- Patents Expire 20 Years From First Non-Provisional Asserted Priority Application, Plus Any Term Extension Or Adjustments: Patents filed after June 8, 1995, expire 20 years after earliest non-provisional U.S. or PCT priority application they cite. 35 U.S.C. § 154(a)(2) (“ending 20 years from the date on which the application for the patent was filed in the United States or, if the application contains a specific reference to an earlier filed application or applications under section 120, 121, 365(c), or 386(c), from the date on which the earliest such application was filed.”); 35 U.S.C. § 154(a)(3) (“Priority under section 119, 365(a), 365(b), 386(a), or 386(b) shall not be taken into account in determining the term of a patent.”) [Sec. 119(e) governs priority to provisional application.]
- Multiple Grounds For Extension Or Adjustment Of Patent Term: Patent Office may extend term under Sec. 154(b) (patent term adjustment (PTA)) or 156 (Hatch-Waxman Act) (patent term extension (PTE)). May be extended for time spent on appeal, or delayed response by PTO, a regulatory review period, etc. See Actelion (Fed. Cir. 02/06/18) (aff’g district court approval of PTO extension calculation under 154(b): provisions “only restore ‘undue delays in patent examination caused by the PTO’ as provided by Congress”). See Supernus (Fed. Cir. 01/23/19) (rev’g PTO; “USPTO may not count as applicant delay a period of time during which there was no action that the applicant could take to conclude prosecution of the patent.”)
- Patent Term Extension (Section 156) May Be Applied To Patent Subject To Terminal Disclaimer: Section 156 patent term extension is from the expiration date resulting from the terminal disclaimer. Merck (Fed. Cir. 03/29/07).
- Sec. 156(b)(2) Extension Is Limited To Methods Of Using Approved Product As Defined In Sec. 156(f): Biogen (Fed. Cir. 04/21/20) (aff’g non-infringement: § 156(b)(2) Hatch-Waxman Act extension does not apply because de-esterified form of active ingredient not same product under § 156(f) (defining “product” as “the active ingredient of . . . a new drug . . . including any salt or ester of the active ingredient”)).
- Obviousness Double Patenting Doctrine Does Not Invalidate Patent Based On Otherwise Proper Patent Term Extension (Section 156): Novartis AG (Ezra) (Fed. Cir. 12/07/18) (aff’g that obviousness double patenting does not invalidate a patent term extension where patent owner had two patents covering product/method subject to regulatory review and, as permitted, selected one for a five year extension of term, so expires 22 years after issue date, and after the second, later-filed patent).
- Obviousness Double Patenting Doctrine May Invalidate Patent Based On Otherwise Proper Patent Term Adjustment (Section 154(b)): “While the expiration date used for an ODP analysis where a patent has received PTE is the expiration date before the PTE has been added, the expiration date used for an ODP analysis where a patent has received PTA is the expiration date after the PTA has been added” regardless of whether or not a terminal disclaimer has been filed. In re Cellect (Fed. Cir. 08/28/23) (aff’g obviousness double patenting rejection of “related patents that claim priority from the same application that … claim overlapping subject matter and that have different expiration dates only because of PTA,” in ex parte reexamination, not subject to terminal disclaimers, using PTA expiration dates to determine which patents expired later).
- But, PTA Giving First-Filed And First-Issued Patent A Later Expiration Date Than Child Patents With Same Priority Date Cannot Invalidate Patent Under Obviousness-Type Double Patenting: “A first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date,” in view of “the purpose of the ODP doctrine, which is to prevent patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent to that subject matter,” and because ruling otherwise would “effectively abrogate the benefit Congress intended to bestow on patentees when codifying PTA.” Allergan (Fed. Cir. 08/13/24) (rev’g district court obviousness-type invalidity finding and distinguishing Cellect as not addressing this question of law at least in part because no party had presented it, and distinguishing Gilead (holding that “a later-issued but earlier-expiring patent can qualify as a ODP reference to invalidate an earlier-issued but later-expiring patent” because that involved a separate chain of applications with priority dates).