(a)
(b)
(1) Noninfringement, absence of liability for infringement or unenforceability.
(2) Invalidity of the patent or any claim in suit on any ground specified in part II as a condition for patentability.
(3) Invalidity of the patent or any claim in suit for failure to comply with—
(A) any requirement of section 112, except that the failure to disclose the best mode shall not be a basis on which any claim of a patent may be canceled or held invalid or otherwise unenforceable; or
(B) any requirement of section 251.
(4) Any other fact or act made a defense by this title.
(c)
(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.
(July 19, 1952, ch. 950, 66 Stat. 812; Pub. L. 89–83, §10, July 24, 1965, 79 Stat. 261; Pub. L. 94–131, §10, Nov. 14, 1975, 89 Stat. 692; Pub. L. 97–164, title I, §161(7), Apr. 2, 1982, 96 Stat. 49; Pub. L. 98–417, title II, §203, Sept. 24, 1984, 98 Stat. 1603; Pub. L. 104–41, §2, Nov. 1, 1995, 109 Stat. 352; Pub. L. 106–113, div. B, §1000(a)(9) [title IV, §§4402(b)(1), 4732(a)(10)(A)], Nov. 29, 1999, 113 Stat. 1536, 1501A–560, 1501A–582; Pub. L. 107–273, div. C, title III, §13206(b)(1)(B), (4), Nov. 2, 2002, 116 Stat. 1906; Pub. L. 112–29, §§15(a), 20(g), (j), Sept. 16, 2011, 125 Stat. 328, 334, 335.)
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