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Federal Court sets aside PMPRB decision regarding COPAXONE Syringes for the second time
On April 30, 2013, Justice Zinn of the Federal Court set aside a decision of the PMPRB wherein it ordered Teva to pay the government $2,801,285 for having sold COPAXONE Syringes (glatiramer acetate) at an "excessive price" between 2004 and 2010. This is not the first time a decision of the Board regarding COPAXONE has been overturned by the Federal Court.
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Supreme Court of Canada news
Apotex denied leave to appeal re: Apo-Omeprazole tablets. On April 25, 2013, the Supreme Court denied Apotex leave to appeal a Federal Court of Appeal decision (reported in the January 2013 issue of Rx IP Update) dismissing Apotex's appeal of the Federal Court's rejection of Apotex's challenge to decisions denying an NOC for Apo-Omeprazole tablets. The application was dismissed as being outside the 30-day limit, and the Federal Court refused to extend the time limit. The Court also dismissed Apotex's claims that it had a vested interest to an NOC. The Court determined that the Minister is fully entitled to revisit scientific issues at any point in the process up to the actual issuance of an NOC. The Court of Appeal disagreed with Apotex's arguments that 1. its application was not subject to the 30-day filing requirement, 2. it did meet the test for an extension of time, and 3. it did have a vested right to an NOC.
Apotex Inc v Canada (Health), February 5, 2013 (SCC Case No. 35209).
Federal Court of Appeal decision — 2012 FCA 322.
Federal Court decision — 2011 FC 1308.
Health Canada news
Government of Canada reports on new approach to natural health products. As reported in the February 2013 edition of Rx IP Update, the Government of Canada has implemented new measures for regulating natural health products ("NHPs").
The Natural Health Products Regulations ("NHP Regulations") came into effect in 2004. Under the NHP Regulations, natural health products sold in Canada require a licence, and Canadian sites that manufacture, package, label and import these products require a site licence. Products already on the market when the NHP Regulations came into effect also require licences, which resulted in unprocessed applications. The Government therefore introduced the Natural Health Products (Unprocessed Product Licence Applications) Regulations ("NHP-UPLAR") in August 2010, which allowed products to be legally sold in cases where Health Canada had not completed its licensing decision in 180 days. NHP-UPLAR ended in February 2013, and in the same month the Parliamentary Secretary of Health announced a new approach to natural health products that includes new policies, process improvements and newly revised guidance for licensing NHPs. Features of the new approach are product licensing in 180 days or less and a continued recognition of safety as the top priority.
On April 11, 2013, the Parliamentary Secretary of Health announced that the new approach played a key role in clearing a backlog of more than 10,000 natural health product applications.
News release. February 2, 2013, news release. Regulating natural health products in Canada.
Health Canada launches Clinical Trials Database. Health Canada has announced that it will publish certain information regarding Clinical Trial Applications for which Health Canada provided a No-Objection Letter. The database will be implemented in May and will include certain information for trials that were authorized as of April 1, 2013.
Notice.
Patented Medicine Prices Review Board news
Voluntary Compliance Undertakings. The Board recently accepted a Voluntary Compliance Undertaking ("VCU") for Novo Nordisk's NOVOLIN.
VCU.
New NEWSletter released. The PMPRB has released its April 2013 NEWSletter.
NEWSletter.
New analytical reports. As reported in the November 2011 edition of Rx IP Update, the National Prescription Drug Utilization Information System ("NPDUIS") is a partnership between the PMPRB and the Canadian Institutes for Health Information that aims to provide analyses of drug price, utilization and cost trends in Canada to support drug plan policy decision-making for participating levels of government. On April 5, 2013, the PMPRB, under the NPDUIS initiative, released two analytical reports:
The Use of Blood Glucose Test Strips in Select Public Drug Plans, 2008
New Drug Pipeline Monitor - April 2013- The New Drug Pipeline report is the fourth edition of the report and provides information on drugs currently under development that may have an impact on federal, provincial and territorial drug plan expenditures.
Hearing Panel accepts VCU from Galderma. As reported in the November 2012 issue of Rx IP Update, the PMPRB issued a notice that a hearing would be held to determine whether Galderma was selling or sold TACTUO (adapalene and benzoyl peroxide topical gel) in any market in Canada at a price that in the Board's opinion is or was excessive and, if so, what order (if any) should be made. On April 29, 2013, the Hearing Panel released an Order accepting the joint draft submission of the Board Staff and Galderma, which provided a draft VCU.
Order. VCU.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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travoprost/timolol maleate ophthalmic solution (DUOTRAV)
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Applicants:
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Alcon Canada Inc and Alcon Research, Ltd
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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 12, 2013
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Court File No.:
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T-630-13
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,129,287 and 2,181,172. Apotex alleges invalidity and non-infringement.
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Medicine:
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dutasteride (AVODART)
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Applicants:
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GlaxoSmithKline Inc and GlaxoSmithKline LLC
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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 18, 2013
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Court File No.:
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T-671-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,170,047. Apotex alleges invalidity and non-infringement.
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Other proceedings
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Applicant:
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Novartis Pharmaceuticals Canada Inc
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Respondent:
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Health Canada and the Minister of Health
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Date Commenced:
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March 27, 2013
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Court File No.:
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T-530-13
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Comment:
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Judicial review seeking an Order prohibiting the Minister of Health from disclosing, in response to a request under the Access to Information Act, third party information belonging to Novartis.
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