NOT FOR PUBLICATION

UNITED STATES DISTRICT COURT 

DISTRICT OF NEW JERSEY

__________________________________________ 

 ) 

DEPOMED, INC. and VALEANT ) 

INTERNATIONAL (BARBADOS) SRL, ) 

 ) 

 Plaintiffs, ) 

 ) 

v. ) Civil Action No. 11-3553 (JAP) 

 ) 

SUN PHARMA GLOBAL FZE, SUN ) MEMORANDUM OPINION

PHARMACEUTICAL INDUSTRIES ) 

LTD., and SUN PHARMACEUTICAL ) 

INDUSTRIES INC., ) 

 ) 

 Defendants. ) 

_________________________________________ ) 

PISANO, Judge 

Plaintiffs Depomed, Inc. and Valeant International (Barbados) SLR (collectively 

“Plaintiffs” or “Depomed”) bring this patent infringement action against defendants Sun Pharma 

Global FZE, Sun Pharmaceutical Industries Ltd., and Sun Pharmaceutical Industries Inc. 

(collectively “Defendants” or “Sun”). The five patents asserted in this case, assigned to 

Plaintiffs, are United States Patent No. 6,340,475 (the “’475 Patent”), United States Patent No. 

6,635,280 (the “’280” Patent”), United States Patent No. 6,488,962 (the “’962 Patent”), United 

States Patent No. 7,736,667 (the “’667 Patent”), and United States Patent No. 7,780,987 (the 

“’987 Patent”). The patents relate to drug-delivery systems that provide controlled delivery of an 

incorporated drug in the upper gastrointestinal system. Presently before the Court is the parties’ 

request for claim construction. 

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I. BACKGROUND

 There are five patents-in-suit, all of which relate to a drug-delivery system that allows for 

extended, controlled release of an incorporated drug into the upper gastrointestinal system, which 

includes the stomach and upper small intestines. Plaintiffs design, develop, and market 

pharmaceutical products that use this technology, one of those products being the diabetes drug 

Glumetza (metformin hydrochloride). Defendants seek to market a generic version of Glumetza, 

and, to that end, they submitted an Abbreviated New Drug Application (“ANDA”) to the U.S. 

Food and Drug Administration (“FDA”) pursuant to 21 U.S.C. § 355(j). In their ANDA, 

Defendants certified pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) that the ’475 Patent, ’280 

Patent, ’962 Patent, and ’987 Patent are invalid or will not be infringed by Defendants’ generic 

version of Glumetza. Plaintiffs filed this patent infringement lawsuit against Defendants, 

claiming that Defendants’ generic Glumetza will infringe the ’475 Patent, ’280 Patent, ’962 

Patent, ’987 Patent, as well as the ’667 Patent. 

 The ’475 Patent and ’280 Patent, issued on January 22, 2002 and October 21, 2003 are 

directed towards “extending the duration of drug release within the stomach during the fed 

mode.” (See generally, ’475 Patent and ’280 Patent.) Conventional tablets or capsules can 

release a drug too quickly when they come into contact with body fluids, which results in an 

unwanted transient overdose followed by a period of underdosing. (See ’475 Patent, 1:30-25.)1

 

In addition, some drugs, including metformin hydrochloride, must be absorbed high in the 

gastrointestinal tract in order to work properly. (Id. 2:21-33.) However, the drug may be forced 

 

1

 Citations to the patents-in-suit will be in a column:line format. Further, because the ’475 

Patent and ’280 Patent are based on the same patent application, Ser. No. 08/870,509, they share 

the same disclosure. Thus, throughout the remainder of this Memorandum Opinion, citations to 

these two patents will be only to the ’475 Patent with the understanding that those cited portions 

of the ’475 Patent also appear in the ’280 Patent, unless otherwise noted. 

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out of the stomach and through the passage leading to the intestines (the “pylorus”) before the 

drug has time to release completely and be absorbed. (See id.; see also 3:16-41.) 

 The ’475 and ’280 Patents address these and other related issues. The patents teach a 

dosage form2 comprising a “drug dispersed in a polymeric matrix” that “swells upon ingestion.” 

(Id. 5:57 – 6:3.) Particularly for highly soluble drugs like metformin hydrochloride, “the 

swelling of the polymeric matrix thus achieves two objectives—(i) the tablet swells to a size 

large enough to cause it to be retained in the stomach during the fed mode, and (ii) it retards the 

rate of diffusion of the highly soluble drug long enough to provide multi-hour, controlled 

delivery of the drug into the stomach.” (Id. 6:18-24.) 

 The ’962 Patent, issued on December 3, 2002, claims an improvement of the extendedrelease technology of the ’475 and ’280 Patents and covers “tablet shapes to enhance gastric 

retention of swellable controlled-release oral dosage forms.” (See generally ’962 Patent.) The 

’962 Patent teaches that dosage forms of particular shapes and sizes are both easy to swallow and 

resist escape through the pylorus into the intestines. (See id. 3:22-42.) “The shape that achieves 

this result is a non-circular, non-spherical shape which, when projected onto a planar surface, has 

two orthogonal axes of different lengths[.]” (Id. 3:27-30.) An example of a shape with these 

characteristics is an oval. (Id. 4:15-16.) In addition, the dosage form must be of a size such that 

when the dosage form swells, the shorter axis of the dosage form expands to a size large enough 

so that it resists passage through the pylorus. (Id. 4:22-31.) 

 The ’667 Patent, issued on June 15, 2010 teaches a “shell-and-core dosage form 

approaching zero-order drug release.” (See generally ’667 Patent.) The dosage forms 

contemplated by the ’667 Patent contain a polymeric matrix, but in a “dual-matrix configuration” 

 

2

 A “dosage form” contains an active ingredient (the drug) and excipients, which are 

inactive components that provide certain desirable characteristics to the dosage form. 

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with “one matrix forming a core of polymeric material in which drug is dispersed and the other 

matrix forming a casing that surrounds and fully encases the core, the casing being of polymeric 

material that swells upon imbibition of water.” (Id. 7:9-13.) Such dosage forms allow the 

release rate of the drug to be substantially constant over several hours, with release being 

confined to the upper gastrointestinal tract. (Id. 7:5-8.) 

 The final patent-in-suit, the ’987 Patent, was issued on August 24, 2010. The ’987 Patent 

is directed towards a “monolithic film coating for obtaining controlled release of drugs from oral 

dosage forms.” (’987 Patent, 1:10-11.) The coating comprises, among other things, a poly 

glycol. (Id. 4:28-32.) The poly glycol must have a melting point greater than 55° C, and the 

coating must be “cured at a temperature at least equal to or greater than the melting point of the 

poly glycol.” (Id. 4:30-34.) The ’987 Patent explains that this coating can be manipulated to 

obtain a desired drug release profile. (Id. 5:45-48.) 

 The parties requested claim construction to construe terms in each of the patents-in-suit. 

Actually, this is not the first time that a district court has construed terms in several of the 

patents-in-suit. In 2006 and 2007, Judge Charles R. Breyer of the Northern District of California 

construed six terms from the ’475 Patent and ’280 Patent. See Depomed, Inc. v. Ivax Corp., 

Case No. C 06-00100, 2006 U.S. Dist. LEXIS 100311 (N.D. Cal. December 20, 2006); 

Depomed, Inc. v. Ivax Corp., 532 F. Supp. 2d 1170 (N.D. Cal. 2007) (collectively “Ivax”). And 

in 2011, Judge Phyllis J. Hamilton construed nine terms from the ’475 Patent, ’280 Patent, and 

’962 Patent. See Depomed, Inc. v. Lupin Pharms., Inc., Case No. C 09-5587, 2011 U.S. Dist. 

LEXIS 52839 (N.D. Cal. May 17, 2011) (“Lupin”). Indeed, a few of the disputed terms in this 

case overlap with those already construed by Judge Hamilton and Judge Breyer, although the 

parties here have identified a number of additional disputed terms. The parties submitted 

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opening briefs on March 5, 2012, (DE 45, 47), and responsive briefs on May 4, 2012, (DE 51, 

53). The Court held a Markman hearing on July 18, 2012. This Opinion addresses the proper 

construction of the twenty-five (25) disputed terms. 

II. LEGAL STANDARD

 In order to prevail in a patent infringement suit, a plaintiff must establish that the patent 

claim “covers the alleged infringer’s product or process.” Markman v. Westview Instruments, 

Inc., 517 U.S. 370, 374 (1996). “It is a ‘bedrock principle’ of patent law that ‘the claims of a 

patent define the invention to which the patentee is entitled the right to exclude.’” Phillips v. 

AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (internal quotations omitted) (citing Vitronics 

Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Consequently, the first step in 

an infringement analysis involves determining the meaning and the scope of the claims of the 

patent. Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 988 (Fed. Cir. 1995). 

Claim construction is a matter of law for the court. Markman v. Westview Instruments, Inc., 52 

F.3d 967, 979 (Fed. Cir. 1995), aff’d 517 U.S. 370. Therefore, it is “[t]he duty of the trial judge . 

. . to determine the meaning of the claims at issue.” Exxon Chem. Patents, Inc. v. Lubrizol 

Corp., 64 F.3d 1553, 1555 (Fed. Cir. 1995). 

 Generally, the words of a claim are given their “ordinary and customary meaning,” which 

is defined as “the meaning that the term would have to a person of ordinary skill in the art in 

question at the time of the invention.” Phillips, 415 F.3d at 1312-13 (citations omitted). In this 

regard, the Federal Circuit has noted: 

It is the person of ordinary skill in the field of the invention 

through whose eyes the claims are construed. Such person is 

deemed to read the words used in the patent documents with an 

understanding of their meaning in the field, and to have knowledge 

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of any special meaning and usage in the field. The inventor’s 

words that are used to describe the invention—the inventor’s 

lexicography—must be understood and interpreted by the court as 

they would be understood and interpreted by a person in that field 

of technology. Thus the court starts the decisionmaking process by 

reviewing the same resources as would that person, viz., the patent 

specification and the prosecution history. 

Id. (quoting Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1477 (Fed. Cir. 1998)). 

 In order to determine the meaning of a claim as understood by a person skilled in the art, 

a court may look to various sources from which the proper meaning may be discerned. These 

sources include intrinsic evidence, which consists of “the words of the claims themselves, the 

remainder of the specification, [and] the prosecution history,” id. at 1314, and extrinsic evidence 

“concerning relevant scientific principles, the meaning of technical terms, and the state of the 

art,” id.

 When considering the intrinsic evidence, the court’s focus must begin and remain on the 

language of the claims, “for it is that language that the patentee chose to ‘particularly point[] out 

and distinctly claim[] the subject matter which the patentee regards as his invention.’” 

Interactive Gift Express, Inc. v. Compuserve, Inc., 256 F.3d 1323, 1331 (Fed. Cir. 2001)(quoting 

35 U.S.C. § 112, ¶2). The specification is often the best guide to the meaning of a disputed term. 

Honeywell Int’l v. ITT Indus., 452 F.3d 1312, 1318 (Fed. Cir. 2006). It is improper, however, to 

import limitations from the specification into the claims. Seachange Int’l v. C-COR Inc., 413 

F.3d 1361, 1377 (Fed. Cir. 2005). The court may also consider as intrinsic evidence a patent’s 

prosecution history, which is evidence of “how the inventor understood the invention and 

whether the inventor limited the invention in the course of prosecution, making the claim scope 

narrower than it would otherwise be.” Phillips, 415 F.3d at 1317. 

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 While a court is permitted to turn to extrinsic evidence, such evidence is generally of less 

significance and less value in the claim construction process. Id. at 1317. Extrinsic evidence is 

evidence that is outside the patent and prosecution history, and may include expert testimony, 

dictionaries, and treatises. Id. The Federal Circuit has noted that caution must be exercised in 

the use of extrinsic evidence, as this type of evidence may suffer from inherent flaws affecting its 

reliability in the claim construction analysis. Id. at 1319 (“We have viewed extrinsic evidence in 

general as less reliable than the patent and its prosecution history in determining how to read 

claim terms.”). While “extrinsic evidence may be useful to the court, . . . it is unlikely to result 

in a reliable interpretation of patent claim scope unless considered in the context of the intrinsic 

evidence.” Extrinsic evidence may never be used to contradict intrinsic evidence. Id. at 1322-

23. 

 Finally, the Court will give deference to the prior claim constructions announced in Lupin

and Ivax. Although issue preclusion is inapplicable, the Supreme Court in Markman noted that 

treating claim construction as a purely legal issue will allow “intrajurisdictional certainty through 

the application of stare decisis.” Markman, 517 U.S. at 391. Therefore, “[w]hile a court’s 

previous opinions [do] not have issue preclusive effect against [Defendants] in this case, to the 

extent the parties do not raise new arguments, the court will defer” to previous constructions of 

the same patent claims. Kx Indus., L.P. v. Pur Water Purification Prods., 108 F. Supp. 2d 380, 

387 (D. Del. 2000). 

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III. CONSTRUCTION OF THE CLAIM TERMS

A. “Polymeric Matrix” 

 The term “polymeric matrix” appears in the ’475 Patent and ’280 Patent. Plaintiffs 

define the term to mean “a surrounding medium comprising polymer.” Defendants construe the 

term as “a polymeric formulation containing a sufficient amount of suitable polymer or polymer 

mix to provide extended, controlled release of a drug dispersed throughout the formulation.” 

Plaintiffs assert that Defendants’ construction reads limitations into the term. But Defendants 

counter that the “limitations” in their construction are not limitations at all because the claims 

themselves so limit the term. 

 Claim 1 of the ’475 Patent reads as follows: 

A controlled-release oral drug dosage form for releasing a drug . . . 

, said dosage form comprising a solid polymeric matrix with said 

drug dispersed therein at a weight ratio of drug to polymer of from 

about 15:85 to about 80:20, said polymeric matrix being one that 

swells upon imbibition of water thereby attaining a size large 

enough to promote retention in the stomach during said fed mode, 

that releases said drug into gastric fluid by the dissolution and 

diffusion of said drug out of said matrix by said gastric fluid, that 

upon immersion in gastric fluid retains at least about 40% of said 

drug one hour after such immersion, and that remains substantially 

intact until all of said drug is released. 

(‘475 Patent, Claim 1.) The claim is clear as to the characteristics of the polymeric matrix. It 

must swell upon imbibition of water, it must have a weight ratio of drug to polymer of from 

about 15:85 to about 80:20, and it must attain a size large enough to promote retention in the 

stomach during the fed mode. (Id.) Defendants argue that the construction of the term must 

reflect these required characteristics. However, although the claims require an oral drug dosage 

form to have these characteristics in order to fall within the scope of the invention, the Court 

finds it improper to define this simple, straightforward term in such a drawn-out manner. 

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 First, Defendants’ construction would render the claim language redundant several times 

over. For example, Defendants argue that it is necessary to include the limitation that the 

polymeric matrix contain a “sufficient amount of polymer.” But the claims already specify what 

amounts are required to practice the invention. (See ’475 Patent, 17:48-50 (“a solid polymeric 

matrix with said drug dispersed therein at a weight ratio of drug to polymer of from about 15:85 

to about 80:20”); see also ’280 Patent, 23:4-6 (“solid polymeric matrix with said drug 

incorporated therein at a weight ratio of drug to polymer of from about 0.01:99.9 to about 

80:20”).) Defendants admit that their construction includes limitations that are expressly 

required by the claims. Yet it is exactly for this reason that those limitations do not need to be 

repeated in the construction of “polymeric matrix.” See e.g., Intervet Inc. v. Merial Ltd., 617 

F.3d 1282, 1290 (Fed. Cir. 2010) (criticizing a construction that included a limitation that was 

already included in the same claim). In addition, a person of ordinary skill in the art would 

understand that the polymeric matrix is the first of two components that make up the dosage 

form; the second component, the “drug dispersed therein,” is separate and should be defined 

independently. (See Hopfenberg Decl. ¶ 66, DE 45-42.) Therefore, the Court also rejects the 

aspect of Defendants’ construction that includes a construction of “drug dispersed therein” in the 

construction of “polymeric matrix.” 

 Second, Defendants’ construction is vague and would not achieve the purpose of claim 

construction. “The construction of claims is simply a way of elaborating the normally terse 

claim language in order to understand and explain, but not to change, the scope of the claims.” 

Terlep v. Brinkmann Corp., 418 F.3d 1379, 1382 (Fed. Cir. 2005) (citing Embrex, Inc., v. Serv. 

Eng’g Corp., 216 F.3d 1343, 1347 (Fed. Cir. 2000)). Here, defining “polymeric matrix” using 

the words “suitable” and “sufficient amount” only serves to add vagueness to the term, such that 

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Defendants’ proposed construction would itself require additional defining. See E-Pass Techs., 

Inc. v. 3Com Corp., 473 F.3d 1213, 1220 (Fed. Cir. 2007) (explaining that the words the court 

uses in construing a claim should not be limitations that require additional interpretation). 

“Claim interpretation is the process of giving proper meaning to the claim language,” AbTox, 

Inc. v. Exitron Corp., 122 F.3d 1019, 1023 (Fed. Cir. 1997), not assigning a construction to a 

term that is more unhelpful than the term by itself. No person of ordinary skill in the art, for 

instance, would believe the “polymeric matrix” to be made of “unsuitable” polymer, and it is 

therefore of no benefit to construe the “polymeric matrix” to be made of only “suitable” polymer. 

Defendants’ construction, in sum, does not help the Court in its role as claim construer. 

 The Court will instead adopt Plaintiffs’ construction with one alteration. The 

specifications of the ’475 and ’280 Patents explain that a drug is dispersed in the polymeric 

matrix. “[T]he beneficial effects” are “achieved by using a formulation in which the drug is 

dispersed in a polymeric matrix.” (’475 Patent, 5:57-59.) The drug also can be mixed with or 

impregnated in the polymeric matrix. (See ’475 Patent, 10:40-41.) Therefore, the polymeric 

matrix is properly understood by a person of ordinary skill in the art as a “medium.” (See

Hopfenberg Decl. ¶ 65.) Defendants take issue with the use of the modifier “surrounding,” 

arguing that the word is not in the patents. Plaintiffs, however, agreed to drop “surrounding” 

from the construction. (Markman Hearing Tr. 33:4-7.) Finally, the ’475 Patent and ’280 Patent 

also make clear that the polymeric matrix is composed of “polymer,” and the patents list a 

number of polymer and polymer derivatives that may make up the polymeric matrix. (See ’475 

Patent 7:56-8:67.) The Court will therefore construe “polymeric matrix” to mean “a medium 

comprising polymer.” 

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 B. “Solid polymeric matrix with drug dispersed therein” and “one or more 

 polymers forming a solid polymeric matrix with said drug incorporated 

 therein” 

 The first term, “solid polymeric matrix with drug dispersed therein,” is found in both the 

’475 Patent and ’280 Patent. Plaintiffs’ construction of this first term is “a medium comprising 

polymer that surrounds drug particles.” Defendants define the first term to mean “a solid 

polymeric matrix with the drug dispersed throughout the matrix.” The second term, “one or 

more polymers forming a solid polymeric matrix with said drug incorporated therein” is in the 

’280 Patent. Plaintiffs define the second term as “one or more polymeric materials forming a 

medium that surrounds drug particles.” Defendants contend that the second term means “the 

drug is dispersed throughout a solid polymeric matrix formed by one or more polymers.” 

 The dispute between the parties with respect to these related terms focuses on whether 

“dispersed therein” means “dispersed throughout” the polymeric matrix. Plaintiffs assert that 

Defendants’ definition, which requires the drug be “dispersed throughout” the polymeric matrix, 

is too narrow. In support of their argument, Plaintiffs point to an embodiment that calls for a 

“drug-impregnated polymer matrix,” and Plaintiffs explain that this means that the drug is 

dispersed in the polymeric matrix like the yolk of an egg is dispersed in egg white (i.e., the egg 

yolk is centered, like a core, within the surrounding egg white). (’475 Patent, 10:40-41.) 

Plaintiffs illustrate this embodiment in Figure 1 of their opening brief, reproduced below. 3 

 

3

 Figure 1 from Plaintiffs’ opening brief is not a drawing found in either the ’475 or ’280 

Patents, but instead was generated by Plaintiffs for purposes of illustrating their egg yolk 

analogy. The Court must look upon this extrinsic evidence with caution as it “is not part of the 

patent and does not have the specification’s virtue of being created at the time of patent 

prosecution for the purpose of explaining the patent’s scope and meaning.” Phillips, 415 F.3d at 

1318. 

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(Pls.’ Opening Br. at 14; DE 45.) Thus, Plaintiffs argue that, to the extent that Defendants’ 

construction requires that the drug be evenly distributed throughout the polymeric matrix, it is 

wrong because it reads out the “drug-impregnated” embodiment. 

 Neither patent elaborates on what it means to disperse a drug by impregnating it into the 

matrix, nor do any of the examples appear to use this method. However, a drug-impregnated 

polymeric matrix, as Plaintiffs understand it, would not accord with the “slow, continuous” 

delivery of the drug to the upper gastrointestinal system. (’475 Patent, 2:59-65.) If there was a 

drug core within the polymeric matrix, drug release into the stomach would not necessarily be 

continuous since the core’s dissolution and diffusion would be delayed. 

 Besides the inference the Court takes from the phrase “slow, continuous” delivery, there 

is no additional intrinsic evidence to shed light on what a “drug-impregnated” polymeric matrix 

entails. Thus, the Court will turn to expert testimony for help in defining this term. See

Callaway Golf Co. v. Acushnet Co., 576 F.3d 1331, 1338 (finding that “evidence of accepted 

practice within the art, when not at variance with the intrinsic evidence, is relevant to the 

question of how a person of skill in the pertinent field would understand the term.”). Plaintiffs’ 

expert, Dr. Harold B. Hopfenberg, has over forty years of experience in polymer science, and he 

specifically studies polymers used in controlled-release drug delivery systems, (see Hopfenberg 

Decl. ¶¶ 2-8), thus making his expert opinion particularly helpful in understanding the person of 

ordinary skill in the art of the patents-in-suit. 

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 Dr. Hopfenberg takes issue with Plaintiffs’ understanding of a drug-impregnated 

polymeric matrix. Upon considering Figure 1 from Plaintiffs’ opening brief, Dr. Hopfenberg 

expressed concern that the illustration is “ambiguous” and does not “[have] anything to do with 

what the patent is about. If you take it literally, it’s just a –- a small element of that matrix.” 

(Hopfenberg Dep. 140:8-21; Defs.’ Ex. 17 to Bogad Decl.; DE 53-3.) Instead, Dr. Hopfenberg 

offered his own illustration of what the patent describes, depicted below in Figure 2 and Figure 

4: 

 

 

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(Hopfenberg Decl. ¶ 55.) Dr. Hopfenberg explained that “[w]hen I say ‘drug dispersed in a 

polymeric matrix,” . . . I’m directed to Figure 2,” which depicts drug particles separated in space 

by solid polymeric matrix. Moreover, he stated that Figure 4, a magnified shot of Figure 2, “is 

really the ultimate picture of what this invention is about.” (Hopfenberg Dep. 139:19-21.) Dr. 

Hopfenberg apparently envisions a “drug-impregnated” matrix to be something different than 

Plaintiffs’ egg yolk analogy, and he finds no support for such an analogy in the patent. (See id.

at 108:13-15.) Accordingly, Dr. Hopfenberg’s opinion is that a drug-impregnated matrix, as it is 

understood by a person of ordinary skill in the art, does not mean a drug core within a polymeric 

matrix shell. And Dr. Hopfenberg’s illustrations of the dispersed drug in Figure 2 and Figure 4 

show the drug being located “throughout” the polymeric matrix. 

 Further, it is not necessary that the drug be dispersed evenly in the polymeric matrix. (Id.

at 139:8-17.) Indeed, Defendants stated during the Markman hearing that their definition does 

not require the drug to be distributed “homogenously” (i.e., evenly) in the polymeric matrix. 

(Markman Hearing Tr. 60:22-61:4.) Finally, Defendants’ definition is consistent with the other 

ways in which a drug is dispersed in the polymeric matrix such as incorporated and mixed. (See 

’280 Patent, 7:58; ’475 Patent 10:40-41.) 

 Therefore, “solid polymeric matrix with drug dispersed therein” means “a solid 

polymeric matrix with the drug dispersed throughout the matrix”; and “one or more polymers 

forming a solid polymeric matrix with said drug incorporated therein” means “the drug is 

dispersed throughout a solid polymeric matrix formed by one or more polymers.” 

 

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 C. “Said polymeric matrix being one that swells upon imbibition of water 

 thereby attaining a size large enough to promote retention in the stomach 

 during the fed mode” and “said dosage form being one that when swollen in 

 a dimensionally unrestricted manner as a result of imbibition of water is of a 

 size exceeding the pyloric diameter in the fed mode to promote retention in 

 the stomach during the fed mode” 

 The first term, “said polymeric matrix being one that swells upon imbibition of water 

thereby attaining a size large enough to promote retention in the stomach during the fed mode” is 

in the ’475 Patent. The second term, “said dosage form being one that when swollen in a 

dimensionally unrestricted manner as a result of imbibition of water is of a size exceeding the 

pyloric diameter in the fed mode to promote retention in the stomach during the fed mode,” is 

found in the ’280 Patent. 

 During the Markman hearing, the parties agreed to Judge Hamilton’s construction. 

(Markman Hearing Tr. 40:6-15)); see also Lupin, 2011 U.S. Dist LEXIS 52839, at *23. 

Therefore, the terms “said polymeric matrix being one that swells upon imbibition of water 

thereby attaining a size large enough to promote retention in the stomach during the fed mode” 

and “said dosage form being one that when swollen in a dimensionally unrestricted manner as a 

result of imbibition of water is of a size exceeding the pyloric diameter in the fed mode to 

promote retention in the stomach during the fed mode” mean “the dosage form, which comprises 

a polymeric matrix, increases in size due to the ingress of water, such that when the dosage form 

is introduced into the stomach in the fed mode, the dosage form remains in the stomach for 

several hours.” 

D. “Dissolution and Diffusion” 

 The term “dissolution and diffusion” is found in both the ’475 Patent and ’280 Patent. 

Plaintiffs’ proposed construction is “rapid dissolution of the drug by the gastric fluid followed by 

slow diffusion of the drug out of the matrix, such that the drug is released at a rate primarily 

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controlled by the rate of diffusion.” Defendants define the term to mean “rapid dissolution of the 

drug, followed by slow diffusion of the drug out of the water-swollen polymeric matrix, such 

that the drug is released at a rate controlled by the rate of diffusion from such matrix.” 

 This term was construed in both Ivax and Lupin, and Plaintiffs simply adopt the 

construction announced by Judge Breyer in Ivax. See Ivax, 532 F. Supp. 2d at 1181. Neither 

party in this case has an issue with the word “primarily” being part of the construction, (see

Markman Hearing Tr. 62:3-63:6), and the intrinsic evidence makes clear that the rate of release 

is controlled “primarily” by diffusion. (See ’475 Patent, 5:57-61, 6:14-16.) Rather, the parties’ 

dispute is whether the polymeric matrix must be “water-swollen” as Defendants’ construction 

would require.4 

 Plaintiffs assert that there is no support for this precondition in the specification, but 

Plaintiffs are incorrect. The patents state that “[t]he release rate of a drug from the matrix is 

primarily dependent upon the rate of water imbibition and the rate at which the drug dissolves 

and diffuses from the swollen polymer.” (’475 Patent, 9:7-10, 3:13-15.) As a matter of scientific 

principle, a drug will not dissolve without a solvent (a fluid), and if the drug is not dissolved in a 

fluid, it will not diffuse out of the matrix. (See Hopfenberg Decl. ¶ 59). The specification 

explains that swelling and dissolution/diffusion have a cause-effect relationship. (See ’475 

Patent, 6:22-24.) Moreover, Plaintiffs’ own expert agrees that “water will enter the dosage form 

to cause matrix swelling and dissolution of the dispersed drug followed by diffusion of the drug 

out of the water-swollen matrix.” (Hopfenberg Decl. ¶ 77.) 

 

4

 This argument was not before either Judge Breyer or Judge Hamilton. However, Judge 

Hamilton recognized that the “release of water-soluble drugs can be achieved using a polymeric 

matrix that swells to create a diffusion barrier so that water-soluble drugs are released primarily 

by diffusion[.]” Lupin, 2011 U.S. Dist. LEXIS 52839, at *25. 

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 Therefore, the Court will construe the term “dissolution and diffusion” to mean “rapid 

dissolution of the drug, followed by slow diffusion of the drug out of the water-swollen matrix, 

such that the drug is released at a rate primarily controlled by the rate of diffusion.” 

E. “Releases said drug into gastric fluid by the dissolution and diffusion of said 

 drug out of said matrix” and “releases said drug into gastric fluid by the 

 dissolution and diffusion of said drug out of said matrix by said gastric fluid” 

 These terms are found in the ’475 and ’280 Patents. Defendants offer one construction 

for both terms: “the water swollen polymeric matrix controls the dissolution and diffusion of the 

drug into the gastric fluid.” Plaintiffs do not offer a specific construction because each of the 

words within this larger disputed phrase are being construed already. The Court agrees with 

Plaintiffs. The Court is construing the terms “dissolution and diffusion” and “polymeric matrix”, 

and the parties have agreed on the construction of “gastric fluid.” No further construction is 

necessary. (See also Pls.’ Ex. 41 to Andre Decl.; DE 45-41.) 

F. “Releases substantially all of said drug within about eight hours after such 

 immersion”, “until substantially all of said drug is released”, and “while 

 releasing substantially all of said drug within said stomach where said drug 

 is maintained in an acidic environment” 

 The first term, “releases substantially all of said drug within about eight hours after such 

immersion,” is from the ’475 Patent. The second term, “until substantially all of said drug is 

released,” is from the ’280 Patent. And the third term, “while releasing substantially all of said 

drug within said stomach where said drug is maintained in an acidic environment,” is found in 

both the ’475 and ’280 Patents. Plaintiffs offer one construction for all three terms: “at least 

about 80% of the drug has been released after eight hours of immersion in gastric fluid.” 

Defendants define the terms separately. Defendants’ construction for the first term is “about 

100% of the drug has been released into gastric fluid.” Defendants define the second term to 

mean “until about 100% of the drug has been released into gastric fluid.” And Defendants’ 

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construe the third term to mean “releasing about 100% of the drug in the stomach having a pH 

value of less than 7.” 

 The parties’ dispute focuses on the meaning of “substantially all.” Defendants argue that 

the term should be given its plain and ordinary meaning of “about 100%,” but “substantially all” 

must be understood in the context of how the term is used in the claims and specification. See

Phillips, 415 F.3d at 1313 (quoting Multiform Desiccants, Inc., 133 F.3d at 1477). The 

specification first describes drug release in terms of how much remains in the matrix, rather than 

how much is released: 

The amount of polymer will be sufficient . . . to retain at least 

about 40% of the drug within the matrix one hour after ingestion 

(or immersion in the gastric fluid). Preferably, the amount of 

polymer is such that at least 50% of the drug remains in the matrix 

one hour after ingestion. More preferably, at least 60%, and most 

preferably at least 80%, of the drug remains in the matrix one hour 

after ingestion. In all cases, however, the drug will be substantially 

all released from the matrix within about ten hours, and preferably 

within about eight hours, after injection[.] 

(’475 Patent, 9:25-35.) The patents also depict graphically the amount of drug released over 

time. The figures depicting the release of metformin hydrochloride are reproduced below from 

the ’475 Patent and ’280 Patent. 

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(’475 Patent, Figure 1, Figure 2, Figure 5, Figure 7, and Figure 9.) Each of these figures show 

the percentage released over time by various oral dosage units comprising polymeric matrices 

and metformin hydrochloride.5

 (See ’475 Patent, Example 1, Example 4, and Example 5.) 

Figure 1 depicts the release rates for three dosage forms, one of which released 100% of its 

metformin hydrochloride in six hours, and two of which released only about 90% after nine 

hours. The dosage forms appearing in Figure 4 released about 100% of their metformin 

hydrochloride after eight hours. The dosage form appearing in Figure 5 released about 90% of 

metformin hydrochloride after eight hours. The dosage forms depicted in Figure 7 released just 

over 90% of their metformin hydrochloride after eight hours. And the dosage form depicted in 

 

5

 Of course, the ’475 and ’280 Patents are not limited to dosage forms that release 

metformin hydrochloride. Figures 2, 3, 6, and 8 depict the release rates of other drugs. These 

figures show release rates anywhere from just over 60% to 100% release after eight hours. 

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Figure 9 released just over 70% of its metformin hydrochloride after eight hours, and 80% after 

ten hours. 

 These results reveal wide, varying release rates at the eight hour mark, thereby making 

the meaning of “substantially all” unclear. At the very least, the specification demonstrates that 

the patent applicants meant something other than “about 100%.” “In some cases . . . claim 

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

meaning of commonly understood words” but in this case, “determining the ordinary and 

customary meaning of the claim requires examination of terms that have a particular meaning in 

a field of art.” Phillips, 415 F.3d at 1314 (internal citation omitted). 

 Judge Breyer also recognized the problem with construing “substantially all” based solely 

on the intrinsic evidence.6

 See Ivax, 2006 U.S. Dist. LEXIS 100311, at *13-14. “[R]oughly 

two-thirds (21 out of 31) of the formulations reported in the patent released at least 80% of the 

drug after eight hours” but “only three of the samples actually demonstrated a release between 

80% or 90%.” Id. Instead of relying on “the degree of testing that the patentee chose to 

perform—or to report” Judge Breyer sought “[a] firmer foundation, preferably rooted in the 

science[.]” Id. at *14. Judge Breyer relied upon, and Plaintiffs urge this Court to rely upon, 

FDA’s “Guidance for Industry: Extended Release Oral Dosage Forms: Development, Evaluation, 

and Application of In Vitro/In Vivo Correlations” published in September 1997 (hereinafter 

“FDA Dissolution Guidance”). (See Pls.’ Ex. 12 to Andre Decl.; DE 45-12.) 

 Defendants assert that it is improper for any court to rely on the FDA Dissolution 

Guidance because it was published in September 1997, just after the patentees filed their priority 

 

6

 The defendant in Ivax proposed that “substantially all” meant “at least 90%.” Ivax, 2006 

U.S. Dist. LEXIS 100311, at *12. Here, Sun proposes “at least 90%” as an alternative 

construction. (Defs.’ Opening Br. at 18; DE 47) 

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application for the ’475 and ’280 Patents on June 6, 1997. However, the FDA Dissolution 

Guidance expressly relies upon sources published and information gathered before the priority 

application date. (See Pls.’ Ex. 12 at 2.) It therefore is unreasonable to argue that a person of 

ordinary skill in the art at the time of the invention would not have been aware of the principles 

contained in the FDA Dissolution Guidance simply because it was published three months after 

the patentees filed their priority application. While the later publication date would prevent its 

consideration, for example, in an 35 U.S.C. § 103 obviousness analysis, the Court finds that the 

FDA Dissolution Guidance is properly considered during claim construction as evidence of the 

understanding of one skilled in the art. Moreover, the FDA Dissolution Guidance does not raise 

many of the concerns often associated with extrinsic evidence. See Phillips, 415 F.3d at 1318. 

In particular, the FDA Dissolution Guidance was published at the time of patent prosecution, was 

written by and for those skilled in the art, and therefore reflects the understanding of a skilled 

artisan in the field. See id. 

 The FDA Dissolution Guidance explains that, with respect to in vitro dissolution testing, 

the same testing reported in the ’475 and ’280 Patents, results should be gathered at a minimum 

of three time points: the early, middle, and late stages of dissolution). (Pls.’ Ex. 12 at 16-17.) 

“The last time point should be the time point where at least 80% of drug has dissolved.” (Id. at 

17.) In other words, the appropriate end point for testing dissolution of a drug is when 80% of 

the drug is released. Therefore, the Court agrees with and gives appropriate deference to Judge 

Breyer’s reliance on the FDA Dissolution Guidance and will adopt Plaintiffs’ proposed 

construction. The terms “releases substantially all of said drug within about eight hours after 

such immersion,” “until substantially all of said drug is released,” and “while releasing 

substantially all of said drug within said stomach where said drug is maintained in an acidic 

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environment” mean “at least 80% of the drug has been released after eight hours of immersion in 

gastric fluid.” 

 G. “Until all of said drug is released” 

 This term is in the ’475 Patent. Plaintiffs define the term to mean “until the plateau of the 

dissolution profile characterizing drug release from the swollen dosage form is reached,” and 

Defendants define it as “until all of the drug has been released into the gastric fluid.” Similar to 

the previous terms, (see Discussion, supra, Part III.F), the parties’ dispute focuses on the word 

“all.” Defendants maintain that “all” has the plain and ordinary meaning of 100%, but Plaintiffs 

disagree, arguing that those words have special meaning in the context of the ’475 Patent. 

 The claim elements in which the term appears require that the polymeric matrix 

“remain[] substantially intact until all of said drug is released.” (’475 Patent, Claim 1, Claim 34; 

see also ’475 Patent, 9:35-36.) Defendants argue, and the Court agrees, that “all of said drug” 

must have a meaning different than “substantially all of said drug.” See Symantec Corp. v. 

Computer Assocs. Int’l, Inc., 522 F.3d 1279, 1289 (Fed. Cir. 2008)(“[W]hen construing terms in 

the body of a claim, the general assumption is that different terms have different meanings[.]”). 

The ’475 Patent discloses that the dosage form will not always, and often does not, release 100% 

of the incorporated drug, and therefore, Defendants’ construction cannot be correct. (See, e.g., 

’475 Patent, Figure 1.) But there nothing else in the intrinsic evidence to assist the Court in 

determining what meaning the patentees intended to give “all of said drug.” 

 In construing this term, and faced with essentially the same opposing constructions,7

Judge Hamilton again turned to the FDA Dissolution Guidance document to determine the 

 

7

 Depomed offers the same construction here as it offered in Lupin. See Lupin, 2011 U.S. 

LEXIS 52839, at *31. The defendant in Lupin argued that “until 100% of the drug is dissolved . 

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meaning that a person of ordinary skill would give to this term. The FDA Dissolution Guidance 

explains that “[if] the maximum amount dissolved is less than 80%, the last time point should be 

the time when the plateau of the dissolution profile has been reached.” (Pls.’ Ex. 12 at 17.) 

FDA’s “Guidance for Industry: SUPAC-MR: Modified Release Solid Oral Dosage Forms” 

explains that the endpoint of dissolution testing should occur “until either 80% of the drug from 

the drug product is released or an asymptote is reached.” (Pls.’ Ex. 11 to Andre Decl. at 8; DE 

45-11.) Put differently, when the plateau or asymptote of the dissolution profile is reached, all of 

the drug that is going to be released has been released; and it makes sense that the polymeric 

matrix will remain substantially intact until this occurs in order to carry out the extended, 

controlled release function. Moreover, unlike Defendants’ construction, Plaintiffs’ construction 

would ensure that no embodiment is read out of the claim because not all dosage forms disclosed 

in the patent release 100% of the drug contained in the dosage form. See Adams Respiratory

Therapeutics, Inc. v. Perrigo Co., 616 F.3d 1283, 1290 (Fed. Cir. 2011). Therefore, the Court 

will construe the term “until all of said drug is released” to mean “until the plateau of the 

dissolution profile characterizing drug release from the swollen dosage form is reached.” 

H. “At a weight ratio of drug to polymer of from 15:85 to 80:20”, “at a weight 

 ratio of drug to polymer of from 0.1:99.99 to 80:20”, and “a solid polymeric 

 matrix with said drug dispersed therein at a weight ratio of drug to polymer 

 of from about 15:85 to about 80:20” 

The terms “at a weight ratio of drug to polymer of from 15:85 to 80:20” and “at a weight 

ratio of drug to polymer of from 0.1:99.9 to 80:20” both appear in the ’280 Patent. Plaintiffs 

argue that these terms do not need construction as they can be given their plain and ordinary 

meaning. Defendants do not dispute that Plaintiffs’ construction is correct, but they nonetheless 

 

. . ,” id., whereas in this case, Sun argues that the term means “until all of the drug has been 

released . . . .” 

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offer a construction that they believe is easier to understand: “the weight of drug is [15 to 

80%/0.1% to 80%] relative to the total weight of drug and polymer in the solid polymeric 

matrix.” Indeed the specification confirms that Defendants’ construction is simply another way 

of expressing the claim term. (’280 Patent, 9:50-60.) There is therefore no need to construe 

these first two terms. 

The third term, “a solid polymeric matrix with said drug dispersed therein at a weight 

ratio of drug to polymer of from about 15:85 to about 80:20,” appears in the ’475 Patent. 

Plaintiffs define the term to mean “a medium comprising polymer that surrounds drug particles 

at a drug to polymer ratio from 14.4:85.6 to 80.8:19.2.” Defendants similarly construe the term 

to mean “a polymeric matrix at a drug to polymer weight ratio from 14.4:85.6 to 80.8:19.2.” The 

parties thus do not dispute the meaning of “about 15:85 to about 80:20,” (see Pls.’ Ex. 41), but 

instead differ only in the definition of “a solid polymeric matrix with said drug dispersed 

therein.” The Court already has construed “a solid polymeric matrix with said drug dispersed 

therein,” and need not define it again here. Therefore, the Court will construe the term “a solid 

polymeric matrix with said drug dispersed therein at a weight ratio of drug to polymer of from 

about 15:85 to about 80:20” to mean “a solid polymeric matrix with said drug dispersed therein 

at a weight ratio of drug to polymer of from 14.4:85.6 to 80.8:19.2.” 

I. “Dosage form consisting essentially of a solid monolithic matrix with said 

 drug contained therein” 

 This term appears in the ’962 Patent. Plaintiffs argue that the term does not require 

construction. Defendants define the term to mean “dosage form with a solid monolithic matrix 

containing the drug and no other components that restrict swelling of the matrix.” 

 The Court agrees with Plaintiffs that this term does not require independent construction. 

First, “consisting essentially of” has an accepted meaning in patent law and does not need further 

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definition. “By using the term ‘consisting essentially of,’ the drafter signals that the invention 

necessarily includes the listed ingredients and is open to unlisted ingredients that do not 

materially affect the basic and novel properties of the invention.” PPG Indus. v. Guardian Indus. 

Corp., 156 F.3d 1351, 1354 (Fed. Cir. 1998). Second, the parties have agreed that the phrase 

“solid monolithic matrix” means “single entire matrix.” (See Pls.’ Ex. 41.) 

 Finally, neither party offers a specific definition for the phrase “drug contained therein.” 

Defendants’ proposed construction does not give any separate meaning to this phrase. Plaintiffs 

suggest that the phrase is already being defined by the Court, although the Court is construing 

“drug dispersed therein” as opposed to “drug contained therein.” Nevertheless, the ’962 Patent, 

which is an improvement upon the ’475 and ’280 Patents, adopts similar, and sometimes 

identical, language to the ’475 and ’280 Patent with respect to swellable polymers and their use 

in extended, controlled release technology. (Cf. ’962 Patent, 4:48-52, with ’475 Patent, 7:54-58; 

cf. ’962 Patent, 3:52-61, with ’475 Patent, 5:57-66.) In addition, the ’962 Patent uses 

“dispersed” and “contained” interchangeably when referring to the drug’s location in the 

polymeric matrix. (See id. 7:31-32, 3:52-53.) The Court will therefore will give “drug contained 

therein” in the term “dosage form consisting essentially of a solid monolithic matrix with said 

drug contained therein” the same meaning as “drug dispersed therein.” (See Discussion, supra, 

Part III.B.) 

 J. “Swells in an unrestricted manner along both such axes” 

The term “swells in an unrestricted manner along both such axes” is found in the ’962 

Patent. Plaintiffs argue that this term can be given its plain and ordinary meaning, but 

alternatively propose that the term means “imbibition of fluid causes an increase in volume of 

the matrix, wherein the relative length of both axes after imbibition of fluid is substantially the 

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same as the relative dimensions of the original matrix.” Defendants’ construction of the term is 

“no component of the dosage form hinders swelling of the matrix in any dimension (i.e. prevents 

completely or partially the matrix from swelling).” 

 For the reasons set forth during the Markman hearing, (see Markman Hearing Tr. 53:2-

22), the Court finds that this term does not require construction. 

K. “Said matrix has a shape which when projected onto a plane” and “said 

 matrix being non-circular in shape and having a first and second orthogonal 

 axes of unequal length” 

 Both terms appear in the ’962 Patent. Plaintiffs contend both terms can be given their 

plain and ordinary meaning. Defendants define “said matrix has a shape which when projected 

onto a plane” to mean “the largest planar projection of the tablet.” Defendants construe the term 

“said matrix being non-circular in shape and having a first and second orthogonal axes of 

unequal length” to mean “the largest planar projection of the shape has a first and second 

orthogonal axes of unequal length.” 

 The main dispute concerns Defendants’ use of the word “largest” to modify “planar 

projection.” The claim in which these terms appear states in part: 

A controlled-release oral drug dosage form . . . said dosage form 

comprising a solid monolithic matrix with said drug contained 

therein, said matrix being non-circular in shape and having a first 

and second orthogonal axes of unequal length . . . wherein said 

matrix has a shape which when projected on to a plane, is either an 

oval or a parallelogram. 

(’962 Patent, Claim 1.) The specification explains that the shape of the dosage form is important 

because certain shapes prevent the dosage form from escaping through the pylorus. (Id. 3:22-

28.) “The shape that achieves this result is a non-circular and non-spherical shape which, when 

projected onto a planar surface, has two orthogonal axes of different lengths[.]“ (Id. 3:28-31.) 

The specification lists possible shapes for the dosage form—“oval, triangle, almond, peanut, 

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‘bow tie,’ parallelogram, trapezoidal, pentagonal, and hexagonal, provided . . . that the largest 

planar projection of the shape has at least two orthogonal dimensions, one being larger than the 

other.” (Id. 4:10-12.) 

 Defendants thus argue that the “planar projection” referred to in Claim 1 of the ’962 

Patent must be the “largest planar projection.” However, Defendants’ definition would read out 

several embodiments. Claim 1 requires that the matrix have “a shape which when projected onto 

a plane, is either an oval or a parallelogram.” (Id., 11:24-25.) But the largest planar projections 

of several of the shapes listed in the specification are neither an oval nor a parallelogram. For 

example, the largest planar projection of a trapezoid is neither an oval nor parallelogram, as 

illustrated below. 

 

 

 

The same is true for a triangle, pentagram, bow tie, or hexagon. Therefore, Defendants’ 

construction thus reads out embodiments described in the specification and complicates a term 

that can be given its plain and ordinary meaning. The Court agrees with Plaintiffs that these 

terms do not require construction. 

L. “An oval” 

 The term “an oval” appears in the ’962 Patent. Plaintiffs’ proposed construction is “any 

curve that is closed and concave towards the center wherein the geometric form bounded by the 

closed curve has first and second orthogonal axes of unequal length.” Defendants define the 

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term to mean “a shape that has a curve that is closed and concave toward the center and has an 

overall non-circular shape from all dimensions.” 

 In the context of Claim 1, where the term appears, “an oval” is two-dimensional since the 

oval is a projection onto a plane. (’962 Patent, 11:24-25.) It therefore is improper for 

Defendants to define the term in a three-dimensional context because “an oval,” as it is used in 

the claim, is only two-dimensional rather than three-dimensional. (See Markman Hearing Tr. 

74:12-18.) Apart from this reference to “all dimensions,” there is no material difference between 

the two proposed constructions since both use the language a “curve that is closed and concave 

towards the center.” In addition, there can be no serious dispute that the shapes contemplated by 

the ’962 Patent, including an oval, require axes of unequal length. (See, e.g., ’962 Patent, Claim 

1; Claims 2-9 (requiring the “shorter” axis to be of a particular length).) 

 Finally, the construction proposed by Plaintiffs was the construction agreed upon in 

Lupin. See 2011 U.S. Dist. LEIXS 52839, at *42-43. Plaintiffs assert that, for the sake of 

consistency, the Court should adopt this construction. The Court agrees, Markman, 517 U.S. at 

391, and will define “an oval” to mean “any curve that is closed and concave towards the center 

wherein the geometric form bounded by the closed curve has a first and second orthogonal axes 

of unequal length.” 

M. “First solid polymeric matrix” 

 The term “first solid polymeric matrix” is from the ’667 Patent. Plaintiffs propose that 

this term can be given its plain and ordinary meaning. Defendants define the term to mean “a 

solid polymeric formulation containing a sufficient amount of a suitable polymer or polymer mix 

to provide extended, controlled release of a drug dispersed throughout the formulation.” 

Defendants explain, and the Court agrees, that this term is not materially different than the term 

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“polymeric matrix” appearing in the ’475 and ’280 Patents. The only difference is that the 

polymeric matrix of the ’667 Patent is in a “dual-matrix configuration, one matrix forming a core 

of polymeric material in which the drug is dispersed and the other matrix forming a casing that 

surrounds and fully encases the core, the casing being of polymeric material.” (’667 Patent 7:8-

10.) There is, for this reason, a “first” and “second” polymeric matrix required in the ’667 

Patent, (id. 21:41-41, 43), but there is no difference in the “polymeric matrix” among the ’667, 

’475, and ’280 Patents. 

 Consequently, the Court will apply the same reasoning to “first solid polymeric matrix” 

here as it did for “polymeric matrix” above. (See Discussion, supra, Part III.A.) 

Specifically, Defendants’ proposed construction uses language that is unhelpful in furthering the 

understanding of term and that repeats elements already in the claim language. (See ’667 Patent, 

21:36-41.) However, it is not necessary to define the term this way because it would render the 

claim language redundant and more confusing than the term itself. The Court will therefore 

define “first solid polymeric matrix” to mean “a first medium comprising polymer.” 

N. “A core comprising a first solid polymeric matrix with said drug dispersed 

 therein” 

 This term is found in the ’667 patent. Plaintiffs propose that the term means “a core 

comprising a first medium comprising polymeric materials that surrounds drug particles.” 

Defendants define the term to mean “the core of a drug dosage form comprising a drug dispersed 

throughout a first solid polymeric matrix.” 

 The dispute between the parties is whether “drug dispersed therein” means that the drug 

is located “throughout” the matrix or whether the matrix simply “surrounds” the drug. Although 

the Court has resolved the dispute over the meaning of “drug dispersed therein,” as it appears in 

the ’475 and ’280 Patents, (see, Discussion, supra, Part III.B.), the claim term “a core comprising 

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a first solid polymeric matrix with said drug dispersed therein” is in a different patent—the ’667 

Patent. Still, the parties advance the same arguments. In particular, Plaintiffs argue that 

Defendants’ construction excludes embodiments where the drug is localized in the dosage form, 

the drug is a core, or the drug is in clusters. 

 In advancing this argument, Plaintiffs essentially suggest that the drug may be a core, 

within the first polymeric matrix core, within the polymeric matrix shell. But the ’667 Patent 

forecloses this possibility because the ’667 Patent contemplates a dual-matrix configuration 

rather than a triple configuration. The specification explains the invention is “a dual-matrix 

configuration, one matrix forming a core of polymeric material in which drug is dispersed and 

the other matrix forming a casing that surrounds fully and encases the core . . . , the shell and 

core being configured such that the drug contained in the core is released from the dosage form 

by diffusion through the shell.” (’667 Patent 7:9-17.) Consequently, the ’667 Patent does not 

provide for a drug to be dispersed in the dosage form such that the drug must first diffuse out of 

its own core, second out of the polymeric matrix core, and third out of the polymeric matrix 

shell. In fact, this would be contrary to the required “zero-order drug release,” which means a 

constant drug release. (’667 Patent, 7:3-6.) 

 Moreover, the ’667 Patent does not recite an embodiment requiring a drug-impregnated 

matrix, but this embodiment was Plaintiffs’ justification, with regard to the ’475 and ’280 

Patents, for disagreeing with the word “throughout.” In fact, all examples listed in the ’667 

Patent disclose dosage forms in which the core was prepared by “mixing together” or “blending” 

the drug and polymer or polymer mix. (See, e.g., ’667 Patent, 13:46-50; 18:64-67.) 

 In addition, the Court is satisfied that Defendants’ use of “throughout” would not exclude 

embodiments where the drug dispersed in the polymeric matrix core is dispersed unevenly. 

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Defendants’ construction does not require that the drug be incorporated homogenously or evenly 

throughout a first solid polymeric matrix. Nor would the specification support such a 

construction. The Court will therefore construe “a core comprising a first solid polymeric matrix 

with said drug dispersed therein” to mean “the core of a drug dosage form comprising a drug 

dispersed throughout a first solid polymeric matrix.” 

O. “A second solid polymeric matrix that swells upon imbibition of water to a 

 size large enough to promote retention in the stomach while the stomach is in 

 the fed mode” 

 

This term is found in the ’667 Patent. Plaintiffs assert that the term does not require 

construction, but they alternatively suggest it should be construed to mean “a second medium 

comprising polymeric materials which increases in size such that when the dosage form is 

introduced into the stomach in the fed mode, the dosage form remains in the stomach for several 

hours.” Defendants define the term to mean “a second, solid polymeric formulation comprised 

of a water-swellable polymer that surrounds and fully encases the core, is of a sufficient 

thickness and strength that it is not disrupted by the swelling and remains intact and of a size 

large enough to promote gastric retention; the ‘shell.’” 

 Except for the word “second,” the Court has already construed this term as it appears in 

the ’475 Patent, and there is no reason to depart from that construction. The claim language is 

the same between the two patents, (cf. ’667 Patent, 21:43-45, with ’475 Patent, 17:50:53), as are 

the specifications’ disclosures with respect to this aspect of both inventions, (see ’667 Patent, 

8:19-23; ’475 Patent, 7:54-58). The Court will therefore construe the term “a second solid 

polymeric matrix that swells upon imbibition of water to a size large enough to promote 

retention in the stomach while the stomach is in the fed mode” to mean “a second solid 

polymeric matrix which increases in size due to the ingress of water such that when the dosage 

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form is introduced into the stomach in the fed mode, the dosage form remains in the stomach for 

several hours.” 

P. “Hydroxyalkyl-substituted cellulose” 

The term “hydroxyalkyl-substituted cellulose” appears in the ’667 Patent. Plaintiffs 

believe the term does not require construction because the term has a plain and ordinary meaning 

to those skilled in the art. Defendants define the term to mean “a cellulose derivative having the 

structure 

which dissolves in the GI tract in a predictably delayed manner wherein at least one R has a free 

hydroxyl group and is represented by –(AO)mH wherein A is a straight chain or branched alkyl.” 

 This term appears in the ’667 Patent only once. Claim 1 requires that the “second 

polymeric matrix comprise a polymer independently selected from the group consisting of 

poly(ethylene oxide), a cross-linked polyacrylic acid, and a hydroxyalkyl-substituted cellulose.” 

(’667 Patent, 21:61-65.) While the specification does not use the term “hydroxyalkylsubstituted cellulose” it lists as examples of “suitable “cellulose polymers and their derivatives,” 

which include hydroxyalkyl-substituted celluloses such as “hydroxymethyl cellulose, 

hydroxyethyl cellulose, hydroxypropyl cellulose, [and] hydroxypropylmethyl cellulose.” (’667 

Patent, 8:31-35.) Further, the specification explains that “[p]referred cellulosic polymers are 

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alkyl-substituted cellulosic polymers that ultimately dissolve in the [gastrointestinal] tract in a 

predictably delayed manner.” (’667 Patent, 8:62-64.) 

 At the very least, the Court cannot read into the term the phrase “dissolves in the GI tract 

in a predictably delayed manner” since this is from a preferred embodiment. The patent 

expressly states that “preferred” cellulose polymers are those that are alkyl-substituted and 

ultimately dissolve in the gastrointestinal tract in a predictably delayed manner. (Id. 8:63-65.) 

Defendants offer no basis for including this phrase in their construction, other than that the 

phrase appears in the specification. However, Defendants cannot lift a characteristic from a 

preferred embodiment and insert into the claim. Seachange Int'l, 413 F.3d at 1377. 

 As to Defendants’ proposed chemical structure and formula for “hydroxyalkylsubstituted cellulose,” the parties offer vastly different expert opinions. “It is permissible, and 

often necessary, to receive expert evidence to ascertain the meaning of a technical or scientific 

term or term of art so that the court may be aided in understanding . . . what [the instruments] 

actually say.” Markman, 52 F.3d at 981 (quoting U.S. Indus. Chems., Inc. v. Carbide & Carbon 

Chems. Corp., 315 U.S. 668, 678 (1942)). Plaintiffs’ expert, Dr. Hopfenberg, states in his expert 

report that in his opinion, the term does not need construction because a person of ordinary skill 

in the art would readily understand the meaning of “hydroxyalkyl-substituted cellulose.” (See

Hopfenberg Decl. § 145.) 

 Defendants’ expert, Dr. Umesh Banakar, does not expressly disagree that a person of 

ordinary skill in the art would readily understand the term. Instead, he responds to deposition 

testimony given by Dr. Hopfenberg, in which Dr. Hopfenberg discounts Defendants’ proposed 

construction. Dr. Banakar and Dr. Hopfenberg do agree on two things. Both recognize the 

structure in Defendants’ construction as the basic structure for cellulose, where the “Rs” are 

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hydrogens making the “ROs” hydroxyl groups (one hydrogen + one oxygen) attached to the 

glucose backbone (appearing in Defendants’ construction as the repeating hexagon shape). (See

Banakar Decl. ¶ 24, DE 53-1; Hopfenberg Dep. 256:2-4, 257:8-16.) Dr. Banakar and Dr. 

Hopfenberg both explain that all cellulose derivatives have a hydroxyl group attacked to the 

glucose backbone. 

 What is disputed, however, is what the “Rs” stand for in the hydroxyalkyl-substituted 

cellulose. In particular, the experts disagree as to whether the glucose backbone must have at 

least one hydroxyl group in addition to the straight chain or branched alkyl group, or whether the 

hydroxyl and the straight chain or branched alkyl are together off of the glucose backbone. Dr. 

Hopfenberg states that the “R” can either be a hydroxyl group or straight chain or branched alkyl 

group, but not both. (Hopfenberg Dep. 251:7-9 (“It’s incorrect to say R has a free hydroxyl 

group. R is either a hydrogen or it’s an alkyl group.”).) But Dr. Banakar states that a person 

skilled in the art “would understand that a hydroxyalkyl-substituted cellulose [] has an R group 

that has a straight chain or branched alkyl that has a free hydroxyl group,” where “–(AO)mH 

represents a straight chain or branched alkyl with a hydroxyl group,” and where “there will be 

the same number of hydroxyl groups as the number for ‘m.’” (Banakar Decl. ¶ 24.) 

Accordingly, Dr. Banakar supports the view that requires the hydroxyl and straight chain or 

branched alkyl to be together off of the glucose backbone. And it is Dr. Banakar’s view that is 

described in Defendants’ construction. 

 In support of their definition, Defendants point to the structure of hydroxypropyl 

methylcellulose (one of the ’667 Patent’s preferred alkyl-substituted celluloses) as it is detailed 

in an article entitled “Modulation of drug release from hydrophilic matrices.” (See Defs.’ Ex. 13 

to Bogad Decl. at 3; DE 47-14.) The article illustrates the general structure of cellulose ether, 

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explains that “the R-group can be a single or a combination of substituents, and that 

hydroxypropyl methylcellulose “contains methoxyl (CH3-O-) and hydroxypropoxyl 

(CH3CHOHCH2-O-) substituents.” (Id. at 2-3.) 

 However, the article’s explanation of the structure of hydroxypropyl methylcellulose is 

not consistent with Defendants’ construction. Even if the hydroxypropyl group fits in the –

(AO)mH formula, Defendants’ construction would not provide at all for the methyl group. 

Further, if the Defendants’ construction requires the methyl group to also fit in the –(AO)mH 

formula, it is wrong because the methyl group does not have a free hydroxyl group. Nor does 

Defendants’ definition explain what atoms and/or groups will replace the “Rs” in the chemical 

structure not containing an –(AO)mH. 

 Ultimately, the Court agrees with Dr. Hopfenberg that Defendants’ construction is 

confusing, incomplete, and would not serve to aid the jury in understanding the meaning of 

“hydroxyalkyl-substituted cellulose.” Again, Defendants attempt to complicate a term, whose 

scope does not appear to be genuinely disputed and that has plain and ordinary meaning to a 

person of ordinary skill in the art. Therefore, the Court finds that “hydroxyalkyl-substituted 

cellulose” does not require construction. 

Q. “Curing the coated oral dosage form at a temperature of at least 55° C” 

 This term appears in the ’987 Patent. Plaintiffs assert that the term does not need 

construction. Defendants propose the term means “the coated oral dosage form is raised to a 

temperature of at least 55° C.” The dispute over this term focuses on whether the dosage form 

must be cured at 55° C or whether the dosage form’s internal temperature must reach 55° C. 

 The claim is itself sufficient to resolve this dispute because the language requires “curing 

. . . at a temperature of at least 55° C to form the stable controlled release monolithic coating.” 

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(’987 Patent, 25:1-3; 26:3-5 (emphasis added).) It does not require that the oral dosage form be 

cured “to” a temperature of at least 55° C. If there was ever any doubt, however, the 

specification settles the issue: 

During the coating process, the product temperature range is 

maintained between about 25° C to about 40° C for about 3-5 

minutes at a low pan speed and low air flow . . . . The coated tablet 

cores are placed onto a tray and cured (post coating thermal 

treatment) in an electrical or steam oven at a temperature above the 

temperature of the melting point of polyethylene glycol or 

derivative thereof [55° C]. . . The curing time is preferably about 2 

to about 7 hours. The cured coated tablets are subsequently cooled 

to room temperature. 

(’987 Patent, 10:37-53.) Accordingly, it is clear that the patentees distinguished between tablets 

being cured at a certain temperature and tablets being heated or cooled to a certain temperature. 

 The 55° C temperature requirement derives from the melting point of poly glycol. “The 

coat formulation also [comprises] a poly gycol with a melting point of greater than 55°C . . . or a 

suitable polyglycol derivative[] having a melting point of at least 55 deg C.” Accordingly, 

Defendants argue that the dosage form itself must be raised to a temperature of at least 55° C so 

that the poly glycol coating will melt. But the ’987 Patent never calls for the poly glycol coating 

to melt; rather, the purpose of the curing is to “form the stable controlled release monolithic 

coating.” (’987 Patent, 25:1-3.) 

 The embodiments disclosed in the ’987 patent further confirm that there is there no 

requirement that the coating melt. (See, e.g., ’978 Patent, 13:21-23 (“After application of the 

coating the tablets were cured in an oven at 62±2° C for about 2 hours. This temperature is 

above the melting temperature of the polyethylene glycol 8000.”).) Defendants simply assume 

that because the patent defines the curing temperature with reference to a melting point, the 

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coating must actually melt. But that assumption finds no support in the intrinsic evidence. 

Therefore, the Court agrees with Plaintiffs that this term requires no construction. 

 

IV. CONCLUSION 

 For the reasons stated herein and for the reasons set forth on the record during the 

Markman hearing, the Court construes the terms of United States Patent No. 6,340,475, United 

States Patent No. 6,635,280, United States Patent No. 6,488,962, United States Patent No. 

7,736,667, and United States Patent No. 7,780,987 as announced in the Order accompanying this 

Memorandum Opinion. 

Dated: August 3, 2012 

 /s/ JOEL A. PISANO 

 United States District Judge 

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