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LPR 1-12a. DISCLOSURE REQUIREMENTS FOR PATENT CASES ARISING UNDER 21 U.S.C. § 355 (HATCH-WAXMAN ACT)

(a) In patent cases arising under 21 U.S.C. § 355 (Hatch-Waxman Act), the NDA holder or patent owner must serve a Disclosure of Asserted Claims and Infringement Contentions in the form required under LPR 1-6 not later than 14 days after the answer is filed or 21 days after service of the complaint, whichever is earlier.

(b) The ANDA filer or accused infringer must serve its Disclosure of Non-Infringement, Invalidity, and Unenforceability Contentions in the form required under LPR 1-8 not later than 45 days after service of the NDA holder's or patent owner's disclosure.