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Ontario Court rejects claim for unjust enrichment under Regulations
The Ontario Superior Court of Justice has dismissed a claim by Apotex for unjust enrichment under the Patented Medicines (Notice of Compliance) Regulations.
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Federal Court of Appeal allows impeachment action to proceed regarding an expired patent on the basis that rights under the Statute of Monopolies of Ontario could be affected
On December 5, 2012, the Federal Court of Appeal allowed Apotex's impeachment action regarding two patents relating to quinapril (ACCUPRIL) to proceed, even though one of the patents at issue had expired. The parties agreed that the action with respect to the patent was moot; however, Apotex argued that dismissal of the action will affect rights under the Statute of Monopolies of Ontario and section 8 of the Patented Medicines (Notice of Compliance) Regulations.
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Patented Medicine Prices Review Board news
Voluntary Compliance Undertakings. The Board recently approved Voluntary Compliance Undertakings ("VCUs") for Pfizer's LYRICA (pregabalin, VCU), Eisai's BANZEL (rufinamide, VCU) and HALAVEN (eribulin mesylate, VCU), and Baxter's PROCYTOX (cyclophosphamide), UROMITEXAN (mesna) and IFEX (ifosfamide) (VCU).
New PMPRB Rules. On November 23, 2012, new Rules of Practice and Procedure for the PMPRB came into force. According to the Regulatory Impact Analysis Statement, the objective in adopting these rules is to regulate the practice and procedure of Board hearings to enhance the transparency of the Board's activities, consistency in the exercise of the Board's formal powers, fairness to all parties appearing before the Board, and the timely completion of hearings. The proposed rules codify terminology and practices already informally adopted by the Board, incorporate practices to improve areas such as expert witnesses and case management, and introduce or amend timelines for certain steps in a proceeding.
Patented Medicine Prices Review Board Rules of Practice and Procedure. Patent Act, SOR/2012-247.
Health Canada news
Proposed amendments to the Food and Drug Regulations (Schedule F). On December 22, 2012, proposed amendments to the Food and Drug Regulations that would repeal Schedule F were published. Schedule F lists medicinal ingredients required to be sold by prescription in Canada. Under the current Food and Drug Regulations, medicinal ingredients can only be added or removed from Schedule F by approval from the Governor in Council. The proposed amendments would enable the Minister of Health to establish a list of prescription drugs and to provide that the list be incorporated by reference into the Food and Drug Regulations. Adding or removing a drug will still require scientific review under the proposed amendments, which are intended to make it easier and quicker to assign prescription status to a drug.
Health Canada has prepared a draft guidance document, draft new Prescription Drug List and a question-and-answer document related to the proposed amendments. Public consultation is open until March 7, 2013.
Canada Gazette. Consultation. Draft guidance document. Question-and-answer document. Proposed Prescription Drug List.
Health Canada guidance on drug establishment licences. On December 21, 2012, Health Canada released a guidance document relating to drug establishment licences and licensing, together with a list of frequently asked questions.
Guidance document. Frequently asked questions.
Eli Lilly challenges Canadian law under NAFTA
On November 7, 2012, Eli Lilly served the Government of Canada with a Notice of Intent to Submit a Claim to Arbitration under NAFTA Chapter 11 ("Notice"). The claim relates to Eli Lilly's STRATTERA (atomoxetine). In an impeachment action, the Federal Court of Canada held that the patent claiming the use of atomoxetine to treat attention deficit hyperactivity disorder was invalid on the basis of inutility (lack of demonstrated utility and lack of sound prediction; reported in the October 2010 issue of Rx IP Update). The Court of Appeal upheld this decision (reported in the August 2011 issue of Rx IP Update), and the Supreme Court of Canada denied leave to appeal. In the Notice, Eli Lilly alleges that as a result of recent developments in Canadian law relating to utility and disclosure, in particular the "promise doctrine" and disclosure requirements, Canada is in contravention of its international obligations regarding patent rights.
According to the Notice, Eli Lilly seeks to have the Government of Canada "rectify the situation" and remedy violations to investment obligations owed to Eli Lilly. If the consultations are not successful then Eli Lilly will submit a claim for damages, which it estimates to be not less than $100 million.
Notice of Intent. Government notice.
Eli Lilly and Company v Teva Canada Limited (SCC Case No. 34396).
Federal Court of Appeal decision — 2011 FCA 220.
Federal Court decision — 2010 FC 915.
Recent Court decisions
Court of Appeal upholds decision denying NOC for Apo-Omeprazole. As reported in the December 2011 issue of Rx IP Update, the Federal Court rejected 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 Court refused to extend the time limit. The Court also dismissed Apotex's claims that it had a vested interest in 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.
Apotex appealed, arguing that its application was not subject to the 30-day filing requirement, it did meet the test for an extension of time and it did have a vested right to an NOC. The Court of Appeal disagreed on all three issues and upheld the lower Court's decision.
Apotex Inc v Canada (Health), December 7, 2012.
Federal Court of Appeal decision — 2012 FCA 322.
Federal Court decision — 2011 FC 1308.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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moxifloxacin hydrochloride (VIGAMOX)
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Applicants:
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Alcon Canada Inc and Bayer Intellectual Property GmbH
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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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December 5, 2012
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Court File No.:
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T-2178-12
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 1,340,114 and 2,192,418. Apotex alleges non-infringement and invalidity and asserts patent ineligibility.
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Medicine:
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moxifloxacin hydrochloride (VIGAMOX)
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Applicants:
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Alcon Canada Inc and Alcon Pharmaceuticals 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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December 5, 2012
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Court File No.:
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T-2179-12
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,342,211. Apotex alleges non-infringement and invalidity and asserts patent ineligibility.
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Medicine:
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bortezomib mannitol boronic ester (VELCADE)
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Applicant:
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Janssen 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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Millennium Pharmaceuticals Inc
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Date Commenced:
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December 7, 2012
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Court File No.:
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T-2194-12
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,203,936. Teva alleges invalidity.
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Medicine:
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bortezomib mannitol boronic ester (VELCADE)
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Applicant:
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Janssen Inc
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Respondents:
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Teva Canada 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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December 7, 2012
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Court File No.:
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T-2195-12
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,435,146. Teva alleges non-infringement and invalidity.
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Medicine:
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bupropion hydrochloride (WELLBUTRIN XL)
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Applicants:
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Valeant Pharmaceuticals International Inc, Valeant International Bermuda and Valeant Canada LP/Valeant Canada SEC
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Respondents:
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The Minister of Health and Pharmascience Inc
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Date Commenced:
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December 27, 2012
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Court File No.:
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T-2284-12
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,524,300 and 2,168,364. Pharmascience alleges non-infringement with respect to the ’364 Patent but does not make any allegations with respect to the ’300 Patent in its NOA, indicating it is addressed in another NOA.
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Medicine:
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imatinib mesylate (GLEEVEC)
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Applicant:
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Novartis Pharmaceuticals Canada Inc
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Respondents:
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Cobalt Pharmaceuticals Company and The Minister of Health
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Respondent/Patentee:
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Novartis AG
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Date Commenced:
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December 28, 2012
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Court File No.:
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T-2289-12
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,093,203, 2,483,199, and 2,622,808. Cobalt alleges non-infringement and invalidity with respect to the ’199 and ’808 Patents. Cobalt agrees to await expiry of the ’203 Patent.
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Other proceedings
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Medicine:
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olopatadine hydrochloride (PATANOL)
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Applicant:
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The Commissioner of Competition
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Respondent:
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Alcon Canada Inc
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Date Commenced:
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December 13, 2012
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Court File No.:
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T-2223-12
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Comment:
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Ex parte motion for an Order, pursuant to paragraphs 11(1)(b) and
11(1)(c) of the Competition Act, requiring Alcon to produce records and information that explain the disruption to the supply of PATANOL.
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Medicine:
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sildenafil citrate (VIAGRA)
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Plaintiff:
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Teva Canada Limited
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Defendants:
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Pfizer Canada Inc, Pfizer Inc and Pfizer Ireland Pharmaceuticals
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Date Commenced:
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December 21, 2012
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Court File No.:
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T-2280-12
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Comment:
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Pursuant to Section 8 of the NOC Regulations, Teva seeks compensation for losses suffered as a result of the Order of Prohibition that was granted against Teva until after the expiry of Pfizer's 2,163,446 Patent. The Supreme Court held that the patent was "void." Teva is seeking compensation for losses suffered between April 25, 2008 and November 8, 2012 and seeks aggravated, punitive and/or exemplary damages.
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To check the status of Federal Court cases, please click here.
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