Disclosure, Inquiry, and Other Agencies

This notice restates two duties that are easy to collapse into one. The first is disclosure: information material to patentability must be given to the Office. The second is inquiry, and it is the one that creates work, because it obliges a party submitting a paper to review documents to identify material information rather than to disclose only what happens to be at hand. The notice's specific concern is inconsistency across agencies, naming statements made to the USPTO that conflict with statements submitted to the FDA. For anyone whose client talks to more than one regulator, the two duties together mean the patent file and the regulatory file are not separate universes.

Two Duties, Stated Separately on Purpose

The second duty is affirmative, not passive. A party that discloses everything it happened to hold has satisfied the first duty and not necessarily the second. That is the distinction most often collapsed, and it turns the inquiry duty into a search obligation rather than a filing one.

The notice states who carries the weight and why: "The USPTO relies on each individual who is subject to these duties to abide by them", and the duties "are imposed to assist patent examiners and administrative patent judges in evaluating patentability effectively and efficiently".

Inconsistency Itself Is the Risk

The notice is "intended to clarify the duties, including as to materials or statements material to patentability or statements made to the USPTO that are inconsistent with statements submitted to the" FDA and other governmental agencies. That makes inconsistency a risk distinct from non-disclosure. A statement can be individually accurate at each agency and still create exposure if the two cannot both be true.

A firewall between regulatory counsel and patent counsel is exactly the arrangement that makes an inconsistency likely and an inquiry inadequate. Connecting the patent file to the regulatory file for the same technology is what the two duties, read together, ask for.

• The pharmaceutical framing is prominent and the duties are general. The notice dwells on drug patents; nothing in the two duties is limited to them.
• This is a clarification, not a new rule. It does not amend the regulations. It describes how the Office reads obligations that already existed.
• "Reasonable under the circumstances" is the whole question and is not answered here. The standard is stated; its content depends on facts the notice does not supply.
• The notice is four years old at the date above, the oldest document in this cluster.

What This Does Not Decide

• It does not say whether particular information is material.
• It does not say whether a specific inquiry was reasonable.
• It does not say whether any conduct breached a duty.

Educational, not legal advice. This page reports what an authority says. Applying it to a matter is work for a registered practitioner with the file in front of them.