 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
March 2011 In this issue: Federal Court of Appeal sets aside "termination" of moot application and orders "dismissal" » Supreme Court of Canada news » Federal Court grants Order of prohibition for GSK's rosiglitazone against Pharmascience » Portions of pleading alleging estoppel based on decision in prior NOC proceeding allowed to stand » |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Federal Court of Appeal sets aside "termination" of moot application and orders "dismissal" On June 22, 2009, the Court of Appeal set aside an Order of Justice Shore granting a prohibition Order relating to levofloxacin and remitted the matter to him for redetermination. Subsequently, the relevant patent expired and the Minister granted a notice of compliance to Apotex. Janssen sought to have the application reconsidered, while Apotex sought to have it dismissed for mootness. Justice Shore recused himself and the matter was referred to Justice Hughes, who determined that the application was moot but made an Order "terminating" rather than "dismissing" the application. Janssen appealed Justice Shore's recusal and Apotex appealed the Order "terminating" rather than "dismissing" the application. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Supreme Court of Canada news Validity of data protection provision (leave sought). As reported in the December 2010 Special Edition of Rx IP Update, the Federal Court of Appeal upheld the Federal Court's decision to dismiss challenges by Apotex and the Canadian Generic Pharmaceutical Association ("CGPA") to the validity of the data protection provisions of the Food and Drug Regulations (section C.08.004.1) and the Food and Drugs Act (section 30(3)). On February 7, 2011, both Apotex and the CGPA filed for leave to appeal to the Supreme Court. Apotex Inc. v. Minister of Health, et al.; Canadian Generic Pharmaceutical Association v. Attorney General of Canada, et al. (SCC Case Nos. 34084, 34085). Availability of validity attack based on "invalid selection" (leave denied). Novopharm had filed an application for leave to appeal the Federal Court of Appeal's decision setting aside a decision of the Federal Court finding Eli Lilly's patent for the compound olanzapine (ZYPREXA) invalid. The Trial Judge held that the ’113 patent was an invalid selection patent and that olanzapine was an "almost invention." The Court of Appeal allowed the appeal on the issues of anticipation, obviousness and double patenting, but sent the case back to the Federal Court on the issues of utility and sufficiency of disclosure. Novopharm's application for leave to appeal was denied on February 10, 2011. Novopharm Limited v. Eli Lilly Canada Inc., July 21, 2010 (SCC Case No. 33870). | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Other news Canadian Generic Pharmaceutical Association releases report on economic impact of proposed pharmaceutical IP provisions in Canada-EU trade negotiations. On February 7, 2011, the Canadian Generic Pharmaceutical Association released a report on the economic impact of proposed pharmaceutical intellectual property provisions in a Comprehensive Economic & Trade Agreement, which is currently being negotiated between Canada and the European Union ("The Canada-European Union Comprehensive Economic & Trade Agreement: An Economic Impact Assessment of Proposed Pharmaceutical Intellectual Property Provisions"). The draft provisions include:
Report on access to information requests. Health Canada has released its 2009-2010 Annual Report to Parliament on the Access to Information Act. The report cites statistics for access to information requests, including that 1481 new requests were made and 1504 requests were completed in 2009-2010, and reports on the timelines for response by Health Canada. Report. |
Recent Court decisions Patented Medicines (Notice of Compliance) Regulations Federal Court grants Order of prohibition for GSK's rosiglitazone against Pharmascience. On March 1, 2011, the Federal Court granted an Order of prohibition on the basis that Pharmascience's allegation of invalidity of the patent claiming rosiglitazone (GlaxoSmithKline ("GSK")'s AVANDIA) was not justified. Pharmascience alleged that the patent was invalid for obviousness, insufficiency, inutility, lack of sound prediction and claims broader than the invention made or disclosed. In his decision, Justice Hughes reviewed the jurisprudence on how a patent description, and in particular the "promise" of a patent, should be read. With respect to the allegations of lack of sufficiency, inutility and lack of sound prediction, which Justice Hughes held were "all bound up together" by Pharmascience, Justice Hughes agreed with GSK that the promised utility had been established by the inventors as of the date of invention, and therefore the patent did not have to demonstrate the utility in the disclosure. GlaxoSmithKline Inc. v. Pharmascience Inc., March 1, 2011. Portions of pleading alleging estoppel based on decision in prior NOC proceeding allowed to stand. As reported in the November 2010 issue of Rx IP Update, in an impeachment action by Apotex relating to sildenafil citrate (Pfizer's VIAGRA), Apotex moved to strike a portion of Pfizer's defence, pleading that Apotex was estopped from contesting the validity of the patent at issue by reasons of res judicata, issue estoppel, collateral estoppel, comity and abuse of process. Pfizer asserted that the prior notice of compliance ("NOC") proceedings between the parties on the same patent entitled it to raise the allegations. Apotex argued that NOC proceedings have no precedential effect and that Pfizer's pleading should therefore be struck. The motion was denied, and Apotex appealed. The Federal Court struck the plea of res judicata on consent but otherwise dismissed the appeal, stating that the issues in Pfizer's pleading had not been squarely raised previously and that it was not sufficiently plain and obvious to warrant that they be struck out. Apotex appealed, and the Court of Appeal allowed the appeal in part. The Court held it "plain and obvious" that Pfizer's defences of issue estoppel, collateral estoppel, comity and abuse of process cannot bar litigation of validity in the impeachment action, and should therefore be struck. However, the Court held that it may be open to a judge to apply issue estoppel or abuse of process in a later proceeding to prevent relitigation, particularly of subsidiary factual and legal issues, in order to preserve judicial resources, promote the integrity of the justice system, prevent inconsistent findings, and prevent abuse. Accordingly, the remaining paragraphs at issue, which related to subsidiary findings of the Applications Judge, were permitted to stand. Apotex Inc. v. Pfizer Ireland Pharmaceuticals, June 11, 2010. Trademark Opposition Board decisions Board allows Bayer's opposition to registration of BAYER in association with dental products and topical skin balms. Bayer opposed Robert Victor Marcon's application for the trademark BAYER for use in association with dental products and topical skin balms. The Board allowed Bayer's opposition and rejected the application on the ground of confusion with the registered BAYER trademarks. Bayer Aktiengesellschaft v. Marcon, January 24, 2010. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
New Court proceedings Patented Medicines (Notice of Compliance) Regulations
Other proceedings
To check the status of Federal Court cases, please click here. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
