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Federal Court upholds Lundbeck's escitalopram patent, grants injunction and accounting of profits
On March 12, 2013, the Federal Court dismissed Apotex's action to impeach the patent claiming escitalopram (Lundbeck's CIPRALEX), declared the patent valid and infringed by Apotex and Apotex Pharmachem, and granted certain remedies to Lundbeck.
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Supreme Court of Canada news
Oral hearing scheduled to determine Eli Lilly's leave application regarding olanzapine patent. The Supreme Court ordered a May 13, 2013 oral hearing to determine Eli Lilly's leave application regarding the selection patent claiming olanzapine (ZYPREXA). As reported in the October 2012 issue of Rx IP Update, the Federal Court of Appeal upheld the decision of Justice O'Reilly of the Federal Court invalidating Eli Lilly's patent. Justice O'Reilly had found that the utility promised by the patent had not been demonstrated and could not have been soundly predicted.
Eli Lilly Canada Inc et al v Novopharm Limited, March 28, 2013 (SCC Case No. 35067).
Federal Court of Appeal decision — 2012 FCA 232.
Federal Court decision — 2011 FC 1288.
Takeda seeks leave to appeal decision denying data protection for the enantiomer DEXILANT. As reported in the February 2013 issue of Rx IP Update, the Federal Court of Appeal dismissed Takeda's appeal and affirmed the Minister of Health's refusal to list DEXILANT (dexlansoprazole) on the Register of Innovative Drugs. Dexlansoprazole is one of the enantiomers of the previously approved racemate lansoprazole (currently marketed as PREVACID). The Minister held that dexlansoprazole was not eligible for listing on the Register because it was a variation that is specifically excluded from the definition of "innovative drug" in section C.08.004.1 of the Food and Drug Regulations. The majority of the Federal Court of Appeal agreed with the Minister that the language of the definition is clear and the five listed categories of substances are automatically considered variations of previously approved drugs.
Takeda Canada Inc v Canada (Health), March 19, 2013 (SCC Case No. 35276).
Federal Court of Appeal decision — 2013 FCA 13.
Federal Court decision — 2011 FC 1444.
Gilead denied leave to appeal decision determining that a claim for a combination of ingredients was not eligible for listing on the Patent Register. On March 22, 2013, the Supreme Court denied Gilead leave to appeal a Federal Court of Appeal decision (reported in the November 2012 issue of Rx IP Update) that a patent containing claims for a formulation comprising tenofovir disoproxil fumarate, emtricitabine and a non-nucleoside reverse transcriptase inhibitor (NNRTI) and claims for a "chemically stable combination" of such ingredients was not eligible for listing on the Patent Register against its new drug submission for Gilead's COMPLERA. COMPLERA contains tenofovir disoproxil fumarate, emtricitabine and rilpirivine, an NNRTI. The Minister held the patent was ineligible for listing as the patent referenced NNRTIs as a class without specifying rilpirivine. The Federal Court of Appeal held that the product specificity requirement under section 4(2)(a) of the Patented Medicines (Notice of Compliance) Regulations ("PMNOC Regulations") was not met as the patent claims did not make "specific reference" to the medicinal ingredient rilpirivine but only the broad class of compounds.
Gilead Sciences Canada Inc v Minister (Health), March 22, 2013 (SCC Case No. 35123).
Federal Court of Appeal decision — 2012 FCA 254.
Federal Court decision — 2012 FC 2.
Health Canada news
Health Canada guidance on drug-device interface. Health Canada released a guidance document regarding the classification of products at the device-drug interface to determine whether it is regulated as a "device" or a "drug." Factors that influence the classification are set out in the guidance document.
Notice. Guidance document.
Changes to the product monograph of pharmaceutical drug products. Health Canada has announced a new process to inform generic drug manufacturers of safety labelling changes to the Product Monographs of brand name drugs. A table indicating updates and new safety information in the monograph and identifying the updated sections of the monograph will be regularly posted on the Health Canada website.
Notice. Table.
Revision to Health Canada guidance on drug establishment licences. As reported in the January 2013 edition of Rx IP Update, on December 21, 2012, Health Canada released a guidance document relating to drug establishment licences and licensing. Health Canada published a revised guidance document on April 1, 2013, which supersedes the previous version.
Revised guidance document.
Government of Canada news
Report on the intellectual property regime in Canada. On May 1, 2012, the Standing Committee on Industry, Science and Technology adopted a motion to study the intellectual property regime in Canada and how this regime contributes to advancing innovation. The Committee conducted hearings from May 10, 2012, to February 15, 2013, and heard from 50 witnesses. The Committee recently tabled its report, which includes a discussion of the Comprehensive Economic and Trade Agreement ("CETA") and intellectual property protection in the Canadian pharmaceutical industry. With regard to specific challenges facing the Canadian pharmaceutical industry, the report concludes that:
- The Committee recommends that the Government of Canada ensure the pharmaceutical IP regime strikes a balance between encouraging investment in the development of new innovative drugs while ensuring Canadians have access to affordable pharmaceuticals.
- The Committee recommends that the Government of Canada undertake an independent, evidence-based review of challenges facing the brand-named pharmaceutical sector in Canada to determine the most appropriate solutions and steps to be taken.
Report.
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
AstraZeneca successful in obtaining prohibition Order against Ranbaxy for its generic esomeprazole product. The Federal Court granted AstraZeneca an Order prohibiting the Minister of Health from issuing a notice of compliance (NOC) to Ranbaxy for its generic esomeprazole product, which was compared to AstraZeneca's NEXIUM, until the expiry of Canadian Patent 2,170,647 (’647 Patent). The ’647 patent relates to a multiple unit tableted enteric dosage formulation of omeprazole or esomeprazole. The sole issue in the proceeding was whether Ranbaxy's allegation of obviousness was justified.
Justice O'Keefe applied the "obvious to try" test and concluded that it was not more or less self-evident to try to obtain the invention. With respect to whether it was more or less self-evident that the method employed would work, Justice O'Keefe noted that the prior art teaches away from the existence of such a solution or alternatively indicates that such a solution is extremely complex and technologically difficult. Justice O'Keefe further noted that the experimentation required was prolonged, complex and, as evidenced by the limited number of studies investigating the process, far from routine. Finally, on the issue of motivation, Justice O'Keefe concluded that even if the prior art provided sufficient motivation, there remained a "lion in the path" significant enough to dissuade a person skilled in the art. Ranbaxy has appealed.
AstraZeneca Canada Inc v Ranbaxy Pharmaceuticals Canada Inc, March 5, 2013.
Federal Court decision — 2013 FC 232.
Federal Court dismisses AstraZeneca's application for Order of prohibition for Teva's generic version of SEROQUEL XR. On March 7, 2013, the Federal Court dismissed AstraZeneca's applications for an Order prohibiting the Minister of Health from issuing an NOC to Teva for its generic sustained release quetiapine product, which was compared to AstraZeneca's SEROQUEL XR. In its two notices of allegation regarding different tablet strengths of its product, Teva alleged that AstraZeneca's patent for a sustained release formulation of quetiapine was invalid for obviousness, inutility, insufficiency, and ambiguity. The Federal Court held that the subject of the patent was "obvious to try," concluding that "it was more or less self-evident to try to obtain a sustained release formulation of quetiapine using HPMC [hydroxypropyl methylcellulose], and that the person skilled in the art would have had a fair expectation of success." The Federal Court did not consider Teva's remaining allegations.
AstraZeneca Canada Inc v Teva Canada Limited, March 7, 2013.
Federal Court decisions — 2013 FC 245 and 2013 FC 246.
Federal Court allows Novartis's application for Order of prohibition for Teva's generic version of zoledronic acid IV infusion. On March 19, 2013, Justice Hughes of the Federal Court allowed Novartis's application for an Order of prohibition regarding zoledronic acid IV infusion (Novartis's ZOMETA and ACLASTA). Justice Hughes held that while Teva's allegation of obviousness with respect to one of the patents (that includes a claim for a genus of compounds that includes zoledronic acid) was not justified, its allegations of inutility and lack of sufficiency were justified. The application relating to that patent was therefore dismissed. However, Novartis's application was allowed with respect to the other patent (which includes a claim specific to zoledronic acid) as Justice Hughes held that Teva's allegations of obviousness, lack of utility and insufficiency were not justified. Justice Hughes held that the date of publication (i.e. issue date) was the relevant date for considering sufficiency of the patent, which was an "old" Act patent (filed before October 1, 1989).
Novartis Pharmaceuticals Canada Inc v Teva Canada Limited, March 19, 2013.
Federal Court decision — 2013 FC 283.
Other decisions
Apotex's action for damages in the Ontario Superior Court temporarily stayed pending the outcome of appeals from section 8 damages decision in the Federal Court. Apotex is suing Sanofi and Schering in the Ontario Superior Court for additional damage claims arising from Sanofi's prohibition proceeding against Apotex regarding its Apo-Ramipril product. Apotex claims treble damages pursuant to the UK Statute of Monopolies and the Ontario Statute of Monopolies, damages or an accounting of profits pursuant to s. 53.2 of the Trademarks Act, and disgorgement of Sanofi's profits generated from the sale of Ramipril as a consequence of the improper issuance of a patent and/or the delay in Apotex being permitted to sell Apo-Ramipril due to Sanofi's invocation of the PMNOC Regulations.
Sanofi brought a motion to strike or, in the alternative, a stay of the action pending the outcome of Sanofi's appeal in the Federal Court of Appeal from the decision of the Federal Court regarding section 8 damages (reported in the June 2012 issue of Rx IP Update) and any appeal therefrom. In granting the temporary stay, Justice Stinson noted that there was substantial overlap between many of the issues in the present proceeding and those in the Federal Court action, that it was self-evident that the factual foundation of the damage claims in the present action overlap significantly with that of the Federal Court action, and that the outcome of the appeal of the Federal Court action is likely to resolve at least some of the issues raised in the present action.
Apotex Inc v Schering Corporation, March 7, 2013.
Ontario Superior Court decision — 2013 ONSC 1411.
Federal Court of Appeal dismisses AstraZeneca's appeal of decision allowing a section 8 claim regarding Apotex's generic omeprazole product. On March 11, 2013 the Federal Court of Appeal dismissed AstraZeneca's appeal of Justice Hughes's decision finding that Apotex is entitled to section 8 damages regarding its omeprazole capsule product. AstraZeneca challenged two aspects of the decision: i) whether it was relevant to the section 8 claim that AstraZeneca had sued Apotex for infringement of the patent in issue and the infringement trial had not yet been completed (it is scheduled to be heard in April 2014), and ii) whether it was relevant to the section 8 claim that during the period in which section 8 damages were claimed Apotex intended to manufacture its product at a manufacturing site other than the one mentioned in its pending regulatory submission. The Federal Court of Appeal dismissed the first ground of appeal, noting that while a judge has discretion to reduce damages under s. 8(5) based on an ex turpi causa argument which could include an infringement claim, in this case it will be for the judge trying the infringement action to ensure that overall, taking both proceedings together, a party is compensated for its provable loss, if any, on proper principles, no more and no less. With respect to the second ground of appeal, the Federal Court of Appeal concluded it was a reasonable finding that Apotex could have manufactured its product at either of its two manufacturing facilities and nothing in the applicable regulatory regime would have precluded Apotex from doing so.
AstraZeneca Canada Inc v Apotex Inc, March 11, 2013.
Federal Court of Appeal decision — 2013 FCA 77.
Federal Court decision — 2012 FC 559.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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olopatadine hydrochloride (PATANOL)
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Applicants:
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Alcon Canada Inc, Alcon Research, Ltd and Kyowa Hakko Kirin Co, Ltd
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Respondents:
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Mylan Pharmaceuticals ULC and The Minister of Health
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Date Commenced:
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February 22, 2013
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Court File No.:
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T-343-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,195,094. Mylan alleges invalidity and non-infringement.
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Medicine:
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travoprost (TRAVATAN Z)
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Applicants:
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Alcon Canada Inc and Alcon Research, Ltd
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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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February 22, 2013
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Court File No.:
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T-345-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,129,287. Teva alleges invalidity and non-infringement.
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Medicine:
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travoprost (TRAVATAN Z)
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Applicants:
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Alcon Canada Inc and Alcon Research, Ltd
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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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February 22, 2013
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Court File No.:
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T-346-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,606,370. Teva alleges invalidity.
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Medicine:
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bimatoprost (LUMIGAN RC)
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Applicants:
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Allergan Inc and Allergan, 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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February 26, 2013
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Court File No.:
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T-360-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,585,691. Teva alleges invalidity and non-infringement.
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Medicine:
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dutasteride (AVODART)
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Applicants:
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GlaxoSmithKline Inc and GlaxoSmithKline LLC
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Respondents:
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Cobalt Pharmaceuticals Company and The Minister of Health
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Date Commenced:
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March 8, 2013
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Court File No.:
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T-427-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,170,047. Cobalt alleges invalidity and non-infringement.
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Medicine:
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pemetrexed disodium (ALIMTA)
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Applicant:
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Eli Lilly Canada Inc
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Respondents:
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Hospira Healthcare Corporation and The Minister of Health
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Respondent/Patentee:
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Eli Lilly and Company
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Date Commenced:
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March 11, 2013
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Court File No.:
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T-434-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,400,155. Hospira alleges invalidity and non-infringement.
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Medicine:
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lanthanum carbonate hydrate (FOSRENOL)
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Applicant:
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Shire Canada Inc
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Respondents:
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Mylan Pharmaceuticals ULC and The Minister of Health
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Respondent/Patentee:
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Shire Holdings AG
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Date Commenced:
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March 14, 2013
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Court File No.:
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T-450-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,536,959. Mylan alleges non-infringement.
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Medicine:
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lanthanum carbonate hydrate (FOSRENOL)
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Applicant:
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Shire Canada Inc
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Respondents:
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Mylan Pharmaceuticals ULC and The Minister of Health
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Respondent/Patentee:
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Shire International Licensing BV
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Date Commenced:
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March 14, 2013
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Court File No.:
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T-451-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,216,437. Mylan alleges invalidity and non-infringement.
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Other proceedings
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Medicine:
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infliximab (REMICADE)
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Plaintiff:
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Hospira Healthcare Corporation
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Defendant:
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The Kennedy Institute of Rheumatology
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Date Commenced:
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March 6, 2013
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Court File No.:
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T-396-13
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Comment:
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Claim seeking a declaration that Patent No. 2,261,630 ("Anti-INF Antibodies and Methotrexate in the Treatment of Autoimmune Disease") is invalid and a declaration that Hospira's proposed product will not infringe the ’630 patent.
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Product:
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oral care products, including tooth whitening dental strips
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Plaintiffs:
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The Procter & Gamble Company, Procter & Gamble Inc
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Defendant:
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CLIO USA, Inc
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Date Commenced:
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March 12, 2013
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Court File No.:
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T-442-13
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Comment:
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Claim for a declaration that Patents Nos. 2,293,528, 2,293,352, 2,338,331 and 2,487,113 are valid and have been infringed by CLIO.
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Medicine:
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quetiapine fumarate (SEROQUEL XR)
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Plaintiffs:
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AstraZeneca Canada Inc, AstraZeneca Pharmaceuticals LP and AstraZeneca UK Limited
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Defendant:
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Teva Canada Limited
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Date Commenced:
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March 13, 2013
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Court File No.:
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T-444-13
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Comment:
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Infringement claim regarding Patent No. 2,251,944.
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