SHIRE DEVELOPMENT, LLC, SHIRE PHARMACEUTICAL DEVELOPMENT, INC., COSMO TECHNOLOGIES LIMITED, GIULIANI INTERNATIONAL LIMITED, NKA NOGRA PHARMA LIMITED, Plaintiffs-Appellees
WATSON PHARMACEUTICALS, INC., NKA ACTAVIS, INC., WATSON LABORATORIES, INC. - FLORIDA, NKA ACTAVIS LABORATORIES FL, INC., WATSON PHARMA, INC., NKA ACTAVIS PHARMA, INC., WATSON LABORATORIES, INC., Defendants-Appellants
from the United States District Court for the Southern
District of Florida in No. 0:12-cv-60862-DMM, Judge Donald M.
Haug, Frommer Lawrence & Haug LLP, New York, NY, argued
for plaintiffs-appellees. Also represented by Elizabeth
Murphy, Erika Selli, Jason Aaron Lief, Andrew S. Wasson.
Arthur Maddox, Maddox Edwards, PLLC, Washington, DC, argued
for defendants-appellants. Also represented by Jeremy J.
Edwards, Kaveh Saba.
Prost, Chief Judge, TARANTO and HUGHES, Circuit Judges.
Hughes, Circuit Judge.
(collectively, Shire) sued Defendants (collectively, Watson)
for infringing claims 1 and 3 of U.S. Patent No. 6, 773, 720
by filing Abbreviated New Drug Application No. 203817 with
the Food and Drug Administration seeking to market a generic
version of Shire's mesalamine drug, LIALDA®. Because
Watson's ANDA Product does not satisfy the Markush group
requirements in claim 1(b), we reverse and remand with
instructions to enter judgment of non-infringement.
'720 patent is directed to a controlled-release oral
pharmaceutical composition of mesalamine (also known as
mesalazine or 5-amino-salicylic acid) used to treat certain
inflammatory bowel diseases. Shire Dev., LLC v. Watson
Pharm., Inc., 787 F.3d 1359, 1361 (Fed. Cir. 2015) (2015
Decision). That composition includes the mesalamine active
ingredient; an inner, lipophilic matrix; an outer,
hydrophilic matrix; and other optional excipients. '720
patent col. 2 11. 36-44.
matrix is hydrophilic, it "has an affinity for
water" and therefore "readily dissolves in"
it. 2015 Decision, 787 F.3d at 1362 n.l; see Shire Dev.
LLC v. Watson Pharm., Inc., No. 12-60862-CIV, 2016 WL
1258885, at *6 (S.D. Fla. Mar. 28, 2016) (2016 Trial
Decision) (noting the parties' stipulated-to definition
of "hydrophilic" as "having an affinity to
water"). Conversely, when a matrix is lipophilic, it
"has an affinity for lipids" and therefore
"resists dissolving in water." 2015 Decision, 787
F.3d at 1362 n.l; see id. at 1365 (noting the
parties' stipulated-to definition of
"lipophilic" as "poor affinity towards aqueous
asserts claims 1 and 3 of the '720 patent. In relevant
part, claim 1 reads:
1. Controlled-release oral pharmaceutical compositions
containing as an active ingredient 5-amino-salicylic acid,
a) an inner lipophilic matrix consisting of
substances selected from the group consisting of
unsaturated and/or hydrogenated fatty acid, salts, esters or
amides thereof, fatty acid mono-, di- or triglycerids, waxes,
ceramides, and cholesterol derivatives with melting points
below 90° C, and wherein the active ingredient is
dispersed both in said [sic] the lipophilic matrix and in the
b) an outer hydrophilic matrix wherein the
lipophilic matrix is dispersed, and said outer hydrophilic
matrix consists of compounds selected from the group
consisting of polymers or copolymers of acrylic or
methacrylic acid, alkylvinyl polymers, hy-droxyalkyl
celluloses, carboxyalkyl celluloses, polysaccharides,