September 2018

Certificate of Supplementary Protection Regime: First Anniversary Update

September 21, 2018 marked the first anniversary of the certificate of supplementary protection (CSP) regime. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the time invested in research and obtaining regulatory approval in Canada, followed from Canada’s commitments under CETA (the Canada-European Union Comprehensive Economic and Trade Agreement, see our earlier article here). As we look back on the previous year, we will recap how the regime works and provide an update on CSPs granted and rejected to date.

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Upcoming webinar:

Join us on Thursday October 4th, for a special webinar where we will review the Certificate of Supplementary Protection (CSP) regime that was implemented one year ago.  We will provide a review of CSP eligibility and the application process, outcomes to date, and tips on co-ordinating prosecution, regulatory, and litigation strategies.

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Amended PMNOC Regulations: First Anniversary Update

As previously reported, the amended Patented Medicines (Notice of Compliance) Regulations (“Regulations”) came into force on September 21, 2017, heralding significant changes to the landscape for pharmaceutical companies in Canada. The amendments flowed from Canada’s obligations under CETA (the Comprehensive Economic and Trade Agreement; see also the Canada-European Union Comprehensive Economic and Trade Agreement Implementation Act). Among other changes, the amendments ended dual litigation and provided the innovator a right of appeal, thus bringing the Regulations much closer to the Hatch-Waxman scheme in the US (see our chart here for a comparison). As noted in our companion article, the Regulations also extend to certificates of supplementary protection.

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SCC denies Sobeys leave to appeal in loyalty rewards program dispute with Alberta College of Pharmacists

On August 9, 2018, the Supreme Court of Canada denied Sobeys’ application for leave to appeal (docket no. 37864) from the Alberta Court of Appeal (ABCA)’s decision in a dispute regarding the Alberta College of Pharmacists (the “College”)’s policy prohibiting pharmacists/pharmacies from offering loyalty rewards programs or inducements to patients.

The ABCA held that the policy was intra vires the College under the Health Professions Act and reasonable (Alberta College of Pharmacists v Sobeys West Inc., 2017 ABCA 306), disagreeing with the application judge regarding the appropriate standard of review and on the merits (Sobeys West Inc. v Alberta College of Pharmacists, 2016 ABQB 138; Sobeys West Inc. v Alberta College of Pharmacists, 2016 ABQB 232).

This decision follows the Supreme Court’s 2016 refusal to grant Sobeys leave to appeal a British Columbia Court of Appeal decision allowing the College of Pharmacists of British Columbia to prohibit “customer incentive programs”: Sobeys West Inc. v College of Pharmacists of British Columbia, 2016 BCCA 41; SCC docket no. 36917.

PMPRB News

Urszula Wojtyra
uwojtyra@smart-biggar.ca

The Patented Medicine Prices Review Board (PMPRB) has released its 4th edition CompassRX report, Annual Public Drug Plan Expenditure Report for 2016/17. The report was prepared as part of the National Prescription Drug Utilization Information System (NPDUIS), and examines public drug plan expenditures in Canada, including analyzing the main factors that drive annual changes in prescription drug expenditures.

PMPRB has also released the 2017 Supplement to the Market Intelligence Report, Biologic Response Modifier Agents, 2015, both produced under the NPDUIS initiative. Using data from 2017, the Supplement provides updated information for market trends analyzed in the original report, which focuses on certain biologics that the report refers to as “biologic disease-modifying antirheumatic drugs or biologic DMARDs.”

Lastly, the PMPRB has released its 2017 Annual Report. The 2017 Annual Report includes a review of the PMPRB’s regulatory activities, analyses of sales and price trends of pharmaceuticals, as well as an overview of NPDUIS and analysis of research and development expenditures. On August 22, 2018, the Minister of Health tabled the 2017 Annual Report with the Clerks of the House of Commons and the Senate.

Interim Order permits import of FDA-approved drug to address Canadian shortage of epinephrine auto-injectors

Katie Lee
KHLee@smart-biggar.ca

Drug shortages are an important issue in the health care system that Health Canada and the industry have been actively trying to address. On August 27, 2018, the Minister of Health made an order permitting the immediate importation and sale of epinephrine auto-injectors for use in emergency treatment of life-threatening allergic reactions, to address the shortage of EpiPen products. The order was approved on September 4, 2018, and will remain in effect until the earliest of one year after the order was made, repealed, or any regulations that address the need come into effect.

The interim order permits the importation of FDA-approved AUVI-Q, manufactured by Kaléo Inc., which has not been approved in Canada. This is the first time an interim order under section 30.1(2)(a) of the Food and Drugs Act has been used to address the shortage of an approved product. Interim orders, which can be made if the Minister believes immediate action is required to deal with a significant risk to health, safety or the environment, are one of several mechanisms available to provide access to products that have not been approved in Canada. Other mechanisms include: the importation of a drug on the List of Drugs for an Urgent Public Health Need enacted under Part C, Division 10 of the Food and Drug Regulations (as previously reported), and the Special Access Programme.

EpiPen products are reimbursed under certain public drug programs, including Ontario’s recent OHIP+ program, which provides drugs for free to those in Ontario 24 years of age and under. AUVI-Q does not appear to be covered under the OHIP+ program so it is unclear the extent to which the Interim order will sufficiently address the shortage, even if AUVI-Q is available in Canada.

Prohibition denied for Ranbaxy's bupropion extended-release tablets

On August 20, 2018, the Federal Court dismissed Valeant's PMNOC application regarding Ranbaxy's bupropion extended-release tablets (Valeant's WELLBUTRIN XL) and Patent No. 2,524,300. Justice McVeigh held that Ranbaxy's allegation of non-infringement was justified: Valeant Canada LP v Ranbaxy Pharmaceuticals Canada Inc., 2018 FC 847. Justice McVeigh found that "permeation enhancer" in the amount of "about 20% to about 40% of the moisture barrier dry weight" is an essential element, construed "permeation enhancer" to exclude polyethylene glycol and triethyl citrate, and construed "about" to mean a range of plus or minus 10%. Therefore, the amount of permeation enhancer in the Ranbaxy formulation was outside the scope of the range claimed and Ranbaxy's allegation of non-infringement was found justified.

New Court Proceedings

For complete details about these proceedings, click here.

PMNOC Proceedings

lenalidomide (REVLIMID): Celgene v Natco Pharma

apixaban (ELIQUIS): Bristol-Myers Squibb and Pfizer v Teva

daptomycin (CUBICIN): Cubist and Sunovion v Teva

Other Proceeding

Herpes Zoster vaccine (SHINGRIX): GlaxoSmithKline v The Minister of Health

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