Resource Library

Canada is an attractive market for pharmaceutical manufacturers. Most Canadian consumers have some form of drug coverage through government programs and/or private insurance. Below are ten patent and regulatory topics that in-house counsel need to know before bringing an innovative product to Canada.

Editor's note: This article was updated to reflect recent developments; the original version of this article was published on December 16, 2020.

The September 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations introduced a new scheme for pharmaceutical patent linkage litigation in Canada. That scheme is now much closer to the United States' (US) Hatch-Waxman scheme, but with remaining key differences that are explained in this chart.

Amendments to the Canadian Patent Act and enactment of the Certificate of Supplementary Protection Regulations flowing from the Canada-European Union (EU) Comprehensive Economic and Trade Agreement introduced a new framework in Canada for the issuance of Certificates of Supplementary Protection (CSPs).

This chart compare key aspects of the two regimes, Canada's and the EU's.

Patented medicine regulations in Canada can be complex and the review process is fast-paced. In this Top Ten, in-house counsel will learn the essential points of how to prepare for the "Regulations" review. Editor's note: This article was updated to reflect recent developments; a prior version of this article was published on August 6, 2020.

This is a sample business development agreement, for a non-exclusive cooperative marketing relationship to promote collection services (governed by Ohio law).

This is a sample request for proposal for valuation services.

Are you an in-house professional interested in teaching a law school course? You may wonder how peers who teach law school designed their syllabus. Take a look at the syllabus developed by Veta T. Richardson, ACC President and CEO, and Justin Connor, Executive Director, Center for Industry Self-Regulation.

Teaching law school is an exciting opportunity for in-house counsel to share their practical knowledge and help develop the next generation of lawyers. View a compilation of course proposals, syllabi, and exams, that have been created and used by members of the in-house community who have taught or are teaching a class in law school.

This is a sample briefing by law school professors to their students regarding graded assignments. This material was created by Veta T. Richardson, President and CEO of the Association of Corporate Counsel, and Justin Connor, Executive Director of the Center for Industry Self-Regulation, as part of their law school course titled "In-house Counsel: Law and Practice."

The COVID-19 pandemic launched the Occupational Safety and Health Administration (OSHA) into the national spotlight. The agency is using its platform to roll out increased enforcement. This article discusses proactive measures employers should take to avoid enforcement actions.