If this email is not displayed correctly please click here

Healthcare & Life Sciences

10 July 2019
Brandon Heard Supreme Court of Canada denies Apotex leave to appeal in two cases

Canada - Smart & Biggar/Fetherstonhaugh

The Supreme Court of Canada has denied Apotex leave to appeal in two recent cases. In the first case, Apotex sought leave to appeal a decision of the Ontario Court of Appeal permitting Sanofi and Schering to amend their defences to claims relating to ramipril. In the second case, Apotex sought leave to appeal a decision of the Federal Court of Appeal relating to damages awarded to Eli Lilly in respect of Apotex's infringement of process patents relating to cefaclor.

Author: Brandon Heard
Read more
Brandon Heard Guidance document on reporting adverse reactions to marketed health products

Canada - Smart & Biggar/Fetherstonhaugh

Health Canada has published its Overview of the Reporting Adverse Reactions to Marketed Health Products – Guidance Document for Industry. The guidance document provides market authorisation holders with assistance on how to report adverse reactions to pharmaceutical drugs, biologics, radiopharmaceutical drugs and natural health products.

Author: Brandon Heard
Read more
Sean Griffin Lethal injection opinion from DOJ OLC threatens FDA's claims-based interpretation of 'intended use'

USA - Sidley Austin LLP

In a recent opinion, the Office of Legal Counsel (OLC) in the US Department of Justice concluded that an article intended to effectuate capital punishment by a state or the federal government is not subject to regulation by the Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act. The OLC's opinion appears to have been issued as a result of litigation involving the FDA's obligation to block the entry of misbranded and unapproved drugs used under state lethal injection protocols.

Authors: Sean Griffin, Joseph R Guerra, Coleen Klasmeier
Read more

Recent updates

Katie Lee Proposed regulations set to amend process for sale of drugs for medical emergencies

Canada - Smart & Biggar/Fetherstonhaugh

Author: Katie Lee
José Alberto Campos Vargas Software – the unregulated medical device

Mexico - Sanchez DeVanny Eseverri SC

Author: José Alberto Campos Vargas
Robert J Conlan Jr Third Circuit finds individual ownership interest in corporation not required for False Claims Act liability

USA - Sidley Austin LLP

Authors: Robert J Conlan Jr, Kristen A Knapp

ONLINE MEDIA PARTNERS