S. 2658: Medication Affordability and Patent Integrity Act

This legislation, known as the Medication Affordability and Patent Integrity Act, proposes several amendments to existing laws regarding drug approval and patent application processes. Here are the main elements of the bill:

1. Purpose of the Bill

The primary aim of the bill is to enhance transparency and integrity in the patenting and approval processes for medications and biological products by requiring drug sponsors to submit and certify certain patent-related information to both the Food and Drug Administration (FDA) and the United States Patent and Trademark Office (USPTO).

2. Disclosure Requirements

Under the bill, sponsors of drug applications and holders of approved drug applications must:

• Certify to the FDA that the information they provide regarding patents is complete and consistent with what they have provided to the USPTO.
• Submit to the USPTO all information pertinent to a patent's validity that they have submitted to the FDA, as well as any FDA responses to that information.
• Ensure that this information remains confidential, preserving trade secrets and sensitive financial details.

3. Definition of Applicable Patents

The bill specifies what constitutes an "applicable patent." This includes patents that:

• Claim a drug or biological product subject to an application or license.
• Have been issued, assigned, or licensed to the sponsor of the application.

4. Inclusion of Certifications in Applications

All new drug applications submitted after the enactment of the bill must now include certifications regarding applicable patents. This includes detailing how the information related to these patents aligns with the information supplied to both the FDA and the USPTO.

5. Penalties and Enforcement

The legislation introduces enforcement mechanisms to ensure compliance, allowing the FDA to take action if the required certifications are not submitted by the sponsors. There is also a clause that provides a defense against patent infringement claims if a patent owner fails to disclose required information.

6. Impact on Existing Applications

For applications submitted before the bill's enactment, the new requirements will apply only to new patents issued after the enactment date and to any submissions made after that date regarding previously issued patents.

Relevant Companies

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