Monday, March 14, 2022

Amneal wins at CAFC over an appeal by ALMIRALL

The outcome:

Almirall, LLC (“Almirall”) appeals from the final written decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board (the “Board”) holding that claims 1–8 of U.S. Patent 9,517,219 (the “’219 patent”) would have been obvious over the cited prior art at the time the alleged invention was made.1 See Amneal Pharms. LLC v. Almirall, LLC, No. IPR2019-00207, 2020 WL 2833274 (P.T.A.B. May 29, 2020) (“Decision”). For the reasons provided below, we affirm.

Of the technology

Adapalene is a compound used for treating dermatological conditions, sometimes in combination with dapsone. See Decision at *18. The ’219 patent includes 62 generalized composition embodiments, ’219 patent, col. 6 l. 58– col. 12 l. 40, and eight specific example formulations, id. at col. 12 l. 42–col. 15 l. 33. Several of the examples are described as including adapalene. Independent claims 1 and 6 read as follows: 1. A method for treating a dermatological condition selected from the group consisting of acne vulgaris and rosacea comprising administering to a subject having the dermatological condition selected from the group consisting of acne vulgaris and rosacea a topical pharmaceutical composition comprising: about 7.5% w/w dapsone; about 30% w/w to about 40% w/w diethylene glycol monoethyl ether; about 2% w/w to about 6% w/w of a polymeric viscosity builder comprising acrylamide/sodium acryloyldimethyl taurate copolymer; and water; wherein the topical pharmaceutical composition does not comprise adapalene.

The issues:

Almirall raises two challenges on appeal. First, Almirall contends that the Board erred in presuming obviousness based on overlapping ranges. Second, Almirall argues that the Board’s obviousness determinations were unsupported by substantial evidence. We review the Board’s legal determinations de novo, In re Elsner, 381 F.3d 1125, 1127 (Fed. Cir. 2004), but we review the Board’s factual findings underlying those determinations for substantial evidence, In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000). A finding is supported by substantial evidence if a reasonable mind might accept the evidence as adequate to support the finding. Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938).


“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (citing In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997)); see also E.I. du Pont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1006 (Fed. Cir. 2018); Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004). “The point of our overlapping range cases is that, in the absence of evidence indicating that there is something special or critical about the claimed range, an overlap suffices to show that the claimed range was disclosed in—and therefore obvious in light of—the prior art.” E.I. du Pont, 904 F.3d at 1008. A presumption of obviousness does not shift the burden of persuasion to the patentee to prove nonobviousness, but a presumption establishes that, “absent a reason to conclude otherwise, a factfinder is justified in concluding that a disclosed range does just that—discloses the entire range.” Id.


But even if we agreed with Almirall that the presumption does not apply in this case, the outcome would be the same. Ultimately, despite Almirall’s attempts to argue otherwise, this case does not depend on overlapping ranges. It is simply a case of substituting one known gelling agent for another


Amneal responds that substantial evidence supports the Board’s finding that Garrett effectively teaches the negative adapalene claim limitation. We agree with Amneal. Almirall’s argument is contrary to our precedent. “[A] reference need not state a feature’s absence in order to disclose a negative limitation.” AC Techs., S.A. v., Inc., 912 F.3d 1358, 1367 (Fed. Cir. 2019). Instead, it was reasonable for the Board to find that, in the context of Garrett, a skilled artisan would recognize that the reference discloses a complete formulation—excluding the possibility of an additional active ingredient. See, e.g., Novartis Pharms. Corp. v. Accord Healthcare, Inc., 21 F.4th 1362, 1373 (Fed. Cir. 2022) (recognizing that for negative limitations, “the disclosure must be read from the perspective of a person of skill in the art”). It is undisputed that Garrett discloses dapsone formulations that lack adapalene. The Board thus did not err in concluding that Garrett discloses the negative adapalene claim limitation.


We agree with Amneal. A finding of a reasonable expectation of success does not require absolute predictability of success. See OSI Pharms., LLC v. Apotex Inc., 939 F.3d 1375, 1385 (Fed. Cir. 2019). The Board’s reasonable expectation of success analysis is supported by substantial evidence. The Board credited Amneal’s expert’s testimony that a person of ordinary skill would have understood that use of Nadau-Fourcade’s A/SA gelling agents in Garrett’s formulation would have been routine and predictable because the agents were known for use in topical compositions with water insoluble drugs. Furthermore, the Board found that a person of ordinary skill would not have expected any incompatibilities. The Board analyzed the record evidence and found that Carbopol® and Sepineo® were recognized to be interchangeable and equivalent gelling agents that could be used in topical formulations containing dapsone, and that they could be used in the same concentration range. We are therefore not persuaded that the Board erred in analyzing the evidence provided by Amneal and its impact on whether a skilled artisan would have had a reasonable expectation of success in combining these prior art teachings to achieve the claimed invention.


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