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September 2011 In this issue: Federal Court of Appeal sets aside Order of prohibition for latanoprost » Supreme Court of Canada news » Patented Medicine Prices Review Board news » Mylan not required to produce documents related to manufacturing process » AstraZeneca granted Order of prohibition against Mylan regarding anastrozole (ARIMIDEX) » |
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Federal Court of Appeal sets aside Order of prohibition for latanoprost The Federal Court of Appeal has set aside an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex: Apotex Inc. v. Pfizer Canada Inc., 2011 FCA 236, reversing 2010 FC 447 ("Latanoprost II"). In a previous ruling, the Court of Appeal had dismissed an appeal by Pharmascience Inc. from a prohibition Order issued by the same Federal Court Judge for the same drug and the same patent: Pharmascience Inc. v. Pfizer Canada Inc., 2011 FCA 102, affirming 2009 FC 1294 ("Latanoprost I"). |
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Supreme Court of Canada news Eli Lilly files leave to appeal holding of invalidity of atomoxetine patent. As reported in the August 2011 issue of Rx IP Update, the Federal Court of Appeal affirmed the Federal Court's decision that the patent claiming atomoxetine (Eli Lilly's STRATTERA) was invalid on the bases of inutility and lack of sound prediction. Eli Lilly has sought leave to appeal. Eli Lilly and Company v. Teva Canada Limited (SCC Case No. 34396). Mylan, Cobalt and Apotex denied leave to appeal prohibition Orders regarding escitalopram. On August 25, 2011, the Supreme Court dismissed leave applications from Mylan (formerly Genpharm), Cobalt and Apotex relating to escitalopram (Lundbeck's CIPRALEX). As reported in the February 2011 issue of Rx IP Update, Cobalt, Mylan and Apotex had applied for leave to appeal a decision of the Federal Court of Appeal, which dismissed the generic manufacturers' appeals on grounds of invalid selection patent, anticipation, obviousness, lack of sound prediction and inutility, ambiguity and insufficiency of disclosure, and procedural fairness and inadequacy of reasons. Apotex Inc. v. Lundbeck Canada Inc. November 25, 2010. |
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Health Canada news Posting of Prescribing Information on the Health Canada website. On July 29, 2011, Health Canada announced that effective immediately, Prescribing Information will be posted on its website in the same location as the Product Monograph (in the Drug Product Database (DPD) Online Query). (Notice.) Proposed revisions to the Guidance Document: PM(NOC) Regulations. On August 17, 2011, Health Canada released proposed revisions to its Guidance Document: Patented Medicines (Notice of Compliance) Regulations for stakeholder consultation. The revisions are being proposed in light of perceived concerns regarding the current requirement that drug manufacturers who submit administrative drug submissions pursuant to a licensing agreement (administrative NDSs and administrative ANDSs), comply with section 5 of the PM(NOC) Regulations. Stakeholders have questioned whether the current requirement is redundant in that a drug manufacturer who submits an administrative drug submission pursuant to a licensing agreement must re-address patents listed on the Patent Register in respect of the innovative drug prior to receiving a Notice of Compliance ("NOC"). The proposed revision states, in part:
Any comments should be provided to Health Canada by October 16, 2011 (opml_bmbl@hc-sc.gc.ca). (Notice.) |
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Patented Medicine Prices Review Board news New NEWSletter released. The PMPRB has released its July 2011 NEWSletter. (Newsletter.) Voluntary Compliance Undertakings. The Board recently accepted Voluntary Compliance Undertakings for Bristol-Myers Squibb Canada Co.'s SINEMET CR (levodopa and carbidopa) (Notice) and Paladin Laboratories Inc.'s TRINIPATCH (nitroglycerin) (Notice). Ratiopharm considered a "patentee" and needs to report to PMPRB. On June 30, 2011, the PMPRB released its decision requiring ratiopharm Inc. ("ratiopharm," now Teva) to provide (i) sales and pricing information with respect to certain medicines it sold in Canada and (ii) revenue and research and development expenditures. This decision followed the same Panel's decision in the excessive-pricing proceeding related to ratiopharm and the medicine ratio-Salbutamol HFA, as reported in the July 2011 issue of Rx IP Update (ratio-Salbutamol decision). The Panel held that the principles canvassed in its ratio-Salbutamol decision were applicable, and ratiopharm was considered a "patentee" under section 79(1) of the Patent Act with regard to 12 different drugs because it was entitled to exercise rights "in relation to" the patent. The Panel held that it, rather than the parties involved, ought to determine whether ratiopharm's right to sell or resell a medicine amounted to a right "in relation to" a patent pertaining to a medicine sold in Canada. For this reason, and similar to the ratio-Salbutamol decision, an agreement in which the patent rights holder expressly reserved all patent rights was not sufficient to prevent ratiopharm from being considered a patentee for the purposes of the PMPRB. The Panel looked at the individual circumstances regarding the 12 medicines to determine whether a medicine sold by ratiopharm was a patented medicine during the relevant time periods. In respect of ten drugs (ratio-Omeprazole, -Ketorolac, -Brimonidine, -Paroxetine, -Cefuroxime, -Lamotrigine, In regards to two additional drugs sold by ratiopharm (ratio-Fenofibrate FC and -Tamsulosin), the Panel held that there was a strong inference that a patent pertained to both of the drugs, and ordered ratiopharm to produce further information and documentation to allow the Panel to determine whether it had jurisdiction over these drugs. Additionally, the Panel held that ratiopharm must report the prescribed information concerning its revenue, and research and development expenditures for each year that ratiopharm is considered a patentee. To address the concern that the amount spent on research and development by pharmaceutical companies reported to Parliament would appear artificially inflated by the amount spent by "generic" companies, the Board proposed to separate out the "generic" and brand-name components of the industry. Ratiopharm has filed an application for judicial review with the Federal Court. PMPRB decision – PMPRB-08-D3-ratiopharm decision. |
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Other news Google Inc. pays $500M fine over U.S. drug ads originating from Canadian Internet pharmacies. On August 24, 2011, the U.S. Department of Justice ("Department") announced that Google Inc. had entered into an agreement with the Department to pay $500M for allowing online Canadian pharmacies to place advertisements through its AdWords program targeting consumers in the United States. The press release indicates that Google had knowledge that the Canadian pharmacies were advertising through its AdWords program, and that U.S. consumers were purchasing prescription drugs from these online pharmacies. In return for no criminal prosecutions, in addition to the fine, Google also agreed that it will cooperate with the government's ongoing investigations, and to two years probation. |
Recent Court decisions Patented Medicines (Notice of Compliance) Regulations Mylan not required to produce documents related to manufacturing process. Bristol-Myers Squibb Canada Co. ("BMS") appealed from a Prothonotary's refusal of a request, pursuant to section 6(7) of the Regulations, for production of Mylan's documents related to a manufacturing process for efavirenz (BMS's SUSTIVA). Justice Mactavish determined that the Prothonotary did not err in concluding on a balance of probabilities standard that the requested information was neither important nor required. In particular, the Court agreed that the expert evidence adduced on the motion, which alleged potential conversion of Mylan's efavirenz starting material to the crystal form claimed by the patent at issue during manufacturing, was more equivocal or speculative than that adduced in GlaxoSmithKline Inc. v. Pharmascience Inc. (2002 FCT 683), wherein a similar request for production was granted. BMS has appealed the decision (A-278-11). Bristol-Myers Squibb Canada Co. et al. v. Mylan Pharmaceuticals ULC, July 25, 2011. AstraZeneca granted Order of prohibition against Mylan regarding anastrozole (ARIMIDEX). On August 29, 2011, the Federal Court granted an Order of prohibition holding that Mylan's allegation of invalidity of the patent claiming anastrozole (AstraZeneca's ARIMIDEX) was not justified. Mylan had alleged that the patent was invalid on the bases of obviousness and that utility had not been demonstrated or soundly predicted at the time of filing the patent application. The Court held that the patent promised inhibition of the enzyme aromatase, and that the inventors had demonstrated the promised utility. The Court also rejected Mylan's obviousness argument. Mylan may appeal as of right. AstraZeneca Canada Inc. v. Mylan Pharmaceuticals ULC, August 29, 2011. |
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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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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 |
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