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The following is a mid-year review of the top IP and regulatory law developments in life sciences in Canada.
by Nancy Pei
1. Substantive patent law developments: the Supreme Court of Canada (SCC) will hear an appeal regarding the utility “promise” doctrine on November 8, regarding AstraZeneca’s patent relating to esomeprazole (NEXIUM). Other substantive patent law developments include the Federal Court of Appeal’s confirmation that the correct test for determining whether an invention is obvious under the “obvious to try” test is still whether it was “more or less self-evident” to try to obtain the invention, and not a lower standard, such as whether the solution provides a “fair expectation of success” or whether “the skilled person had good reason to pursue predictable solutions”. The Federal Court of Appeal also clarified the test for double-patenting.
2. Section 8 and other claims following failed Patented Medicines (Notice of Compliance) Regulations proceedings: the Federal Court of Appeal overturned Teva’s $125 million award (venlaxafine, EFFEXOR XR) for improper reliance on hearsay evidence and remitted the matter to the trial judge for redetermination. Apotex was denied leave from the SCC regarding a decision striking an unjust enrichment claim against Eli Lilly. However, Apotex’s damage claim based on alleged improper issuance of a patent/a failed prohibition proceeding pursuant to the Trademarks Act and Statutes of Monopolies has been permitted to proceed. The SCC also denied leave in a proposed class action regarding VIAGRA, which sought to allege that consumers had been overcharged as a result of Pfizer’s unsuccessful prohibition proceeding.
3. Quantification of damages: the SCC declined to hear Apotex’s proposed appeal regarding the relevance of a non-infringing alternative in assessing damages for patent infringement in a case involving lovastatin (MEVACOR). The Federal Court awarded Janssen close to $20 million from Teva for infringing its patent relating to levofloxacin (LEVAQUIN).
4. CETA/TPP: with the legal review completed in February, CETA will likely be in force in 2017. Key provisions are expected to include (i) an innovator right of appeal under the PMNOC Regulations; (ii) the end to “dual litigation”; and (iii) patent term restoration. Both CETA and TPP (which also includes a patent term restoration requirement) still require ratification.
5. PMPRB’s strategic objectives as set out in its 2015-2018 Strategic Plan are: (1) consumer-focused regulation and reporting; (2) framework modernization; (3) strategic partnerships and public awareness; and (4) employee engagement. The PMPRB released a number of reports including reports analyzing generic drug pricing and public drug plan expenditures. Sandoz has sought leave from the Supreme Court of Canada regarding the Federal Court of Appeal’s decision that the PMPRB has jurisdiction over its pricing. Alexion has sought leave to intervene. Alexion’s separate challenge in the Federal Court regarding the constitutionality of the PMPRB provisions remains pending.
6. Health Canada/CADTH new transparency initiatives include an expanded Health Canada listing of Regulatory Decision Summaries and Submissions Under Review. Further, flowing from Vanessa’s Law, Health Canada released a Draft Guide on Disclosure of Confidential Business Information, an interim approach to drug safety updates, and an Issue Identification Paper for comment regarding mandatory reporting of serious adverse drug reactions by healthcare institutions. CADTH will no longer accept confidential drug prices submitted after April 1.
7. Biologics update: Health Canada released a draft Revised Guidance Document regarding Information and Submission Requirements for Subsequent Entry Biologics. Five SEBs have been approved to date OMNITROPE (Sandoz, 2009), REMSIMA/INFLECTRA (Celltrion, Hospira, 2014 – a patent impeachment/infringement trial will start in September), BASAGLAR (Eli Lilly, 2015), and GRASTOFIL (Apotex, 2015). The Children’s Hospital of Eastern Ontario (CHEO) settled with Transgenomic, allowing “CHEO and all other Canadian public sector hospitals and laboratories the right to test Canadians for Long QT syndrome on a not-for-profit basis … without legal roadblocks from [the] gene patents.”
8. Patent litigation practice: the Federal Court permitted a “quia timet” patent infringement claim to proceed. Teva brought an impeachment action regarding patents relating to tenofovir disoproxil fumarate products (TRUVADA and VIREAD), and in turn Gilead sued for infringement. The Court dismissed Teva’s motion to strike Gilead’s claim, as while Teva had not yet launched, its regulatory submission was likely on patent hold and Teva had stated its intention to launch as soon as it obtained its notice of compliance. In May, the Federal Court issued new case management guidelines for PMNOC applications to more closely manage them.
“Blinding” of experts in PMNOC applications (e.g. as to the generic’s product) has met with mixed results: one judge found it not determinative; another weighed it as a relevant factor in preferring one expert’s testimony over another.
9. Competition law: in March, the Competition Bureau released updated Intellectual Property Enforcement Guidelines which describe the Bureau’s approach to conducting investigations of potentially anti-competitive activities relating to intellectual property, including settlements in PMNOC proceedings and “product switching”.
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