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Nalpropion Pharmaceuticals, Inc. v. Actavis Laboratories Fl, Inc.

United States Court of Appeals, Federal Circuit

August 15, 2019

NALPROPION PHARMACEUTICALS, INC., Plaintiff-Appellee
v.
ACTAVIS LABORATORIES FL, INC., Defendant-Appellant

          Appeal from the United States District Court for the District of Delaware in No. 1:15-cv-00451-RGA, Judge Richard G. Andrews.

          Dominick A. Conde, Venable LLP, New York, NY, argued for plaintiff-appellee. Also represented by Christopher P. Borello, Joshua Daniel Calabro, Zachary Garrett, Brendan M. O'Malley.

          Jonathan D. Ball, Greenberg Traurig LLP, New York, NY, argued for defendant-appellant. Also represented by Scott Joseph Bornstein, Justin Albano MacLean, Richard Charles Pettus.

          Before Prost, Chief Judge, Lourie and Wallach, Circuit Judges.

          OPINION

          Lourie Circuit Judge.

         Actavis Laboratories FL, Inc. ("Actavis") appeals from the judgment of the U.S. District Court for the District of Delaware that (1) its proposed naltrexone hydrochloride and bupropion hydrochloride extended-release tablets, which are the subject of Abbreviated New Drug Application No. 208043 (the "ANDA product"), would infringe claim 1 of U.S. Patent 7, 375, 111 ("the '111 patent"), claims 26 and 31 of U.S. Patent 7, 462, 626 ("the '626 patent"), and claim 11 of U.S. Patent 8, 916, 195 ("the '195 patent"); (2) the asserted claims are not invalid; (3) the effective date of any FDA approval of ANDA No. 208043 shall be no earlier than the latest expiration of the '111, '626, and '195 patents; and (4) Actavis is permanently enjoined from manufacturing, using, or selling its ANDA product before the expiration of the patents in suit. Orexigen Therapeutics, Inc. v. Actavis Labs. FL, Inc., 282 F.Supp.3d 793 (D. Del. 2017) ("Decision"); Final Judgment, Orexigen Therapeutics, Inc. v. Actavis Labs. FL, Inc., No. 1:15-cv-451 (D. Del. Oct. 26, 2017), ECF No. 186. Because we conclude that the district court did not err in finding claim 11 of the '195 patent not invalid for lack of written description, but did err in finding that claim 1 of the '111 patent and claims 26 and 31 of the '626 patent would not have been obvious in view of the prior art, we affirm-in-part and reverse-in-part.

         Background

         Appellee Nalpropion Pharmaceuticals, Inc. ("Nalpropion")[1] holds New Drug Application No. 200063 for and markets Contrave® for weight management in overweight or obese adults. Relevant here are the three Orange Book-listed patents for Contrave® that Nalpropion asserted against Actavis: the '626, '195, and '111 patents.

         The '626 patent is drawn to a method for treating overweight or obesity comprising (1) diagnosing an individual as suffering from overweight or obesity by body mass index, (2) administering bupropion in an amount effective to induce weight loss, and (3) administering naltrexone in an amount effective to enhance the weight loss activity of bupropion. '626 patent col. 38 l. 60-col. 39 l. 4. Nalpropion asserted claims 26 and 31. Claim 26 depends from claim 25, which recites:

A method of treating overweight or obesity, comprising administering a weight loss effective amount of a first and second compound to an individual who has been diagnosed as suffering from overweight or obesity in order to treat said overweight or obesity, wherein said first compound is bupropion, or a pharmaceutically acceptable salt thereof, and said second compound is naltrexone, or a pharmaceutically acceptable salt thereof, and wherein the weight loss activity of said first and second compounds is enhanced compared to the administration of the same amount of either compound alone.

Id. col. 40 ll. 16-26. Claim 26 adds the additional limitation that naltrexone and bupropion "are administered together." Id. col. 40. ll. 27-30. Claim 30 depends from claim 25 and requires that at least one of the drugs be in a "sustained-release formulation," id. col. 40 ll. 41-44, while claim 31, which depends from claim 30, requires that the drugs be "administered in a single oral dosage form," id. col. 40 ll. 45-49.

         The '195 patent is also directed to methods of treating overweight or obesity, but the claims are drawn to specific dosages of sustained-release naltrexone and bupropion that achieve a specific dissolution profile. At issue here is claim 11:

A method of treating overweight or obesity having reduced adverse effects comprising orally administering daily about 32 mg of naltrexone and about 360 mg of bupropion, or pharmaceutically acceptable salts thereof, to a person in need thereof, wherein the bupropion or pharmaceutically acceptable salt thereof is administered as a sustained release formulation, wherein the naltrexone or pharmaceutically acceptable salt thereof is administered as a sustained release formulation, and wherein said sustained release formulation of naltrexone has an in vitro naltrexone dissolution profile in a dissolution test of USP Apparatus 2 Paddle Method at 100 rpm in a dissolution medium of water at 37° C. of:
a) between 39% and 70% of naltrexone released in one hour;
b) between 62% and 90% of naltrexone released in two hours; and
c) at least 99% in 8 hours;
wherein about 16 mg of said sustained release formulation of naltrexone or a pharmaceutically acceptable salt thereof is administered twice daily, and about 180 mg of said sustained release formulation of bupropion or a pharmaceutically acceptable salt thereof is administered twice daily.

'195 patent col. 31 l. 5-col. 32 l. 3.

         Finally, the '111 patent is directed to a composition of sustained-release bupropion and naltrexone for affecting weight loss. Asserted here is claim 1:

A composition for affecting weight loss comprising:
(a) a sustained release formulation of bupropion or a pharmaceutically acceptable salt thereof in an amount effective to induce weight loss in an individual; and
(b) a sustained release formulation of naltrexone or a pharmaceutically acceptable salt thereof in an amount effective to enhance the weight loss effect of the bupropion or salt thereof;
wherein said composition is in a single oral dosage form fixed combination.

'111 patent col. 41 ll. 26-35.

         Actavis filed an ANDA seeking to enter the market with a generic version of Contrave® prior to the expiration of the patents in suit, and Nalpropion responded by bringing an action for patent infringement, alleging that Actavis's ANDA product would infringe the '111, '626, and '195 patents. Actavis in turn brought invalidity counterclaims, challenging claim 11 of the '195 patent as invalid for lack of adequate written description and challenging claim 1 of the '111 patent and claims 26 and 31 of the '626 patents as invalid as obvious. The district court held a bench trial on all of these issues and held each claim not invalid and infringed. Decision, 282 F.Supp.3d at 797.

         First, the district court considered Actavis's written description argument. Actavis argued that claim 11 of the '195 patent lacked adequate written description support because its claimed dissolution profile was achieved using the USP Apparatus 2 Paddle Method ("USP 2"), but the specification discloses data obtained using the different USP Apparatus 1 Basket Method ("USP 1"). The court was not persuaded that the use of a different method from what is prescribed in the claim presented a written description problem, holding that "whether the dissolution data reported in the specification was obtained using the basket method or the paddle method is not relevant to whether the inventors had possession of the invention." Id. at 802. Instead, the court credited Nalpropion's expert who opined that a person of ordinary skill would recognize that the inventors possessed an embodiment of the invention as described in Table 10, regardless whether USP 2 or a "'substantially equivalent' method" was used. Id. at 801 (citation omitted).

         Next, the district court addressed the question of obviousness of claim 1 of the '111 patent and claims 26 and 31 of the '626 patent. Actavis argued that it would have been obvious for a person of skill to combine bupropion and naltrexone for treating overweight and obesity because both drugs were known to cause weight loss, but the court disagreed, finding Actavis's argument to be "a classic case of hindsight bias." Id. at 809.

         Actavis appealed from the district court judgment, and we have jurisdiction under 28 U.S.C. § 1295(a)(1).

         Discussion

         On appeal from a bench trial, we review a district court's conclusions of law de novo and its findings of fact for clear error. Braintree Labs., Inc. v. Novel Labs., Inc., 749 F.3d 1349, 1358 (Fed. Cir. 2014). "A factual finding is clearly erroneous when, despite some supporting evidence, we are left with a definite and firm conviction that the district court was in error." Alcon Research Ltd. v. Barr Labs., Inc., 745 F.3d 1180, 1186 (Fed. Cir. 2014) (citing Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006)). "The burden of overcoming the district court's factual findings is, as it should be, a heavy one." Polaroid Corp. v. Eastman Kodak Co., 789 F.2d 1556, 1559 (Fed. Cir. 1986). "Where there are two permissible views of the evidence, the factfinder's choice between them cannot be clearly erroneous." Anderson v. City of Bessemer City, 470 U.S. 564, 574 (1985) (citing United States v. Yellow Cab Co., 338 U.S. 338, 342 (1949)).

         Whether a claim satisfies the written description requirement is a question of fact, Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), that we review for clear error, Alcon, 745 F.3d at 1190. "Whether an invention would have been obvious at the time it was made is a question of law, which we review de novo, based on underlying facts, which we review for clear error." Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1366 (Fed. Cir. 2011) (citing Media Techs. Licensing, LLC v. Upper Deck Co., 596 F.3d 1334, 1337 (Fed. Cir. 2010)).

         The district court rejected Actavis's invalidity arguments that (1) claim 11 of the '195 patent is invalid for lack of adequate written description and (2) claim 1 of the '111 patent and claims 26 and 31 of the '626 patent are invalid as obvious. We address the court's holdings in turn.

         I. Written Description

         Claim 11 of the '195 patent recites a method of treating overweight or obesity comprising orally administering about 16 mg of naltrexone and about 180 mg of bupropion, both in sustained-release formulations administered twice daily. This method claim also requires that the claimed naltrexone formulation have an in vitro dissolution profile

in a dissolution test of USP Apparatus 2 Paddle Method at 100 rpm in a dissolution medium of ...

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