The Broad Use of Patent Flexibilities in the United States

Authors

  • Carlos Augusto Conde Gutiérrez Docente investigador del Departamento de la Propiedad Intelectual de la Universidad Externado de Colombia
  • Nicolas Rodríguez Rodríguez Abogado de la Universidad Externado de Colombia, especializado en Propiedad Industrial, Derechos de Autor y Nuevas Tecnologías de la misma institución

DOI:

https://doi.org/10.36151/RPIID.2025.2.3.05

Keywords:

flexibilities, patents, international exhaustion, government use, march-in rights, United States, Bolar exception

Abstract

This article examines how the United States has implemented the provisions of the TRIPS Agreement—particularly those referred to as “patent flexibilities”—and highlights the extensive development of these measures. During the negotiations that led to the TRIPS Agreement, the United States advocated for limiting the flexibilities inherent in the treaty. Nonetheless, at the domestic level, selective mechanisms have been adopted—such as the doctrine of international exhaustion, exceptions, government use, and march-in rights for inventions financed with federal funds—that restrict the rights granted to patent holders, and injuctions. The analysis seeks to provide researchers, scholars, and policymakers with tools to implement similar mechanisms in their jurisdictions.

References

Bodenhausem, G. H. C. (1967). Guide to the Application of the Paris Convention for the Protecion of Industrial Property as Revised at Stockholm in 1967. United International Bureaux for the Protection of Intellecual Property.

Conde Gutiérrez, C. A. (2016). Métodos Terapéuticos o Quirúrgicos para el Tratamiento Humano o Animal y Métodos de Diagnóstico Aplicados a los Seres Humanos o a los Animales. In Derecho de Patentes (pp. 581–606). Universidad Externado de Colombia.

Conde Gutiérrez, C. A. (2017). Una Aproximación a la Propiedad Intelectual y la Regulación de Acceso a Recursos desde la Perspectiva del Contrato Social y la Justicia Global. In Fundamentos y Crítica a la Propiedad Intelectual.

Correa, C. M. (2020). Guía para la concesión de licencias obligatorias y uso gubernamental de patentes farmacéuticas. http://www.southcentre.int

Fisher, W. (2001). Theories of intellectual property. New Essays in the Legal and Political Theory of Property, 168–199. http://xa.yimg.com/kq/groups/27799060/1918334176/name/iptheory.pdf

Halewood, M. (1997). Regulating Patent Holders: Local Working Requirements and Compulsory Licences at International Law Regulating Patent Holders. Osgoode Hall Law Journal, 352(35), 243–287.

Herrera Sierra, L. F. (2015). La doctrina del fair use frente a los retos impuestos por el entorno digital. Estudio del caso google books. Revista La Propiedad Inmaterial, 20, 57. https://doi.org/10.18601/16571959.n20.04

Maune, J. (2011). Patent Secrecy Orders: Fairness Issues in Application of Invention of Secrecy Act. Texas Intellectual Property Law Journal, 20. https://heinonline.org/HOL/Page?handle=hein.journals/tipj20&id=481&div=&collection=

Merges, R. (2013). Justifying Intellectual Property. Harvard University Press.

Mossoff, A. (2012). Saving Locke from Marx: the Labour Theory of Value in Intellectual Property Theory. Social Philosophy and Policy, 29, 283–317.

National Institute of Standards and Technology. (2023). Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights. https://www.federalregister.gov/documents/2023/12/08/2023-26930/request-for-information-regarding-the-draft-interagency-guidance-framework-for-considering-the

South Center. (2021). TRIPS Flexibilities relating to Enforcement. https://ipaccessmeds.southcentre.int/wp-content/uploads/2021/07/Enforcement-1.pdf

Suárez, J. E. S. (2025). Fundamentos históricos de la constitucionalización de la propiedad intelectual en la Republica de Colombia. Revista La Propiedad Inmaterial, 39, 215–244. https://doi.org/10.18601/16571959.N39.08

Vázquez, C. M. (1997). What Is Eleventh Amendment Immunity? Yale Law Journal, 106(6), 1683–1806. https://doi.org/10.2307/797319

Watal, J., & Taubman, A. (2015). The making of the TRIPS Agreement: Personal insights from the Uruguay Round negotiations. www.wto.org

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Published

2025-10-31

Issue

Section

Tribuna práctica y opinión legal

How to Cite

The Broad Use of Patent Flexibilities in the United States. (2025). Revista Propiedad Intelectual E innovación Digital, 2(3), 161-178. https://doi.org/10.36151/RPIID.2025.2.3.05