IN THIS ISSUE:
Federal Court of Appeal requires PMPRB to re-determine whether patent ‘pertains to’ Galderma’s DIFFERIN
Court strikes Novo Nordisk’s judicial review application of Minister’s acceptance of Teva’s liraglutide ANDS
Federal Court of Appeal dismisses first PMNOC interlocutory appeal granted leave
New Canadian Patent Rules will be in force October 30, 2019
Health Canada News
Regulations will require hospitals to report serious adverse drug reactions and medical device incidents
Bill C-97 receives Royal Assent, Advanced Therapeutic Products Consultation opened
Health Canada opens consultation on draft guidance document distinguishing between promotional and non-promotional activities for health products
Health Canada, TPD and BGTD annual reports released
Guidance Updates
Market Access
Biosimilars no longer reviewed by CADTH
PMPRB Steering Committee on Modernization of Price Review Process Guidelines releases final report
New Court Proceedings
Federal Court of Appeal requires PMPRB to re-determine whether patent ‘pertains to’ Galderma’s DIFFERIN
By Urszula Wojtyra
On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB or Board) and returned to the Board the matter of whether the invention of the 237 patent – which the Court of Appeal found was the use of a 0.3% concentration of adapalene for the treatment of dermatological disorders – ‘pertained’ to Galderma’s DIFFERIN (0.1% adapalene): Attorney General of Canada v Galderma, 2019 FCA 196. In determining whether “an invention pertains to the medicine”, the Court held that the phrases “rational connection or nexus” or “merest slender thread” cannot supplant the statutory language, which requires that “the invention is intended or capable of being used for the medicine.”
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Court strikes Novo Nordisk’s judicial review application of Minister’s acceptance of Teva’s liraglutide ANDS
By Urszula Wojtyra
The Federal Court struck Novo Nordisk’s judicial review application challenging the decision of the Minister of Health to accept for review an Abbreviated New Drug Submission (ANDS) filed by Teva Canada for its Teva-liraglutide product, relying on Novo Nordisk’s VICTOZA (a biologic) as a Canadian reference product: Novo Nordisk Canada v Canada (Health) 2019 FC 822. In striking the application, the Court concluded that Novo Nordisk had neither direct nor public interest standing in the matter. In support of its argument for public interest standing, Novo Nordisk and the intervenor BIOTECanada argued that the Minister of Health failed to apply the Biosimilars Guidance Document to Teva’s product, which requires that a submission for approval of a biosimilar must be made by way of a New Drug Submission (NDS), rather than by an ANDS, and must satisfy a more stringent standard than an ANDS. The Court found, however, that it had not been established that Teva-liraglutide was a biologic, as it could have been chemically synthesized; it was therefore speculative that the Minister departed from the Biosimilars Guidance Document. Furthermore, the Court held that it was speculative that the Minister had actually determined that Teva’s submission is reviewable as an ANDS and capable of being approved by way of an ANDS, as the Minister of Health had only accepted the ANDS for review. Novo Nordisk may appeal as of right. Novo Nordisk has a pending action against Teva under the Patented Medicines (Notice of Compliance) Regulations relating to the same submission.
Federal Court of Appeal dismisses first PMNOC interlocutory appeal granted leave
By Katie Lee
Most interlocutory decisions under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) are made by prothonotaries of the Federal Court (FC). Under the pre-amended PMNOC Regulations, a party was permitted to appeal any such decision to a FC judge, as of right and a further appeal could be made to the Federal Court of Appeal (FCA), also as of right. Under the amended PMNOC Regulations (see our article here), any appeal of an interlocutory order made by a prothonotary or judge of the FC must be heard by the FCA, and only if the FCA grants leave.
The first FCA decision in an appeal of an interlocutory order under the amended PMNOC Regulations issued on June 27, 2019. The FCA dismissed Apotex’s appeal of a prothonotary’s decision declining to order Bristol-Myers Squibb (BMS) to answer five discovery questions in an action relating to apixaban (BMS’ ELIQUIS): Apotex v Bristol-Myers Squibb Canada, 2019 FCA 194. The questions generally related to BMS’ pleading alleging e.g. “advantages and benefits” of apixaban, as disclosed and claimed in the patent at issue. The FCA found that the Prothonotary was entitled to arrive at a view of what was best for the particular proceeding and saw no reviewable error that would justify its intervention.
New Canadian Patent Rules will be in force October 30, 2019
By David Schwartz
On July 10, 2019, the government of Canada published the final version of the new Patent Rules, which will come into force October 30, 2019. The new Rules substantially alter Canadian patent practice, and include many changes needed to permit Canada to ratify the Patent Law Treaty (PLT). We provide a detailed analysis of the changes here.
Health Canada News
Regulations will require hospitals to report serious adverse drug reactions and medical device incidents
By Katie Lee
On June 10, 2019, the Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting – Hospitals)and Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting — Hospitals) were published. These amendments were enacted further to Vanessa’s Law (see updated chart). Once the amendments are in force on December 16, 2019, all hospitals will be obligated to provide specific information relating to serious adverse drug reactions and medical device incidents within 30 days of first documenting the reaction or incident in the hospital. On June 26, 2019, Health Canada announced these new reporting requirements, and published Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Overview to provide information on how to comply with the requirements.
Bill C-97 receives Royal Assent, Advanced Therapeutic Products Consultation opened
By Katie Lee
On June 21, 2019, Bill C-97 received Royal Assent. Bill C-97 includes amendments to the Food and Drugs Act, including a new framework for “Advanced Therapeutic Products”, and will come into force on a day to be fixed. On July 18, 2019, Health Canada opened a consultation seeking feedback on what Health Canada should consider in developing new clinical trial regulations, as well as implementing the pathway for Advanced Therapeutic Products. The consultation will close on August 30, 2019.
Health Canada opens consultation on draft guidance document distinguishing between promotional and non-promotional activities for health products
By Abigail Smith
On July 5, 2019, Health Canada announced a consultation on its new draft guidance: The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products. Health product advertising, defined as including “any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device”, is strictly regulated in Canada. If a message is not considered to “promot[e]…sale or disposal”, it is not subject to the relevant provisions of the Food and Drugs Act and Regulations. This guidance is intended to clarify and outline factors and circumstances that contribute to rendering a message or activity non-promotional. The document updates Health Canada’s 1996 policy on the subject, which was last updated in 2005 for administrative purposes. Comments will be accepted until September 3, 2019 .
Health Canada, TPD and BGTD annual reports released
By Brandon Heard
On June 27, 2019, Health Canada published Drug and medical device highlights 2018: Helping you maintain and improve your health, an annual highlights report for 2018. The report provides information regarding Health Canada drug (human or veterinary use) and medical device approvals, as well as published safety issues in 2018. In summary, in 2018, Health Canada approved 78 new drugs for human use (40 involving new active substances), 135 new generic drugs, and 4 biosimilars.
Moreover, the Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) released their Drug Submission Performance Annual Reports for the 2018-2019 Fiscal Year, which include information and statistics relating to drug submission review activity from April 1, 2018 to March 31, 2019.
Guidance Updates
By Lynn Ing
Health Canada released a revised Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs on June 28, 2019, effective immediately. Revisions include clarifying additions on the requirements for cross-licensed products for an Administrative Certification Form and Letter of Authorization, a Drug Notification form and labelling.
Health Canada has also released an updated Good Label and Package Practices Guide for Prescription Drugs. The June 21, 2019 update introduces only administrative edits to the 2016 guidance on labelling and packaging of prescription pharmaceuticals, biologics, and radiopharmaceuticals under Health Canada’s Plain Language Labelling Initiative.
Market Access
Biosimilars no longer reviewed by CADTH
By Urszula Wojtyra
The Canadian Agency for Drugs and Technologies in Health (CADTH) released Issue 8 of its Pharmaceutical Reviews Update announcing updates, including to its Procedure and Submission Guidelines for the CADTH Common Drug Review. The update also announced that effective June 1, 2019, CADTH will no longer review biosimilars through the Common Drug Review (CDR) or the pan-Canadian Oncology Drug Review (pCODR). The decision was made subsequent to an internal review, which included a consultation with the pan-Canadian Pharmaceutical Alliance (pCPA), of the streamlined biosimilar review process launched in February 2018 (reported here). Reasons for the change include the prevention of possible delays to access of new biosimilars and resource allocation at CADTH. Biosimilars should therefore be filed directly with the jurisdictions and pCPA.
PMPRB Steering Committee on Modernization of Price Review Process Guidelines releases final report
By Abigail Smith
On July 2, 2019, the PMPRB Steering Committee on the Modernization of Price Review Process Guidelines released its final report summarizing its deliberations in providing stakeholder feedback on the PMPRB’s proposed new framework for regulation of the prices of patented medicines. PMPRB officials presented a draft of this report to the Steering Committee on May 13, 2019 (see our previous report here). The PMPRB will publish draft guidelines for public consultation once the Board has had an opportunity to review the Steering Committee’s final report and following final publication of the amended Patented Medicines Regulations .
New Court Proceedings
For complete details about these proceedings, click here.
PMNOC Actions
ESBRIET capsules, tablets (pirfenidone): Hoffmann-La Roche and InterMune v Sandoz
ZYTIGA (abiraterone acetate): Janssen and BTG v Dr. Reddy’s Laboratories
XARELTO (rivaroxaban): Bayer v Dr. Reddy’s Laboratories
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