Free Redacted Document - District Court of Delaware - Delaware

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 1 of 29

REDACTED VERSION ­ PUBLICLY FILED

IN THE UNTED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWAR
GLAXO GROUP LIMITED
Plaintiff,
v.
) ) ) ) ) )

Civil Action No. 04-171-KAJ

TEV A PHACEUTICALS USA, INC. and

TEV A PHACEUTICAL INUSTRIS
LIMITED

)
)

CONFIDENTIAL FILED UNDER SEAL

Defendants.

) ) )

TEV A'S BRIEF OPPOSING GLAXO'S BRIEF CONSTRUING THE DISPUTED CLAIM TERMS OF U.S. PATENT NO. 5.068.249
YOUNG CONAWAY STARGATT & TAYLOR, LLP Josy W. Ingersoll (# 1088) Adam W. Poff (# 3990) Karen E. Keller (# 4489) The Brandywine Building
1000 West Street, 17th Floor

P.O. Box 391 Wilmington, DE 19899 Telephone: (302) 571-6600

kkeller~ycst.com

MERCHA & GOULD P.e.
Mark D. Schuman Ronald A. Daignault Jeffer Ali Jeffrey C. Brown 3200 IDS Center 80 South 8th Street Minneapolis, MN 55402
Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd.

Dated: July 28, 2006

DBO 1 :2158300.1

058956.10 i i

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 2 of 29

REDACTED VERSION ­ PUBLICLY FILED

TABLE OF CONTENTS

i. NATUR AN STAGE OF THE PROCEEDINGS ..............................................1
II. SUMARY OF THE ARGUMENT.......... ............ ........... .....................................1
III. RESPONSE TO GLAXO'S STATEMENT OF THE FACTS ...............................4
IV. ARGUMNT ............... ....... ..... .............. ................. ............................................ .....5
A. The Law Of Claim Construction........... ....... ............. ............. ..... .......... .......5
B. Teva's Response To Glaxo's Constrction Of

Terms ...............................11

1. "Ethanol" Must Be Constred To Align With The
Intrisic Record, Not Teva's Formulation..................................... i

i

2. The Claim Term "Stabilizing Effective Amount" Should

Be Construed To Define What A Substantial Enhancement In Stability Means.... ................ ............. ............. .................. ......... .14
3. This Court Should Reject Glaxo's Efforts To Import

Redundant Limitations Into The '249 Patent Claims ...................17
4. This Cour Should Reject Glaxo's Efforts To Import
Extraneous Limitations Into Claims 2 and 3 Of Patent In The Interpretation Of

The '249

The Phrases "2.5% To 10% WeightIolume" And "7% to 8% WeightIolume".............19
Claim 11 Is Wrong ................................21

5. Glaxo's Constrction Of

6. This Cour Canot Issue And Advisory Opinion To

Constre Limitations That Teva Admits........................................22
V. CONCLUSION ......... .................... ............. .............................. ........ ............... ..... ..23

D801 :2158300.1

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 3 of 29

REDACTED VERSION ­ PUBLICLY FILED

TABLE OF AUTHORITIES

FEDERA CASES
CVI/Beta Ventures, Inc. v. Tura LP, 112 F.3d 1146 (Fed. Cir. 1997)........................................................................................21
Du Pont de Nemours & Co. v. Philips Petroleum Co., 849 F .2d 1430 (Fed. Cir. 1988)..... .......... ..................... ................................... ............... ..19
Glaxo Wellcome, Inc. v. Impax Laboratories,

356 F .3d 1348 (Fed. Cir. 2004)........... .......................................... ................................. .15

Hoganas AB v. Dresser Industrial, Inc.,
9 F .3d 948 (Fed. Cir. 1993)... ............ ............. ..... .............. .............. ............... .......... ........19

In re Beaver, 893 F.2d 329 (Fed Cir. 1989) ....................................................................................20, 21
Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898 (Fed. Cir. 2004) .........................................................................................20
NeoMagic COlp. v. Trident Microsystems, Inc., 287 F.3d 1062 (Fed. Cir. 2002)........................................................................................12
Philips v. AWH COlp., 363 F .3d 1207 (Fed. Cir. 2004)............... ..... .............. .................................... ....................6

Philips v. AWH Corp., 376 F.3d 1382 (Fed. Cir. 2004).....................................................................................6, 7
Philips v. AWH Corp., 415 F.3 d 1303 (Fed. Cir. 2005)................................................................................ passim
Renishaw PLC v. Marposs Societa' per Azioni,

158 F.3d 1243 (Fed Cir. 1998)...................................................................................11, 19
Rexnord COlp. v. Laitram Corp., 274 F.3d 1336 (Fed. Cir. 2001).. ............................... ................ ............. ......................... .21
SRI International v. Matsushita Electric Corp. of America, 77 5 F .2d 1107 (Fed. Cir. 1985)..... ......... ....... .................................... ................. ....... ...... .12

Semned, Inc. v. Richard-Allan Medical Industrial, Inc., 888 F.2d 815 (Fed. Cir. 1983).................... ...................... .............. ................ ......... ........ .18

DB01:2158300.1

11

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 4 of 29

REDACTED VERSION ­ PUBLICLY FILED

Southwall Technologies v. CardinalIG Co.,
54 F.3d 1570 (Fed. Cir. 1995)..........................................................................4, 18,21,22

Tandon Corp. v. lTC,

831 F.2d 1017 (Fed. Cir. 1987) .......................................................................................20
Texas Digital Sys., Inc v. Telegenix, Inc., 308 F.3d 1193 (Fed. Cir. 2002)..........................................................................................8

Toro Co. v. White Consolidated Industrial, Inc., 199 F .3d 1295 (Fed. Cir. 1999).............. ......... ........ ....... ................. .......................... .......20
u.s. Surgical Co. v. EthicOll, 103 F.3d 1554 (Fed. Cir. 1997)...... ............................. ...... .................. ..... ............... .........22
White v. Dunbar,

119 U.S. 47 (1886).... ............... ............................... .................................. ..................... ..22

Wilson Sporting Goods Co. v. Hilericli & Bradsby Co., 442 F .3d 1322 (Fed. Cir. 2006)............ ............. ...... ........... ........................... ............ .12, 13

FEDERA STATUTES
21 U .S.C. § 3550) ....... .... ...... ...... .................. ..... ....... ....................... ...... ................ ..............1

35 U.S.C. § 112................................................................................................7,8,9, 10, 11
35 U.S. C. § 112, ~ 4................................ ................................................ .......................... .14

D801:2158300.1

11

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 5 of 29

REDACTED VERSION ­ PUBLICLY FILED

I. NATURE AN STAGE OF THE PROCEEDINGS
This patent infrngement action was intiated by Glaxo following Teva's
submission of

an Abbreviated New Drug Application (" ANA") under 21 U.S.c. §

355(j) to the Food and Drug Administration ("the FDA") for approval of a generic
formulation of Glaxo's Zantac(ß oral solution, a brand-name drug covered by U.S. Patent

No. 5,068,249 (the "'249 patent"). Glaxo has conceded that the '249 patent claims do not
literally cover Teva's ranitidine oral solution because the claims require the inclusion of
ethanol while Teva's formulation does not include ethanoL.

Teva's generic formulation is different from the claims of

the '249 patent because

it includes Redacted rather than ethanol, among other differences.

For its part, Teva has admitted that its formulation has all of

the elements of

the

claims ofthe '249 patent except: 1) "a stabilizing effective amount of;" 2) "ethanol;" 3)

"2.5% to 10% weight/volume ethanol;" and 4) "7% to 8% weight/volume ethanoL."
Teva's Opening Brief in Support of

its Claim Constrction ("Teva's Opening Brief') was

submitted at the same time Glaxo submitted its Opening Claim Constrction Brief
Constring the Disputed Claim Terms of

Glaxo's U.S. Patent No. 5,068,249. This brief

is submitted by Teva in opposition to the arguents set forth by Glaxo in its opening

brief on claim interpretation.

II. SUMY OF THE ARGUMENT
The paries agree that, in light ofTeva's stipulation concernng all other
limitations, four terms in dispute are:
1) "ethanol," a term common to all claims of

the '249 patent;

DB01:2158300.1

1

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 6 of 29

REDACTED VERSION ­ PUBLICLY FILED

2) "stabilizing effective amount," a term found in Claims 1-10 but not in Claims
11 and 12;

3) "2.5 % to 10% weight/volume ethanol," a term found only in Claim 2; and
4) "7% to 8% weight/volume ethanol," found in Claims 3, 11 and 12.
Despite Teva's stipulation, Glaxo also seeks an advisory opinion to construe claim

language not at issue: "aqueous formulation for oral administration," found in Claims II 0, and "aqueous formulation of ranitidine suitable for oral admnistration," found in
Claims 11 and 12.
Glaxo's constrction of

the term "ethanol" is wrong because it is a semantic effort

to align the text of its issued claim with the accused formulation, not an objective effort
to define the term in light of

the intrnsic record. Not once did the inventor, its counsel,
prosecution, identify ethanol as an "organc

or the Examiner, during nearly five years of

compound," or as "a lower aliphatic hydrocarbon group having two carbon atoms and

one - OH group." The extrsic record cited by Glaxo does not even use these phrases to
define ethanoL. Those phrases are the product of litigation strategy, solely derived from

Glaxo's attorneys and retained expert. Glaxo's constrction is inspired solely by its
desire to capture Teva's accused product within the scope of

its invention, and its

proposed definition should be rejected.
Glaxo's construction of

the term "stabilizing effective amount" is not a definition

at aIL. It essentially defies "stabilzing effective amount" with a circular definition of an
amount that stabilzes, adding only the verb "enhance" to define the effect of ethanol on

the formulation. The '249 patent was not granted to reward the use of ethanol to merely
"enhance" the stability of ranitidine - it was granted for what Glaxo alleged was a

DBO 1:2158300.1

2

058956.1 0 i 1

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 7 of 29

REDACTED VERSION ­ PUBLICLY FILED

"surprising," "substantial," and "important" enhancement ofrantidine stabilty. The
Patent Office granted Glaxo's claims only after it showed a statistically signficant
improvement in shelf life to the Examiner in a declaration submitted by its scientist, Dr.

Hempenstall. Moreover, there is no need to redundantly import the "aqueous
formulation" language into the remaining claims by means of defining "stabilzing

effective amount." Glaxo's constrction of

"stabilizing effective amount" should be

rejected.

Glaxo's construction of"2.5% to 10% weight/volume ethanol" and "7% to 8%
weight/volume ethanol" repeats the text of each limitation verbatim, but then adds the clause, "sufficient to enhance the stability of the ranitidine active ingredient in the

aqueous formulation for oral administration." Glaxo's constrction is redundant,
importing two limitations into Claims 2 and 3 that already exist by virte of

the fact that

each claim is dependent on Claim 1. Glaxo' s constrction also impermissibly re-wrtes
Claims 11 and 12 by importing "stabilzing effective amount," into those claims.
Claims 11 and 12 do not, on their face, contain any requirement of a stabilizing

effective amount of ethanoL. Claim constrction is an effort to understand disputed claim

limitations existing in the issued patent, not an opportnity for Glaxo to have ths Cour
re-write its claims altogether.

There is no controversy concernng whether Teva's formulation contains an
"aqueous formulation for oral administration," and this Court should refrain from
providing Glaxo an advisory opinion on that claim language.

DBOI :2158300.1

3

058956.10 i I

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 8 of 29

REDACTED VERSION ­ PUBLICLY FILED

III. RESPONSE TO GLAXO'S STATEMENT OF THE FACTS
Glaxo's statement of facts, especially its essay on the development of

the original

ZantacCI syrp and Glaxo's efforts to gain FDA approval for various measurements of
the shelf life of its commercial product is interesting, but largely not relevant to the task
before the Cour. As explained in more detail below, the Federal Circuit has been very

clear that, when construing patent claims, evidence beyond the four corners of the

intrsic record, while sometimes helpful, is less reliable than the patent and its
prosecution history. Phillps v. AWH Corp., 415 F.3d 1303, 1318 (Fed. Cir. 2005)

(explaining potential sources of extrinsic evidence and advising that although such

evidence may be useful to a cour, "it is unlikely to result in a reliable interpretation of
patent claim scope unless considered in the context of

the intrsic evidence."). Glaxo's

efforts to use the improvement in shelflife of

its commercial product (18-24 months) as a

way of defining the improvement in stability provided by the '249 patent is erroneous.

The intrnsic evidence, in particular the Declaration by Dr. Hempenstall durig the
prosecution of the patent, is the evidence that ths Cour should use and examine. Dr.

Hempeiistall never cited to an improved shelflife from 18 to 24 months.

The Federal Circuit has explicitly cautioned that ". . . undue reliance on extrnsic
evidence poses the risk that it wil be used to change the meaning of claims in derogation
of the 'indisputable public records consisting of

the claims, the specification and the

prosecution history,' thereby undermining the public notice function of

patents." Id. at

1319 (citing Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1578 (Fed. Cir.

1995)). Glaxo's "Techncal Background" section almost exclusively cites to expert

opinion, an extrinsic source recognzed by the Phillps court as "generated at the time of

DBOI:2158300.1

4

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 9 of 29

REDACTED VERSION ­ PUBLICLY FILED

and for the purpose of litigation and thus can suffer from bias that is not present in

intrnsic evidence." Id. at p. 1318. It is difficult to understand why so much of Glaxo's
construction relies upon the extrinsic record, all of

which is hidden from public view until

developed in the context oflitigation. Regardless, this Court, as directed by Philips,
should keep such evidence in its appropriate, secondary context.

IV. ARGUMENT
A. The Law Of Claim Construction
This Court has before it two briefs stating each party's view of

the appropriate

standard by which to constre patent claims. Both paries rely primarily upon the

Phillps decision, which is not surprising. Glaxo's opening brief, however, under the
rubric of

"relevant background" injects a suspicious amount of extrinsic evidence.
"ethanol," a simple and key element of

Glaxo's constrction of

the claimed invention,

undeniably fids its only support with Glaxo's expert, Dr. Anderson, who proposes a
definition not once contemplated, mentioned, or discussed in the intrnsic record. For this

reason, a detailed examination of Philips is waranted, as this recent decision provides a
new look at patent claim constrction analysis, designed (ultimately) to create more
certainty in the analysis.

The principal issue in Phillps was to what extent the specification should be

relied on and resorted to in claim constrction. ¡d. at 1312. In Phillps, the Federal
Circuit mandated that intrnsic evidence, paricularly the claim language, is the
cornerstone of claim construction.

The Philips court analyzed "the extent to which (the cour) should resort to and
rely on a patent's specification in seeking to ascertain the proper scope" of

the claims. Id.

DBOI:2158300.1

5

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 10 of 29

REDACTED VERSION ­ PUBLICLY FILED

at 1312. At issue was the meaning of

the term "baffle" as used in plaintiff

Phillps'

patent. Id. At the district court level, the parties agreed on the term's broad dictionary
definition, but disagreed over the term's ordinary and customary meaning. The district

court considered the claims and the specification and held that a "baffe" must "extend
inward from the steel shell walls at an oblique or right angle to the wall face." The
district court's interpretation did not follow the dictionar definition. Based on this

interpretation, the distrct court granted summary judgment of non-infngement. Id.
On appeal, a three-judge panel of

the Federal Circuit held that the term's ordinar

meaning was that of its dictionary definition, but held that "(t)he ordinary meaning of a
term must be considered in view of

the intrsic evidence: the claims, the specification,

and the prosecution history." Philips v. AWH Corp., 363 F.3d 1207, 1213 (Fed. Cir.

2004). The Federal Circuit limited the term's ordinar meanng, as determined from a
dictionary, based on the specification: "From the specification( J . . . baffes must be

oriented at angles other than 90 degrees." Id. Thus, the majority sustained the distrct

cour's grant of summar judgment of noninfrngement, though on different grounds.
Dissenting, Judge Dyk argued that the Federal Circuit's decision limited the

claims to the preferred embodiment. Id. at 1216 (Dyk, 1., dissenting). He argued that the
court should have adopted the term's plain meanng from a dictionary, which would have
been "something for deflecting, checking, or otherwise regulating flow," and that
summar judgment of

non-infrngement should have been reversed. Id. at 1218 (Dyk, J.,

dissenting).

The Federal Circuit agreed to rehear the case en banc "to resolve issues
concerng the constrction of

patent claims." Philips v. AWH Corp., 376 F.3d 1382

DBO 1 :2158300.1

6

058956.101 i

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 11 of 29

REDACTED VERSION ­ PUBLICLY FILED

(Fed. Cir. 2004). This en baiic decision resulted in a tightening of

the rules regarding

claim constrction. The en banc decision held that intrnsic evidence should be the
primary source of claim interpretation. The words of the claim are to always be given
their ordinar customary meaning to one of ordinary skil in the art at the time of

the

invention. 415 F.3d at 1313. In some situations, this constrction would be readily

apparent. Id. at 1314. In those situations where the ordinar and customary meanng of a
claim term is not readily apparent, however, a court should analyze the intrnsic evidence,

and not the extrnsic evidence, to understand the meaning of a claim term as understood
by persons of ordinary skil in the ar. Id.

The Philips court began its tutorial on proper claim constrction analysis by
focusing on intrinsic evidence. Intrnsic evidence was the most important evidence, as

necessitated by 35 U.S.C. § 112. The staring point for claim constrction must be the
specification because § 112, paragraph 1, requires a patentee to describe the invention in

"full, clear, concise, and exact terms as to enable" one skilled in the art to make and use

the invention. Moreover, paragraph 2 of § 112 requires a patentee to conclude with

claims "parcularly pointing out and distinctly claiming the subject matter the applicant
regards as his invention." Section 112 requires an inventor to describe in the patent the
actual invention being patented. There can be no better source to determe the tre

meanng of a claim than the specification and claims that meet the requirements of § 112.
The Federal Circuit then reiterated that the claims themselves provide "substantial
guidance" about the meanng of claim terms. ¡d. at 1314. The context in which the term

is used and other claims (both asserted and unasserted) in the patent can provide guidance

DBOI:2158300.1

7

058956.1 0 11

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 12 of 29

REDACTED VERSION ­ PUBLICLY FILED

on the meanng of

the claims. Id. Moreover, usage of a term in one claim can help

define the meaning of

the same term in other claims. Id.

Next, the specification was touted as the "single best guide" to understanding not

only the meaning of a disputed term, but the scope of the claim. Id. at 1315. The Court
noted that the importance of

the specification derived from 35 U.S.C. § 112, requiring that

the specification describe the claimed invention in "full, clear, concise, and exact terms."

Id. at 1316. Claims are to be construed consistently with the specification, regardless of

whether this gives a claim term a defition that is different than the meanng it would
otherwise possess. Id. A court may "rely heavily" on the specification for guidance in

claim constrction. Id. at 1317.
After discussing the importance of

the specification, the Federal Circuit also

stated that the prosecution history should be consulted, if in evidence. Id. The
prosecution history is useful to demonstrate how the inventor understood the invention.
Id. However, because the prosecution history often lacks the clarity of

the specification,

it is less useful for claim constrction. Id.

Afer discussing the proper evidence to determine the meanng of claim terms, the

Philips court then discussed the status of extrnsic evidence. The Phillps court rejected
the line of cases following the opinion set forth in Texas Digital Sys., Inc. v. Telegenix,

308 F.3d 1193 (Fed. Cir. 2002), in which the court advocated claim constrction methodology that placed heightened reliance on dictionares (extrnsic evidence).
Evidence beyond the four comers of the patent, while sometimes helpful, was less

reliable than the patent and its prosecution history. 415 F.3d at 1318. The Philips court
recited five reasons why extrinsic evidence was troublesome in claim constrction:

OBOI :2158300.1

8

058956.1 011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 13 of 29

REDACTED VERSION ­ PUBLICLY FILED

(1) extrinsic evidence is not par of the patent and was not created for the

purpose of explaining the patent's scope and meaning;
(2) extrnsic evidence may not reflect the understanding of a person of

ordinary skil in the art because it may not have been written for such a
person;
(3) extrinsic evidence such as expert reports and testimony is prepared at the

time of and for the purpose of litigation and may suffer from bias;
(4) there is such a large unverse of extrnsic evidence, much of be of

which might

"marginal relevance;"

(5) use of extrinsic evidence may be used to change the meaning of claims

and undermine the public notice function of patents.
Id. at 1318-1319.

In the eyes of the Federal Circuit, the Texas Digital case "placed too much

reliance on extrisic sources such as dictionares, treatises, and encyclopedias and too

little on intrnsic sources.. .." Id. at 1320. The Philips cour disagreed with the
suggestion that the specification was only to be consulted after the ordinar meanig was

determined from dictionaries or treatises. Id. Giving dictionar defitions of claim
terms a more prominent role than the specification and prosecution history improperly
restrcted the role of

the specification in claim constrction. Id. The Texas Digital court's

methodology of staring with a dictionary if a definition in the specification was
expressly present was "inconsistent with our rulings that the specification is 'the single

best guide to the meanng of a disputed term. '" Id. Moreover, a dictionar definition
would improperly divorce the claim terms from the context of the rest of

the patent. Id.

at 1321. Such abstract constrctions of claim terms were inconsistent with patent law.

Staring with the broad dictionary defition and failing to recognze how the

DBO 1 :2158300.1

9

058956. i 0 1 1

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 14 of 29

REDACTED VERSION ­ PUBLICLY FILED

specification limits the definition wil cause overly broad construction of claims and
claim terms. Id.
Dictionary use was, however, not entirely baned. Id. at 1322. The Federal

Circuit recognized that "there is no magic formula or catechism for conducting claim
constrction." Id. at 1324. Judges must "attach the appropriate weight to be assigned to

those sources in light of

the statutes and policies that inform patent law." Id. The
the embodiments in the

Federal Circuit recognized that it can be difficult to determine if

specification are the outer limits of

the claim term or are merely exemplary in natue. !d.

at 1323. However, the Federal Circuit stated that resolving this problem within the
context of the patent itself would "captue the scope of

the actual invention" most

properly. Id. at 1324.

Based on the methodology adopted by the Federal Circuit, it rejected defendant

A WH's argument that the term "baffles" should be interpreted restrctively and held:

Although deflecting projectiles is one of the advantages of the baffes of
the '798 patent, the patent does not require that the inward extending
strctures always be capable of performing that function. Accordingly, we conclude that a person of skill in the ar would not interpret the disclosure

and claims of the '798 patent to mean that a structure extending inward

from one of the wall faces is a "baffe" if it is at an acute or obtuse angle, but is not a "baffe" if it is disposed at a right angle.

Id. at 1327. Based on its constrction, the cour remanded the infrngement claims to the
district court for further proceedings. Id. at 1328.
To summarize, the Philips decision marks a departe from the former canons of
claim construction that allowed courts to fully consider both intrnsic and extrnsic

evidence. In an attempt to create more certainty in claim constrction, the Federal Circuit
narowed the scope of

relevant materials upon which courts should base their judgments

OBD 1 :2158300.1

10

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 15 of 29

REDACTED VERSION ­ PUBLICLY FILED

regarding the proper scope of claim language. To put it concisely, the Philips analysis
emphasizes fidelity to the language of

the claim allowed by the Patent Office and

disclosed to the public:

Ultimately, the interpretation to be given a term can only be determined and confirmed with a full understanding of what the inventors actually invented
and intended to envelop with the claim. The constrction that stays tre to

the claim language and most naturally aligns with the patent's description of the invention wil be, in the end, the correct constrction.
Id. at 1316 (quoting Renishaw PLC v. Malpass Societa' per Azioni, 158 F.3d 1243,
1250 (Fed. Cir. 1998)).
B. Teva's Response To Glaxo's Construction Of

Terms
the claim terms at issue is set fort in Teva's

Teva's support for its construction of

Opening Brief, and wil not be repeated here. Because Teva's constrctions align with
the inventor's description of

the invention and with the prosecution history they should
this brief

be adopted. The remainder of

is focused on why G1axo's constrctions are

wrong.
1. "Ethanol" Must Be Construed To Align With The Intrinsic

Record, Not Teva's Formulation.
Glaxo's construction finds no support in the intrinsic record, and must be rejected.

When the '249 patent issued to the public in 1991, it disclosed and claimed "ethanol" in
each of

its 12 claims. (CoL. 2, line 66 - CoL. 4, line 18). Thoughout the patent, the term

"ethanol" was used 14 separate times. (Exhibit G at M026-029) ('249 patent with all
instances of

"ethanol" highlighted and numbered). Not once did the inventor believe it

necessary to describe ethanol as "a lower aliphatic hydrocarbon," or an "organc
compound." Durig nearly five years of

prosecution before the Patent Offce, there is not

DBOl :2J58300.1

11

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 16 of 29

REDACTED VERSION ­ PUBLICLY FILED

once any mention by Glaxo, the Examiner, or Dr. Hempenstall, of the term "ethanol" as a

"lower aliphatic hydrocarbon," or an "organic compound."
Glaxo's construction, in trth, is designed to read the '249 patent claims on

Teva's accused formulation, an exercise prohibited by patent law. The Federal Circuit is

explicit that "claims may not be constred with reference to the accused device."
NeoMagic Corp. v. Trident Microsystems, Inc., 287 F.3d 1062, 1074 (Fed. Cir. 2002);
SRIlntl v. Matsushita Elec. C01p. of Am., 775 F.2d 1107, 1118 (Fed. Cir. 1985) (en

banc). Indeed, the Federal Circuit has recently affmned this rule, stating "a court may

not use the accused product or process as a form of extrnsic evidence to supply
limitations for patent claim language." Wilson Sporting Goods Co. v. Hilerich &
Bradsby Co., 442 F.3d 1322, 1331 (Fed. Cir. 2006). The Hilerich court recognzed that

this rule does not forbid the cour from "any glipse of

the accused product or process,"
the

but was clear that courts must not tailor "a claim constrction to fit the dimensions of

accused product or process and to reach a preconceived judgment of infngement or

nonifrngement." Id. In other words, the rule "forbids biasing the claim constrction
process to exclude or include specific features of

the accused product or process." Id.

This is precisely what G1axo is doing with its proposed definition.
Glaxo's defition suraced for the first time in this litigation. It is supported only

by Dr. Anderson in his first expert report, disclosed on March 16, 2006, more than

fourteen years after the '249 patent issued. (Exhbit E at M021, Anderson 3/16/06 Expert
Report, ii 74). Dr. Anderson proposed that "ethanol" may be defined by its chemical
name, but in addition should contain the clause

""ac\eò ~eu

(Id. at ii

DBO 1 :2158300.1

12

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 17 of 29

REDACTED VERSION ­ PUBLICLY FILED

72). Dr. Anderson (on behalf of Glaxo) cites to two
this definition, neither of

Redacted

to conjure

which actually state that "ethanol" is referred to by those skilled

in the art as

Redacted

Dr. Anderson alone, in his expert report, suggests this definition, apparently by
combining both

Redacted

Neither of

those references, alone, contain the

language proposed by Dr. Anderson, however. In the same report, Dr. Anderson also
notes that

Redacted

, is

(Id. at' 74). Dr. Anderson has engaged in the practice prohibited
by Hilericli.

Dr. Anderson's definition suggests, by linguistic semantics alone, that Redacted

and ethanol are equivalent compounds. Indeed, one need only substitute, in Dr.

Anderson's defiition of ethanol, the words
the reader is left with Dr. Anderson's definition of

~ev

Å~C\;

~eÒ

and

This semantics

game should be seen for what it is -- a transparent effort to constre the claim language as
close as semantically possible to the accused formulation, which uses
not ethanoL.

Redacted

Teva's constrction, rather than aggregating and combining dictionar definitions
(as Dr. Anderson did), distils various dictionar definitions to their common elements.
As pointed out in Teva's Opening Brief, common to all dictionary definitions is that

ethanol is a chemical with the formula C2H50H. This minimalist definition comports

with the absence of a defintion of ethanol in the specification and prosecution history of
the patent.

DB01:2158300.1

13

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 18 of 29

REDACTED VERSION ­ PUBLICLY FILED

Teva's constrction most closely aligns with the intrsic record, while Glaxo's
relies solely upon extrinsic, biased, and litigation inspired expert opinion. For these
reasons, and for the reasons stated in Teva's Opening Brief, this Court should reject
Glaxo's construction, and adopt Teva's.
2. The Claim Term "Stabilizing Effective Amount" Should Be

Construed To Define What A Substantial Enhancement In

Stabilty Means.
Claims 1 - 10 are the only claims in the '249 Patent with the limitation
"stabilizing effective amount." The limitation is part of Claims 2-10 by virte of the fact

that each claim is dependent upon Claim 1. 35 U.S.C. § 112, ii 4 ("A claim in dependent
form shall be construed to incorporate by reference all the limitations of the claim to
which it refers.").
The "stabilzing effective amount" limitation was added during prosecution to

Claim 1 by amendment, but not to Claims 11 or 12. (000139-140) 1 (amending only

Claim 1). No matter how this limitation is constred, it is not present in Claims 11 or 12
of

the '249 patent and should not be added to Claims 11 and 12 through claim

interpretation. If Glaxo had intended the "stabilizing effective amount" limitation to be a
par of Claims 11 and 12, it should have amended those claims to include it, just as it had
amended other claims to include it.

Glaxo's assertion that "stabilzing effective amount" is a limitation that appears in
Claim 11 (and by dependency also in Claim 12) is predicated on a legally unsupportable
statement oflaw. Olaxo relies upon a vague recogntion of

what it asserts is "case law"

supporting the notion that "consistency of claim interpretation" mandates that "stabilzing

OB01:2158300,1

14

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 19 of 29

REDACTED VERSION ­ PUBLICLY FILED

effective amount" be read into independent Claim 11, even though the issued patent
clearly does not include the limitation. (Glaxo Brf. at pp. 23-24) (citing Glaxo Wellcome,

Inc. v. Impax Labs., Inc. 356 F.3d 1348, 1356 (Fed. Cir. 2004)).

Glaxo misreads the holding of Impax Labs. In Impax Labs, the court properly

held that where subject matter is relinquished by amendment durng prosecution in one
claim, the same subject matter is also relinquished for all other claims "containing the

same limitation." Impax Labs, 356 F.3d at 1356. The Impax court also noted that
"( c )laims that do not recite the amended term are not subject to an estoppel." Id. Here,

Claims 11 and 12 do not recite the "stabilizing effective amount" limitation. Glaxo's
vague notion of

"consistency of claim interpretation" does not apply here.

Glaxo's underlying construction of

"stabilizing effective amount" also is not

aligned in any way with the '249 patent specification, nor is it consistent with the

prosecution history. Indeed, Glaxo's defition is not a defiition at alL. It is circular.
Glaxo defines the limitation "stabilzing effective amount" as any amount "sufficient to
enhance the stability of ranitidine." (Glaxo Brf. at pp. 23-24). The specification,

however, declares that ranitidine syrps "may be substantially enhanced by the addition
of ethanol to the formulation." (CoL. 1, lines 40-44) (emphasis added). Durng

prosecution, the Examiner demanded experimental data "to show a definite improvement

over" the prior art. (G000200). Glaxo's scientist, Dr. Hempentsall, provided data to that

Patent Office and declared that it showed "a signficant and surprising enhancement in

the stability ofrantidine." (G000209). Only after a "significant and surprising"

i File history documents, referenced herein with the range GOOOlll through G000308, are
attached as Exhibits 2 and 3 to the Joint Claim Constrction Statement filed on June 30, 2006 (D.l. Nos. 106-107).

DBOI :2158300.1

15

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 20 of 29

REDACTED VERSION ­ PUBLICLY FILED

improvement in stability was demonstrated to the Patent Offce, did Glaxo receive its
claims.
Glaxo's expert agrees. Dr. Anderson's testimony on this point was not equivocaL.
He was asked during his deposition about the '249 patent specification's use of

the phrase

"substantially enhanced," and the following exchange occurred:

f\eÒ3cteò

(Exhibit H at M031, Anderson Depo. p. 53, ll. i 0-18). The bottom line is that Glaxo was

not granted a patent for the use of ethanol to simply "enhance" ranitidine stability. The
Examiner demanded evidence of a measurable "definite improvement over" the prior art.

(G000200). Glaxo responded with data and analysis, allegedly showing a "signficant

and surrising enhancement in stabilty ofranitidine." (G000209). Had Glaxo advocated
during prosecution (as it does now) that the addition of ethanol merely serves "to enhance

the stability ofranitidine," Glaxo would not have received its patent.

Under Glaxo's defiition, a formulation with ethanol that can be shown to
increase the shelf life of that formulation by even one day would "enhance the stability
of'rantidine. The Examiner, who demanded evidence of

"a definite improvement over"

the prior ar formulation, would not have seen one additional day of shelf life to be "a

definite improvement." To the contrar, Glaxo presented data and analysis purporting to
prove that ethanol alone, when added to its ranitidine formulation, resulted in an increase

DBO 1 :2158300.1

16

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 21 of 29

REDACTED VERSION ­ PUBLICLY FILED

from 13 months to 19 months of

shelf

life, when measured at 30° C. (G0002l1). Glaxo's

test compared a formulation with ethanol to the same formulation without ethanol in

order to support this assertion. (G00209). ("The advantageous effect resulting from the
addition of ethanol to an aqueous based ranitidine formulation can readily be determined
by comparing the stability of

the ranitidine in a formulation according to the present

invention and the same formulation but without added ethanoL.").

Teva's proposed definition, however, is taken directly from the prosecution

history. The specification provides no guidance except to show that the stability of

ranitidine solution must be "substantially enhanced." Teva's opening brief shows where
in Dr. Hempenstalls declaration each word ofTeva's proposed definition finds support.
(D.L No. 101, pp. 13-14). This definition, fully supported by

the intrnsic evidence, is the

one that should be adopted under Phillps.
Glaxo's circular definition of

"stabilizing effective amount" ignores the intrnsic

record. In contrast, Teva's constrction closely follows the methodology employed by

Dr. Hempenstall to measure a "signficant and surrising enhancement in stability of the

ranitidine." (G000209). Whle Teva proposes a definition that actually ariculates what
it means to "substantially" enhance rantidine stability (consistent with the '249 patent
specification), Glaxo's constrction ignores any aspect of

what the enhancement actually

is. Glaxo's proposed constrction should, therefore, be rejected.
3. This Court Should Reject Glaxo's Efforts To Import

Redundant Limitations Into The '249 Patent Claims.
Another signficant problem with Glaxo's proposed constrction of

"stabilzing

effective amount" is that Glaxo's constrction also imports the extraneous clause
"contained in an aqueous formulation for oral administration," into its definition of

DB01:2 158300. i

17

058956. i 0 11

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 22 of 29

REDACTED VERSION ­ PUBLICLY FILED

"stabilizing effective amount." Glaxo attempts to import this extraneous limitation into

the term, despite the fact that that language already is in Claims 2-10 by virte of those
claims' dependency on Claim 1.

The Federal Circuit has long been explicit that a patentee may not proffer a claim

interpretation "for the purposes of litigation that would alter the indisputable public
record consisting of the claims, the specification and the prosecution history, and treat the
claims as a 'nose of wax.''' South

wall Technologies v. Cardinal IG Co., 54 F.3d 1570,

1578 (Fed. Cir. 1995) (citing Senmed, Inc. v. Richard-Allan Med.lndus., Inc., 888 F.2d

815,819 n. 8 (Fed. Cir. 1983)). Should Glaxo's construction be adopted, this Court
would read an unecessary redundancy into Claims 1-10. Read literally, under Glaxo's

constrction, Claim 1 would be molded to twice state that the formulation involved is an
aqueous formulation for oral administration, as follows:
A pharmaceutical composition which is an aqueous formulation for oral
administration of an effective amount of rantidine and/or one or more

physiologically acceptable salts thereof, said formulation comprising a stabilizing effective amount an amount sufficient to enhance the stabilty
of the ranitidine active ingredient contained in an aqueous formulation
for oral administration of ethanol and said composition having a pH in

the range of6.5-7.5.
(Col. 2, line 67 - Co!. 3, line 4) (emphasis (bold), Glaxo's proposed change (underline)

added, and original claim language deleted (strcken out)). The same redundancy would
then be incorporated into each of

the claims dependent on Claim 1, Claims 2-10. Further,

should "stabilizing effective amount" also be read into Claim 11, the same redundancy
would be read into Claims 11-12. Such a liberal claim revision is explicitly prohibited by
law. SoutJiwall Technologies, 54 F.3d at 1578.

DB01:2158300.1

18

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 23 of 29

REDACTED VERSION ­ PUBLICLY FILED

Moreover, this constrction improperly imports extraneous and unecessar

limitations into the claims. As stated in Teva's Opening Brief, district courts are
consistently cautioned by the Federal Circuit to be careful not to import undue limitations
into the definitions of claim terms when they are not necessar. See Renisliaw PLC v.
Mmposs Societa' per Azioni, 158 F.3d 1243, 1248 (Fed Cir. 1998) ("If

we need not rely

on a limitation to interpret what the patentee meant by a particular term or phrase in a
claim, that limitation is 'extraneous' and cannot constrain the claim.") (citations omitted);

see also Hogaiias AB v. Dresser Indus., Inc., 9 F.3d 948,950 (Fed. Cir. 1993) ("It is
improper for a court to add 'extraneous' limitations to a claim, that is, limitations added

wholly apart from any need to interpret what the patentee meant by paricular words or

phrases in the claim.") (quoting Du Pont de Nemours & Co. v. Plillps Petroleum Co.,
849 F.2d 1430, 1433 (Fed. Cir. 1988)).
4. This Court Should Reject Glaxo's Efforts To Import
Extraneous Limitations Into Claims 2 And 3 Of

The '249

Patent In The Interpretation Of The Phrases "2.5% To 10%
WeightIolume" And "7% to 8% WeightNolume."

Glaxo's back-up scheme for importing the "stabilizing effective amount"
limitation into every claim of

the '249 patent begins with a spurious constrction of

"2.5% to 10% weight/volume," and "7% to 8% weight/volume" as recited in Claims 2
and 3 respectively. Glaxo's constrction repeats each volume-based limitation verbatim,

but adds its construction of "stabilizing effective amount" to both phrases. Glaxo needs

to import this limitation into Claims 2 and 3 because this defition for Claim 3 is critical
to Glaxo' s effort to read "stabilizing effective amount" into Claim 11.

However, Claims 2 and 3 already have the "stabilzing effective amount"
limitation (no matter how that clause is constred) by virte of

their respective

DBO 1 :2 1 58300.1

19

058956.101 1

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 24 of 29

REDACTED VERSION ­ PUBLICLY FILED

dependency on Claim 1. Glaxo' s construction would read yet another redundancy into
Claims 2 and 3 that is not necessary. Both claims, by operation oflaw, have all of

the

limitations of Claim 1, with the further restriction on each formulation requiring differing
specific amounts of ethanoL. There is no need to repeat the "stabilizing effective amount"

limitation in the text of Claims 2 or 3. That limitation already is present, and has nothing
to do with the specific volume limitations of ethanoL.

To the contrary, the presence of a dependent claim that adds a paricular limitation
gives rise to a presumption that the limitation in question is not present in the

independent claim. See Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898,910 (Fed.
Cir. 2004). As applied here, the specific volumetric limitations stated in Claims 2 and 3
are presumed to be absent from Claim 1, not equated to the "amount" limitation stated in

Claim 1, as Glaxo suggests. Indeed, it is reasonable to conclude that Glaxo meant to
maintain a difference between Claim 1 and each of the other claims with numerical
ranges when it had the opportnity to add the "stabilizing effective amount" language to
the numerical range claims, such as Claims 11 and 12, but did not do so. See Toro Co. v.

White Consol.lndus., Inc., 199 F.3d 1295 (Fed. Cir. 1999) ("There is presumed to be a
difference in meaning and scope when different words and phrases are used in separate

claims.") (citing Tandon Corp. v.ITC, 831 F.2d 1017,1023 (Fed. Cir. 1987). Put another
way, Glaxo did not "functionally define" the numerical limitations on the amount of
ethanol in any maner, even though it could have.

Glaxo argues that its constrction of Claims 2 and 3 is consistent with the "legal
doctrne that dependent claims incorporate all of the limitations of

the independent claim

from which they depend." (Glaxo Brf. at p. 31) (citing 35 U.S.C. § 112 para. 4 and In re

DBO 1 :2158300.1

20

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 25 of 29

REDACTED VERSION ­ PUBLICLY FILED

Beaver, 893 F.2d 329,330 (Fed Cir. 1989)). Glaxo is correct that such a legal doctrine
exists, but Glaxo's claim construction actually contradicts the doctrne. The fact that
dependent claims incorporate all of the limitations of

the independent claim from which

they depend means that Glaxo's constrction would read "stabilizing effective amount"
into Claims 2 and 3 twice. Such redundancy is nothing but an effort by Glaxo to re-wrte
its claims, and must be rejected. SouthwaU Tech., 54 F.3d at 1578.
5. Glaxo's Construction Of Claim 11 Is Wrong.

The true motivation behind Glaxo' s proposed interpretation of Claims 2 and 3 is

that equating "7% to 8% weight/volume ethanol," as recited in Claim 3, with a
"stabilizing effective amount," allows Glaxo to import the same limitation into Claim 11.
In general, it is true that the same claim limitation in different claims should be construed

consistently. Phillps, 415 F.3d at 1314 (stating that "claim terms are normally used
consistently throughout the patent, the usage of a term in one claim can often iluminate
the meaning of

the same term in other claims.") (citing Rexnord COlp. v. Laitram COlp.,

274 F.3d 1336, 1342 (Fed. Cir. 2001); and CVI/Beta Ventures, Inc. v. Tura LP, 112 F.3d
1146, 1159 (Fed. Cir. 1997)). Thus, if

Glaxo succeeds in equating the "7% to 8%

weight/volume" limitation of Claim 3 with a "stabilzing effective amount," then Glaxo
argues that "7% to 8% weight/volume" as it appears in Claim 11 should be similarly
constred. Glaxo's argument, however, fails on two grounds.

First, as established above, there is no legal basis for importing the limitation
"stabilizing effective amount" into Claim 2 or Claim 3, because that limitation already is

present in those claims due to their respective dependency on Claim 1. Second, Claim

11, as considered and issued by the Patent Offce, simply does not include the "stabilzing

DB01:2158300.1

21

058956.1

OJ 1

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 26 of 29

REDACTED VERSION ­ PUBLICLY FILED

effective amount" limitation. Glaxo's constrction would effectively re-write Claim 11
and Claim 12 to import a limitation that they do not have. Such a revision of

issued

claim terms is prohibited. Southwall Tech., 54 F.3d at 1578.

Moreover, Glaxo could have amended Claim 11 to include the "stabilizing

effective amount" limitation, but it did not. Glaxo's failure to amend Claim 11 to include
this limitation cannot be cured before this Court. The public and Teva have relied upon
the text of issued Claims 11 and 12 since 1991, and they may not be amended now.

Phillps, 415 F.3d at 1312. ("Because the patentee is required to 'define precisely what his invention is,' the Cour explained, it is 'unjust to the public, as well as an evasion of
the law, to construe it in a maner different from the plain import of its terms. "'(citing
White v. Dunbar, 119 U.S. 47, 52 (1886)).
6. This Court Cannot Issue An Advisory Opinion To Construe

Limitations That Teva Admits.
Teva explained, in its opening claim construction brief, that courts need not
constre claim limitations that a defendant concedes are met by the accused process.

(D.L No. 157 at pp. 18-19). Teva has admitted its formulation is an aqueous formulation

for oral administration, so this Court need not constre ths limitation. U.S. Surgical Co.
v. EthicOll, 103 F.3d 1554, 1568 (Fed. Cir. 1997).

OB01:2158300.1

22

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 27 of 29

REDACTED VERSION ­ PUBLICLY FILED

V. CONCLUSION
For the reasons stated above, Teva respectfully urges the Court to adopt its
proposed constructions of

the disputed claim terms presented for constrction.

YOUNG CONAWAY STARGATT &
TAYLOR, LLP

vi'- ¿
JÓs W. Ingersoll (# 1 88) Karen E. Keller (# 4489) Young Conaway Stargatt & Taylor, LLP The Brandywine Building 1 000 West Street, 17th Floor P.O. Box 391 Wilmington, DE 19899 Telephone: (302) 571~6600 kkeller(êycst.com

MERCHAT & GOULD P.C.
Mark D. Schuman Ronald A. Daignault
J effer Ali

Jeffrey C. Brown 3200 IDS Center 80 South 8th Street

Mireapolis, MN 55402
Telephone 612~332~5300

Teva Pharmaceuticals USA, Inc. and Teva Phannaceutical Industries, Ltd.

Dated: July 28, 2006

DBO 1:2158300.1

23

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 28 of 29

REDACTED VERSION ­ PUBLICLY FILED

CERTIFICATE OF SERVICE

I, Karen E. Keller, Esquire, hereby certify that on July 28, 2006, I caused to be
electronically filed a tre and correct copy of the foregoing document with the Clerk of

the Court

using CM/CF, which wil send notification that such fiing is available for viewing and
downloading to the following counsel of record:

Francis DiGiovann, Esquire Connolly Bove Lodge & Hutz LLP The Nemours Building 1007 North Orange Street Wilmington, DE 19801
I further certify that on June 30, 2006, I caused a copy of

the foregoing document to be

served by hand delivery on the above-listed counsel of

record and on the following non-

registered paricipants in the maner indicated:

BY E-MAL AND FEDEX
Brian P. Murhy, Esquire
Thomas Puppa, Esquire

Morgan Lewis & Bockius, LLP 101 Park Avenue

New York, NY 10178-0060
YOUNG CONA WAY STARGATT & T AYLOR, LLP

11. aAJ AV.i Kar~. Keller (N . 4489)

~ ~~

The Brandywine Building 1000 West Street, 17th Floor
Wilmgton, Delaware 19801

(302) 571-6600

kkellerêycst.com
Attorneys for Teva Pharmaceuticals USA, Inc. and
Teva Pharmaceutical

Industries, Ltd.

0801:2137690.1

058956.1011

Case 1:04-cv-00171-GMS

Document 137

Filed 08/04/2006

Page 29 of 29