Opinion ID: 4502549
Heading Depth: 3
Heading Rank: 2

Heading: Inherency Based on Mere Possibility

Text: “[A] limitation or the entire invention is inherent and in the public domain if it is the ‘natural result flowing from’ the explicit disclosure of the prior art.” Schering Corp., 339 F.3d 1373 at 1379 (citations omitted). Inherency “may not be established by probabilities or possibilities.” Bettcher Indus., Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639 (Fed. Cir. 2011). Case: 19-2396 Document: 58 Page: 13 Filed: 01/29/2020 GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC. 13 On appeal, Galderma argues that the district court erroneously found that McDaniel inherently discloses the claimed efficacy limitations. Galderma’s Br. 28–32. According to Galderma, the district court erroneously based this conclusion on the mere possibility that a POSA would have been able to practice McDaniel’s disclosed method with Soolantra®. Teva, on the other hand, argues that McDaniel “discloses” the Soolantra® formulation, and therefore it inherently anticipates the claimed efficacy limitations, regardless of any other formulations McDaniel also discloses. Teva’s Br. 38–39. We agree with Galderma that the district court’s finding of inherent anticipation is erroneous. As we have explained, the district court’s conclusion that McDaniel discloses the Soolantra® formulation conflates the principles of enablement and anticipation. The proper inquiry for inherent anticipation is whether the claimed efficacy limitations “necessarily result” from practicing McDaniel. See, e.g., Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 960–61 (Fed. Cir. 2014) (affirming judgment that claims were not inherently anticipated where the prior art only showed that the limitation might occur, not that it inevitably occurred). What a POSA would have been able to practice based on Manetta’s disclosure is not at issue. The district court mistakenly relied on Perricone v. Medicis Pharm. Corp., 432 F.3d 1368 (Fed. Cir. 2005) to find inherent anticipation. In Perricone, the anticipatory reference “disclosed compositions includ[ing] all the various ingredients in the concentrations claimed by [the patentee].” 432 F.3d at 1376. We found that “the district court correctly applied the inherency doctrine” because the prior art reference at issue “disclose[d] the very same composition” as the claimed invention and taught its use in the manner claimed. Id. at 1379. We concluded that “[u]sing the same composition claimed by [the patentee] in the same manner claimed by [the patentee] naturally results in the same claimed . . . benefits.” Id. Case: 19-2396 Document: 58 Page: 14 Filed: 01/29/2020 14 GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC. Unlike Perricone, here, McDaniel does not disclose the “very same composition” as the patents-in-suit; it only discloses topical ivermectin formulations generally. The record does not show that practicing McDaniel’s general disclosure of 1% ivermectin, “formulated into a cosmetically-acceptable topical lotion, cream, or gel,” necessarily achieves the claimed efficacy limitations. Teva did not demonstrate that the use of any such formulation inevitably results in the claimed efficacies. Notably, Teva’s own formulation expert testified that formulation parameters such as excipients can impact drug release, J.A. 6491, which affects whether a formulation has “any sort of therapeutic value.” J.A. 6481. This is not a case, as Teva suggests, of an anticipating reference disclosing non-anticipating alternatives. Teva’s Br. 39–40. It is true that anticipation is not defeated by a showing that the allegedly anticipating reference also discloses non-anticipating alternatives. See, e.g., Perricone, 432 F.3d at 1376. But that is not the question before us. The inquiry here is whether the claimed efficacy limitations are an inherent result of practicing McDaniel’s disclosed 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. Teva has provided no basis for us to conclude with certainty that all 1% formulations within the scope of McDaniel’s disclosure will inevitably achieve the claimed efficacy limitations. Accordingly, we conclude that the district court’s inher- ent anticipation analysis was clearly erroneous.