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Apotex awarded section 8 damages regarding pantoprazole
On December 11, 2013, the Federal Court released its ninth decision on the merits under section 8 of the Patented Medicines (Notice of Compliance) Regulations ("PMNOC Regulations"). In Apotex Inc v Takeda Canada Inc, 2013 FC 1237 (pantoprazole, PANTOLOC), Justice Phelan determined certain issues, which provided direction from which the parties could arrive at the quantum of Apotex's compensation. Failing agreement on quantum, the Court may be required to settle the specific amount of compensation.
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Health Canada news
Updated Guidance Documents: Health Canada has updated the following Guidance Documents to reflect amendments to the Food and Drug Regulations published on June 19, 2013, which replace Schedule F with the Prescription Drug List and a regulatory process with an administrative process, as reported in the January 2013 edition of Rx IP Update:
Patented Medicine Prices Review Board news
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 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 2013, the NPDUIS released two new reports. The Drivers of Prescription Drug Expenditures — A Methodological Report discusses the drivers of the two components of prescription drug expenditures: drug costs and dispensing fees. The New Drug Pipeline Monitor — December 2013 provides information on drugs currently under development that may have an impact on federal, provincial and territorial drug plan expenditures.
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
Federal Court dismisses application for prohibition Order re: olopatadine. Justice Barnes dismissed Alcon's application for an Order of prohibition regarding a topical ophthalmic solution containing olopatadine (marketed by Alcon as PATANOL). Apotex alleged non-infringement and invalidity. The decision focused on claims construction, in particular, the construction of "treating" and "allergic eye diseases" in the two claims at issue, which are use and composition claims 'for treating allergic eye diseases.'
Apotex argued that olopatadine was a known antihistamine useful for treating human allergenic eye diseases, and that therefore the patent asserted a monopoly over a known compound for an old use. Alcon argued that the claims should be construed contextually, limiting the words "treating" and "allergic eye diseases" to the discovery of olopatadine's usefulness as a mast cell stabilizer and an antihistamine to treat diseases of the human eye where mast cell degranulation is implicated. Justice Barnes rejected Alcon's construction, stating that he found "no basis for ignoring the otherwise plain language of" the claims at issue. On this basis, the allegation of obviousness was found justified as he concluded that the patent "purports to claim a monopoly over olopatadine for its known utility for the treatment of allergic eye diseases."
Alcon Canada Inc. v Apotex Inc, April 11, 2012
Federal Court decision — 2012 FC 410.
Court of Appeal dismisses Apotex's appeal of motion to set aside prohibition order regarding olanzapine. On December 4, 2013 the Court of Appeal dismissed Apotex's appeal of a Judge's dismissal of its motion seeking to: (i) set aside a prohibition Order (which had been affirmed on appeal) and (ii) dismiss the application seeking the prohibition Order regarding the patent claiming olanzapine (Eli Lilly's ZYPREXA). Apotex brought the motion on the basis of a declaration of invalidity of the patent at issue, subsequent to issuance of the Order of prohibition. The Court of Appeal held, "[t]his Court has unequivocally held on several occasions that a finding that a patent is invalid does not enable the Court to reach back and retroactively dismiss an application for an order of prohibition granted earlier ..." and there was no basis to find that the decisions were "manifestly wrong."
Apotex Inc v Eli Lilly Canada Inc, December 4, 2013
Federal Court of Appeal decision — 2013 FCA 282.
Federal Court decision — 2010 FC 952.
Federal Court allows applications for prohibition order in part re: tenofovir disoproxil fumarate. On December 20, 2013, Justice Barnes granted prohibition orders against Teva in respect of its tenofovir disoproxil fumarate (TDF) product until the expiry of Gilead Science ("Gilead")'s patent claiming tenofovir disoproxil (TD) in three separate applications, two brought by Gilead and one by Bristol Myers Squibb (BMS). TD is a prodrug of tenofovir, which can be used to treat HIV/AIDS, either alone or in combination. Specifically, it uses the carbonate promoiety of disoproxil. TDF is a fumarate salt of TD. Gilead markets two different drugs containing TDF: TRUVADA and VIREAD, and BMS markets ATRIPLA, which also contains TDF.
In each application, Justice Barnes held that Teva's anticipation and obviousness allegations regarding Gilead TD patent were not justified, while its obviousness allegation regarding Gilead TDF patent was justified. Justice Barnes issued his decision and reasons in Gilead Sciences v Teva Canada Limited, 2013 FC 1270 and they apply equally to Gilead Sciences v Teva Canada Limited, 2013 FC 1272 and Bristol-Myers Squibb v Teva Canada Limited, 2013 FC 1271.
Regarding the TD patent, Justice Barnes noted that the prior art taught nothing about a carbonate prodrug solution to overcome the bioavailability limitations of tenofovir and therefore it did not anticipate the claim. Justice Barnes also noted that an obviousness challenge would not succeed if the prior art only established that something might work and that the "strength of the ability to predict success is the lynchpin to an obvious to try analysis and not necessarily whether the means or methods employed to arrive at the result were well-known." He found that there were sufficient material elements of predictive uncertainty in the prior art to dispel Teva's assertion of obviousness. He also found that the lengthy and multi-step process followed by the Gilead inventors also supported that the discovery of TD was inventive.
Regarding the TDF patent, Justice Barnes considered the question: whether using fumaric acid as a salt former with TD was "obvious to try" and whether it was more or less self-evident that a suitable pharmaceutical salt would result. On the facts, Justice Barnes concluded that although a skilled person might not have predicted with a high degree of certainty that fumaric acid could be used to produce an acceptable salt formulation for TD, there would still be an expectation that, with routine screening of a handful of acidic salt formers, one or more acceptable compounds would emerge. He therefore found the salt patent obvious. He also drew a negative inference from Gilead's failure to adduce evidence in respect of the invention story on this patent.
Gilead Sciences v Teva Canada Limited, December 20, 2013
Federal Court decision — 2013 FC 1270.
See also: Gilead Sciences v Teva Canada Limited, 2013 FC 1272 and Bristol-Myers
Squibb v Teva Canada Limited, 2013 FC 1271
Other decisions
Ontario Divisional Court strikes Apotex's unjust enrichment claim for disgorgement of profits. Apotex filed a claim against Eli Lilly for, inter alia, damages pursuant to section 8 of the PMNOC Regulations, damages or an accounting of profits pursuant to sections 7 and 53.2 of the Trademarks Act, disgorgement of revenues or profits from the sale of STRATTERA (atomoxetine) and damages or an accounting of profits as may be otherwise available in law, all based on an allegation of delay in marketing its generic version of atomoxetine by the steps that Eli Lilly took under the PMNOC Regulations. As reported in the August 2012 edition of Rx IP Update, the Ontario Superior Court refused to strike all but Apotex's claim for "damages or an accounting of profits as may be otherwise available in law." Eli Lilly appealed Justice Macdonald's decision not to strike the unjust enrichment claim for disgorgement of profits. The Ontario Divisional Court relied on the Abbott summary judgment decision of Justice Quigley as affirmed by the Ontario Court of Appeal (reported in the January 2013 and October 2013 editions of Rx IP Update), and held that the unjust enrichment allegations "arise from the Patent Regulations which are a part of a complete statutory code governing patent law." Accordingly, the Court held that it was plain and obvious that the claim disclosed no cause of action and struck the claim.
Apotex Inc v Eli Lilly and Company, September 19, 2013
Ontario Divisional Court decision — 2013 ONSC 5937.
Ontario Superior Court decision — 2012 ONSC 3808
Federal Court agrees with Apotex; Minister's interpretation of "identical medicinal ingredients" was unreasonable. On December 23, 2013 Justice Kane allowed Apotex's judicial review application of Health Canada's decision to refuse to review the ANDS of Apotex's Apo-Telmisartan. Apotex seeks to market its generic version of telmisartan (MICARDIS). The TPD determined that Apotex's finished product differs from the Canadian Reference Product (CRP) MICARDIS because in the CRP the medicinal ingredient is telmisartan-sodium, whereas Apo-Telmisartan contains telmisartan-potassium. The Minister took the position that the medicinal ingredient found in the finished product or dosage form must be identical to the CRP. Apotex argued that the starting ingredient was identical insofar as it was telmisartan. With respect to whether there was a breach of procedural fairness, Justice Kane found that "[a]lthough there were some irregularities in the approval process and the application of the Reconsideration Policy, these irregularities, on their own or cumulatively, do not result in a breach of procedural fairness." Justice Kane however found that the Minister's decision regarding the interpretation of the phrase "identical medicinal ingredients" in the definition of "pharmaceutical equivalent" in section C.08.001.1 of the Food and Drug Regulations was unreasonable. The decision of the Minister not to accept the ANDS for review was therefore quashed and sent back for reconsideration.
Apotex Inc v Canada (Health), December 23, 2013
Federal Court decision — 2013 FC 1217
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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solifenacin succinate (VESICARE)
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Applicant:
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Astellas Pharma Canada, Inc
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Respondents:
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Sandoz Canada Inc and the Minister of Health
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Respondent/Patentee:
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Astellas Pharma Inc
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Date Commenced:
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November 22, 2013
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Court File No.:
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T-1920-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,208,839. Sandoz alleges non-infringement (certain claims only) and invalidity.
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Medicine:
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zoledronic acid IV infusion (ACLASTA)
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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 the 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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November 29, 2013
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Court File No.:
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T-1969-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,410,201. Teva alleges invalidity.
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Medicine:
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solifenacin succinate (VESICARE)
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Applicant:
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Astellas Pharma Canada, 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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Astellas Pharma Inc
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Date Commenced:
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November 29, 2013
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Court File No.:
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T-1970-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,208,839. Apotex alleges non-infringement (claim 12 only) and invalidity.
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Medicine:
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varenicline tartrate (CHAMPIX)
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Applicant:
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Pfizer Canada Inc and Pfizer Products Inc
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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 5, 2013
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Court File No.:
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T-2011-13
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,316,921, 2,447,405 and 2,467,490. Actavis alleges non-infringement (certain claims only) and invalidity.
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Other proceedings
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Medicine:
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quinapril (PMS-Quinapril)
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Plaintiffs:
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Bernard Charles Sherman and Apotex Inc
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Defendants:
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Pharmascience Inc
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Date Commenced:
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November 25, 2013
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Court File No.:
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T-1935-13
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Comment:
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Patent infringement action regarding Patent No. 2,355,347.
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Medicine:
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Drug "A"
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Applicant:
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Hospira Healthcare Corporation
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Respondents:
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Minister of Health and Attorney General of Canada
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Date Commenced:
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November 28, 2013
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Court File No.:
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T-1963-13
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Comment:
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Application for judicial review of a decision of Minister of Health refusing to issue a Notice of Compliance to Hospira for "Drug A" (the subject matter of a previous judicial review under Court Files Nos. T-116-07 (2010 FC 213) and A-126-10 (2010 FCA 345)). The Minister declined to issue an NOC on the basis of data protection granted to a third party after the filing of Hospira's new drug submission.
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Medicine:
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clopidogrel (PLAVIX, Apo-clopidogrel)
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Plaintiffs:
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Sanofi, Bristol-Myers Squibb/Sanofi Pharmaceutical Partnership, Sanofi Winthrop Pty Ltd, sanofi-aventis Australia Pty Ltd, sanofi-aventis New Zealand Limited, Bristol-Myers Squibb Australia Pty Ltd, Squibb Manufacturing Company, Sanofi Winthrop Industrie S.A., and ER Squibb & Sons, LLC
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Defendants:
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Apotex Inc
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Date Commenced:
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December 5, 2013
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Court File No.:
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T-2000-13
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Comment:
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Patent infringement action regarding Patent No. 1,336,777, based on manufacture, construction and export.
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Medicine:
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clopidogrel (PLAVIX, Apo-clopidogrel)
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Plaintiffs:
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Sanofi, Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership, Bristol-Myers Squibb Sanofi Canada Partnership, Bristol-Myers Squibb Canada Co, Sanofi-Aventis Canada Inc, Squibb Manufacturing Company, ER Squibb & Sons, LLC and Sanofi Winthrop Industrie S.A.
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Defendants:
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Apotex Inc
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Date Commenced:
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December 5, 2013
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Court File No.:
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T-2002-13
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Comment:
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Patent infringement action regarding Patent No. 1,336,777, based on importation, manufacture, use, and sale.
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Medicine:
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clopidogrel (PLAVIX, Riva Clopidogrel, Sandoz Clopidogrel, Co Clopidogrel, Mylan-clopidogrel, Q-clopidogrel, Teva-clopidogrel, Silvem Clopidogrel, PMS-clopidogrel, Dom-clopidogrel, Ran-Clopidogrel)
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Plaintiffs:
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Sanofi, Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership, Bristol-Myers Squibb Sanofi Canada Partnership, Bristol-Myers Squibb Canada Co, Sanofi-Aventis Canada Inc, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership, sanofi-aventis Australia Pty Ltd, sanofi-aventis New Zealand Limited, Bristol-Myers Squibb Australia Pty Ltd, Squibb Manufacturing Company, ER Squibb & Sons, LLC and Sanofi Winthrop Industrie S.A.
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Defendants:
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Laboratoire Riva Inc/T-2003-13
Sandoz Canada Inc/T-2004-13
Actavis Pharma Company/T-2005-13
Mylan Pharmaceuticals ULC and QD Pharmaceuticals ULC/T-2006-13
Teva Canada Limited/T-2007-13
Sivem Pharmaceuticals ULC/ T-2008-13
Pharmascience Inc and 115013 Canada Inc (aka Dominion Pharmacal)/T-2009-13
Ranbaxy Pharmaceuticals Canada Inc/T-2010-13
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Date Commenced:
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December 5, 2013
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Comment:
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Patent infringement actions regarding Patent No. 1,336,777, based on importation, manufacture, use, sale, and export.
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To check the status of Federal Court cases, please click here.
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