IN THIS ISSUE:
Federal Court dismisses Servier's application for order of prohibition regarding salt patent for perindopril arginine
FCA upholds issuance of NON-W letter and cancellation of reconsideration process for Apotex omeprazole magnesium tablet ANDS
Infringement based on making/selling under existing NOC for one strength struck from action under the PMNOC Regulations triggered by NOA based on different strength
Update on PMPRB Guidelines Modernization
Health Canada News
Proposed Regulations would amend process for sale of drugs for emergencies, including under SAP
Release of revised Certificates of Supplementary Protection Guidance
Release of Guidance Document: Regulatory requirements for Drug Identification Numbers
Guidance Document Re: Reporting Adverse Reactions to Marketed Health Products
Supreme Court of Canada News
New Court Proceedings
Federal Court dismisses Servier’s application for order of prohibition regarding salt patent for perindopril arginine
By Katie Lee
On May 8, 2019, Justice Roy dismissed Servier’s application for a prohibition order under the pre-amended Patented Medicines (Notice of Compliance) Regulations for Canadian Patent No. 2,423,825 (825 Patent) and perindopril arginine/amlodipine product (Servier’s VIACORAM): Les Laboratoires Servier v Apotex Inc, 2019 FC 616. Apotex had alleged that the patent was invalid for obviousness, overbreadth, inutility and insufficiency. The 825 Patent claimed the arginine salt of perindopril and its hydrates.
The Federal Court held that the allegations of inutility and insufficiency were not justified. However, Justice Roy dismissed the application, finding that Apotex’s allegations of obviousness and overbreadth were justified. With respect to overbreadth, the Court construed the claims to include all forms of arginine and its hydrates, whereas (1) the inventors had only ever made the perindopril salt with the naturally occurring form, L-arginine; and (2) the inventors did not have reason to believe that a hydrate of perindopril arginine could form. Based on these findings, Justice Roy found that the Servier had not discharged its burden of disproving the allegation that the claims were broader than the invention. With respect to obviousness, the Court found that arginine salts were known, and that a skilled person would have known that a structured salt screen conducted to search for a solution to the stability issues of the known salt, perindopril erbumine, would have been available by the filing date.
FCA upholds issuance of NON-W letter and cancellation of reconsideration process for Apotex omeprazole magnesium tablet ANDS
By Abigail Smith
On April 24, 2019, the Federal Court of Appeal (FCA) affirmed the Federal Court’s (FC) dismissal of Apotex’s application for judicial review of a decision by the Minister of Health relating to its Apo-Omeprazole (omeprazole magnesium) delayed release tablets: Apotex Inc v Canada (Health), 2019 FCA 97. The Minister had issued a Notice of Non-Compliance – Withdrawal (NON-W) letter in respect of Apotex’s abbreviated new drug submission on the basis that the tablets were not bioequivalent to the relevant Canadian reference product. Apotex sought reconsideration, but after the parties could not agree on the formulation of the question for reconsideration, the Minister cancelled the reconsideration process and issued a final NON-W letter.
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Infringement based on making/selling under existing NOC for one strength struck from action under the PMNOC Regulations triggered by NOA based on different strength
By Lynn Ing
The Federal Court has granted in part Pharmascience’s motion to strike out portions of Teva’s statement of claim under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) relating to glatiramer acetate (Teva’s COPAXONE; Pharmascience’s GLATECT): Teva Canada v Pharmascience Inc, 2019 FC 595.
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Update on PMPRB Guidelines Modernization
By Lynn Ing
In its April 2019 NEWSletter, the Patented Medicine Prices Review Board (PMPRB) announced that the Steering Committee on Guidelines Modernization would hold its final meeting on May 13, 2019, to discuss both a draft report of its deliberations and the Working Group’s final report (released March 6, 2019). Once the Steering Committee’s report has been finalized and the regulatory amendments have been published in Part II of the Canada Gazette (expected this spring), the PMPRB will release its draft Guidelines for public consultation.
Health Canada News
Proposed Regulations would amend process for sale of drugs for emergencies, including under SAP
By Katie Lee
On May 3, 2019, two sets of proposed amendments to the Food and Drug Regulations were published:
The proposed amendments contain provisions which would streamline the process for providing access to unauthorized drugs for medical emergencies. Access to the drugs will continue to be facilitated through the Special Access Program (SAP) for human drugs, and the Emergency Drug Release Program (EDR) for veterinary products. There are currently approximately 500 drugs with active status on the SAP and 45 in the EDR.
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Release of revised Certificates of Supplementary Protection Guidance
By Urszula Wojtyra
On May 15, 2019, Health Canada released the third publication of the Guidance Document: Certificates of Supplementary Protection. The changes reflect organizational changes at Health Canada, a third version of the Certificate of Supplementary Protection application form and updates to the fee payment instructions.
Release of Guidance Document: Regulatory requirements for Drug Identification Numbers
By Urszula Wojtyra
On May 3, 2019, Health Canada released the new Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs). The Guidance Document is stated to provide “assistance on the interpretation of the regulatory requirements associated with a DIN” and “guidance to manufacturers on their obligation to accurately report to Health Canada [certain] notifications for a change of drug status.” This Guidance Document replaces a number of Health Canada documents including:
- Guidance Document: Cancellation of a Drug Identification Number (DIN) and Notification of Discontinuation of Sales
- Issuance of Drug Identification Numbers for New Drugs
Guidance Document Re: Reporting Adverse Reactions to Marketed Health Products
By Brandon Heard
On May 23, 2018, Health Canada published Overview of the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry. “This guidance document provides market authorization holders (MAHs) with assistance on how to comply with the Food and Drugs Act, the Food and Drug Regulations and the Natural Health Products Regulations with respect to reporting adverse reactions (ARs) to marketed health products”, including: pharmaceutical drugs, biologics, radiopharmaceutical drugs and natural health products. These ARs are to be reported to the Canada Vigilance Program of the Marketed Health Products Directorate (MHPD) of Health Canada.
Supreme Court of Canada News
By Brandon Heard
SCC denies Apotex leave to appeal ramipril pleadings amendment decision. As previously reported, Apotex sought leave to appeal a decision of the Ontario Court of Appeal (2018 ONCA 890) permitting Sanofi and Schering to amend their defences to claims under the Ontario Statute of Monopolies, U.K. Statute of Monopolies and Trade-Marks Act. Apotex’s claims rely on Sanofi-Aventis Canada v Apotex Inc, 2009 FC 676 (“invalidity decision”), which found certain claims of Canadian Patent No. 1,341,206 invalid on the basis of the “promise doctrine”. The ONCA permitted Sanofi and Schering to plead that AstraZeneca Canada Inc. v Apotex Inc, 2017 SCC 36 – which rejected the promise doctrine as “unsound” – rendered the invalidity decision suspect. On May 16, 2019, the Supreme Court denied Apotex’s application for leave to appeal (Case No. 38471).
SCC denies Apotex leave to appeal cefaclor damages decision re: non-infringing alternative defence. As previously reported, Apotex sought leave to appeal a decision of the Federal Court of Appeal (2018 FCA 217) relating to damages awarded to Eli Lilly in respect of Apotex’s infringement of process patents relating to cefaclor. The FCA concluded that a non-infringing alternative defence was not available to Apotex. On May 23, 2019, the Supreme Court denied Apotex’s application for leave to appeal (Case No. 38485).
New Court Proceedings
For complete details about these proceedings, click here.
PMNOC Actions
ESBRIET capsules (pirfenidone): Hoffmann-La Roche and InterMune v Sandoz
NEXAVAR (sorafenib): Bayer v Teva
ACTONEL DR (sodium risedronate): Allergan v Apotex
VELCADE (bortezomib mannitol boronic ester): Janssen v Taro
Other Proceedings
SPRAVATO (esketamine hydrochloride): Janssen v The Minister of Health
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