‘Domestic’ IPR enforcement includes the COVID TRIPS waiver and border enforcement.

Multilateral IP Rules. TRIPS established minimum standards of IP protection that most WTO members must provide, based on core WTO nondiscrimination principles. It set civil, administrative, and criminal enforcement procedures and remedies, and border measures. TRIPS obligations are subject to WTO enforcement.

TRIPS has certain exceptions and flexibilities. It allows compulsory licensing for patents in specific circumstances, and exempts least-developed countries from most obligations until July 1, 2034, and pharmaceutical-related obligations until January 1, 2033. In the 2001 WTO “Doha Declaration,” WTO members agreed to interpret TRIPS to support WTO members’ right to protect public health, particularly to promote access to medicines. TRIPS has elicited some stakeholder debate about how it seeks to balance innovation and other aims.

COVID-19 “TRIPS Waiver

A major WTO debate has centered on how best to provide global access to COVID-19 vaccines and therapeutics, and whether to “waive” or offer greater flexibilities for TRIPS obligations. In 2022, WTO members approved a five-year “TRIPS waiver” of patent-related obligations for COVID-19 vaccines. The Biden Administration’s support for the waiver divided Members of Congress. WTO members are now debating whether to extend the waiver to COVID-19 diagnostics and therapeutics.

Other IPR treaties, dating back to the 1800s and on which TRIPS builds, are administered by WIPO, a specialized U.N. agency. Newer WIPO treaties, notably the “Internet Treaties,” address digital IPR issues that are not in TRIPS.

U.S. IPR Trade Objectives. Since 1988, Congress has included IPR protection as a principal negotiating objective in trade promotion authority (TPA). The 2015 TPA (P.L. 114-26), which expired in 2021, directed the executive to ensure that U.S. FTAs “reflect a standard of protection similar to that found in U.S. law,” and apply existing IPR protection to digital media through the WIPO “Internet

Treaties.” It added new objectives to address cyber theft, protect trade secrets and proprietary information, and “foster innovation and access to medicines.”

IPR in U.S. Trade Agreements. Since NAFTA, U.S. FTAs have included IPR obligations that build on TRIPS. The United States-Mexico-Canada Agreement (USMCA), the most recent U.S. FTA, contains new or updated IPR commitments, compared to other U.S. FTAs, including on criminal penalties for trade secret theft, IPR enforcement in the digital environment, and enhanced disciplines for GIs.

Some limited trade deals also have IPR commitments. For example, in the 2020 U.S.-China “phase one” agreement, China committed not to require technology transfer and to strengthen IP enforcement, but most U.S. concerns about technology transfer and IP theft remain unresolved. IPR does not appear to be a top focus of current Biden Administration trade initiatives, such as in the Indo-Pacific, but may come up as it relates to digital trade negotiations.

Other Tools. U.S. IPR-related trade tools also include

• “Special 301” of the amended Trade Act of 1974: USTR identifies countries with inadequate IPR regimes in its annual statutorily required “Special 301” report. USTR reviews online and physical “notorious” markets involved in IPR infringement in a separate annual report. It can also investigate and enforce U.S. IPR through Section 301 of the Trade Act of 1974 (as USTR did with China in 2018).

• Section 337 of the amended Tariff Act of 1930: Per this law, the U.S. International Trade Commission (ITC) may ban U.S. imports that infringe on U.S. IPR. If the ITC finds a violation, it may issue an exclusion order or cease and desist order. Section 337 cases have been largely patent-focused, though the number of trade secrets-related cases have been growing.

• Seizures: CBP enforces IPR at U.S. borders by seizing goods that infringe on U.S. copyrights and trademarks, and enforcing Section 337 exclusion orders.

• U.S. Generalized System of Preferences (GSP): Under this program, the President considers a developing country’s IPR policies and practices when extending duty-free benefits on U.S. imports from such country. A bill to renew GSP, which expired at the end of 2020, is pending in the 118th Congress.

Issues for Congress

Trade Policy Priorities. Congress may use potential TPA renewal to reaffirm or modify U.S. trade negotiating objectives on IPR. U.S. trade policy generally has promoted IPR expansion, but some stakeholders have debated this approach. USMCA sparked debate on the role of patents and data exclusivity in incentivizing innovation and supporting access to medicines, a debate renewed by the COVID-19 pandemic. The growth of digital trade also poses issues for online intermediary liability, cross-border data flows, data protection, and cyber theft of trade secrets.

Remedies for U.S. IP Holders. Congress may evaluate the timeliness of longstanding U.S. IPR trade remedies. The ITC takes an average of 18 months to reach a final determination in Section 337 investigations. CBP may face particular challenges assessing risk, given high volumes of low-value shipments, which constitute a large share of IPR seizures. Tracking IPR infringement in e-commerce shipments and supply chains poses further challenges.

Congress also may monitor the implementation of new IPR remedies (e.g., P.L. 117-336, which authorizes sanctions for theft of U.S. trade secrets by certain foreign actors).

Trading Partners’ IPR Commitments. Congress may consider which measures may be most effective in strengthening global IPR protections. Options include to enhance U.S. trade monitoring and enforcement of trading partners’ IPR obligations; direct the Administration to pursue new FTA negotiations that prioritize IPR issues; and expand the scope of ongoing executive trade initiatives to include IPR. Congress also may examine whether to change existing U.S. trade tools to advance IPR to increase their effectiveness or balance with other public policy objectives.

Multilateral Issues. Congress may continue to oversee and shape U.S. multilateral engagement on IPR. A key issue may be the TRIPS COVID-19 waiver; questions remain over the effectiveness of this approach to promote global COVID-19 treatments access; its implications for U.S. technological competitiveness (e.g., vis-à-vis China); and the role of Congress in changing U.S. obligations under international IPR rules. See CRS Report RL34292, Intellectual Property Rights and International Trade.