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25 January 2016
Still no clarification from Supreme Court on utility
Patent infringement actions
Patent with claim for single medicinal ingredient against fixed-dose combination
Patented Medicine Prices Review Board
Trans-Pacific Partnership free trade agreement
First biologic decision under Patented Medicines (Notice of Compliance) Regulations
Patented Medicines (Notice of Compliance) Regulations and data protection statistics
This update highlights developments in Canadian life sciences IP and regulatory law in 2015.
In November 2014 Apotex discontinued its appeal to the Supreme Court of Canada on the eve of the hearing of its appeal regarding the validity of Sanofi-Aventis's patent claiming clopidogrel bisulfate (Plavix). Had the appeal proceeded, the Supreme Court of Canada was expected to provide guidance on the 'promise' doctrine of utility and the test for sound prediction of utility. Apotex and Mylan subsequently sought leave to appeal from the Supreme Court of Canada in the celecoxib (Celebrex) litigation, which also raised issues of utility, including 'promise' of the patent. The Supreme Court of Canada denied leave on April 23 2015. Following dismissal by the Federal Court of Appeal of its appeal of a Federal Court decision invalidating its patent for esomeprazole (Nexium) for lack of demonstrated/sound prediction of utility, on September 29 2015 AstraZeneca sought leave to appeal from the Supreme Court of Canada; a decision is pending. The Federal Court's finding in Nexium that the patent disclosure requirement for sound prediction applies only to new use patents was followed by the Federal Court in an October 9 2015 decision relating to sofosbuvir (Sovaldi).
Following unsuccessful enforcement of their patents under the Patented Medicines (Notice of Compliance) Regulations, patentees have been sued in a variety of actions on various grounds:
On January 23 2015 the Federal Court ordered Apotex to pay Eli Lilly over C$100 million in damages for infringing sales of cefaclor (Eli Lilly's Ceclor). On June 18 2015 the Federal Court ordered Apotex and Apotex Pharmachem Inc to pay over C$61 million to Adir and Servier for their profits from infringing sales of perindopril (Servier's Coversyl). In both cases the court rejected Apotex's non-infringing alternative arguments. However, on July 23 2015, in a case relating to lovastatin (Merck's Mevacor), the Federal Court of Appeal held that the availability of a non-infringing alternative may be a relevant consideration when assessing damages for patent infringement. As the defence was rejected on the facts, the lower court's award of over C$119 million in damages to Merck was upheld. On September 29 2015 Apotex sought leave to appeal from the Supreme Court of Canada in Lovastatin; a decision is pending. Apotex's appeals in Cefaclor and Perindopril are pending.
On March 16 2015 the Federal Court found AstraZeneca's omeprazole (Losec) formulation patent valid and infringed by Apotex. AstraZeneca's reference is pending. Apotex's appeal is pending. On October 9 2015, in the only other pharmaceutical patent action decision on the merits, the Federal Court invalidated an Idenix patent and dismissed attacks on a Gilead patent claiming sofosbuvir (Sovaldi); Idenix has appealed.
Following pre-publication on May 2 2015, the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations came into force on June 19 2015 and were published on July 1 2015 to address court decisions that were inconsistent with the policy intent of the Patented Medicines (Notice of Compliance) Regulations. On July 17 2015 the Federal Court of Appeal held that a patent with a claim for a formulation naming one medicinal ingredient (spinosad) was eligible for listing against a fixed-dose combination product containing spinosad and milbemycin oxime (Trifexis).
On August 10 2015 the Federal Court dismissed Photocure's application challenging the minister of health's denial of data protection for hexaminolevulinate hydrochloride (HAL HCl) (Cysview) on the basis that HAL HCl was an ester of a previously approved medicinal ingredient, aminolevulinic acid hydrochloride (Levulan Kerastick). On November 6 2015 the Federal Court upheld the minister's decision not to issue a notice of compliance for Hospira's oxaliplatin for injection pending expiry of the data protection term for Eloxatin. While Hospira's new drug submission was filed before Sanofi-Aventis's new drug submission for Eloxatin, the court found that the minister was correct that post-filing amendments to a new drug submission can trigger data protection.
On September 11 2015 Alexion Pharmaceuticals filed an application seeking a declaration that the Patent Act scheme for regulating the prices of patented medicines is unconstitutional. On November 6 2015 the Federal Court of Appeal reversed Federal Court decisions and found that Sandoz and ratiopharm were 'patentees' for the purpose of the Patented Medicine Prices Review Board provisions of the Patent Act. In December 2015 the Patented Medicine Prices Review Board released it strategic plan for 2015 to 2018.
On October 5 2015 the government of Canada announced that the members of the Trans-Pacific Partnership had successfully concluded negotiations on a free trade agreement and the text was released on November 5 2015 (for further details please see "Canada concludes TPP negotiations – IP aspects"). The agreement will require that parties provide a patent term adjustment to compensate for the "unreasonable curtailment of the effective patent term as a result of the marketing approval process". Canada has already committed to providing such protection in the Canada-EU Comprehensive Trade and Economic Agreement, which remains to be ratified.
On November 10 2015, in the first decision on a subsequent-entry biologic product in an application brought under the Patented Medicines (Notice of Compliance) Regulations, the Federal Court dismissed Amgen's application for an order prohibiting the issuance of a notice of compliance to Apotex for its proposed filgrastim product (Grastofil), which relied on a comparison to Amgen's Neupogen. Apotex succeeded in its allegation of obviousness and Amgen appealed. Apotex received its notice of compliance on December 7 2015, which is the fifth subsequent-entry biologic approved in Canada (after Omnitrope (2009), Remsima/Inflectra (2014) and Basaglar (2015)). Separately, Amgen's prohibition proceeding relating to Samsung Bioepis's version of the recombinant antibody etanercept (Amgen's Enbrel) is pending.
Based on the 14 Federal Court Patented Medicines (Notice of Compliance) Regulations decisions reported by year-end, the patentee succeeded on the merits regarding three patents in four cases and the generic manufacturer succeeded regarding 11 patents in 10 cases. The Federal Court of Appeal affirmed all six Patented Medicines (Notice of Compliance) Regulations appeals (patentee on three patents, generic manufacturer on four patents).(1)
For further information on this topic please contact Nancy Pei at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
(1) See summary table here. See also the Therapeutic Products Directorate report providing a statistical overview of Health Canada's administration of the Patented Medicines (Notice of Compliance) Regulations and data protection, and the Therapeutic Products Directorate's and the Biologics and Genetic Therapies Directorate's Drug Submission Performance Annual Reports.
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