Intendis, Inc. (“Intendis”) and Dow Pharmaceutical Sciences, Inc. (“Dow”) filed a patent infringement action against River’s Edge Pharmaceuticals, LLC (“River’s Edge”). Dow owns the patent-in-suit and Intendis is the exclusive licensee. According to the district court, “[t]he ‘383 patent is listed by the Food and Drug Administration (FDA) as covering Desonate®, which is a topical aqueous gel composition indicated for the treatment of skin disorders such as acne. Intendis is the owner of an approved New Drug Application (NDA) for Desonate®.”
River’s Edge submitted an Abbreviated New Drug Application (“ANDA”), which sought to engage in the commercial manufacture, use, sale, offer for sale or importation of a generic gel based on the listed drug Desonate. River’s Edge moved for judgment on the pleadings. River’s Edge asserted that there could be no literal infringement as a matter of law because the infringement allegations were expressly contradicted by the patent specification attached to the complaint. Intendis and Dow contended, on the other hand that at this stage, the relevant inquiry should not focus on assessing the merits of the case but instead should focus on whether the plaintiff is entitled to reach the discovery stage of litigation in order to seek evidence to support their claim.
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