35 U.S.C. § 326

Conduct of post-grant review

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(a)Regulations.—The Director shall prescribe regulations—(1) providing that the file of any proceeding under this chapter shall be made available to the public, except that any petition or document filed with the intent that it be sealed shall, if accompanied by a motion to seal, be treated as sealed pending the outcome of the ruling on the motion;(2) setting forth the standards for the showing of sufficient grounds to institute a review under subsections (a) and (b) of section 324;(3) establishing procedures for the submission of supplemental information after the petition is filed;(4) establishing and governing a post-grant review under this chapter and the relationship of such review to other proceedings under this title;(5) setting forth standards and procedures for discovery of relevant evidence, including that such discovery shall be limited to evidence directly related to factual assertions advanced by either party in the proceeding;(6) prescribing sanctions for abuse of discovery, abuse of process, or any other improper use of the proceeding, such as to harass or to cause unnecessary delay or an unnecessary increase in the cost of the proceeding;(7) providing for protective orders governing the exchange and submission of confidential information;(8) providing for the filing by the patent owner of a response to the petition under section 323 after a post-grant review has been instituted, and requiring that the patent owner file with such response, through affidavits or declarations, any additional factual evidence and expert opinions on which the patent owner relies in support of the response;(9) setting forth standards and procedures for allowing the patent owner to move to amend the patent under subsection (d) to cancel a challenged claim or propose a reasonable number of substitute claims, and ensuring that any information submitted by the patent owner in support of any amendment entered under subsection (d) is made available to the public as part of the prosecution history of the patent;(10) providing either party with the right to an oral hearing as part of the proceeding;(11) requiring that the final determination in any post-grant review be issued not later than 1 year after the date on which the Director notices the institution of a proceeding under this chapter, except that the Director may, for good cause shown, extend the 1-year period by not more than 6 months, and may adjust the time periods in this paragraph in the case of joinder under section 325(c); and(12) providing the petitioner with at least 1 opportunity to file written comments within a time period established by the Director.(b)Considerations.—In prescribing regulations under this section, the Director shall consider the effect of any such regulation on the economy, the integrity of the patent system, the efficient administration of the Office, and the ability of the Office to timely complete proceedings instituted under this chapter.(c)Patent Trial and Appeal Board.—The Patent Trial and Appeal Board shall, in accordance with section 6, conduct each post-grant review instituted under this chapter.(d)Amendment of the Patent.—(1)In general.—During a post-grant review instituted under this chapter, the patent owner may file 1 motion to amend the patent in 1 or more of the following ways:(A) Cancel any challenged patent claim.(B) For each challenged claim, propose a reasonable number of substitute claims.(2)Additional motions.—Additional motions to amend may be permitted upon the joint request of the petitioner and the patent owner to materially advance the settlement of a proceeding under section 327, or upon the request of the patent owner for good cause shown.(3)Scope of claims.—An amendment under this subsection may not enlarge the scope of the claims of the patent or introduce new matter.(e)Evidentiary Standards.—In a post-grant review instituted under this chapter, the petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence.(Added Pub. L. 112–29, § 6(d), Sept. 16, 2011, 125 Stat. 308.)Statutory Notes and Related SubsidiariesEffective Date

Section effective upon the expiration of the 1-year period beginning Sept. 16, 2011, and applicable only to patents described in section 3(n)(1) of Pub. L. 112–29 (35 U.S.C. 100 note), with certain exceptions and limitations, see section 6(f)(2), (3) of Pub. L. 112–29, set out as a note under section 321 of this title.

Notes of Decisions
Cited in 14 cases (7 in the last 5 years), 2014–2025 · leading case: Virtualagility Inc. v. salesforce.com, Inc.
Virtualagility Inc. v. salesforce.com, Inc. (2014) cafc · cites it 4× “, one year from institution of the proceeding, see 35 U.S.C. § 326 (a)(11)), 7 VA would still suffer undue prejudice because it is a small company with limited after the date of the stay motion—for example, the fact that the PTAB granted the CBM petition, any claim amendments…”
Aqua Products, Inc. v. Matal (2017) cafc · cites it 2× “…§§ 321–329, among them a burden-of-persuasion provision just like § 316(e). See 35 U.S.C. § 326 (e). I do not think that the burden of persuasion falls out- side the Director’s § 316(a) authority merely because burdens of persuasion are treated as “substantive” for various…”
Versata Development Group, Inc. v. SAP America, Inc. (2015) cafc · cites it 2× “As noted, this statute is applicable to post-grant reviews and CBM proceedings; the PTAB acts for the Director in deciding whether to institute a review, see 35 U.S.C. § 326 (c); 37 C.”
Return Mail, Inc. v. United States Postal Service (2017) cafc · cites it 2× “, 35 U.S.C. § 326 (a)(3), (5), (8), (10), (12).”
Sightsound Technologies, LLC v. Apple Inc. (2015) cafc · cites it 2× “First, 35 U.S.C. § 326 , which is applicable to CBM review through the PGR provisions, grants the PTO authority to “prescribe regulations .”
Intellectual Ventures II LLC v. Jpmorgan Chase & Co. (2015) cafc · cites it 2× “…to the date on which a petition is granted and proceedings are insti- tuted. 35 U.S.C. § 326 (a)(11). If a proceeding actually began with the filing of the petition, the PTO’s regula- tions would seem to be in direct conflict with the congres- sional record. Compare 37 C.F.”
Medytox, Inc. v. Galderma S.A. (2023) cafc · cites it 2× “The Board found that, “at this stage of the proceeding, and based on the current rec- ord,” Medytox had not shown a reasonable likelihood that it satisfied the statutory and regulatory requirements un- der 35 U.S.C. § 326 (d) and 37 C.”
Versata Software, Inc. v. Callidus Software, Inc. (2014) ded · cites it 2× “See 35 U.S.C. § 326 (a)(ll), 37 C.F.R. 42.”
Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc. (2023) cafc · cites it 3× “…written description in the ’961 patent itself, the Board instituted PGR. Under 35 U.S.C. § 326 (a)(11) and 37 C.F.R. § 42.200 (c), the Board had one year to issue a Final Written Decision subject to a six-month extension for “good cause.” On S”
Medytox, Inc. v. Galderma S.A. (2023) cafc · cites it 2× “The Board found that, “at this stage of the proceeding, and based on the current rec- ord,” Medytox had not shown a reasonable likelihood that it satisfied the statutory and regulatory requirements un- der 35 U.S.C. § 326 (d) and 37 C.”
L'Oreal USA, Inc. v. Olaplex, Inc. (2021) cafc “…a propo- sition of unpatentability by a preponderance of the evi- dence.” 35 U.S.C. § 326 (e). A Olaplex does not contest the Board’s finding that there are no differences between the combined teachings of Pratt and Tanabe and the claimed invention. Specifically, Olapl”
Genentech, Inc. v. Eli Lilly and Company (2021) casd “Opp’n at 15 (citing 35 U.S.C. § 326 (e); Microsoft Corp.”
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