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04 February 2019
Proposed PMPRB amendments still under consideration; litigation matters pending
Certificates of supplementary protection
Amended PMNOC Regulations
Decisions on the merits
Section 8 and other claims following failed PMNOC Regulations
Damages and accounting references
Treaty and legislative updates
Consultation on national pharmacare
This article examines the key developments in life sciences IP and regulatory law which took place in 2018.
Four biosimilars were approved in 2018, with the final one – BGP Pharma's Fulphila (pegfilgrastim), a biosimilar of Neulasta – obtaining approval in December.
Further, there are a number of ongoing biosimilar litigation matters (for further details please see "Mid-year biosimilars update").
In January 2018 there was a consultation on different approaches to the naming of biological drugs, including biosimilars (for further details please see "Stakeholder consultation on naming of biological drugs, including biosimilars").
In February 2018 the Canadian Agency for Drugs and Technologies in Health (CADTH) revised its biosimilar review process (for further details please see "CADTH outlines revisions to biosimilar and pharmaceutical review programmes").
In March 2018 the Federal Court found that a patent for use of inliximab (Janssen's Remicade) was valid and infringed by Hospira's biosimilar Inflectra, which was approved in 2014 (for further details please see "New use patent valid and infringed by biosimilar").(1)
In January 2018 the CADTH published its environmental scan relating to biosimilars: Biosimilars — Regulatory, Health Technology Assessment, Reimbursement Trends, and Market Outlook (for further details please see "Mid-year biosimilars update").
In October 2018 the CADTH published the International Policies on the Appropriate Use of Biosimilar Drugs. Health Canada's listing of submissions under review includes biosimilars, which now include sponsor names for new entries.
The proposed Regulations Amending the Patented Medicines Regulations remain under consideration; they were not finalised and in force on 1 January 2019 as originally planned (for further details please see "Canada releases proposed amendments to patented medicines pricing regulations"). The potential changes to the Patented Medicine Prices Review Board's (PMPRB's) pricing criteria include:
The proposed amendments contributed to Canada's appearance on the Office of the US Trade Representative's 2018 Priority Watch List (for further details please see "PMPRB forming working group on guideline reform").
A steering committee on the proposed reform and associated guidelines held its first meeting in June 2018. Its work, and that of a technical working group, is ongoing (for further details please see "Patented Medicine Prices Review Board's multi-stakeholder steering committee holds first meeting").(2)
In June 2018 Alexion's application for leave to appeal a decision dismissing its challenge to the constitutionality of certain PMPRB provisions of the Patent Act was dismissed (for further details please see "Alexion denied leave to appeal in case challenging constitutionality of PMPRB's remedial powers"). The following court cases are pending:
The PMPRB's 2017 Annual Report was released in August 2018 (for further details please see "Recent PMPRB reports").
Certificates of supplementary protection (CSPs) provide an additional patent-like protection term of up to two years and intend to partly compensate innovators for the time that is required to obtain regulatory approval. Canada's regime came into force on 21 September 2017 (for further details please see "Publication of final regulations on patent linkage and term restoration relating to CETA").(3)
GlaxoSmithKline's application for judicial review of the rejection of a Shingrix CSP application remains pending.
Substantial amendments to the Patented Medicines (Notice of Compliance) (PMNOC) Regulations came into force on 21 September 2017 (for further details please see "Publication of final regulations on patent linkage and term restoration relating to CETA").(4)
On 11 May 2018 Health Canada issued updated guidance matters including the Patent Register eligibility of CSPs (for further details please see "Health Canada issues updated guidance on PMNOC Regulations").
In July 2018 Health Canada released the Therapeutic Products Directorate Statistical Report 2017/2018, which provided an overview of its administration of the PMNOC Regulations and data protection regime for the year ending 31 March 2018, including related court activity under both regimes (for further details please see "Health Canada releases statistical report on PMNOC Regulations and data protection").
Various procedural decisions were made in 2018 (for further details please see "Amended PMNOC Regulations: first anniversary update"), including as follows:
By November 2019, barring any extensions of the statutory stay, all applications under the pre-amended PMNOC Regulations will be concluded, marking the end of a 26.5-year era.
There were only three PMNOC decisions on the merits in 2018:
There were also three decisions on the merits in impeachment and infringement actions:
The Federal Court separately held that AstraZeneca was entitled to a declaration of infringement in AstraZeneca's esomeprazole (Nexium) infringement action against Apotex. This followed the Supreme Court of Canada's decision to strike down the promise doctrine (for further details please see "Apotex not entitled to reopen trial on esomeprazole (Nexium) patent validity" and "Promise doctrine struck down and AstraZeneca's NEXIUM patent upheld as useful").
There were no appeal decisions on the merits in PMNOC applications or liability-phase decisions in infringement and impeachment actions. However, the Federal Court of Appeal did confirm that an infringer has no right to elect a patentee's remedy (for further details please see "Federal Court of Appeal confirms patent infringer not entitled to dictate appropriate remedy").
In 2018, there were three decisions on the merits (including one appeal) regarding claims under the pre-amended Section 8:
Eli Lilly's subsequent application for leave to appeal was dismissed (for further details please see "Court dismisses Section 8 damages appeal and grants cross-appeal").
Separately, in November 2018, in an action by Apotex for compensation from Sanofi and Schering under the Ontario Statute of Monopolies, the UK Statute of Monopolies (premised on the assertion of an invalid patent) and the Trademarks Act, the Ontario Court of Appeal granted Sanofi and Schering leave to amend their defences to plead that the Federal Court had relied on the wrong legal principles in finding the patent at issue invalid in light of special circumstances arising from the subsequent Supreme Court of Canada's Nexium decision, which had struck down the promise doctrine (for further details please see "Court allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed" and "Promise doctrine struck down and AstraZenca's NEXIUM patent upheld as useful").
The Federal Court of Appeal dismissed Teva's appeal relating to Janssen's damages and costs (C$19 million) for its infringement of Janssen's patent for levofloxacin (Levaquin) and affirmed that Janssen US had standing to make a claim because it did not have to demonstrate that it had engaged in conduct in Canada that would otherwise amount to infringement (for further details please see "Federal Court of Appeal dismisses Teva's levofloxacin damages appeal"). Teva's subsequent application for leave to appeal was dismissed.
Servier and ADIR succeeded(10) in the redetermination of the profits reference relating to perindopril (Servier's Coversyl); the Federal Court again dismissed Apotex's non-infringing alternative (NIA) defence. The court found that Apotex would not have called on foreign third parties to manufacture perindopril to supply its affiliates in the United Kingdom and Australia (for further details please see "Apotex fails to establish that it would have obtained non-infringing product from foreign suppliers"). Therefore, the court reaffirmed the original C$61 million profits award against Apotex.
The Federal Court of Appeal allowed in part Apotex's appeal of a decision which had awarded Eli Lilly over C$100 million for Apotex's infringement of patents relating to the antibiotic cefaclor (for further details please see "Federal Court of Appeal overturns cefaclor damages decision on prejudgement interest issue"). The Federal Court had awarded Eli Lilly C$75 million in prejudgment interest as damages for the lost time value of its lost profits. The Federal Court of Appeal remitted the decision to the Federal Court for reconsideration solely on the issue of interest. The court also provided guidance regarding the application and objective of the NIA defence.
The United States-Mexico-Canada Agreement (USMCA), which (if ratified) will replace the North American Free Trade Agreement (NAFTA), was signed on 30 November 2018. The changes required by the USMCA include:
On 1 December 2017 significant proposed amendments to the Patent Rules were released – mainly to implement the Patent Law Treaty (for further details please see "New Patent Rules: 12 notable changes and tips"). The amendments are expected to come into force in 2019.
Amendments to the Patent Act (Bill C-86, Budget Implementation Act 2018 No 2) came into force on 13 December. Among others, the changes include:
The Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), which was approved on 6 November 2014, amended the Food and Drugs Act and granted new powers to the minister of health directed at post-marketing oversight of therapeutic products (for further details please see "Update on Vanessa's Law" and "Mid-year life sciences highlights"). A guidance document on notifying Health Canada of foreign actions and a revised guidance document on post-notice of compliance changes are also available (for further details please see "Health Canada publishes revisions to Guidance Document" and "Health Canada news: September 2018").
In July 2018 the Federal Court ordered Health Canada to release the requested complete copies of all sections of each clinical study report and all electronic datasets from certain clinical trials under the confidential business information provision (for further details please see "First judicial consideration of Vanessa's Law: Health Canada must disclose requested clinical trial data").
On 22 June 2018 Health Canada permitted biological (including biosimilar) and pharmaceutical new drug submission sponsors to seek an aligned review between Health Canada and CADTH and the Canadian Agency for Drugs and Technologies in the National Institute of Excellence in Health and Social Services (for further details please see "Health Canada news: September 2018").
Health Canada's Drug Submission Performance Annual Reports for the year ending 31 March 2018 reported on review activity in 2017 to 2018, including approval times. A Drug and Medical Device Highlights 2017 report from July 2018 includes:
In August 2018 the minister of health made an interim order permitting the import and sale of FDA-approved epinephrine auto-injectors, AUVI-Q, for use in the emergency treatment of life-threatening allergic reactions to address the shortage of EpiPen products (for further details please see "Interim order permits import of FDA-approved drug to address Canadian shortage of EpiPens").
As of 1 October 2018 Health Canada expanded its Submissions Under Review List, including to abbreviated new drug submissions (ANDS) (submissions for generic products)(11) and the addition of sponsor names to new drug submissions and supplemental new drug submissions. Health Canada also expanded its Regulatory Decision Summaries (accessible here) to extend to final positive and final negative decisions for ANDS and supplemental ANDS that may be of interest, including where it deviated from guidance (for further details please see "Health Canada to implement further pre-market transparency initiatives for prescription drugs"). In December 2018 Health Canada released a helpful comprehensive list of its drug and medical device databases, including the above.
In December 2018 Health Canada released an action plan for medical device reform.
On 27 February 2018 the creation of the Advisory Council on the Implementation of National Pharmacare was announced (for further details please see "Federal Budget 2018 announces advisory council for national pharmacare programme"). On 19 April 2018 the Standing Committee on Health released a report which advocates for the establishment of a national pharmacare programme – specifically, a single payer, universal, publicly funded prescription drug coverage programme for all Canadians (for further details please see "Proposed national pharmacare programme and prescription and generic drug pricing modifications").
On 20 June 2018 the council was launched, together with the release of a discussion paper and the opening of a public consultation, which closed on 28 September 2018 (for further details please see "Shire's VYVANSE patent valid, prohibition order issued" and "National pharmacare advisory council seeks feedback").
In December 2017 the Ontario Superior Court of Justice held that Apotex was entitled to more than C$11 million, plus interest, for losses resulting from delays in the US Food and Drug Administration's approval of Apotex's amoxicillin-clavulanic acid and levodopa-carbidopa products, which had been caused by contractual breaches and negligence by MDS Pharma Services, a contract research organisation (for further details please see "Apotex granted damages for delayed FDA approval of two products").
In August 2018 the Federal Court of Appeal dismissed Apotex's appeal of the dismissal of its application for review of Health Canada's decision to require Apotex to submit additional information for the products manufactured or tested in Apotex's facilities in India (for further details please see "Apotex's appeal in judicial review of decision seeking further information from India facilities dismissed"). Apotex has sought leave to appeal.
For further information on this topic please contact Nancy Pei at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (firstname.lastname@example.org). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
(2) See latest status here.
(3) A chart which compares CSPs to European supplementary protection certificates is available here. Further, for a first anniversary update which provides a summary of the regime's elements (including key deadlines) and the nature of the rejections to that date was published please see "Certificate of supplementary protection regime: first anniversary update".
(4) See the comparison to the Hatch-Waxman regime here.
(11) The Generic Submissions Under Review List is available here.
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