37 C.F.R. 1.765 Duty of disclosure in patent term extension proceedings.

1. (a) A duty of candor and good faith toward the Patent and Trademark Office and the Secretary of Health and Human Services or the Secretary of Agriculture rests on the patent owner or its agent, on each attorney or agent who represents the patent owner and on every other individual who is substantively involved on behalf of the patent owner in a patent term extension proceeding. All such individuals who are aware, or become aware, of material information adverse to a determination of entitlement to the extension sought, which has not been previously made of record in the patent term extension proceeding must bring such information to the attention of the Office or the Secretary, as appropriate, in accordance with paragraph (b) of this section, as soon as it is practical to do so after the individual becomes aware of the information. Information is material where there is a substantial likelihood that the Office or the Secretary would consider it important in determinations to be made in the patent term extension proceeding.
2. (b) Disclosures pursuant to this section must be accompanied by a copy of each written document which is being disclosed. The disclosure must be made to the Office or the Secretary, as appropriate, unless the disclosure is material to determinations to be made by both the Office and the Secretary, in which case duplicate copies, certified as such, must be filed in the Office and with the Secretary. Disclosures pursuant to this section may be made to the Office or the Secretary, as appropriate, through an attorney or agent having responsibility on behalf of the patent owner or its agent for the patent term extension proceeding or through a patent owner acting on his or her own behalf. Disclosure to such an attorney, agent or patent owner shall satisfy the duty of any other individual. Such an attorney, agent or patent owner has no duty to transmit information which is not material to the determination of entitlement to the extension sought.
3. (c) No patent will be determined eligible for extension and no extension will be issued if it is determined that fraud on the Office or the Secretary was practiced or attempted or the duty of disclosure was violated through bad faith or gross negligence in connection with the patent term extension proceeding. If it is established by clear and convincing evidence that any fraud was practiced or attempted on the Office or the Secretary in connection with the patent term extension proceeding or that there was any violation of the duty of disclosure through bad faith or gross negligence in connection with the patent term extension proceeding, a final determination will be made pursuant to § 1.750 that the patent is not eligible for extension.

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A duty of candor and good faith toward the USPTO, the Secretary of Health and Human Services, and the Secretary of Agriculture rests on the patent owner or its agent, on each attorney or agent who represents the patent owner, and on every other individual who is substantively involved on behalf of the patent owner in a patent term extension proceeding. All such individuals who are aware, or become aware, of material information adverse to a determination of entitlement to the extension sought, which has not been previously made of record in the patent term extension proceeding, must bring such information to the attention of the Office or the Secretary, as appropriate, as soon as it is practicable to do so after the individual becomes aware of the information. Information is "material" when there is a substantial likelihood that the Office or the Secretary would consider it important in determinations to be made in the patent term extension proceeding. Any such material information should be submitted to the Director of the United States Patent and Trademark Office, the Secretary of Health and Human Services, or the Secretary of Agriculture, as appropriate, accompanied by a copy of each written document being disclosed. The information may be submitted through a registered practitioner. The USPTO patent electronic filing system includes the document description "Disclosure Under 37 CFR 1.765 in a Patent Term Extension Application" (document code TERM.PTE.DIS) for disclosures to the USPTO under 37 CFR 1.765.

A determination of eligibility for an extension or the issuance of a certificate will not be made if clear and convincing evidence of fraud or attempted fraud on the Office or a Secretary is determined to be present, or the duty of disclosure is determined to have been violated through bad faith or gross negligence in connection with the patent term extension proceeding. Since the determination as to whether a patent is eligible for extension may be made solely on the basis of the representations made in the application for extension, a final determination to refuse a patent term extension because of fraud or a violation of the duty of disclosure is expected to be rare. See MPEP § 2010.

It is possible that during the processing of a patent term extension, the patent owner becomes aware of situations where the filing of a terminal disclaimer might be necessary or desired. For example, if patent infringement litigation has commenced and the accused infringer advances that the patent is invalid on the basis of nonstatutory obviousness type double patenting, then the patent owner might choose to file a terminal disclaimer to preempt the defense if the patent that is the basis for the nonstatutory obviousness type double patenting has not expired. Boehringer Ingelheim Int’l GmbH v. Barr Laboratories Inc., 592 F.3d 1340, 93 USPQ2d 1417, 1422-23 (Fed. Cir. 2010). When a terminal disclaimer is filed for a patent during the processing of an application for patent term extension, any required updates to information already of record should be made pursuant to 37 CFR 1.765. For example, if the calculation of term changes because the patent’s expiration date changes, then an updated calculation of the term should be submitted for the application for patent term extension via the USPTO patent electronic filing system. Patent owners can use the USPTO terminal disclaimer forms (e.g., forms PTO/SB/25a or PTO/SB/26a) available at www.uspto.gov. Alternatively, patent owners can draft and file a self-prepared terminal disclaimer that meets the requirements of 37 CFR 1.321. See MPEP § 1490.