How can the US President create a waiver for patent enforcement?

Question

According to a recent statement by the US Trade Representative:

“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures. The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines. We will actively participate in text-based negotiations at the World Trade Organization (WTO) needed to make that happen. Those negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved.

Which law authorizes the US President to decide which patents will be enforced? Isn't this something that only the US Congress can decide?

Answer 1

These statements aren't saying that the US President is waiving patent protections, but that the administration supports waiving patent protections. Specifically, the current administration is voicing support for a request to the World Trade Organization (WTO) to temporarily allow its members to ignore their obligations to protect other nations' patents.

In early October 2020, India and South Africa submitted this request to the WTO. This part of that request sums up what they are asking for:

12. In these exceptional circumstances, we request that the Council for TRIPS recommends, as early as possible, to the General Council a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19.

The TRIPS Agreement they reference is the Agreement on Trade-Related Aspects of Intellectual Property Rights, which is an agreement made by all members of the WTO to give a minimum set of intellectual property protections to citizens of other member nations. The above request by India and South Africa asks the group in the WTO that oversees TRIPS to ask the WTO's main decision-making group, the General Council, to adjust the TRIPS agreement to waive certain protections for patents related to COVID-19.

This policy change by the Biden administration could put enough pressure on the WTO to accept this request, or at least a modified version. However, the WTO General Council has the final decision to waive these patent protections, not the US President or even the US Congress, since they are WTO obligations that other nations agreed to follow.

Answer 2

I'm not a patent lawyer and the legislative framework regarding the status of the WTO agreements in the US is pretty complex, but under FSIA a US company by itself doesn't have a lot of recourse if a foreign government decides to compulsorily license a US patent to a company in that foreign country. Basically the US company mostly can't sue the foreign government directly, unless there are some other treaties that allow that.

Although a seemingly infrequent issue, the ability to sue domestic and foreign sovereign entities in intellectual property disputes has been the subject of recent seminal U.S. Supreme Court and Appellate Court decisions. In these decisions, the Courts addressed statutes that seek to abrogate sovereign immunity to allow suits by private individuals against foreign and domestic states in intellectual property actions. While the Supreme Court has now made it clear that a state cannot be sued for copyright (or patent) infringement, the Second Circuit held that a foreign entity may be sued in U.S. courts under certain circumstances. [...]

Applying the FSIA commercial activity exception, the Second Circuit Court of Appeals denied the Welsh Government’s motion to dismiss Pablo Star’s complaint for copyright infringement based on sovereign immunity. The Court found the Welsh Government’s use of two photos of Dylan Thomas and his wife in promotional material for Welsh-related tourism in the United States fell within the commercial activity exception. Pablo Star Ltd. v. The Welsh Government, 961 F.3d 555 (2nd Cir. 2020).

According to FSIA, sovereign immunity does not preclude jurisdiction in U.S. courts if the action is “based…upon commercial activity carried on in the United States by the foreign state.” 28 U.S.C. Sec. 1605(a)(2). Thus, to be able to sue a foreign state for copyright infringement as commercial activity under this provision, the action must meet the two statutory requirements: first, the action must be based on “commercial activity,” and second, the activity must be carried on in the United States.

[...] a suit can be brought in U.S. courts against a foreign sovereign for copyright infringement (and likely patent and trademark infringement) if the infringing action is part of the foreign government’s commercial activity in the United States.

So it looks like FSIA generally precludes [private] lawsuits (in US courts) against foreign countries/sovereigns for what what they do in their own territory/jurisdiction (unless some treaties say otherwise.)

If, on the other hand, the US government is opposed to such a compulsory licensing measure it can "raise hell" in various ways from direct sanctions to actions at the WTO (back when it still had a functioning dispute resolution mechanism, which the US has mostly sabotaged in the meantime.) Anyhow, what I'm trying to say is that the position of the US government matters, a lot. It can/does basically act as proxy protecting US companies in IP matters.