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Method of Treatment Efficacy Benchmarks Avoid Inherency Attack

In Galderma Labs. v. Teva Pharm. USA, Inc., Appeal Nos. 2019-2396 and 2020-1213 (Fed. Cir,. January 29, 2020), a Fed. Cir. panel of Judges Moore, O’Malley and Stoll reversed a district court finding that three Galderma patents (US Pat. Nos. 9,809,587, 9,223,117 and 9,223,118) on methods for treating inflammatory lesions of acne with a 1% ivermectin formulation, Soolantra© were invalid as inherently anticipated by a patent (McDaniel) disclosing the use of a 1-5% ivermectin formulation to treat acne, that was enabled “as to the formulation” by a patent disclosing the Soolantra© composition (Manetta).

The panel’s analysis is interesting because each of the patents recited efficacy benchmarks such as “as early as 2 weeks after the initial administrating of the pharmaceutical composition, a significant reduction in inflammatory lesion count (‘117 patent).” The parties agreed that the benchmarks’ terms were definable and it was not disputed that the Soolantra© composition necessarily achieves the claimed efficacy limitations. The district court based its inherency finding on the parties’ stipulation that Manetta enables McDaniel so that a POSA would be able to practice McDaniel’s disclosed treatment method with Manetta’s formulation without undue experimentation.

Not so fast, said the panel, noting:

“A patent is invalid for anticipation if a single prior art reference discloses each and every limitation of the claims invention either expressly or inherently. [citing Schering Corp. v Geneva] ‘As long as the reference discloses all of the claim limitations and enables the ‘subject matter that falls within the scope of the claims at issue,’ the reference anticipates.’”

The panel agreed with Galderma that “the district court confused enablement with anticipatory disclosure” and that the Fed. Cir. has “looked to additional references ‘solely to show enablement of an anticipatory reference,’ not….for whether an enabled reference discloses all claim limitations…[Manetta’s]  enablement does not mean that McDaniel discloses the specific formulation disclosed in Manetta.” The panel agreed with Galderma that a second reference should not be relied upon “for a very specific teaching” [of a claim limitation] needed to support anticipation, and “[w]hether a prior art reference is enabled is a separate question from whether it discloses, expressly or inherently, the claimed limitations at issue…The stipulation cannot mean, as Teva suggests, that McDaniel discloses the specific Soolantra© formulation…McDaniel does not contain the specific disclosure that is necessary for a finding of anticipation: an ivermectin formulation…that necessarily achieves the claimed efficacy limitations.”

The next paragraph may be helpful for practitioners who encounter an Examiner who bases an anticipation rejection on his opinion that the POSA could “immediately envision” a missing claim element. The court stated that “[t]he parties’ stipulation concerned the enablement of McDaniel. What a POSA ‘envisions’ on the other hand is undoubtedly a question of disclosure, not enablement.”

The panel wrapped its analysis up by concluding that “Teva did not demonstrate that the use of any such [Daniel] formation [even one containing 1% ivermectin in a pharmaceutically acceptable carrier] inevitably results in the claimed efficacies…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© formulations; 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.” The panel found that the district court in fact found that McDaniel lacks an express disclosure of the claimed efficacy limitations, but simply found that the treatment results, “as enabled by the Manetta formulation” were inherently disclosed.

The opinion also notes that Teva also asserted that the Galderma claims were invalid as anticipated or obvious over Manetta alone, or Manetta taken with McDaniel. It seems that only the recited efficacy limitations were missing in Manetta, which contains only 4 picture claims to methods of treating acne with 1% and 1.4% ivermectin. On remand, I think we can assume that Teva would rely on Manetta as the anticipatory reference. Would Teva even need to rely on McDaniel [unless Manetta did not disclosure the use of Soolantra to treat these particular acne patholgies]? Why wouldn’t Manetta inherently anticipate the Galderma claims? I will leave it to those more invested in the ultimate outcome of this litigation to inform us about that.


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