The U.S. Court of Appeals for the Federal Circuit has reversed and remanded a district court judgment that claims of three patents directed to a topical treatment for rosacea are invalid as anticipated. In Galderma Laboratories, L.P., et al. v. Teva Pharmaceuticals USA, Inc., Nos. 2019-2396, 2020-1213 (Jan 29, 2020), the Federal Circuit, without oral argument, agreed with Galderma that the district erred in using multiple references in its anticipation analysis, and in finding inherency based on "mere possibility."
By way of background, the patents at issue relate to Galderma's topical rosacea treatment, Soolantra®. Galderma holds an approved New Drug Application ("NDA") for Soolantra®, and the patents are listed in the Orange Book. Teva eventually filed an Abbreviated New Drug Application ("ANDA") directed to a generic version of the drug. In response to Teva's paragraph IV certification asserting that the claims of the patents-in-suit were invalid, unenforceable, and/or not infringed, Galderma filed this suit against Teva, alleging infringement under 35 U.S.C. § 271(d)(2)(A). Following a bench trial in June 2019, the district court found each asserted claim invalid as anticipated by U.S. Patent No. 5,952,372 ("McDaniel"). The district court found that McDaniel expressly disclosed various claim limitations, and inherently disclosed claimed efficacy limitations.
On appeal, the Court first agreed with Galderma that the district court erred in looking outside the McDaniel reference for its anticipation analysis. Specifically, Galderma argued that the lower court erred by finding the asserted claims anticipated based on disclosures found in two references, in contravention of settled law that anticipation must be based on disclosure in a single reference. The Court rejected Teva's arguments, namely, that anticipation is evaluated from the perspective of one of ordinary skill in the art ("POSA"), and that the knowledge of such a person can be shown via extrinsic evidence without running afoul of the single-reference rule for anticipation. The Court expressly found that Teva's arguments ignore the axiom that a patent claim can only be invalid for anticipation if a single reference discloses each and every limitation of the claimed invention, and that turning to another reference "for a very specific teaching" runs afoul of these settled principles.
The Court also rejected Teva's alternative argument that the doctrine of enablement justified the district court's reliance on the second reference for a specific teaching, finding that Teva confused anticipation and enablement, just as the district court had. Per the Federal Circuit, whether a prior art reference is enabled is a separate question from whether it discloses, expressly or inherently, the claimed limitations at issue.
The Court expressly distinguished its prior decision in Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368 (Fed. Cir. 2001), where the Court held that certain method of treatment claims directed to "premedicating" were anticipated by a prior art reference suggesting premedicating generally, even though the reference did not "actually employ premedication." There, the Court said it was permissible to "look to any references that establish that [the main reference's] suggestion of [premedicating] would have been enabling to one of skill in the art more than one year prior to [the] earliest filing date of [the patent]." The Court distinguished its anticipation finding in Bristol-Myers and the district court's finding of anticipation here, noting that in Bristol-Myers, the asserted anticipatory reference contained the very disclosure that was found to be enabling based on other references. By contrast, the anticipatory reference here did not contain the specific disclosure necessary for a finding of anticipation. The Court said, "We refuse to look to [a second reference] to incorporate a specific disclosure not found in [the alleged anticipatory reference] McDaniel."
On the question of inherency, the Federal Circuit agreed with Galderma that the district court erroneously found that McDaniel inherently discloses the claimed efficacy limitations based this conclusion on the mere possibility that a POSA would have been able to practice McDaniel's disclosed method with Soolantra®. The Court found that the district court's conclusion that McDaniel discloses the Soolantra® formulation conflates the principles of enablement and anticipation. Noting that the proper inquiry for inherent anticipation here is whether the claimed efficacy limitations "necessarily result" from practicing McDaniel, the Court held that "[w]hat a POSA would have been able to practice based on [a second reference's] disclosure is not at issue."
The Court said that, contrary to Teva's argument, this was not a case of an anticipating reference disclosing non-anticipating alternatives. Rather, "[t]he inquiry here is whether the claimed efficacy limitations are an inherent result of practicing McDaniel's dis-closed methods. The answer is no because: (1) McDaniel does not disclose the specific Soolantra® formulation; and (2) as Teva's expert acknowledged, variation in formulation parameters will undoubtedly affect the results achieved from the use of McDaniel's disclosed formulations."
Finally, the Court agreed with Galderma that the district court correctly found that McDaniel does not expressly disclose the claimed efficacy limitations, concluding that such a finding was implicit in the lower court's analysis.
The Court declined to address Teva's obviousness defense, which was not reached by the district court. The Court reversed the district court judgment and remanded for consideration of Teva's remaining invalidity defenses.
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