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Applications to prohibit Mylan-tadalafil dismissed
As reported last month, in January, Lilly succeeded in obtaining an order of prohibition against Mylan in respect of Canadian Patent 2,226,784 (the 784 Patent) relating to the use of tadalafil (Lilly's CIALIS). That prohibition application was heard consecutively with two other prohibition applications by Lilly against Mylan relating to the same drug. In February, the Court dismissed the two further applications.
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Servier's application for prohibition order dismissed re: Apotex's 60 mg modified release gliclazide
On February 16, 2015, Justice Roy dismissed Servier's application for a prohibition order regarding Apotex's 60 mg modified release gliclazide tablet (Servier's DIAMICRON MR): 2015 FC 108. Justice Roy found in Apotex's favour on infringement and validity (obviousness and utility).
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Federal Court dismisses Janssen's applications to prohibit NOC for Teva's bortezomib product
In November and December 2014, the Federal Court dismissed Janssen Inc.'s two applications to prohibit the Minister of Health from issuing a Notice of Compliance (NOC) to Teva Canada Limited for its generic injectable bortezomib product (which was compared to Janssen's VELCADE). Teva's NOC issued on December 18, 2014. The public reasons for the decisions were released in February, 2015.
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Supreme Court of Canada set to hear quantification of section 8 damages appeal on April 20
As we reported previously, sanofi-aventis was granted leave to appeal from the Federal Court of Appeal's decision which addressed quantification of damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations relating to ramipril. Laboratoire Riva Inc., the Canadian Generic Pharmaceutical Association (CGPA) and Canada's Research-Based Pharmaceutical Companies (Rx&D) have sought leave to intervene. The hearing of sanofi-aventis' appeal is tentatively scheduled for April 20, 2015.
sanofi-aventis, et al v Apotex Inc, et al, SCC Case No. 35886.
Federal Court decision — 2012 FC 553.
Federal Court of Appeal — 2014 FCA 68.
Patented Medicine Prices Review Board January NEWSletter released
The PMPRB released the January 2015 issue of its NEWSletter which includes CPI-based price-adjustment factors for 2016, clarification on the Board's Guidelines on existing drug products subsequently sold by another patentee, and the approval of a Voluntary Compliance Undertaking (VCU) for Actavis Specialty Pharmaceutical Co.'s GELNIQUE (oxybutynin chloride).
CADTH news
The Canadian Agency for Drugs and Technologies in Health (CADTH) has released its strategic plan for 2015-2018. The plan, entitled Informing Choices in a New Era of Health Care in Canada, aims to position CADTH as a "key resource to the health care system in Canada" by meeting the following goals: (i) Delivering Value: inform health policy and clinical practice by getting the right information to the right decision-makers at the right time; (ii) Expanding Reach: build receptivity for health evidence; and (iii) Setting the Standard: champion meaningful evidence and leading methods.
CADTH's Canadian Drug Expert Committee (CDEC) recommends that INFLECTRA (infliximab Subsequent Entry Biologic (SEB)) be listed on formularies. As we reported previously, in January 2014 Health Canada approved Celltrion Healthcare Co. Ltd.'s REMSIMA and INFLECTRA, two antibody SEBs to Janssen's REMICADE, that contain a monoclonal antibody, infliximab, as the medicinal ingredient. Ownership of the latter product was subsequently transferred to Hospira Health Care Corporation. On December 19, 2014, the CDEC recommended that INFLECTRA be listed on formularies in accordance with the Health Canada-approved indications (treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, and psoriatic arthritis), provided: (i) it is used in patients for whom infliximab is considered to be the most appropriate treatment option and (ii) it is listed in a manner similar to REMICADE. The costs considered by the CDEC were: INFLECTRA at $650 per 100 mg vial and REMICADE (under the Ontario Exceptional Access Program) at $987.56 per 100 mg vial.
CDEC Final Recommendation — Inflectra.
Health Canada's Summary Basis of Decision for Inflectra.
Government of Canada files counter memorial in Eli Lilly NAFTA challenge
As we reported previously, Eli Lilly filed its memorial in its arbitration under the North American Free Trade Agreement (NAFTA) seeking damages from the Government of Canada. Eli Lilly asserts 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 January 27, the Government of Canada filed its counter memorial.
Health Canada News
Notice regarding the Guidance Document: Patented Medicines (Notice of Compliance) Regulations: On February 3, Health Canada issued a notice advising that two sections of its Guidance Document regarding the Patented Medicines (Notice of Compliance) Regulations ("PM(NOC Regulations") Regulations have recently been the subject of decisions of the Federal Court and Federal Court of Appeal. As a result of the Court decisions, there has been an impact on Health Canada's application of the PM(NOC) Regulations: (i) section 4 regarding patent listing against combination products and (ii) section 5 regarding administrative drug submissions.
Health Canada's practice regarding listing patents pursuant to s. 4 for combination products has been impacted most recently by a decision relating to the combination product containing abacavir and lamivudine, Viiv's KIVEXA (ViiV Healthcare ULC v Teva Canada Limited, 2014 FC 893, as previously reported; appeal scheduled for April 13, 2015). As we have previously reported, Industry Canada has also announced that it plans to amend the PM(NOC) Regulations to clarify the listing requirements as they relate to patents for single medicinal ingredients against combination drugs.
Health Canada's practice regarding the requirement to address patents for administrative new drug submissions has been impacted by Pfizer Canada Inc v the Minister of Health, 2014 FC 1243 (previously reported) and Actelion Pharmaceuticals Canada Inc v Attorney General of Canada, 2014 FC 1249.
Notice.
Regulations to require mandatory reporting of drug shortages: On February 10, the Government of Canada announced it will advance regulations requiring drug manufacturers to publicly report drug shortages. According to the announcement, "[t]imely, comprehensive and reliable information on actual and anticipated drug shortages will be made publicly available by manufacturers on a new, independent third-party website." In the meantime, manufacturers are expected to voluntarily post information on all shortages on the industry-run website, www.drugshortages.ca. Additionally, Health Canada maintains a register of companies that have committed to publicly notify drug shortages and discontinuances on the industry-run website. In an ongoing effort to advance drug supplier transparency and accountability for public notification of drug shortages and discontinuances, Health Canada also posts letters that it has issued to manufacturers that fail to provide notification of drug shortages.
Announcement.
New online tool for drug safety information: On February 12, the Government of Canada announced the launch of Drug and Health Product Register, a website “designed to provide Canadians with easy access to consumer-friendly information on medicines and vaccines in order to better ensure the health and safety of themselves and their families.” As this is a pilot project, it currently only provides the top 100 prescribed brand name and generic drug products.
Announcement.
Health Canada publishes list of therapeutic products with paediatric information available in their labelling. On February 12, Health Canada issued a notice that it has published a list on its website of all marketed therapeutic products that have paediatric information related to safety and efficacy available in their labelling. In addition to indicating whether the medication is authorized for use in children, the list also identifies innovative drug products that have been granted the paediatric extension (6 months) to data protection (8 years) following the inclusion of results of paediatric clinical trials in their labelling.
Notice; Listing of therapeutic products with paediatric information available in their labelling.
British Columbia Court of Appeal sets aside certification order in sibutramine class action
On January 22, 2015, the British Columbia Court of Appeal allowed an appeal of an order of the Supreme Court of British Columbia certifying a class action in favour of the plaintiffs. The class action was commenced against the defendants Abbott Laboratories and Apotex Inc. on behalf of Canadian patients who had used or purchased sibutramine (MERIDIA and Apo-Sibutramine), alleging that the drug increased the risk of cardiovascular events, including heart attack and stroke. On appeal, Abbott and Apotex argued that the plaintiffs failed to meet the criteria for certification under s. 4 of the Class Proceedings Act by failing to adduce some evidence of a workable methodology to prove causation of damages on a class-wide basis. The Court held that the plaintiffs had only put forward evidence suggesting an increased risk for patients using sibutramine with pre-existing heart conditions, and there was no evidence before the certification judge of a method of establishing that sibutramine actually increased the risk of harm to the wider class of patients. The Court concluded that the question of causation was incapable of resolution based on the evidence at the certification hearing and, accordingly, the certification order was set aside.
Charlton v Abbott Laboratories Ltd, 2013 BCSC 1712.
Charlton v Abbott Laboratories Ltd, 2015 BCCA 26.
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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Applicants:
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Janssen 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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Millennium Pharmaceuticals, Inc
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Date Commenced:
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February 18, 2015
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Court File No.:
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T-233-15
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,203,936. Teva alleges non-infringement (certain claims only) and invalidity.
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Medicine:
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methylphenidate hydrochloride (CONCERTA)
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Applicants:
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Janssen Inc and Alza Corporation
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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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February 20, 2015
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Court File No.:
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T-247-15
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,264,852. Apotex alleges improper listing, non-infringement and invalidity.
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Other proceedings
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Medicine:
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vitamin D (DDROPS, D3-DOL)
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Applicant:
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Ddrops Company, Reinhold Vieth and Elaine Vieth
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Defendant:
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Jamp Pharma Corporation
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Date Commenced:
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January 30, 2015
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Court File No.:
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T-141-15
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Comment:
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Patent infringement action regarding Patent No. 2,578,881 and the vitamin D3 liquid supplement "D3-DOL."
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Medicine:
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marihuana
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Applicant:
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Cen Biotech Inc
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Respondents:
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The Minister of Health
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Date Commenced:
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February 20, 2015
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Court File No.:
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T-262-15
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Comment:
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Application seeking an Order compelling the Minister of Health to issue to the applicant a provisional or full licence under the Marihuana for Medical Purposes Regulations.
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