Us Congress 2023-2024 Regular Session

Us Congress Senate Bill SB79

Introduced
1/25/23  
Refer
1/25/23  

Caption

Interagency Patent Coordination and Improvement Act of 2023 This bill establishes the Interagency Task Force on Patents to support coordination and communication between the U.S. Patent and Trademark Office (PTO) and the Food and Drug Administration (FDA) on activities relating to patents for human drugs and biological products. The task force's duties shall include sharing information about (1) the processes of each agency, including how each agency evaluates applications (e.g., patent applications at the PTO and new drug applications at the FDA); and (2) new approvals of patents, human drugs, biological products, and new technologies. The task force must also establish a process that requires (1) the PTO to request from the FDA information relating to certain patent applications to help patent examiners carry out their duties, (2) the FDA to provide such information to the PTO, and (3) the PTO to assist the FDA in its ministerial role of listing patents.

Impact

The impact of SB79 on state laws and federal operations centers around its goal to create a more cohesive framework for evaluating patent applications related to pharmaceuticals. By formalizing the relationship between the PTO and the FDA, proponents argue that the legislation will minimize redundancies, facilitate more informed patent decisions, and ultimately enhance innovation in the drug development process. This change will likely reduce delays in the patent examination process and expedite the approval of new drugs in the market, thereby benefiting consumers and manufacturers alike.

Summary

Senate Bill 79, titled the 'Interagency Patent Coordination and Improvement Act of 2023', seeks to enhance collaboration between the United States Patent and Trademark Office (PTO) and the Food and Drug Administration (FDA) regarding patents related to human drugs and biological products. The bill establishes an Interagency Task Force on Patents, which is charged with sharing information about each agency's review processes and evaluations of patent applications and drug approvals. This initiative is expected to streamline operations and improve the quality of patent examinations by enabling better access to important data that may reside across federal agencies.

Sentiment

Sentiment surrounding SB79 appears to be largely positive among lawmakers and industry stakeholders, who recognize the need for improved coordination in patent matters. Supporters highlight the potential benefits to public health and safety, as well as the fostering of greater compliance with federal standards. However, there may be underlying concerns regarding how information is shared and the possibility of undermining the confidentiality of proprietary data, which could be met with resistance from some industry players wary of increased transparency in their patent processes.

Contention

Notable points of contention in discussions surrounding SB79 include the protection of confidential information exchanged between the PTO and the FDA. Stakeholders stress the importance of establishing robust protocols to prevent any inadvertent disclosure of sensitive data during the review process. Moreover, the balance of power between the two agencies in terms of patent scrutiny and oversight may lead to discussions on potential regulatory overlaps, ensuring that both agencies' functions remain defined and do not impede on one another.

Companion Bills

US HB1717

Identical bill Interagency Patent Coordination and Improvement Act of 2023

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