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Supreme Court upholds validity of Ontario Regulations prohibiting prescription "private label products"
On November 22, 2013, the Supreme Court of Canada upheld the validity of Ontario Regulations prohibiting "private label products" (Katz Group Canada Inc v Ontario (Health and Long-Term Care), 2013 SCC 64).
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CIPO news
Examples of purposive construction analysis of medical use claims for statutory subject matter evaluation. On November 14, 2013, the Canadian Intellectual Property Office (CIPO) published examples of purposive construction of medical use claims for statutory subject matter evaluation. The publication follows CIPO's recent examination guidelines respecting medical use claims (discussed in the July 2013 edition of the Rx IP Update).
Examples
Health Canada news
Amendments to the Food and Drug Regulations come into force. Health Canada has released a Notice to stakeholders that amendments to the Food and Drug Regulations extending the requirements of drug establishment licensing and Good Manufacturing Practices (GMP) to active ingredients used in pharmaceutical drugs for human use only came into force on November 8, 2013. As reported in the June 2013 edition of Rx IP Update, these amendments to the Regulations were made earlier this year.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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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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Accord Healthcare Inc and 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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October 24, 2013
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Court File No.:
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T-1747-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,203,936. Janssen pleads that Accord has not alleged non-infringement or invalidity and "has also not alleged that it will await expiry of the '936 Patent, in a format that is unequivocal, as is required by the Regulations."
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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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Accord Healthcare Inc and 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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October 24, 2013
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Court File No.:
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T-1748-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,435,146. Accord alleges non-infringement (certain claims only) and invalidity.
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Medicine:
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gliclazide MR tablets (DIAMICRON)
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Applicant:
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Les Laboratoires Servier and Servier Canada Inc
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Respondents:
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Mint Pharmaceuticals Inc and the Minister of Health
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Date Commenced:
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October 25, 2013
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Court File No.:
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T-1752-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,629,670. Mint alleges non-infringement and invalidity.
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Medicine:
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calcipotriol and betamethasone (DOVOBET)
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Applicant:
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Leo Pharma Inc
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Respondents:
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Teva Canada Limited and Minister of Health
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Respondent/Patentee:
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Leo Pharma A/S
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Date Commenced:
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October 31, 2013
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Court File No.:
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T-1791-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,370,565. Teva alleges non-infringement (certain claims only) and invalidity.
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Medicine:
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celecoxib (CELEBREX)
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Plaintiffs:
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Pfizer Canada Inc and GD Searle & Co
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Defendants:
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Mint Pharmaceuticals Inc and the
Minister of Health
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Date Commenced:
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November 1, 2013
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Court File No.:
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T-1798-13
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Comment:
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Application for Order of prohibition until expiry of Patent No 2,177,576. Teva alleges non-infringement (certain claims only) and invalidity.
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Other proceedings
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Medicine:
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pyrithione zinc shampoos and conditioners (CLEAR and DOVE)
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Plaintiffs:
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The Procter & Gamble Company and Procter & Gamble Inc
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Defendants:
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Unilever Canada Inc, Unilever United States Inc, Conopco Inc, dba Unilever, Unilever PLC and Unilever NV
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Date Commenced:
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October 24, 2013
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Court File No.:
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T-1751-13
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Comment:
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Patent infringement action regarding Patents Nos. 2,370,938 and 2,370,939.
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Medicine:
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valacyclovir hydrochloride (VALTREX, CO VALACYCLOVIR)
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Plaintiffs:
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GlaxoSmithKline Inc, The Wellcome Foundation Limited, Glaxo Group Limited, GlaxoSmithKline Intellectual Property (No 2) Limited, GlaxoSmithKline Trading Services Limited, GlaxoSmithKline Export Limited, GlaxoSmithKline LLC and Glaxo Wellcome SA
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Defendants:
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Cobalt Pharmaceuticals Company and Cobalt Pharmaceuticals Inc
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Date Commenced:
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October 28, 2013
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Court File No.:
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T-1763-13
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Comment:
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Patent infringement action regarding Patent No. 1,340,083.
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Medicine:
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valacyclovir hydrochloride (VALTREX, MYLAN- VALACYCLOVIR)
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Plaintiffs:
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GlaxoSmithKline Inc, The Wellcome Foundation Limited, Glaxo Group Limited, GlaxoSmithKline Intellectual Property (No 2) Limited, GlaxoSmithKline Trading Services Limited, GlaxoSmithKline Export Limited, GlaxoSmithKline LLC and Glaxo Wellcome SA
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Defendants:
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Mylan Pharmaceuticals ULC
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Date Commenced:
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October 28, 2013
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Court File No.:
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T-1764-13
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Comment:
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Patent infringement action regarding Patent No. 1,340,083.
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Medicine:
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valacyclovir hydrochloride (VALTREX, AURO- VALACYCLOVIR)
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Plaintiffs:
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GlaxoSmithKline Inc, The Wellcome Foundation Limited, Glaxo Group Limited, GlaxoSmithKline Intellectual Property (No 2) Limited, GlaxoSmithKline Trading Services Limited, GlaxoSmithKline Export Limited, GlaxoSmithKline LLC and Glaxo Wellcome SA
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Defendants:
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Auro Pharma Inc
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Date Commenced:
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October 28, 2013
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Court File No.:
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T-1766-13
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Comment:
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Patent infringement action regarding Patent No. 1,340,083.
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Medicine:
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olanzapine (ZYPREXA, Apo-olanzapine)
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Plaintiffs:
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Apotex Inc and Apotex Pharmachem Inc
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Defendants:
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Eli Lilly Canada Inc, Eli Lilly and Company, Eli Lilly and Company Limited and Eli Lilly SA
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Date Commenced:
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November 7, 2013
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Court File No.:
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CV-13-492419
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Comment:
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Action for treble damages pursuant to section 4 of An Act concerning Monopolies, and Dispensation with penal laws, etc; damages pursuant to the Regulations; and/or an accounting of the defendants' profits, based on assertions including that Patent No. 2,014,113 Patent "is and always has been invalid, void and of no effect and accordingly, should have never issued."
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To check the status of Federal Court cases, please click here.
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