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Court quashes NOC for Teva-Exemestane issued from a cross-referenced submission; Teva is required to separately address Pfizer's patent
On December 19, 2014, Justice Gleason of the Federal Court set aside the Minister of Health's decision granting Teva a Notice of Compliance (NOC) for exemestane (Pfizer's AROMASIN): Pfizer Canada Inc v Canada (Attorney General) — 2014 FC 1243.
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Supreme Court of Canada matters
Mylan and Apotex seek leave to appeal in celecoxib litigation. As we reported previously, the Federal Court of Appeal upheld prohibition Orders in the celecoxib litigation and rejected Mylan and Apotex's arguments relating to the "promise" of the patent. Mylan and Apotex have each sought leave to appeal.
Mylan Pharmaceutical ULC v Pfizer Canada Inc, et al, SCC Case No. 36228.
Apotex Inc v Pfizer Canada Inc, et al, SCC Case No. 36227.
Federal Court decisions — 2014 FC 38 (Mylan); 2014 FC 314 (Apotex).
Federal Court of Appeal — 2014 FCA 250.
Abbvie seeks leave to appeal in STELARA litigation. As we reported previously, the Federal Court of Appeal ordered a new trial in the STELARA litigation and, in a separate decision, also set aside an injunction that had issued against Janssen at trial. Abbvie has now sought leave to appeal.
Abbvie Corporation, et al v Janssen Inc, SCC Case No. 36232.
Federal Court decisions — 2014 FC 55; 2014 FC 489.
Federal Court of Appeal decisions — 2014 FCA 242; 2014 FCA 241.
Industry Canada news
Proposed amendments to Schedule 1 of the Patent Act (drugs eligible for export under Canada's Access to Medicines Regime (CAMR)). As we reported previously, the Government is proposing an amendment to Schedule 1 of the Patent Act to add three HIV/AIDS therapies, which include efavirenz, emtricitabine and tenofovir disoproxil to the list of patented pharmaceutical products. The proposed amendments have been published in the Canada Gazette. Written representations may be submitted by January 19, 2015.
Health Canada news
Plain Language Initiative. As we reported previously, as part of Health Canada's Plain Language Labelling Initiative, Health Canada has released revisions to Part II of the Guidance Document for Product Monographs — Patient Medication Information. Health Canada is now proposing revisions to Part I: Health Professional Information and Part II: Scientific Information – Guidance Document: Product Monograph as part of the Plain Language Labelling Initiative. Consultation is open for comment until March 4, 2015.
Notice. Consultation document.
Health Canada requests product quarantine from two sites in India. Health Canada reported on December 23, 2014 that Canadian importers have agreed to its request to stop the importation and distribution of products from two sites in India (Dr. Reddy's Laboratories in Srikakulam and IPCA Laboratories in Pithampur) due to data integrity concerns.
Information Update.
Patented Medicine Prices Review Board news
Voluntary Compliance Undertakings. The Board approved Voluntary Compliance Undertakings (VCUs) for Novartis's LAMISIL (terbinafine hydrochloride, VCU) and EMD's GONAL F (follitropin alfa, VCU).
Two new NPDUIS analytical reports released by the PMPRB. The National Prescription Drug Utilization Information System (NPDUIS) is a partnership between the Patented Medicine Prices Review Board (PMPRB or the "Board") and the Canadian Institutes for Health Information that aims to provide analyses of drug price, utilization and cost trends in Canada to support drug plan policy decision-making for participating levels of government. In December 2014, the NPDUIS released two new reports:
- The New Drug Pipeline Monitor — December 2014 provides information on drugs currently under development that may have an impact on future drug plan expenditures. Now in its sixth edition, it provides an update on 31 drugs previously identified in the pipeline, and 10 new additions.
- Generic Drugs in Canada, 2013 is a report comparing 2013 generic drug prices and markets in Canada with those of other industrialized countries. An accompanying Analysis Brief of the report states that "despite a significant reduction in Canadian generic drug prices in recent years, they remain appreciably higher than international levels." The Report also surprisingly found that the greatest gap in Canadian and international generic drug prices was found for drugs with the highest number of suppliers (six or more suppliers) and for drugs with sales of $10 million or more. This report updates previous NPDUIS research (Analytical Snapshot: International Generic Price Comparison, Early 2011), reported previously, and highlights the changes in Canadian generic pricing that has taken place since 2011.
Ontario proposes amendments to establish a framework for generic pricing
On November 5, 2014, the government of Ontario proposed amendments to regulations made under the Ontario Drug Benefit Act to establish a pricing framework for certain generic drug products approved for listing on the Ontario Drug Benefit (ODB) Formulary/Comparative Drug Index. Currently, the pricing framework requires manufacturers to set generic prices at 25% of the brand reference product for solid dosage forms and 35% for non-solid dosage forms. The proposed regulation sets the price of a single source generic product listed on the Formulary on or after April 1, 2013 at 75% of the brand reference product when the Executive Officer has an agreement with the manufacturer of the relevant brand reference product respecting the payment of a volume discount or other amount by the manufacturer in respect of the brand product, and at 85% of the brand reference product where there is no such agreement. Dual source generic products would be priced at 50% of the brand reference product, and if there are 3 or more generic products, then the current price rules apply. Comments were accepted until December 21, 2014.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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insulin glargine solution (100 units/mL) (LANTUS, BASAGLAR)
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Applicants:
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sanofi-aventis Canada Inc and sanofi-aventis Deutschland GmbH
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Respondents:
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Eli Lilly Canada Inc and the Minister of Health
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Date Commenced:
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October 31, 2014
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Court File No.:
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T-2247-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,490,116. Eli Lilly alleges non-infringement 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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Actavis Pharma Company and the Minister of Health
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Date Commenced:
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December 10, 2014
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Court File No.:
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T-2510-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,264,852. Actavis alleges improper listing, 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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Actavis Pharma Company 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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December 11, 2014
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Court File No.:
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T-2526-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,203,936. Actavis 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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Pharmascience Inc 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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December 12, 2014
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Court File No.:
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T-2535-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,371,684. Pharmascience 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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Pharmascience Inc 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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December 12, 2014
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Court File No.:
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T-2536-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,226,784. Pharmascience 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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Pharmascience Inc 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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December 12, 2014
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Court File No.:
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T-2537-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,379,948. Pharmascience 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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Pharmascience Inc 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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December 12, 2014
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Court File No.:
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T-2538-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,181,377. Pharmascience alleges non-infringement and invalidity.
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Medicine:
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ziprasidone hydrochloride (ZELDOX)
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Plaintiff:
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Pfizer Canada Inc and Pfizer Products Inc
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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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January 5, 2015
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Court File No.:
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T-3-15
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,274,338. Auro alleges non-infringement and invalidity
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