S2658-119

What This Bill Does

The Medication Affordability and Patent Integrity Act imposes parallel duties on sponsors and holders of new drug applications and biologics license applications. For covered patents, they must certify to FDA that specified regulatory submissions are consistent with information and communications supplied to the Patent and Trademark Office. They must also send USPTO information material to patentability that they give FDA, along with FDA's responses, and certify that the patent-office submission is complete and consistent. Covered material includes chemistry, manufacturing, and controls information and statements characterizing patents, prior art, novelty, nonobviousness, or patent scope, including information added by a regulator. For final reported text, an applicable patent must be issued to, assigned to, or exclusively licensed to the sponsor or holder. The duties apply to new applications and to specified post-enactment communications or patents associated with older applications. USPTO must protect confidential commercial, trade-secret, and financial material, except information it determines the public needs to understand the scope of granted claims. A failure to make the required certification becomes a prohibited act under federal drug law. In patent litigation, an accused infringer receives a defense when the patent owner or predecessor negligently or intentionally failed to make a required disclosure. The final text withholds that defense from a covered foreign person under the Defense Production Act.

Who Benefits and How

Generic-drug and biosimilar applicants gain access to a litigation defense when a patent owner or predecessor failed to disclose required FDA-related information to USPTO. USPTO examiners gain material patentability information and may disclose what the public needs to understand granted-claim scope. FDA gains formal consistency certifications, courts gain a statutory consequence for material nondisclosure, and patients and payers may benefit if invalid or improperly obtained exclusivity is easier to challenge. Patent owners that make complete, consistent submissions gain a clearer compliance record.

Who Bears the Burden and How

Brand-drug and biologic sponsors and application holders must compare regulatory and patent-office records, transmit covered information and FDA responses, certify completeness and consistency, and maintain those duties for later communications and patents. FDA and USPTO must receive, evaluate, protect, and sometimes disclose sensitive submissions. Patent owners face greater infringement-litigation risk when they or predecessor owners negligently or intentionally omit required information. Courts must adjudicate the new defense. Covered foreign persons cannot invoke the defense and therefore face a higher litigation barrier than otherwise eligible domestic defendants.

Key Provisions

• Requires drug and biologic sponsors to certify consistency between specified FDA and USPTO representations.
• Requires submission to USPTO of FDA-provided or FDA-responsive information material to patentability.
• Defines covered regulatory statements, timing rules, and applicable patents, including exclusive licenses in the final text.
• Protects confidential submissions while allowing disclosure needed to explain granted-claim scope.
• Creates a prohibited-act consequence for missing FDA certifications.
• Provides an infringement defense for negligent or intentional disclosure failures by a patent owner or predecessor.
• Limits the defense by excluding covered foreign persons.