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NPDUIS releases International Generic Price Comparison report
The National Prescription Drug Utilization Information System (NPDUIS) is a partnership between the Patented Medicine Prices Review 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. On August 28, 2013, the NPDUIS released a new analytical report entitled Analytical Snapshot: International Generic Price Comparison, Early 2011. The Report captures some of the changes in Canadian generic pricing that occurred between 2008 and the first quarter of 2011. The NPDUIS's last publication on generic price comparison was released in September 2011: Generic Drugs in Canada: International Price Comparisons and Potential Cost Savings (reported in the November 2011 issue of Rx IP Update).
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CDR Subsequent Entry Biologic Pilot Project Under Review
In June 2009, the Common Drug Review (CDR) announced its Subsequent Entry Biologic (SEB) pilot project, noting the need arose as SEBs are a new category of Health Canada submissions with different data requirements. The purpose of the pilot is to "determine the CDR requirements for the SEB submissions; establish the evaluative framework for conducting the CDR review; and through interactions with Health Canada, gain an increased understanding of Health Canada's approach to assessing SEBs" (CDR Update — Issue 62). In August 2013, the CDR issued an update on the project, noting that to date, only one CDR review has been conducted for an SEB and further information regarding CDR submission requirements for SEBs is anticipated this fall. In the interim, manufacturers can direct written questions to requests@cadth.ca.
CDR Update — Issue 90.
Recent Court decisions
Other decisions
Novartis' judicial review of Minister's decisions under Access to Information Act dismissed. Novartis brought three judicial review applications appealing the Minister of Health's decisions to disclose Novartis' internally generated "narratives" regarding suspected adverse events. In a single set of reasons, Justice Hughes dismissed Novartis' applications, finding that Novartis had not discharged its burden of proving that the "narratives" were exempt from disclosure under either section 20(1)(b) or (c) of the Access to Information Act. Regarding section 20(1)(b), Justice Hughes found that even if the "narratives" were kept confidential, they did not contain commercial, scientific or technical information. Regarding section 20(1)(c), Justice Hughes found that Novartis failed to show that the information could reasonably be expected to result in material financial loss or gain to it, or prejudice a competitive position.
Novartis Consumer Health Canada Inc v Health Canada — May 31, 2013
Federal Court decision — 2013 FC 508.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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deferasirox (EXJADE)
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Applicant:
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Novartis Pharmaceuticals Canada 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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Novartis AG
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Date Commenced:
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June 20, 2013
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Court File No.:
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T-1095-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,255,951. Teva alleges invalidity and non-infringement.
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Medicine:
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vardenafil hydrochloride trihydrate (LEVITRA)
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Applicant:
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Bayer Inc
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Respondents:
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The Minister of Health and Attorney General of Canada
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Date Commenced:
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June 20, 2013
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Court File No.:
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T-1098-13
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Comment:
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Application for judicial review of a decision of the Minister of Health refusing to add Canadian Patent No. 2,492,747 to the Patent Register.
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Medicine:
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pantoprazole magnesium (TECTA)
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Applicant:
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Takeda Canada Inc and Takeda GmbH
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Respondents:
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The Minister of Health and Mylan Pharmaceuticals ULC
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Date Commenced:
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June 28, 2013
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Court File No.:
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T-1161-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,341,031. Teva alleges invalidity and non-infringement.
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Medicine:
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rasagiline mesylate (AZILECT)
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Applicant:
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Teva Canada Innovation and Teva Pharmaceutical Industries Ltd
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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 5, 2013
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Court File No.:
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T-1192-13
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Comment:
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Application for an Order of prohibition until expiry of Patent No. 2,174,499. Apotex alleges invalidity and non-infringement.
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Medicine:
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norgestimate + ethinyl estradiol tablets (TRI-CYCLEN LO)
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Applicant:
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Janssen Inc and Janssen Pharmaceuticals Inc
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Respondents:
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Minister of Health and Famy Care Ltd
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Date Commenced:
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July 11, 2013
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Court File No.:
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T-1218-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,356,747. Famy Care alleges invalidity and non-infringement.
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Medicine:
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drospirenone + ethinylestradiol (YAZ)
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Applicant:
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Bayer Inc and Bayer Pharma Aktiengesellschaft
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Respondents:
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Famy Care Limited and The Minister of Health
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Date Commenced:
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July 17, 2013
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Court File No.:
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T-1247-13
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,179,728 and 2,382,426. Famy Care alleges invalidity and non-infringement.
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Medicine:
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exemestane (AROMASIN)
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Applicant:
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Pfizer Canada Inc
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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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August 2, 2013
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Court File No.:
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T-1321-13
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Comment:
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Application for judicial review of the issuance of a notice of compliance (NOC) to Teva, without requiring Teva to first serve a notice of allegation (NOA) addressing Patent No 2,409,059. Pfizer pleads that Generic Medical Partners (GMP) also received an NOC, and that Office of Patented Medicines and Liaison (OPML) advised that GMP had filed proof of service of an NOA on Pfizer which service is denied, and that Teva filed a submission cross-referenced to GMP's submission. Pfizer also challenges Health Canada's Guidance Document: Patented Medicines (Notice of Compliance) Regulations insofar as it provides that a person that files an Abbreviated New Drug Submission (ANDS) cross-referenced to another ANDS approved on the basis of a comparison to an innovative drug is not required to separately address patents on the Patent Register.
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Medicine:
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moxifloxacin (AVELOX)
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Applicant:
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Bayer Inc and Bayer Intellectual Property GmbH
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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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August 22, 2013
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Court File No.:
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T-1414-13
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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. Teva alleges invalidity and non-infringement.
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Medicine:
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moxifloxacin ophthalmic solution (VIGAMOX)
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Applicant:
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Alcon Canada Inc, Alcon Pharmaceuticals Ltd and Bayer Intellectual Property GmbH
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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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August 22, 2013
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Court File No.:
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T-1415-13
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 1,340,114, 2,192,418 and 2,342,211. Teva alleges invalidity and non-infringement.
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Other proceedings
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Medicine:
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quetiapine fumarate extended-release (SEROQUEL XR, Teva-Quetiapine)
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Plaintiff:
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Teva Canada Limited
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Defendant:
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AstraZeneca Canada Inc
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Date Commenced:
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August 7, 2013
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Court File No.:
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T-1338-13
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Comment:
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Action for section 8 damages related to the prohibition proceedings in Court Files Nos. T-1259-11 and T-1905-11 (decisions reported as 2013 FC 245 and 2013 FC 246).
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Medicine:
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drospirenone + ethinylestradiol (YASMIN, ZARAH 21, ZARAH 28)
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Plaintiff:
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Bayer Inc and Bayer Pharma Aktiengesellschaft
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Defendant:
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Cobalt Pharmaceuticals Company
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Date Commenced:
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August 14, 2013
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Court File No.:
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T-1379-13
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Comment:
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Infringement action regarding Patent No. 2,382,426 and Cobalt's Zarah 21 and Zarah 28 products.
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To check the status of Federal Court cases, please click here.
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