To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office.
This bill requires pharmaceutical companies to share consistent information between the FDA and the Patent and Trademark Office when seeking approval for new drugs and biologics. Specifically, drug sponsors must certify that all clinical data, patent statements, and communications submitted to the FDA match exactly what they provided to the Patent Office, and vice versa. The bill applies to new drug applications submitted after the law's enactment and to patents issued after that date. If a company fails to comply with these disclosure requirements, the FDA can deny drug approval, and defendants in patent infringement lawsuits can use the company's non-disclosure as a legal defense. The legislation aims to prevent pharmaceutical companies from making inconsistent claims about their drugs to different agencies in ways that might improperly extend patent protections or delay generic competition.
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