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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 Third-Party Charitable Sales Promotion and Licensing Agreement, between a not-for-profit organization and a for-profit company, for the for-profit company to sell products promoting a cause of the non-profit organization in the United States, and for the payment of resulting royalties to the non-profit organization.

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.

This Wisdom of the Crowd (ACC member discussion), compiled from responses posted on the Nonprofit Organizations Forum, discusses whether it is common for non-profit entities to refuse to agree to representations & warranties in a contract.

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.

This guide provides corporate counsel and international practitioners with comprehensive jurisdiction-by-jurisdiction guidance to digital health laws and regulations around the world.

Topics covered include digital health technologies, data use, data sharing, intellectual property, commercial agreements, AI and machine learning, and liability.