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Supreme Court of Canada News
Amgen seeks leave to appeal from Supreme Court regarding dismissal of its appeal of Apotex/filgrastim decision. As previously reported, the Federal Court of Appeal dismissed Amgen’s appeal from a decision declining to grant a prohibition order regarding Apotex’s filgrastim product GRASTOFIL (a subsequent entry biologic (SEB) to Amgen’s NEUPOGEN): Amgen Canada Inc v Apotex Inc, 2016 FCA 196. The Court relied on its prior decisions finding that once a notice of compliance has issued, an appeal from a failed prohibition application is moot, and declined to exercise its discretion to hear the moot appeal. On August 9, 2016, Amgen filed for leave to appeal to the Supreme Court of Canada.
Supreme Court grants leave to intervenors in esomeprazole (NEXIUM) case. As previously reported, the Supreme Court of Canada will hear an appeal of the Federal Court of Appeal decision affirming a trial decision invalidating AstraZeneca’s patent relating to esomeprazole (NEXIUM) for lack of utility. The Supreme Court has granted leave to intervene to the following organizations: Innovative Medicines Canada and BIOTECanada (jointly), the Centre for Intellectual Property Policy, the Canadian Generic Pharmaceutical Association, the Fédération internationale des conseils en propriété intellectuelle, the Intellectual Property Owners Association and the Intellectual Property Institute of Canada. The hearing is scheduled for November 8, 2016.
Eli Lilly and Canadian Government file post-hearing briefs in NAFTA challenge
As previously reported, Eli Lilly filed suit under the North American Free Trade Agreement (NAFTA) seeking damages from the Government of Canada. Eli Lilly asserts 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. The hearing concluded on June 8, 2016, and post-hearing submissions were filed by Eli Lilly and the Canadian Government on July 25, 2016.
Patented Medicine Prices Review Board releases July NEWSletter
The Patented Medicine Prices Review Board (PMPRB) released the July 2016 issue of its NEWSletter. Highlights include an invitation to submit feedback in response to the Guidelines Modernization Discussion Paper and the series of questions it puts forward regarding possible reform of its Compendium of Policies, Guidelines and Procedures by October 24, 2016; results of the Notice and Comment period on incremental reforms to the Compendium of Policies, Guidelines and Procedures; and the approval of Voluntary Compliance Undertakings for SAMSCA (tolvaptan; Otsuka Canada Pharmaceutical Inc.), ACTIMMUNE (interferon gamma 1b; Horizon Pharma Ireland Limited), CIALIS (tadalafil; Eli Lilly Canada Inc.), SPIRIVA RESPIMAT (tiotropium bromide monohydrate, Boehringer Ingelheim (Canada) Ltd.), XALKORI (crizotinib, Pfizer Canada Inc.), and FIBRISTAL (ulipristal acetate, Allergan Inc.).
PMPRB NEWSletter — July 2016, Vol 20, Issue 3.
Health Canada gives notice regarding electronic regulatory filings
On July 8, 2016, Health Canada gave notice regarding its Common Electronic Submissions Gateway (CESG) and electronic Common Technical Document Format (eCTD). As of January 1st, 2017, all regulatory filings under 10 GB in size will have to be filed using the CESG. The CESG has been used by Health Canada for electronic submissions since February 2014, and the scope of regulatory activities accepted via the CESG has expanded since and will continue to expand. Health Canada also provided advanced notice that it is considering January 1st, 2018 as the date by which all NDS, SNDS, ANDS and SANDS regulatory activities for human drugs will have to be filed in eCTD format. Comments regarding this advanced notice can be provided up until August 31, 2016.
Court Decisions
Federal Court declares Import Ban against Apotex companies unlawful. In a decision issued June 15, 2016, the Federal Court declared the Minister of Health (Minister)’s August 31, 2015 decision that varied the terms and conditions of Apotex’s Drug Establishment Licences (ELs) in respect of its two facilities in India, Apotex Pharmachem India Pvt Ltd (APIPL) and Apotex Research Private Limited (ARPL) (“2015 Amendment”), unlawful: Apotex Inc v Minister of Health, 2016 FC 673. This is the second judicial review involving a decision of the Minister restricting importation of drugs from APIPL and ARPL. As previously reported, the Federal Court, on October 14, 2015, quashed a previous Import Ban (“2014 Import Ban”) on product from these facilities on the basis that the Minister issued the Import Ban for an improper purpose and denied Apotex procedural fairness. Although the judicial review was found to be moot, since the 2015 Amendment and the restrictions on import it imposed had ceased to exist, the Court decided to exercise its discretion to hear the application noting, in particular, the continued existence of an adversarial context. The Court found that the 2015 Amendment, in effect, sustained a decision previously quashed by the Federal Court by maintaining in part the 2014 Import Ban and that the 2015 Amendment could not be justified on the facts due to the lack of evidence before the Minister that supported any reasonable belief that an Import Ban was necessary at the time of the 2015 Amendment.
Federal Court of Appeal upholds Federal Court’s dismissal of motion to vary section 8 judgment; later finding of infringement, not a new matter arising after judgment. On July 5, 2016, the Federal Court of Appeal affirmed a decision of the Federal Court that dismissed AstraZeneca’s motion to vary a judgment (2012 FC 559, previously reported) awarding Apotex damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations in respect of Apotex’s omeprazole product (AstraZeneca’s LOSEC): AstraZeneca Canada Inc v Apotex Inc, 2016 FCA 194. Following the section 8 judgment, the Federal Court found, in a different proceeding (previously reported), that Apotex’s omeprazole product infringed AstraZeneca’s Patent No. 1,292,693 (‘693 patent). AstraZeneca unsuccessfully raised this possibility as a defence in the section 8 proceeding. On this motion, AstraZeneca argued that the finding of infringement was a new matter that arose after and required the variation of the section 8 judgment.
The Federal Court of Appeal agreed with the Motions Judge that the section 8 judgment already considered the possibility that Apotex might be found to infringe the ‘693 patent. The realization of that possibility made no difference. The Court noted that inconsistent findings in infringement and section 8 proceedings create difficulties, and adopted the statement of an earlier panel of the Court of Appeal which affirmed the section 8 judgment (2013 FCA 77, previously reported): “it will be for the Judge hearing ‘the infringement action to ensure that overall, taking both proceedings together, a party is compensated for its provable loss, if any, on proper principles, no more and no less.’” The references regarding both the infringement and section 8 proceeding are scheduled to be heard together.
Apotex’s unjust enrichment and Trademarks Act claims regarding sildenafil allowed to proceed. Apotex brought an action against Pfizer arising from the Supreme Court of Canada’s finding that Patent No. 2,163,446 (‘446 patent), pertaining to sildenafil (Pfizer’s Viagra), was invalid. Pfizer moved to strike Apotex’s claims under: section 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations), the Trademarks Act, unjust enrichment, nuisance, conspiracy, and the maxim “no right without a remedy” from Ashby v White (1703), 2 Raym Ld 938. On August 8, 2016, an Ontario Superior Court judge struck only the PMNOC Regulations and Ashby v White claims: Apotex Inc v Pfizer Ireland Pharmaceuticals, 2016 ONSC 4966.
The Court found that it was “plain and obvious” that Apotex’s claim under section 8 of the PMNOC Regulations had no legal basis. Pfizer’s application for a prohibition order in respect of the ‘446 patent was not withdrawn, discontinued or dismissed. It was successful. The Supreme Court of Canada’s later finding of invalidity in a different proceeding did not entitle Apotex to section 8 damages. The Court also struck the claim based on the maxim borrowed from Ashby v White as it does not ground a distinct cause of action.
The Trademarks Act and unjust enrichment claims however were allowed to proceed. The Court found that it is an open question whether the PMNOC Regulations form a “complete code” that ousts other remedies. The Court found that Apotex’s claim for unjust enrichment was distinguishable from a similar claim previously struck by the Ontario Court of Appeal (2015 ONCA 305, reported here) for failure to articulate a corresponding deprivation. In this matter, Apotex pleaded an entitlement only to those revenues that it was deprived of by the delay it faced in receiving a notice of compliance for its product.
The Court also declined to strike any of the claims for private nuisance, public nuisance, or conspiracy, finding it was not plain and obvious that any were doomed to fail and that Apotex pleaded the essential elements of each tort.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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tadalafil (CIALIS)
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Applicants:
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Eli Lilly Canada Inc
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Respondents:
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Dominion Pharmacal and The Minister of Health
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Respondent/Patentee:
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ICOS Corporation
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Date Commenced:
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July 7, 2016
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Court File No.:
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T-1101-16
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Comment:
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Application for Order of prohibition regarding Patent No. 2,226,784. Dominion alleges non-infringement and invalidity.
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Medicine:
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aripiprazole (ABILIFY)
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Applicants:
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Bristol-Myers Squibb Canada and Otsuka Pharmaceutical Co Ltd
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Respondents:
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Pharmascience Inc and The Minister of Health
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Date Commenced:
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July 22, 2016
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Court File No.:
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T-1217-16
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Comment:
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Application for Order of prohibition regarding Patents Nos. 2,426,921; 2,713,466; 2,689,052; 2,688,934; 2,688,915; 2,689,051; 2,429,496; 2,700,314; 2,526,562; and 2,511,619 Pharmascience alleges non-infringement and invalidity.
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Medicine:
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testosterone topical solution (AXIRON)
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Applicants:
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Acrux DDS Pty Ltd and Eli Lilly Canada Inc
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Respondents:
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Apotex Inc and The Minister of Health
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Date Commenced:
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July 29, 2016
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Court File No.:
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T-1259-16
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Comment:
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Application for Order of prohibition regarding Patents Nos. 2,489,865 and 2,610,708. Apotex alleges non-infringement and invalidity.
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Medicine:
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everolimus (AFINITOR)
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Applicant:
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Novartis Pharmaceuticals Canada Inc
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Respondents:
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Teva Canada Limited and The Minister of Health
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Respondent/Patentee:
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Novartis AG
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Date Commenced:
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July 29, 2016
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Court File No.:
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T-1260-16
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Comment:
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Application for Order of prohibition regarding Patent No. 2,351,580. Teva alleges non-infringement and invalidity.
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Medicine:
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everolimus (AFINITOR)
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Applicant:
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Novartis Pharmaceuticals Canada Inc
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Respondents:
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Teva Canada Limited and The Minister of Health
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Respondent/Patentee:
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Novartis AG
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Date Commenced:
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July 29, 2016
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Court File No.:
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T-1262-16
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Comment:
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Application for Order of prohibition regarding Patent No. 2,438,504. Teva alleges non-infringement and invalidity.
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Other Proceedings
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Medicine:
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eculizumab (SOLIRIS)
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Applicant:
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Alexion Pharmaceuticals Inc
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Respondents:
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Attorney General of Canada
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Date Commenced:
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July 13, 2016
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Court File No.:
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T-1160-16
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Comment:
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Application seeking to quash the Patented Medicine Prices Review Board’s decision granting amendments to a Statement of Allegations “that permit imposition of retroactive confiscatory liability on Alexion”.
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