ICOS Corporation
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Date Commenced:
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April 4, 2014
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Court File No.:
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T-850-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,226,784. Teva alleges non-infringement (certain claims only), and invalidity.
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Medicine:
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gatifloxacin (ZYMAR)
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Applicant:
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Allergan Inc
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Respondents:
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Apotex Inc and the Minister of Health
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Respondent/Patentee:
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Senju Pharmaceutical Co, Ltd and Kyorin Pharmaceutical Co, Ltd
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Date Commenced:
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April 7, 2014
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Court File No.:
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T-852-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,307,632. Apotex alleges non-infringement (certain claims only), and invalidity.
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Medicine:
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bortezomib (VELCADE)
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Applicant:
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Janssen Inc
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Respondents:
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Dr. Reddy's Laboratories, Inc and Dr. Reddy's Laboratories Limited and the Minister of Health
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Respondent Licensee and Sub-Licensor:
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Millennium Pharmaceuticals Inc
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Respondent Patentee:
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United States of America represented by the Secretary, Department of Health and Human Services
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Date Commenced:
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April 15, 2014
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Court File No.:
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T-919-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,435,146. Dr. Reddy's alleges non-infringement.
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Medicine:
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varenicline tartrate (CHAMPIX)
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Applicant:
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Pfizer Canada Inc and Pfizer Products Inc
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Respondents:
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Apotex Inc and the Minister of Health
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Date Commenced:
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April 17, 2014
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Court File No.:
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T-928-14
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,316,921; 2,447,405 and 2,467,490. Apotex alleges non-infringement and invalidity regarding all three patents.
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