HR4570-119

What This Bill Does

The Interagency Patent Coordination and Improvement Act builds a formal USPTO-FDA coordination structure for patents involving human drugs and biological products. The findings state that patent decisions may depend on information held by other federal agencies and that applicants sometimes submit representations to both USPTO and FDA. The bill requires the USPTO Director, through a new Interagency Task Force on Patents, to consult with the FDA Commissioner on patent decisions or actions involving human drugs and biologics. USPTO and FDA must enter into or update a memorandum of understanding. The task force must include staff with operational, administrative, technical, medical, pharmacological, clinical, and scientific expertise and must share information about agency processes, new drug and biologic approvals, new technologies, prior art, and scientific trends. It must establish processes for USPTO requests to FDA for information useful in patent examination. USPTO must report to the House and Senate Judiciary Committees within four years on FDA information sharing, usefulness to examiners, recommendations for Congress, and other agencies suitable for similar coordination.

Who Benefits and How

USPTO patent examiners benefit from access to FDA scientific, clinical, pharmacological, and approval information. FDA reviewers benefit from a formal channel for communicating information relevant to drug and biologic patents. Generic drug manufacturers benefit if stronger examination reduces weak or inconsistent pharmaceutical patent claims. Patients using prescription drugs benefit if better patent examination improves competition and lowers patent-related barriers over time.

Who Bears the Burden and How

USPTO must create and staff the patent task force, consult FDA, request information, and report to judiciary committees. FDA must appoint qualified employees, share appropriate information, and maintain the memorandum of understanding. Brand-name drug sponsors may face closer comparison between FDA submissions and patent representations. Patent applicants for human drugs and biologics must expect greater interagency scrutiny of prior art and scientific representations.

Key Provisions

• Establishes an Interagency Task Force on Patents for USPTO and FDA coordination.
• Requires USPTO consultation with FDA on patents and patent actions involving human drugs and biological products.
• Directs USPTO and FDA to enter into or update a memorandum of understanding.
• Requires information sharing on agency processes, approvals, new technologies, prior art, and scientific trends.
• Requires a four-year USPTO report on FDA information use, examiner usefulness, congressional recommendations, and other agency coordination opportunities.