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Competition Bureau releases White Paper on Patent Litigation Settlements
The Competition Bureau has released a white paper titled "Patent Litigation Settlement Agreements: A Canadian Perspective" in connection with the George Mason University School of Law Conference: Global Antitrust Challenges for the Pharmaceutical Industry held on September 23, 2014.
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Text of CETA released
As reported in the September 29, 2014 IP Update, the text of CETA (the Comprehensive Economic and Trade Agreement between Canada and Europe) was released on September 26, 2014. The release follows the conclusion of an agreement in principle on October 18, 2013 (see report) and an announcement on August 5, 2014 that the text had been finalized. Chapter 22 in particular, includes provisions specifically impacting pharmaceuticals/biologics in three areas: (i) patent term restoration (PTR); (ii) innovator right of appeal under the Patented Medicines (Notice of Compliance) Regulations; and (iii) data protection. Please see our IP Update for more information regarding the patent term restoration provision.
Federal Court upholds 'matching requirement' for listing a patent for a single compound against a fixed-dose combination product.
As reported in the June 2014 edition of Rx IP Update, a Prothonotary summarily dismissed Viiv's application against Teva for a prohibition Order regarding a combination product containing abacavir and lamivudine, Viiv's KIVEXA. The patent explicitly claimed only abacavir, and contained no claim for the combination of abacavir and lamivudine. Citing the Federal Court of Appeal's decision in Gilead Sciences Canada v Minister of Health, 2012 FCA 254 ("Gilead"), the Prothonotary held that "the medicinal ingredient or formulation approved in the NOC must "match up" and be claimed in the patent sought to be listed." As the patent claimed only one of the active ingredients, she held it was not eligible for listing. Viiv also commenced two proceedings against Apotex relating to the same patent (related to KIVEXA and to a combination product containing abacavir, lamivudine and zidovudine, Viiv's TRIZIVIR). In June, 2014, the same Prothonotary summarily dismissed those proceedings for the same reasons.
On September 18, 2014, the Federal Court dismissed Viiv's appeals, relying on the Court of Appeal's decision in Gilead. Viiv has appealed.
Viiv Healthcare ULC v Canada (Minister of Health), April 3, 2014.
Prothonotary's decision — 2014 FC 328.
Federal Court decision — 2014 FC 893.
Health Canada news
Natural Health Products Policy released. On August 29, 2014, Health Canada released the "Natural Health Products Compliance and Enforcement Policy" which describes its compliance and enforcement approach respecting natural health products under the Food and Drugs Act and the Natural Health Products Regulations. The Policy replaces the previous Policy, and was implemented on September 1, 2014. It is to be used in conjunction with the Compliance and Enforcement Policy.
Announcement. Natural Health Products Compliance and Enforcement Policy.
New Patent Form IV. On September 18, 2014, a new PDF fillable form for Form IV for the Patent List under the Patented Medicines (Notice of Compliance) Regulations became available.
PDF fillable Form IV.
Health Canada imposes import ban on products from three sites in India, including Apotex. Health Canada reported on September 30, 2014 that it took action to stop the import of health products from the following sites in India:
- Apotex Pharmachem India Pvt Ltd (APIPL)
- Apotex Research Private Limited (ARPL)
- IPCA Laboratories
Information Update.
Inspectorate Program Annual Report. Health Canada has released the Health Canada Inspectorate Program Annual Inspection Summary Report for 2013-2014. The Inspectorate Program is responsible for monitoring continued compliance of health products authorized for sale in Canada with the Food and Drugs Act and its associated Regulations. According to the Report, the health product industry in Canada has a high level of compliance with the Food and Drugs Act and its associated Regulations.
Inspectorate Program Annual Inspection Summary Report 2013-2014.
PMPRB tables 2013 Annual Report
On September 15, 2014, the Minister of Health tabled the PMPRB's 2013 Annual Report before Parliament. The report contains compliance and enforcement statistics, including that 1,343 patented drug products for human use were under the PMPRB's jurisdiction in 2013 and that the Board approved 6 Voluntary Compliance Undertakings (to the end of May 2014) and completed two price hearings. The Board also reports that the sales of patented drug products in Canada increased by 6.5% to $13.6 billion in 2013 and that the R&D expenditures reported by patentees were $752.8 million in 2013, a decline of 15.9% over 2012.
The Board has also published a summary of key information this year in the Annual Report 2013: In Brief.
Communiqué. Annual Report 2013. Annual Report 2013: In Brief.
Supreme Court of Canada matters
Pharmaprix and Sandoz seek leave to appeal regarding Quebec subpoenas. On September 4, 2014, Pharmaprix and Sandoz sought leave to appeal to the Supreme Court of Canada from a decision of the Quebec Court of Appeal, which annulled a stay issued by the Quebec Superior Court on subpoenas that ordered Pharmaprix and Sandoz (the respondents) to attend at the Régie de l'assurance maladie du Québec's (the Board) office and produce certain documents related to pricing, rebates, and discounts including related to activities outside of Quebec, requested pursuant to a Board investigation.
The respondents had sought to quash the subpoenas in the Quebec Superior Court, which granted a stay of the subpoenas pending the hearing on the merits. The Court of Appeal annulled the stay, holding that (1) there was no prima facie serious question as to whether the Board had jurisdiction to issue subpoenas dealing with business transactions outside of Quebec, (2) it was not demonstrated that producing documents would cause the appellants irreparable harm, and (3) the balance of inconvenience favours the Board considering the public interest in fair pricing of drugs.
Pharmaprix Inc, et al v Régie de l'assurance maladie du Québec, et al, SCC Case No. 36040
Quebec Court of Appeal decisions — 2014 QCCA 1184, 2014 QCCA 1288.
Quebec Superior Court decision — 2014 QCCS 2143.
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
Federal Court dismisses Alcon's application for Order of prohibition for Apotex's generic version of TRAVATAN Z. On August 11, 2014, the Federal Court dismissed Alcon's application for an Order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex for its generic travoprost product, which was compared to Alcon's TRAVATAN Z. The Federal Court held that Apotex's allegation of obviousness relating to Alcon's formulation patent was justified, but rejected the allegation of lack of utility.
Alcon Canada Inc v Apotex Inc, August 25, 2014.
Federal Court decision — 2014 FC 791.
Federal Court vacates bifurcation of determination of start date for section 8 proceeding. As reported in the June 2014 edition of Rx IP Update, in February 2014, Pfizer was successful in bringing a motion for bifurcation of a section 8 proceeding regarding atorvastatin (Pfizer's LIPITOR). Pfizer has asserted a start date resulting in a three month liability period, whereas Apotex had asserted a three-year liability period. Pfizer moved to bifurcate the determination of the start date from the remainder of the issues. In granting Pfizer's motion, Prothonotary Aalto considered several factors, including the complexity of the issues, whether there would be a saving of cost and time and whether bifurcation could facilitate settlement of the remaining issues, and ordered bifurcation, holding that bifurcation of the start date issue would "lead to saving of cost, time and judicial resources." On September 15, 2014, in granting Pfizer leave to amend its Statement of Defence and Counterclaim, Prothonotary Aalto vacated the bifurcation order and scheduled the trial to commence on all issues on April 4, 2016.
Apotex Inc v Pfizer Canada Inc,
Prothonotary's decision — 2014 FC 876.
Other decisions
Court of Appeal upholds ruling adding sanofi-aventis as party in Hospira data protection challenge. As reported in the May 2014 edition of Rx IP Update, sanofi-aventis successfully brought a motion to be added as a party to Hospira's application for judicial review. In the application, Hospira asserts that the data protection provision does not apply to its new drug submission (NDS) because it was filed before the innovator's drug was listed on the Register of Innovative Drugs (Register) and in any event, it did not directly or indirectly compare its product to the innovator's drug. Hospira's notice of application did not identify the innovator or the drug.
On the basis of sanofi-aventis' belief that the drug is oxaliplatin and sanofi-aventis' ELOXATIN containing oxaliplatin was listed on the Register on June 15, 2007, sanofi-aventis brought a motion to be added as a party. Prothonotary Tabib granted sanofi-aventis intervener status finding that the order sought by Hospira will directly prejudice sanofi-aventis. That decision was upheld by Justice Mactavish and subsequently the Court of Appeal.
Hospira Healthcare Corporation v Canada (Health), September 9, 2014.
Prothonotary's decision — 2014 FC 179.
Federal Court decision — 2014 FC 235.
Federal Court of Appeal decision — 2014 FC 194.
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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Apotex 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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21 August 2014
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Court File No.:
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T-1797-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,203,936. 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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Apotex Inc and the 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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21 August 2014
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Court File No.:
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T-1799-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,435,146. Apotex alleges non-infringement and invalidity.
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Medicine:
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escitalopram (CIPRALEX)
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Applicant:
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Lundbeck Canada Inc
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Respondents:
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Accord Healthcare Inc and the Minister of Health
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Respondent Patentee:
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H. Lundbeck A/S
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Date Commenced:
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25 August 2014
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Court File No.:
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T-1819-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,373,757. Accord Healthcare alleges non-infringement.
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Medicine:
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esomeprazole (NEXIUM)
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Applicants:
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AstraZeneca Canada Inc and AstraZeneca AB
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Respondents:
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Teva Canada Limited and the Minister of Health
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Date Commenced:
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27 August 2014
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Court File No.:
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T-1856-14
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,186,037, 2,290,963, 2,346,988 and 2,170,647. Teva alleges non-infringement and invalidity.
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Medicine:
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moxifloxacin (AVELOX)
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Applicants:
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Bayer Inc and Bayer Intellectual Property GmbH
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Respondents:
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Auro Pharma Inc and the Minister of Health
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Date Commenced:
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28 August 2014
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Court File No.:
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T-1875-14
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 1,340,114 and 2,192,418. Auro accepts that an NOC will not issue until expiry of the 114 patent and alleges non-infringement and invalidity regarding the 418 patent.
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Other proceedings
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Medicine:
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Not disclosed
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Applicants:
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Photocure ASA
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Respondents:
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The Minister of Health and the Attorney General of Canada
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Date Commenced:
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19 August 2014
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Court File No.:
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T-1774-14
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Comment:
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Application for judicial review of a decision of the Minister of Health refusing to add a drug to the Register of Innovative Drugs (data protection).
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Medicine:
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eletriptan (RELPAX)
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Plaintiff:
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Apotex Inc
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Defendant:
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Pfizer Canada Inc
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Date Commenced:
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26 August 2014
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Court File No.:
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T-1843-14
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Comment:
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Action seeking damages for alleged delay in issuance of an NOC for Apo-Eletriptan by reason of a PM(NOC) proceeding.
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Medicine:
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travoprost ophthalmic solution (TRAVATAN Z)
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Plaintiff:
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Apotex Inc
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Defendant:
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Alcon Canada Inc
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Date Commenced:
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26 August 2014
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Court File No.:
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T-1844-14
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Comment:
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Action seeking damages for alleged delay in issuance of an NOC for Apo-Travoprost Z by reason of a PM(NOC) proceeding.
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Medicine:
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travoprost ophthalmic solution (TRAVATAN Z)
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Plaintiff:
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Alcon Canada Inc, Alcon Laboratories, Inc, Alcon Pharmaceuticals Ltd, and Alcon Research, Ltd
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Defendant:
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Apotex Inc
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Date Commenced:
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29 August 2014
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Court File No.:
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T-1885-14
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Comment:
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Infringement action regarding Patent No. 2,606,370.
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Medicine:
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drospirenone / ethinyl estradiol (YAZ)
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Plaintiff:
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Apotex Inc
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Defendant:
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Bayer Inc
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Date Commenced:
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9 September 2014
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Court File No.:
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T-1934-14
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Comment:
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Action seeking damages for alleged delay in issuance of an NOC for Apo-Drospirenone by reason of a PM(NOC) proceeding.
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To check the status of Federal Court cases, please click here.
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