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.
The district court agreed with Intendis and Dow, noting that "Rule 84 provides that the forms in the Appendix of the FRCP illustrate the brevity that the rules contemplate. Form 18 of the FRCP Appendix of Forms sets forth an example of a complaint for patent infringement." Form 18 requires:
(1) an allegation of jurisdiction; (2) a statement that the plaintiff owns the patent; (3) a statement that defendant has been infringing the patent "by making, selling, and using [the device] embodying the patent"; (4) a statement that the plaintiff has given the defendant notice of its infringement; and (5) a demand for an injunction and damages.
The district court also noted that it had ordered the plaintiff to amend the complaint to include detailed allegations of patent infringement and that the complaint satisfied the pleading requirements. "In the instant case, this court ordered the plaintiffs to amend their complaint [Doc. No. 35]. Thereafter, the plaintiffs amended their complaint to include detailed allegations of patent infringement, including identifying which claims are purportedly being infringed and how those claims are being infringed. Assuming the veracity of all of the plaintiffs' allegations, the plaintiffs have met their burden to state a claim for relief, even in light of Iqbal and Twombly."
Accordingly, the district court denied the motion for judgment on the pleadings and did not directly rule on the issue of whether the patent specification contradicted the theory of infringement.
Intendis, Inc. and Dow Pharmaceutical Sciences, Inc. v. River's Edge Pharmaceuticals, LLC, Case No. 1:11-CV-01634-RLV (N.D. Ga. Aug. 23, 2012)