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).

Corporate mergers, asset acquisitions, and divestitures often include a variety of environmental components or considerations – some of which can be nuanced – that can affect and can be affected by other non-environmental components.

This article offers six strategic considerations for businesses to successfully navigate the negotiation and execution of transactions involving industries or operations subject to significant environmental regulations.

This is a sample request for proposal for valuation services.

Often overlooked are the impacts wildfires can have on oil and gas operations. The potential for wildfires to cause severe damage underscores the need for stringent fire safety protocols. 

This articles provides steps oil and gas operators can take in preparation for and prevention of a wildfire.

This article looks at the Public Company Accounting Oversight Board’s proposed auditing standards which feature major implications for ESG that could upend corporate audits.

This is a brief outline of recent environmental, social, and governance (ESG) developments, together with links to additional materials.