Expiration of Patent; Extension Of Term

  • Patents Expire 20 Years From First Non-Provisional Asserted Priority Application, Plus Any Term Extension: 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 Of Patent Term: Patent Office may extend term under Sec. 154(b) or 156 (Hatch-Waxman Act). 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.”)
  • 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”)).
  • Double Patenting Doctrine Does Not Invalidate Otherwise Proper Patent Term Extension: 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).

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