February 2019

Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal

As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their generic o-desmethyl-venlafaxine (ODV) succinate products (Pfizer’s PRISTIQ) until expiry of Patent No. 2,436,668 (668 Patent). On January 25, 2019, the Federal Court of Appeal (FCA) dismissed both Apotex’s and Teva’s appeals: Teva v Pfizer, 2019 FCA 15; Apotex v Pfizer, 2019 FCA 16.

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Health Canada News

Health Canada announces decision on naming of biologic drugs

As previously reported, Health Canada conducted stakeholder consultations and analysis of issues related to the naming of biologic drugs, including biosimilars. On February 14, 2019, Health Canada announced its Policy Statement on the Naming of Biologic Drugs, which states that “biologic drugs, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix” (currently used in the United States). Further, both the brand and non-proprietary names should be used throughout the medication use process to allow biologics that share the same non-proprietary name to be distinguished by their unique brand names. To implement this naming convention, Health Canada will: (i) update related guidance/amend the regulations; (ii) communicate with stakeholders on the importance of recording both brand and non-proprietary names throughout the medication use process; and (iii) undertake activities to assist pharmacovigilance, including updating ADR reporting forms. Health Canada also published a “What We Heard Report” summarizing stakeholder comments made during the consultation.

Health Canada announces further steps on the “Action Plan on Medical Devices”

Further to Health Canada’s “Action Plan on Medical Devices” (previously reported here), Health Canada has released the following:

• Notice: Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality - Informing Canadians about medical device treatment options – Further to Part III of the Action Plan on Medical Devices, Health Canada has begun to publish Regulatory Decision Summaries for Class III medical device licenses (e.g. orthopedic implants and blood glucose monitors) starting January 31, 2019 on Health Canada’s Drug and Health Product Register.
  
  
• Scientific Advisory Committee on Medical Devices Used in the Cardiovascular System – Announcement of Meeting – March 1, 2019 – On February 1, Health Canada issued a Notice announcing an upcoming meeting of Health Canada’s Scientific Advisory Committee on Medical Devices used in the Cardiovascular System. Health Canada stated that advice received from this meeting will be used to facilitate and enhance the review process for medical devices used in the cardiovascular system.
  
  
• Scientific Advisory Committee on Health Products for Women (SAC-HPW): Nomination Call for Members – On January 30, 2019, Health Canada published a nomination call for members for an external Scientific Advisory Committee on Health Products for Women (SAC-HPW). The SAC-HPW will provide advice on issues regarding women’s health and regulation of medical devices and drugs.
  
  
• Consultation on Draft Guidance Document for Software as a Medical Device (SaMD) – Health Canada has developed the Draft Guidance to better define regulatory compliance requirements for emerging technologies. Consultation on the Draft Guidance Document closes on March 29, 2019.
  
  

Health Canada releases “Overview of the format and content for post-market drug benefit-risk assessment in Canada – guidance document”

Katie Lee
KHLee@smart-biggar.ca

On February 8, 2019, Health Canada released the Overview of the format and content for post-market drug benefit-risk assessment in Canada – guidance document. The objective of the Guidance Document is to assist Market Authorization Holders in developing a post-market benefit-risk assessment for a marketed drug when requested.

The purpose of a benefit-risk assessment is to determine whether sufficient evidence exists to demonstrate that the benefits of a product continue to outweigh the risks. A benefit-risk assessment may, for example, be requested voluntarily, or under the authority of section 21.31 of the Food and Drugs Act and section C.01.052 of the Food and Drug Regulations, which were enacted by Vanessa’s Law (see update of our previously published chart here).

Proposed changes to OHIP+ Program

The OHIP+ program, also known as Children and Youth Pharmacare program, was implemented on January 1, 2018 by the Province of Ontario to provide free prescription drug coverage for all children and youth 24 years of age or younger, regardless of family income or whether the child / youth is covered by private insurance. Under the current OHIP+ program, the province is always the first payor for eligible drug products, even if the child / youth is also covered by private insurance.

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Costco Pharmacies receive $7.25M penalty for accepting drug rebates

On February 1, 2019, the Ontario Ministry of Health and Long-Term Care (“Ministry”) announced that CWC Pharmacies (Ontario) Ltd. (“Costco Pharmacies”), a subsidiary of Costco, was ordered to pay an Administrative Monetary Penalty (“AMP”) of $7.25M for accepting payments from certain generic manufacturers which violated the prohibition on drug rebates.

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Apotex seeks leave from Supreme Court of Canada in cefaclor damages action

As previously reported, the Federal Court of Appeal (FCA) allowed in part Apotex’s appeal of a decision awarding Eli Lilly over $100 million for Apotex’s infringement of eight process patents related to the antibiotic cefaclor. The FCA rejected Apotex’s argument that a non-infringing alternative would have been available to Apotex during the relevant period. The FCA remitted the decision to the Federal Court for reconsideration solely on the issue of prejudgment interest: Apotex v Eli Lilly, 2018 FCA 217. On January 22, 2019, Apotex applied to the Supreme Court of Canada for leave to appeal (Docket No. 38485).

Court upholds Minister’s refusal to list ELANCO patent due to filing date

The Federal Court has dismissed Elanco’s application for judicial review of the Minister of Health’s refusal to list Canadian Patent No. 2,812,704 on the Patent Register in respect of IMPRESTOR (pegbovigrastim): Elanco v Canada (Attorney General), 2019 FC 5. The Minister assigned a filing date for Elanco’s New Drug Submission (NDS) as the date the Veterinary Drugs Directorate determined the submission to be administratively complete, rather than the date on which all substantive components of the submission were provided for evaluation. All substantive components had not initially been submitted as Health Canada had agreed that Elanco could participate in a phased submission process, aligned with the timeline for submission of data to the United States Food and Drug Administration to enable simultaneous reviews. The Judge found that the Minister’s determination of the filing date was reasonable. Since Elanco filed its patent application after the NDS filing date, the patent did not meet the timing requirements for listing eligibility under subsection 4(6) of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations). Elanco did not appeal.

Ontario Court of Appeal dismisses appeal of judgment awarding Apotex damages from contract research organization for delayed FDA approval of two products

As previously reported, in December 2017, Apotex was awarded over $11M in damages and pre-judgment interest for losses flowing from delays in the US Food and Drug Administration’s (FDA) approval of Apotex’s amoxicillin-clavulanic acid and levodopa-carbidopa products caused by the contractual breaches and negligence of MDS Pharma Services (MDS), a contract research organization hired to carry out bioequivalence studies for those products. On January 16, 2019, the Court of Appeal for Ontario dismissed MDS’ appeal and Apotex’s cross-appeal of that judgment: Apotex Inc v Nordion (Canada) Inc, 2019 ONCA 23. The Court rejected MDS’ argument that the trial judge had erred in finding that Apotex’s claim was not time-barred. Rather, the Court found that the limitations period did not begin to run until 6 months after the date on which the trial judge concluded that it began. The Court found no palpable and overriding error in the trial judge’s interpretation of the contract or his finding that Apotex had adequately mitigated its damages. With respect to Apotex’s cross-appeal, the Court found no palpable and overriding error in the trial judge’s assessment of damages, and rejected Apotex’s argument that damages ought to have been fixed at $12.6M.

New Court Proceedings

For complete details about these proceedings, click here.

PMNOC Actions

abiraterone acetate (ZYTIGA): Janssen and BTG v Sandoz

abiraterone acetate (ZYTIGA): Janssen and BTG v Pharmascience

fingolimod (GILENYA): Novartis v Natco

fampridine (FAMPYRA): Biogen and Acorda v Pharmascience

Other Actions

naproxen/esomeprazole magnesium (VIMOVO): Mylan v AstraZeneca

fingolimod (GILENYA): Novartis v Accord, Apotex, Marcan, Mylan, Pharmascience, Taro and Teva

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