Galderma Labs., Nestle Skin Health S.A. et al. v. Amneal Pharm. LLC et al.
Docket No. 2019-1021
LOURIE, MOORE, STOLL
March 25, 2020
Brief Summary: DC finding of infringement of certain claims affirmed as statements made in related IPR was not prosecution history estoppel; finding of infringement of others reversed for lack of “particularized testimony”.
Summary: Amneal appealed DC finding that it infringes the asserted claims of Galderma’s “Chang Patents” (US 8,206,740; 8,394,405; and 8,470,364) and the “Ashley II Patents” (US 8,603,506; US 9,241,946) relating to low-dose doxycycline formulations for treating skin disease (e.g., acne, rosacea). IPR proceedings regarding the Chang Patents are referred to in the FC panel opinion (see FN1). The Chang Patents relate to compositions of an Immediate Release (IR) (defined by the ‘740 patent as having “no enhanced, delayed or extended release effect”) and a Delayed Release (DR) (not expressly defined) component. The DC found “that Amneal’s product contained the equivalent of the claimed 10 mg DR portion and entered judgment of infringement of Amneal” (infringement under the doctrine of equivalents (DOE)), which Amneal was incorrect because “clearly and unmistakably surrendered subject matter” during the ‘740 IPR (Aylus Net., FC 2017) such that the claim could not encompass “a drug that begins dissolving or ‘leaking’ in the stomach”. While Galderma agreed with this definition, the FC panel explained that the Board rejected that limited definition and thereby “clearly put the public on notice that the meaning of delayed release…is not limited to formulations requiring that there by no substantial release in the stomach” (i.e., “those arguments do not impact claim scope”). The FC distinguished its American Piledriving decision (FC 2011), in which “the patentee had ‘unambiguously argued’ a particular construction during reexamination and, ‘regardless of whether the Examiner agreed…its statements still inform the proper construction”, because those statements were “not made during [IPR] review”, “were used to inform claim construction not prosecution history estoppel”, and the examiner did not “clearly and expressly reject the patentee’s proposed construction” (see also Shire Dev., FC 2015). The FC panel also found that the DC “did not clearly err in finding infringement under the” DOE since “Amneal’s product’s combination ‘performs the same function in the same way to achieve the same result as the 10 mg DR portion claimed in Chang”.
The DC also found infringement of the Ashley II Patents under the DOE. Galderma argued the FC panel lacked jurisdiction to hear that portion of the appeal because of “actions taken by Amneal regarding its ANDA after filing its Notice of Appeal”, but the FC panel held “that Amneal’s actions did not divest this court of subject matter jurisdiction” and “that there remains a justiciable controversy” (Ferring, FC 2014; W.T. Grant, US 1953). The Ashley II Patents relate to methods for treating rosacea by oral administration of low-dose doxycycline “wherein the amount results in no reduction of skin microflora during a six-month treatment, without administering a bisphosphonate compound.” This DC judgment was reversed “[b]ecause the record wholly lacked the particularized testimony to find infringement”.