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 generallyChudik (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 Cir. 05/11/20) (non-precedential) (same).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).
Patent Defenses is a research tool maintained by Klarquist since 2004. Visit klarquist.com to learn more about us.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.