Free Redacted Document - District Court of Delaware - Delaware

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWAR

GLAXO GROUP LIMITED )

v. )

Plaintiff, )
) )

Civil Action No. 04-171-KAJ
)

TEV A PHARCEUTICALS USA, INC. and )

TEV A PHACEUTICAL INUSTRIS )

LIMITED )
YOUNG

CONFIDENTIAL FILED UNDER SEAL

Defendants. ))
CONAWAY STARGATT &

TEV A'S BRIEF IN OPPOSITION TO GLAXO'S MOTION FOR SUMMARY JUDGMENT OF PATENT INFRINGEMENT

TAYLOR, LLP Josy W. Ingersoll (# 1088) Adam W. Poff (# 3990) Karen E. Keller (# 4489)

The Brandywine Building 1 000 West Street, 17th Floor P.O. Box 391 Wilmington, DE 19899 Telephone: (302) 571-6600 kkeller~ycst. com
MarkD. Schuman

Ronald A. Daignault
J effer Ali

Jeffrey C. Brown Merchant & Gould P.C. 3200 IDS Center 80 South 8th Street Minneapolis, MN 55402
Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd.

Dated: July 28, 2006

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T ABLE OF CONTENTS

i. STATEMENT OF THE NATUR AN STAGE OF THE PROCEEDING.........1
II. SUM Y OF THE ARGUMENT.................................... ......... ............. ............1
II. STATEMENT OF THE FACTS .... ................. ................ ..... .......... .......... ....... ........3

A. The Experts Do Not Agree That In Teva's
Formulation Performs The Same Functions As Ethanol .............................3

B. Glaxo's Summary onts Own Expert Opinion Omits A Critical
Failure Of Proof...........................................................................................4
C. The Experts Have Opposite Conclusions On Whether
In Teva's Formulation Stabilizes Rantidine In Any Marer.........6

\,eÒ

D.

Glaxo Has Not Analyzed Whether Alone Stabilizes Ranitidine In Teva's Generic Formulation ..................................................8
Dr. Kibbe

~eÒ'l v

E.

Concludes
................................................11

F. The Experts Disagree On The "Proportionality" Of Of

The Amounts

Ethanol Recited In Claims 2-3 and 11-12.............................................12

G. The "Novopharm Development Report" Alleged To Have

"Gone Missing" Is Attached As Exhibit 27 To The Declaration Supporting Glaxo' s Opening Brief........ ............ ............................. ...... ....13

IV. ARGUMENT ......................................... ................ ............................................... .16

A. Teva, Not Glaxo, Is Entitled To Summary Judgment..............................17
1. Glaxo Lacks Sufficient Evidence Showing Teva's

Formulation Meets The "Ethanol" Claim Limitation Under The Doctrne Of Equivalents ............... ............. ......................... ....18
a.
The Law Of The Doctrine Of Equivalents.........................

18

b.
c.

"Ethanol" Means "Ethanol" And Nothing More ...............19
Glaxo Has Failed To Prove That Ethanol In A Ranitidine Solution ................. ............. ......... .................... .l9
Has All Of

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2. Glaxo Also Has Failed To Prove That Teva's Formulation

Meets The "Stabilizing Effective Amount Of' Element Of
Claims 1-10............ ........ ........... .............. ............ ................ ......... ..21
B. Alternatively, Genuine Issues Of

Material Fact Preclude A Finding That Any Claim Element Is Satisfied Under The Doctrine Of Equivalents............................................. .............................. .22
1.

The Competing Expert Opinions Of Glaxo And Teva Preclude Summary Judgment Against Teva ..................................22 Whether Teva's Formulation Is Substantially Different
From The Claimed Invention Is A Question Of

2.

Fact ....................25

3.

Infrngement Under The Doctrne Of

Glaxo Misstates The Law Concerning The Test For Equivalents ........................27

4.

~ Does Not Support Any Inference Of

eòac\eò

Infrngement By Teva............................ ....................................... .29
C. The Glaxo v. Pharmadyne Decision Is Not Binding Or

Persuasive Precedent.. ......... .............. ........................................................ .29
D. There Is No Factual Or Legal Basis For The Extreme

Evidentiary Sanction Glaxo Seeks .................. .................................. ....... ..31

V. CONCLUSION ................. ......................................................... ............ ............... .33

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TABLE OF AUTHORITIES

FEDERA CASES
Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141 (1989)............... ................ ......... ....... ......................... ................................ .27
Cryovac Inc. v. Pechiliey Plastic Packaging, Inc., 430 F. Supp. 2d 346 (D. DeL. 2006).................................................................................22

Curtis T. Bedwell & Sons, Inc. v. International Fidelity Ins. Co.,

843 F.2d 683 (3d Cir. 1988) ..........................................................................................31
Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co.,

535 U.S. 722 (2002)....................................................... ................................................. .26
Glaxo Wellcome, Inc. v. Pharmadyne COlp.,

32 F. Supp. 2d 265 (D. Md. 1998)...........................................................................passim
Goodman v. Mead Johnson & Co.,

534 F.2d 566, 573 (3d Cir. 1976).....................................................................................l7
Graver Tank & Manufacturing Co. v. Linde Air Products Co., 339 U.S. 650 (1950).. .............. ..... ......... ............... ...................................................... ..6, 19
Hilgraeve COlp. v. McAfee Assocs., Inc., 224 F.3d 1349 (Fed. Cir. 2000)......................................................................22, 23, 24, 25

Hilton-Davis Chemical Co. v. Warner-Jenkinson Co. Inc.,
62 F .3d 1512 (Fed Cir. 1995)............. ..... ........................ ......... .......... ....... .... .................. .27
Ins. COJp. of Ir. v. Compagnie Des Bauxites De Guiliee,

456 U.S. 694 (U.S. 1982)......... ......... ............. .............................................. ................... .31
Legett & Platt, Inc. v. HickOlY Springs Mfg. Co.,

285 F.3d 1353 (Fed. Cir. 2002)................................................. ..................................... ..22

Liafail, Inc. v. Learning 2000, Inc., 2002 U.S. Dist. LEXIS 24803 (D. Del 2002) .................................................................31
Microsoft COlp. v. IQ Tech., Inc., 1993 U.S. App. LEXIS 16128 (Fed. Cir. 1993) ..............................................................17
Petrocell v. DaimlerCluysler Corp.,
2006 U.S. Dist. LEXIS 11972 (D. DeL. 2006) .....................................................17,27,29

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Playtex Prods., Inc. v. Proctor & Gamble Co., 400 F.3d 901 (Fed. Cir. 2005)..........................................................................................18
Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133 (2000) ........................................................................................................17
Southland Sod Farms v. Stover Seed Co., 108 F.3d 1134 (9th Cir. 1997) .........................................................................................22
Spear v. Commissioner (Estate of Spem),

4l F .3d 103 (3d Cir. 1994)...... .................... ........................................ .................. ........ ...31

State Farm Fire & Casualty Co. v. Estate of Jenner, 856 F.2d 1359 (9th Cir. 1988) .........................................................................................22
United Carbon Co. v. Binney & Smith Co.,

317 U.S. 228 (1942)................................. ....................... ............................................... ..26

Warner-Jenkinson Co. v. Hilton Davis Chemical Co.,
520 U.S. 17 (1997).........................................................................................18,26,28,29

FEDERA STATUTES
21 U.S. C. § 3 55U) . .............. .............. ................ ........... .............................................. ..........1

Fed. R. Civ. P. 56( c) .. ....... ....... ....... ......................... ........ ........................... ................ .......17

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1. STATEMENT OF

THE NATURE AND STAGE OF THE PROCEEDING

This is a patent infrngement action initiated by Glaxo following Teva's

submission of an Abbreviated New Drug Application ("ANA") under 21 U.S.C. §
355U) to the Food and Drug Administration ("the FDA") for approval of a generic

formulation ofGlaxo's ZantacCI 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.

Ò

Teva's generic formulation is different from the claims of

the '249 patent because

~eò~

v"ø

it includes

rather than ethanol, among other differences.
the elements of

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

the

claims of

the '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."
Glaxo has moved for summar judgment of

patent infrngement, asserting Teva's generic

formulation infrnges all claims of

the '249 patent under the doctrine of equivalents.

II. SUMMY OF THE ARGUMENT
Glaxo's motion should be denied because "ethanol" in the claims of

the '249

patent can have no range of equivalents beyond "ethanoL." Teva's affirmative motion for
summar judgment sets forth in detail that five distinct legal and policy limitations on the
use of

the doctrine of equivalents prevent Glaxo from expanding the claims ofthe '249

patent beyond the disclosed and claimed "ethanoL" (D.I. No. 104). Teva's position is
that the doctrine of equivalents is not available to Glaxo in this matter but, for sake of

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brevity, those arguents wil not be repeated here. Those arguments alone, however,

justify the denial of Glaxo's motion.
Assuming this Court deems some range of equivalents to be appropriate, then
Glaxo's motion also should be denied because Glaxo has failed to prove that the
in Teva's formulation meets the claim term "ethanol" under the doctrie

~ø

d bfl

ø'ò

of equivalents. Moreover, Glaxo has failed to prove infrngement of claims i -10 because
there is no evidence that

, in any amount, meets the claim term

"stabilizing effective amount." It is not disputed that the use of

bufferig salts and other

preservatives enhance the stability ofranitidine oral solutions (which are in Teva's
formulation), and Glaxo cannot prove that the addition of
contributes in

any manner to the stability ofTeva's formulation. At the very least, genuine issues of
material fact preclude judgment as a matter oflaw on the question of

whether Teva's

formulation infringes under the doctrne of equivalents, assuming Glaxo is entitled to
expand its claims under the doctrine in any respect.
This Court also should reject Glaxo's request for a negative inference of

patent

infrngement. Glaxo not only has the document in question, but also relies on the
document to support its motion. Glaxo's improper discovery motion (never mentioned to
Teva until now) is based on nothing but naked inferences that are built upon a blatant
mischaracterization of

the record. Glaxo hopes to conjure a false impression of discovery

misconduct, where none exists. There is no legal or factual basis for the severe
evidentiar sanction Glaxo requests, and the Court should deny Glaxo' s request.

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III. STATEMENT OF

THE FACTS

Glaxo's Statement of

Facts omits important context and ignores other material
the viability of

facts necessar for this Cour's evaluation of

Glaxo's motion.

A. The Experts Do Not Agree That In Teva's
Formulation Performs The Same Functions As EthanoL.
Glaxo's expert opinion is contradicted, not confirmed, by the analysis of

Teva's

expert, Professor Arhur H. Kibbe, Ph.D. Professor Kibbe unequivocally concludes, in
his opening report, as follows:

'leÒ

~eÒI(V
(Exhibit 15 at A098, Kibbe Report, March 14,2006, ir 86) (original emphasis). Dr.
Kibbe also concludes that

(Id. at A093, ~

66.) Moreover, Dr. Kibbe advises, and Glaxo does not dispute, that the basic chemical
structure of
is significantly different from ethanoL. (Id. at A095-A097,

irir 76-83.) Dr. Kibbe concludes

(Id. at A097, ir 82.)

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Dr. Kibbe also will testifyl in rebuttal to Dr. Anderson's analysis. Dr. Kibbe's
rebuttal report explains in detail that Dr. Anderson's analysis is
, (Exhibit 16 at A101, Kibbe Rebuttal

Report, April 24, 2006, ii 5). Ultimately, Dr. Kibbe concludes that

f\eÒac\eò

(Id. at ii 3b.)

Dr. Kibbe also specifically challenges Dr. Anderson's conclusion concerning the

in which ethanol stabilizes ranitidine in oral solutions in comparison to Teva's
formulation. Dr. Kibbe notes that the impurties measured in each of

Dr. Anderson's
(Id. at A104, ii

tests degrade at rates that are

14.) (emphasis added). Using Dr. Anderson's own tables, Dr. Kibbe concludes:

~C9

(Z q,,~

(Id. at A104-105, ii 15.) Dr. Kibbe, after further analyzing the degradants shown in Dr.
Anderson's report, concludes that \

~t1

(Id. at A107, ii 24.)
B. Glaxo's Summary Of Its Own Expert Opinion Omits A Critical
Failure Of Proof.

Dr. Kibbe's report refutes the conclusions reached by Dr. Anderson. This, by
itself, creates fact issues for the Court to decide. Putting Dr. Kibbe's opinions aside,
i Neither part contends the other's respective expert evidence is not admissible under Rule 702

of the Federal Rules of Evidence, as no Daubert motions have been fied.

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however, even Glaxo' s own expert report and deposition testimony fail to make out a

case of infringement under the doctrine of equivalents. Dr. Anderson presented no
evidence to this Court proving that
ethanol in an oral ranitidine solution.
performs all of

the functions of

Dr. Anderson, in his first of several expert reports, declared that ethanol performs

~eÒaC\e

Ò
(Exhibit 1 at A002, Anderson Report,

March 16, 2006, ~ 40). Dr. Anderson confirmed in his deposition that, as taught by the
'249 patent,

(Exhibit 17 at A132-A133, Anderson Depo. pp. 71-72).
As a confirmation of

Dr. Anderson's opinion, Dr. Long, the inventor ofthe '249 patent,
because it did not perform the antimicrobial (preservative)

abandoned

fuction. (Exhibit 8 at A039-A041, Long Tr. at pp. 408-09; 445, lines 1_~)2; Glaxo
Wellcome, Inc. v. Pliarmadyne Cmp., 32 F. Supp. 2d 265,278 (D. Md. 1998).

Regarding the solvent function, Dr. Anderson testified that, as taught by the '249 patent,
(Exhibit 17 at

A133-A134, Anderson Depo. pp. 72-73). Even in his deposition, Dr. Anderson admitted
that ethanol

in ranitidine formulations, both as taught in the

'249 patent, and as used in Glaxo's syrp. (Id. at A134, p. 73)

tieN
2 Citing to the tral transcript of

'-aCoJ

(ect

Dr. Long's testimony in Glaxo v. Pliarmadyne.

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Dr. Anderson, however, did no analysis to determine whether the in Teva's formulation performs the function of
(Id. at A131, p. 64)

~eÒac\eò
He also did not analyze whether the Teva's formulation acts as
A130, p. 58)
in
(Id. at

Dr. Anderson, therefore, provides no opinion concernng

whether

performs all

'of ethanol in the '249 patent.

Dr. Anderson's report and deposition show that Glaxo has no proof that the
in Teva's formulation provides all of

the same functions, or their substantial

equivalent, of

the functions performed by ethanol in Glaxo's patent. Under Graver Tank,
lack of proof

this is a fatal

under the function, way, result test.

Redacted

c.

The Experts Have Opposite Conclusions On Whether

In Teva's Formulation Stabilizes Ranitidine In Any Manner.
Dr. Kibbe also contradicts Dr. Anderson's analysis concernng whether

stabilizes rantidine in Teva's formulation as claimed by the '249 patent. Dr.
Kibbe's rebuttal report explains in detail that

(Exhbit 16 at Al13-AI16, ~~ 45-52). Indeed,
Dr. Kibbe's analysis ofthe same data Dr. Anderson reviewed supports the conclusion
that

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(Id. at A115A116, ~ 52i

Dr. Anderson also admitted in his deposition that

~eÒac\eå
(Exhibit 17 at A121-AI23, Anderson Depo.
pp.20-22). For instance, with reference to Exhibit 6 of

Dr. Anderson's first report,

(Exhibit 17 at A124-A126, Anderson Depo. pp. 25-27).

Moreover, Dr. Anderson (at least in his expert report) asserts that

Redacted
(Exhibit 18 at AI51-152, ir 61; Exhibit 17 at AI27-AI29,

Anderson Depo. pp. 31-33). In fact, when comparng two batches of solution with
to two
, in three of

the possible four

comparisons, the lower confidence level from the Teva formulation overlaps with the
upper confidence level of the Glaxo formulations without ethanoL. In three of the four
tests, Teva's
formulation did not improve rantidine stability in a

statistically significant manner.
3 Glaxo's brief seems to suggest that the test for stability is whether the applicant to the FDA asks
Dr Hempenstall in the prosecution of

for a 24-month stability rating or not. (Glaxo Brf. at pp. 2, 5 and 16.). This is not the test used by the '249 patent, and it is not the test used by its own expert, Dr. Anderson.

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D.

Glaxo Has Not Analyzed Whether

Alone Stabilizes

Ranitidine in Teva's Generic Formulation.
There is no evidence before this Cour that compares Teva's formulation with
to Teva's formulation without

. The only comparson

presented by Glaxo (Dr. Anderson) is an analysis ofTeva's formulation compared to
"the prior art formulation," Glaxo's formulation without ethanoL. Dr. Anderson admitted

in his deposition that

f\edacted (Exhibit 17 at A135-136; Anderson Depo.
pp. 197-198.) He did not make this comparson even though he testified that it would

have been relatively routine for Glaxo or another independent lab4 to have done so. (Id.
at A137-AI38, pp. 211-212). Aside from any direct proof of infrngement, the lack of

testing supports an inference that Dr. Anderson suspected that a head-to-head comparson
ofthe Teva formulation with and without ethanol would have resulted in a showing of

no

stabilizing effect for
and relatively simple test.

That is why he did not do this highly probative

Redacted

There is ample evidence suggesting that other components ofTeva's formulation
act to stabilize the solution, and Glaxo has not even attempted to prove that

has an additional stabilizing effect on Teva's formulation, much less the sole

excipient responsible for a "substantial" enhancement, as taught by the '249 patent. The
undisputed evidence shows that Teva's formulation is different in many respects from

4 Although Glaxo repeatedly declares Dr. Anderson's analysis to be "independent," in fact it is

not. Dr. Anderson extrapolated from the existing
data to reach his conclusions. (Exhibit 17 at A1l9-A120, Anderson Depo. pp. 15-16).
~Id. at

A134D-E, Anderson Depo. pp. 142-143). His deposition may also have uncovered data that
(Id. at A134A-E, Anderson Depo. pp. 139-143). His

analysis is in no way independent, as Glaxo repeats throughout its brief.

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Glaxo's ZantacCI syrp. (Glaxo Brf. at p. 13, table 1) (providing a formulation
comparison between Glaxo and Teva's formulations). The Teva formulation, of course,

differs from Glaxo's syrp in that it has

- and not ethanoL. (Id.)

JreÒ

There are further important differences. Teva's formulation includes more

~eÒ0.C~
listed in Teva's ANA application as "
00 i 67). Teva's formulation also lists
"

. (Id.) Both ingredients are
(Exhibit 19 at A158, document T

(Glaxo Brf. at p. 13, table 1). In Teva's

formulation, there is
syrp. (Id.) Except for the amount ofrantidine and the amount of

than is present in Glaxo's

the other buffering

agent, no other ingredient in Teva's formulation contains the same amount as the
corresponding ingredient in Glaxo's ZantacCI syrp. (Id.)

There is no dispute that the presence of

buffering agents and preservatives in a

ranitidine formulation signficantly improves the stability ofranitidine oral formulations.
Dr. Anderson, in fact, states in his rebuttal report that

tieN \.aCte
(Exhibit 20 at Cf

AI62-AI63, Anderson Rebuttal Report, April 24, 2006 at ~ 23). Dr. Anderson's opinion,
however, flatly contradicts another Glaxo patent.

British Patent No.2, 142,820, the "Padfield" reference, states "the shelf1ife of

aqueous based formulations containig ranitidine . . . may be signficantly enhanced if the
pH of the formulation is adjusted within the range of 6.5-7.5." (Exhibit 11 at A050, lines
19-21) (D.I. No. 105) (emphasis added). Padfield also teaches that the pH of

the

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formulation "is adjusted on manufacture within the range 6.5-7.5 by means of the use of

suitable buffer salts. ..." (Exhibit 11 at A050, lines 31-32).5 As in the Padfield
reference, an early development report6 associated with Teva's formulation states that

~edacted
Langer Decl., D.I. Nos. 99 and 100).
It is the
not the

(Glaxo Exhibit 27, attached to

that stabilizes Teva's formulation.

This is how it was designed. The Padfield patent, although owned by Glaxo, has now
expired and is available for the public to use. Glaxo's own Padfield patent and Teva's
(Novopharm's) development report both consistently conclude that

Teva's forn1Ulation also contains

Glaxo's ZantacCß syrp. (Glaxo Brf. at p. 13). Dr. Anderson contends that

, but Dr. Kibbe disagrees. (Exhibit 16 at A 116,
Kibbe Rebuttal Report, April

24, 2006 ~~ 53-57). Dr. Kibbe concludes that

J:eaaCteCl

(Id. at ~ 55.)

5 U.S. Patent 4,585,790 to Padfield (Exhibit 21) is the corresponding U.S. patent to British Patent

2,142,820. The identical language cited above can be found at Exhbit 21 at A169, Col. 1, lines
27-31 and Col. 1, lines 48-50.

6 As explained in the following section, the development report, authored by Novopharm (a

Canadian company that Teva acquired six years ago) was produced by Teva in Februar of2005. 7 Although Dr. Anderson is of the opinion that

the fact is that he never compared Teva's . to the same product
without (Exhibit 17 at A135-138, Anderson Depo. pp. 197-198; 211-212).

Such a comparison could have eliminated the effect of both solutions being equal, but he did not perform this test, although it would have been routine for either Glaxo or another lab to have done so.

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Glaxo certainly knows how to analyze the stability ofranitidine formulations. In
fact, Dr. Hempenstall declared during prosecution of

the '249 patent that "(t)he

advantageous effect resulting from the addition of ethanol to an aqueous based ranitidine
formulation can readily be determined by comparng the stability of

the ranitidine in a

formulation according to the present invention and the same formulation but without the

ethanol added." (G000209, Dr. Hempenstall Dec1 at ~ 5)8 (emphasis added). Glaxo has

not done this comparson with Teva's formulation and, therefore, cannot state what, if
any "advanta£eous effect" results from the use of
in Teva's formulation.

"''3C\e ~eu

Ò

E.

Dr. Kibbe explains that

(Exhibit 15 at A097-A098, ~~ 84-86). Dr. Kibbe explains that

(Exhibit 16 at A107, Kibbe Rebuttal Report, April

24, 2006 ~ 22). Dr. Kibbe also notes that

/YeN

'-qCt
conflct with Dr. Anderson's conclusion. (Id. at AI04-105, ~~ 14-16.) Ultimately, Dr. eCf
Kibbe concludes that

(Id. at A108, ~ 29.)

8 File history documents, referenced herein within the range G0001 1 1 through G000308, are

attached as Exhibits 2 and 3 to the Joint Claim Constrction Statement fied on June 30, 2006 (D.l. Nos. 106-107).
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Moreover, Teva has learned in discovery that another Glaxo scientist, Dr. Bird,

held an opinion internally at Glaxo similar to Dr. Kibbe's in the present matter. Both are

contrary to Dr. Anderson's supposed "independent analysis." Dr. Bird analyzed Glaxo's
stability data and concluded that

(Exhibit 12 at A054) (D.!. No. 105) (emphasis added). She
stated, however, that
(Id.)

(emphasis added). Yet, Dr. Hempenstall, when he submitted his Declaration to the Patent
Office, omitted some of Glaxo' s stability data and concluded that the ranitidine stability

was "a highly signficant and valuable improvement." (G000211).9 Notwithstanding the
inference that Dr. Hempenstall intended to deceive the Patent Office, there is certainly
objective, factual, and independent evidence corroborating Dr. Kibbe's conclusions in
this matter.

"'laC\e ~eV

Ò

F. The Experts Disagree On The "Proportionality" Of The Amounts Of
Ethanol Recited In Claims 2-3 and 11-12.

Dr. Kibbe, in his rebuttal report, specifically takes issue with Dr. Anderson's
conclusion that

(Exhbit 16 at All1, ~ 39)

Dr. Kibbe also
notes,

9 Both Dr. Hempenstall and Dr. Anderson omitted data in their analysis and both concluded that

ethanol Dr. Bird looked at
DBOI:2158224.1

(Exhibit 12 at

A054) (D.!. No. 105).

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This amount far exceeds the volume ranges recited in
claim 2-3, and 11-12 of

the '249 patent. (Exhibit 16 at AIII-AI12, Kibbe Rebuttal

Report, April

24, 2006, ~,i 39-42).

G. The "Novopharm Development Report" Alleged To Have "Gone

Missing" Is Attached As Exhibit 27 To The Langer Declaration

~eÒ

Supporting Glaxo's Opening Brief.

~eÒ'(C~

The quest for the so-called "Novopharm Development Report" is a tempest in a
teapot, stirred by Glaxo alone. A careful review of

the documents relied on by Glaxo

shows that the substance of what several witnesses have identified as the "Novopharm

Development Report" was located and produced to Glaxo on February 11,2005, months

before Glaxo fist moved this Court for its production. (Exhibit 22 at A171). Indeed,
Glaxo relies on this very document that it claims has "gone missing" in its moving papers

to constrct its tenuous inferences of copying by Novophar. (Glaxo Exhibit 27 to
Langer Decl., D.I. Nos. 99 and 100).

Unraveling Glaxo's deception concerning the ''Novophar Development Report"

requires some context. Teva acquired Novophar in April of2000. (Exhibit 23 at
AI72-A173).10 Teva adopted Novopharm's

(Exhibit 2 at A008) (D. 1. No. 105). An email from a Novophar employee

dated September 9,2004, was produced to Glaxo on February 11,2005, document no. T
07268. (Glaxo Exhibit 30 to Langer Decl.). This email to Sarah Lahtinen, a Director

of

10 Teva Press Release, AprilS, 2000, ww.tevapharm.com/pr/2000/pr_237.asp. The acquìsìtion
occurred more than sìx years ago. Teva's acquìsìtion ìs hardly "recent," as suggested by Glaxo.

(Glaxo Brf. at p. 2) (describìng Novopharm as "a recently acquìred wholly-owned subsìdìary of'

Teva.).

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Regulatory Affairs with Novophar, asks another employee to
for the solution at issue to see if

Novopharm's prior product development team

had

Aedacted
(Id.) (emphasis added).

The email was apparently printed out by Ms. Lahtinen, and she wrote the numbers

of seven trials on the prit -out of the email. (Id.) She then sent the print out to another
person:

(Id.) The very next page in the document
the

production after the printed email with the wrtten notes (Id.) is a copy of

(Glaxo Exhibit 27 to Langer Decl., p. T07269). Half
way down the page is a section entitled
added).
Novopharm as it developed the formulation prior to Teva's acquisition of

(Id.) (emphasis

the development process of
Novo ph

ar.

(Id. at pp. T07269-71.) The following pages include the same seven trals that Ms.

Lahtinen listed on the print-out of the email. (Id.) The
. is the
During the May 19, 2005, deposition of

,ientified in the September 9,2004, email.

Tamas Szederkenyi, Novophar's Senior

Director of Analytical Research & Development, Glaxo questioned Mr. Szederkenyi extensively about this series of documents, all marked as a single document, deposition

Exhibit No.7. (Exhibit 24 at AI75-AI83, Szederkenyi Depo. pp. 157-165; Exhibit 25 at
A184-A205, Depo. Exhibit 7). When Glaxo took the deposition ofTeva's corporate
designee on the subject ofTeva's efforts to locate documents responsive to Glaxo's
discovery requests including the "Development Report,"11 however, Glaxo separated the
1 i The excerpts from this deposition, reproduced at pp. 29-30 of Glaxo' s Brief, are taken out of

context. The record reflects that the same witness was questioned extensively about the efforts

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September 9,2004, email from the documents immediately following it. (Compare
Glaxo Exhibit 30 (first page) and Olaxo Exhibit 27 (and following pages) with Exhibit

25, Depo Exhibit 7). Olaxo questioned the Teva designee using the email and the
, section as ifboth were separate documents, leaving the
false impression that the report referenced in the email and the email had not been

produced together and did not belong together. (Exhibit 26 at A219-221, Wrigley Depo.

ò pp. 87-89).
lieòa.C\e Glaxo exacerbated the confusion it engendered regarding the development report

by stubbornly queryng Novopharm witnesses that lacked any foundation to comment
about a "Novopharm Development Report." Mr. Fernandes, for instance, was shown the
September 9, 2004, email and asked
(Exhibit 27 at A223, Fernandes Depo. p. 141).12 He responded:
(!d.)

Undeterred, Glaxo continued, stating

that Teva in fact goes through to search for and locate documents when requested in litigation. (Exhibit 26 at AZ07-AZ15, Wrigley Depo. pp. 56-64). The designee was asked whether such a

search was conducted in this case for " and the

witness responded (Id. at 69.) She was also asked whether a search was done for and she responded, after an agreement was reached conceming the privilege, she responded (ld. at AZ17, p. 70.) The designee also testified that she searched and she responded (ld.) (ld. at She was also asked and she responded AZ18, p. 72.) The designee is a member ofTeva's in-house legal departent, so (understandably) questions that might reflect communications with outside counsel were cautiously guarded throughout the deposition. However, when put into the appropriate context, Glaxo was clearly not "totally shutdown" in its inquiry concerning what Teva has done to look for and produce documents in this case. This is most likely why Glaxo has not, before serving its

summary judgment motion, sought to overrle any objection or instrction occurrng in the
deposition of

Ms. Wrigley.

12 Glaxo highlights Mr. Fernandes' testimony to prove that the development report existed and

what was in it. (Glaxo Brf. at pp. 27-28). In fact, Mr. Fernandes' testimony was all speculation and the deposition testimony explicitly confirms this. (Exhibit 27 at AZ23-AZ24, Fernandes
Depo. pp. 141-142).

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(Id. at A223-224, pp.141-142.) Mr. Fernandes then offered
(Id. at A224, p. 142.) A few pages later in
the deposition, Glaxo turned its query to the tables on the documents following the email,

where Mr. Fernandes testified

l-ed3cted
educate Mr. Fernandes' speculation.

(Id. at A225-226, pp. 145-146.) Glaxo did riot

show the two documents together to Mr. Fernandes, in their proper context, to even help

Regardless, by divorcing the September 9,2004, email from its context in the
production, and inquiring üfTeva's corporate designee about a document created by

Novophar in the mid-1990s, Glaxo created the confusion. Glaxo, in fact, has had the
document it alleges has "gone missing" since Februar of2005.

iv. ARGUMENT
Teva maintains that Glaxo is not entitled to expand the scope of its claims to

include anything but ethanol under the doctrne of equivalents. Absent reliance on the
doctrine of equivalents to expand the scope of

its patent claims beyond the use of ethanol

to stabilize ranitidine, Glaxo's infrngement claims fail as a matter oflaw, as the term
"ethanol" is common to all claims of the '249 patent. The legal and factual basis
supporting summary judgment of non-infrngement is set forth in detail in Teva's Brief

In

Support Of

Motion For Sumary Judgment Of

Non-Infrngement, and is incorporated

herein. (D.L No. 104). For the reasons stated in that brief, Glaxo's motion should be
denied.

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~eu

..ß,c\eÒ
Should this Court deem Glaxo entitled to some expansion of its patent under the
doctrine of equivalents, then Glaxo has failed to prove that the

in Teva's
the '249 patent. At the

formulation is the equivalent of

the "ethanol" in the claims of

very least, there are fact issues in dispute about the alleged equivalency of

A. Teva, Not Glaxo, Is Entitled To Summary Judgment.

Rule 56(c) permits summar judgment where there are no genuine issues of
material fact and the moving party is entitled to judgment as a matter of

law. Fed. R. Civ.

P. 56(c). In considering whether a triable issue of

material fact precludes Glaxo's

motion, the Cour "must review the evidence and constre all inferences in the light most

fàvorable to the non-moving party." Petrocell v. DaimlerChrysler COJp., 2006 U.S.
Dist. LEXIS 11972, * 10-11 (D. DeL. 2006) (attached as Exhibit 32 at A244-A249)

(citng Goodman v. Mead Johnson & Co., 534 F.2d 566, 573 (3d Cir. 1976)). Furher,
this Court has recognized that, when conducting such a review, it "should not make
credibility determinations or weigh evidence." Id. at * 11 (citing Reeves v. Sanderson
Plumbing Prods., Inc., 530 U.S. 133, 150 (2000)). Here, Teva is entitled to summar

judgment of non-infrngement, as Glaxo has failed to establish even a prima facie case of
infrngement under the doctrne of equivalents. See Microsoft Corp. v. IQ Tech., Inc.,

1993 U.S. App. LEXIS 16128, * 8 (Fed. Cir. 1993) (attached as Exhibit 33 at A250-

A252) (Patentee has the burden to prove infrngement even in declaratory judgment for
non-infrngement actions). If this Court believes that Glaxo has presented a prime

facie

case of equivalents, then there are fact issues that preclude summary judgment.

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1. Glaxo Lacks Suffcient Evidence Showing Teva's Formulation

Meets The "Ethanol" Claim Limitation Under The Doctrine Of Equivalents.
a. The Law Of

The Doctrine Of Equivaleiis

Analyzing patent infrngement is a two-step process. First, standing in the shoes of one skilled in the art, a cour should construe any disputed claim terms. Playtex
Prods., Inc. v. Proctor & Gamble Co., 400 F.3d 901, 905-06 (Fed. Cir. 2005). Second, a
court should compare the properly constred claims to the accused product or process.
Id. at 906.

The doctrine of equivalents, when applied too broadly, "conflcts with the
definitional and public-notice functions of

the statutory claiming requirement." Warner-

Jenkinson Co. v. Hilton Davis Chemical Co., 520 U.S. 17,29 (1997). As a result, the

Supreme Court has been clear that "the doctrne of equivalents must be applied to
individual elements of

the claim, not to the invention as a whole." Id. Furthermore,

even as applied to individual elements, the doctrne "is not allowed such broad playas to effectively eliminate that element in its entirety." Id. "A focus on individual elements
and a special vigilance against allowing the concept of equivalence to eliminate

completely any such elements" is critical to the analysis of whether a claim element is

met under the doctrne of equivalents. Id. at 40.
For this reason, application of

the "triple identity test, albeit imperfect, is

appropriate here. This test, one that Glaxo concedes is "the most common expression" of the test of equivalents, states that equivalent infrngement lies where "a substitute
element matches the function, way, and result of

the claimed element." Id. at 40. Glaxo

relies solely on the doctrne of equivalents to establish its infrngement claim against

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Teva, as its claims are literally limited to "ethanoL" As ariculated by Graver Tank, the

alleged equivalent must perform substantially the same fuction in substantially the same
way to achieve substantially the same result. Graver Tank, 339 U.S. at 608.
b. "Ethanol" Means "Ethmiol" And Nothing More.

..3c\ed Glaxo disclosed and claimed its invention narowly, claiming ethanol as the ~eu
stabilizing agent. It claimed narowly even though the inventor, Dr. Long, foresaw that
also would stabilize ranitidine. He abandoned
because

it did not perform the other necessary functions in the ranitidine solution, such as the
antimicrobial function. Teva's brief supporting its motion for sumary judgment

completely argues this and this argument wil not be repeated here. Glaxo is not entitled
to a finding that

is the equivalent of ethanol as a matter of law. (See

D.L No. 104 at pp. 20-36).

c. Glaxo Has Failed To Prove That Has
Of Ethanol In A Ranitidine Solution.
Under either parties' proposed constrction of

the term "ethanol," Glaxo's

evidence of infrngement under the doctrne of equivalents is insufficient as a matter of
law, because Glaxo has no evidence that the
performs each
show that
performs:
in Teva's formulation

that ethanol performs. In this case, Glaxo must
performs

that its expert admits ethanol

Redacted
(Exhibit 1 at A002, Anderson Report, March 16, 2006, ~ 40).

Glaxo, however, presents no evidence that

performs

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and (at best) there is a fact issue underlying whether

performs

\.eÒ
òø.C ~e During his deposition, Dr. Anderson admitted that he had no evidence that
(Exhibit 17 at
A131, Anderson Depo. p. 64)

Dr. Anderson also admitted that

(Exhibit 17 at A130, Anderson Depo. at p. 58)

Moreover, Dr. Long, the inventor ofthe '249 patent, abandoned the use of
because it did not provide an antimicrobial function. (Exhibit 8 at A039-04l,

lie(fqCt

ect

Long Tr. at 408-09; 445, lines 1-8). Using the evidence from Glaxo's own expert and
inventor, Glaxo has failed to prove that
performs

of ethanol in the invention. This, alone, justifies summary judgment in favor ofTeva on
Glaxo's infrngement claim.

With respect to
meet its burden of

(as a stabilizer for ranitidine), Glaxo also cannot
in

proof. Glaxo has never analyzed whether the

Teva's formulation is the cause of

that formulation's measured shelf1ife. At best,

Glaxo's evidence shows that Teva's formulation, when compared to G1axo's formulation

without ethanol has a longer shelf life. There is no evidence, however, comparing the

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shelf

life ofTeva's formulation with

to the same formulation without

Consequently, there is no way to know, based on the evidence before
the Court, whether

has anything whatsoever to do with the stability of

Teva's formulation. In fact, the clear evidence suggests that Teva's use of,

Redacted
noting

maintains the stability ofrantidine in

Teva's formulation. (Glaxo Exhibit 27, p. T072700) (Novopharm development report,

Glaxo has the burden to prove infrngement by a preponderance of

the evidence.

Glaxo has failed to meet its burden here.
2. Glaxo Also Has Failed To Prove That Teva's Formulation

Meets the "Stabilizing Effective Amount or' Element of Claims
1-10.
The paries have differing positions on the appropriate construction of "stabilizing

effective amount of," as recited in Claim 1 and incorporated into Claims 2-9 by
dependency. Under either pary's constrction, however, Glaxo has failed to meet its

burden of proof on this element. As explained above, there is no evidence before this
Court analyzing whether the addition of
. is the cause of

the stability of

Teva's formulation. Glaxo has only compared Teva's formulation to Glaxo's
formulation without ethanoL. This proves nothing with respect to the effect (if any) of
on the stabilty ofrantidine in Teva's formulation. Indeed, this head-

to-head comparison is what Glaxo argued to get its patent. (G000209, ii 5). Sumar
judgment in Teva's favor on Glaxo's claim of

infrgement is therefore additionally

proper on this basis.

Redacted
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B. Alternatively, Genuine Issues Of Material Fact Preclude A Finding

That Any Claim Element Is Satisfied Under The Doctrine Of Equivalents.
Assuming the Court finds that Glaxo has presented suffcient evidence to survive
Teva's Motion for summary judgment, then Glaxo's motion should be denied because
material facts are in dispute that hinge upon the veracity and credibility of Glaxo' s

expert, and the motivation behind the development ofTeva's formulation. Legett &
Platt, Inc. v. HickoJY Springs Mfg. Co., 285 F.3d 1353, 1359-60 (Fed. Cir. 2002)

(reversing summary judgment of non-infrngement where expert witness and fact witness

testimony created issues of fact). This Cour has recognzed, as have other cours, that
summary judgment is paricularly inappropriate where the declaration of

the non-moving

party's expert witness demonstrates issues of

fact exist. Cryovac Inc. v. Pechiney Plastic

Packaging, Inc" 430 F. Supp. 2d 346, 356 (D. DeL. 2006) (finding disagreement among

experts as to whether prior ar would motivate one of ordinar skill in the ar to make
invention at issue "creates a genuine issue of

material fact, and thus, summar judgment

on obviousness must be denied."); see also Southland Sod Farms v. Stover Seed Co., 108

F.3d 1134, 1144 (9th Cir. 1997) ("Summary judgment is inappropriate where an expert's
testimony supports the nonmoving party's case.").
1. The Competing Expert Opinions of Glaxo and Teva Preclude

Summary Judgment Against Teva.

It is improper for a court to attempt to weigh the credibility of an expert's opinion

on a motion for summary judgment. State Farm Fire & Casualty Co. v. Estate of Jenner,
856 F.2d 1359, 1365 (9th Cir. 1988). Patent cases are no different; a genuine issue of
material fact exists where the paries' expert witnesses give conflicting opinions as to the
structure and operation of the patents and products in question. Hilgraeve Corp. v.

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McAfee Assocs., Inc., 224 F.3d 1349, 1353 (Fed. Cir. 2000) (vacating grant of summary

judgment because the parties' experts disagreed on how the patented softare interacted
with the computer operating system). Assuming Glaxo is legally permitted to invoke the

doctrne of equivalents, and further assuming Glaxo has set forth suffcient evidence to
make out aprimafacie case of

infrngement, Glaxo's motion should stil be denied on the

sole basis that both parties' experts draw opposite conclusions on three material issues.

First, both Dr. Anderson and Dr. Kibbe disagree on the ultimate question of
whether

can be considered an equivalent of ethanol in any chemical
the '249

formulation, an issue that effects a finding of infrngement of every claim of

patent. Dr. Kibbe explained, in his first expert report, that

Redacted
explained that

(Exhibit 15 at A095-A097, ~~ 76-83.) Dr. Kibbe
(Id.)

Further, Dr. Kibbe explained that
(Id.)

"md ethanol have distinctly different physical and chemical

characteristics. (Id., ~~ 80-81.) Dr. Kibbe explains that

(!d. at A097-098, ~~ 84-86.)

Dr. Kibbe explains that

Redacted
(Exhibit 16 at AI07, ~

22.) Dr. Kibbe also notes that
a finding in conflict

with Dr. Anderson's conclusion. (Id. at AI04-A105, ~ 15). Ultimately, Dr. Kibbe

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concludes that

Redacted
(Id.

at A108, '129).

Second, both experts draw different conclusions from the data used by Dr.

Anderson to infer that -stabilizes rantidine in any amount. (Supra,
"Facts" § C). This issue effects any finding of infrgement of Claims 1-10 of the '249
patent, all of

which contain the "stabilizing effective amount of' limitation. Dr. Kibbe's

central position is that Dr. Anderson's
(Exhibit

16 at Al13-AI16, ~~ 45-52). This is so because Dr. Anderson failed to account for or

analyze whether ethanol and might effect
the stability of ranitidine. (Id. at A116, ~ 54). Dr. Anderson, of course, does not agree.
Third, the experts have opposing views on whether the specific numerical ranges
of ethanol, as recited in claims 2-3 and 10-11, are mathematically proportionate to the
amount of

. in Teva's formulation. (Supra, "Facts" § F). Indeed, the

generic formulation at issue in Pharmadyne was different from Teva's proposed
formulation, principally in that Teva's formulation uses
while the generic at issue in Pliarmadyne used 12.5% (w/v)

Redacted

Pliarmadyne, 32 F.Supp. 2d at p. 281. Interestingly, Glaxo's retained expert in

Pharmadyne concluded that 12.5% (w/v) was equivalent to 7.5% (w/v)
ethanoL. Id. at 287. In this case, Glaxo's expert concludes that Teva's.
,is equivalent to 7.5% (w/v) ethanoL. The two Glaxo experts even
disagree.

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Employing Dr. Anderson's ratio methodology, and assuming (as the PharJ1adyne
court held) that 12.5%

is equivalent to 7.5% ethanol, the ratio is 1.67

(12.5% -+ 7.5%). For the 7%-8% EtOH claim (claim 2), the proportionate upper limit of
would be 13.33% (1.67 multiplied by 8).
used in Teva's formulation) is outside this range, and would therefore be outside of

(as

the

scope of the percentage limitation of claim 2 of

the '249 patent Fl edacted
infrngement in this case. See,

Each of

these issues, alone or in combination, (assuming Glaxo has presented a

prima

facie case at all) precludes summary judgment of

e.g., Hilgraeve COJp., 224 F.3d at 1353.
2. Whether Teva's Formulation Is Substantially Different From

The Claimed Invention Is A Question Of Fact.
The facts before this Cour support the conclusion that Novophar's development
of

the ranitidine formulation that ultimately became Teva's formulation was a carefully
the '249 patent, while at the same time

constructed effort to design around the claims of

developing a solution that was bioequivalent to Glaxo's ZantacC! syrp. As stated by the
Supreme Court in Graver Tank, "(a) finding of equivalence is a determination of

fact,"

predicated on the "balancing of credibility, persuasiveness and weight of evidence." 339
u.s. at 609-610.

Subrata Mazumder, Teva's corporate designee on the subject ofTeva's

development of its formulation, testified that he was instrcted to develop a formulation
that did not contain ethanol because of
(Exhibit 29 at A233, Mazumder Depo. p. 82). Novophar's development report

confirms that one of the specific challenges facing Mr. Mazumder

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Redacted
same report lists
as

(Glaxo Exhibit 27, p. T 07270). The

in the formulation, and explicitly states that

,(Id.) There is no mention in
the report that the purpose of
Moreover, excluding water, only 2 of

in the formulation is to stabilize rantidine.

the 12 other ingredients in Teva's formulation are

in the san1e amounts as the corresponding ingredients in Glaxo's ZantacCI syrp. (Glaxo

Brf. at p. 13). Of course,

is not in the ZantacCI syrp at all. (Id.)

A reasonable fact finder could conclude, based on this evidence, that the

development of the accused formulation was the action of "an incremental innovator
designing around the claims, yet seeking to capture as much as is permissible of

the

patented (formulation)." Warner-Jenkinson, 520 U.S. at 36. Such conduct is not only
perfectly appropriate, but is the type of conduct that the patent system encourages. The
purpose of a patent claim, after all, is to provide notice to competitors regarding the scope
of

the patent grant. United Carbon Co. v. Binney & Smith Co., 317 U.S. 228,232 (1942)

("The inventor must inform the public. . . of

the limits ofthe monopoly asserted, so that

it may be known which features may be safely used or manufactured without a license
and which may not") (internal quotes omitted). A full and complete disclosure of

the

invention allows competitors to understand the bounds of the invention and encourages

innovation by challenging those competitors to explore and create non-infrnging uses of
the claimed invention. See Festo COJp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535

U.S. 722, 731 (2002). The Supreme Court has repeatedly emphasized that the "carefully

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crafted bargain" at the hear ofthe United States patent system "depends almost entirely
upon a backdrop of free competition in the exploitation of unpatented designs and

innovations." Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 150-51
(1989).

While Glaxo, based on nothing but inference, characterizes the development of
Teva's forn1Ulation as the "actions of a copyist," the evidence compels the opposite

conclusion. Regardless, when considering the evidence on a motion for summar
judgment, all inferences of fact must be constred "in the light most favorable" to Teva,
the non-moving party on this issue. Petrocell, 2006 U.S. Dist. LEXIS 11972 at * 10-l1

(Exhibit 32). There is sufficient evidence in the record to enable a reasonable trier of fact

to find that Novophar's development ofTeva's ANA formulation were efforts to
design around the '249 patent claims, a fact that does not support a finding of

infrngement under the doctrne of equivalents. Glaxo's motion must, therefore, be
denied.
3. Glaxo Misstates The Law Concerning The Test For

Infringement Under The Doctrine Of Equivalents.
As stated above, the development ofTeva's formulation was a concerted effort to
design around the '249 patent, not "the actions of a copyist," as Glaxo contends. Glaxo' s
attempt (at p. 15 of

its brief) to elevate evidence pertaining to alleged "copying" beyond

its proper context should be weighed with great skepticism by this Court, ifnot rejected
out of

hand. Glaxo's sole basis for the assertion that such evidence allows a fact finder to

infer that the alleged innger has made only an insubstantial change is the Federal
Circuit's 1995 opinion, Hilton-Davis Chemical Co. v. Warner-JenÃ.nson Co. Inc., 62

F.3d l512 (Fed Cir. 1995). This is the very opinion that was reversed by the Supreme

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Court in its 1997 Warner-Jenkinson decision. Warner-Jenkinson, 520 U.S. at 41. (ruling
that because the Federal Circuit "did not consider all of

the requirements as described by

us today, particularly as related to prosecution history estoppel, and the preservation of
some meaning for each element in a claim, we reverse and remand for further
proceedings consistent with this opinion." (emphasis added)).

The Supreme Court's reversing opinion specifically rejected the Federal Circuit's

suggestion that an alleged infrnger's behavior (whether seen as copying or as efforts to

design around a patent) permits a rebuttal inference concernng whether the accused

equivalent represents a substantial change. 520 U.s. at 36. The Supreme Court was
explicit in rejecting the very proposition of law that Glaxo proposes:
According to the Federal Circuit, a person aiming to copy or aiming to

avoid a patent is imagined to be at least marginally skilled at copying or avoidance, and thus intentional copying raises an Irerence--rebuttable by

proof of independent development--of having only insubstantial
differences, and intentionally designng around a patent claim raises an

inference of substantial differences. This explanation leaves much to be desired. At a minimum, one wonders however to distinguish between the intentional copyist making minor changes to lower the risk of legal action, and the incremental innovator designng around the claims, yet seeking to capture as much as is permissible of the patented advance.
520 U.S. at 36-37 (emphasis added). Glaxo, by parenthetically citing the underlying
Federal Circuit decision, implies that it would be appropriate for a fact finder to infer that

copying by the alleged infrnger means the alleged equivalent is not substantially

different from the patent at issue. This is not the law. The Supreme Court ruled that
"intent plays no role in the application of

the doctrine of equivalents," and relegated

evidence pertaining to the independent development of

the alleged infrger as simply

"probative" evidence of whether one of ordinary skill in the ar would consider the

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alleged equivalent to be interchangeable with the element of

the patent claim at issue.

520 U.S. at 36.
4.

-

f\edac\ed
fact that

Does Not Support Any Inference Of Infringement
By Teva.

The same principal applies to the inferences that Glaxo attempts to draw from the

Despite admitting that "Novopharm did not expressly acknowledge that
the Pliarmadyne decision was the reason for" Novopharm's decision, Glaxo nonetheless

asks this Court to infer that the Pharmadyne decision was the reason for Novophar's
withdrawaL. (Glaxo Brf. at pp. 26-27). Such an inference is not permitted on summar

judgment. Petrocell, 2006 U.S. Dist. LEXIS 11972 at * 10-11 (Exhibit 32). Glaxo asks

this Cour to further infer (assuming Novophar's decision was related to the
Pliarmadyne decision) that Novopharm's decision is somehow relevant to Teva's actions

when it adopted and developed its own ANA formulation, many years later. Glaxo's
conclusions are nothing but speculation, much less a reasonable inference of fact.

and not the negative inference that Glaxo
urges in its favor.

C. The Glaxo v. P/iarmadyiie Decision Is Not Binding Or Persuasive Precedent.
Glaxo's recitation of the facts and conclusions of

the cour in Glaxo Wellcome,

Inc. v. Pliarmadyne COJp., 32 F. Supp. 2d 265 (D. Md. 1998) has no relevance

whatsoever to the issues before this Cour. The accused foimulation in Phamiadyne also

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contained 12.5%

and 25% sorbitol in comparison to Teva's

formulation with

Pliarmadyne, 32 F.

Supp. 2d at 281. The Pliarmadyne formulation also included anydrous citrc acid,
Id. at

saccharin sodium, and methyparaben,13

278. The Pliarmadyiie decision has no bearing on Teva's formulation, and Teva has a
constitutional right to its own independent adjudication of whether its formulation
infrnges the '249 patent in any maner.

Redacted

Moreover, in Pliamiadyne, G1axo's U.S. Patent No. 4,585,790 (padfield) also was
at issue. Pharmadyiie, 32 F. Supp. 2d at 268. The '790 patent is the U.S. equivalent of
the '249 patent.
the '820 "Padfield reference" that G1axo faced during prosecution of

(Exhibits 11 and 21). The Padfield reference addressed the use of "suitable buffer salts"

to adjust the pH level ofrantidine formulations. (Exhibit 21 at A169, Co1. 1, i. 50).
Glaxo stated, in the '790 patent, that "(w)e have surprisingly found that the shelflife of
aqueous based formulations containing ranitidine . . . may be signficantly enhanced if the
pH of

the formulation is adjusted within the range of6.5-7.5." (Id., Co1. 1,11.27-31). The

defendant in Pliarmadyne, was held to have infrnged the '790 patent. 32 F. Supp. 2d at
271.

(Glaxo Exhibit 41, p. LVM 0045).

The developers ofTeva's formulation were free to use, and in fact did use,
to

because the '790 patent has now expired. (Glaxo
Exhibit 27, p. T07270). The Teva formulation was developed in an entirely different
context than the Pharmadyne formulation and contains entirely different components.
13 Methylparaben was eliminated from Glaxo's NDA formulation (Exhibit 18 at A144, ~ 38).

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In Support Of For this reason, and for the reasons stated in Teva's Brief

Motion For

Summar Judgment Of

Non-Infrgement, the Pharmadyne decision has no bearing

under the facts before this Court.
D. There Is No Factual Or Legal Basis For The Extreme Evidentiary
Sanction Glaxo Seeks.

Having failed to meet its burden of proof on the single issue of infrngement
before this Court, Glaxo resorts to misrepresenting the record to manufacture an untimely

and false allegation of discovery misconduct so that it can be relieved of its burden of

proof on the issue of infrngement. As the authority relied upon by Glaxo makes clear,
however, the evidentiary sanction that Glaxo seeks is the type of extreme sanction

reserved only for extraordinar circumstances where a party deliberately and
intentionally refused to comply with an explicit and direct order to produce discovery.

Spear v. Commissioner (Estate ofSpem), 41 F.3d 103, 109 (3d Cir. 1994) (citng Ins.
Corp. of Ir. v. Compagnie Des Bauxites De Guinee, 456 U.S. 694 (U.S. 1982)); Liafail,

Inc. v. Learning 2000, Inc., 2002 U.S. Dist. LEXIS 24803, *9-13 (D. Del 2002) (refusing

to sanction Liafail immediately and first orderig Liafail to "correct its apparent wrongs")

the alleged loss of
(Exhibit 28). Moreover, prejudice to the party complaining of

evidence is a critical factor to issuing such a punitive sanction. Curtis T Bedwell & Sons,
Inc. v. International Fidelity Ins. Co., 843 F.2d 683, 691 (3d Cir. 1988) (listing prejudice
as a factor in determining appropriate sanction for discovery misconduct).

Here, no discovery misconduct has occurred, no order was ever issued, and the very report that Glaxo claims has "gone missing" was in fact in Glaxo's possession all
the time. Glaxo canot possibly be prejudiced in any way. There is no basis for the relief

Glaxo seeks.

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Beyond the confusion Teva now has resolved for this Court concerning the
document, confusion created by Glaxo, Glaxo should be ashamed of its

misrepresentations to this Court concernng whether this Court ordered the production the

document. Glaxo boldly proclaims that "(t)he Cour ordered the Report produced in
response to Glaxo's letter requests for assistance," followed by a cite to two hearngs

before the Court, one occurrng on June 30, 2005, the other on October 7,2005. (Glaxo
Brf. at p. 28.) There was no such order from the Court in either hearng.
During the June 30, 2005, hearing, Teva explained that the development work at issue was "done for a division that was sold off and is now a separate company."
(Exhibit 30 at A235, p. 10,11. 19-20.) The Court inquired as to whether either party had
engaged in an effort to acquire the documents from that company, and Teva advised that

the efforts had just begun. (Id. at p. 10-11.) The Cour admonished both paries to work
together in the discovery effort, but ultimately stated that "there is really nothing for me

to rule on right now and I'm not going to rule on it." (Id. at p. 11.) Contrary to Glaxo's
representation, this Court did not order "the Report produced in response to Glaxo's letter
requests for assistance." (Glaxo Brf at p. 28.) This is a far cry from an "order" of

this

Court to produce the Report at issue, as Glaxo represents in its brief.

During the October 2005 hearing before this Court, Teva explained that it had
done all that it could do to locate and produce development documents within its

possession and control. (Exhibit 3 i at A237-239, October 7,2005 Hearig Transcript at
pp. 11-13). Teva advised that some further documents may be in the possession and
control ofPharmascience, a company that acquired a division of

Novophar not acquired

by Teva. (Id. at A239-240, pp. 13-14.) Teva also attempted to convince Pharascience

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to voluntarly produce what documents it had, yet Pharmascience declined. (Id.) Teva
advised Glaxo of

this fact, and further updated the Court during the October 7,2005,

hearing, ultimately tellng the Court that "We have nothing else to give." (Id. at A 241, p.
15).

This Court advised Glaxo that Teva's explanation as to its lack of control over

Pharmascience, "sounds like a pretty good excuse to me." (Id. at A242, p. 23)
(commenting further that "Pharmascience isn't owned, operated or controlled by Teva. If
(Pharmascience) want(s) to stand on their rights under Canadian Law, I'm not sure what

it is you want me to do in that regard, Mr. Murphy"). In response, Glaxo's counsel
stated:

MR. MUHY: ... Let me address Pharmascience. Given counsel's
representations, I agree with you, there is nothing more we can ask ofTeva the client chooses to expend the resources and we won't. We'll pursue it if to make a constitutional challenge to a Canadian statute, which I think is highly unlikely.
(Id. at A 243, p. 24.) As counsel predicted, Glaxo did not proceed with a "constitutional challenge" to the law in Canada, and (apparently) gave up the effort. The Court did not
order the report produced at any time in this case.

Redacted

v.

CONCLUSION

Glaxo should not be permitted to employ the doctrne of equivalents to expand its

claims to include

as a matter of law. Even if it is so permitted,

summary judgment in favor ofTeva on Glaxo's infrngement claims is warranted. Glaxo
has utterly failed to prove that any claim of

the '249 patent is infrnged by Teva's
performs all the

formulation because it has not analyzed whether

functions of ethanoL. Moreover, Glaxo has never compared Teva's formulation with the

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Redacted
same formulation without

, and cannot, therefore prove its infrngement

case. Assuming fuher that the Court rules that Glaxo has presented a prima facie case
on its claims, those claims canot be resolved on su