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Supreme Court grants Apotex leave to consider PLAVIX patent for the second time
As reported in the January 2014 special edition of Rx IP Update, on January 30, 2014, the Supreme Court of Canada granted Apotex leave to appeal a decision of the Federal Court of Appeal which overturned a Federal Court's decision invalidating the patent that claims clopidogrel bisulphate (sanofi-aventis' PLAVIX) (SCC Case No. 35562; Federal Court of Appeal decision 2013 FCA 186; reversing Federal Court decision 2011 FC 1486).
Health Canada and Federal Court made important biologic decisions related to monoclonal antibodies in January 2014
As reported in the January 20, 2014 issue of IP Update — Canada, (i) on January 15, 2014, Health Canada approved two antibody subsequent entry biologics, both containing the monoclonal antibody, infliximab, as the medicinal ingredient and (ii) the Federal Court concluded that Janssen Inc (Janssen)'s antibody drug STELARA (ustekinumab) infringed Abbvie Corporation's patent for the use of an antibody with certain characteristics for the treatment of psoriasis, and that the patent was valid.
Health Canada news
Electronic health product submissions comes to Canada. On January 31, 2014, Health Canada announced the launch of the Common Electronic Submissions Gateway (CESG), making it possible for companies to begin sending drug authorization data to Health Canada online using a special dedicated channel of the United States Food and Drug Administration's existing system.
Announcement. Common electronic submissions gateway. FDA's blog about the CESG.
CADTH reports on subsequent entry biologics
The Canadian Agency for Drugs and Technologies in Health ("CADTH") has recently released an Environmental Scan — a short report on current or emerging issues in health care technology — entitled "Subsequent Entry Biologics — Emerging Trends in Regulatory and Health Technology Assessment Frameworks." The report contains an overview of the subsequent entry biologic ("SEB") landscape, and the purpose is to understand the implications for Canada and the world, to assist in developing approaches to the review and reimbursement of SEBs.
Patented Medicine Prices Review Board news
New NEWSletter released. The PMPRB released the January 2014 issue of its NEWSletter. The NEWSletter publishes, inter alia, changes to submissions by patentees on level of therapeutic improvement, 2013 CPI-based price-adjustment factors, a new lagged CPI-adjustment methodology initiative to be implemented for 2015, and 2015 CPI-based price-adjustment factors for patented drug products.
Revision to NPDUIS study Wholesale Up-charge Policies of Canada's Public Drug Plans. On January 11, 2014, the PMPRB made a revision to the NPDUIS analytical study, Wholesale Up-charge Policies of Canada's Public Drug Plans (originally posted on the PMPRB website on December 29, 2011; reported in the January 2012 issue of Rx IP Update) to change the text for Nova Scotia to accurately reflect the reimbursement policies in place as of December 2011.
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
Federal Court dismisses application for prohibition Order re: efavirenz. Justice Barnes dismissed Bristol-Myers Squibb ("BMS"), Gilead Sciences and Merck Sharp & Dohme's application for an Order of prohibition regarding a combination anti-retroviral medicine containing efavirenz (marketed by BMS as ATRIPLA). Teva asserted obviousness and anticipation of Patent No. 2,279,198 (the 198 Patent) which claims Form I efavirenz, and non-infringement. The infringement issue turned on whether Teva's starting medicinal compound would convert to Form I efavirenz during the tablet manufacturing process. Justice Barnes found that in the absence of grinding or prolonged exposure to temperatures exceeding those used by Teva, the Teva starting material would not convert to Form I efavirenz. Because the infringement issue was determinative, Justice Barnes did not consider the validity allegations.
Bristol-Myers Squibb v Teva Canada Limited, January 13, 2014
Federal Court decision — 2014 FC 30.
Federal Court of Appeal dismisses appeal of prohibition Order re: zoledronic acid. As reported in the October 2013 edition of Rx IP Update, Justice Hughes had dismissed Novartis' application for an Order prohibiting the Minister of Health from issuing a Notice of Compliance to Cobalt in respect of zoledronic acid (Novartis' ACLASTA) on the ground of unpatentable subject matter. The Court of Appeal upheld this decision, concluding that Justice Hughes neither erred in construing the patent, nor in concluding that a method of medical treatment is not patentable subject matter.
Novartis Pharmaceuticals Canada Inc v Cobalt Pharmaceuticals Company, January 27, 2014
Federal Court of Appeal decision — 2014 FCA 17.
Federal Court decision — 2014 FC 30.
Other decisions
Federal Court of Appeal upholds invalidity of VIAGRA patent on basis of insufficiency. On January 22, 2014, the Court of Appeal dismissed Pfizer's appeal of Justice Zinn's judgment granting Apotex's motion for summary judgment impeaching the patent claiming the use of sildenafil for treatment of erectile dysfunction, on the basis of insufficiency, following the Supreme Court's decision in Teva Canada Ltd v Pfizer Canada Inc, 2012 SCC 60 ("Teva SCC"). The decision of Justice Zinn was reported in the December 2012 edition of Rx IP Update. The Court of Appeal agreed with Pfizer that Teva SCC was based on a particular construction "which cannot be conclusive for all purposes because, in the context of an application under the NOC Regulations ... any conclusion on the construction of the patent is necessarily provisional." However, the Court of Appeal found there was no evidence that addresses how the skilled reader would have construed the specification and why that construction casts doubt on the construction adopted in Teva SCC.
Apotex Inc v Pfizer Ireland Pharmaceuticals, January 22, 2014
Federal Court of Appeal decision — 2014 FCA 13.
Federal Court decision — 2012 FC 1339
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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mixed amphetamine salts (ADDERALL XR)
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Applicant:
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Shire Canada Inc
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Respondents:
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Pharmascience Inc and the Minister of Health
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Respondent/Patentee:
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Shire LLC
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Date Commenced:
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January 16, 2014
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Court File No.:
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T-259-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,348,090. Pharmascience alleges non-infringement and invalidity.
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Other proceedings
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Medicine:
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telmisartan (Apo-Telmisartan, Apo-Telmisartan HCTZ)
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Plaintiffs:
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Apotex Inc
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Defendants:
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Minister of Health and the Attorney General of Canada
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Date Commenced:
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December 31, 2013
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Court File No.:
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T-2131-13
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Comment:
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Application for judicial review of the Minister of Health's decision refusing to issue notices of compliance to Apotex for its Apo-Telmisartan and Apo-Telmisartan HCTZ tablets. Apotex alleges that the Minister is under a mandatory duty to issue the NOCs having regard to the Federal Court's decision in Apotex Inc v Canada (Health), 2013 FC 1217.
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Medicine:
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quinapril (ACCUPRIL and ACCURETIC)
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Plaintiffs:
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Apotex Inc
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Defendants:
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Pfizer Canada Inc, and Pfizer Inc
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Date Commenced:
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December 30, 2013
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Court File No.:
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CV-13-495640
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Comment:
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Action for damages for breach of contract. Apotex alleges breach of a Settlement Agreement.
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To check the status of Federal Court cases, please click here.
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