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Federal Court of Appeal confirms “obvious to try” test still requires it be “more or less self-evident” to try to obtain the invention
On December 15, 2015, the Federal Court of Appeal dismissed an appeal by Eli Lilly and ICOS of a Federal Court decision which dismissed their application for an order prohibiting the Minister of Health from issuing a notice of compliance for Mylan’s tadalafil tablets (Eli Lilly’s CIALIS). The Federal Court decision was previously reported. The Federal Court of Appeal, among other things, confirmed 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”. See our IP Update for more information on the appeal and the underlying decision.
Eli Lilly Canada Inc v Mylan Pharmaceuticals ULC — 2015 FCA 286
Federal Court decision — 2015 FC 178
Supreme Court of Canada news
Pfizer seeks leave on settlement made prior to amalgamation. As previously reported, the Federal Court of Appeal upheld the Federal Court’s finding that a settlement agreement between Pfizer and ratiopharm (later amalgamated with Teva), which precluded a section 8 action against Pfizer for ratio-sildenafil, did not preclude Teva from pursuing section 8 damages against Pfizer for Novo-sildenafil (now Teva-sildenafil). On December 17, 2015, Pfizer filed for leave to appeal to the Supreme Court.
Pfizer Canada Inc, et al v Teva Canada Ltd (SCC Case No. 36772)
Court of Appeal decision — 2015 FCA 257
Federal Court decision — 2015 FC 760
Apotex denied leave to appeal decision striking claim for unjust enrichment in section 8 action relating to atomoxetine. On January 14, 2016, the Supreme Court denied Apotex leave to appeal a decision of the Ontario Court of Appeal affirming a Divisional Court decision striking Apotex’s plea of unjust enrichment from its statement of claim also seeking damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) relating to atomoxetine (Eli Lilly’s STRATTERA). As previously reported, the Ontario Court of Appeal struck Apotex’s claim for unjust enrichment as Apotex experienced no corresponding deprivation: “Apotex was never deprived of the portion of Lilly’s revenues represented by its monopolistic profits because Apotex would never have earned those profits.” Apotex Inc v Eli Lilly and Company and Eli Lilly Canada (SCC Case No. 36538)
Ontario Court of Appeal decision — 2015 ONCA 305
Ontario Divisonal Court decision — 2013 ONSC 5937
Ontario Superior Court decision — 2012 ONSC 3808
Patented Medicine Prices Review Board news
2014 Annual Report. On December 10, 2015 the Minister of Health tabled the 2014 Annual Report, which includes information on the Patented Medicine Prices Review Board (PMPRB)’s activities, patentee compliance, sales and price trends, and expenditures. The report highlights that sales of patented drugs in Canada increased by 3.1% in 2014 to $13.7 billion. Average price of patented drugs was stable in 2014, but Canadian prices were third highest among the PMPRB’s seven comparator countries. Spending on pharmaceutical R&D by patentees in Canada declined to 4.4% of sales, the lowest rate since PMPRB began reporting in 1988. The PMPRB had 61 open investigations in 2014, and five Voluntary Compliance Undertakings were signed.
PMPRB 2014 Annual Report
2015-2018 Strategic Plan. The PMPRB recently announced its Strategic Plan which was the result of a year-long strategic planning process. The objective of the Strategic Plan was to address “threats and opportunities in its operating environment”. In particular, the PMPRB has noted that drug prices have recently been rising relative to comparison countries while average R&D spending as a percentage of sales has been declining. According to the Strategic Plan, the PMRPB’s four main strategic objectives for 2015-18 are: (1) consumer-focused regulation and reporting; (2) framework modernization; (3) strategic partnerships and public awareness; and (4) employee engagement.
PMPRB Strategic Plan 2015-2018
December NEWSletter. Highlights of the December issue include a Notice and Comment for amendments to its Compendium of Policies, Guidelines and Procedures; update of price source for Germany effective January 2016; notice of Voluntary Compliance Undertakings in relation to CARNITOR IV and LOPROX; and publication of pre-hearing conference decisions relating to the SOLIRIS proceedings.
PMPRB NEWSletter — December 2015, Vol 19, Issue 4
Study relating to the generic market and private drug plans. The PMPRB, through the National Prescription Drug Utilization Information System, released the first of a three-part study which explores issues in private drug plans, including the assessment of the increased use of generic drugs in private drug plans following the loss of market exclusivity for many blockbuster innovator drugs.
Private Drug Plans in Canada, Part I: Generic Market 2005-2013 — December 4, 2015
Health Canada News
Draft Revised Guidance Document: Information and Submission Requirements for Subsequent Entry Biologics. On December 7, 2015, Health Canada released a draft of the Revised Guidance Document that provides guidance to sponsors to enable them to satisfy the information and regulatory requirements for the authorization of Subsequent Entry Biologics (SEBs) in Canada. The deadline for comments is February 15, 2016. According to the Notice, the key revisions include:
- Section 2.1.3, Reference Biologic Drug: Further guidance is provided with respect to considerations in the selection of a reference biologic drug. This also includes revisions to Section 2.1.3.1 Considerations for the use of a non-Canadian reference biologic drug, to provide clarity on establishing a link between the non-Canadian reference and Canadian reference biologic drug.
- Section 2.3.3, Non-Clinical and Clinical Information: Additional detail is provided with respect to considerations when performing non-clinical and clinical studies for SEBs, including discussion with respect to immunogenicity, the use of the most sensitive population in clinical trial design and a new section on extrapolation.
- Section 2.4, Post-Market Requirements: Updated information with respect to periodic benefit-risk evaluation reports and labelling changes for product class type-specific safety information, including Health Canada’s considerations in the review of a Supplemental New Drug Submission and the use of previously demonstrated similarity provided in the original New Drug Submission to support a change.
- Section 3.0, Consultation with the Biologics and Genetic Therapies Directorate: A new section which promotes early consultation with Health Canada, as well as the launch of three year pilot for SEB Scientific Advice Meetings to allow for discussion of an SEB with Health Canada early in the development process.
Notice. Draft — Revised Guidance Document.
Health Canada and United States Food and Drug Administration hold joint public consultation. In December 2015, Health Canada and the US FDA held a meeting regarding the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines currently under development. Prior to the meeting, a public consultation took place in November 2015, and experts from Health Canada, the FDA, and the association of the Pharmaceutical Research and Manufacturers of America provided updates on ongoing ICH activities. There are a number of different guidelines that are currently under consideration, and Health Canada has since released some new ICH guidance documents, as well as draft guidance documents for consultation, and questions and answers.
Notice. Health Canada’s ICH site.
Canadian government files rejoinder on the merits in Eli Lilly’s NAFTA challenge
As previously reported, Eli Lilly filed a Notice of Arbitration pursuant to the North American Free Trade Agreement (NAFTA) seeking damages from the Government of Canada, asserting that the Canadian judiciary’s application of the promise doctrine to Eli Lilly’s STRATTERA (atomoxetine) and ZYPREXA (olanzapine) patents contravenes Canada’s obligations under NAFTA and the Patent Cooperation Treaty (PCT). Eli Lilly’s Reply Memorial was filed on September 11, 2015, and the Canadian government recently responded by filing its Rejoinder Memorial on the merits on December 8, 2015. The Canadian government argues, among other things, that Eli Lilly’s challenge is outside the Tribunal’s jurisdiction and that Canada’s law on utility and its application to Eli Lilly’s patents are not an unlawful expropriation in breach of Article 1110.
Bayer successfully opposes registration of FASPRIN in association with pharmaceutical compositions containing NSAIDs
On November 16, 2015, the Trademarks Opposition Board found that the Applied Medical Research’s applied-for mark FASPRIN was confusing with Bayer’s registered trademark, ASPIRIN.
Bayer Aktiengesellschaft v Applied Medical Research — 2015 TMOB 203
Executive Officer has jurisdiction to regulate pharmaceutical wholesalers
1671183 Ontario Inc. o/a Pharma Stop sought judicial review of a Varied Rebate Order made by the Executive Officer of Ontario Public Drug Programs. The Rebate Order imposed a financial penalty of $2,936,591 for receipt of unlawful rebates from generic manufacturers. The Executive Officer is responsible for enforcing anti-rebate provisions in the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act.
The Rebate Order followed an inspector’s report stating that Amerisource Bergen bought drugs from generic manufacturers and sold them to Pharma Stop, who would be paid “professional allowances” by the manufacturers. Pharma Stop would then resell the product to Amerisource Bergen or others. Pharma Stop also bought product directly from the manufacturer and was paid a professional allowance by the manufacturer. The impugned payments to Pharma Stop were in the range of 40% of the product price.
On November 20, 2015, the Ontario Divisional Court rejected Pharma Stop’s submissions, finding there was no question that the Executive Officer had the jurisdiction to regulate pharmaceutical wholesalers under the two Acts. The Court held that the impugned payments did not fall under the exception for professional allowances in the two Acts because they were not “for the purpose of direct patient care”, as required by the regulatory scheme. Accordingly, Pharma Stop received prohibited rebates, and the Executive Officer had the jurisdiction to impose a rebate order. The Court also found that the Executive Officer had acted within her jurisdiction, including delegating investigatory power to inspectors and using information obtained from Amerisource Bergen to investigate Pharma Stop.
1671183 Ontario Inc o/a Pharma Stop v Ontario (Ministry of Health and Long-Term Care) — 2015 ONSC 6779 (Div. Ct.)
Federal Court of Appeal dismisses Teva’s appeal of failed motion to strike in VIAGRA section 8 case
In a decision delivered from the bench on December 8, 2015, the Federal Court of Appeal dismissed Teva’s appeal from the decision of a judge, dismissing its appeal from the decision of a prothonotary. The prothonotary had refused to strike certain paragraphs in Pfizer’s statement of defence and counterclaim in Teva’s action for damages under section 8 of the PMNOC Regulations relating to sildenafil (VIAGRA).
The relevant paragraphs related to Pfizer’s defences that Teva’s sale of sildenafil tablets would have infringed Pfizer’s patent and industrial design and amounted to passing off under the TradeMarks Act. With respect to Pfizer’s defence relating to patent infringement, Teva argued that it would be an abuse of process to relitigate the validity of the patent as the result of the prohibition proceeding was binding in the section 8 action. Teva further objected to Pfizer Products, the owner of the VIAGRA tablet get-up trade-mark, being named as a plaintiff to the counterclaim and sought an order either striking the counterclaim or ordering that it be tried as a separate action.
The Federal Court of Appeal acknowledged uncertainty in the law regarding the interpretation of section 8 of the PMNOC Regulations, but noted that this uncertainty supported the decision not to strike the relevant paragraphs. The Court declined to interfere with the decision of the Federal Court.
Teva Canada Limited v Pfizer Canada Limited, 2015 FCA 280)
Federal Court decision — 2015 FC 306
Federal Court — Prothonotary’s Order
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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bimatoprost (LATISSE)
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Applicants:
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Allergan Inc and Allergan, Inc
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Respondents:
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The Minister of Health and Sandoz Canada Inc
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Date Commenced:
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December 10, 2015
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Court File No.:
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T-2068-15
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Comment:
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Application for order of prohibition until expiry of Patent No. 2,475,106. Sandoz alleges non-infringement and invalidity.
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Other proceedings
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Medicine:
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Emergen-C
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Plaintiff:
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Corinna Armstrong
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Defendant:
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Pfizer Canada Inc and Pfizer Inc
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Date Commenced:
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November 19, 2015
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Court File No.:
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T-1956-15
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Comment:
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Proposed class action against Pfizer for allegedly making false, misleading representations as to the health benefits of Emergen-C, a powdered drink vitamin supplement, contrary to the Competition Act.
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Medicine:
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vitamin D (equate Vitamin D3 Drops and Dr. Nutrition Baby D Drops)
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Plaintiffs:
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The D Drops Company Inc, Reinhold Vieth, Elaine Vieth and DDrops Company
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Defendant:
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Nutralab Canada Corp
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Date Commenced:
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November 25, 2015
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Court File No.:
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T-1975-15
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Comment:
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Action for infringement of Patent No. 2,578,881 and trademark infringement.
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Medicine:
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ledipasvir/ sofosbuvir (HARVONI)
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Plaintiffs:
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Abbvie Inc, Abbvie Corporation and Abbvie Ireland Unlimited Company
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Defendants:
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Gilead Sciences, Inc, Gilead Sciences Canada, Inc and Gilead Sciences Ireland Unlimited Company
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Date Commenced:
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November 26, 2015
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Court File No.:
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T-1990-15
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Comment:
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Action for infringement of Patent No. 2,857,339.
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Medicine:
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omeprazole magnesium tablets
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Applicant:
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Apotex Inc
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Respondent:
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Minister of Health and Attorney General of Canada
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Date Commenced:
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November 30, 2015
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Court File No.:
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T-2011-15
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Comment:
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Application for judicial review of the decision of the Minister to cancel the reconsideration of Apotex’s regulatory submission for omeprazole magnesium tablets and to treat its submission as withdrawn.
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