US government files statement of Interest in Arbutus v Moderna case, testing scope of 28 USC 1498(a) government use of patents for acquisition and distribution of COVID 19 vaccines

On February 14, 2023, USDOJ filed a Statement of Interest of the United States, in the patent dispute between Arbutus Biopharma, Genevant Sciences, and Moderna.

A copy of the filing is here: arbutus.moderna.USG.statementofinterest

This is an important, and while not unexpected, strong filing by the US government. Here are a few quotes:

Indeed, the contractor’s compliance with the contract’s obligations alone demonstrate the benefit: the Government obtains goods and services for which it pays is alone sufficient to demonstrate the procurement is “for the Government” and “for the benefit of the Government.”

and

Government has received the benefit of its contract, namely, procuring the vaccine that it then offered for free public distribution in an effort to thwart the COVID-19 pandemic. See Hughes Aircraft, 534 F.2d at 901 (finding benefit in meeting governmental objectives or interests).

The US government distinguished this case from two different cases cited by the parties, Larson v. United States, 26 Cl. Ct. 365 (1992), and Saint-Gobain Ceramics & Plastics, Inc. v. II-VI Inc., 369 F. Supp. 3d 963 (C.D. Cal. 2019), and concludes with this comment:

Under the facts of this case, the sales of the vaccine to the Government pursuant to the terms of the ’-0100 Contract, which expressly includes the FAR clauses granting the Government’s authorization and consent, satisfy the requirements of 28 U.S.C. § 1498(a) that the procurement was “for the Government” and with its authorization and consent. And to the extent that any doubt otherwise existed, the Government’s filing of this statement of interest and confirmation of its authorization and consent should resolve the issue. Accordingly, to the extent that any liability exists for infringement of the Patents-in-Suit by the manufacture or use of vaccine procured under the ’-0100 Contract, the patentee is limited to pursuing a claim against the United States in the Court of Federal Claims under 28 U.S.C. § 1498(a).

For more on the use of 28 USC 1498(a) in the context of COVID 19, and more generally the use of FAR 52.227-1, see:

2022:3 KEI Briefing Note: Selected differences between Article 30, 31 and 44 of the WTO TRIPS Agreement as regards non-voluntary use of patented inventions

2022:2: KEI Briefing Note: U.S. federal government FAR 52.227-1 authorizations (for non voluntary use of patents) disclosed in 173 SEC exhibits

2022:1 KEI Briefing Note: Selected U.S. Government COVID Contracts with Authorization and Consent to Non-Voluntary Use Of Third Party Patents.