** NOT FOR PUBLICATION **

UNITED STATES DISTRICT COURT

DISTRICT OF NEW JERSEY

____________________________________

:

MEDEVA PHARMA SUISSE A.G., :

et al., :

:

Plaintiffs, : Civil Action No. 10-cv-4008

:

v. : OPINION

:

PAR PHARMACEUTICAL, INC., :

et al., :

:

Defendants. :

:

____________________________________:

Plaintiffs Medeva Pharma Suisse A.G. (“Medeva”), Warner Chilcott

Pharmaceuticals, Inc. and Warner Chilcott Company, LLC (“Warner Chilcott,”)

(collectively referred to as “Plaintiffs”) bring this patent infringement action alleging,

inter alia, infringement of U.S. Patent No. 5,541,170 (“the ‘170 patent”) by Defendants

Par Pharmaceutical, Inc. (“Par”) and Emet Pharmaceuticals, LLC (“Emet,” collectively

referred to as “Defendants”) in submitting their Abbreviated New Drug Application

(“ANDA”) to market a generic version of the Asacol® drug product, which is approved

for the treatment of an inflammatory disease of the large intestine. Asacol® is

currently produced by Warner Chilcott and covered by the ’170 patent owned by

Medeva.

Before the Court is the parties’ request that the Court construe the following

terms in dispute within the claims of the ’170 patent: 1) “whereby the dosage form

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releases the 5-amino-salicylic acid, salt or ester to the right side of the colon” /

“whereby the 5-amino-salicylic acid is released to the right side ofthe colon”; 2)“a layer

which is insoluble in gastric juice and in intestinal juice below pH 7 but soluble in

colonic intestinal juice”; and 3)“said solid oral dosage form being coated so as to release

the 5-amino-salicylic acid, salt or ester to the right side of the colon.” A Markman

hearing was held on October 18, 2011. The Court has considered the written

submissions of the parties, along with the certifications and testimony of Plaintiffs’

expert, Dr. Roland Bodmeier, and Defendants’ expert, Dr. Edmund Elder, Jr.. The

Court shall construe the terms in the context of the asserted claims as set forth herein.

I. BACKGROUND

In light of the protracted prosecution history relating to the ‘170 patent, and the

parties’ reliance upon various aspects of that history, the Court includes a lengthier

than usual background section in this Opinion. That said, this section provides only

an overview and there are specific aspects of the prosecution history that are

addressed, where relevant, in the body of the Opinion.

A. The ’170 Patent

The ’170 patent, entitled “Orally Administrable Pharmaceutical Compositions,”

claims certain pharmaceutical compositions that allow selective administration of a

pharmacologically active agent to the large intestine (also known as “the colon”). The

claims of the ’170 patent include Asacol® and its methods of production. 

The active ingredient of Asacol® is mesalamine (5-amino-salicylic acid, or

5-ASA). Mesalamine has been used since the 1970s in treating diseases or ailments

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of the colon, especially ulcerative colitis or Crohn’s disease. Ulcerative colitis begins

at the rectum and then progresses backwards through the colon, in some patients all

the way to the beginning of the ascending colon. Prior to the ‘170 patent invention,

mesalamine was administered in the form of the drug substance sulphasalazine

(“SASP”), a complex drug substance that is broken down to mesalamine and

sulphapyridine by colonic bacteria. Although SASP was effective, patients often

suffered serious side effects. Realizing that the sulphapyridine was responsible for

such side effects, pharmaceutical companies directed efforts toward developing a way

of delivering mesalamine to the colon that retained SASP’s effectiveness but avoided

its side effects. However, the prior art to the ‘170 patent did not achieve such a goal,

and orally administered dosage forms were generally absorbed into the blood stream

in the stomach or small intestine before reaching the colon. 

The ‘170 patent describes a solid oral dosage form containing mesalamine,

coated with an anionic polymer (or polymers) designed to remain intact until reaching

the colon, and to release the mesalamine to the colon without substantial leaching

before reaching the colon. Based in part on the fact that the pH in the human

gastrointestinal tract increases from the stomach to the colon, by which point the pH

reaches about 7, the inventors found a formula for the layer that is insoluable below

pH 7, but soluble above pH 7. Once the dosage form reaches the colon, the coating

layer begins to dissolve, and accordingly mesalamine is administered to the colon. 

B. Prosecution History

On July 28, 1982, following a clinical trial demonstrating that the claimed

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formulation was as effective as SASP in treating ulcerative colitis, the inventors filed

an application for a U.S. patent (No. 82/000235). After several continuation

applications (No. 06/482,331, No. 06/735,727, No. 07/584,386, No. 07/858,449 and No.

08/032,167), the inventors filed a divisional application (No. 08/401,696) on March 10,

1995, which ultimately led to the issuance of the ‘170 patent on July 30, 1996. 

Meanwhile, the patent application of No.08/032,167 was followed by another

continuation application (No.08/448,300), for which the Patent Office issued U.S.

Patent No. 5,541,171 (“the ‘171 patent”).1 In filing the divisional application, which

separated out the claims ultimately incorporated into the ’170 patent, the patentees

sought to patent broader claims than those ultimately incorporated into the ‘171

patent. 

In short, the ’170 and ‘171 patents flow from the same earlier continuation

applications. The following chart illustrates the history of these related patents.

[next page]

1 Even though Plaintiffs made no claim that Defendants’ ANDA infringed

upon the ‘171 patent, Defendants filed a counterclaim for declaratory judgment

regarding the validity of the ‘171 patent. This Court dismissed it on the ground that

Defendants lack standing to bring the counterclaim based upon Plaintiffs’ offering of

a covenant not to sue Defendants on the ‘171 patent. Medeva Pharma Suisse A.G. v.

Par Pharm., Inc., 774 F.Supp.2d 691, 699 (D.N.J. 2011), aff'd, 2012 U.S. App. LEXIS

1516 (Fed. Cir. Jan. 25, 2012).

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The prosecution history for the ’170 patent, and the related ‘171 patent, is

extensive, spanning over fourteen years. As noted above, the use of 5-ASA topically on

the colon was a familiar treatment; it was the patentees’ ability to ensure that the

treatment did not leach out before reaching the colon that made their invention unique. 

Hence, throughout the prosecution of the patent, the patentees spent significant time

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distinguishing their formulation from the prior art. In this connection, the patentees

further emphasized the high organ specificity of their coating and dosage form, and

that the mesalamine was “dumped” into the colon, rather than consistently released

in small amounts prior to, throughout, and following the colon. The several

continuation applications were occasioned by the patentees’ failure to convince a given

examiner that their invention was not obvious to one familiar with the prior art. 

Through their perseverance, the patentees were ultimately able to convince the

examiners that their patents should be issued.

There are three types of prior art distinguished by the patentees throughout the

prosecution history that are relevant here. One prior art was the use of a coating

comprised of mixtures of Eudragit S & Eudragit L, in certain thicknesses, which

thickness was insufficient to ensure that the 5-ASA did not leach out before reaching

the colon. Contrary to the prior art, the patentees contended that their coating was

thicker and, consequently, did not dissolve too early in the intestinal tract. In this

connection, the patentees also noted that they used coatings comprised only of

Eudragit S, as opposed to both S & L, along with other polymers. 

Another prior art was the use of a resin in the coating formulation that effected

a time release-based delivery. Rather than employing a time-release carrier system

for delivering the drug, the patentees’ formulation was pH-dependent; the patentees’

coating would not dissolve until it reached the area of the intestines that contains pH

7 fluids. The patentees further argued that a pH-based carrier system is more reliable

because release ofthe drug from a time-release system may vary from two to five hours

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and, thereby, release too early during the digestive process before reaching the colon.

Finally, the patentees distinguished all prior oral administrations of 5-ASA as

not specified to prevent release of 5-ASA before reaching the colon.

C. Comparing the ’170 and ‘171 patents

As noted, the ‘170 and ‘171 patents share the same parent applications, those

filed from 1982 through 1993. However, per the divisional application filed in 1995,

the patentees split their application into two. Divisional Application No. 08/401,696

became the application for what was ultimately issued as the ’170 patent, and

Continuing Application No. 08/448,300 became the application for what was ultimately

issued as the ‘171 patent. 

Generally, divisional applications are submitted by applicants where the PTO

has imposed a restriction requirement on the applicants’ original application. “An

examiner enters a restriction requirement when he determines that the application

includes claims to independent and distinct inventions.” 4A-12 Chisum on Patents §

12.04; see 35 U.S.C. § 121 (“If two or more independent and distinct inventions are

claimed in one application, the Director may require the application to be restricted to

one of the inventions.”). Thereafter, the applicant must elect one of the inventions to

pursue. See 37 C.F.R. § 1.142. After the applicant has elected one of the inventions,

the patent examiner will withdraw from further consideration all claims for the

nonelected inventions. 4A-12 Chisum on Patents § 12.04. An applicant who wishes to

pursue what was withdrawn “may file a divisional application claiming the nonelected

inventions ....” Id. 

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A key difference between the ‘171 patent and the ’170 patent here is that the

former expressly excludes coating mixtures of Eudragit S & Eudragit L whereas the

latter does not. Further, as noted, the patentees sought broader claims in the

divisional application that resulted in the ’170 patent. 

D. Disputed Claims

The parties present three disputed terms for construction in claims1, 6 and 7 of

the ‘170 Patent. The claim language reads:2

Claim 1

1. An orally administrable pharmaceutical composition for selectively

administering 5-amino-salicylic acid, or pharmaceutically acceptable salt or ester

thereof, to the large intestine, comprising a solid oral dosage form containing a

pharmaceutically effective amount for the treatment of ulcerative colitis or Crohn’s

disease of the colon of said 5-amino-salicylic acid, salt or ester, said solid oral dosage

form being coated with a layer which is insoluble in gastric juice and in intestinal juice

below pH 7 but soluble in colonic intestinal juice, whereby the dosage form releases the

5-amino-salicylic-acid, salt or ester to the right side of the colon.

Claim 6

6. A method for treating ulcerative colitis or Crohn’s disease of the colon

comprising orally administering to a person suffering therefrom the composition of

claim 1 whereby the 5-amino-salicyclic acid is released to the right side of the colon.

Claim 7

7. An orally administrable pharmaceutical composition for selectively

administering 5-amino-salicylic acid, or pharmaceutically acceptable salt or ester

thereof, to the large intestine, comprising a solid oral dosage form containing a

pharmaceutically effective amount for the treatment of ulcerative colitis or Crohn's

disease of the colon of said 5-amino-salicylic acid, salt or ester, said solid oral dosage

form being coated so as to release the 5-amino-salicylic acid, salt or ester to the right

side of the colon. 

2 The disputed terms are highlighted.

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To understand the parties’ proposed constructions, a basic schematic of the

gastrointestinal tract is useful.

Bodomeier Decl. dated Jun. 2, 2011 at ¶ 11. 

As this schematic illustrates, the ileum precedes the cecum (also referred to as

the caecum) and the ascending colon. Both parties agree that, in common parlance,

“colon” refers to the area beginning with the ascending colon (or “right side of the

colon”) and does not include the ileum. This area, the ascending colon, is also referred

to by the parties as the “large intestine.” One of the parties’ key claim construction

disputes is whether the patentees taughtthattheir formulation of 5-ASA would release

in both the ileum and the ascending colon. To be clear, the parties refer in their

proposed constructions specifically to the distal ileum (or terminal ileum), which is the

latter most part of the ileum adjacent to the cecum. The patentees used distal ileum

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and terminal ileum interchangeably throughout the prosecution history. For ease of

reference, the Court will use the term distal ileum except when quoting prosecution

history statements, the parties’ briefs, or proposed constructions that refer to the

terminal ileum.

The parties’ proposed constructions of the disputed terms are as follows:

Disputed Terms Plaintiffs’ Construction Defendants’ Construction

A layer which is insoluble in gastric

juice and in intestinal juice below

pH 7 but soluble in colonic

intestinal juice (Claim 1)

The dosage form is coated

with at least one layer that

has sufficient thickness so

that the coating does not

fully dissolve or

disintegrate in gastric juice

and in intestinal juice

below pH 7, but does

dissolve or disintegrate in

colonic intestinal juice.

None of the layer dissolves

(i.e., the layer is insoluble)

in aqueous medium below

pH 7 but the layer does

dissolve below pH 7.5. 

This excludes layers

containing mixtures of

Eudragit S and Eudragit L.

Whereby the dosage formreleasesthe

5-amino-salicylic-acid,salt or esterto

the right side of the colon (Claim 1)

Substantially all of the drug

leaves the dosage form in

the distal part of the small

intestine or the ascending

colon.

The coating reliably releases

all of the active ingredient

contained in the dosage form

to the right side of the colon

(i.e., the ascending colon,

and not the terminal ileum).

Whereby the 5-amino-salicylic-acid is

released to the right side of the colon

(Claim 6)

(same) (same)

Said oral dosage form being coated so

as to release the 5-amino-salicylicacid, salt or ester to the right side of

the colon (Claim 7)

Substantially all of the drug

leaves the dosage form in

the distal part of the small

intestine or the ascending

colon.

The coating is insoluble

below pH 7, i.e. Eudragit S,

and thereby reliably

releases all of the active

ingredient contained in the

dosage form to the right

side of the colon (i.e., the

ascending colon, and not

the terminal ileum).

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II. LEGAL STANDARDS

A. General Claim Construction Standard

Claims define the scope of the inventor’s right to exclude. Phillips v. AWH

Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005). Claim construction determines the

correct claim scope, and is a determination exclusively for the court as a matter of

law. Markman v. Westview Instruments, Inc., 52 F.3d 967, 978-79 (Fed. Cir. 1995)

(en banc). Indeed, the court can only interpret claims, and “can neither broaden nor

narrow claims to give the patentee something different than what it has set forth” in

the specification. E.I. Du Pont de Nemours v. Phillips Petroleum Co., 849 F.2d 1430,

1433 (Fed. Cir. 1988). 

This interpretive analysis begins with the language of the claims, which is to

be read and understood as it would be by a person of ordinary skill in the art. Dow

Chem. Co. v. Sumitomo Chem. Co., 257 F.3d 1364, 1372 (Fed. Cir. 2001); see also

Markman, 52 F.3d at 986 (“The focus [in construing disputed terms in claim

language] is on the objective test of what one of ordinary skill in the art at the time

of invention would have understood the terms to mean”); Phillips, 415 F.3d at

1312-13. In construing the claims, the court may examine both intrinsic evidence

(e.g., the patent, its claims, the specification and prosecution history) and extrinsic

evidence (e.g., expert reports, testimony and anything else). Pitney Bowes, Inc. v.

Hewlett-Packard Co., 182 F.3d 1298, 1309 (Fed. Cir. 1999). However, claims may not

be construed with reference to the accused device, which means that the court may

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not construe a claim to fit the dimensions of the accused device, thus to prejudice the

claim construction by “excluding or including specific features of the accused device.”

Wilson Sporting Goods Co. v. Hillerich & Bradsby Co., 442 F.3d 1322, 1330 (Fed. Cir.

2006). Nevertheless, the knowledge of the accused device before or during claim

construction is not only permissible, but also necessary to claim construction because

it “supplies the parameters and scope of the infringement analysis.” Id. at 1330-31;

Lava Trading Inc. v. Sonic Trading Mgmt., 445 F.3d 1348, 1350 (Fed. Cir. 2006).

In interpreting the disputed terms, it is well settled that the Court should look

first to the intrinsic evidence. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576,

1582 (Fed. Cir. 1996). Generally, words in patent claims are given their “ordinary

and accustomed meaning as understood by one of ordinary skill in the art” at the

priority date of the patent application. Dow Chem., 257 F.3d at 1372; K-2 Corp. v.

Salomon S.A., 191 F.3d 1356, 1362 (Fed. Cir. 1999). The claims must be construed

objectively in the context of both the particular claim and the entire patent because

“the claims themselves provide substantial guidance as to the meaning of particular

claim terms,” and claim terms are normally used consistently throughoutthe patent.

Phillips, 415 F.3d at 1313-14.

Moreover, courts are instructed to look to the specification, which is a written

description of the invention. “[C]laims ‘must be read in view of the specification, of

which they are a part.’” Id. at 1315 (quoting Markman, 52 F.3d at 979). Indeed, the

specification is perhaps “the single best guide to the meaning of a claim term” due to

its statutory requirements of being in “full, clear, concise, and exact terms.” Id. at

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1316; see 35 U.S.C. §112. “The specification acts as a dictionary when it expressly”

or implicitly defines terms used in the claims. Markman, 52 F.3d at 979. Thus, it

effectively limits the scope of the claim. On Demand Mach. Corp. v. Ingram

Industries, Inc., 442 F.3d 1331, 1340 (Fed. Cir. 2006). Due to its nature, “the

specification ‘is always highly relevant to the claim construction analysis. Usually

it is dispositive.” Id. (quoting Vitronics Corp., 90 F.3d at 1582).

Extrinsic evidence includes all evidence external to the patent and prosecution

history, i.e., expert and inventor testimonies, dictionaries, and learned treaties. 

Markman, 52 F.3d at 980. It is considered only where the intrinsic evidence does not

provide a sufficient description to resolve ambiguities in the scope of the claim. See

Vitronics, 90 F.3d at 1583; Johnson Worldwide Assocs. v. Zebco Corp., 175 F.3d 985,

989 (Fed. Cir. 1999). However, the Federal Circuit cautioned, in Phillips, that

dictionary definitions should not be used to interpret patent claim terms in a manner

thatis divorced from the context and description ofthe invention in the specification.

Phillips, 415 F.3d at 1321. The Phillips court reasoned that because of the nature of

the patent claims, the dictionary definitions, as extrinsic evidence, are usually less

reliable than the patent documents themselves in establishing the ordinary meaning

of a claim term. Id. at 1314; Toro Co. v. White Consol. Indus., 199 F.3d 1295, 1299

(Fed. Cir. 1999). Ultimately, extrinsic evidence cannot be used to vary or contradict

claim terms when their meanings are discernible from intrinsic evidence. C. R. Bird,

Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004). 

B. Disclaimers and Disavowals

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“[I]n certain cases, the specification may reveal an intentional disclaimer, or

disavowal, of claim scope by the inventor.” Ventana Medical Systems, Inc. v. Biogenex

Laboratories, Inc., 473 F.3d 1173, 1181 (Fed. Cir. 2006) (quoting Phillips, 415 F.3d

at 1316) (internal citations omitted). In such cases, the Federal Circuitinterprets the

claim more narrowly than it otherwise would in order to give effect to the patentee’s

intent to disavow a broader claim scope. Id. (citing Honeywell Int'l, Inc. v. ITT

Indus., Inc., 452 F.3d 1312, 1319-20 (Fed. Cir. 2006); SciMed Life Sys., Inc. v.

Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1342-44 (Fed. Cir. 2001). 

However, pointing solely to “general statements by the [patentee] indicating

that the invention is intended to improve upon prior art” will not demonstrate that

the patentee intended to “disclaim every feature of every prior art device discussed

in the ‘BACKGROUND ART’ section of the patent.” Id. See also Thorner v. Sony

Computer Entertainment America LLC, 669 F.3d 1362 (Fed. Cir. 2012) (“Mere

criticism of a particular embodiment encompassed in the plain meaning of a claim

term is not sufficient to rise to the level of clear disavowal.”) (quoting Epistar Corp.

v. Int'l Trade Comm'n, 566 F.3d 1321, 1335 (Fed. Cir. 2009)). 

Moreover, the Federal Circuit has found it “particularly important not to limit

claim scope based on statements made during prosecution ‘[a]bsent a clear disavowal

or contrary definition.” Digital-Vending Services Intern., LLC v. University of

Phoenix, Inc., 672 F.3d 1270, 1273 (Fed. Cir. 2012) (citing August Tech. Corp. v.

Camtek, Ltd., 655 F.3d 1278, 1286 (Fed. Cir. 2011) (quoting Home Diagnostics, Inc.

v. LifeScan, Inc., 381 F.3d 1352, 1358 (Fed. Cir. 2004)). The reason for such a

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stringent rule is “because the prosecution history represents an ongoing negotiation

between the PTO and the applicant, rather than the final product ofthat negotiation,

it often lacks the clarity of the specification and thus is less useful for claim

construction purposes.” Id. (quoting Phillips, 415 F.3d at 1317).

C. Related Applications

Generally, “statements made by the inventor during continued prosecution of

a related patent application can, in some circumstances, be relevant to claim

construction.” Ventana, 473 F.3d at 1184 (citing Microsoft Corp. v. Multi-Tech Sys.,

Inc., 357 F.3d 1340, 1349 (Fed. Cir. 2004)). This is particularly so where “the

prosecution history of one patent is relevant to an understanding of the scope of a

common term in a second patent stemming from the same parent application.” MultiTech, 357 F.3d at 1349. Similar to statements made by the patentee during the

prosecution of an ancestor application, “statements made during the continued

prosecution of a sibling application may inform the meaning of the claim language by

demonstrating how the inventor understood the invention.” Ventana, 473 F.3d at

1184 (citing Phillips, 415 F.3d at 1317). Moreover, the “prosecution history of a

related patent application may inform construction of a claim term, when the two

applications are directed to the same subject matter and a clear disavowal or

disclaimer is made during prosecution of the related application.” TIP Sys., LLC v.

Phillips & Brooks/Gladwin, Inc., 529 F.3d 1364, 1371 (Fed. Cir. 2008). 

Prosecution history estoppel applies with equal force to divisional applications.

See Desper Prods., Inc. v. QSound Labs, Inc., 157 F.3d 1325, 1339 n. 6 (Fed. Cir.

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1998) (relying on common parent application to construe claims in both a divisional

and a related application). However, “[w]hen the applicant is seeking different claims

in a divisional application, estoppel generally does not arise from the prosecution of

the parent.” Biogen, Inc. v. Berlex Laboratories, Inc., 318 F.3d 1132, 1140 (Fed. Cir.

2003).

III. DISCUSSION

The parties’ claim construction arguments relate to two claim terms: the

“release to the right side of the colon” language found in claims1, 6, and 7; and the

“insoluble in gastric juice”language found in claim 1. In addition, Defendants further

argue, via the doctrine of prosecutory estoppel, that the patentees disclaimed

mixtures of Eudragit S and Eudragit L. Finally, Defendants contend that a pH

limitation should be read into claim 7 although that claim includes no such express

limitation. I address each of these issues in turn.

A. Releasing “to the right side of the colon”

Each of the disputed claims speaks of releasing 5-ASA “to the right side of the

colon.” As explained above, 5-ASA must be applied topically, thus, the precise

placement of the formulation onto the colon’s surface is central to the patentees’

invention. In this connection, the parties dispute whether “to the right side of the

colon” should be construed to mean releasing within the distal ileum or the ascending

colon (Plaintiffs’ view) or, alternatively, to release only within the ascending colon

and not within the distal ileum (Defendants’ view). In addition, the parties dispute

what amount of the drug must be released. Plaintiffs construes the claim language

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to mean that “substantially all” (at least 80%) of the drug must be released whereas

Defendants argue that“all”(near 100%) ofthe drug must be released to the right side

of the colon. 

The parties proposed constructions are as follows:

Claim Language Plaintiffs’ Construction Defendants’ Construction

Whereby the dosage form

releases the 5-amino-salicylic

acid, salt or ester to the right

side of the colon (Claim 1) /

Whereby the 5-amino-salicylic

acid is released to the right side

of the colon (Claim 6)/ Said

oral dosage form being coated

so as to release the 5-aminosalicylic-acid, salt or ester to

the right side of the colon

(Claim 7)

Substantially all of the

drug leaves the dosage

form in the distal part of

the small intestine or the

ascending colon. 

The coating reliably releases all

of the active ingredient contained

in the dosage form to the right

side of the colon (i.e., the

ascending colon, and not the

terminal ileum).

1. Distal Ileum

 Defendants argue that their construction comports with the ordinary meaning

of “right side of the colon.” First, they note that the right side of the colon (also

known as ascending colon) is a part of the large intestine, and therefore the small

intestine is not included by definition. Furthermore, because the patentees never

expressly defined “the colon” to include the distal part of the small intestine,

Defendants contend that Plaintiffs’ construction is inconsistent with the claim

language. Citing Merck & Co. v. Teva Pharms. USA, 395 F.3d 1364, 1370 (Fed. Cir.

2005), for the proposition that “[w]hen a patentee acts as his own lexicographer in

redefining the meaning of particular claim terms away from their ordinary meaning,

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he must clearly express that intent in the written description,” Defendants argue that

the patentees did not clearly express an intent to redefine the phrase “right side of

the colon.” 

In support of their argument that the patentees did not intend release in the

distal ileum to be a part of the invention, Defendants point to an example in the

specification. In Example IV in the specification, six capsules were given to each of

six patients (36 capsules in total) and their integrity was tracked over time via X-ray

analysis. Four of the capsules broke in the distal ileum and 23 broke at the colon. 

According to Defendants, the results of the Example show that the patentees

considered the invention exemplified by the 23 capsules that “remained intact after

oral ingestion until they reached the right side of the colon when the capsule broke

releasing its contents,” and not the four capsules that broke in the distal ileum. ’170

patent, col. 7 at 16-19.

By contrast, Plaintiffs contend that the intrinsic evidence confirms that the

claim limitation of “release to the right side of the colon” encompasses liberation of

the drug in the distal portion of the small intestine. For example,

• Example IV—the same example relied upon by Plaintiffs— reports that the

capsules “remained intact in the stomach and proximal small bowel [upper

small intestine]” and then broke either in the “distal ileum” or the colon. ’170

patent col. 7 at 3-7.

• A September 26, 1984 Amendment explains that the patentees’ preference for

a coating thickness between 60 and 160 microns as providing for a coating

“which would reliably break in the terminal ileum or in the proximal large

intestine (ascending caecum and ascending colon usually).”

 

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• A March 14, 1988 Response states that “[t]his unit dosage form [of the

invention] has been developed to carry the [mesalamine] to the last portion of

the small intestine or the first portion of the colon before the coating

disintegrates or dissolves, in order to provide an effective dose of [mesalamine]

to the colon for the treatment of ulcerative colitis or Crohn's disease therein.”

 

• A November 17, 1995 Responsive Amendment states that “[t]he composition of

the claimed invention is embodied in the product Asacol®” and then cites

literature showing Asacol®, an embodiment of the ’170 patent, “break[ing] up

in the terminal ileum or ascending colon.” 

Plaintiffs’ Opening Br. at 12-13 (citations omitted). 

In addition, Plaintiffs argue that the intrinsic evidence also describes the

preferred embodiment of the claims—a solid oral dosage form coated with a thick

Eudragit S coating—as releasing the drug in the distal ileum in order to provide

therapy throughout the colon. Because Defendants construe claims to exclude release

in the distal ileum, Plaintiffs reason that it is contrary to the intrinsic evidence, and

would improperly exclude the preferred embodiment from the claims. As such,

Defendants’ construction must be, according to Plaintiffs, rejected, because “[a] claim

interpretation that reads out a preferred embodiment is rarely, if ever, correct and

would require highly persuasive evidentiary support.” Id. at 13 (quoting Virtonics

Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996)).

More importantly, Plaintiffs emphasize that Defendants’ construction is clearly

contradicted by the expressed definition of the claim term provided by the inventors

in connection with a related application. Plaintiffs note that in a continuation

application (the ’300 application) that ultimately led to issuance of the ‘171 patent,

the patentees expressly stated that “the claim limitations of remaining ‘intact until

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it reaches the colon’ and ‘release to the right side of the colon’ embrace breaking up

in the terminal ileum or ascending colon and releasing in the distal part of the small

intestine.” Id. at 14 (quoting Ainsworth Ex. F at 7). Accordingly, Plaintiffs maintain

that Defendants’ proposalto exclude such release from the claims is inconsistent with

the claim language and the intrinsic evidence.

Furthermore, Plaintiffs cite to the declaration of their expert witness, Dr.

Bodmeier. In his declaration, Dr. Bodmeier explained that because coating

dissolution and tablet disintegration are not instantaneous events, it may be

preferable to design dosage form to disintegrate shortly before entry into the right

side of the colon in the distal portion of the small intestine. Bodmeier Decl., ¶ 29. 

Because the best way to deliver the drug to the very beginning of the right side of the

colon (around the cacum) may be to release the drug near the end of the small

intestine (e.g., in the distal ileum), Plaintiffs claim that a skilled artisan would

understand that release to the right side of the colon includes release in the distal

ileum .

Because the parties do not dispute that the ordinary and customary meaning

of the “right side of the colon” does not include the distal part of the small intestine,

the issue before the Court is whether the patentees clearly expressed their intention

in the patent or prosecution history to either: (a) include the distal part of the small

intestine in the definition of “right side of the colon;” or (b) by claiming that the drug

will release “to” the right side of the colon, expressed their intention that the drug

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release in the distal ileum in order to facilitate topical application in the ascending

colon, as Dr. Bodomeier suggests. 

As an initial matter, I rejectthe argumentthatthe patentees acted as their own

lexicographer by specially defining “right side of the colon” in the specification or the

prosecution history. There is no language in the specification that can be read as

clearly setting forth a special definition of either colon or “right side of the colon.” 

Indeed, the only reference to the distal ileum in the specification is in Example IV,

and that example distinguishes between the distal ileum and the colon: “In a few

patients occasional capsules broke in the distal ileum (4 of 36) but after 12 hours 32

capsules had reached the colon and of these, 23 had broken at this site.” ’170 Patent,

col. 7 at 4-7 (emphasis added). See also File History, 06/482,331 App., Sept. 26, 1984

Amendment at 9 (Ainsworth Decl., Exh. J at WC373) (“[T]he coating would reliably

break in the terminal ileum or in the proximal large intestine (ascending caecum and

ascending colon usually).”) (emphasis added).

However, the claim language envisions an initial breaking or disintegration of

the coating layer in the distal ileum so as to release the 5-ASA in the colon. While,

on the one hand, the patentees describe the invention in the specification as

“remain[ing] intact until it reaches the colon,” see e.g., ‘170 Patent, col. 4 at 20; id. at

4:30; id. at 4:63, the broadly worded claim language of releasing “to” the colon

encompasses the initial dissolution in the distal ileum in order to ensure that the

drug is topically applied on the colon’s surface. Moreover, the Federal Circuit has

repeatedly held it inappropriate to read limitations from the specification into the

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claim. See e.g., Thorner, 669 F.3d at 1366 (“We do not read limitations from the

specification into claims ....”); Phillips, 415 F.3d at 1315, 1323 (“The claims are read

in context with the specification, but limitations from the specification should not be

read into the claims.”). And,“[i]tis the claims that define the metes and bounds ofthe

patentee’s invention.” Thorner, 669 F.3d at 1367. 

It is true that for all the embodiments of the invention discussed in the

specification, it is anticipated that the “dissolution or disintegration [will] not occur

until entry of the coated dosage form into the colon.” Id. col. 4 at 1-3. Nevertheless,

“[i]t is . . . not enough that the only embodiments, or all of the embodiments, contain

a particular limitation.” Thorner, 669 F.3d at 1366. See also Kara Technology Inc.

v. Stamps.com Inc., 582 F.3d 1341 (Fed. Cir. 2009) (“[W]e have expressly rejected the

contention that if a patent describes only a single embodiment, the claims of the

patent must be construed as being limited to that embodiment.”) For a limitation to

be imported from the specification into a claim, the specification must describe the

“present invention” or otherwise make explicit that all contemplated embodiments

of the claim contain the limitation. Id. Indeed, this was the case in SciMed, 242 F.3d

at 1341, a case relied upon by Defendants. Unlike SciMed, the specification here

makes no pronouncement that all contemplated embodiments will break or release

in the colon.

In addition, Example IV in the specification supports my construction of the

“release to the right side of the colon” language. As noted, in that example, the

patentees described the capsules as occasionally breaking “in the distal ileum ....” 

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’170 Patent, col. 7 at 5. I note, however, that the Example IV language suggests that

occasional rather than frequent breaking in the distal ileum was contemplated.

The prosecution history of the ’170 patent further supports my construction. 

There is language in the early prosecution history of both the ’170 and ‘171 patents,

before the patent applications were divided, that embraces release in the distal ileum. 

During prosecution of the ’331 application, in 1984, the patentees stated that they

“obtained a consistent behavior of the coating would reliably break in the terminal

ileum or in the proximal large intestine (ascending caecum and ascending colon

usually).” File History, 06/482,331 App., Sept. 26, 1984 Amendment at 9 (Ainsworth

Decl., Exh. J at WC373). Similarly, in connection with the ’727 application, the

patentees stated that the “dosage form has been developed to carry the 5-ASA to the

last portion of the small intestine or first portion of the colon, before the coating

disintegrates or dissolves ....” File History, 06/737,727 App., Mar. 14, 1988 Response

and Presentation of Evidence Under Rule 12 at 3 (Ainsworth Decl., Exh. K at

WC446).

There is also language embracing initial dissolution in the distal ileum in the

divisional application that ultimately resulted in the issuance of the ‘170 patent,

although that language refers specifically to the preferred embodiment Asacol®. In

the prosecution of that application, the patentees stated that Asacol® “has been

shown to break up in the terminal ileum or ascending colon,” File History, 06/401,696

App., Nov. 17, 1995 Responsive Amendment at 4-5 (Ainsworth Decl., Exh. E at

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WC132-33), and that it “dissolves in the terminal ileum.” Id., Mar. 13, 1996

Responsive Amendment at 4 (Ainsworth Decl., Exh. O at WC180).3

Read together, these statements from the prosecution history support a

construction ofthe “release to the right side ofthe colon” claim language thatincludes

release in the distal ileum.4 That the patentees also intermittently used the phrase

“release . . . in the colon” to describe the drug’s release profile in parts of the

specification and prosecution history does not alter my construction. For example,

Defendants point to language in the specification distinguishing prior art as “not

provid[ing] for release of 5-ASA only in the colon.” ‘170 patent, col. 3: 59-60

(emphasis added). While this isolated statement might suggest that the patentees

used “in the colon” and “to the colon” interchangeably, by reading the sum of the

prosecution history it is clear that their focus was topical application of the 5-ASA to

the colon wall whether the dosage form began to dissolve in the distal ileum or the

ascending colon.

3 Defendants argued at oral argument that Asacol® is not a preferred

embodiment because it did not exist at the time of the original 1984 patent application. 

Even so, Asacol® utilizes a coating of neat Eudragit S, which Defendants do not contest

falls within the bounds of the claims. Moreover, Defendants appear to contend that the

’170 patent claims should be limited to Eudragit S formulations by arguing that the

patentees disavowed mixtures of Eudragit S and Eudragit L.

4 Plaintiffs further point to a clear and unequivocal statement regarding

release to the right side of the colon made during the post-division related patent

application (the ’300 application) for the ‘171 patent. In light of the aforesaid

statements made in connection with the ‘170 patent prosecution, I need not rely on this

statement in the related Patent’s’171 patent file history.

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The Court does not wholesale adopt Plaintiffs’ construction, however. In

construing the claims, “[t]he judge’s task is not to decide which of the adversaries is

correct. Instead, the judge must independently assess the claims, the specification,

and if necessary the prosecution history, and relevant extrinsic evidence, and declare

the meaning of the claims.” Exxon Chem. Patents, Inc. v. Lubrizol Corp., 64 F.3d

1553, 1556 (Fed. Cir. 1995); MEMSTechnology Berhad v. International Trade Com'n,

447 Fed.Appx. 142, 153 (Fed. Cir. Jun. 3, 2011) (same). Following that dictate here,

I adopt a slightly more constrained construction. 

Plaintiffs’ proposed construction is: “Substantially all of the drug leaves the

dosage form in the distal part of the small intestine or the ascending colon.” The

problem with this construction is that it fails to take into account, as reflected by a

careful reading of claim language, specification, and prosecution history, that the

patentees contemplated that the drug would most often release in the colon and that,

much less often,the drug would begin to leave the dosage from while still in the distal

ileum. Moreover, Plaintiffs’ construction also fails to take into account that the

prosecution history statements focus on the dissolution beginning in the distal ileum

so thatthe 5-ASA leaves the dosage form in the colon. The Court appreciates that the

invention’s function in the body is not so precise that the dosage form will never

break or begin to release in the distal ileum. Nevertheless, the prosecution history

strongly suggests that the invention was intended to primarily break and/or release

in the colon even where some dissolution or disintegration of the coating began in the

distal ileum.

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Also supporting my view is that the patentees repeatedly sought to distinguish

the extensive prior art by focusing on the invention’s tendency to release much later

in the digestive system than the prior art. In the specification, for example, the

patentees distinguish prior art using various coating materials on 5-ASA capsules as

unable “to prevent release of 5-ASA until the colon.” ‘170 patent, col. 3:23-25

(emphasis added). See also id. at 3:57-60 (distinguishing time-release capsules as not

providing for “reliable release of 5-ASA only in the colon) (emphasis added). Most

notably, after distinguishing additional prior art based on the use of granules versus

a capsule, and the thickness of the coating used, the specification describes the

invention as follows: 

The Inventors have now found that 5-ASA reliably can be

administered specifically to the large intestine, especially

the colon, by simply coating a solid oral dosage form with a

sufficient thickness of a partly methyl esterified

methylacrylic acid polymer which does not dissolve in

aqueous medium below pH 7 but does dissolve below pH 7.5.

This carrier system differs from those previously disclosed

in relation to 5-ASA in that dissolution or disintegration

does not occur until entry of the coated dosage form into the

colon. In particular, there is substantially no leaching out

of the 5-ASA downstream of the colon in the normal patient.

Id., col. 3:61 - 4:4 (emphasis added). By distinguishing prior art as unable to reliably

dissolve in the colon, without leaching out downstream of the colon, the patentees

contemplated that, on most occasions, the drug would break up in the colon and not

the distal ileum. The patentees’ use of the modifiers “reliably,” as in the “5-ASA

reliably can be administered specifically to the large intestine,” and “substantially,”

as in “there is substantially no leaching out . . . downstream,” further support my

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construction that the drug form only occasionally begins dissolution prior to entering

the ascending colon. Moreover, the specification emphasizes the “high organ

specificity” ofthe “presentinvention,”id., col. 5:50-52, which further clarifies thatthe

dosage form is designed to most often begin dissolution and/or break in the ascending

colon.

Finally, the Court has reviewed the extensive, fourteen-year prosecution history

of the ‘170 patent. While it would take too many pages to recount the history in more

detail here, the Court notes that much of the file is spent distinguishing the prior art

on fine points and defending the patentees’ contention—following multiple

rejections—that the invention reliably releases in a manner that ensures topical

delivery to the colon. There are smatterings of phrases throughout the history that

reference release ofthe drug in the terminal or distal ileum, discussed infra, however,

those statements are farther and fewer between than Plaintiffs suggest. In reading

the file wrapper as a whole, one is left with the firm impression that the patentees

did not anticipate the drug often or regularly dissolving or releasing in the distal

ileum.5 Cf. Computer Docking Station Corp. v. Dell, Inc., 519 F.3d 1366, 1379 (Fed.

Cir. 2008) (explaining that the “totality of the prosecution history informs the

disavowal inquiry”) (quoting Rheox, Inc. v. Entact, Inc., 276 F.3d 1319, 1326 (Fed.

Cir. 2002)) (internal quotation marks omitted). Accordingly, the Court’s construction

5 In this regard, the Court notes that the parties did not provide the Court

with the entire file wrapper for the ‘170 patent perhaps due to the lengthy prosecution

period. The Court reviewed those portions provided by the parties.

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(set forth below) will take into account the limited circumstances in which the

patentees envisioned the dosage form beginning to dissolve or break in the distal

ileum. The construction will further take into account that the drug will not be

released prior to reaching the distal ileum. In my view, this sort of construction best

reflects the high organ specificity of the invention and the patentee’s focus on

“dumping” the drug into the colon for topical treatment. 

2. The amount to be released

I adopt Plaintiffs’ proposed construction that “substantially all” as opposed to

“all” of the 5-ASA must be released in the colon.6 Defendants acknowledged at oral

argument that the claim language contemplates less than 100% of the drug being

released in the colon. However, Defendants maintain that the amount of the release

has to be close to that percentage. TR 71:14-19. 

Defendants further contend that release must reliably reach near 100% release

to the right side of the colon. Defendants’ argument relies on language in the patent

and the prosecution history, in which the patentees frequently use the term “reliable”

to describe the administration ofthe 5-ASA. Defendants’ Opening Br. at 17-18 (citing

‘170 patent col. 3 at 61-66) (“The Inventors have now found that 5-ASA reliably can

be administered specifically to the large intestine....”); Id., col. 3 at 57-60

(distinguishing prior art that “does not provide for reliable release of 5-ASA only in

6 While the parties’ proposed constructions refer to the 5-ASA as “the drug”

(Plaintiffs’ Construction) or “the active ingredient” (Defendants’ construction), I

consider their alternate descriptions to be distinctions without a difference because the

5-ASA is the active ingredient (drug) in the invention.

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the colon”); File History, 08/032,167 App., Nov. 10, 1994 Response to Final Rejection

at 3 (Koh Decl., Ex. Y at WC684) (same). See also File History, 06/735,727 App., Jul.

11, 1988 Appeal Brief at 5 (Koh Decl., Ex. S at WC474) (“Applicants have discovered

that 5-ASA can be reliably administered specifically to the large intestine, and

especially the colon ....”). Based on the frequent usage of the term “reliable” in this

fashion, Defendants reason that it is not sufficient that an occasional tablet

arbitrarily releases all of its contents in the right side of the colon, but the dosage

form must “reliably,” i.e., almost always, release all of its contents in the colon. 

Defendants’ Opening Br. at 18.

By contrast, Plaintiffs propose that the claim language be construed to require

that “substantially all” of the 5-ASA be released. First, Plaintiffs draw the Court’s

attention to a part of the specification where the patentees described the claimed

formulation as differing from the prior art in that “there is substantially no leaching

out of the 5-ASA downstream of the colon in the normal patient.” Plaintiffs’ Opening

Br. at 15 (quoting ‘170 patent col. 4 at 3-4). Based on this specification language,

Plaintiffs reason that a skilled artisan would understand this to mean that the

claimed formulation need not achieve perfect release to the right colon and instead

may release an insubstantial amount of drug elsewhere. Id. at 15-16. Thus,

Defendants’ construction to impose the standard of perfection on the release,

according to Plaintiffs, departs from the understanding of a skilled artisan. Id.

Plaintiffs further note that their construction is supported by extrinsic evidence. 

Plaintiffs’ expert explained that “a skilled artisan would understand that when a

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drug is formulated, variation in content, manufacturing, and performance will often

lead to less than 100% ofthe labeled strength being released.” Plaintiffs’ Opening Br.

at 15 (quoting Bodmeier Decl. at 35). As such, release from a dosage form is typically

considered complete when “a substantial amount of drug (generally around 80%)” is

released. Id. Indeed, the official specifications for drug products listed in the United

States Pharmacopeia (“USP”) in 1980 indicate that “release” is considered complete

when a substantial amount (i.e., approximately three-quarters of the drug product)

is released from the dosage form. Id. at 16 (quoting Bodmeier Decl. at 37-40).

Plaintiffs additionally note that, as set forth in the description of the dissolution test

specifications in the General Chapter of the 1980 USP, it was not expected that each

and every tablet meet that specification. Rather, the USP anticipates that, on

average, 75% to 80% of the drug will be released in the intended location. Id. (citing

Bodmeier Decl. at 39).

Regarding the amount of the drug to be released, the Court finds that the

phrase “substantially all” represents whatthe patentees intended to claim. Although

the term “all” was not included in the patent itself, the Court recognizes that the

patentees have repeatedly used thatterm during prosecution ofthe patent. However,

in the Court’s view,they did notintend the term “all” to mean 100%. To release 100%

of 5-ASA to the right side of the colon would be impractical, if not impossible.

Furthermore,the ordinary and customary meaning of the term in the pharmaceutical

industry was, as Plaintiffs point out, the average of 80%—not 100%. Because the

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term “substantially all” properly represents this consensus, the Court agrees with

Plaintiffs regarding this issue. 

The Court also finds, however, that the term “reliable” properly illustrates the

manner in which the release of the drug was intended to occur. As Defendants

correctly indicate,the term “reliable” was repeatedly used throughout the prosecution

history and the specification. More importantly, it is the term “reliable” that the

patentees used in pointing out the prior art’s disadvantage, as well as in presenting

their invention to the Patent Office, and thus to the world. See e.g., ‘170 patent, col.

3 at 61-66. Moreover, given that such a term implies consistency in performance, the

Court agrees with Defendants that the proper construction would include the

meaning of the term “reliable.” 

Accordingly, I construe the pertinent language of claims 1, 6, and 7 as follows:

Whereby substantially all of the 5-ASA reliably leaves the

dosage form in the ascending colon and no amount of the 5-

ASA is released prior to the dosage form reaching the distal

ileum. 

By including the qualifiers substantially and reliably, this construction reflects that

the drug will almost always be released in the colon yet the construction leaves room

for the possibility that it might occasionally begin release in the distal ileum. By

stating that no amount is released prior to the dosage form reaching the distal ileum,

the construction makes clear that the drug may not be released upstream. As the

patentees emphasized throughout the specification and prosecution history, pre-distal

ileum release was replete in the prior art.

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In my view, this is how a person of ordinary skill in the art would understand

the above claim terms and, while avoiding the error of importing a limitation from the

specification into the claim language, this construction avoids the converse evil of

divorcing the claim language from the specification. This construction “capture[s] the

scope of the actual invention more accurately,” Phillips, 441 F.3d at 1324, than both

parties’ proposed constructions which reflect the all-or-nothing approach of fully

embracing or rejecting dissolution and release in the distal ileum. I, further, find it

unnecessary to consider the testimony of the parties’ dueling experts who each offer

opinions in support of their client’s constructions. Because the intrinsic evidence

makes the patentee’s intention clear, resort to extrinsic evidence is not required but

left to the Court’s discretion. See Atofina v. Great Lakes Chemical Corp., 441 F.3d

991, 996 (Fed. Cir. 2006); Phillips, 441 F.3d at 1312-17. I see no need to resort to

expert testimony here.

B. “Insoluble in gastric juice”

Claim language in claim 1 of the ‘170 patent (and, by default, the dependent

claim 6) indicates that the coating used in the patentees’ carrier system consists of

“a layer which is insoluble in gastric juice and in intestinal juice below pH 7 but

soluble in colonic intestinal juice.” The parties’ claim construction dispute revolves

around both the meaning of “layer” and the meaning of “insoluble,” although their

arguments relating to these two terms are intertwined. They proposed the following

claim constructions.

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Claim Language Plaintiffs’ Construction Defendants’ Construction

A layer which is insoluble in

gastric juice and in intestinal

juice below pH 7 but soluble

in colonic intestinal juice

(Claim 1)

The dosage form is coated with

at least one layer that has

sufficient thickness so that the

coating does not fully dissolve

or disintegrate in gastric juice

and in intestinal juice below pH

7, but does dissolve or

disintegrate in colonic intestinal

juice.

None of the layer dissolves

(i.e., the layer is insoluble) in

aqueous medium below pH 7

but the layer does dissolve

below pH 7.5. This excludes

layers containing mixtures of

Eudragit S and Eudragit L.

Defendants contend that the term “insoluble” in claim 1 should be interpreted

according to its ordinary and customary meaning to a person of ordinary skill in the

art at the time of the invention. In support of their position, Defendants cite

technical treatises in the 1980 time frame, including Pharmaceutical Sciences,

wherein the term “insoluble” was defined in descriptive terms to mean no more than

one part of solute dissolves in 10,000 parts of solvent. See e.g., Koh Decl., Ex. B at

PAR24480. In Defendants’ view, an insoluble layer will have no more than 0.01% of

the layer dissolve in gastric or intestinal juices below pH 7.

Defendants further rely on language in the specification where, in describing

the characteristics of copolymers used in the prior art, the patentees explained the

difference between two copolymers as follows:

Such a copolymer (available under the Registered Trade

Mark “Eudragit” S) ... is known to be insoluble in gastric

juice and poorly soluble in intestinal juice while an

analogous copolymer (available under the Registered Trade

Mark “Eudragit” L) ... is insoluble in gastric juice but is

readily soluble in intestinal juice. 

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‘170 patent col. 2 at 31-40. Based on this language, Defendants argue that the

patentees understood that the term “insoluble,” in accordance with its ordinary

meaning, is the same as or less soluble than “poorly soluble,” and differs in scale from

“readily soluble.” Defendants’ Open. Br. at 8.

Defendants also emphasize the prosecution history where the patentees

distinguished their claimed dosage form from other dosage forms with a coating layer

containing a mixture of Eudragit S and Eudragit L in a 1984 amendment. There, the

patentees explained that such a coating layer “does not in fact achieve the desired

result” because such coatings would “commence disintegration” and “commence

dissolution” below pH 7, whereas their claimed dosage form showed “no

disintegration” below pH 7 (such as at pH 6.7 or 6.8). File History, 06/482,331 App.,

Sept. 26, 1984 Amendment at 8-9 (Koh Decl., Ex. F at WC372-73). According to

Defendants, this prosecution history confirms that the patentees intended for the ‘170

patent to cover only those coatings where none of the layer dissolved below pH 7, i.e.,

those that did not commence disintegration and remained fully intact while in pH 7

fluids. Finally, Defendants rely on an in vitro study (“In Vitro Study”) disclosed by

the patentees in the prosecution history that could be read to suggest that mixtures

of Eudragit S and L mixtures are disavowed.7

7 “In vitro’ experiments are performed in artificial environments outside

living organisms (such as in a test tube or culture media), while ‘in vivo’ experiments

are performed within living organisms.” In re ‘318 Patent Infringement Litig., 583 F.3d

1317, 1325 (Fed. Cir. 2009).

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By contrast, Plaintiffs argue that the claim language is easily understood by a

skilled artisan and requires no further construction. However, should the Court

determine that the language requires construction, Plaintiffs suggest that it should

be construed to mean that “the dosage form is coated with at least one layer that has

sufficient thickness so that the coating does not fully dissolve or disintegrate in

gastric juice and in intestinal juice below pH 7, but does dissolve or disintegrate in

colonic juice.” Plaintiffs’ Opening Br. at 17. In support of their position, Plaintiffs

rely on the testimonies of both parties’ experts, wherein they explain that the

solubility of a coating layer must be evaluated based on the performance of the layer

as a whole, not individual components. TR at 47:3-48:21; Bodmeier Decl. at 48. 

Because the performance of the layer will depend upon the “chemical and physical

interaction” of all of the components rather than each component standing alone,

Plaintiffs claim that the phrase “[n]one of the layer” in Defendants’ construction is

at odds with the claim language, which refers to the coating “layer” as an indivisible

construct. Plaintiffs’ Opening Br. at 17-18.

Plaintiffs also note that because the claim language refers to biological fluids,

Defendants’ construction, which is based upon in vitro performance rather than in

vivo, should be given less weight in claim construction. Id. at 18. In addition,

Plaintiffs point out that Defendants’ construction was adopted from extrinsic

evidence (in this case, technical treatises). Id. Because Plaintiffs believe that the

intrinsic evidence clearly showed performance of the coating is to be judged on a

functional basis, not based on an in vitro dissolution test, they argue that the Court

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should not rely on Defendants' construction. Id. (citing Phillips, 415 F.3d at 1319)

(extrinsic evidence is unlikely to result in a reliable interpretation of patent claim

scope unless considered in the context of the intrinsic evidence). 

As an initial matter, the Court find its helpful to first separate out the

arguments relating to the definition of the “layer.” I conclude that the solubility of

the layer is to be evaluated as a whole, rather than by individual components. The

claim itself refers to “a layer, which is insoluble in gastric juice ....” The plain

language of the claim makes clear that only one layer is anticipated hence further

resort to intrinsic or extrinsic evidence is not required to construe the term.

There is one clarification required, however. At oral argument, the Court

inquired whether the solubility requirementis concerned with the performance ofthe

entire layer or whether itis focused on those elements ofthe layer that would prevent

release of the active ingredient (the 5-ASA) to the colon. TR at 49-52. Plaintiffs

agreed that the impetus underlying the claim language is to ensure that the

mesalamine is released at the appropriate location in the body. 

In my view, it is critical for the claim construction to take into account this

clarification which gives meaning to the “release . . . to the right side of the colon”

claim language. Claim 1 claims

a layer which is insoluble in gastric juice and in intestinal

juice below pH 7 but soluble in colonic intestinal juice,

whereby the dosage form releases the 5-amino-salicylic-acid,

salt or ester to the right side of the colon.

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‘170 patent, col. 10:18-20 (emphasis added). By using “whereby” the patentees made

clear that the layer is designed to ensure release of the 5-ASA specifically to the right

side of the colon and not before reaching the distal ileum. Hence the layer solubility

requirement must be understood in this context. See Bicon, Inc. v. Straumann Co.,

441 F.3d 945, 950 (Fed. Cir. 2006) (“[C]laims are interpreted with an eye toward

giving effect to all terms in the claim.”). 

In terms of the definition of insolubility, even Defendants agreed at oral

argumentthatthe coating may dissolve in some small amount and still be considered

“insoluble.” See TR at 70-71. The parties disagree, however, as to what amount of

disintegration is permissible under the claim language. In light of this disagreement,

the Court finds that “insoluble” must be construed. Moreover, as explained in more

detail herein, the Court finds that the patentees did not act as their own

lexicographer and create a special definition of “insoluble” in the patent; neither the

claim, the specification, nor the prosecution history specify how the term should be

defined. Accordingly, the Court must determine the ordinary and customary meaning

of the term.

Plaintiffs’ proposed construction of insoluble, which appears below, is

overbroad. The dosage form is coated with at

least one layer that has sufficient

thickness so thatthe coating does

not fully dissolve or disintegrate

in gastric juice and in intestinal

juice below pH 7, but does

dissolve or disintegrate in colonic

intestinal juice.

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Under this construction, practically any layer would be considered “insoluble” as long

as at least some components of the layer remain intact below pH 7. For example, as

Defendants pointed outin their opening brief, even if 95% of a coating layer dissolves,

such a layer would be considered “insoluble” under Plaintiffs’ proposed construction

because it had not “fully” dissolved or disintegrated. And, as Plaintiffs noted at oral

argument, the coating is typically comprised of additional agents, such as coloring

agents. TR at 47-48. Under Plaintiffs’ “fully” dissolved construction, the coating

could be deemed insoluble when only the coloring agent has not dissolved. Without

any objective standard to define “fully,” this Court is not convinced that Plaintiffs’

construction reflects the ordinary and customary meaning of “insoluble.” 

In addition, by stating that the “layer . . . has sufficient thickness so that the

coating does notfully dissolve ....,”Plaintiffs’ construction suggests thatthe thickness

of the coating determines the polymer’s solubility. This is problematic because the

specification treats solubility and thickness as distinct elements of the coating that,

when properly combined, each helps ensure that the drug is “dumped” into the colon

for topical treatment. 

The specification describes the invention as “[a] solid oral dosage form . . .

coated with an anionic polymer, which is insoluble in gastric juice and in intestinal

juice below pH 7 but soluble in colonic intestinal juice, in a sufficient amount that the

oral dosage form remains intact until it reaches the colon.” ‘170 patent, Abstract

(emphasis added). See also id. at 4:26-31 (same). By describing the polymer as

“insoluble in gastric juice,”the patentees made clear that solubility relates to the type

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of anionic polymer that must be employed. Only after describing the type of polymer

to be employed, i.e., one that is insoluble in gastric juice, do the patentees note that

the dosage form must be coated with a “sufficient amount” of that polymer. Hence

the “sufficient amount” language addresses how much of the polymer must be used

in order to facilitate delivery of the drug to the colon. 

Furthermore, the patentees distinguish the invention from the prior art by

explaining that the invention “coat[s] a solid oral dosage form with a sufficient

thickness of a partly methyl esterified methyacrylic acid polymer which does not

dissolve in aqueous medium below pH 7 but does dissolve below pH 7.5,” and that

this type of coating is “entirely new in concept” because it ensures that “dissolution

or disintegration does not occur until entry of the coated dosage form into the colon.”

Id. at 3:63 - 4:11 (emphasis added). Here, too, the patentees describe the type of

polymer in terms of its solubility and separately note that the polymer must be

employed in a certain thickness. Therefore, Plaintiffs’ proposed construction, which

focuses only on the thickness of the coating, as opposed to both the thickenss and the

solubility of the polymer, is inconsistent with the specification.8

8 This reading of the specification is supported by the deposition testimony

of Defendants’ expert, Dr. Elder, who explains that “[a] coating does not become

insoluble by making it larger or thicker; rather, solubility is an intrinsic chemical

property which does not change with thickness.” Elder Decl., ¶ 12. Moreover, while

Plaintiffs rely on the file history statement, made in prosecution of the ancestor ’386

patent application, that “[t]he requirement of coating thickness is functional, in the

sense that it must be thick enough to keep the tablet substantially intact until the

colon is reached but not so thick as to permit the tablet to be excreted ....” File History,

07/584,386 App., June 4, 1991 Amendment at 10 (Ainsworth Decl., Exh. M at WC532),

that statement merely emphasizes that thickness can affect whether the drug is

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Although Defendants’ proposed construction does not suffer from the same

infirmities as does Plaintiffs, Defendants’ construction is problematic for a different

reason. As noted, Defendants propose the construction that “none of the layer

dissolves ....”9 However, they conceded at oral argument that an insubstantial

amount may dissolve. In light of this concession alone, Defendants’ “none of the

layer” construction must be rejected.

More to the point, neither party has pointed to any express definition of

“insoluble”thatis clearly setforth in the specification or the prosecution history,thus

I conclude that the patentees did not act as their own lexicographer. Accord Aventis

Pharma S.A. v. Hospira, Inc., 675 F.3d 1324, 1331-32 (Fed. Cir. 2012) (concluding

that “patentee did not narrow the ordinary meaning of ‘perfusion’ . . . by either acting

as its own lexicographer or disclaiming claim scope” where nothing in specification

or prosecution history clearly addressed definition of that term). Where a patentee

does not clearly “assign to a term a unique definition that is different from its

ordinary and customary meaning,” by acting as its own lexicographer, the ordinary

and customary meaning of that term applies. Laryngeal Mask Co. Ltd. v. Ambu, 618

F.3d 1367, 1372 (Fed. Cir. 2010). 

released in the desired location in the digestive tract. It does not speak to the

solubility of the polymer used in the coating. 

9 Defendants further seek to include in their construction a limitation

excluding mixtures of Eudragit S and Eudragit L. For the reasons explained infra, I

reject that limitation as unsupported by the specification and prosecution history.

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Accordingly, I turn to dictionary definitions of “insoluble” to aid me in

discerning the ordinary and customary meaning of that term. See Zircon Corp, v.

Stanley Black & Decker,Inc., 452 Fed.Appx. 966 (Fed Cir. 2011) (considering

dictionary definition where claim language is broad enough to encompass more than

one meaning). “In some cases, the ordinary meaning of claim language as understood

by a person of skill in the art may be readily apparent even to lay judges, and claim

construction in such cases involves little more than the application of the widely

accepted meaning of commonly understood words. In such circumstances, general

purpose dictionaries may be helpful.” Phillips, 415 F.3d at 1314. Moreover, resort

to scientific and technical dictionaries is appropriate where the intrinsic evidence

does not define a scientific term to be construed. See Atofina v. Great Lakes

Chemical Corp., 441 F.3d 991, 996 (Fed. Cir. 2006).10 I find this circumstance to be

an appropriate one for resort to a scientific dictionary definition, and turn to the

definition of “insoluble” in the 1980 Pharmaceutical Sciences excerpt in the record.

The 1980 Pharmaceutical Sciences excerpt defines “insoluble” as a layer that

will have no more than 0.01% ofthe layer dissolve. The excerpt explains that “[w]hen

in pharmacopeial texts it has not been possible, or in some instances, desirable, to

10 See also Phillips, 415 at 1318 (“Because dictionaries, and especially

technical dictionaries, endeavor to collect the accepted meanings of terms used in

various fields of science and technology, those resources have been properly recognized

as among the many tools that can assist the court in determining the meaning of

particular terminology to those of skill in the art of the invention. Such evidence, we

have held, may be considered if the court deems it helpful in determining ‘the true

meaning of language used in the patent claims.’”).

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indicate exact solubility, a descriptive term has been used. The following table

indicates the meaning of such terms:

Descriptive 

terms

Parts of solvent 

for 1 part of solute

Very soluble Less than 1

Freely soluble From 1 to 10

Soluble From 10 to 30

Sparingly soluble From 30 to 100

Slightly soluble From 100 to 1000

Very slightly soluble From 1000 to 10,000

Practically insoluble, or insoluble More than 10,000

Koh Decl., Exh. B at PAR24480 (emphasis added). See also Koh Decl., Exh. C at

PAR24560 (same); id., Exh. D (British Pharmacopˆia) at PAR24467 (same).

I conclude that this definition reflects the ordinary and customary definition of

“insoluble” at the time of the initial application that ultimately led to the issuance of

the ‘170 patent. I find it particularly appropriate to rely on this definition here where

the definition does not contradictthe intrinsic evidence of record. Compare Advanced

Fiber, 674 F.3d at 1374 (“[W]e conclude that the district court erroneously construed

‘perforated’ using extrinsic evidence that contradicts the intrinsic evidence of

record.”). This definition is consistent with the definition of insoluble from the

McGraw-Hill Dictionary of Scientific and Technical Terms, a scientific dictionary

relied upon by the Federal Circuit in ascertaining the ordinary and customary

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meaning of claim terms. See e.g.,Wavetronix LLC v. EIS Electronic Integrated Sys.,

573 F.3d 1343, 1333 (Fed. Cir. 2009) (relying on The McGraw-Hill Dictionary of

Scientific and Technical Terms 1159-60 (5th ed. 1994) for its definition of “local

device”); L.B. Plastics, Inc. v. Amerimax Home Prods., Inc., 499 F.3d 1303, 1308 (Fed.

Cir. 2007) (affirming district court’s reliance on The McGraw-Hill Dictionary of

Scientific and Technical Terms 2288 (6th ed. 2002) for its definition of “welding”);

Atofina, 441 F.3d at 999 (citing The McGraw-Hill Dictionary of Scientific and

Technical Terms 307 (4th ed. 1989) for its definition of “catalyst”). The McGraw- Hill

definition of insoluble is “[i]ncapable of being dissolved in another material ....” The

McGraw-Hill Dictionary of Scientific and Technical Terms 1084 (6th ed. 2002). Like

the USP treatise definition, the McGraw-Hill definition makes clear that only a

minute amount of the layer may dissolve.11

As noted earlier, Plaintiffs additionally argue that reliance on this definition is

inappropriate because it reflects an in vitro dissolution standard while, in Plaintiffs’

view, the specification and claims make clear that solubility is to be determined on

functionally, i.e., in vivo, based on how it performs in actual gastrointestinal fluids.

I reject this argument. For one, the specification refers to “aqueous medium” to

describe the solubility of prior art uses of Eudragit S and Eudragit L. See ‘170

patent, col. 2:45-47. Furthermore, Plaintiffs relied on both in vivo and in vitro studies

11 Moreover, while Plaintiffs urge the Court not to consult the USP treatise

in defining “insoluble,” Plaintiffs rely on this same treatise in support of their

“substantially all” proposed construction language discussed supra.

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throughout the prosecution history and, indeed, acknowledge that “in vivo

performance may be predicted through in vitro tests ....” Pl. Open. Br. at 18 n.10

(emphasis in original). While Plaintiffs suggest that this reliance does not justify

incorporating an in vitro standard into the claim construction, there is likewise no

basis for reading into the claim an in vivo-based dissolution standard. Hence, I find

reliance on the Pharmaceutical Sciences definition appropriate here.

Thus, giving the terms “layer” and “insoluble” meaning in the context of claims

1 and 6, I construe “a layer which is insoluble in gastric juice and in intestinal juice

below pH 7 but soluble in colonic intestinal juice” to mean:

a layer of which no more than 0.01% of that layer dissolves

in gastric or intestinal juices below pH 7, but does dissolve

or disintegrate in colonic intestinal juice. 

This construction differs from Defendants’ construction in that it does not require

that “none” of the layer dissolve. It allows for .01% of the layer to dissolve or

disintegrate. It also differs from Plaintiffs’ construction in that it is more definite

than “fully” dissolve. In the Court’s view, this construction best harmonizes the claim

language, the specification, and the prosecution history.

C. Eudragit S and L Limitation (Claims 1 and 7)

Defendants contend that the patentees clearly and unmistakably excluded

layers of mixtures of Eudragit L and Eudragit S from the claimed invention, both in

the specification and during prosecution. Turning first to the specification language,

Defendants argue that the patentees distinguished prior art formulations having

coating layers of Eudragit L alone, as well as mixtures of Eudragit L and Eudragit

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S, because in all cases such coatings dissolved below pH 7. ‘170 patent, col. 3 at

46-49; see also id., col. 2 at 49-50 (“As far as we are aware, said mixtures [of Eudragit

S and Eudragit L] invariably dissolve below pH 7.”). By contrast, the patentees

emphasized thattheir invention does not dissolve in such conditions. ‘170 patent, col.

3 at 61-66. 

Second, according to Defendants, the prosecution history clearly disclaims the

mixtures of Eudragit L and Eudragit S from claim 1. In an amendment filed on May

20, 1985, during the prosecution of an ancestor patent application (the ’727

application), the patentees stated that they amended the claims “to make them more

specific to the polymer used in the working examples, Eudragit S.” File History,

06/482,331 App., May 20, 1985 Preliminary Amendment at 6 (Koh Decl., Exh. I at

WC391). In their explanation, the patentees stated “the purpose of this

characterization is to make clear that mixtures of Eudragit L and Eudragit S are

excluded from the claims.” Id. at 7 (Koh Decl., Exh. I at WC392) (emphasis in

original). Defendants further argue that the patentees reiterated in several of the

early ancestor applications that coating layers containing mixtures of Eudragit L and

Eudragit S were known in the prior art, and would not achieve the desired claimed

result—releasing the 5-aminosalicylic acid to the right side of the colon:

• “Applicants’ own experience has revealed that mixing

of Eudragit S and Eudragit L does not, in fact,

achieve the desired result ... capsules thus coated

would probably commence disintegration on entering

the duodenum which is a pH of 6.8 and will not

remain intact until reaching the colon.” See File

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History, 06/482,331 App., Sept. 26, 1984 Amendment

at 9 (Koh Decl., Ex. F at WC372-373). 

• “With combinations of Eudragit L and Eudragit S,

applications were still unable to achieve the desired

result of capsules which reliably broke in the very

distal ileum or caecum.” Id. at 11 (Koh Decl., Ex. F at

WC374).

• “Mixtures of [Eudragit] L + S polymers would not be

suitable.” File History, 06/482,331 App., In Vitro

Study at 4 (Koh Decl., Ex. H at WC421) (“In Vitro

Study”).

• For Eudragit L and Eudragit S coating mixtures, “in

all cases the coating dissolved below pH 7.” File

History, 06/482,331 App., Oct. 14, 1983 Amendment

at 8 (Koh Decl., Ex. J at WC346) (emphasis in

original).

• “A film of Eudragit L and Eudragit S in the ration 1:2

commences dissolution at about pH 6.7.” File

History, European Patent, Dec. 1, 1988 Declaration

at ¶ 2 (Koh Decl., Ex. G at EX461, 2).

In addition, Defendants note that the patentees even submitted to the Patent

Office data, i.e., the In Vitro Study, with coatings containing mixtures of Eudragit L

and Eudragit S. In the study, the patentees demonstrated that in an aqueous

solution buffered to a pH 6.8, either “[c]omplete disintegration” occurred or

“[f]ragments remained,” whereas there was “[n]o disintegration” for the coating only

containing Eudragit S. In Vitro Study at 1-4. As such, Defendants believe that this

is further evidence that the patentees did not believe mixtures of Eudragit L and

Eudragit S would be suitable for the claimed invention. Id. at 4.

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As extrinsic evidence, Defendants further indicate that Brian Evans, one of the

inventors, stated during his deposition on September 17, 2009, that when even a

small amount of Eudragit L was added to the coating layer, the Eudragit L would

cause the coating to “dissolve slightly” below pH 7 and therefore would not be a

workable formulation:

Question: Do I take it from these initial dissolution results

you ruled out any amount of Eudragit L in the formula?

Answer: Yes ... it was unsuitable because we wanted the

product to remain intact until the distal ileum, so after

looking at it in an in vitro situation we decided to - not to go

ahead with it.

Question: The presence of a small amount of Eudragit L

would have caused the coating to dissolve slightly below pH

7. Is that accurate?

Answers: Yes. What Rohm Pharma [the manufacturer of

the Eudragit products] give in their literature are the

various ratios you could use, and the pH ranges that they

would then disintegrate in, so I took that as a guide, but did

a whole range of them, so it was too early. Whatever

concentration we used with the [Eudragit] L, it was going to

go too early for us.

Koh Ex. E at 187:12-188:16. Based on this testimony, Defendants argue that

extrinsic evidence also clearly supports their position that the patentees disclaimed

mixtures of Eudragit L and Eudragit S from claim 1.12

12 The Court notes, at the outset, that it will not base its construction of the

claims on an inventor’s subjective intent. See Howmedica Osteonics Corp. v. Wright

Medical Technology, Inc., 540 F.3d 1337, 1346-47 (Fed. Cir. 2008) (“[t]he subjective

intent of the inventor when he used a particular term is of little or no probative weight

in determining the scope of a claim.”)

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Plaintiffs contend that Defendants’ proposed construction is unsupported by the

claim language, and should be rejected. For one, Plaintiffs argue, Defendants’

reliance on prosecution history statements wherein the inventors found mixtures of

Eudragit L and Eudragit S not suited for their purposes is misplaced. In the In Vitro

Study, the patentees conducted a series of experiments to find the optimal coating

composition for 5-ASA, using three different types of formulas. Plaintiffs especially

point out that the inventors used only Formula 3, which Plaintiffs contend was

comprised of a mixture of Eudragit S and Eudragit L,13 in transit time studies as well

as coating thickness studies. TR at 23:4-26:4. Based on these test reports, Plaintiffs

argue that the patentees intended to claim mixtures of Eudragit L and Eudragit S.

Id. Although Plaintiffs acknowledge that the report contained the statement that

“[m]ixtures of L+S polymers would not be suitable,” they contend that, when read in

context, this statement does not give rise to the level of an express disclaimer

sufficient to limit the scope of the claim.

As to the alleged disclaimer made during prosecution of the ’331 application,

Plaintiffs concede that the patentees amended the proposed claims early in 1985 to

exclude the mixture of Eudragit L and Eudragit S. However, Plaintiffs contend that

the purpose of the amendment was to limit the scope of that particular ancestor

application (the ’331 application). More to the point, Plaintiffs argue, the amended

language in the ’331 application was ultimately adopted to the ‘171 patent—not the

13 More details of the composition of Formula 3 are discussed infra at ¶ 56-

57.

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‘170 patent. Hence Plaintiffs reason that such disclaimer is only valid as to the ‘171

patent and that such limitation should not be read into claims of the ‘170 patent. 

Plaintiffs apply this same rationale to a similar disclaimer found in the prosecution

history of the ’727 application.

Plaintiffs further point to a responsive amendment made in 1995 in support of

their proposed claim construction. In this amendment, the patentees explained that

the reason they submitted the divisional application (which resulted in the issuance

of the ‘170 patent) was to provide for other coatings to be used. See File History,

06/401,696 App., Nov. 17, 1995 Responsive Amendment at 4-5 (Ainsworth Decl., Exh.

E at WC132-33). Moreover, there are several parts of the ’170 specification wherein

the patentees indicate that other polymers are also acceptable:

• “It is expected that any anionic polymer having the

dissolution profile specified above can be used in the

practice of the invention subject, of course, to

compatibility with the relevant active agent.” ‘170

patent, col. 4:35-38 (emphasis added).

• “Obviously, a certain amount of trial-and-error

experimentation will be required before ascertaining

the optimum thickness of a particular polymer on a

particular solid oral dosage form but such

experimentation is well within the capability of a

man of average skill in the art.” Id., col. 4:67-5:5

(emphasis added).

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Because the ‘170 patent refers to non-Eudragit S polymers, Plaintiffs argue that the

disclaimer of the mixture of Eudragit L and Eudragit S is not applicable to the claims

of the ‘170 patent.14

While Defendants’ arguments seem persuasive at first blush, it becomes clear

upon reading the prosecution history as a whole that the prosecution history

statements relied upon by Defendants are from ancestor applications that must be

construed as applicable only to the related ‘171 patent which expressly excludes

mixtures of Eudragit L and Eudragit S. Thus, while Defendants point to language

in the prosecution history of the ancestral ’727 application stating that “mixtures of

Eudragit L and Eudragit S are excluded from the claims,” ’727 App., May 20, 1985

Preliminary Amendment, at 1-4 (Ainsworth Decl., Ex. N) (emphasis in original),15 in

the subsequent Divisional Application that resulted in the ‘170 patent, the patentees

indicated that they were seeking broader claims than previously sought in such

ancestral applications. 

14 Plaintiffs further argue that, because they interpret the solubility

limitation in claim 1 as relevant only to its performance in the body, i.e., in vivo

performance, that Defendants’ construction to exclude the mixture of Eudragit L and

Eudragit S is erroneous. I do not address this argument because I conclude, for the

reasons explained herein, that the patentees did not disclaim mixtures of Eudragit L

and Eudragit S.

15 See id. at 6 (“The Examiner lists a series of some six different expressions

that are considered unjustified by the disclosure of the specification. In response to

this objection, applicants have amended their claims to make them more specific to the

polymer used in the working examples, Eudragit S.”) 

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In this connection, Plaintiffs argue that the reason the patentees divided the

then-pending ’167 continuation application into what was ultimately issued as two

separate patents was to patent the Eudragit S coating formulation through the ‘171

patent yet patent multiple coating formulations through the ‘170 patent. To support

this argument, they point to a responsive amendment to the Divisional Application

which states thatthe claims are “broad.” File History, 06/401,696 App., Nov. 17, 1995

Responsive Amendment at 4 (Ainsworth Decl., Exh. E at WC132). 

The Court does not find use of the word “broad” alone makes clear the

patentees’ intent to encompass other anoinic formulations such as a mixture of

Eudragit S and Eudragit L, however, additional language in the responsive

amendment supports the view that such mixtures were not excluded. The text

explains that, while one of the examples in the specification teaches Eudragit S,

[i]t is submitted that given the task of providing other

coatings insoluble in gastric juice and intestinal juice having

a pH below 7 but soluble in colonic intestinal juice that

would release 5-ASA from the dosage form to the right side

of the colon, one skilled in the art of drug composition

formulation and pharmacokinetics could do so without

undue experimentation.

Id. (emphasis added). Had the patentees intended to limit the scope of the ’170

patent to Eudragit S coatings, there would have been no need to discuss how “other

coatings” could be formulated. 

Importantly, the prosecution history further suggests that the patentees

envisioned the use of notjust“other coatings” but other polymers containing mixtures

of anionic groups. In an amendment to the 08/032,167 ancestor patent application,

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the patentees distinguished the use of Eudragit coatings in the prior art by stating

that “[t]here is no suggestion [in the art] that any tablet should be coated with

Eudragit S coatings of the thickness (60 to 150 microns) required by the present

Invention. Further, there is no reference to the use of any Eudragit coating to

maintain tablets or other oral dosage forms substantially intact until the colon is

reached.” File History, 08/032,167 App., April 18, 1994 Amendment at 16 (Koh Decl.,

Exh. N at WC621). By contrasting “Eudragit S” and “any Eudragit coating,” the

patentees made clear that they intended to claim additional Eudragit coatings or

mixtures thereof. Moreover, since the patentees subsequently limited the ‘171 patent

to only Eudragit S coatings, their reference in the prosecution history to “any

Eudragit coating” should be interpreted in the context of ‘170 patent to potentially

include mixtures of Eudragit S and Eudragit L.

More importantly, the specification for the ‘170 patent explains that Eudragit

S and Eudragit L are both anionic copolymers. ‘170 patent, col. 2:33-35. For

Eudragit S, the ratio of free carboxyl groups to ester groups is approximately 1:2. For

Eudragit L, in contrast, the ratio is 1:1. Consistent with this description of Eudragit

S’s ratio of free carboxyl groups to ester groups, the ‘171 patent claims include the

express limitation that “said oral dosage form is coated with a . . . layer of an anionic

copolymer of methacrylic acid and methacrylic acid methyl ester in which the ratio

of free carboxyl groups to ester groups is about 1:2 ....” ‘171 patent, claims1, 9, and

12 (emphasis added). The ‘170 patent claims, in contrast, do not include an express

Eudragit S coating formulation limitation. 

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For this reason, it is inappropriate to interpret the ’727 ancestor patent file

history statement, which incorporates Eudragit S, as limiting the ‘170 patent. It is

better to view the statement as related to the ‘171 patent claims which explicitly

incorporate the Eudragit S formulation. It is true that “prosecution disclaimer may

arise from disavowals made during the prosecution of ancestor patent applications.”

Ormco Corp. v. Align Technology, Inc., 498 F.3d 1307, 1314 (Fed. Cir. 2007). But, just

as “the prosecution of one claim term in a parent application will not limit different

claim language in a continuation application,” Invitrogen Corp. v. Clontech Labs.,

Inc., 429 F.3d 1052, 1078 (Fed. Cir. 2005), so too will prosecution disclaimers relating

to claim language in an ancestral patent fail to limit different claim language in a

divisional application. See Biogen, 318 F.3d at 1140 (“When the applicant is seeking

different claims in a divisional application, estoppel generally does not arise from the

prosecution of the parent.”) 

This is not to say that the prosecution history is a model of clarity. In my view,

the patentees could have more precisely explained the scope ofthe claims they sought

through the divisional application leading to the ‘170 patent. The Federal Circuit has

noted that this sort of lack of clarity is usually because “the prosecution history

represents an ongoing negotiation between the PTO and the applicant, rather than

the final product of that negotiation ....” Phillips, 415 F.3d at 1317. Nevertheless,

courts are directed to consider the prosecution history as a whole. Martek

Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1377 (Fed. Cir. 2009) (“In

determining whether there has been a clear and unmistakable surrender of subject

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matter, the prosecution history must be examined as a whole.”) (quoting Bayer AG

v. Elan Pharm. Research Corp., 212 F.3d 1241, 1252 (Fed. Cir. 2000)). Reading the

totality of the prosecution history here, and considering the Divisional Application

language, I conclude that the patentees did not clearly disclaim mixtures of Eudragit

S and Eudragit L for the ‘170 patent.

Review of the specification for the’170 patent further supports my conclusion

that the patentees did not disavow mixtures of Eudragit S and Eudragit L. On the

one hand, as Defendants point out, there is language disparaging mixtures of

Eudragit S and Eudragit L. In discussing prior art, the specification states that “as

far as we are aware, said mixtures [of Eudragit S and Eudragit L] invariably dissolve

below pH 7.” ‘170 patent, col. 2 at 49-50. The specification further states that the

mixtures of Eudragit S and Eudragit L in each of the examples disclosed in the

European Specification prior art “dissolved at below pH 7,” which could be

characteristic of Eudragit mixtures comprised in part of Eudragit L. On the other

hand, the specification language states that “any anionic polymer having the

dissolution profile specified above,” ‘170 patent, col. 4 at 35-36 (emphasis added), i.e.,

a polymer that “does not dissolve in aqueous medium below pH7 but does dissolve

below pH 7.5,” id., col. 3:64-66, may be used in the coating. This statement leaves

open the possibility that mixtures of Eudragit S and Eudragit L could be used should

those mixtures be formulated in a manner that meets the dissolution profile. In the

face of this sort of potentiality, it cannot be said that the patentees clearly disavowed

all mixtures of Eudragit S and Eudragit L . 

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In addition, the specification language takes on a more nuanced meaning when

read in context. While the specification states uncompromisingly that “as far as we

are aware, said mixtures [of Eudragit S and Eudragit L] invariably dissolve below pH

7,” earlier in that same paragraph the patentees explain that the mixtures of

Eudragit S and Eudragit L found in the prior art were “usually employed to provide

a coating of between about 25 and about 40 microns thick ....” Id., col. 2:40-42. It is

clear from this preceding sentence that when the patentees state that “said mixtures

invariably dissolve below pH 7,” they are referring to mixtures employed in coatings

of about 25 to 40 microns thick. As explained supra, the specification further makes

clear that both the thickness of the coating and the type of polymer employed help

ensure that the drug is delivered to the ascending colon. In this light, the patentees’

seemingly absolute statement is not as clear and unmistakable as it first appears. 

Moreover, the Federal Circuit has made clear that criticism of a particular

embodiment or technique “d[oes] not rise to the level of clear disavowal.” Thorner,

669 F.3d at 1366 (quoting Epistar Corp. v. Int'l Trade Comm’n, 566 F.3d 1321, 1335

(Fed. Cir. 2009)).16

16 While Defendants cite Astrazeneca AB, Aktiebolaget Hassle, KBI-E, Inc.

v. Mutual Pharmaceutical Co., Inc., 384 F.3d 1333, 1337 (Fed. Cir. 2004), for the

proposition that critique of prior art serves as a disavowal, the Thorner Court limits

Astrazeneca to its facts. Specifically, Thorner describes Astrazeneca as “limiting a 

patentee to particular examples of solubilizers when it stated in the specification that

‘[t]he solubilizers suitable according to the invention are defined below.” Thorner, 669

F.3d at 1366 (emphasis in original). Defendants have not pointed to similar language

in the specification here.

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In concluding that the patentees did not clearly and unmistakably disavow

mixtures of Eudragit S and Eudragit L, I considered the In Vitro Study cited by the

parties but find that an internal ambiguity renders it unhelpful. The study begins

by comparing Eudragit S and L. Koh Decl., Exh. H at 1. It then sets out three

formulas: Formula 1—Eudragit S only; Formula 2—a 1:2 ratio of Eudragit L to S;

and Formula 3—another 1:2 ratio of Eudragit L to S. Id. at WC418-419. At the

conclusion of the in vitro test results, the study states that “Mixtures of L + S

polymers would not be suitable.” and that “a coating of neat Eudragit-S should be

capable of remaining intact ....” Id. at WC421. Thereafter, the study describes an in

vivo “transit time” test involving capsules “coated with an excess of Eudragit-S (200

ml of Eudragit-S Formula 3) ....” Id. The result of this test is that “200 mls of a 3%

Eudragit-S solution . . . was sufficient to protect the capsules from disintegration.” 

Id. at WC423. Finally, the study describes a coating thickness, in vitro test designed

to discover “the optimum range of acrylic coating thickness which would allow

successful delivery ofthe dosage form to the terminal ileum/ascending colon and then

to dissolve in the environmental pH thereby enabling the capsule or tablet to rapidly

disintegrate.” Id. The study does not state what sort of coating—Eudragit S alone

(i.e., neat Eudragit S) or a mixture of Eudragit S and Eudragit L—was used.

Both the Court and the parties considered competing interpretations of the

study at length during oral argument. See TR at 24-25, 61, 93-94, 106-111. Most of

the confusion stems from the study’s use of what appears to be two different Formula

3s. In the initial in vitro test, the authors refer to Formula 3 as a 1:2 ratio of

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Eudragit L (1 g) to Eudragit S (2 g). Yet, in the in vivo transit time test results, the

authors refer to Formula 3 as 200 ml of Eudragit S. Despite this ambiguity, Plaintiffs

seek to rely on the results of the coating thickness test to provide context for the

statement in the initial in vitro test that “[m]ixtures of L + S polymers would not be

suitable.” Conversely, Defendants rely on the aforesaid statement as a clear and

unmistakable disavowal. In my view, with the inherent ambiguity in the study, I

cannot fully discern the import and context of the “[m]ixtures . . . ” statement and,

consequently, do not find that it supports Defendants’ argument.

In reaching my conclusion that mixtures of Eudragit S and Eudragit L are not

excluded from the ‘170 patent, I further note the Federal Circuit’s acknowledgment

of the inherent difficulty in construing claims where predecessor applications or

patents were drawn to narrow claims, yet claims in the successive applications are

arguably broader than the invention described in the specification. See Saunders

Group, Inc. v. Comfortrac, Inc., 492 F.3d 1326, 1335-36 (Fed. Cir. 2007). In addition

to posing “interdependent problems of both claim construction and validity,” id. at

1336, the circuit has explained that

the problem is a difficult one, made more so by the failure of

applicants to state expressly to the examiner, whether for

tactical reasons or otherwise, the extent to which they

intended their new claims to depart from the scope of the

claims in the predecessor applications. In many such cases,

as in this one, we and the district court are required to draw

sometimes conflicting inferences from different sources of

guidance as to proper claim construction and to weigh those

conflicting inferences in reaching a conclusion as to the

proper construction. 

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Id. 

Perhaps this has been the circumstance here. While I am convinced after a

thorough review ofthe entire prosecution history and specification thatthe patentees

did not intend to exclude mixtures of Eudragit S and Eudragit L in the ‘170 patent,

there are certainly aspects of the prosecution history, particularly when read in

isolation, that could lead one to conclude that the mixtures were excluded. Indeed,

some portions ofthe specification also supportthat view. Nonetheless, “[p]rosecution

disclaimer does not apply to an ambiguous disavowal.” Computer Docking, 519 F.3d

at 1376. Hence, while the patentees could have certainly better clarified the breadth

of the ‘170 patent claims, I conclude that they did not intend to narrow the claims in

the manner Defendants suggests. In short, reading the claim language, the

specification, and the prosecution history in conjunction, I find that there is an

insufficient basis for concluding that the patentees clearly disavowed Eudragit S and

Eudragit L mixtures.

D. pH Limitation for Claim 7

Claim Language Plaintiffs’ Construction Defendants’ Construction

said solid oral dosage form

being coated so asto release the

5-amino-salicylic acid, salt or

ester to the right side of the

colon. 

Substantially all of the

drug leaves the dosage

form in the distal part of

the small intestine or the

ascending colon.

The coating is insoluble below

pH 7, i.e., Eudragit S, and

thereby reliably releases all of the

active ingredient contained in the

dosage form to the right side of

the colon (i.e., the ascending

colon, and not the terminal

ileum). (emphasis added)

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Defendants seek to import a pH limitation into claim 7 which, on its face, does

not include such a requirement. This is in contrast to claim 1 which includes that

limitation, as the following comparison illustrates.

Claim 1

1. An orally administrable pharmaceutical composition for

selectively administering 5-amino-salicylic acid, or pharmaceutically

acceptable salt or ester thereof,to the large intestine, comprising a solid

oral dosage form containing a pharmaceutically effective amountfor the

treatment of ulcerative colitis or Crohn’s disease of the colon of said 5-

amino-salicylic acid, salt or ester, said solid oral dosage form being

coated with a layer which is insoluble in gastric juice and in intestinal

juice below pH 7 but soluble in colonic intestinal juice, whereby the

dosage form releases the 5-amino-salicylic-acid, salt or ester to the right

side of the colon.

Claim 7

7. An orally administrable pharmaceutical composition for

selectively administering 5-amino-salicylic acid, or pharmaceutically

acceptable salt or ester thereof,to the large intestine, comprising a solid

oral dosage form containing a pharmaceutically effective amountfor the

treatment of ulcerative colitis or Crohn’s disease of the colon of said

5-amino-salicylic acid, salt or ester, said solid oral dosage form being

coated so as to release the 5-amino-salicylic acid, salt or ester to the

right side of the colon. 

While comparison of these two claims strongly suggests that the patentees did not

intend for claim 7 to contain a pH limitation, Defendants nonetheless argue that the

limitation should be read into claim 7 from the specification which repeatedly

references the pH solubility requirement and distinguishes prior art on that basis.

Although Defendants are correct in noting that the pH solubility requirement

is one of the ways the patentees distinguished the prior art, it is not the only way. 

As discussed above in construing the solubility requirement in the context of claim

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1, the patentees also distinguished the prior art based on the thickness of the oral

dosage form coating which the patentees treated as a distinct concept in the

specification. Thus, I am not persuaded by Defendants’ argument that the patentees’

criticism of non-pH based carrier systems (such as time-release based systems) in the

prior art means that a pH limitation must be imported in all claims. 

Indeed, such a conclusion would be contrary to Federal Circuit precedent that

“when a patent claim does not contain a certain limitation and another claim does,

that limitation cannot be read into the former claim in determining either validity or

infringement.” Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1326

(Fed. Cir. 2003) (internal citation marks omitted). There is a rebuttable presumption

that “different claims are of different scope.” Id.; In re Katz Interactive Call

Processing Patent Litig., 639 F.3d 1303, 1313 (Fed. Cir. 2011).17 Defendants have

not pointed to intrinsic or extrinsic evidence sufficient to overcome that presumption

here. To the contrary, the prosecution history makes clear that the patentees

intended for claim 7 to be distinct from claim 1; the patentees explicitly stated in the

1996 responsive amendment in the divisional application that claim 7 differs from

claim 1 in that the pH solubility requirement is absent. File History, 08/401,696

App., Mar. 13, 1996 Responsive Amendment at 3 (Ainsworth Decl., Exh. O at

WC179). 

17 While that presumption is especially strong when it relates to a dependent

and independent claim, see SunRace Roots Enterprise Co., Ltd. v. SRAM Corp., 336

F.3d 1298, 1303 (Fed. Cir. 2003), the presumption is likewise applicable to two

independent claims.

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While the question whether claim 7 is enabled and/or invalid is a question to

be resolved on another day, that claim 7 does not provide for a carrier system by

which the dosage form will release to the right side of the colon raises a substantial

question in the Court’s mind as to whether the claim is enabled. Nevertheless, for

claim construction purposes it is clear that the patentees did not intend for claim 7

to include a solubility requirement.

Defendants further point to the following prosecution history language from the

same responsive amendment: “The composition of Claim [7] is embodied in the

product Asacol®.” Id. at 3. Defendants argue that, by using “is”, the patentees 

intended to designate Asacol® as “the” sole embodiment of this claim—not just a

preferred embodiment. As such, Defendants argue, the scope of the claim must be

limited to the coating used for Asacol®, which is Eudragit S. Defendants rely on

Edwards Lifesciences LLC v. Cook Inc., 582 F.3d 1322 (Fed. Cir. 2009), for the

proposition that “when the preferred embodiment is described in the specification as

the invention itself, the claims are not necessarily entitled to a scope broader than

that embodiment.” Id. at 1330 (quoting Chimie v. PPG Indus. Inc., 402 F.3d 1371,

1379 (Fed. Cir. 2005)).

When read in context, the aforesaid language does not support Defendants’

contention that the patentees described Asacol® as the sole embodiment of claim 7

or that the patentees described Asacol® as “the present invention.” In context, the

statement reads: 

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[T]he question presented is whether the definition of the

coating as being such as to release the 5-amino-salicylic

acid, salt, or ester to the right side of the colon,

distinguishes [certain] Prior Art . . . The composition of

Claim [7] is embodied in the product Asacol®. As indicated

in the response of November 17, 1995, Laursen, et al., Gut

31, 1271-1276 (1990) describes Asacol® as tablets of 5-

amino-salicylic acid coated with Eudragit S and states that

most tablets have been shown to break up in the terminal

ileum or ascending colon and Fig. 7 of Stolk, et al. shows

that once the coating is removed from Asacol®,the 5-aminosalicylic acid (5-ASA) dissolves very quickly. . . . There is no

5-ASA held in reserve; all the 5-ASA is released. . . . It is

submitted that Claim [7] distinguishes Said Prior Art

combination because the provision of active ingredient

release profile in an oral dosage form whereby the oral

dosage form releases the 5-ASA to the right side ofthe colon,

is unobvious.

Id. at 3-4 (emphasis in original). This passage makes clear that, first of all, the

patentees were addressing the “so as to release the 5-amino-salicylic acid, salt, or

ester to the right side of the colon” language—not the solubility requirement. Second, 

the patentees distinguished Asacol® from prior art by noting that it releases of all of

the 5-ASA in the colon without holding any 5-ASA in reserve. In this context, “[t]he

composition of Claim [7] is embodied in the product Asacol®” statement serves to

introduce the patentees’ reliance on Asacol® for illustrative purposes. Nothing in this

passage suggests that Asacol® is the sole embodiment of claim 7. Thus, Defendants’

reliance on Edwards is misplaced.18

18 Defendants’ reliance is further misplaced because Edwards interpreted

language in the specification, which is usually entitled to more weight than prosecution

history statements. See Phillips, supra at 1316 (describing the specification as “the

single best guide to the meaning of a claim term”).

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Although I reject Defendants’ claim construction, I do not suggest that their

argument lacks intuitive force. As I noted in connection with my analysis of the

mixtures of Eudragit S and Eudragit L limitation, there are statements that, when

read in isolation, support Defendants’ arguments. For example, in the 1996

responsive amendment, the patentees describe Asacol® as “representing the

invention.” File History, 08/401,696 App., Mar. 13, 1996 Responsive Amendment at

8 (Ainsworth Decl., Exh. O at WC184). Critically, however, the patentees did not

state that Asacol® was the only representation of the invention. Throughout the

amendment, the patentees present Asacol® as an example, perhaps, the prime

example. But there is nothing in the prosecution history language foreclosing the

possibility of additional embodiments. I am further convinced of this by recalling that

this responsive amendment is part of the divisional application. As explained supra,

the purpose ofthe divisional application that resulted in the ‘170 patent was to secure

broader claims. To read the patentees’ statements narrowly would be to ignore the

application of which the amendment was a part.

In this connection, I note that Defendants pointto the Federal Circuit’s decision

in Alloc, Inc. v. International Trade Com'n, 342 F.3d 1361 (Fed. Cir. 2003), arguing

that the patentees may not recapture through the 1996 responsive amendment what

they allegedly disavowed early in the prosecution history and in the specification. 

Alloc, however, did not involve a divisional application that created a larger context

within which to interpret the patentees’ subsequent incorporation of broader claims.

Moreover, in Saunders, supra, the Federal Circuit distinguished Alloc in a manner

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relevant here. The specification in Saunders criticized prior art cylinders based on

their lack of pressure seals, noting thatthose cylinders “typically” could not maintain

adequate traction force. However, because the specification did not state that the use

of pressure seals was the “only way” to maintain traction force, the circuit concluded

that the specification did not support a narrowing construction. Saunders, 492 F.3d

at 1333. Likewise, here, although the specification disparages non-pH-based carrier

systems, the specification does not state that pH-based systems are the only means

by which the 5-ASA may be released to the right side of the colon.19

Accordingly, I construe claim 7 consistently with the manner in which I

construed claim 1, and not including the additional limitation proposed by

Defendants: 

said solid oral dosage form being coated so that

substantially all of the 5-ASA leaves the dosage form in the

ascending colon and no amount of the 5-ASA is released

prior to the dosage form reaching the distal ileum.

19 Alloc is further distinguishable on its facts. The patent in that case

involved flooring products and methods for installing those products. In importing a

limitation that there be “play” between the components of the locking joints in the

flooring products, the court reasoned that the specification in that case taught “that the

invention as a whole, not merely a preferred embodiment, provides for play in the

positioning of the floor panels.” 342 F.3d at 1369. Here, by contrast, the Eudragit S

coating is a preferred embodiment. In addition, there was express language in the

prosecution history describing “[t]he claimed ‘play’ [as] of the present invention.” Id.

at 1371. As noted above, no such “present invention” language is present (pun

intended) here.

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I reject Defendants’ attempt to incorporate a solubility requirement or language

limiting claim 7 to Eudragit S coatings into the construction.20

IV. CONCLUSION

For the foregoing reasons, the Court adoptions the following claims

constructions.

Disputed Terms Construction

A layer which is insoluble in gastric

juice and in intestinal juice below pH

7 but soluble in colonic intestinal

juice (Claim 1)

A layer of which no more than 0.01% of that layer

dissolves in gastric or intestinal juices below pH 7, but

does dissolve or disintegrate in colonic intestinal juice. 

Whereby the dosage form releases the

5-amino-salicylic-acid, salt or ester to

the right side of the colon (Claim 1)

Whereby substantially all of the 5-ASA reliably leaves

the dosage form in the ascending colon and no amount

of the 5-ASA is released prior to the dosage form

reaching the distal ileum. 

Whereby the 5-amino-salicylic-acid is

released to the right side of the colon

(Claim 6)

(same)

Said oral dosage form being coated so

asto release the 5-amino-salicylic-acid,

salt or ester to the right side of the

colon (Claim 7)

Said solid oral dosage form being coated so that

substantially all of the 5-ASA leaves the dosage form in

the ascending colon and no amount of the 5-ASA is

released prior to the dosage form reaching the distal

ileum.

20 Plaintiffs further argue that it would be impermissible for the Court to

limit a claim to Eudragit S, a trademarked drug name. I need not address this

argument as I reject the Eudragit S limitation for the reasons stated supra.

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Date: June 1, 2012

/s/ Freda L. Wolfson 

Freda L. Wolfson, U.S.D.J.

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