Obviousness-type double patenting (“ODP”) is a judicially-created doctrine that has its roots in 35 U.S.C. § 101, which states that an inventor may obtain “a patent” (i.e., a single patent) for an invention. In re Lonardo, 119 F.3d 960, 965 (Fed. Cir. 1997). ODP “is intended to prevent a patentee from obtaining a time-wise extension of patent for the same invention or an obvious modification thereof” and prevents an inventor from claiming a second patent for claims that are not patentably distinct from the claims of a first patent. Id.

Terminal Disclaimer

A terminal disclaimer of the remaining later term of a related patent may be filed with the USPTO to overcome an ODP rejection assuming that the first patent has not yet expired. See 35 U.S.C. § 253 and 37 C.F.R. § 1.321. A terminal disclaimer also requires that common ownership of the affected patents be maintained.

Patent Term Extension (“PTE”)

Patent Term Extension (“PTE”), under 35 U.S.C. § 156, as part of the Hatch-Waxman Act, restores the patent term which was effectively “lost” due to pre-market approval requirements before a regulating agency (such as the Food and Drug Administration, and the United States Department of Agriculture) in connection with a product such as a drug, medical device, or food additive.

ODP does not invalidate a validly obtained PTE even in the absence of a terminal disclaimer because the PTE term is calculated from the disclaimed expiration date, not the original expiration date, for purposes of ODP. Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367 (Fed. Cir. 2018); Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317, 1322 (Fed. Cir. 2007) (“a patent term extension under [35 U.S.C.] § 156 is not foreclosed by a terminal disclaimer” because a “patent term extension is from the expiration date resulting from the terminal disclaimer and not from the date the patent would have expired in the absence of the terminal disclaimer”).

Patent Term Adjustment (“PTA”)

A Patent Term Adjustment (“PTA”) under 35 U.S.C. § 154 may add time to a patent's term because of USPTO delay during prosecution. The USPTO typically calculates the PTA as a matter of course as part of the notice of issuance for a patent.

ODP in View of PTA

The Federal Circuit recently held that a patent may be found invalid for ODP if its PTA results in later-expiring claims absent a terminal disclaimer. In re: Cellect, LLC, No. 22-1293, — F.4th — (Fed. Cir. Aug. 28, 2023).

Accordingly, PTE extends beyond a disclaimed term, while PTA does not. In other words, a terminal disclaimer cuts off any extended patent term granted through PTA. A patent may be held invalid for ODP if there is no terminal disclaimer with respect to its PTA term.

The Federal Circuit held that the statutory language makes clear that a PTA cannot adjust a term beyond the disclaimed date in any terminal disclaimer. For example, § 154 mentions terminal disclaimers, but § 156 does not. Also, § 154(b)(2)(B) expressly excludes patents in which a terminal disclaimer was filed from the benefit of a term adjustment beyond that disclaimed date for delays caused by the USPTO, but that no similar prohibition existed in § 156. See Merck, 482 F.3d at 1322.

The upshot is that the ODP analysis must be performed on patents that have received PTA based on the expiration date including the PTA. Accordingly, a patent may be found invalid for ODP if its PTA results in later-expiring claims absent a terminal disclaimer.

The patentee in Cellect argued that it should not be penalized for the USPTO's delays. The Federal Circuit was not swayed by such equitable concerns.

The ability of the applicant to show good faith during prosecution does not entitle it to a patent term to which it otherwise is not entitled. An applicant's ability to show that it did not engage in gamesmanship in obtaining a grant of PTA is not sufficient to overcome a finding that it has received an unjust timewise extension of term.

Although the filing of a terminal disclaimer would have obviated the ODP, none was filed in this case. And now after the earlier patents have expired, the opportunity for filing a terminal disclaimer has passed. Noting that “[a] terminal disclaimer is not an escape hatch to be deployed after a patent expires,” the Federal Circuit affirmed that the patent claims at issue were unpatentable for ODP.

Professor Crouch would “consider eliminating non-statutory double patenting” as “a vestige of history.”

The patent attorneys at Thomas P. Howard, LLC enforce patents and defend against infringement in litigation nationwide including in Colorado.