IN THIS ISSUE:
Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing
CADTH releases 2018-2021 Strategic Plan
Apotex fails to establish it would have obtained non-infringing perindopril from foreign third-party suppliers; original $61+ million profits award stands
Comparing Patent Term Extension Regimes Between Canada (CSPs) and the EU (SPCs)
First CSPs issue, application fee increased on April 1
Supreme Court of Canada leave applications
HEALTH CANADA NEWS
Consultation on draft guidance governing public release of clinical information contained in drug submissions and medical device applications
Health Canada reports on public feedback from consultations on the proposed approach to regulation of cannabis
Health Canada intends to propose post-market amendments to the Medical Devices Regulations
COURT DECISIONS
Apotex not entitled to reopen trial on esomeprazole (NEXIUM) patent validity
Two procedural decisions relating to HERCEPTIN under the amended PMNOC Regulations: confidentiality rules cannot be varied until action commenced; motion to dismiss may be brought prior to completion of examinations for discovery
Ontario Court of Appeal dismisses summary judgment appeal in section 8 case
New court proceedings
Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing
By Abigail Smith
While common among member countries of the Organisation for Economic Co-operation and Development (OECD), Canada does not have a national pharmacare program, i.e. a single system of public insurance coverage for prescription drugs. On April 19, 2018, the Standing Committee on Health (Committee) released Pharmacare Now: Prescription Medicine Coverage for All Canadians, a report advocating the establishment of a national pharmacare program – specifically, a single payer universal publicly funded prescription drug coverage program for all Canadians, as an insured service under the Canada Health Act.
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CADTH releases 2018-2021 Strategic Plan
By Andrew Mandlsohn
On April 16, 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) announced the release of its strategic plan for 2018-2021 entitled “Transforming How We Manage Health Technologies in Support of Better Health, Better Patient Experience, and Better Value”, and a brief summary overview of the plan. The CADTH, a health technology assessment agency, plans to transition to a health technology management agency by “[c]losing the gap between evidence, policy, and practice”, “[a]dopting a life-cycle approach to health technology assessment”, and “[a]nticipating health system and technology trends, and develop[ing] agile management strategies.”
Apotex fails to establish it would have obtained non-infringing perindopril from foreign third-party suppliers; original $61+ million profits award stands
By Urszula Wojtyra
Servier and its related company ADIR were successful in another chapter of patent litigation relating to perindopril (Servier’s COVERSYL): the Federal Court again dismissed Apotex’s non-infringing alternative defence, finding that Apotex would not have called on foreign third parties to manufacture perindopril to supply Apotex affiliates in the UK and Australia. The Court thereby re-affirmed its original judgment that Apotex Inc. and Apotex Pharmachem Inc. (collectively Apotex) must pay all their profits attributable to infringement of ADIR’s patent: ADIR v Apotex Inc, 2018 FC 346.
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Comparing Patent Term Extension Regimes Between Canada (CSPs) and the EU (SPCs)
By Nancy Pei
Amendments to the Patent Act and enactment of the Certificate of Supplementary Protection Regulations flowing from the Canada-European Union (EU) Comprehensive Economic and Trade Agreement (CETA, see our article here) introduced a new framework in Canada for the issuance of Certificates of Supplementary Protection (CSPs). CSPs provide an additional patent-like protection term, and are intended to partly compensate the innovator for the time required for research and obtaining regulatory approval in Canada. CSPs are similar to the European system of Supplementary Protection Certificates (SPCs), with a number of key differences, including a shorter capped term of 2 years, as compared to 5 years in the EU. Key aspects of the two regimes are compared in the chart below.
A special thank you to Daniel Wise, partner, Carpmaels & Ransford, for contributing the SPC details.
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First CSPs issue, application fee increased on April 1
By Katie Lee
Health Canada has issued the first Certificates of Supplementary Protection (CSPs) against the following approvals: neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily A/neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily B (Pfizer’s TRUMENBA), letermovir (Merck’s PREVYMIS), and guselkumab (TREMFYA)(see: Register of Certificates of Supplementary Protection). In addition, the CSP application fee as of April 1, 2018 is $9,192.
Supreme Court of Canada leave applications
By Katie Lee
Teva seeks leave in levofloxacin damages assessment.
As previously reported, the Federal Court of Appeal (FCA) dismissed Teva’s appeal on the quantification of damages from infringement of Janssen’s patent for levofloxacin (LEVAQUIN). The FCA rejected Teva’s arguments, finding that the Federal Court did not err in constructing the hypothetical world, and that the Federal Court’s factual findings were open to it on the evidence. On March 26, 2018, Teva applied to the Supreme Court of Canada for leave to appeal (docket no. 38033).
Supreme Court denies leave regarding natural health product licence.
On April 12, 2018, the Supreme Court of Canada dismissed The Winning Combination’s leave to appeal (docket no. 37697). The Federal Court of Appeal decision had set aside the order of mandamus compelling the Minister of Health to grant a licence to The Winning Combination for its natural health product, RESOLVE (as previously reported).
Health Canada News
Consultation on draft guidance governing public release of clinical information contained in drug submissions and medical device applications
By Brandon Heard
As previously reported, on December 9, 2017, Heath Canada released proposed amendments to the Food and Drug Regulations and Medical Devices Regulations providing for the public release of clinical information contained in drug submissions and medical device applications. On April 10, 2018, Health Canada published a draft guidance document addressing implementation of the proposed amended regulations. According to the guidance:
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Implementation will occur in 4 phases to take place over 4 years. In the first phase, Health Canada plans to proactively publish clinical information contained in any (i) new drug submission (NDS) for a new active substance, (ii) supplemental new drug submission (SNDS) containing confirmatory trials, or (iii) application to switch an authorized medicinal ingredient to non-prescription status. By year 4, this will expand to clinical information in any NDS, SNDS, abbreviated new drug submission (ANDS), or supplemental abbreviated new drug submission (SANDS) as well as any Class III or IV medical device application.
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Upon issuance of a negative regulatory decision, the publication process will be delayed 30 days for the manufacturer to seek reconsideration or an appeal. Publication will be initiated upon completion of any reconsideration or appeal.
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The manufacturer will be notified by email of the list of documents that will be publically released and will have 20 days to propose redactions and de-identify the data. Data anonymization must be explained in a separate “Anonymization Report”.
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Redactions may be proposed for certain categories of clinical information that remain confidential business information (previously reported).
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Clinical information from past submissions will be available upon request through Health Canada’s clinical information portal.
Health Canada is seeking stakeholder comments on the draft guidance, which may be submitted until June 25, 2018.
Health Canada reports on public feedback from consultations on the proposed approach to regulation of cannabis
By Andrew Mandlsohn
Bill C-45, An Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts (“Cannabis Act”) is currently before the Senate with a vote expected no later than June 7, 2018 (see Introduction of the Cannabis Act: Questions and Answers). The Government intends to publish final regulations as soon as possible following Royal Assent of the Cannabis Act. Rather than pre-publishing draft regulations, the Government released regulatory proposals by way of a consultation paper (previously reported). On March 19, 2018, Health Canada announced the release of its report entitled “Proposed Approach to the Regulation of Cannabis: Summary of Comments Received During the Public Consultation”. The report provides a summary of comments received on the consultation paper, including on matters such as licences, permits and authorizations, security clearances, a national Cannabis Tracking System, cannabis products, packaging and labelling and cannabis for medical purposes, and also provides additional details on the proposed regulation in these and other areas.
Health Canada intends to propose post-market amendments to the Medical Devices Regulations
By Andrew Mandlsohn
On April 10, 2018, Health Canada issued a Notice of Intent to “propose regulatory changes to strengthen the post-market surveillance and risk management of medical devices in Canada.” The intended amendments are to reflect changes made to the Food and Drugs Act (FDA) following the enactment of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law). The proposed changes will, among other things, provide the Minister of Health with the authority to: (i) request analytical issue reports from a manufacturer when there is suspicion of a safety concern; (ii) require manufacturers to prepare annual reports and to notify Health Canada of any significant change in the safety of a medical device; (iii) compel manufacturers to conduct a reassessment and to require tests and studies; and (iv) require manufacturers to provide notification to Health Canada of any risk communications, changes to labelling, recalls, assessments, and suspensions, or revocations occurring in other countries. Health Canada intends to pre-publish the proposed regulatory amendments in 2019.
Court Decisions
Apotex not entitled to reopen trial on esomeprazole (NEXIUM) patent validity
By Lynn Ing
After the Supreme Court of Canada (SCC) held that AstraZeneca’s patent relating to esomeprazole (NEXIUM) was not invalid for inutility (see SCC strikes down “promise doctrine”) and the SCC’s dismissal of Apotex’s post-judgment motion for reconsideration and rehearing (see Update on AstraZeneca SCC), Apotex sought to raise new grounds of patent invalidity in the Federal Court, premised on “overpromising” under insufficiency, wilful misleading and overbreadth. Justice Locke dismissed Apotex’s motion (AstraZeneca v Apotex, 2018 FC 185): the validity of the patent was finally decided by the SCC; any doubt that might have remained about the SCC’s intent was resolved by the SCC’s dismissal of Apotex’s motion. Justice Locke also held that AstraZeneca was entitled to a declaration of infringement and ordered the quantification of AstraZeneca’s damages or Apotex’s profits. Apotex has appealed.
Two procedural decisions relating to HERCEPTIN under the amended PMNOC Regulations: confidentiality rules cannot be varied until action commenced; motion to dismiss may be brought prior to completion of examinations for discovery
By Abigail Smith
As previously reported, substantial amendments to the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) came into force on September 21, 2017. The following reports on two court decisions addressing procedure under these amendments.
On March 1, 2018, Prothonotary Aylen ruled that the Court lacked jurisdiction to consider a motion under section 5(3.7) of the PMNOC Regulations to vary confidentiality rules imposed by the person who served the notice of allegation under section 5(3.5) until an action has been commenced: Genentech, Inc. v Pfizer Canada, 2018 FC 233. Pfizer served eight Notices of Allegation on Roche with respect to Pfizer’s New Drug Submission for its TRAZIMERA product (a biosimilar of Hoffmann La-Roche’s HERCEPTIN (trastuzumab)), and simultaneously imposed confidentiality rules on those documents. Prior to the commencement of actions, Roche and Genentech (the patent owner) filed a “motion/application” to vary those rules. The Court dismissed the motion/application, finding that in the absence of proceedings, it lacked jurisdiction to consider Roche and Genentech’s “motion/application”.
On March 15, 2018, Prothonotary Aylen dismissed Pfizer’s motion to dismiss, adjourn, or delay a motion by Amgen under section 6.08 of the PMNOC Regulations seeking to summarily dismiss Roche and Genentech’s action against Amgen, which also relates to patents for Roche’s HERCEPTIN (trastuzumab):Genentech, Inc. v Amgen Canada, 2018 FC 303. The Prothonotary decided as follows:
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Amgen’s motion, on its face, was not bereft of any prospect of success. She likened motions under section 6.08 to those under former section 6(5)(b) and motions to strike under Rule 221 of the Federal Court Rules.
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She similarly refused to delay hearing Amgen’s motion until after the completion of examinations for discovery. The PMNOC Regulations imposed no temporal restriction on such motions and based on the schedule proposed by Amgen, Roche and Genentech would have the benefit of full documentary discovery prior to filing their motion materials.
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Lastly, she refused to extend the 24 month statutory stay as a result of Amgen’s motion as it was not found to amount to misconduct warranting extension of the stay.
Ontario Court of Appeal dismisses summary judgment appeal in section 8 case
By Brandon Heard
As previously reported, the Ontario Superior Court of Justice dismissed Abbott and Takeda’s motion for summary judgment in an action brought by Apotex under section 8 of the PMNOC Regulations. The action relates to lansoprazole, the active ingredient in Apo-Lansoprazole and Abbott’s PREVACID. On April 5, 2018, the Ontario Court of Appeal dismissed Abbott and Takeda’s appeal: Apotex Inc. v Abbott Laboratories Limited, 2018 ONCA 332. The appellants argued that Apo-Lansoprazole could not and would not have received regulatory approval in April 2007 and Apotex was not entitled to damages. The Court of Appeal disagreed, concluding that the motions judge did not err in finding that Apo-Lansoprazole would have received approval in April 2007. This date was consistent with Apotex’s expert evidence and the timing of Health Canada’s letter indicating that Apo-Lansoprazole was approvable in the real world. While Health Canada subsequently reversed its position, that reversal could only be relevant to the quantum of Apotex’s damages and did not render the earlier letter void ab initio.
New Court Proceedings
PM(NOC) Proceedings
L-lysine-d-amphetamine (VYVANSE): Shire v Apotex
vardenafil hydrochloride (STAXYN): Bayer v Jamp
teriparatide (FORTEO): Eli Lilly v Apotex
filgrastim (NIVESTYM): Amgen v Pfizer
Other Proceedings
Kripps Pharmacy (1979) v Attorney General of Canada
S-adenosylmethionine/silybin (AVENTI Liver Complete): Nutramax v Aventix Animal
synthetic estriol/lactobacillus acidophilus (GYNOFLOR): Acerus Pharmaceuticals v The Minister of Health; The Attorney General of Canada
Antibody testing for food sensitivity or intolerance: W Jean Dodds v Harvey Tenenbaum; Accumetrics Animal Health; Allergenics; Viaguard Animal Health
Antibody testing for food sensitivity or intolerance: W Jean Dodds v Mindy Tenenbaum; Canadian Dog Group; Allergy Test My Pet
liraglutide (VICTOZA): Novo Nordisk v The Minister of Health; Teva
urofollitropin (BRAVELLE): Ferring v The Minister of Health
For complete details about these proceedings, click here.
Selected Rankings
Canadian IP Impact Case of the Year
AstraZeneca v Apotex (NEXIUM)
LMG Life Sciences
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Canada’s Intellectual Property Litigation Firm of the Year
Benchmark Canada
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