Free Redacted Document - District Court of Delaware - Delaware

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELA WAR

GLAXO GROUP LIMITED,
Plaintiff,
v.

Civil Action No. 04-171

CONFIDENTIA FILED UNER SEAL

TEV A PHARMACEUTICALS USA, INe. and TEV A PHARMACEUTICAL INUSTRIS LIMITED,
Defendants.

TEV A'S OPENIG BRIF IN SUPPORT OF MOTION FOR SUMRY JUDGMENT OF NON-INRIGEMENT
YOUNG CONAWAY ST ARGATT & TAYLOR, LLP Josy W. Ingersoll (# 1088) Adam W. Poff (# 3990) Karen E. Keller (# 4489) The Brandywne Building 1 000 West Street, 17th Floor P.O. Box 391 Wilmington, DE 19899 Telephone: (302) 571-6600

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

Jeffrey C. Bro\V 3200 IDS Center 80 South 8th Street Minneapolis, MN 55402
Teva Pharmaceuticals USA, Inc. and Teva
Pharmaceutical

Industries, Ltd.

Dated: June 30, 2006

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TABLE OF CONTENTS
Pa~e

I. STATEMENT OF THE NATUR AN STAGE OF
THE PROCEED IN G ........ ....... .......... ........... .............. ........ .............................. ....... ....... 1

II. SUMMAY OF THE ARG'UMENT ..............................................................................2
m. STATEMENT OF THE FACTS ................................................................................... 4

A. Teva's Formulation 'UsesRedacted ".................................................... 4
B. Glaxo' s Form ulation 'Uses Ethanol.................................................................... 5
C. Glaxo' s Paten t Claims ......................................................................................... 6
D. A Comparison Between Teva's Formulation And The

Claims Of The '249 Patent ................................................................................. 6

E. The Development Of Glaxo's Formulation .............................................. 7
F. G laxo' s '249 Patent Specifications ...................................................................... 9

G. The Prosecution Of The '249 Patent .............................................................. 11
1. Overvie,v .............. .......... ............... ............... .......................................... 11

2. The Details Of The Prosecution.......................................................... 12

H. Literal Infringem en t .............. ...................................... ......... ..... ........................ 19

IV. AR G'UNT . ... ......................................... .... ........................ ......................................... 19

A. The Law Regarding SummaryJ udgment .................................................. 19
B. The La,v Of Patent Infringement .....................................................................20
C. Teva's Formulation Does Not Infringe The Claims Of

The '249 Patent 'Under The Doctrine Of Equivalents ...................................20
1. Glaxo Is Estopped From Broadening The Term

"Ethanol" Beyond Just Ethanol Because It Surrendered By Argument Any Broader Subject Matter ..................................... 23
2. Glaxo Is Estopped From Broadening The Term "Ethanol"

Beyond Just Ethanol Because It Made Narrowing Amendments
To The Claims During The Prosecution Of

The '249 Patent........... 27

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3. Glaxo Is Estopped From Broadening The Term "Ethanol"

To Mean Because That Interpretation

Would Vitiate The Claim Element "Ethanol" ................................30
4. Glaxo Is Estopped From Broadening The Term "Ethanol"

Was Waived Or Dedicated To The Public ....................................31
5. Glaxo Is Estopped From Broadening The Term "Ethanol"

To Mean Because

To Mean _ Because Such A Hypothetical
Claim Would Be Invalid...............................,........................................ 33

D. Even If Glaxo's Claim Can Legally Be Broadened To Include

Teva Does Not Infringe The Claim Because Glaxo Has Failed To Meet Its Burden Of Proof ...................................... 37
E. The Glaxo v. Pliarmadyiie Decision Is Not Binding Or

Persuasive P reced ent ................ ...... .......... ....... ........ ............... ........................... 38

V . CON CL U SI 0 N ... .................................................... .......... ........ ................. .... ................ 39

Redacted

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TABLE OF AUTHORITIES
FEDERAL CASES
Amgen. Inc. v. Hoechst Marion Roussel, Inc., 287 F. Supp. 2d 126 (D. Mass.
2003) ............................ ...... ..... ........................................................................ ........................ 29

Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141 (1989).......................................... 21
Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005) ........................................................................ 36

Chiuminatta Concrete Concepts, Inc. v. Cardinal Industries, Inc., 145 F.3d 1303
(Fed. Cir. 1998) ......................................... .............. ...... ............................. ............ ....... .......... 33

Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) ................................................ 20

Del Mar Avionics, Inc. v. Quinton Instrument Co., 836 F.2d 1320 (Fed. Cir. 1987) ....................................................................................... ................................................ 39
Festa Coip. v. Shoketsu Kinzoku Kogyo Kabushiki Co.,

535 U.S. 722 (2002)................................................................................ 3, 4, 21, 22, 27, 28, 29, 38

In re Fisher, 427 F.2d 833 (CCPA 1970)...................................................................................... 36

Freedman Seating Co. v. American Seating Co., 420 F.3d 1350 (Fed. Cir. 2005).......................30
Genetech, Inc. V. Wellcome Found., Ltd., 29 FJd 1555 (Fed. Cir. 1994) .................................... 24
Gla:\'o Wellcome, Inc. v. Pharmadyne CO/p., 32 F. Supp. 2d 265

(D. Md. 1998) ......................................................................................................... 7, 18,24,38,39
Graver Tank & .Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 94 L. Ed. 1097, 70 S. Ct. 854 (1950) ................................................................................................3,34,37,38
Johnson & Johnston Assocs. Inc. v. R.E. Service Co., 285 F.3d 1046 (Fed. Cir. 2002) ....................................................................................................................... 3,22,25,32

Kustom Signals, Inc. v. Applied Concepts, Inc., 264 F.3d 1326 (Fed. Cir. 2001) ......................... 30

Lewmar Mm'ine, Inc. v. Barient, Inc., 827 F.2d 744 (Fed. Cir. 1987)....................................... 3, 34
Ma;'1vell v. J Bakel', Inc., 86 F.3d 1098 (Fed. Cir. 1996).............................................................. 31
MEHL/Biophile 1m

'I Coip. v. Milgraum, 192 F.3d 1362 (Fed. Cir. 1999) ...................................34

North American Vaccine, Inc. v. American Cyanamid Co., 7 F.3d 1571 (Fed. Cir. 1993) .............................................................................................................................. . ........ 35
Novartis COlp. v. Ben Venue Labs, Inc., 271 F.3d 1043 (Fed. Cir. 2001)..................................... 34

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Phariiacia & Upjo!1l Co. v. Mylan Pharms., Inc., 170 F.3d 1373

(Fed. Cir. 1999)........................ ..... ......... ........ .................. ................................. .......... ....... 21, 25, 26

Philíps v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) ........................................................... 3,20

Sage Products, Inc. v. Devon Industries, Inc., 126 F.3d 1420
(Fed. Cir. 1997)................................................................................................................... 4, 22, 3 I
SmÍlhKlíne Beecham Coip. v. Excel Pliarms., Inc., 356 F.3d 1357 (Fed. Cir.

2004) .......................................... ................................................................. ..................... ....... 28

Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524 (Fed. Cir. 1987)...................................... 36
Tanabe Seiyaku Co. Ltd v. lTC, 109 F.3d 726 (Fed. Cir. 1997) .................................... 3, 10,23,24

Tronzo v. Biomet, Inc., 156 F.3d 1154 (Fed. Cir. 1998)......................................................3,22,30

Union Carbide COIP. v. Ali. Can Co., 724 F.2d 1567 (Fed. Cir. 1984)........................................ 19
United Carbon Co. v. Binney & SmÍlh Co., 317 U.S. 228 (1942) ................................................. 21
UnÍled States Gypsum Co. v. Nat'l Gypsum Co., 74 F.3d 1209 (Fed. Cir. 1996) .......................... 19

Warner-Jenkinson, 520 U.S. at 29 ........................................................................................... 20, 30
Wilson Sporting Goods Co. v. Davíd Geoffrey & Assocs., 904 F.2d 677 (Fed Cir.

1990) ..................................................................................................................... 22, 33, 34, 35

FEDERA STATUTES
21 U.S. C. § 35 5U)............. .............. .......... .......................................................... ........... .................. 1

35 U.S.C. § 103................................................................................................ 12, 13, 15, 16, 17,18
35 U.S.C. § 112.................................................................................................. 3, 12, 13, 16,35,36
35 U.S.C. § 1 12 ~ 2........................................................................................................................20

Fed. R. Civ. P. 56(c) ..................................................................................................................... 19

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I. STATEMENT OF TIlE NATU AND STAGE
OF THE PROCEEDING
Glaxo owns a patent covering the use of ethanol to stabilize oral solutions ofranitidine.!
Ranitidine is a chemical compound that belongs to a class of drugs commonly referred to as
histamine type 2 (H2) receptor antagonists (or I-h antagonists or H2 blockers). Ranitidine halts the

chemical reaction that causes the production of acid in the stomach and, therefore, ranitidine is

used to treat those who suffer from various gastro-esophageal disorders relating to the production

of excessive gastric acid. Teva seeks to introduce a generic version of Glaxo's oral ranitidine
solution.

Before Teva can sell its generic formulation, Teva must submit an Abbreviated New
Drug Application ("ANDA") to the Food and Drug Administration ("the FDA") for approval.2

Because Glaxo has reported to the FDA that its ZantaciI oral solution is covered by U.S. Patent

No. 5,068,249 (hereinafter "the '249 patent", Teva certified in its ANDA that Glaxo's patent
"will not be infringed by the manufacture, use, or sale of

the new drug for which the application

is submitted.,,3 In compliance with the Hatch-Waxan Act, Teva also provided Glaxo with
notice of its certification.4
As a result ofTeva's notice, Glaxo brought this action, alleging infringement of

the '249

patent.5 In this suit, Glaxo concedes 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 formulation includes Redacted rather than
ethanoL. For its par, Teva has admitted that its formulation has all of the elements 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."

i The brand name for ranitídine is Zantac~.
1 See 21 U.se. § 355(j).

3 See 2 i U.se. § 355(j)(2)(A)(vii)(IV). 4 See 21 U.S.e. § 355(j)(2)(B). 5 See 21 u.se. § 355(j)(5)(B)(iii).

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Teva can only infringe the '249 patent, if at all, under the doctrine of equivalents. Teva's
motion for summary judgment is concerned with only one of

the four claim elements at issue, the

claim element "ethanoL."

In accordance with the Scheduling Order, Teva respectfully moves for summary
judgment, seeking

judgment as a matter ofJaw that Teva's ranitidine fonnulation does not

infringe the claims of the' 249 patent. Judgment as a matter of law is appropriate because
"ethanol" in the claims of

the '249 patent can have no range of equivalents beyond "ethanoL."

Even if some range of equivalents would be appropriate, Glaxo has failed to prove that the

Redacted

in Teva's formulation performs al1 of

the functions that ethanol performs in

Glaxo's ranitidine fonnulation. This is an essential element ofGlaxo's proof, and it is lacking in
this case.

II. SUMARY OF THE ARG'UNT
Teva asks this Court to rule that Glaxo cannot use the doctrine of equivalents to broaden

the scope of its patent to cover a fonnulation that it did not disclose or claim. The undisputed
record establishes that Glaxo experimented with the use of, Redacted in its ranitidine

formulation months before it filed its first patent application. Glaxo also foresaw its use as a
stabilizer for the ranitidine. Nonetheless, Glaxo did not disclose or claim the use of ~edac\ed
Redacted ,in its patent. Glaxo only disclosed and claimed ethanoL. In fact, to convince the Patent

Offce that it had invented anything at all, Glaxo presented laboratory experiments only showing
that ethanol resulted in a surprising increase in the stability (or shelflife) of

its formulation.

Glaxo argued that "on

Iv

by the present invention" would one of ordinar skill in the art recognize

the stabilizing benefits of ethanoL. By disclosing, claiming and arguing only ethanol above al1

other available commonly known excipients, Glaxo clearly delineated the scope of its invention

to the use of ethanol to increase the stabilty of a ranitidine oral solution and nothing else.
Five legal doctrines prevent Glaxo from relying on the doctrine of equivalents to expand
the claims of

the '249 patent beyond the disclosed and claimed "ethanoL" First, arguments made

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by a patentee to obtain the patent bar expansion of

his claims. See Tanabe Seiyaku Co. Ltd v.

lTC, 109 F.3d 726 (Fed. Cir. 1997) Second, prosecution history estoppel bars a patentee from
expanding the scope of

his patent claims to include subject matter surrendered by amendment
his patent. See Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535

during prosecution of

U.S. 722 (2002). Third, the doctrine of equivalents does not allow a patentee to vitiate claim
limitations in an equivalents analysis. See Tronzo v. Biomet, Inc., 156 F.3d 1154 (Fed. Cir.

1998). Fourth, this case is analogous to cases on waiver and dedication to the public. A patentee
waives the right to recapture subject matter that was disclosed, but not claimed, in his patent. See
Johnson & JO!1Iston Assocs. Inc. v. R.E. Senice Co., 285 FJd 1046 (Fed. Cir. 2002). Fifth, a

claim should be interpreted to be valid, if possible. Lewmar Marine, Inc. v. Bariel1, Inc., 827
F.2d 744, 749 (Fed. Cir. 1987), cert. denied, 484 U.S. 1007 (1988). If

expanding a claim under

the doctrine of equivalents would render the claim invalid under 35 U.S.C. § 112, that
interpretation is improper. See Philips v. AWHCOlp., 415 F.3d 1303, 1316 (Fed. Cir. 2005)("ln
light of the statutory directive that the inventor provide a "full" and "exact" description of

the
the claims.").

claimed invention, the specification necessarily informs the proper construction of

Even if

the Court determines that the patent claims are entitled to some range of

equivalents, Gla.xo still must prove that Redacted performs the same function, in the same
way, to achieve the same results as the ethanol in its formulation. Graver Tank & Mfg. Co. v.

Linde Air Prods. Co. 339 U.S. 605, 608, 94 L. Ed. 1097, 70 S. Ct. 854 (1950). Ethanol performs

Redacted

in Gla.xo's formula:

Redacted

(Exhibit 1 at A002,6 Anderson Rpt., March 16, 2006, ~ 40) Gla.xo has no proof on

functions 1 and 2 and, therefore, it has failed to meet its burden of proof under the doctrine of
equivalents.

6 As used in this brief, references to "Exhibit" are to the Exhibits attached to the Appendix supporting
Teva's Motion In Summary Judgment of

Non-Infringement, fied herewith.

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Glaxo cannot, as a matter oflaw, claim that Teva's Redacted fonnulation is
equivalent to its ethanol fonnulation. Such a result would fundamentally violate several doctrines of patent law, all of which follow from the premise that the Patent Offce should be the first
arbiter of the patentability of foreseeable equivalents of an invention. A patentee must present the

full range of his invention for examination in the Patent Offce or he wil lose what he has not

subjected to examination. Indeed, as bet\veen "a patentee who had a clear opportnity to
negotiate broader claims but did not do so, and the public at large, it is the patentee who must
bear the cost of its failure to seek protection for (a) foreseeable alteration of its claimed

(invention)." Sage Products, Inc. v. Devon Industries. Inc., 126 F.3d 1420, 1426 (Fed. Cir.
1997).

m. STATEMENT OF THE FACTS
The doctrine of equivalents should not be used to broaden the scope of Glaxo's patent
claims to capture Redacted because Glaxo foresaw, but did not disclose or claim, the use

of Redacted as a stabilizer for ranitidine. Glaxo only disclosed and convinced the Patent

Offce that ethanol provided the surprising results that distinguished it from the prior art. Any
other holding would distort the principles of fairness and equity that underlie the doctrine of

equivalents. A patentee should only be allowed to capture subject matter that was unforeseeable
to the inventor at the time of

the invention and insubstantial in comparison to the corresponding

claim limitation. See Festa Coip. v. Shoketsu Kinzoku, 535 U.S. 722, 741 (2002). That is not the

case here. As explained below, the use of, Redacted as a stabilizer for ranitidine was
foreseen by Dr. Long, the inventor. Indeed, he even recorded his knowledge in a notebook.
A.
Teva's Formulation 'Uses

Redacted

The original fonnulation work for the accused oral ranitidine solution was perfonned by
Novopharn1 Limited of Canada. (Exhibit 2 at A007-A009; Exhibit 3 at AO 1 0). 111 April 2000,
Teva acquired Novophann, adopted Novophann's research on that oral ranitidine solution, and

modified it to comport with Teva's phannaceutical research equipment and protocols. (Exhibit 2

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at A008. The stated objectives for the ranitidine oral solution were two-fold.

Redacted
, (Exhibit 4 at AO 12; Exhibit 5 at AO i 5-AO 16).

To accomplish these objectives, Novopharm consulted "published information" for Glaxo's
product, including the '249 patent. (Exhibit 4 at AO 12-AO 13). After analyzing that information,

Novopharm decided that it should avoid
of the claims of

Redacted

'in view

the '249 patent and

ld. Novopharm, therefore, took affrmative steps to
design around the '249 patent and make a non-infringing formulation.
Teva's oral ranitidine product has the following formula:

Redacted

(Exhibit 7 at AO 17). Teva's formulation uses

Redacted

B. Glaxo's Formulation Uses Ethanol

Glaxo's ranitidine oral solution has the following formula:
Ingredient
Quantity per 1 mL

Redacted
7 pH also stabilizes ranitidine and Glaxo had a patent covering that as well, U.S. Pat. No. 4,585,790 to

Padfield. It has expired, however, and the public is free to use that technology. (Exhibit 6 at A013-24) (Response to Request to Admit No.1 14).

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Ò Òac\e Re

(Exhibit 1 at A004, Anderson Report, March 16, 2006, ~ 52). Glaxo's formulation uses ethanoL.
C. Glaxo's Patent Claims

The '249 patent contains 12 claims. Claims 1 and 11 are independent. They are as
follows:
1. A pharmaceutical composition which is an aqueous formulation for oral

administration of an effective amount of ranitidine and/or one or more physiologically acceptable salts thereof, said formulation comprising a stabilizing effective amount of ethanol and said composition having a pH in the range of 6.5-7.5.
11. A pharaceutical composition which is an aqueous formulation of ranitidine

suitable for oral administration containing 150 mg ranitidine per 10 ml dose expressed as freebase, said formulation having a pH in the range 7.0 to 7.3 and also containing 7% to 8% weight/volume ethanol based on the complete formulation.
(Co!. 2, line 67 - Col. 3, line 4; Co!. 4, lines 10-16)(emphasis added). Each claim of

the '249

patent requires the inclusion of ethanol in the formulation.
D. A Comparison Between Teva's Formulation And The Claims Of

The '249

Patent
For purposes of

this motion, the difference between Teva's formulation and the claims of

the '249 patent is that Teva's formulation does not contain ethanol. Rather, it contains Redacted
Glaxo has admitted that Teva's formulation does not literally infringe the claims of

the

'249 patent.8

8 (Exhibit 6 at A019) (Glaxo Response to Request for Admission No. 87).

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E. The Development Of Glaxo's Formulation

Beginning in the early 1980s, Glaxo began developing a ranitidine oral solution, i.e.,

Zantac(ß syrup. Glaxo Wellcome, Inc. v. Pharmadyne Coip., 32 F. Supp. 2d 265, 277 (D. Md.
1998).9 The original formulation was based on an earlier Zantac(ß solution for injectable use. Id.
(Exhibit 8 at A034-36, Long Tr. at pp. 277-79).10 In November 1983, Glaxo submitted a "Notice
of Claimed Investigational Exemption for a New Drug for Zantac(ß (ranitidine hydrochloride)

Syrup" to the FDA. Id. (Exhibit 8 at A033, Long Tr. at p. 276). As described in its November
1983 FDA notice, the original formulation for ZantacCI oral solution included a preservative
system composed of

three preservatives, but it did not contain any ethanoL. Pharmadyne, 32 F.
the

Supp. 2d at 277. Dr. Long noticed that there was a decrease in the concentration of one of

preservatives over time. Pliarmadyiie at 278.11 He had the product analyzed by Glaxo
microbiologists who discovered that the formulation was contaminated with a microbial
contaminant called Pseudomonas cepacia. Id. 12 (Exhibit 8 at A 038, Long Tr. at p. 281).

To combat the microbial contamination problem, Dr. Long explored the use of
as a preservative for the formulation, but it failed:

Redacted

Redacted

(Exhibit 8 at A039-A041, Long. Tr. at 408-09; 445, lines 1-8); Pharmadyne at 278. Dr. Long's
notebook from that time period shows the use of 2.5% Redacted did not eradicate the

9 Teva cites to Glaxo v. Pharmad)'l1e to establish basic facts that are not in dispute. As will be discussed

later, the case is not binding precedent for this Cour.
10 Cites to "Long Tr." are to the trial transcript of PharmadYlJe bench triaL. By stipulation and this Cour's Order of

the specific witness, i.e., inventor Long, in the Glaxo v. May 12,2006, this testimony is

evidence in this case. i I See (Exhibit 6 at A020) (Glaxo Response to Request for Admission at p. I 4, No. 90). 12 See (Exhibit 6 at A023) (Glaxo Response to Request for Admission at p. I 6, No. 93).

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Pseudomonas cepacia or enhance the preserving power of

the system. (Exhibit 9 at A042-A043).

The notebook cOIToborates Dr. Long's testimony.

Dr. Long's notebook, however, also contains another entiy by Dr. Long. In that entry,

Dr. Long considered Redacted function as a stabilizer in an oral ranitidine solution, as
opposed to a preservative. (Exl1ibit 10 at A045). As reproduced below, Dr. Long compared the

Redacted

for various properties, including stability, in July

of 1985, before the first application for the '249 patent was fied:

FleC/acteC/

(Exl1ibit 10 at A045)(emphasis added). Dr. Long's notebook shows that he believed the

Impol1antly, Dr. Long also assessed both

~ø and ethanol's effect on the
while ethanol was

"eÒ Id. Ò'/v .
Id.

noting that Redacted was

13 The words preceding Dr. Long's notation are unclear. Whether Dr. Long wrote that

Redacted

effect on the . Redacted was Redacted or that FleC/a
is immaterial to the undisputable fact that Dr. Long foresaw the use of cteel as a stabilizer for

ranitidine before his patent application was filed. Id. The fact that Dr. Long found that

Redacted
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Dr. Long's notebook confins that he foresaw the use of Redacted as a stabilizer

for ranitidine before he filed his first patent application on December 12, 1986.
F. Glaxo's '249 Patent Specification

Glaxo's '249 patent specification discloses nothing but ethanol to stabilize the ranitidine

oral solution. Starting immediately with the Abstract, Glaxo claims that the invention is a
formulation "enhanced by the addition ofethano!." (emphasis added). The title of

the invention

further emphasizes the use of ethanol: "AQUEOUS RANITIDINE COMPOSITION

STABILIZED WITH ETHANOL." (emphasis added). In the Background of the Invention,
Gla.xo describes how it "surprisingly found that the stability ofranitidine in aqueous based

formulations and more particularly aqueous based fonnulations for oral administration may be
substantially enhanced by the addition of ethanol to the formulation." (Co!. 1, Jines 40-44)

(emphasis added). Glaxo then describes the "present invention" as a pharmaceutical composition

containing ranitidine, other components and "also containing ethano!." (Co!. 1, lines 45-48)

(emphasis added). The pharaceutical composition \vil contain at least one conventional
pharmaceutical excipient "in addition to the ethanol and ranitidine." (Co!. 1, lines 50-52)
(emphasis added). And again:

The amount of ethanol present in the formulation is such that the resulting

fonnulation has enhanced ability. Preferably the amount of ethanol in the
composition on a weight-volume basis of the complete formulation is within the
range of 2.5% to 10%, and more particularly is between 5% to 10% wlv, more especially 7-8% w/v.

(Co!. I, lines 54-60) (emphasis added).
The patent specification then states that, "the amount of ethanol in the formulation for
oral administration, expressed as a percentage of

the complete formulation on a weight/volume

did not have antimicrobial (preservative) properties and abandoned it for that reason does not mean that it still would not stabilize ranitidine. "Antimicrobial properties" and "increased stability" are separate concepts. See Exhibit 1 at A002, Anderson Report, March 16,2006, ii 40; Pharadyne at 270-71 ("Glaxo
rejected Redacted... as to its use as an agent against pseudnmonas cepacia, not as an agent for

stabilization.") The clear fact is that Dr. Long foresaw the use of Redacted as a stabilizer for ranitidine but did not disclose it in his patent application or claim it.

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basis, is preferably within the range 2.5 to 10%, and more particularly between 5 to 10%, more

especially 7-8%." (Co!. 2, lines 30-34) (emphasis added). The patent specification also describes
the process for preparing the formulation:

The aqueous formulations for oral administration are conveniently prepared by

mixing an aqueous solution of ranitidine and/or one or more of its
physiologically acceptable salts together with ethanol and the excipients, with aqueous solution or dispersion of the viscosity-enhancing agent.

(Co!. 2, lines 38-43) (emphasis added). Finally, the '249 patent ends with only one example, an
example which contains 7.5% ethanol. (Col. 2, lines 53-65).

Interestingly, Glaxo described a number of other common pharaceutical excipients that
could be used in the formulation as alternatives. For each of

those classes of excipients, Glaxo
suitable preservatives include on(e) or

gave examples. For instance, Glaxo said that "examples of

more alkyl hydroxybenzoates such as methyl, ethyl, propyl and/or butyl hydroxybenzoates."

(Co!. 2, lines 12-13) (emphasis added). For viscosity enhancing agents, Glaxo said that examples
"include Xanthan gum, sorbitol glycerol, sucrose, or a cellulose derivative such as
carboxymethylcellulose or a salt thereof of a Cl-4 alh."yl and/or a hydroxy-C2-4 alh."yl ether of

cellulose such as methy1cellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose,
hydroxyethylmethylcellulose and hydroxypropylmethylcellulose." (Co

i. 2, lines 15-21). Glaxo

provided examples of sweeteners: "sweeteners include saccharin sodium, sodium cyclamate,
sorbitol and sucrose." (Col. 2, lines 22-23). Finally, Glaxo listed examples of

flavoring agents:

"flavouring agents include 'mint' flavours such as peppermint flavouring agents." (Co

i. 2, lines

24-25). Regarding the ethanol stabilizer, however, Glaxo provided no other examples or

alternatives that could be used or that were contemplated. This suggests to one skiled in the art
that only ethanol provides the claimed benefit of enhanced ranitidine stability. See Tanabe
Seiyaku Co. Ltd v. lTC, 109 F.3d 726, 732 (Fed. Cir. 1997)(By describing a specific base-solvent
combination instead of a class of ketone solvents, while also describing other reactants of

the

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claimed process by class, the specificaIly claimed combination suggests to a person skiled in the
ar that other ketones may not be useful for the reaction.)

The '249 patent specification contains no data to indicate how ethanol stabilizes

ranitidine or how much stabilization is necessary. The patent only gives one formula and that
formula contains only ethanoL. Moreover, the patent specification describes only ethanol as the

stabilizing agent and nothing more. Importantly, when other chemicals might be alternatives,

the patent lists them. It lists them for preservatives, for viscosity enhancing agents, for
sweeteners, and for flavoring. Notably, however, there are no alternatives listed for ethanoL.
G. The Prosecution Of The '249 Patent

1. Overview
Glaxo fied the first patent application in a chain of patent applications that eventually led
to the '249 patent on December 11, 1987, as USSN 07/131,442 ("the '442 application") entitled
"Pharmaceutical Compositions." (G000236-237). J4 The '442 application claimed priority to a

patent application fied in the United Kingdom on December 12,1986, Serial Number 8,629,781.
(G000246; G000249). The '442 application was abandoned in favor of

application Serial No.

07/344,620 ("the '620 application"), which was filed on April 28, 1989. (GOO 111- i i 2). The

'620 application was continued as application Serial No. 07/494,804 ("the '804 application"),
from which the '249 patent eventually issued. '249 patent, page i.

Importantly, each of Glaxo's patent applications disclosed only ethanol as the excipient
that gave the surprising increase in the stability of ranitidine. None of

the applications suggested

that it would be acceptable to substitute any other excipient for ethanol as a stabilizing agent. The
applications also made no mention of, Redacted, as a stabilzer for ranitidine, even though

Dr. Long had foreseen Redacted
application was fied.

stabilizing effect on ranitidine before the first

j.: File history documents, referenced herein as "GOOO L i i through G000308" are attached as Exhibits :2 and

3 to the Joint Claim Constrction Statement fied contemporaneously with this brief.

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The first application (like each of

the others) clearly states that the addition of ethanol is

the invention:

We have now surprisingly found that the stability ofranitidine in aqueous based formulations and more paricularly aqueous based formulations for oral administration may be substantially enhanced by the addition of ethanol to the formulation.
(G000255)( emphasis added).15
2. The Details Of The Prosecution

On December 11, 1987, Glaxo filed U.S. Patent Application No. 07/131,442 (the '442

application). The specification in the '442 application is essentially the same as the application
that ultimately issued as the '249 patent. The '442 application contained 14 claims. Two of

those

claims were independent, claims 1 and 13. They are as follows:

1. A pharmaceutical composition which is an aqueous formulation of ranitidine and/or one or more physiologically acceptable salts thereof, said formulation also
containing ethanoL.

13. A pharaceutical composition which is an aqueous formulation ofranitidine

suitable for oral administration containing 150 mg ranitidine per 10 ml dose expressed as freebase, said formulation having a pH in the range 7.0 to 7.3 and

also containing 7% to 8% weight/volume ethanol based on the complete
formulation.

(G000243-244).
On May 5, 1988, the Examiner issued a rejection. (G000263). He rejected all i 4 claims
of

the '442 application. Id. He rejected claims 1-10 as indefinite under 35 U.S.e. § 112, second

paragraph. (G000264). The Examiner also rejected claims 1-12 under 35 U.se. § 112, first
paragraph. Id. Finally, the Examiner rejected claims 1-14 as being obvious in light of

the prior

art under 35 U.S.e. § 103. The Examiner stated that "the art teaches the co-joining ofranitidine
and an alcohol; e.g. ethanoL." (G000265). "The addition of a non-critical pH limit and noncritical amounts are not seen as patentable limitations to the various claims." Id.

15 The application also uses the tenus "stability" and "shelflife" interchangeably. (0000254-255).

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On November 7,1988, Glaxo responded to the Examiner's rejection. It amended its
claims to narow the claim element "ethanoL." It did so by requiring that the ethanol be present in

a "stabilizing effective amount." The amendment was as follows:
1. (Amended) A pharaceutical composition which is an aqueous fonnulation of

ranitidine and/or one or more physiologically acceptable salts thereof, said formulation also containing a stabilzing effect amount of ethanol and said
composition having a pH in the range of 6.5 to 7.5.
(G000267).
Glaxo also cancelled claim 4. Id. Glaxo argued that because the claims had been

amended, the 35 U.S.e. § 112, second paragraph, rejection had been eliminated. (G000268).

Glaxo also argued that the claims were not obvious over the prior art. (G000268-269). The
substance of those arguments are not relevant to this summary judgment motion.
On November 29,1988, the Examiner again rejected all of the pending claims of

the '442

application, claims 1-3 and 5-14. (G00027I ). The Examiner maintained his obviousness

rejections under 35 U.S.C. § 103. (G000272). Glaxo did not respond to this rejection and the
application was abandoned on November 29, 1989. (G000275).
Before the '442 patent was abandoned, Glaxo filed a continuation application, Serial No.

07/344,620 (the '620 application). (GOOOl12-113). That application was fied on April 28,1989.
Id. The '620 application was identical to the original '442 patent application and had the same
original

14 claims. (GOOOI17-122). Glaxo did not fie a preliminar amendment changing the
14 claims of

claims and, therefore, on June 28, 1989, the Examiner again rejected all

the '620

application. (GOOOI30). He used the same rejections that were used in the '442 application.

(GOOOI31-132). In addition, the Examiner added another rejection. (G000132). That rejection is
unrelated to the substance of

this summary judgment motion.

On October 30, 1989, Glaxo fied an Amendment to the claims. (GOOO 139-146). Glaxo

amended claim 1 to again narrow the claim element "ethanol" to a subset of ethanol, namely "a

stabilizing effective amount of. The amended claim is as follows:

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1. (Amended) A pharaceutical composition which is an aqueous formulation
for oral administration of ranitidine and/or one or more physiologically

acceptable salts thereof, said formulation also containing a stabilizing effective amount of ethanol and said composition having a pH in the range of6.5 to 7.5.
(GOOOI39).

Glaxo also again cancelled claim 4 and essentially made the same arguments that it had
made in the '442 patent application. (GOOOI40-145). Unlike in the '442 application, however,
Glaxo disclosed an additional reference to the Examiner. (GOOOI44, 146). That reference was

UK Patent Application 2, 120,938A. Id. Glaxo stated that UK Patent Application 2, 120,938A
"relates to the combination of anti-ulcer drugs such as ranitidine together with salicylic acid or a
salt thereof." (GOOO 144). Glaxo further stated that in the UK application, the excipients "may be

formulated in water or organic solvents including a reference to lower aliphatic alcohols,

optionally in admixture with water." Id. (emphasis added). Glaxo argued, however, that, "there
is absolutely no teaching which would lead one of ordinary skill in the ar to select ethanol in
combination with ranitidine in the expectation of providing an oral formulation which is

stabilized in the presence of ethanoL." Id. (emphasis added). Glaxo therefore argued that its
invention was the selection of ethanol over other lower aliphatic alcohols, such as those
specifìcaIly found in the U.K. application.

By this disclosure, Glaxo acknowledged that ranitidine had been available in the prior ar
and that it had been in formulations containing lower aliphatic alcohoL.

Redacted

is a

lower aliphatic alcohoL. 16 Glaxo had the opportnity in the face of this prior art to broaden its

claims to include Redacted in addition to ethanol and to argue to the Examiner that both

of these excipients were patentable as stabilizers. It did not do this, however. It only argued that
ethanol stabilized the formulation. It argued that its invention was the selection of ethanol over
other lower aliphatic alcohols. The Examiner never had a chance to determine whether. Redacted

was patentable as a stabilizing agent for ranitidine. Glaxo told the Patent Offce that a

16 See (Exhibit 1 at A005, Dr. Anderson's expert report, March 16, 2006, ~ 64).

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combination of ranitidine and lower aliphatic alcohols, such as Redacted . were known in

the prior ar, but that the invention selected ethanol over them.
On November 14, 1989, the Examiner rejected all of

the then pending claims, claims 1-3

and 5-14. (G000160). Important to this motion, the Examiner maintained the obviousness

rejection under 35 U.S.e. § 103. (G000161). The Examiner stated that a new reference, "Chem.
Abst. 97-shows ranitidine with an alcohol (2-propanol). Id. This ar clearly precludes applicant's
claims to ranitidine and ETOH."lï Id. The Examiner continued, "97-does show an alcohol and

ranitidine in a formulation. Id. "As for the allegation of enhanced stability, it has not been

demonstrated for the compositions unæd as contrasted with any of other pH parameters." Id. By
this rejection, the Examiner again indicated that the combination of alcohols and ranitidine was in

the prior ar and that Glaxo had not shown any data establishing enhanced stabilty resulting from
the inclusion of ethanoL. See id. The Examiner made this rejection finaL. Id.

On March 14, 1990, Gla.xo filed a file wrapper continuation application, application

Serial No. 07/494,804 (the '804 application). (G000163-166). This is the application that
ultimately issued as the '249 patent.

On May 4, 1990, the Examiner again rejected all the claims pending in the application,
claims 1-3 and 5-14. (GOOO 169). The Examiner essentially maintained the rejection in the
18 (GOOO 170-171).
previous application, the '620 patent application.

On October 31, 1990, Glaxo fied an Amendment. (GOOOI73-178). In the Amendment,

Glaxo narrowed claim 1 by inserting "an effective amount" before the term "of ranitidine" and
the phrase "also containing" was inserted in place of

the phrase "comprising." (GOOOI73). As

amended, the claims is as follows:

1. A pharmaceutical composition which is an aqueous formulation for an oral

administration an effective amount of ranitidine and/or one or more
17 ETOH is ethanoL. See Examiner's November 13, 1989 Rejection at p.l (G000161), which uses "ethanol"

and "EtOH" interchangeably. 18 The Examiner added an additional rejection of double patenting which is not relevant to this summar
judgment motion.

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physiologically acceptable salts thereof, said formulation comprising a stabilizing effective amount of ethanol and said composition having a pH in the range of 6.5
to 7.5.

Jd.

Gla.xo also cancelled claims 8-11 and added new claims J 5- J 7. Id. New claims 15-17 all

depended on independent claim 1. Id. Glaxo argued that the amendments to claim 1 should
eliminate the 35 U.S.e. § 112 rejections. (GOOOI74). Glaxo also argued that the claims were not

obvious under 35 U.S.C. § 103. (G000175). It argued that the "references do not lead one of

ordinary skil in the art in any way to expect that stabilty ofranitidine in an aqueous oral
formulation could be enhanced by the presence of ethanol and does not suggest the presence of
t-tha.DOI in such compositions." Id. (emphasis added). As to the first reference - 97,61 014G-

Glaxo said that "there is no teaching whatever that the stability of ranitidine or its salts as an
aqueous formulation for oral administration is enhanced by the presence of ethanol and there is no suggestion that ethanol should be included in pharmaceutical formulations containing

ranitidine as presently claimed." Id. (emphasis added). As to the second reference - Chemical
Abstract J 04 102280Z--Glaxo wrote that, "(a)gain, there is absolutely no teaching in this

reference that would lead one of ordinary skil in the ar to expect that ethanol would enhance the
stability of ranitidine in aqueous oral formulations or would suggest to one of ordinary skil in the

art that ethanol should be added to such formulations." (G000175-176). (emphasis added).
Glaxo concluded the Amendment by stating that it was in the process of preparing a Declaration

to substantiate the "unexpected effect of ethanol in enhancing the stability of ranitidine in aqueous oral formulations." (GOOOI77). (emphasis added). Gla.xo expected to have that

Declaration available in about six weeks. Jd.
On Januar 22, 1991, the Examiner again rejected all of the pending claims of the

application, claims 1-3, 5-7, and 12-17. (GOOO 198). The Examiner stated that the prior rejections

in the Offce Action of May 4, 1990, had been overcome by the Amendment fied on October 31,
1990. (GOO 199). The Examiner, ho\vever, raised new objections in light of additional documents

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that had been filed by Glaxo on Januar 10, 1991. Id. In the new rejections, the Examiner said
that the claims were obvious under 35 U.S.C. § 103. (GOOO i

99-200). The Examiner argued that

the invention was obvious in light of

Padfield (GB 2142820)("Padfield"). Id. Padfield was

owned by Glaxo. (Exhibit II, . 820 patent, cover). The Examiner noted that in Padfield, Glaxo
already had been awarded a patent for ranitidine formulations having enhanced stability at a pH
of 6.5 to 7.5. (G000200).

The Examiner asked Glaxo to demonstrate, through experimental data, that its purported

invention produced "unexpected results," showing "a definite improvement over" Glaxo's prior
patent, Padfield. Id. The Examiner wrote that because Glaxo's prior patent (Padfield) taught "an

aqueous composition of ranitidine, it is considered well within the state of the ar to choose

ethanol as an additive which would be considered pharaceutically acceptable when formulating

this composition." Id. (emphasis added).
The Examiner again asked for evidence from Glaxo that its choice of ethanol was not

mercly a "choice among known conventional excipients," as Glaxo had stil, four vears after
filing: its first application, not substantiated its claim that ethanol (above other available
excipients) produced "any unexpected results." Id.
On May 10, 1991, Glaxo requested reconsideration of

the January 22,1991, rejection and

argued that its prior patent (Padfield) did not teach an enhancement of ranitidine formulations

using ethanoL. (G000204-207). In support of its claim to the unique and specific benefits of
ethanol to stabilze ranitidine, Glaxo submitted the Declaration of one of its scientists, Dr.

Hempenstall. (G000208-211). Dr. Hempenstalls declaration provided experimental data that the

Patent Offce had demanded since its first rejection. Id. Dr. Hempenstall, who at the time was "a
Research Leader" in the Pharmacy Division of

Glaxo, declared that ethanol added to Glaxo's

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ranitidine formulation, resulted in a "surprising enhancement in the stability of

the ranitidine . . .."

( G000209).19

The experimental data submitted by Dr. Hempenstall demonstrated enhanced stability by

alleging an increase in the shelf life of the various formulations with ethanol as compared to the
same formulations without ethanoL. (G000211). Dr. Hempenstall concluded that his data showed

that "a significant and surprising enhancement in the stability ofthe ranitidine is achieved by the

addition of ethanoL." (G000209). (emphasis added).

Using Dr. Hempenstalls Declaration, Glaxo argued extensively to the Patent Offce that
the use of ethanol as a stabilizing agent for ranitidine was not obvious. (G000204-207). The
sheer volume of references to ethanol (and nothing else) as the stabilizer in this invention is

highlighted by the final argument that Glaxo made to the Examiner which convinced the
Examiner to allow the patent:
The Offcial Action bases the rejection of

the present application under 35 U.S.e. § 103 on a statement that the use of ethanol is considered merely to be a choice among known conventional excipients. Applicant acknowledges that ethanol has
previously been used in pharaceutical compositions. However, the purpose for

which ethanol has been included has been either as a solvent or as a preservative against bacterial contamination. There was, however, no reason to suppose that either of these functions of ethanol would have had any beneficial effects in terms of limiting the degradation of ranitidine in aqueous formulations thereof.

For this reason, there would have been no motivation whatever for one of
ordinary skill in the art to include ethanol in an aqueous ranitidine formulation. Ranitidine is very soluble in water and ethanol is quite unnecessary to assist in

19 Glaxo's uncorroborated data, essential to the issuance of

the '249 patent, was proven to be of

dubious

origin in the Pharmadyne case. Pharmadyne, 32 F. Supp. 2d at 313. Dr. Hempenstal1 only disclosed a

the data supporting the experiments Glaxo had performed, apparently to enhance the appearance subset of of an increase in stabilty. ld. This led the Pliarmadyne cour to conclude that there was the appearance of
improper behavior by Glaxo in prosecuting the patent" and that it was "great." Pliarmadyne at 312. The

Pliarmadyne cour, however, found that Dr. Hempenstalls failure to provide the Patent Offce with a complete disclosure ofthe experimental data did not amount to an intentional, knowing fraud on the Patent Office. Pliarmadyne at 313. In this litigation, Teva has learned that another Glaxo scíentist, Mrs. Bird, analyzed Glaxo's stabilty data and concluded that "the presence of ethanol appears to produce a slight improvement in stabilty." (Exhibit 12 at A054) (emphasis added). "1 thin it is debatable whether or not you pursue this patent claim. The analysts can see no chemical reason why ethanol should enhance stability. ld. Dr. Hempenstall was copied on this memo, yet he told the Patent Offce that his analysis of the data (found to be incomplete by the Pliarmadyne Court) showed that the ranitidine stabilty was "a highly significant and valuable improvement." (000021 I).
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the dissolution of ranitidine in the formulation. In addition, other and better
preservatives are available.

Furthermore, there is a clear disincentive against the use of ethanol in aqueous formulations. Thus, an important use of ranitidine is in the treatment of peptic ulcers and related conditions, and it is well known that alcohol (i.e. ethanol) can
aggravate such conditions. In fact, the amount of ethanol required for use

according to the present invention is at such a low level that no adverse effects are observed as a result of the presence of ethanol, but fairly clear and beneficial effects on drug stability are evident.
However, the fact that ethanol has a known effect in aggravating one of the main conditions that the compositions according to the invention are intended to treat would be a clear disincentive to including ethanol without knowledge of the beneficial effects on stability. This knowledge is, of course, provided only by the
present invention. Thus, there was no motivation whatever for one of ordinary
skil in the ar to include ethanol in aqueous ranitidine formulations and the

beneficial effects obtained by the use of ethanol were most definitely unexpected.
(G000205-206)( emphasis added).
The Examiner allowed Glaxo's claims on June 3,1991. (G000212).

H. Literal Infringement
Teva's proposed ranitidine formula contains water and

Redacted

(Exhibit 7 at A028-A029). This is in contrast to the '249 patent having a
preferred 7.5% w/v of ethanoL. (Col. 2, line 59). Glaxo, in response to a request to admit, has
conceded that Teva's formulation does not literally infringe the '249 patent.20 Because the

doctrine of equivalents is not available to expand the claim element "ethanol" as a matter of law,
dismissal of Glaxo's infringement claims is appropriate.

IV. ARGUMENT
A. The Law Regarding Summary Judgment

The standard for summary judgment in a patent case is no different from any other type
of

case. Union Carbide Corp. v. Am. Can Co., 724 F.2d 1567, 1571 (Fed. Cir. 1984). "Summary

judgment is appropriate when there is no genuine issue as to any material fact and the moving
part is entitled to judgment as a matter of

law." Fed. R. Civ. P. 56(c); United States Gypsum Co.

20 See (Exhibit 6 at AD 19) (Glaxo Response to Request for Admission No. 87).

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V. Nat'l Gypsum Co., 74 F.3d 1209, 1212 (Fed. Cir. 1996). Here, this Court should rule as a

matter of law that Teva's formulation does not infringe the '249 patent because the doctrine of
equivalents is not available to expand the scope of

the claim limitation "ethanol" as a matter of

law.
B. The Law Of Patent Infringement

The first step of any infringement analysis involves determining the scope and meaning
of

the asserted claims. Cybor COlp. v. F'AS Techs., Inc., 138 F.3d 1448, 1454 (Fed. Cir. 1998)(en

banc). The Federal Circuit patent law is now clear that the intrinsic record (the patent claims, the
patent specification and the patent prosecution history) is the primary source of evidence to
properly construe the meaning of a patent claim. See Philips v. AWH COlp., 415 F.3d 1303 (Fed.

Cir. 2005)(en banc).

Here, the parties disagree as to the meaning of the term "ethanol," but under either

definition Teva is entitled to summary judgment of non-infringement. No matter what the
definition of "ethanol" is, it cannot be expanded to cover
Legal limitations on the application of

Redacted as a matter of law.

the doctrine of equivalents are questions of law,

appropriate for summary determination. W m7ier-Jenkinson, 520 U.S. at 39, n.8 ("As stated by the
Warner-Jenkinson Court, the various legal limitations on the application of

the doctrine of

equivalents are to be determined by the court."). Id.
C. Teva's Formulation Does Not Infringe The Claims Of Under The Doctrine Of

The '249 Patent

Equivalents
the doctrine of equivalents to capture the use of

Glaxo must resort to the application of

Redacted

as an infringing equivalent of its invention. The doctrine of equivalents,

however, is not available to Glaxo here.

A core tenet of patent law is that a patentee must "particularly point() out and distinctly
claim() the subject matter which the applicant regards as his invention." 35 U.S.e. § 112 ~ 2.

Inventors are required to describe their work in "full, clear, concise, and exact terms," to foster a

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balance encouraged by the law between "inventors, who rely on the promise of the law to bring
the invention forth, and the public, which should be encouraged to pursue innovations, creations,
and new designs beyond the inventor's exclusive rights." Festa CO/po v. Shoketsu Kinzoku, 535
U.S. 722, 731 (2002).

Indeed, the purpose of a patent claim 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
the limits of

(1942)("The inventor must infonn the public. . . of

the monopoly asserted, so that it

may be known which features may be safely used or manufactured without a license and which
may not"(intemal 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-infringing uses of

the claimed invention. See Festa,

535 U.S. at 731.

The Supreme Court has long recognized that the "carefully crafted bargain" at the heart
of the 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. 17nmder Craft

Boats, Inc., 489 U.S. 141, 150-51 (1989). Here, Glaxo has disclosed and claimed precisely what

it regarded as its invention - the use of ethanol to enhance ranitidine stability. Glaxo's narow
prosecution of

those claims gave notice to its competitors that its patent covered the use of

ethanol to enhance the stability of ranitidine syrup fonnulations, and nothing more.

The doctrine of equivalents inherently conflcts with the well-founded notice objectives
of patent law. At least five important legal bars that spring from the notice function of patents prevent Glaxo from broadening the '249 patent under the doctrine of equivalents. First,
prosecution history estoppel bars a patentee from expanding his claims to embrace subject matter

surrendered by argument to the Patent Offce. Pharmacia & Upjohn Co. v. Mylan Pharms.. Inc.
170 F.3d 1373, 1377 (Fed. Cir. 1999). Second, prosecution history estoppel bars a patentee from
expanding his claims to embrace subject matter surrendered by amendment during the

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prosecution of

the patent. Festa Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722

(2002). Third, the patentee cannot use the doctrine of equivalents to vitiate claim limitations.
Tl'nzo v. Biomet, Inc., 156 F.3d 1154, 1160 (Fed. Cir. 1998). Fourth, a patentee may waive or
dedicate to the public aspects of

the invention that might have been claimed. Johnson &

Johnston Assocs. Inc. v. R.E. Service Co., 285 F.3d i 046 (Fed. Cir. 2002). The facts in this case
are analogous to this line of cases. Fift, Wilson Sporting Goods prevents a patentee from

expanding claims under the doctrine of equivalents to such a degree that the hypothetical claim
covering the equivalent would be invalid. See Wilson Sporting Goods Co. v. David Geoffrey &
Assocs., 904 F.2d 677, 683 (Fed Cir. 1990).
Each of these five bars prevents the use of

the doctrine of equivalents by Gla.o to claim

infringement by Teva's formulation. Each legal bar, although focused on different aspects of

the

patenting process, furthers a common underlying tenant of patent law - that the Patent Offce
should be the first arbiter of

what is patentable. Sage Products, Inc. v. Devon Industries, Inc., 126

F.3d 1420, 1424 (Fed. Cir. i 997). If a patentee does not subject the full, known scope of

his

invention to the Patent Offce for its scrutiny, the patentee later wil be bared from broadening
his claims under the doctrine of equivalents. There is no dispute here that Glaxo claimed a
narrow improvement over its own prior patent (Exhibit 11) and over patents by others which used

lower aliphatic alcohols in conjunction with ranitidine. The field was so crowded that Glaxo was

forced to argue that ethanol alone imparted increased stabilty to its formulations. Even then, it
was forced to provide data as proof. Glaxo did not argue that Redacted was patentable as

a stabilizer for ranitidine even though Dr. Long had thought of that idea before the patent
application was fied. By disclosing, claiming and arguing only ethanol, Glaxo advised the public

that its invention was only a very narrow slice of

the field of art - that narrow slice was ethanol as

a stabilizer.

When inventors claim narrowly, courts also apply the doctrine of equivalents narrowly, if
at aIL. Sage Products, Inc. v. Devon Industries, Inc., 126 F.3d 1420, 1424 (Fed. Cir.

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1997)(affrming summary judgment of non-infringement and noting the case to be an example of
"why the law restricts application of the doctrine of equivalents without further fact finding" in

some cases.). The Federal Circuit has been clear that a contrar rule would cause claim language
to be "reduced to functional abstracts, devoid of meaningful structural

limitations on which the

public could rely." 126 F.3d at 1424. This tenant is fully realized only when an applicant
precisely and fully discloses the full extent of his invention to the Patent Offce, so that
competitors can rely on the scope of the disclosed, claimed and examined invention in order to
avoid infringement. Here, Gla,'xo disclosed, claimed, argued and ultimately persuaded the Patent

Offce that its invention was ethanol as a stabilizing agent in its ranitidine oral solution. Glaxo is
entitled to no more scope of patent protection than that.
1. Glaxo Is Estopped From Broadening The Term "Ethanol" Beyond

Just Ethanol Because It Surrendered By Argument Any Broader Subject Matter
Arguments and representations made to the Patent Offce by Glaxo limit the scope of
available equivalents. See Tanabe Seiyaku Co. Ltd v. lTC, 109 F.3d 726, 733 (Fed. Cir. 1997).
To overcome the Examiner's obviousness rejections, Glaxo argued that "on Iv

by the present

invention," would one of ordinar skil in the art recognize the stabilizing benefits of ethanol in
the forn1Ulation. (G000206)(emphasis added). These arguments responded to the Examiner's

assertion that the selection of ethanol among other "known conventional excipients" was merely a

matter of design choice. (G000200). By this argument, Glaxo surrendered any claim to other
"known conventional excipients," such as Redacted for use as a stabilzing agent in its

ranitidine formulation. (G000204-211). Glaxo also argued that its invention was the selection of
ethanol over other lower aliphatic alcohols.

The facts in Tanabe are surrisingly similar to the facts in this case. Tanabe owned a

patent for preparing the pharaceutical product, diltiazem hydrochloride. The claimed process
included an "N-alh.)Ilation" chemical reaction using a starting material referred to as "TZP" in an
acetone solvent. The accused process used an "N-alkylation" chemical reaction and "TZP" as a

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staring materiaL. The accused process, however, used butanone as the solvent. See Tanabe, 109
F.3d at 729. Butanone and acetone are similar; they both are "ketones" (organic compounds

having a "carbonyl group"). Id. Moreover, they are "homologs," that is, they differ only in that butanone contains an additional "methylene group." Id. There was evidence in Tanabe, as there
is here, that the inventor had experimented with a number of solvents before filing its patent

application, but disclosed to the Patent Offce and claimed only one type of solvent. 109 F.3d at
732.
During prosecution of

the patent application, Tanabe overcame obviousness rejections by

arguing that its process using acetone "gave unexpectedly better results than other combinations
of

bases and solvents." Id. at 733. The Tanabe court, therefore, limited the doctrine of

equivalents to the deliberately narrowed claim at issue, so as not to undermine the notice function

the public is entitled to rely on to avoid infringement. See id. The Tanabe court drew upon
Federal Circuit precedent to note that:
the doctrne of equivalents is not available for the attainment in court of a scope of

protection which encompasses subject matter deliberately removed from
examination by the PTO during prosecution through narrow claiming. . .. It is
of

impermissible to erase under the doctrine of equivalents "meaningfl limitations the claim on which the public is entitled to rely in avoiding infringement."

Tanabe, 109 F.3d at 732 (quoting Genentech, Inc. v. Wel/come Found., Ltd., 29 F.3d 1555,1568

nAI (Fed. Cir. 1994)).
In this case - as in Tanabe - the patented and accused compounds belong to the same
class of chemicals (i.e. they both are alcohols), but are nonetheless different chemicals. See

Glaxo v. Pliarmadyne at 267. The difference between the acetone and butanone in Tanabe is
analogous to the difference between ethanol and Redacted in this case.

As in Tanabe, Glaxo experimented with both ethanol and Redacted

In th is case,

Redacted ,failed for reasons unrelated to the stability ofranitidine, i.e., a lack of

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antimicrobial (preservative) properties.21 As in Tanabe, Glaxo limited its disclosure in the

specification and its claims to one specific compound - ethanoL. Finally, as in Tanabe, Glaxo
obtained its patent by presenting experimental data to show "surprising results" stemming from

the use of ethanol alone. Just as the inventor in Tanabe was precluded from utilizing the doctrne
of equivalents to undo its narrow claim scope to capture subject matter it deliberately did not

present for the Patent Office's review, so should Glaxo be precluded from capturing the use of
Redacted within the scope of its issued claims through the doctrine of equivalents.

In the concurring opinion in Johnson & Johnston Assocs. Inc. v. RE. Service Co., 285 F.3d 1046 (Fed. Cir. 2002), Judge Rader suggested a unified theory of infringement under the

doctrine of equivalents that is useful here. Judge Rader's opinion advocates that infringement by
equivalents should be predicated on a showing by the patentee that the alleged equivalent was not

foreseeable at the time of drafting. Johnson, 285 F.3d at 1057. Judge Rader's well-reasoned
opinion is that "( w)hen one of ordinary skil in the relevant ar would foresee coverage of an
invention, a patent drafter has an obligation to claim those foreseeable limits." Johnson &
Johnston Assocs., Inc. v. R.E. Service Co., 285 F.3d at 1057 (Rader, J. concurring). "In other

words, the patentee has an obligation to draft claims that capture all reasonably foreseeable ways

to practice the invention. The doct