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Salix Pharmaceuticals, Inc., et al. v. Lupin Ltd., et al., C.A. No. 12-1104-GMS (D. Del. Dec. 17, 2013).

Salix Pharmaceuticals, Inc., et al. v. Lupin Ltd., et al., C.A. No. 12-1104-GMS (D. Del. Dec. 17, 2013).

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claim construction
claim construction

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01/27/2014

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IN THE UNITED STATES DISTRICT COURT
OR
THE DISTRICT OF DELAWARE SALIX PHARMACEUTICALS, INC. and DR. F ALK PHARMA GmbH, Plaintiffs,
V
LUPIN LIMITED and LUPIN PHARMACEUTICALS, INC., Defendants.
________________________________
)
Civil Action No. 12-1104-GMS
ORDER CONSTRUING THE TERMS OF
U.S.
PATENT NOS. 6,551,620; 7,547,451; 8,337,886; and 8,496,965
After having considered the submissions
of
the parties, and hearing oral argument on the matter, IT
IS
HEREBY ORDERED, ADJUDGED, and DECREED that, as used in the asserted claims
of
U.S. Patent Nos. 6,551,620 ( the '620 patent ), 7,547,451 ( the '451 patent ), 8,337,886 ( the '886 patent ), and 8,496,965 ( the '965 patent ):
1
The court adopts the parties' proposed construction for the term
pellet
to mean small, free-flowing spherical or semi-spherical particles formed from an agglomeration
of
bulk drugs and excipients using wet mass extrusion/ spheronization.
1
1
The plaintiffs Salix Pharmaceuticals, Inc. ( Salix ) and Dr. Falk Pharma GmbH ( Dr. Falk ) (collectively, plaintiffs ) and the defendants Lupin Limited and Lupin Pharmaceuticals, Inc. (collectively, Lupin ) agreed upon the construction
of
the term pellet
in
the Joint Claim Chart. (D.I. 84-1.)
In
the absence
of
a genuine dispute, the court will not construe this term.
See
2
Micro International Ltd.
v.
Beyond Innovation Technology
Co.
Ltd.
521
F.3d 1351, 1360 (Fed. Cir. 2008);
US. Surgical Corp.
v.
Ethicon Inc.
I
03
F .3d 1554, 1568 (Fed. Cir. 1997).
Case 1:12-cv-01104-GMS Document 118 Filed 12/17/13 Page 1 of 15 PageID #: 1134
 
2.
The court adopts the parties' proposed construction for the term
mean maximal plasma concentration
o
the 5-aminosalicylic acid
i is
reached
at
to have its plain and ordinary meaning.
2
3.
The term
matrix-forming polymer
is
construed to mean polymers, except pHsensitive enteric polymers, that are used to form the non gel-forming polymer matrix. At the
Markman
hearing, the plaintiffs clarified its position and stated that matrix-forming polymer or polymers are used in the creation
of
the polymer matrix, (Tr.
3
at 11:19-21
,
and that the polymer matrix in the claims
of
the '965 patent is a non gel-forming polymer matrix,
(id.
at 68:1-10, 72:8-9). Plaintiffs also conceded the patentee disclaimed pH-sensitive enteric polymers during prosecution
of
the '620 patent.
(See id.
at
69:24
70:6; JAllO.) Thus, the parties agree that the matrix-forming polymer means polymers that are used to form the non gel-forming polymer matrix.
(See
Tr.
at 69:22-24; D.I. 100 at 9.) But Lupin argues the specification and prosecution history
of
the patents-in-suit further limit the matrix-forming polymer
to
a member
of
the three specific polymers disclosed in the specification (Eudragit® RS/RL/NE). (D.I. 100 at 5-9.) The court disagrees.
t
is
well established that courts indulge a 'heavy presumption' that claim terms carry their full ordinary and customary meaning unless the patentee unequivocally imparted a novel meaning
to
those terms or expressly relinquished claim scope during prosecution.
Omega Eng
g Inc.
v.
Raytek Corp.,
334 F.3d 1314,
1323
(Fed. Cir. 2003) (citations omitted). Additionally, the court will not limit broader claim language
to
[a]
single [embodiment] 'unless the patentee has
2
After submission
of
claim construction briefing, but prior to oral argument, the parties reached agreement as to the meaning
of
this term.
In
the absence
of
a genuine dispute, the court will not construe this term.
See
2
Micro Int l.,
521
F.3d at 1360;
US. Surgical,
103
F.3d at I 568.
3
Tr. refers to the Nov. 21, 2013
Markman
Hearing Transcript.
0.1.
115.)
2
Case 1:12-cv-01104-GMS Document 118 Filed 12/17/13 Page 2 of 15 PageID #: 1135
 
demonstrated a clear intention to limit the claim scope using words or expressions
o
manifest exclusion or restriction, '
Abbott Labs.
v
Sandoz, Inc.,
566 F.3d 1282, 1288 (Fed. Cir. 2009)
quoting Liebel-Flarsheim
Co
v
Medrad, Inc.,
358 F.3d 898, 906 (Fed. Cir. 2004)). Here, the common specification teaches: Suitable matrix-forming polymers are,
for example,
those polymers which are known in the prior
rt
as coating lacquers for delayed release pharmaceuticals, such
as,for example,
(meth)acrylic ester copolymers.
Among the polymers
which are essentially insoluble in the intestinal tract and permeable to intestinal fluids and the active compound, those are preferred which are insoluble or particularly preferably water-insoluble in the intestinal tract. Methyl acrylate copolymers and ammoniometh-acrylatc copolymers
o
the type such as can be obtained under the tradename Eudragit® RS/RL/NE are
particularly preferred.
(JA067 at col. 3,
11
43-5 (emphasis added).) The court finds the patentee did not use words or expressions
o
manifest exclusion or restriction to limit the matrix-forming polymer to the particularly preferred embodiments.
See Abbott Labs,
566 F.3d at 1288. Indeed, the patentee did the exact opposite by using the words for example and among the polymers. Accordingly, the court will not limit matrix-forming polymer to the Eudragit® RS/RL/NE preferred embodiments. Similarly, the court finds Lupin's prosecution disclaimer arguments are meritless. During the prosecution
o
the '620 patent, which is the only patent-in-suit that specifically limits the matrix-forming polymer to Eudragit® RS/RL/NE, the examiner rejected the pending claims as unpatentable over Marvola in view
o
Heafield.
See
JA103.) The examiner stated that Marvola teaches a composition containing the active compound and a pH-sensitive enteric polymer
in
the core, such as Eudragit®
S
to control the drug release. While the examiner acknowledged that Marvola does not teach use
o
Eudragit® RS/RL/NE expressly disclosed in 3
Case 1:12-cv-01104-GMS Document 118 Filed 12/17/13 Page 3 of 15 PageID #: 1136

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