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Bayer Pharma AG v. Watson Laboratories, Inc.

United States Court of Appeals, Federal Circuit

November 1, 2017

BAYER PHARMA AG, BAYER INTELLECTUAL PROPERTY GMBH, BAYER HEALTHCARE PHARMACEUTICALS, INC., Plaintiffs-Appellees
v.
WATSON LABORATORIES, INC., ACTAVIS PHARMA, INC., Defendants-Appellants

         Appeal from the United States District Court for the District of Delaware in No. 1:12-cv-00517-GMS, Judge Gregory M. Sleet.

          David I. Berl, Williams & Connolly LLP, Washington, DC, argued for plaintiffs-appellees. Also represented by Bruce Genderson, Dov Philip Grossman, Aaron P. Maurer, Adam Lawrence Perlman, Thomas S. Fletcher, Galina I. Fomenkova.

          William M. Jay, Goodwin Procter LLP, Washington, DC, argued for defendants-appellants. Also represented by Elizabeth Holland, Robert V. Cerwinski, Brian Robinson, New York, NY; David Zimmer, Boston, MA.

          Before Lourie, Moore, and O'Malley, Circuit Judges.

          Moore, Circuit Judge.

         Watson Laboratories, Inc. appeals the District of Delaware's final judgment holding Watson failed to prove by clear and convincing evidence that claims 9 and 11 of U.S. Patent No. 8, 613, 950 ("the '950 patent") would have been obvious. We hold the district court clearly erred in finding a skilled artisan would not have been motivated to use the claim elements. Considering the district court's clear error together with the remainder of its fact findings, we conclude that claims 9 and 11 of the '950 patent would have been obvious. We therefore reverse.

         Background

         In 2003, the Food & Drug Administration ("FDA") granted Bayer[1] approval to market vardenafil hydrochlo-ride trihydrate to treat erectile dysfunction ("ED") under the name Levitra. Vardenafil belongs to a class of ED drugs called phosphodiesterase inhibitors. When the FDA approved Levitra, two other phosphodiesterase inhibitors were already on the market: Pfizer launched sildenafil under the name Viagra in 1998, and Eli Lilly launched tadalafil under the name Cialis in 2003. Levitra, Viagra, and Cialis are each formulated as immediate-release tablets that are swallowed whole.

          The '950 patent issued on December 24, 2013. It claims priority to March 1, 2005 and lists Bayer as its assignee. It is directed to a formulation of vardenafil "in the form of an uncoated tablet which disintegrates rapidly in the mouth, " commonly referred to as an oral disintegrating tablet ("ODT"). See '950 patent at claim 8. Bayer markets a commercial embodiment of the '950 patent, vardenafil ODT, under the name Staxyn.

         Watson filed an Abbreviated New Drug Application ("ANDA") with the FDA seeking approval to market a generic version of Staxyn. Bayer filed the instant case asserting infringement of the '950 patent. Claims 9 and 11, both of which depend from claim 8, are the only claims at issue:

8. A drug formulation in the form of an uncoated tablet which disintegrates rapidly in the mouth and releases the drug in the mouth without swallowing the tablet comprising vardenafil hydro-chloride trihydrate, and at least two sugar alcohols.
9. The drug formulation according to claim 8, wherein said sugar alcohols are a mixture of sorbitol and mannitol.
11. The drug formulation of claim 8, wherein at least one sugar alcohol is sorbitol.

         The parties agree that claim 8's requirement that the formulation "releases the drug in the mouth" means it is an immediate-release formulation.

         The district court held a six-day bench trial to consider the validity of the '950 patent. Watson argued the claimed formulation of vardenafil would have been obvious to a person of ordinary skill in the art based on multiple exemplary references showing a motivation to: (1) create an ODT formulation of vardenafil[2]; (2) select mannitol and sorbitol as sugar alcohols[3]; and (3) make the ODT formulation immediate-release. The district court rejected each of Watson's arguments. It found a person of ordinary skill in the art would not have been motivated to create an ODT formulation of vardenafil and would not have used mannitol and sorbitol as excipients. It found the prior art taught away from formulating vardenafil ODT as immediate-release. The district court also addressed Bayer's objective evidence of nonobviousness and found it supported its conclusion that Watson failed to prove by clear and convincing evidence that claims 9 and 11 would have been obvious. Watson appeals. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).

         Discussion

         A patent may not issue "if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains." 35 U.S.C. § 103. Obviousness depends on the following factual determinations: "(1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; (3) the level of ordinary skill in the art at the time the invention was made; and (4) objective evidence of nonobviousness, if any." In re Kubin, 561 F.3d 1351, 1356 (Fed. Cir. 2009) (citing Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966)). On appeal from a bench trial, we review the district court's findings of fact for clear error. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1359 (Fed. Cir. 2007). "A finding is 'clearly erroneous' when[, ] although there is evidence to support it, the reviewing court on the entire evidence is left with the definite and firm ...


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