definiens: means a claim of an issued, unexpired Amicus Patent or a Program Patent ( other than a Formulation Patent or a Method of Manufacture Patent ) covering i ) Compound ; or ii ) method of use of the Compound or a Product ( for the avoidance of doubt, claim fOlmats havin, iequivalent scoEe to claims in jurisdictions where claims are not ; availableunder local patent practice shall be eonsidered claims ! ) which : ( a ) has not been revoked or held unenforceable or invalid by a decision of a court or othcr governmental agency of competent jurisdiction, which decision is not appealable or has not been appealed within the time allowed for appeal ; ( b ) has not been disclaimed . denied or admitted to be invalid or unenforceable through reissue . re - examination or disclaimer or otherwise ; or ( c ) has not lapsed, been cancelled or abandoned, or been dedicated to the public . For purposes of this Section 1.199, a means a Patent primarily directed to an invention which is a fornlulation of Compound and one ( 1 ) or more excipients, and a means a Patent primarily directed to an invention which is a method of manufacture of Compound or Product