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IN THIS ISSUE: Federal Court of Appeal upholds invalidity of olanzapine selection patent » Bristol-Myers Squibb obtains Order of prohibition against Mylan regarding efavirenz » Patented Medicine Prices Review Board news » Patent Appeal Board decisions » Federal Court upholds Health Canada refusal to approve product licence for "Maori Miracle" » Federal Court of Appeal upholds invalidity of olanzapine selection patent The Federal Court of Appeal has upheld the decision of Justice O'Reilly of the Federal Court invalidating Eli Lilly's selection patent for the compound olanzapine (ZYPREXA): Eli Lilly Canada Inc v Novopharm Limited, 2012 FCA 232, aff'g 2011 FC 1288. The appeal marks the second time the Court of Appeal has considered the validity of the ZYPREXA patent. Previously, the Court of Appeal had reversed a finding of invalidity by Justice O'Reilly and returned the matter to him for further consideration, including on the issue of utility: Eli Lilly Canada Inc v Novopharm Limited, 2010 FCA 197, rev'g 2009 FC 1018.
Bristol-Myers Squibb obtains Order of prohibition against Mylan regarding efavirenz On September 27, 2012, Justice Barnes of the Federal Court granted Bristol-Myers Squibb ("BMS") an Order prohibiting the Minister of Health from issuing a notice of compliance to Mylan Pharmaceuticals ULC for a generic efavirenz product (BMS's SUSTIVA) until the expiry of Patent No. 2,101,572 (’572), but not Patent No. 2,279,198 (’198). With respect to the ’572 Patent, Justice Barnes held that the notice of allegation was legally insufficient and, in any event, Mylan's inutility allegation was not justified. With respect to the ’198 Patent, Justice Barnes held that Mylan's allegations of anticipation and obviousness were not justified but that BMS had failed to establish that Mylan's allegation of non-infringement was not justified.
Patented Medicine Prices Review Board news Updated Forms 1 and 2 for regulatory filings. As of November 1, 2012, patentees will be required to use the new Form 1 and Form 2 cover sheet templates for regulatory filings. Corresponding changes have also been made to the instructions in the Patentee's Guide to Reporting. Both templates are now available on the PMPRB website in the section titled "Are you a patentee?" PMPRB finds Sandoz is a "patentee" that is subject to reporting requirements. On August 1, 2012, the Board held that the generic manufacturer Sandoz Canada Inc. is a "patentee" and thus falls within the Board's jurisdiction for reporting purposes. Sandoz was therefore ordered to file information relating to five medicines: Sandoz Cyclosporine, - Famciclovir, - Azithromycin, - Estradiol and - Terbinafine. As reported in the July 2011 and September 2011 issues of Rx IP Update, the Board had previously found that another generic manufacturer, ratiopharm Inc., was a "patentee" (a judicial review application is pending in Court File No. T-1252-11). However, the Board noted the present case differs as there are no express licence or distribution agreements between Sandoz and a patentee that could entitle Sandoz to the benefit of or to exercise rights in relation to a patent. First, the Board held that Sandoz is entitled to a benefit or rights in relation to patents as Sandoz is entitled to sell the medicine without being sued for infringement. Sandoz is not the holder of the patents at issue. However, Sandoz is a wholly owned subsidiary of Novartis Canada Inc., which is a wholly owned subsidiary of Novartis AG, the holder of the patents, either directly or through other subsidiaries that it owns or controls. On the evidence, the Board held that the business model of Novartis AG is to use its Sandoz Division to market, whenever possible, generic medicines that are protected from competition by the existence of Novartis AG patents. The Board emphasized that Sandoz is not a patentee merely by being a subsidiary of a patent holder. Second, the Board held that the patents in question pertain to medicines sold in Canada by Sandoz. Sandoz had argued that the patents did not pertain to the medicines in question as no monopoly was created by the patents, the patents were not used, or not used for the medicine, and the medicines did not infringe the patent. The Board rejected these arguments on the basis of ICN Pharmaceuticals Inc v Canada (Patented Medicine Prices Review Board), [1997] 1 F.C. 32 (C.A.). The Board held that ICN had established that the connection between the invention and the medicine can be one of the "merest slender thread"; a given patent need not be demonstrated to provide monopoly control over the production or marketing of the particular dosage or delivery form of the medicine in question. Finally, the Board rejected Sandoz's argument that the Board's regulation over the pricing of generic pharmaceutical products was unconstitutional as being a matter extending beyond Parliament's authority over patents. Sandoz has brought an application for judicial review (Court File No. T-1616-12). PMPRB-10-D2-SANDOZ – Merits reasons and order.
Health Canada news Government of Canada announces development of framework for orphan drugs. Orphan drugs treat rare diseases — life-threatening, seriously debilitating or serious chronic conditions that affect a small number of patients. On October 3, 2012, the Minister of Health announced that Health Canada is developing a modern framework for the designation, authorization and monitoring of orphan drugs in Canada. The announcement indicates that the proposed framework is in the final design stages and will soon be targeted for public consultation. The Government also launched Orphanet, an on-line resource for information regarding rare diseases. News release.
Patent Appeal Board decisions Canadian Patent Office rejects application for fluticasone proprionate MDI on the basis of double patenting. The Commissioner of Patents refused to issue a patent to SmithKlineBeecham for Patent Application No. 2,368,934 (the ’934 Application), titled "Metered Dose Inhaler [MDI] for Fluticasone Propionate" on the basis of obviousness double patenting over Patent No. 2,217,948 (the ’948 Patent), the parent of the ’934 Application, and Patent No. 2,447,517, the divisional of another divisional of the ’948 Patent. The Patent Appeal Board ("PAB") noted that the prohibition against double patenting could exist notwithstanding the fact that the patent would expire on the same date as the other patents, thus resulting in no prolongation of monopoly. The PAB did not agree with the Examiner that an element of a claim is non-essential simply because it is known in the art. The PAB further found that, while an analysis of double patenting is based on a comparison of the claims, claims are to be construed in accordance with the principles of purposive construction, which includes taking into account the patent specification as a whole. The PAB concluded that the claims of the ’934 Application are not patently distinct from the claims of the cited patents. Commissioner's decision #1328.
Recent Court decisions Federal Court upholds Health Canada refusal to approve product licence for "Maori Miracle." Health Canada regulates natural health products through the Natural Health Products Regulations (the "Regulations"), which came into force on January 1, 2004, and the Natural Health Products Directorate ("the Board"). Pursuant to the Regulations, producers of such products must submit a product licence application ("PLA") to the Board and have it approved before the product can be sold. The PLA includes, among other things, information about the safety and efficacy of the natural health product at issue. The Board refused to approve a PLA for Therapeutix's "Maori Miracle" Joint Health Companion, a product containing avian sternal cartilage powder, also known as Kolla2, citing insufficient evidence. The Board's first refusal was reconsidered twice and was twice upheld. The Board based its final refusal on a consideration of the scientific evidence submitted by the applicant and distinguished that evidence from the use of Kolla2 on the grounds of different manufacturing process and dose, different or unspecified type of collagen, and insufficient details on primary data. The Board stated that previous marketing experience alone is insufficient to obtain approval for natural health products. The Federal Court decision relates to the second reconsideration. Justice O'Keefe held that "the Board came to a reasonable finding that" the evidence before it was "deficient." Justice O'Keefe held that the Board repeatedly found that it had insufficient evidence before it on the safety and efficacy of Kolla2 at the recommended conditions of use in the applicant's product. The studies relied on pertained to different types of collagen than that used in Kolla2. North American Nutriceutical Inc v Canada (Attorney General), August 30, 2012.
New Court proceedings Patented Medicines (Notice of Compliance) Regulations
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