- Improper Term Extension Or Adjustment Is An Affirmative Defense: “Invalidity of the extension of a patent term or any portion thereof under section 154(b) or 156 because of the material failure—(1) by the applicant for the extension, or (2) by the Director, to comply with the requirements of such section shall be a defense in any action involving the infringement of a patent during the period of the extension of its term and shall be pleaded. A due diligence determination under section 156(d)(2) is not subject to review in such an action.” 35 U.S.C. § 282(c). See generally Chudik (Fed. Cir. 02/08/21) (aff’g PTO adjustment calculation); SawStop (Fed. Cir. 09/14/22) (aff’g PTO adjustment calculation); Mayo Found. (Fed. Cir. 09/16/19) (2-1) (aff’g PTO adjustment calculation); Intra-Cellular (Fed. Cir. 09/18/19) (same); Pfizer (Fed. Cir. 01/22/16) (2-1) (aff’g judgment approving PTO adjustment calculation); Idorsia (Fed. Cir. 05/11/20) (non-precedential) (same).
- Cannot Challenge Term Adjustment Before Patent Granted: “(B) The determination of a patent term adjustment under this subsection shall not be subject to appeal or challenge by a third party prior to the grant of the patent.” 35 U.S.C. § 154(b)(4)(B).