IP Rights in U.S. Government COVID-19 Vaccine and Therapeutics Contracts

• Date: 01 September 2022
• Author: Kristen O. Riemenschneider and R. Tanny Kang

Published in Landslide, Volume 15, Number 1, 2022. © 2022 by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion

thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the

American Bar Association.

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IP Rights in U.S.

Government

COVID-19 Vaccine

and Therapeutics

Contracts

By Kristen O. Riemenschneider

and R. Tanny Kang

Image: Getty Images

Biopharmaceutical and medtech companies engage in a pleth-

ora of deals for which intellectual property (IP) ownership

and licenses are critical issues. While many of these deals

focus on transactions between nongovernment parties—typi-

cally company-to-company transactions—there are occasionally

company-to-university transactions. Traditionally, when life science

transactions lawyers engage with the government, the interaction is

typically limited to the review of grant paperwork or a short coop-

erative research and development agreement (CRADA)—not the

billion-dollar procurement vehicles common in the defense sector.

Yet, during the COVID-19 pandemic, the U.S. government

was one of the most signicant sources of funding for COVID-

19 vaccine and therapeutic research and development (R&D).

Companies in the biopharma space were required to learn a new

style of contracting, including novel IP regimes, in short order.

Given ongoing global outbreaks, the U.S. government is continuing

to devote considerable funding to COVID-19 medical countermea-

sure (MCM) R&D.

1

This article discusses the unique aspects of

government contracting for life science companies and how that

contracting may overlap with familiar life science IP concepts.

Patents

Most life science transactions involve the assignment and licen-

sure of patents—both “background patents,” i.e., patents that are

preexisting or generated by a party outside the scope of the trans-

action, and “foreground patents,” i.e., patents generated by the

parties in the performance of the transaction. When parties collab-

orate on biopharmaceutical R&D, the parties typically license

background patents, divvy ownership of foreground patents

amongst themselves, and grant back licenses to foreground patents.

These patent ownership and license provisions are highly negoti-

ated and limited in scope so as to enable each party to perform

its R&D obligations while protecting the proprietary nature of

the asset. For example, it is common to preclude a licensee from