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Patent "use" claims for ACLASTA held to be directed to methods of medical treatment and hence unpatentable
On September 25, 2013, the Federal Court dismissed Novartis' application for an Order prohibiting the Minister of Health from issuing a Notice of Compliance to Cobalt in respect of zoledronic acid (Novartis' ACLASTA) on the ground of unpatentable subject matter (Novartis Pharmaceuticals Canada Inc v Cobalt Pharmaceuticals Company), 2013 FC 985.
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Supreme Court of Canada matters
Apotex seeks leave to appeal re: PLAVIX. Apotex has sought leave to appeal from the Federal Court of Appeal decision reversing the Trial Judge's decision which had invalidated the patent that claims clopidogrel bisulfate (sanofi-aventis' PLAVIX) on the basis of lack of utility and obviousness. The Court of Appeal decision was reported in the August 2013 issue of Rx IP Update.
Apotex Inc v sanofi-aventis SCC Case No. 35562
Court of Appeal decision — sanofi-aventis v Apotex Inc, 2013 FCA 186
Federal Court decision — Apotex Inc v sanofi-aventis 2011 FC 1486, reported in the January 2012 issue of Rx IP Update.
Patented Medicine Prices Review Board news
Notice of Hearing. As reported in the May 2013 issue of Rx IP Update, Justice Zinn of the Federal Court set aside a decision of the PMPRB ordering (order, reasons) Teva to pay the government $2,801,285 for having sold COPAXONE Syringes (glatiramer acetate) at an excessive price between 2004 and 2010 (Teva Canada Innovation v Canada (Attorney General), 2013 FC 448). The PMPRB redetermination hearing for COPAXONE is scheduled for October 7-8, 2013.
Federal Court to hear Board decision re: ratio-Salbutamol HFA. As reported in the November 2011 issue of Rx IP Update, on October 17, 2011, the Board issued an Order requiring that ratiopharm (now Teva) pay the Crown an amount of $65,898,842.76 to offset excess revenues for ratio-Salbutamol HFA from July 2002 to June 2010, after the determination by the Federal Court of ratiopharm's application for judicial review of the Board's May 27, 2011 decision (reported in the July 2011 issue of Rx IP Update) in the excessive-pricing proceeding (Court File No. T-1058-11). ratiopharm also sought judicial review of the October 17, 2011 Order in T-1825-11. In a related matter, the Board released its decision on June 30, 2011 requiring ratiopharm to provide (i) sales and pricing information with respect to certain medicines it sold in Canada and (ii) revenue and research and development expenditures (Order; reported in the September 2011 issue of Rx IP Update). Ratiopharm sought judicial review of the Board's June 30, 2011 decision in T-1252-11. The Federal Court will hear all three judicial review applications on November 4-5, 2013.
Eli Lilly serves Notice of Arbitration under NAFTA for STRATTERA and ZYPREXA
As reported in the August 2013 issue of Rx IP Update, on June 13, 2013, Eli Lilly filed a second Notice of Intent seeking arbitration pursuant to the North American Free Trade Agreement ("NAFTA") Chapter 11 regarding Eli Lilly's STRATERRA (atomoxetine) and ZYPREXA (olanzapine), subsequent to its filing of the first Notice of Intent with respect to STRATTERA (reported in the January 2013 issue of Rx IP Update). On September 12, 2013, Eli Lilly filed its Notice of Arbitration, asserting the judiciary's application of the promise doctrine to Eli Lilly's patents contravenes Canada's obligations under NAFTA and the Patent Cooperation Treaty ("PCT"). Eli Lilly seeks "damages for the full measure of direct losses and consequential damages payments Lilly or its enterprise is required to make arising from the improvident loss of its Zyprexa and Strattera patents or its inability to enforce its Zyprexa and Strattera patents."
Notice of Arbitration
Second Notice of Intent
Notice of Intent
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
Ontario Court of Appeal affirms lower court's rejection of claim for unjust enrichment under PMNOC Regulations. As reported in the January 2013 issue of Rx IP Update, the Ontario Superior Court of Justice dismissed a claim by Apotex for unjust enrichment under the Patented Medicines (Notice of Compliance) Regulations ("Regulations"): Apotex Inc v Abbott Laboratories Limited, 2013 ONSC 356.
The decision confirms that:
- a claim for unjust enrichment (seeking disgorgement of revenues or profits) arising under the Regulations is not recoverable, even when the claim is asserted in a court of general jurisdiction; and,
- the Regulations are intended to constitute a complete legislative code, particularly with respect to the availability of equitable remedies beyond the legislative framework.
On September 12, 2013, the Ontario Court of Appeal affirmed the decision (2013 ONCA 555). The Court held that the Regulations constitute "a valid juristic reason for the respondents' profits and revenues" for the section 8 period and this precludes Apotex's claim for disgorgement.
Other decisions
Federal Court of Appeal considers disclosure requirement for sound prediction of utility for a mechanical invention. On September 24, 2013, the Federal Court of Appeal affirmed the lower court's invalidity ruling finding that all but one claim of a patent for helicopter landing gear fail for lack of sound prediction of utility (Bell Helicopter Textron Canada Limiteé v Eurocopter, 2013 FCA 219; affirming 2012 FC 113). Of particular relevance to pharmaceutical patents is the Court's consideration of the disclosure requirement for sound prediction of utility. The Court stated that "where the sound prediction is based on ... common general knowledge and on a line of reasoning ... apparent to the skilled person ..., the requirements of disclosure" for sound prediction "may readily be met by simply describing the invention in sufficient detail such that it can be practiced." A detailed discussion of this decision can be found in the October 1, 2013 issue of IP Update — Canada.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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zoledronic acid (ACLASTA)
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Applicant:
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Novartis Pharmaceuticals Canada Inc
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Respondent:
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Agila Specialties Private Ltd and the Minister of Health
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Date Commenced:
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September 6, 2013
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Court File No.:
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T-1493-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,410,201. Agila alleges non-infringement.
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Medicine:
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abacavir sulfate + lamivudine (KIVEXA)
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Applicant:
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ViiV Healthcare ULC, ViiV Healthcare UK Limited and Glaxo Group Limited
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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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September 12, 2013
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Court File No.:
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T-1517-13
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,216,634 and 2,289,753. Teva alleges invalidity and non-infringement.
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Other proceedings
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Applicant:
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Bayer Inc
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Respondents:
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The Minister of Health
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Defendant:
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n/a
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Date Commenced:
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August 29, 2013
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Court File No.:
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T-1453-13
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Comment:
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Application for judicial review of a decision by the Minister of Health to disclose third party information belonging to the applicant, pursuant to a request under the Access to Information Act.
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Medicine:
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drospirenone + ethinyl estradiol (YASMIN, ZAMINE 21 and ZAMINE 28)
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Applicant:
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Bayer Inc. and Bayer Pharma Aktiengesellschaft
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Respondents:
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Apotex Inc.
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Date Commenced:
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August 30, 2013
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Court File No.:
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T-1468-13
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Comment:
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Action for infringement of Patent No. 2,382,426; Bayer also seeks a declaration of validity.
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Medicine:
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pregabalin (LYRICA, TEVA-PREGABALIN)
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Plaintiff:
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Teva Canada Limited
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Defendant:
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Pfizer Canada Inc, Warner-Lambert Company and Warner-Lambert Company, LLC
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Date Commenced:
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September 6, 2013
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Court File No.:
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T-1496-13
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Comment:
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Action for damages pursuant to s. 8 of the PM(NOC) Regulations as a result of an alleged delay in issuance of Teva's notice of compliance for pregabalin.
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To check the status of Federal Court cases, please click here.
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