We agree with the PTO and conclude that when the '991 patent issued with its terminal disclaimer in effect, that disclaimer became part of the original '991 patent and served to define its term, regardless of any further term that might have been otherwise available in the absence of the disclaimer. To examine the effect of a terminal disclaimer on the term of an original patent, we turn first to 35 U.S.C. § 253, which governs both terminal disclaimers and subject-matter disclaimers. . . . Two aspects of § 253 are important to our analysis.

Id. at 8. The Court relied on 35 U.S.C. § 253, which governs both terminal disclaimers and subject matter disclaimers. First, the Court noted that § 253 dictates that a terminal disclaimer is treated as part of the original patent—the same benchmark used to fix the maximum term for reissued patents in § 251—and that § 253 describes terminal disclaimers and disclaimers of patent claims in parallel, stating that they operate “[i]n like manner.”

Merck & Co. v. Hi-Tech Pharmacal, No. 06-1401 (Fed. Cir. 2007)The U.S. Court of Appeals for the Federal Circuit held today that a patent term extension under 35 USC 156 may be applied to a patent that is subject to a terminal disclaimer under 35 USC 253, handing a victory to Merck in its battle with Hi-Tech Pharmacal over generic Trusopt (dorzolamide HCl opthalmic solution). Hi-Tech had argued that Merck's patent on Trusopt expired in 2004 because a patent term extension on the patent was invalid.As we reported last month, a loss for Merck in this case would have had drastic effects on pharmaceutical companies and patent owners, since the Patent Office has routinely granted patent term extensions on patents that are subject to a terminal disclaimer.

File a TD.Affirmatively disclaim any term of the second patent beyond the term of the first patent. 35 U.S.C. § 253 and 37 C.F.R. § 1.321; In re Longi, 759 F.2d at 894; Ortho Pharm. Corp. v. Smith, 959 F.2d 936, 980 (Fed. Cir. 1992).

In IPR2023-01058, the PTAB declined to institute IPR, finding that Patent Owner had disclaimed all challenged claims under 35 U.S.C. § 243(a), in compliance with 37 C.F.R. § 1.321(a), such that there was no basis on which to have a trial.Petitioner filed a Petition requesting inter partes review of certain claims of the asserted patent. Post-filing of the Petition, Patent Owner filed a statutory disclaimer of the challenged claims. In its Preliminary Response, Patent Owner argued that the PTAB’s precedent required it to preclude institution because Patent Owner had disclaimed each of the Challenged Claims under 35 U.S.C. § 253 in compliance with 37 C.F.R. § 1321.(a). Patent Owner also argued that the statutory disclaimer was not an admission or acquiescence by Patent Owner, and therefore the PTAB should not construe the disclaimer as a request for adverse judgement.Petitioner requested permission to file a motion requesting that the PTAB construe Patent Owner’s disclaimer of all challenged claims as a request for adverse judgement. Patent Owner opposed and a conference call was held. During the call, Petitioner argued that it intended to rely on Arthrex, Inc. v. Smith & Nephew, Inc., 880 F.3d 1345 (Fed. Cir. 2018) to argue that Patent Owner’s disclaimer should be construed to be a request for adverse judgment. The PTAB denied Petitioner’s request for authorization to file the motion, reasoning that Arthrex permits the PTAB to grant adverse judgment when a patent owner cancels all claims at issue prior to institution, but Petitioner failed to identify any persuasive reason why the PTAB should do so in presen

The latest manifestation of this trend is a bill, entitled the "Terminating the Extension of Rights Misappropriated Act of 2019" or the "Term Act," introduced by Representative Hakeem Jeffries (D, NY-8), that would address the drug pricing problem by "prevent[ing] [] double patenting" of claims to patents for prescription drugs.How will the bill achieve its ends? As set forth in Section 2(a) of the bill, it would amend 35 U.S.C. § 253 by introducing a new subsection (c) that reads:(c) DISCLAIMERS OF DRUG PATENT TERM.—(1) IN GENERAL.

This petition asserted as its basis that the disclaimer had not been necessitated by court order or Patent Office requirement, and that the public interest was not implicated because the Office had not yet made the filing public on the Patent Application Information Retrieval (PAIR) database. The Office denied the petition, on the grounds that the attorney of record properly filed the petition and there was no recourse under the patent statute (35 U.S.C. § 253) for the Office to take the requested action. The patentee then filed a second petition, under both 37 C.F.R. § § 1.

The Court also explained that the scope of the bar against double patenting has been well established, with federal courts applying the doctrine’s principles for over a century to preserve the public’s right to use not only the exact invention claimed by an inventor but also obvious modifications of that invention that are not patentably distinct. The Court noted the addition of 35 U.S.C. § 253 in 1952, which in part permits a patentee to disclaim any terminal part of a patent term, as well as the Court’s recognition in In re Robeson, 331 F.2d 610, 614 (CCPA 1964), that § 253’s terminal disclaimer provision provided patent owners a remedy against a charge of obviousness-type double patenting. The Federal Circuit then held that the principle protected by the obviousness-type double patenting doctrine “is violated when a patent expires and the public is nevertheless barred from practicing obvious modifications of the invention claimed in that patent because the inventor holds another later-expiring patent with claims for obvious modifications of the invention,” as “is the case here.”

Merck & Company, Inc. (“Merck”) is the owner of U.S. Patent No. 4,797,413 (“the ’413 patent”), filed on June 26, 1987, which covers the drug dorzolamide, a carbonic anhydrase inhibitor, marketed by Merck under the trademark TRUSOPT®. During prosecution of the ’413 patent, the applicants filed a terminal disclaimer under 35 U.S.C. § 253 to overcome an obviousness-type double-patenting rejection over an earlier Merck patent, U.S. Patent No. 4,677,115 (“the ’115 patent”), which issued on June 30, 1987. Pursuant to the terminal disclaimer, any term of the ’413 patent extending beyond June 30, 2004 (seventeen years from the ’115 patent issuance), was relinquished.

On January 18, 2024, the USPTO rejected a "contingent" terminal disclaimer filed by Acadia Pharmaceuticals Inc. (Acadia) for a patent it owns that is being challenged in a pending litigation as invalid for obviousness-type double patenting. The USPTO ruled that terminal disclaimers could not be made contingent on the occurrence of a future event, in this case the outcome of a double patenting invalidity challenge to the subject patent.By way of background, a terminal disclaimer filed under 35 U.S.C. § 253 is an accepted means of obviating double patenting by ensuring, among other things, that the challenged patent and the patent that formed the basis for the double patenting challenge (the "reference patent") expire on the same date. However, to be effective, the terminal disclaimer must be filed before the expiration date of the reference patent.Acadia had sued MSN Pharmaceuticals, Inc. and MSN Laboratories PVT. Ltd. (MSN) in the District of Delaware under the Hatch-Waxman Act, based on their filing of an Abbreviated New Drug Application seeking FDA approval to market a generic version of Acadia's Nuplazid® drug product before the expiration of patents Acadia had listed in the FDA's "Orange Book."[1] One of the Orange Book-listed patents Acadia asserted in the litigation, U.S. Patent 7,601,740 ('740 patent), issued with 1,249 days of Patent Term Adjustment (PTA) under 35 U.S.C. § 154, based on USPTO delays in issuing the patent, and had also been granted 1,315 days of Patent Term Exte