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

Heading: McDaniel’s Express Disclosures

Text: Finally, we address whether McDaniel expressly discloses the efficacy limitations. Galderma argues that the district court correctly found that McDaniel does not Case: 19-2396 Document: 58 Page: 15 Filed: 01/29/2020 GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC. 15 expressly disclose the claimed efficacy limitations. Galderma’s Reply Br. 14–15. Teva, on the other hand, insists that the district court made no such finding. Teva’s Br. 41– 42. Instead, Teva argues that McDaniel expressly discloses all the efficacy limitations. Id. at 43–55. As to whether the district court found that McDaniel lacks an express disclosure of the claimed efficacy limitations, we conclude that such a finding is implicit in the court’s analysis. The district court’s “Findings of Fact” Nos. 9–11 are reproduced below: 9. McDaniel explicitly discloses a treatment method comprising (1) topically administering, (2) once daily, (3) to a skin area affected by the inflammatory lesions of papulopustular rosacea, (4) a pharmaceutical composition comprising about 1% by weight ivermectin and a pharmaceutically ac- ceptable carrier. 10. McDaniel inherently discloses the treatment results of its treatment method as enabled by the Manetta formulation. 11. McDaniel anticipates claim 12 of the ’587 pa- tent, claims 2, 3, and 6 of the ’117 patent, and claims 6, 7, 10, and 11 of the ’118 patent. Galderma Labs., 390 F. Supp. 3d at 585. In its analysis, the district court first explained how McDaniel expressly discloses every element of “the claimed treatment method,” at the same time noting that it will “separately” address the “various efficacy limitations.” Id. at 586–87. When addressing the claimed efficacy limitations, the district court stated that “the only remaining limitations are those relating to efficacy. Therefore, McDaniel anticipates the asserted claims if the efficacy limitations are inherent to the treatment method.” Id. at 589–90 (emphases added). This language makes clear that the district court concluded that Case: 19-2396 Document: 58 Page: 16 Filed: 01/29/2020 16 GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC. McDaniel does not expressly disclose the efficacy limitations. We see no clear error in this finding. Based on our review of the record, including the expert testimony addressing McDaniel’s disclosures, we conclude that the district court did not clearly err in finding that McDaniel lacks an express disclosure of the claimed efficacy limitations. See, e.g., J.A. 6819–23 (testimony of Dr. Thisted); J.A. 6841–46 (testimony of Dr. Webster); J.A. 6693–99, 6759–64 (testimony of Dr. Gallo). Because the district court did not clearly err in finding that McDaniel lacks an express disclosure of the claimed efficacy limitations, and because the district court clearly erred in its inherent anticipation analysis, McDaniel does not anticipate. Accordingly, we reverse the district court’s finding of anticipation.