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The Association of Corporate Counsel (ACC) is the world's largest organization serving the professional and business interests of attorneys who practice in the legal departments of corporations, associations, nonprofits and other private-sector organizations around the globe.

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Articles

Top 10 Patent and Regulatory Things You Need to Know when Bringing a Biopharma Product to Canada

By Nancy Pei, Principal, Alice Tseng, Principal, Toronto Office and Daphne Lainson, Principal, Ottawa Office, Smart & Biggar LLP

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.

Articles

Canada's New Linkage Litigation Scheme: A Comparison to Hatch-Waxman

By Nancy Pei, Partner, Smart & Biggar LLP and Brian Coggio, Fish & Richardson PC

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.

Articles

Comparing Supplementary Protection Regimes Between Canada (CSPs) and The EU (SPCs)

By Nancy P. Pei, Partner, Smart & Biggar LLP, and Daniel Wise, Carpmaels & Ransford LLP

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.

Sample Forms, Policies, and Contracts

Sample Utility Assignment Agreement

This sample form is for use in the assignment of a utility patent application and related intellectual property rights, from an inventor to a corporation.

Sample Forms, Policies, and Contracts

Assignment and Novation Agreement

This is a sample assignment and novation agreement where the Assignor assigns its rights and obligations under insurance policies to the insured companies, which are the assignees. The sample includes a choice of the laws of the Cayman Islands.

Sample Forms, Policies, and Contracts

Sample IP Assignment Agreement

This is a sample intellectual property assignment agreement, under which a company assigns the rights, title, and interest in and to trademarks, patents, domain names and intangible assets to another company, in connection with a corporate acquisition. This sample includes a choice of New York law.

Sample Forms, Policies, and Contracts

Sample Bill of Sale and Indemnity Agreement (US)

This is a sample bill of sale and indemnity agreement, under which a seller assigns all rights, title, and interest in equipment to a purchaser, and the purchaser agrees to indemnify the seller against liabilities connected to the acquisition, use, or disposal of the conveyed property.

Sample Forms, Policies, and Contracts

Confidentiality and Non-Disclosure Agreement - Sample

This is a confidentiality and non-disclosure agreement between a Delaware corporation (the disclosing company) and another company (the receiving company), in preparation of the receiving company's nomination to the board of directors of the disclosing company. The sample includes a clause selecting the laws of the State of New York.

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