Allergan Sales, LLC v. Sandoz, Inc., Alcon Labs., Inc. et al.

Docket Nos. 2017-1499, -1500, -1558, -1559

December 22, 2017


Brief summary: DC finding of no obviousness affirmed (efficacy limitations not in the prior art of record); finding of literal infringement of certain claims reversed (ANDA does not infringe “narrowly and specifically drawn” claims); and finding of no literal infringement of other claims affirmed (“proposed generic contains 0.2% brimonidine titrate, a distinct pharmaceutical compound that reduces to 0.132% brimonidine”).

Summary: Allergan appealed DC finding that Sandoz’s ANDA does not infringe Allergan’s US 7,030,149; 7,320,976; and 8,748,425 listed on the FDA OB for Combigan® (“a ‘fixed combination’ ophthalmic solution consisting of 0.2% brimondine tartrate and 0.67% timolol maleate for twice-daily dosage”; six additional OB patents not addressed here). Mulitple actions regarding “numerous patents” were consolidated into a single bench trial. Allergan sued Sandoz for direct, induced, and contributory infringement but the DC found no infringement. The DC also found no invalidity based on obviousness or written description (WD), which Sandoz appealed. The FC panel opinion first reviewed the invalidity findings, explaining that it reviews the DC’s legal determinations de novo and factual findings for clear error (Braintree, FC 2014; Honeywell, FC 2010 (obviousness is a question of law based on underlying factual findings); Alcon, FC 2014 (written description is a question of fact))). Allergan argued the ‘149 efficacy limitation was “not suggested nor inherent in any prior art in the record” (which the FC agreed with in its 2013 opinion regarding the ‘149 patent, and on which the DC relied). Here, Sandoz argued “the court erred because the asserted claims merely recite the inherent results of administering an obvious combination” but the FC panel disagreed because “[e]ach asserted claim…expressly recites an additional efficacy limitation that further restricts the method of administering the composition twice daily” that “are not disclosed by any prior art reference in the record” or “inherent in the administration” (‘149 claim 4, administration twice per day “as effective as…timolol twice a day and…brimonidine three times a day”; ‘976 claim 1, “a therapeutically effective amount…twice a day”; ‘425 claims 1-8 (“twice daily…reduces the incidence of one or more adverse events, as compared to…monotherapy three times per day”)). “Accordingly,” the FC panel concluded, “the asserted claims merely recite those administrations of the composition that satisfy the efficacy limitations-but not those that end up in, for example, a loss of efficacy”.

Regarding WD for ‘149 claim 4, the FC panel explained that “a patent must ‘clearly allow persons of ordinary skill in the art to recognize that [he] invented what is claimed” (Ariad, FC 2010 (en banc); Invitrogen, FC 2005 (“Even a single representative embodiment can support written description of a claimed genus.”)) Sandoz argued the claims encompassed “hundreds of combinations” of brimonidine and timolol “in their free base and salt forms”, but the FC credited the DC’s finding “that a person of ordinary skill in the art would have understood the claim to encompass only six possible combinations”; that brimonidine tartrate and timolol maleate were disclosed by the specification, and were the only salts available as of the ‘149 filing date (“The specification therefore discloses a representative-indeed, the sole-embodiment of the claimed genus and a person of ordinary skill[] in the art, reading the specification, would have immediately discerned the claimed limitation.”)

The FC panel found error in the DC’s finding of literal infringement of the ‘425 claims, which relied on equivalency, since the “narrowly and specifically drawn” claims recite 0.2% brimonidine tartrate and 0.5% timolol free base while “[b]oth Combigan® and the proposed generics…contain 0.68% timolol maleate, and ophthalmic compound distinct from 0.5% timolol free base” (“chemical equivalency is not sufficient for literal infringement of these claims…as a matter of law, Combigan® is not the ‘drug claimed in’ the ‘425 patent, and Sandoz’s ANDA does not infringe under § 271(e)(2)(A)” (Warner-Lambert, FC 2003)). The FC panel agreed with the DC’s finding of no literal infringement of ‘149 claim 1 or ‘976 claim 1 which “specifically recite 0.2% brimonidine” while the “proposed generic contains 0.2% brimonidine titrate, a distinct pharmaceutical compound that reduces to 0.132% brimonidine” as confirmed by Allergan’s expert.

This entry was posted in Generics / ANDA, Infringement, Inherency, Obviousness, Written description. Bookmark the permalink.

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