definiens: means a claim of the composition of matter or the method of use of a Compound or Product ( or any component thereof ) for an approved use of such Product contained in : ( a ) an iss ued and unexpired patent that has not been revoked or held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction that is not appealable or has not been appealed within the time allowed for ap peal, and that has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, re -examination or disclaimer or otherwise ; or ( b ) a pending patent application that has not been cancelled, withdrawn or abandoned or fina lly rejected by an administrative agency action from which no appeal can be taken and that has not been pending for more than [ * * * ] from the date of its earliest priority date ( provided that upon the issuance of a claim from such patent application, such claim shall again be deemed to be a Valid Claim ( subject to Section 1.123(a ) ) )