A patent shall be presumed valid. Each claim of a patent (whether in independent, dependent, or multiple dependent form) shall be presumed valid independently of the validity of other claims; dependent or multiple dependent claims shall be presumed valid even though dependent upon an invalid claim. The burden of establishing invalidity of a patent or any claim thereof shall rest on the party asserting such invalidity.

The following shall be defenses in any action involving the validity or infringement of a patent and shall be pleaded:

(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.

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.

In an action involving the validity or infringement of a patent the party asserting invalidity or noninfringement shall give notice in the pleadings or otherwise in writing to the adverse party at least thirty days before the trial, of the country, number, date, and name of the patentee of any patent, the title, date, and page numbers of any publication to be relied upon as anticipation of the patent in suit or, except in actions in the United States Court of Federal Claims, as showing the state of the art, and the name and address of any person who may be relied upon as the prior inventor or as having prior knowledge of or as having previously used or offered for sale the invention of the patent in suit. In the absence of such notice proof of the said matters may not be made at the trial except on such terms as the court requires. 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,

(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.)