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January 2011 In this issue: Supreme Court of Canada News » Canadian Intellectual Property Office news » Patented Medicine Prices Review Board news » Apotex limited to five expert reports in patent impeachment/infringement action » Federal Court rejects Teva’s motion to have re-determination heard on existing Ontario Court refuses to strike Apotex’s claim for unjust enrichment » |
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Federal Court finds lovastatin patent valid and infringed by Apotex and dismisses Apotex’s section 8 action Madam Justice Snider of the Federal Court has rendered judgment in the long-standing patent infringement action between Merck & Co. Inc. and Merck Frosst Canada Ltd. (collectively "Merck") and the defendants Apotex Inc. ("Apotex") and Apotex Fermentation Inc. ("AFI") concerning lovastatin (Merck’s MEVACOR) (Merck v. Apotex, 2010 FC 1265). Justice Snider found that the patent at issue was valid and infringed by the defendants regarding certain lots through the manufacture of lovastatin by AFI and the importation of lovastatin produced by Blue Treasure, a Chinese joint venture with AFI. In a separate judgment, Justice Snider dismissed Apotex’s action under section 8 of the Patented Medicines (Notice of Compliance) Regulations ("Regulations") regarding the same patent (Apotex v. Merck, 2010 FC 1264). |
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Supreme Court of Canada News Supreme Court allows Nu-Pharm's appeal regarding action for damages against Crown. The Supreme Court allowed Nu-Pharm’s appeal of a Court of Appeal Order which had upheld the summary dismissal of its action for damages against the Crown. Nu-Pharm alleged that Health Canada unlawfully advised provincial regulatory authorities, pharmacists, distributors, and public and private insurers that the sale of Nu-Enalapril was unlawful following the quashing of Nu-Pharm's notice of compliance. The Federal Courts found that Nu-Pharm must first be successful on judicial review, establishing that the government’s decision was unlawful. The Supreme Court reversed the decision, finding that Nu-Pharm’s action should be permitted to proceed as the Federal Courts Act did not require Nu-Pharm to be successful on judicial review before bringing its claim for damages. Nu-Pharm Inc. v. Canada (Attorney General), December 23, 2010. |
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Canadian Intellectual Property Office news New Chapter 9 of MOPOP released. On December 1, 2010, the Commissioner of Patents released a revised Chapter 9 of the Manual of Patent Office Practice (MOPOP), effective December 2010. The MOPOP is a guide explaining the operational procedures and examination practices of the Canadian Patent Office and does not reflect binding legal authority. Chapter 9 concerns the requirements for the description portion of the specification of a patent application, replacing the version that had been in place since March 1998. (Notice. MOPOP.) |
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Patented Medicine Prices Review Board news Hearings. The Patented Medicine Prices Review Board ("the Board") held a hearing on December 8, 2010 regarding Sandoz’s alleged failure to file required information with the Board. (Notice of hearing. Schedule of events.) A decision was reserved. |
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Recent Court decisions Minister’s motion to strike Apotex’s application for judicial review seeking to compel issuance of an NOC for Apo-Omeprazole tablets dismissed. Apotex asserts that it filed an abbreviated new drug submission in April 2000, and was advised in March 2003 that its submission was satisfactory and issuance of a notice of compliance ("NOC") was on "patent hold." However, in December 2008, Health Canada revoked the approval status on the basis that the bioequivalence study had not been properly conducted. By way of judicial review, Apotex sought to compel the Minister to issue an NOC, or alternatively, to quash certain decisions by the Minister and order a further review of its drug submission. Apotex alleged a reasonable apprehension of bias against the Minister. The Minister moved to strike the application on the basis that (1) Apotex was out of time, and (2) the application was not limited to a single order and in the alternative, parts of the application, including Apotex’s allegation that it possessed a "vested right" in an NOC on the basis of the March 2003 letter. Justice Pinard dismissed the motion to strike, leaving the determination to the Applications Judge. Apotex Inc. v. Minister of Health and Attorney General of Canada, December 21, 2010. Apotex limited to five expert reports in patent impeachment/infringement action. The Federal Courts Rules limits the number of expert witnesses a party may call to five, unless leave is granted by the Court. In the context of a patent impeachment/infringement action regarding clopidogrel bisulfate/besylate (Sanofi’s PLAVIX), Apotex served eight expert reports on validity, without requesting leave. A Prothonotary required Apotex to bring a motion for leave, which was denied. The Court therefore required Apotex to choose which five of the reports served it would rely on. The Court noted that mere allegations of complexity cannot suffice to justify allowance of more than five expert reports and clarified that no distinction should be drawn between the number of expert witnesses who may be called at trial and the number of expert reports that may be served. Apotex Inc. v. Sanofi-Aventis, December 14, 2010. Safety and efficacy of new drugs may be established by means other than data from clinical trials performed by or on behalf of the sponsor of the submission. Hospira’s new drug submission for an unidentified drug had been rejected at the screening stage. While the Applications Judge dismissed Hospira’s application for judicial review, the Court of Appeal allowed Hospira’s application, referring the matter back to the Minister for reconsideration. The Court of Appeal held that the Food and Drug Regulations do not require pre-clinical and clinical data from clinical trials performed by or on behalf of the applicant. The Court held that while in the vast majority of cases pre-clinical and clinical data performed by the sponsor will be required, the Minister has the discretion to permit, for example, reports of clinical trials conducted by others to meet the requirements of safety and efficacy. Since it was unclear whether the submission was rejected on the basis of the Minister’s view that pre-clinical or clinical data from clinical trials performed by Hospira or on its behalf was an absolute requirement, the matter was sent back to the Minister for reconsideration. Hospira Healthcare Corporation v. Attorney General of Canada (Minister of Health), December 14, 2010. Federal Court rejects Teva’s motion to have re-determination heard on existing record. As reported in the November 2009 edition of Rx IP Update, the Federal Court set aside the Patented Medicines Prices Review Board ("the Board")’s holding that Teva had priced its medicine COPAXONE excessively, and ordered payment of approximately $2.4 million to the Crown. The Applications Judge returned the matter to the Board for redetermination. Teva brought a motion to the Federal Court to have the re-determination take place on the existing record. The Board staff moved to introduce further evidence into the record, and the Board allowed the motion. It also provided terms for responding evidence to be filed and a postponement of the hearing. The Applications Judge heard and dismissed Teva’s motion. The Judge held that although a final decision of the Board could be reviewed by the Court, it is not the Court’s function to exercise continuing supervisory jurisdiction over the steps that the Board takes in the redetermination. Teva Neuroscience G.P.-S.E.N.C v. Canada (Attorney General), November 29, 2010. Ontario Court refuses to strike Apotex’s claim for unjust enrichment. Apotex commenced an action in the Ontario Superior Court for section 8 damages, disgorgement of revenues or profits, unjust enrichment and breach of contract regarding lansoprazole (Abbott’s PREVACID). Abbott brought a motion to strike, arguing that the Regulations constitute a "complete code" and as it references only damages in section 8, no other form of common law relief is available. The Court dismissed the motion, finding that there is no authority for the proposition that common law remedies are ousted by the Regulations. Apotex Inc. v. Abbott Laboratories, Limited, December 15, 2010. |
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New Court proceedings Patented Medicines (Notice of Compliance) Regulations
Other proceedings
To check the status of Federal Court cases, please click here.
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Contact information For more information or to request a copy of any decision, pleading or legislation, please contact: Our pharmaceutical practice group Smart & Biggar/Fetherstonhaugh's pharmaceutical practice group calls upon decades of extensive and in-depth experience to keep your pharmaceutical IP rights where they belong — in your hands. For more information on our group and a full list of its members, please click here. Disclaimer The preceding is intended as a timely update on Canadian intellectual property and regulatory law of interest to the pharmaceutical industry. The contents of this newsletter are informational only and do not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly. To join the Rx IP Update mailing list, be removed from the mailing list or make changes to contact information, please send an e-mail to rxip.update@smart-biggar.ca. smart-biggar.ca | Ottawa | Toronto | Montreal | Vancouver | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
