About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

1 1 (May 1, 2024)

handle is hein.crs/goveptm0001 and id is 1 raw text is: Con re &cnaI flesE h arming I len I ivede a 3rch Service since 1914 Updated May 1, 2024 USMCA: Intellectual Property Rights (IPR) The United States-Mexico-Canada Agreement (USMCA) is a comprehensive free trade agreement (FTA) that entered into force among the three countries in 2020. It updated and replaced the 1994 North American Free Trade Agreement (NAFTA). Chapter 20 of USMCA contains rules to protect and enforce intellectual property rights (IPR). Congress could have an interest in: overseeing implementation of USMCA's IPR commitments; examining the deal's balance on IPR rules to promote innovation and other policy aims; and considering to what extent, if any, USMCA should serve as a precedent for IPR rules in future U.S. trade deals. IPR provisions of USMCA, particularly on patent and regulatory protections, were contentious for some Members of Congress and stakeholders after USMCA was initially signed by the three countries in 2018 (original USMCA); these provisions underwent changes. Some Members and civil society groups had criticized the provisions in the original USMCA as contributing to rising drug costs. Other Members and pharmaceutical industry groups argued that they fostered U.S. innovation. After negotiations between Congress and the U.S. Trade Representative (USTR), the United States, Canada, and Mexico agreed to a protocol of amendment that changed some of the original USMCA's IPR provisions. These changes may support generic competition. The final USMCA, which entered into force in 2020 after enactment of implementing legislation (P.L. 116- 113), incorporated the changes made by the protocol. IPR and Trade ackground IPR are time-limited protections that governments grant to inventors and artists to exclude others from using their inventions and creations without permission. Advancing IPR protection globally has been a U.S. trade negotiating objective since 1988 (P.L. 100-418). NAFTA was the first U.S. FTA to include IPR provisions and served as a model for the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). While NAFTA was significant to the use of trade policy to advance IPR internationally, it predated widespread internet use and other technological advances. The now-expired 2015 Trade Promotion Authority (TPA, P.L. 114-26) reflected prior U.S. negotiating objectives for U.S. trade agreements to reflect a standard of protection similar to that found in U.S. law, and it added new objectives to combat cyber theft and protect trade secrets. Congress approved USMCA under the 2015 TPA. IPR Chapter of USMCA The IPR chapter of USMCA aims to support technological innovation to benefit both producers and users, while promoting a balance of rights and obligations. General obligations include upholding international agreements and providing national treatment-that is, not discriminating against foreign nationals on IPR. Some provisions have separate phase-in periods for Canada and Mexico. IPR obligations are enforceable through USMCA's general government-to-government dispute settlement. (USMCA investor protections also apply to IPR. See CRS In Focus IF11167, USMCA: Investment Provisions.) Patents Patents protect new and useful inventions (e.g., medicines, chemical processes, business technologies, and computer software). USMCA defines patentable subject matter as new products and processes. Unlike some U.S. FTAs, USMCA does not provide patent protection for new uses, methods, or processes of existing inventions. Under TRIPS, patented inventions must receive a minimum of 20 years of protection. As patents are usually filed before regulatory approval is granted, the effective term may be less than 20 years. USMCA requires adjustments of patent terms for unreasonable delays in patent examination or regulatory approvals to restore some of the patent term. Unreasonable delays include a delay of more than five years from the date of filing or three years after a request for examination of an application, whichever is later. USMCA has a notification system and procedures (e.g., judicial or administrative) to assert patent rights or to challenge a patent's validity. USMCA lacks the patent linkage required in some U.S. FTAs, whereby regulatory authorities (e.g., the U.S. Food and Drug Administration, FDA) cannot grant marketing approval to a generic drug without the patent holder's permission. Regulatory Excusivities USMCA's pharmaceutical provisions aim to encourage innovation and access to medicine, and the IPR chapter reaffirms the WTO Doha Declaration on TRIPS and Public Health. Stakeholders debated USMCA's balance on incentivizing innovation for new medicines while allowing for affordable medicines through market entry of generics. Regulatory exclusivity for biologic drugs (drugs made from living organisms), in particular, was a contested issue in the USMCA negotiations. During a regulatory exclusivity period, regulatory authorities cannot approve a generic or biosimilar version of a drug, regardless of patent rights (see text box). The original USMCA required at least 10 years of protection for biologics, but the amended version of the USMCA dropped this provision. The 10-year exclusivity period would not have changed the 12-year exclusivity period in U.S. law, but it would have increased the periods in Canada and Mexico, eight and five years, respectively. Some Members of Congress approved eliminating the 10- year exclusivity period from the original USMCA, arguing that it would have restricted the ability of Congress to lower that period in the United States in the future. Some also approved eliminating it to support competition in the pharmaceutical market. Other Members opposed dropping the exclusivity period, arguing that it is critical for innovation and development of biologics in North America.

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline.

Purchase Access

Already a HeinOnline Subscriber?

Log In

profiles profiles most