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Ontario Court of Appeal upholds injunction preventing online prescription drug retailer selling drugs in the United States from operating call and processing facilities in Ontario
The Ontario Court of Appeal recently upheld an injunction preventing an online prescription drug retailer — one that sources drugs internationally and sells them to customers in the United States without them ever entering Canada — from operating call and processing facilities in Ontario.
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Supreme Court varies VIAGRA ruling, confirms that patent is neither invalid nor void
The Supreme Court of Canada has clarified its ruling in Teva Canada Ltd v Pfizer Canada Inc and has confirmed that the patent in issue is neither invalid nor void, finding instead that Teva had established its allegation and therefore dismissing Pfizer's application for an Order of prohibition.
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Supreme Court of Canada news
Supreme Court denies application for leave to appeal decision denying data protection for the enantiomer DEXILANT. On June 13, 2013, the Supreme Court denied Takeda leave to appeal the Federal Court of Appeal's decision refusing to quash the Minister of Health's decision to refuse to list DEXILANT (dexlansoprazole) on the Register of Innovative Drugs. Dexlansoprazole is one of the enantiomers of the previously approved racemate lansoprazole (currently marketed as PREVACID). The Minister held that dexlansoprazole was not eligible for listing on the Register because it is a variation that is specifically excluded from the definition of "innovative drug" in section C.08.004.1 of the Food and Drug Regulations. As reported in the February 2013 issue of Rx IP Update, the majority of the Federal Court of Appeal agreed with the Minister that the language of the definition is clear and the five listed categories of substances are automatically considered variations of previously approved drugs.
Takeda Canada Inc v Canada (Health), June 13, 2013 (SCC Case No. 35276).
Federal Court of Appeal decision — 2013 FCA 13.
Federal Court decision — 2011 FC 1444.
CIPO News
Guidelines for medical use claims. On June 10, 2013, the Canadian Intellectual Property Office (CIPO) issued guidelines concerning the examination of patent claims relating to medical uses, providing a framework by which examiners are to analyze such claims. This guidance follows CIPO's recent guidelines concerning the requirement for a "purposive construction" of the claims during examination.
Smart & Biggar summary of guidelines. CIPO's medical use guidelines.
Government of Canada news
Plain Language Labelling Initiative. On June 14, 2013, the Minister of Health announced the launch of the Government's "Plain Language Labelling Initiative" for drugs. The initiative is designed to "improve the safe use of drugs by making drug labels and safety information easier to read and understand" and will be implemented with regulatory and guidance updates, development and outreach. Key aspects of the initiative include labels in plain language, standardization of the format of non-prescription drug labels, inclusion of contact information on labels for reporting problems and adverse drug reactions, and that manufacturers provide mock-ups of labels and packages and evidence that drug names will not be confused with other authorized products.
Proposed amendments to the Food and Drug Regulations were published on June 22. Health Canada is also proposing modifications to its processes, including the creation of new documents and revisions to guidance documents. Health Canada has published information for industry regarding the proposed Fact Table and mock-ups and for Canadians regarding the initiative. Consultation with Health Canada is open until September 6.
Amendments and Regulatory Impact analysis statement. Government announcement. Fact sheet. Health Canada announcement of consultation. Information for Industry on the proposed regulatory amendment for a Fact Table. Information for Industry on the proposed regulatory amendments to submit mock-ups of labels. Information for Canadians about the Plain Language Labelling Initiative.
Amendments to the Food and Drug Regulations (Schedule F). Amendments to the Food and Drug Regulations that repeal Schedule F were published on June 14, 2013. Schedule F listed medicinal ingredients required to be sold by prescription in Canada. Under the previous Food and Drug Regulations, medicinal ingredients could only be added or removed from Schedule F by approval from the Governor in Council. The amendments 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 amended Regulations, which are intended to make it easier and quicker to assign prescription status to a drug.
Health Canada has released a related guidance document (Determining Prescription Status for Human and Veterinary Drugs) and a Prescription Drug List.
Canada Gazette. Guidance document. The Prescription Drug List.
Government responds to Standing Committee Report on the Intellectual Property Regime in Canada. As reported in the April 2013 issue of Rx IP Update, the Standing Committee on Industry, Science and Technology had tabled a report that included a discussion of the Comprehensive Economic and Trade Agreement ("CETA") and intellectual property protection in the Canadian pharmaceutical industry. The Government of Canada has now responded to certain recommendations in that report. Among other statements, the response states that "the Government will ensure the patent regime continues to support a vibrant pharmaceutical industry, allows for timely access to new and innovative drugs, while also allowing for the timely entry of lower-priced generic drugs." The response also indicates that "engagement with the pharmaceutical sector will remain a key priority for the Government."
Government Response. Committee Report.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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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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Cobalt Pharmaceuticals Company 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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May 31, 2013
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Court File No.:
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T-966-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,371,684. Cobalt 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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Cobalt Pharmaceuticals Company 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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May 31, 2013
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Court File No.:
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T-967-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,379,948. Cobalt 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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Cobalt Pharmaceuticals Company 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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May 31, 2013
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Court File No.:
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T-968-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,226,784. Cobalt 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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Cobalt Pharmaceuticals Company 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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May 31, 2013
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Court File No.:
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T-969-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,380,087. Cobalt 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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Cobalt Pharmaceuticals Company 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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May 31, 2013
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Court File No.:
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T-970-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,181,377. Cobalt alleges non-infringement and invalidity.
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Other proceedings
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Plaintiff:
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Teva Canada Limited
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Defendants:
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Eli Lilly Canada Inc and Eli Lilly and Company
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Date Commenced:
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June 4, 2013
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Court File No.:
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T-989-13
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Comment:
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Trademark infringement action concerning Teva's registered trademark NOVOPHARM. Teva alleges that Eli Lilly made false and misleading statements to Teva's customers and potential customers concerning Canadian Patent No. 2,041,133 and Teva's generic olanzapine product.
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To check the status of Federal Court cases, please click here.
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