Requires drug and biological product sponsors to certify to the FDA and submit to the Patent Office certain patent-related information, with a defense against drug patent infringement claims for owners who fail to disclose it.

• Requires sponsors of drug applications under the Federal Food, Drug, and Cosmetic Act and biological product applications under the Public Health Service Act to certify that information given to the FDA is consistent with what they gave the Patent and Trademark Office.
• Requires submission to the Patent and Trademark Office of information material to patentability that is provided to the FDA, along with a certification that the submission is complete.
• Makes it a prohibited act to fail to make the required certification, and gives a defense against drug patent infringement suits when the patent owner negligently or intentionally failed to disclose required information, unless the defendant is a covered foreign person.
• Keeps trade secret and confidential information protections for information shared with the Patent Office, except information the Patent Office finds necessary for the public to understand the scope of granted patent claims.

• Health, Education, Labor, and Pensions Committee (Senate)

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