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IN THIS ISSUE: Federal Court of Appeal upholds prohibition Order for anastrozole » Supreme Court of Canada news » Patented Medicine Prices Review Board news » Federal Court allows pleading amendment based on alternative process defence » Federal Court of Appeal affirms that ELOXATIN is an "innovative" drug » Federal Court of Appeal upholds prohibition Order for anastrozole On April 11, 2012, the Federal Court of Appeal dismissed an appeal from a prohibition Order of the Federal Court prohibiting the Minister of Health from issuing a notice of compliance ("NOC") to Mylan Pharmaceuticals ULC for a generic anastrozole product: Mylan Pharmaceuticals ULC v. AstraZeneca Canada Inc. et al., 2012 FCA 109.
Supreme Court of Canada news Supreme Court hears VIAGRA appeal concerning standard of disclosure for demonstrated utility in April 2012. On April 18, 2012, the Supreme Court heard Teva's appeal from the Court of Appeal's refusal to set aside a prohibition Order regarding sildenafil (Pfizer's VIAGRA) and reserved its decision. The Court of Appeal decision dealt with the issues of disclosure and utility. Teva Canada Limited v. Pfizer Canada Inc., et al. (SCC Case No. 33951; webcast of the hearing).
Health Canada news Revisions to the Guidance Document: PM(NOC) Regulations published. On April 2, 2012, Health Canada announced the publication of revisions to its Guidance Document: Patented Medicines (Notice of Compliance) Regulations. Section 3.4.1 of the Guidance Document has been updated to reflect the Office of Patented Medicines and Liaison's administration of section 5 of the Patented Medicines (Notice of Compliance) Regulations ("Regulations") in respect of administrative drug submissions (both new and abbreviated) filed where a manufacturer is licensed to sell a drug identical to a marketed drug (also referred to as a cross-referenced submission). Health Canada's view is that such administrative drug submissions will not trigger section 5 of the Regulations (even if a patent is listed on the Patent Register before the licensee files its administrative new drug submission and after the licensor's submission is filed and therefore not required to be addressed by the licensor), and an NOC will be issuable in respect of such a submission only after the licensor's drug submission receives its NOC. The revisions only apply to a manufacturer that has submitted such a submission on or after April 16, 2012. The Guidance Document is substantially the same as the draft published for comment on August 17, 2011. Guidance Document: Patented Medicines (Notice of Compliance) Regulations.
Patented Medicine Prices Review Board news New NEWSletter released. The PMPRB has released its April 2012 NEWSletter. Proposed changes to the Compendium of Policies, Guidelines and Procedures. The Board is seeking comments on proposed changes to the Compendium of Policies, Guidelines and Procedures by May 14, 2012. The proposed changes include (i) eliminating the 5% investigation trigger, i.e., where the National Average Transaction Price of an existing drug product exceeds the National Non-Excessive Average Price by more than 5%, to avoid a large number of investigations involving excess revenues less than $50,000; and (ii) replacing the three-year period to offset de minimus excess revenues through a Voluntary Compliance Undertaking with a requirement to offset in a timely manner. Proposed changes, side-by-side comparison of current and proposed text and mailing address for comments.
Other news Status of Canada-European Union negotiations on CETA. As reported in the April 2012 issue of Rx IP Update, Canada and the EU aim to conclude negotiations in 2012 on the proposed Comprehensive Economic & Trade Agreement ("CETA"), which includes intellectual property provisions relating to pharmaceuticals. The ninth round of negotiations has now been completed. The Department of Foreign Affairs and International Trade reports that "[t]he negotiating text is now well-advanced, with many chapters closed or parked pending further development, and issues in the remaining chapters narrowed down to key differences where solutions are now being actively explored ... Both Canada and the EU are committed to maintaining the momentum of the negotiations thus far with the aim of concluding in 2012." Status of negotiations and mailing address for submissions.
Recent Court decisions Patented Medicines (Notice of Compliance) Regulations Federal Court allows pleading amendment based on alternative process defence. As reported in the January 2012 issue of Rx IP Update, the Court of Appeal affirmed the Trial Judge's finding of infringement of certain batches of lovastatin (Merck's MEVACOR) by Apotex and Apotex Fermentation (collectively "Apotex"). In the reference to determine damages (scheduled to be heard in April 2013), the Prothonotary denied Apotex leave to amend its Statement of Defence to assert that it could have employed a non-infringing alternative process for producing lovastatin and therefore any damages suffered by Merck due to Apotex's infringing process are not damages at all by virtue of the availability of a non-infringing process. Apotex appealed. On April 18, 2012, the Federal Court allowed Apotex's appeal, concluding that Apotex has advanced an arguable and important point of law and that it is not plain and obvious that the alternative process defence cannot succeed, although this argument faces a "formidable obstacle" to succeed. Merck & Co., Inc. v. Apotex Inc., April 18, 2012. Federal Court of Appeal affirms that ELOXATIN is an "innovative" drug. As reported in the June 2011 issue of Rx IP Update, the Federal Court dismissed Teva Canada's challenge of data protection for ELOXATIN (sanofi-aventis's oxaliplatin) on the basis of prior approvals under the Special Access Programme ("SAP"). On April 4, 2012, the Federal Court of Appeal dismissed Teva's appeal. The Court of Appeal held that the "magic moment of approval is signalled by the issuance of a notice of compliance and a drug identification number." As a result, drugs for which previous authorizations were granted under the SAP are not considered "previously approved" as that term is used in the definition of an innovative drug. Sanofi-aventis had cross-appealed the Federal Court's decision holding that Teva had standing to bring the judicial review application and had done so within the appropriate time limit. The Court of Appeal held that a cross-appeal does not lie in this case as the Federal Court's Order does not adversely affect sanofi-aventis. In any event, it held that Teva did have standing to bring the application, which it brought in a timely fashion as the Minister of Health's decision refusing Teva's request to remove ELOXATIN from the Register of Innovative Drugs was a fresh exercise of discretion and susceptible to judicial review. Teva Canada Limited v. Canada (Health) and sanofi-aventis Canada Inc., April 4, 2012.
New Court proceedings Patented Medicines (Notice of Compliance) Regulations
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