Galderma’s ivermectin claims not inherently anticipated since “claimed efficacy limitations” not disclosed by single prior art reference

Galderma Labs., L.P. et al. v. Teva Pharmaceuticals, Inc.

Docket No. 2019-2396, -1213
January 29, 2020

Brief Summary: DC finding of inherent anticipation reversed as it relied on a second reference to provide limitations missing from the first.

Summary: Galderma appealed DC holding that Orange Book (OB) patents US 9,089,587; 9,233,117; and 9,223,118 are invalid for anticipation (§ 102) due to inherent prior art disclosure. This case relates to Teva’s ANDA No. 210019 regarding a generic of Galderma’s Soolantra® (1% ivermectin topical cream, for treatment of papulopustular rosacea (PPR), NDA N206255, eight other OB patents not addressed here). The FC panel explains that the claims recite “efficacy benchmarks” including reduced “inflammatory lesion count” (e.g., “as early as 2 weeks after the initial administration”, “wherein the subject has 15 or more…before the treatment”, “more reduction…in comparison” to inclusion of metronidazole), “higher investigator’s global assessment success rate” (“IGA”), “delayed time to first relapse”, and “longer relapse-free time of inflammatory lesions”. The parties agreed “significant improvement” means “statistically significant, not due to chance alone, which has a p-value of 0.05 or less”, that “time to first relapse” or “relapse-free time” means “the time elapsed between initial successful treatment to an IGA of rosacea of 0 or 1 to the first reoccurrence of the IGA to 2 or more in the subject”, and “that the Soolantra® formulation necessarily achieves the claimed efficacy limitations.” The DC found “McDaniel inherently disclosed the claimed efficacy limitations…based on the parties’ stipulation that ‘Manetta enables McDaniel…as to the formulation.” Galderma argued that the DC erred in using “multiple references for its anticipation analysis” and because its “finding of inherency [was] based on a ‘mere possibility’”, and disputed “whether McDaniel expressly discloses the claimed efficacy limitations.” Regarding the multiple references argument, the FC panel explained that the DC erroneously “look[ed] to Manetta to incorporate a specific disclosure not found in McDaniel” (“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” (contrasting this case with Bristol-Myers (FC 2001) where prior art suggestion was “found to be enabling based on other references”). Here, the FC panel explained, while “Manetta enables an embodiment of McDaniel, it does not necessarily follow that a POSA reading McDaniel would at once envisage the undisclosed Soolantra® formulation that satisfies the claimed efficacy limitations” (Nidec Motor, FC 2017 (DC cannot “fill in missing limitations simply because a skilled artisan would immediately envision them”); Net MoneyIn, FC 2008). The FC panel also found the DC “mistakenly relied on Perricone” (FC 2005) “to find inherent anticipation” because “McDaniel does not disclose the ‘very same compositions’” (i.e., not one that “necessarily achieves the claimed efficacy limitations”; Schering, FC 2003; Bettcher, FC 2011 (“probabilities or probabilities” not enough)). The FC panel did not address Teva’s obviousness arguments made to the DC since the DC did not decide those.

This entry was posted in Anticipation (35 USC 102), Generics / ANDA, Inherency. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.