Law360, New York ( September 15, 2014, 1:21 PM EDT) -- The generic pharmaceutical business is competitive.[1][2] Profit margins are typically a fraction of those for branded drug products.[3] The majority of those profits are often made in the 180 day limited exclusivity period[4][5][6] afforded the first abbreviated new drug application filer to successfully challenge patent(s) protecting a branded drug.[7] One of the earliest "legal" steps[8] toward becoming a first ANDA filer typically involves obtaining an opinion evaluating the claims of in-force patent(s), especially Orange Book[9] listed patents, covering a branded drug.[10] Opinions provide legal basis for a Paragraph (IV)[11] certification letter and subsequent litigation in which the generic attempts to show that patent(s) covering the branded drug are not infringed, are invalid and/or should not be enforced. A good opinion, in addition to increasing the likelihood of the generic prevailing in litigation or favorably settling the case,[12] also increases the probability that the generic will avoid fee shifting[13] and sanctions.[14] A good opinion can thus be worth its weight in gold....