United States District Court, D. Massachusetts
SHIRE LLC and SHIRE U.S. INC., Plaintiffs,
ABHAI, LLC, Defendant.
MEMORANDUM OF DECISION
WILLIAM G. YOUNG U.S. DISTRICT JUDGE
LLC and Shire US, Inc. ("Shire") commenced this
suit against Abhai, LLC ("Abhai") for alleged
infringement of two of Shire's patents: RE42, 096
("'096 Patent") and RE41, 148 (""148
is the manufacturer of the drug ADDERALL XR, an
amphetamine-based pharmaceutical used in the treatment of
Attention Deficit Hyperactivity Disorder ("ADHD").
Compl. Patent Infringement ("Compl.")
¶ 9, ECF No. 1. The '096 and "148
Patents pertain to a delayed-release medicine, which delivers
two doses of medication: one delivered shortly after
administration, and one delivered about four to six hours
later. Compl. Ex. A, '096 Patent col. 3 11. 10-13, ECF
No. 1-2; Compl. Ex. B, U48 Patent col. 3 11. 23-26, ECF No.
1-3. This delayed-release mechanism allows a patient to take
one pill per day instead of two, which is more convenient for
children, common consumers of ADDERALL XR. '096 Patent
col. 3 11. 5-17; U48 Patent col. 3 11. 16-30.
accomplish that end, the drug is administered via a pill that
contains multiple layers. '096 Patent fig. 2A; '148
Patent fig. 2A. The first layer is an outer shell designed to
dissolve quickly and provide an immediate dose of
amphetamine. Within the first layer of amphetamine is a
second, thicker shell, containing a second dose of
amphetamine, designed to be delivered later in the day.
'096 Patent col. 4 11. 53-65; U48 Patent col. 4 1. 66 -
col. 5 1. 11. A key component of the invention is the
creation of a drug coating that ensures the second dose of
amphetamine is delivered about four to six hours after the
first release. '096 Patent col. 4 11. 6-16; U48 Patent
col. 4 11. 18-29. This coating must withstand the stress of
passing through the stomach without prematurely delivering
the medicine. '096 Patent col. 4 11. 21-30; U48 Patent
col. 4 11. 34-43. Shire accomplished this effect by using a
thicker, PH-resistant shell around the second dose of the
drug. '096 Patent col. 4 11. 31-35; U48 Patent col. 4 11.
Food and Drug Administration ("FDA") issued to
Shire a New Drug Approval for ADDERALL XR for the treatment
of ADHD. Compl. ¶ 13. The FDA has listed the '096
and "148 Patents in its Approved Drug Products with
Therapeutic Equivalence Evaluations (commonly known as
"The Orange Book") . Id.
is a drug manufacturer which recently filed an Abbreviated
New Drug Application ("ANDA") with the FDA to
develop a generic version of ADDERALL XR prior to the
expiration of the "096 and "148 Patents. Compl.
¶ 14; Def. Abhai, LLC's Answer, Defenses,
Countercls. ("Answer") 4, ECF No. 30. Abhai's
ANDA also contained certifications pursuant to 21 U.S.C.
§ 355(j)(2)(A)(vii)(IV) with respect to the "096
and "148 Patents, which set forth the legal and factual
basis for Abhai's position that those patents are
invalid, unenforceable, or would not be infringed by
Abhai's contemplated manufacture and sale of generic
ADDERALL XR. Compl. ¶ 15; Answer 8-9.
September 20, 2016, this Court conducted a Markman
Hearing, during which the parties argued their proffered
constructions of the disputed claims in the "096 and
"148 Patents. This memorandum pertains only to the
manner in which this Court construes the following section of
claims 1 and 12 of the '148 Patent: "a delayed
enteric release dosage form that provides delayed release
upon oral administration . . . ."
analysis is a two-step process: (i) claims must be construed;
and then (ii) the allegedly infringing device is compared to
the properly-construed claims. See Interactive Gift
Express, Inc. v. CompuServe Inc., 256
F.3d 1323, 1330-31 (Fed. Cir. 2001) (citations omitted).
Construing a patent's claims is a matter reserved for the
judge. Markman v. Westview Instruments,
Inc., 517 U.S. 370, 386 (1996) . Since claim
construction is a mixed question of fact and law as the
meaning of the claim term is the meaning understood by a
person skilled in the art, the Supreme Court has recognized
some deference must be shown to a district judge who makes
factual findings in construing a claim. Teva Pharms.,
USA v. Sandoz, Inc., 135 S.Ct. 831, 837-38
starting point for construing claims is the actual claim
language. In particular, "[t]he inquiry into how a
person of ordinary skill in the art understands a claim term
provides an objective baseline from which to begin claim
interpretation." Phillips v. AWH
Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc)
claims should not be interpreted in isolation, because
"the 'ordinary meaning' of a claim term is its
meaning to the ordinary artisan after reading the entire
patent." Id. at 1321. Instead, claim language
is to be read in light of "intrinsic evidence" such
as the specification and prosecution history.Id. at
1313; Vitronics Corp. v. Conceptronic,
Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) ("[T]he
specification is . . . the single best guide to the meaning
of a disputed term.").
courts may "rely heavily on the [specification] for
guidance as to the meaning of the claims, "
Phillips, 415 F.3d at 1317, they are warned not to
read limitations from the specification into the claims,
Texas Dig. Sys., Inc. v. Telegenix,
Inc., 308 F.3d 1193, 1205 (Fed. Cir. 2002) . In certain
circumstances, however, particular uses of language within
the specification can be especially determinative when
construing a claim. For instance, the words "the present
invention" or "this invention" in the
specification can provide clear evidence of a claim
term's scope. Verizon Servs. Corp. v. Vonage
Holdings Corp., 503 F.3d 1295, 1308 (Fed. Cir. 2007)
("When a patent thus describes the features of the
'present invention' as a whole, this description
limits the scope of the invention."). Nevertheless,
these words are not always so limiting, "such as where
the references to a certain limitation as being the
'invention' are not uniform, or where other portions
of the intrinsic evidence do not support applying the
limitation to the entire patent." Absolute Software,
Inc. v. Stealth Signal, Inc., 659 F.3d
1121, 1136 (Fed. Cir. 2011).
it is a well-established principle of claim construction that
language that is repeated throughout other claims in the same
patent should be given identical construction when possible.
Phillips, 415 F.3d at 1314. A corollary to that
canon of construction is the doctrine of claim
differentiation, which provides that "[t]here is
presumed to be a difference in meaning and scope when
different words or phrases are used in separate claims."
Tandon Corp.v.Int'l Trade
Comm'n., 831 F.2d 1017, 1023 (Fed Cir. 1987).
Differently worded but similar claims in related patents,
however, may still be construed identically where those
patents share a specification and other technical details.
Welker Bearing Co.v.PHD, Inc.,
550 F.3d 1090, 1098-99 ...