This bill requires drug and biologic manufacturers to keep the Food and Drug Administration and the U.S. Patent and Trademark Office informed of each other's relevant information when a company is seeking both drug approval and patent protection for the same product. Specifically, companies must certify to the FDA that technical data they submit matches what they told the Patent Office, and must forward to the Patent Office any information relevant to whether a patent should be granted, including data from FDA submissions, along with a certification that the disclosure is complete and consistent. The goal is to prevent companies from telling the two agencies different things about a drug in order to both win approval and secure overly broad patents, a practice critics say can improperly extend market exclusivity and delay cheaper generic or biosimilar competition. The requirements apply to new applications filed after enactment and, for existing applications, to newly issued patents or new communications going forward. Companies that fail to make required disclosures can face FDA enforcement action, and patent owners who negligently or intentionally withhold required information may lose the ability to sue for patent infringement, though this defense would not be available to certain covered foreign entities. Sensitive business information shared between the agencies would retain the same confidentiality protections it has under existing law.
Take Action
Your position
Add a comment
to comment on this bill.
Annotate the text
Highlight any passage on the Summary or Full Text tab to attach a note. Annotations appear on the Annotations tab.