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Text of CETA finalized
As reported in the August 6, 2014 IP Update, the Government of Canada announced that the text of the Comprehensive Economic and Trade Agreement (CETA) was finalized on August 5, 2014. The text has not yet been published.
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Health Canada news
Release of Therapeutic Products Directorate Statistical Report. The Therapeutic Products Directorate released its report containing a statistical overview of Health Canada's administration of the Patented Medicines (Notice of Compliance) Regulations, and data protection under the Food and Drug Regulations for the 2013/2014 fiscal year.
Therapeutic Products Directorate Statistical Report.
Guidance Document for Industry — Review of Drug Brand Names. Health Canada has released a Guidance Document for the Review of Drug Brand Names. The Guidance Document aims to provide market authorization holders direction on the process to be followed and information to be submitted to Health Canada for its assessment of the acceptability of a proposed drug brand name. The Guidance Document applies to prescription products and products administered or obtained through a health professional. A separate brand name assessment framework will be developed for non-prescription (over-the-counter) products and natural health products. Full implementation of the Guidance Document will commence twelve months after registration of the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use), which were registered June 13, 2014 (as reported in the July 2014 issue of Rx IP Update).
Guidance Document for Industry — Review of Drug Brand Names.
Patented Medicine Prices Review Board news
New NEWSletter released. The PMPRB released the July 2014 issue of its NEWSletter. The NEWSletter published, inter alia, the appointment of a new board member and various staffing changes, including the retirement of Sylvie Dupont, and the anticipated fall publication of three NPDUIS studies.
Voluntary Compliance Undertakings. The Board recently approved Voluntary Compliance Undertakings (VCUs) for Novartis's LAMISIL (terbinafine hydrochloride, VCU) and EMD's GONAL F (follitropin alfa, VCU).
Government of Canada serves Statement of Defence in response to Eli Lilly's NAFTA challenge
As reported in the October 2013 issue of Rx IP Update, Eli Lilly filed a Notice of Arbitration pursuant to the North American Free Trade Agreement (NAFTA) seeking damages from the Government of Canada, asserting that the Canadian judiciary's application of the promise doctrine to Eli Lilly's STRATTERA (atomoxetine) and ZYPREXA (olanzapine) patents contravenes Canada's obligations under NAFTA and the Patent Cooperation Treaty (PCT). On June 30, 2014, the Canadian Government served its Statement of Defence.
Supreme Court of Canada grants leave to intervene in PLAVIX appeal
Leave to intervene has been granted to (1) Fédération internationale des conseils en propriété intellectuelle, (2) Canada's Research-Based Pharmaceutical Companies, (3) the Centre for Intellectual Property Policy, (4) the International Association for the Protection of Intellectual Property, (5) BIOTECanada and (6) the Canadian Generic Pharmaceutical Association in the upcoming Supreme Court of Canada hearing of Apotex's appeal regarding the validity of the patent claiming clopidogrel (PLAVIX). The appeal is tentatively scheduled for November 4, 2014. The Supreme Court is expected to address issues regarding the "promise" doctrine of utility, providing guidance on an issue that has been central to a number of pharmaceutical patent decisions in the last number of years (reported in the January 2014 special edition of Rx IP Update)
SCC Case No. 35562.
Recent Court decisions
Portions of challenge to Canada's authority to regulate "natural health products" struck. The plaintiffs, present or past users, manufacturers, or distributors of products that fall within the definition of "natural health product" under the Natural Health Products Regulations (NHPR) brought an action based on constitutional challenges to certain provisions of the Food and Drugs Act and the NHPR, and claiming damages based on alleged Charter breaches and tortious conduct in the implementation and enforcement of the Act and Regulations. The plaintiffs' assertion generally is that food, dietary food supplements and vitamins should be classified as food, and not drugs, and that the enforcement and inspection system to which they are subject to should be akin to the food inspection and enforcement system, not the pharmaceutical and/or prohibited drug system. Justice Russell struck a number of paragraphs of the statement of claim, with leave to amend.
Nick Mancuso et al v Canada (National Health and Welfare), 2014 FC 708.
BC Supreme Court finds College of Pharmacists' ban on inducements and incentives unreasonable. On July 25, 2014, the BC Supreme Court struck down bylaws of the College of Pharmacists of British Columbia prohibiting customer incentive programs offered in conjunction with pharmacy services. The incentive programs included customer benefit and customer loyalty programs. The Court held that the bylaws were unreasonable, as they were overbroad and harmful to the public interest.
Sobeys West Inc v College of Pharmacists of British Columbia, 2014 BCSC 1414.
Trademark decisions
Johnson & Johnson successfully opposes registration of LUMINADERM. NovaBiotics applied to register the trademark LUMINADERM to be used in association with wares generally described as anti-infective, antiseptic, antimicrobial, antiviral, antifungal and antibacterial preparations and substances. Johnson & Johnson ("J&J") successfully opposed the application on the basis of a reasonable likelihood of confusion between LUMINADERM and several of J&J's trademarks which have been registered and/or used in association with various skin lotions and creams and which consist of or incorporate the term LUBRIDERM, and on the ground of non-distinctiveness.
Johnson & Johnson v NovaBiotics Limited, 2014 TMOB 109.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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atazanavir sulfate (REYATAZ)
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Applicants:
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Bristol-Myers Squibb Canada Co, Bristol-Myers Squibb Holdings Ireland and Novartis AG
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Respondents:
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The Minister of Health and Teva Canada Limited
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Date Commenced:
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June 3, 2014
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Court File No.:
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T-1364-14
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,250,840 and 2,317,736. Teva alleges invalidity (certain claims only) and non-infringement (840 patent only).
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Medicine:
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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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Apotex 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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June 9, 2014
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Court File No.:
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T-1392-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,348,090. Apotex alleges non-infringement and 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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Sandoz Canada Inc 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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June 12, 2014
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Court File No.:
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T-1416-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,203,936. Sandoz alleges invalidity and patent ineligibility.
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Medicine:
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infliximab powder (REMICADE)
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Applicants:
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Janssen Inc and The Kennedy Trust for Rheumatology Research
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Respondents:
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Attorney General of Canada, the Minister of Health and Hospira Healthcare Corporation
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Date Commenced:
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July 2, 2014
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Court File No.:
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T-1516-14
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Comment:
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Application for judicial review, seeking to quash the NOC issued to Hospira for INFLECTRA, without requiring Hospira to address Patent No. 2,261,630 listed on the Patent Register.
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Medicine:
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darifenacin hydrobromide (ENABLEX)
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Applicant:
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Merus Labs Luxco S.à.R.L
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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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July 10, 2014
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Court File No.:
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T-1576-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,230,314. Apotex alleges invalidity and non-infringement.
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Medicine:
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darunavir (PREZISTA)
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Applicant:
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Janssen Inc
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Respondents:
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Mylan Pharmaceuticals ULC and the Minister of Health
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Respondent Patentee:
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Janssen R&D Ireland (formerly Tibotec Pharmaceuticals Ltd.)
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Date Commenced:
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July 11, 2014
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Court File No.:
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T-1577-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,485,834. Mylan alleges invalidity and non-infringement.
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Medicine:
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dariferacin hydrobromide (ENABLEX)
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Applicant:
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Merus Labs Luxco S.à.R.L
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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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July 14, 2014
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Court File No.:
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T-1588-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,469,702. Apotex alleges non-infringement and invalidity.
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To check the status of Federal Court cases, please click here.
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