UNITED STATES DISTRICT COURT 

DISTRICT OF NEW JERSEY 

––––––––––––––––––––––––––––––––––––––– 

DEPOMED, INC., and VALEANT 

INTERNATIONAL (BARBADOS) SRL, 

 Plaintiffs, 

v. 

SUN PHARMA GLOBAL FZE, SUN 

PHARMACEUTICAL INDUSTRIES LTD., and 

SUN PHARMACEUTICAL INDUSTRIES 

INC., 

 Defendants. 

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: 

: 

Honorable Joel A. Pisano, U.S.D.J. 

Civil Action No. 11-CV-3553 (JAP) (TJB) 

––––––––––––––––––––––––––––––––––––––– 

SUN PHARMA GLOBAL FZE, SUN PHARMACEUTICAL 

INDUSTRIES LTD., AND SUN PHARMACEUTICAL 

INDUSTRIES, INC.’S RESPONSIVE CLAIM CONSTRUCTION BRIEF 

OF COUNSEL: 

James F. Hurst 

WINSTON & STRAWN LLP 

35 W. Wacker Drive 

Chicago, IL 60601 

(312) 558-5600 

Charles B. Klein 

John K. Hsu 

WINSTON & STRAWN LLP 

1700 K Street, NW 

Washington, DC 20006 

(202) 282-5000

WINSTON & STRAWN LLP 

The Legal Center 

One Riverfront Plaza, Suite 730 

Newark, NJ 07102 

(973) 848-7676 

James S. Richter 

Melissa Steedle Bogad 

Attorneys for Defendants Sun Pharma Global FZE, Sun Pharmaceutical Industries, Ltd., and 

Sun Pharmaceutical Industries, Inc.

 

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TABLE OF CONTENTS 

Page

INTRODUCTION ...........................................................................................................................1 

ARGUMENT ...................................................................................................................................2 

I. Disputed Terms In The ’475 and ’280 Patents ....................................................................2 

A. Terms Describing The Polymeric Matrix ................................................................2 

1. “[P]olymeric matrix” (’475 and ’280 patents) .............................................3 

2. [A] solid polymeric matrix with drug dispersed therein (’475 

patent) ..........................................................................................................5 

3. 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 (’475 Patent) ...........................................8 

4. 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 said/the fed mode (’280 Patent) ................9 

B. Terms Requiring The Water-Swollen Polymeric Matrix To Control 

Release Of The Drug .............................................................................................10 

C. Terms Addressing “All” And “Substantially All” .................................................12 

D. Terms Addressing The Required Drug-To-Polymer Ratios ..................................14 

II. Disputed Terms In The ’667 Patent ...................................................................................15 

A. Terms Relating To First Solid Polymeric Matrix ..................................................15 

B. 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 fed mode ............................................................................................................16 

C. Hydroxyalkyl-substituted cellulose .......................................................................17 

III. Disputed Terms In The ’962 Patent ...................................................................................18 

A. Terms Requiring A Matrix Capable Of Swelling In An Unrestricted 

Manner ...................................................................................................................18 

B. Terms Addressing The Non-Circular Shape Of The Matrix .................................21 

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C. An oval ...................................................................................................................24 

IV. Disputed Term In The ’987 Patent: Curing The Coated Oral Dosage Form At A 

Temperature Of At Least 55° C .........................................................................................27 

CONCLUSION ..............................................................................................................................30 

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TABLE OF AUTHORITIES 

Page(s) 

CASES

Advanced Fiber Tech. (AFT) Trust v. J&L Fiber Servs., Inc., 

-- F.3d --, 2012 WL 1088698 (Fed. Cir. Apr. 3, 2012) ......................................................14, 26 

Becton Dickinson and Co. v. Tyco Healthcare Group, LP, 

616 F.3d 1249 (Fed. Cir. 2010)................................................................................................19 

Bicon, Inc. v. Straumann Co., 

441 F.3d 945 (Fed. Cir. 2006)..................................................................................................10 

Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc., 

334 F.3d 1294 (Fed. Cir. 2003)................................................................................................14 

Cordis v. Medtronic, 

511 F.3d 1157 (Fed. Cir. 2008)..................................................................................................4 

Exxon Chem. Patents Inc. v. Lubrizol. Corp., 

64 F.3d 1553 (Fed. Cir. 1995)....................................................................................................2 

Phillips v. AWH Corp., 

415 F.3d 1303 (Fed. Cir. 2005) (en banc) ................................................................1, 15, 26, 29 

PPG Indus. v. Guardian Indus. Corp., 

156 F.3d 1351 (Fed. Cir. 1998)..........................................................................................19, 21 

Southwall Tech., Inc. v. Cardinal IG Co., 

54 F.3d 1570 (Fed. Cir. 1995)..................................................................................................20 

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INTRODUCTION 

In its opening brief, Sun relied on the intrinsic record and common sense to support its 

constructions. Plaintiffs, in contrast, turned to a 70-page, self-serving expert declaration. The 

Federal Circuit in Phillips held that such “conclusory, unsupported assertions by experts . . . are 

not useful to a court.” Phillips v. AWH Corp., 415 F.3d 1303, 1318 (Fed. Cir. 2005) (en banc). 

This case provides a perfect example of why the Federal Circuit was right.

When confronted with the intrinsic record at deposition, Plaintiffs’ expert agreed with 

Sun on many of the disputed terms. And, remarkably, he rejected Plaintiffs’ interpretation of one 

claim term—“solid polymeric matrix with drug dispersed therein.” When asked about Plaintiffs’ 

purported depiction of that term in their brief (Fig. 1), Plaintiffs’ own expert candidly replied: “I 

just don’t think this has anything to do with what the patent is about.” Ex. 17 (Hopfenberg Dep.) 

at 140:18-19 (emphasis added).1

 

The same could be said for Plaintiffs’ other constructions. For example, Plaintiffs are 

attempting to argue that Sun’s circular tablet infringes the ’962 patent, which requires a noncircular shape. Sun’s position is that the non-circular limitation refers to the largest planar 

projection of the matrix (i.e., the face of the tablet), as opposed to the thickness of the tablet. In 

response, Plaintiffs repeatedly represented to the Court: “There is no support in the intrinsic 

evidence for such a limitation, and Sun does not cite to anything to support the ‘largest’ 

limitation.” Pls. Br. 34 (emphasis added); see also id. at 36. But this argument is frivolous. As 

Sun previously brought to Plaintiffs’ attention, the specification expressly refers to “the largest

planar projection of the shape” of the matrix. Ex. 7 (’962 patent) col. 4, ll. 8-15 (emphasis 

added); Dkt. 43-1 at 55 & 57-58 of 59. 

 

1

 Exhibits 17 through 20 are attached to the May 4, 2012 Declaration of Melissa Steedle Bogad, 

filed herewith. Exhibits 1 through 16 were filed with Sun’s Opening Claim Construction Brief.

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These are just two examples of how Plaintiffs are attempting to mislead the Court into 

adopting constructions necessary to support an infringement claim. Unfortunately for Plaintiffs, 

the intrinsic record does not support their constructions. As one Federal Circuit judge aptly put 

it, constructions are not a “nose of wax to be pushed and shoved into a form that pleases and that 

produces a particular result a court may desire.” Exxon Chem. Patents Inc. v. Lubrizol Corp., 64 

F.3d 1553, 1563 (Fed. Cir. 1995) (Plager, J., concurring). Instead, this Court should be true to 

the intrinsic record and adopt Sun’s constructions. 

ARGUMENT 

The parties have asked the Court to dispute a relatively large number of claim terms. But 

Sun has grouped these terms, thus isolating a discrete number of issues for this Court to resolve.

I. Disputed Terms In The ’475 and ’280 Patents2

A. Terms Describing The Polymeric Matrix 

The claims and the specifications of the patents clearly require a dosage form with a 

specific type of polymeric matrix that: 

 contains a sufficient amount of a suitable polymer or polymer mix to render the 

patented invention operable; 

 has the drug dispersed throughout the matrix; 

 is able to swell due to the ingress of water; and 

 allows for unrestricted swelling. 

Plaintiffs’ expert (Dr. Hopfenberg) conceded in his declaration and at his deposition that 

the claimed polymeric matrix has these “special” properties. Ex. 18 (Hopfenberg Decl.) ¶¶ 55-

60; Ex. 17 at 38:13-25; 123:15-124:13; 127:7-21. Yet, only Sun’s constructions account for 

 

2

 Citations for these two patents will refer to the ’475 patent unless otherwise specified because 

the disclosure in the two patents are identical with the exception of a non-substantive addition in 

the ’280 Patent. 

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them. Plaintiffs’ constructions, in contrast, are overbroad and otherwise inconsistent with the 

intrinsic evidence.

1. “[P]olymeric matrix” (’475 and ’280 Patents) 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

A 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 

A surrounding medium comprising polymer 

There is no dispute that this “polymeric matrix” can be comprised of a single polymer or 

polymer mix. Ex. 17 at 112:16-21. Nor is there any dispute that the purpose of this “polymeric 

matrix” is to help provide extended, controlled release of a drug. Id. at 128:22-129:10. To this 

end, as Plaintiffs’ expert conceded, the patents require a “special” type of polymeric matrix to 

render the claims operable. Ex. 17 at 86:8-87:7; Ex. 18 ¶ 55. In particular, the “polymeric 

matrix” described in the patents contains the following two limitations captured only by Sun’s 

construction: 

First, as the specification makes clear, the claimed polymeric matrix must be made of a 

suitable polymer or polymer mix—e.g., one that will allow the matrix to be water swellable and 

thus provide extended, controlled release of a drug. Ex. 2, col. 5, l. 66–col. 6, l. 3; col. 7, ll. 54-

58. Plaintiffs’ expert readily agreed with this limitation. When asked whether “some polymers 

would be unsuitable for the systems described in the Patents-In-Suit?” he replied “Certainly.” 

Ex. 17 at 123:18-20 (emphasis added). This concession, alone, confirms that Plaintiffs’ 

construction for “polymeric matrix” is overbroad because it includes polymers “unsuitable” for 

the inventions. A person of ordinary skill in the art would understand that the “polymeric 

matrix” at issue in the patents does not capture any surrounding medium comprising polymer, as 

Plaintiffs would have the Court believe. See id.

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Second, the specification also makes clear that the matrix required by the patents must 

have a sufficient amount of the suitable polymer to render the patented invention operable. Ex. 2 

col. 9, ll. 22-41. Again, Plaintiffs’ expert agreed with this limitation. When asked whether one 

would “need enough polymers” to satisfy the drug-to-polymer ratios required by the claims, he 

responded: “That’s my understanding.” Ex. 17 at 127:19-21. 

Plaintiffs nonetheless criticize Sun’s construction as being “front-loaded,” arguing that 

Sun’s construction unnecessarily repeats other claim limitations. But Sun’s construction does 

not result in any redundancies. Instead, unlike Plaintiffs’ construction, Sun’s construction makes 

it clear that the applicants used the term “polymeric matrix” to mean a “special” type of 

polymeric formulation necessary to make the patented invention operable—i.e., a polymeric 

matrix that contains a sufficient amount of a suitable polymer or polymer mix to provide 

extended, controlled release of a drug dispersed throughout the formulation (see next section for 

discussion of “throughout”). The other claim limitations are more specific—e.g., requiring that 

the matrix be water-swellable and satisfy certain drug-to-polymer ratios. 

Plaintiffs also misconstrue Sun’s construction as suggesting that a “polymeric matrix” 

itself should be defined to include the drug. But that is not what Sun is saying. Instead, its 

construction requires a sufficient amount of a suitable polymer such that a drug can be dispersed 

throughout the formulation. As a plain reading of the specification makes clear, if the 

“polymeric matrix” were incapable of having a drug dispersed throughout the formulation (or, to 

use Plaintiffs’ term, “medium”), such matrix would not satisfy the limitations of the claim 

language—thus rendering the patent claims inoperable. Ex. 2, col. 5, l. 57–col. 6, l. 17; see also 

Cordis v. Medtronic, 511 F.3d 1157, 1174 (Fed. Cir. 2008) (“[A] construction that renders the 

claimed invention inoperable should be viewed with extreme skepticism.”). To avoid any 

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confusion, however, Sun would be willing to clarify its construction to read: “A polymeric 

medium containing a sufficient amount of a suitable polymer or polymer mix such that this 

medium can provide extended, controlled release of a drug dispersed throughout the 

formulation.” 

2. [A] solid polymeric matrix with drug dispersed therein (’475 Patent) 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

A solid polymeric matrix with the drug 

dispersed throughout the matrix 

A medium comprising polymer that surrounds 

drug particles 

One or more polymers forming a solid polymeric matrix with said drug 

incorporated therein (’280 Patent) 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

The drug is dispersed throughout a solid 

polymeric matrix formed by one or more 

polymers; see also the constructions for 

“polymeric matrix” and “polymeric matrix 

with drug dispersed therein.” 

One or more polymeric materials forming a 

medium that surrounds drug particles; see 

construction for “polymeric matrix with drug 

dispersed therein” 

Plaintiffs’ expert confirmed Sun’s position that the terms “dispersed therein” and 

“incorporated therein” both mean “dispersed throughout.” He also flatly rejected Plaintiffs’ 

reading of this term. 

First, Plaintiffs’ expert did not dispute that the plain and ordinary meaning of 

“disperse”—as defined by a dictionary he himself cited in his declaration—is “[t]o distribute (as 

fine particles) more or less evenly throughout a medium.” Ex. 17 at 132:25-133:12; 136:8-17 

(emphasis added); see also Ex. 18 ¶ 119. This is precisely how the prior art refers to dispersing a 

drug in a polymeric matrix: “[t]he drug is assumed to be homogeneously dissolved and 

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distributed throughout the polymer” such that “the rate of drug diffusion through the waterswollen polymer is the rate-limiting step.” Ex. 3 at 244 (emphasis added).3

 

Second, Plaintiffs’ expert depicted this claim term as showing the drug dispersed 

throughout the matrix. As he put it: “When I say ‘drug dispersed in a polymeric matrix,’ if we 

believe a picture is worth a thousand words, I’m directed to Figure 2.” Ex. 17 at 38:19-23. He 

further explained that “Figure 4 is really the ultimate picture of what this invention is about.” Id. 

at 136:19-21. As shown below, Dr. Hopfenberg’s Figures 2 and 4 clearly show a drug dispersed 

throughout the matrix: 

Ex. 18 at 25-26. 

Third, Plaintiffs’ expert equated the terms “dispersed therein” and “incorporating 

therein,” agreeing that “‘incorporated’ means the same thing as ‘dispersed’ in terms of the 

patent.” Ex. 17 at 103:2-15, 103:25-104:8. In other words, both “dispersed therein” and 

“incorporated therein” mean “dispersed throughout”—consistent with Sun’s constructions. 

While the evidence above is sufficient to rule in Sun’s favor, the Court should take 

special note of Dr. Hopfenberg’s candid testimony that Plaintiffs have mischaracterized their 

 

3

 Plaintiffs’ expert disputed that the drug necessarily is homogenously distributed throughout the 

polymer. Ex. 17 at 65:19-66:8. But Sun’s construction does not require a homogenous 

distribution throughout the polymer. 

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patents. In their brief, Plaintiffs represented to the Court that Sun’s construction excludes a 

“preferred embodiment[]”—i.e., “an embodiment where the drug is localized in the dosage 

form.” Pls. Br. 13. Citing a reference in the specification saying that the polymer is 

“impregnated” with the drug, Plaintiffs argued that this “impregnated” matrix is “like the yolk of 

an egg being surrounded by the ‘egg white.’” Id. at 16. They went so far as to create a graphic 

(Fig. 1) to illustrate this purported “preferred embodiment”: 

Id. at 14, 16. 

But Plaintiffs’ own expert testified that he has no “sympathy with the drawing”—i.e., 

Plaintiffs’ Figure 1—because “I just don’t think this has anything to do with what the patent is 

about”: 

Q. How would—if you know, how would one go about formulating a drug 

dispersed in a polymeric matrix according to Figure 1 of Exhibit 8 [Plaintiffs’ 

Opening Claim Construction Brief]? 

A. . . . . I would never have proposed this because I think it’s ambiguous, and 

one is not enlightened by this. The only way I can understand this in the context 

of the patent at issue is we’re looking at a small microcosm of Figure 4 [of his 

declaration] focusing on a single particle and the – and the matrix that’s around it. 

So I just don’t think this has anything to do with what the patent is about. If 

you take it literally, it’s just a—a small element of that matrix. 

*** 

Q. So, you would not describe the polymeric matrix in the Patents-in-Suit as like 

a yolk of an egg being surrounded by the egg white? Is that fair? 

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A. The only place I think that does have relevance to the patents is if we were 

looking at a single particle and where the particle itself would be the yolk and 

arbitrarily defined amount of polymer around it would be the white. I—I—I am 

not in sympathy with the metaphor, nor am I in sympathy with the drawing. I’ll 

say no more.

Ex. 17 at 140:4-21; 141:6-19 (emphasis added) (objections to form omitted); see also id. at 

103:2-15; 108:12-20 (explaining that term “impregnated” essentially means “dispersed or 

incorporated”). Nothing more needs to be said. Plaintiffs have overreached according to their 

own expert, and their construction should be rejected for this reason alone. 

3. 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 (’475 Patent) 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

Due to the ingress of water into the 

polymeric matrix, that matrix increases the 

size of the dosage form such that when it is 

introduced into the stomach in the fed 

mode, the dosage form remains in the 

stomach for several hours 

The surrounding medium comprising polymer 

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 

Putting aside the parties’ disagreement with respect to “polymeric matrix,” the sole 

dispute with regard to this term is whether the phrase “due to the ingress of water into the 

polymeric matrix” should be part of the construction. It should be, as confirmed by the intrinsic 

record, Plaintiffs’ expert, and the claim construction ruling by another court. 

First, the phrase “due to the ingress of water” gives meaning to the words “swells upon 

imbibition of water” in the claim term. In fact, the specification uses this precise phrase when 

unequivocally describing the swelling of the matrix: 

The hydrophilicity and water swellability of these polymers cause the drugcontaining matrices to swell in size in the gastric cavity due to ingress of water in 

order to achieve a size that will be retained in the stomach when introduced 

during the fed mode. 

Ex. 2, col. 9, ll. 1-5 (emphasis added). 

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Second, Plaintiffs’ expert, once again, supports Sun’s construction. In his declaration, 

Dr. Hopfenberg described the polymeric matrix of the patents-in-suit as having “a special 

property of being able to absorb or imbibe water” to become a “water-induced” swollen matrix. 

Ex. 18 ¶ 55 (p. 25). He further testified that, although he was “giving away the store,” he has no 

objection to Sun’s construction: “I think the person of ordinary skill knows I have no objection 

with the notion that there would be an ingress of water.” Ex. 17 at 164:7-8, 20-22. 

Third, the court in the Depomed v. Lupin case construed this very term as: “[t]he 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.” Pls. Ex. 10 (Depomed v. Lupin Claim Construction 

Order) at 12 (emphasis added). In so ruling, the Lupin court noted that “[b]oth parties agree that 

because of the ingestion of water, the polymeric matrix increases to a size that causes the dosage 

form to remain in the stomach for some period of time.” Id. at 9 (emphasis added). Plaintiffs 

fail to explain why they changed positions. 

4. 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 said/the fed mode (’280 Patent) 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

Upon unrestricted swelling, the dosage form 

reaches a size larger than the diameter of the 

human pylorus in the fed mode, promoting 

extended retention of the dosage form in the 

stomach 

The polymeric matrix of the drug dosage form 

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 

The dispute here turns on whether this term requires a dosage form with “unrestricted 

swelling.” There is no denying this plain and ordinary reading of this claim term, which 

expressly says the “dosage form” is “swollen in a dimensionally unrestricted manner.” 

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In their brief, Plaintiffs rely on the previous claim constructions in the related Ivax and 

Lupin cases. But the courts in those cases left that phrase with no meaning. Those prior 

constructions thus carry no weight here. See Bicon, Inc. v. Straumann Co., 441 F.3d 945, 950-51 

(Fed. Cir. 2006) (claim limitations cannot be deemed “merely superfluous”). 

Finally, to the extent Plaintiffs quibble with the term “unrestricted swelling,” arguing that 

the patent refers to “dimensionally unrestricted swelling,” that is a distinction without a 

difference. Plaintiffs themselves refer to these phrases interchangeably. See Pls. Br. 32 

(“[T]hroughout the specification are descriptions that the dosage form swells in an unrestricted 

manner when it is placed in contact with water.”) (citing patent at col. 4, ll. 48-53, which says 

“dimensionally unrestricted manner”); compare Ex. 7 at col. 4, ll. 51-52 (“dimensionally 

unrestricted manner”) with id. at col. 11, ll. 19-20 (saying just “unrestricted manner”). In fact, 

Sun would have no objection to construing this term as “Upon dimensionally unrestricted 

swelling, the dosage form reaches a size larger than the diameter of the human pylorus in the fed 

mode, promoting extended retention of the dosage form in the stomach.” 

B. Terms Requiring The Water-Swollen Polymeric Matrix To Control Release 

Of The Drug 

With regard to the following two terms, only Sun’s construction properly includes 

“water-swollen” to characterize the polymeric matrix: 

Dissolution and diffusion (’475 and ’280 Patents) 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

Rapid dissolution of the drug, followed by 

slow diffusion of the drug out of the waterswollen polymeric matrix, such that the 

drug is released at a rate controlled by the 

rate of diffusion from such matrix 

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 controlled by the rate of diffusion 

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Releases said drug into gastric fluid by dissolution and diffusion of said drug 

out of said matrix [by said gastric fluid] (’475 and ’280 Patents) 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

The water-swollen polymeric matrix 

controls the dissolution and diffusion of the 

drug into gastric fluid. See also the 

constructions for “polymeric matrix,” 

“gastric fluid” and “dissolution and 

diffusion.” 

See constructions for “polymeric matrix”, 

“gastric fluid” and “dissolution and diffusion”; 

all other terms are the plain and ordinary 

meaning 

In fact, Sun’s point should not be controversial. First, the intrinsic evidence 

unambiguously says that the polymeric matrix must be water-swollen to release the drug. 

 The specification repeatedly states that the polymeric matrix be “water-swellable 

rather than merely hydrophilic, that has an erosion rate that is substantially slower 

than its swelling rate, and that releases the drug primarily by diffusion.” Ex. 2, col. 5, 

ll. 57-62 (emphasis added). 

 The claims themselves refer to a dosage form or polymeric matrix that “swells upon 

imbibition of water,” Ex. 2, claim 1, and becomes “swollen in a dimensionally 

unrestricted manner as a result of imbibition of water.” Ex. 5, claim 1; see also Exs. 

2 & 5, claims 34 (same, substituting gastric fluid for water). 

Second, Plaintiffs’ expert explained in his declaration that the imbibition of water into the 

claimed polymeric matrix “produces a swollen dosage form that (a) causes the dissolution and 

diffusion of the drug out of the matrix and (b) attains a size that retards the diffusional release of 

drug from the dosage form into the surrounding aqueous environment.” Ex. 18 ¶ 55 (emphasis 

added). At deposition, Plaintiffs’ expert confirmed that Sun’s construction is accurate: 

Q. Okay. And do you see in Sun’s proposed construction [for “dissolution and 

diffusion”], it reads: “Rapid dissolution of the drug, followed by slow diffusion of 

the drug out of the water-swollen polymeric matrix”? Do you see that? 

A. I do. 

Q. Do you agree that that’s an accurate description of dissolution and diffusion? 

MR. ANDRE: Objection to the form of the question. 

A. Yes, that’s accurate. 

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Ex. 17 at 171:20-172:6 (emphasis added). 

Plaintiffs’ expert also failed to support Plaintiffs’ position that “Nothing in the 

specification requires that the polymeric matrix be water-swollen first to effectuate dissolution 

and diffusion.” Pls. Br. 23. In his report, Dr. Hopfenberg said the precise opposite: “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.” Ex. 18 ¶ 77 (emphasis added); see also 

Ex. 17 at 76:15-77:15 (same). 

Third, even the extrinsic evidence says that a controlled release polymeric matrix releases 

the drug “through the water-swollen polymer.” Ex. 3 at 244 (emphasis added).4

C. Terms Addressing “All” And “Substantially All” 

For the following terms, only Sun’s constructions capture the plain and ordinary meaning 

of “all” (i.e., 100%) and “substantially all” (i.e., about 100%): 

Until all of said drug is released (’475 Patent) 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

Until all of the drug has been released into 

the gastric fluid 

Until the plateau of the dissolution profile 

characterizing drug release from the swollen 

dosage form is reached 

Until substantially all of said drug is released (’280 Patent) 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

Until about 100% of the drug has been 

released into gastric fluid 

At least 80% of the drug has been released after 

eight hours of immersion in gastric fluid 

 

4

 Plaintiffs cite the constructions by the Ivax and Lupin courts. But in both cases, the parties did 

not have a dispute on this issue. In fact, the Lupin court noted that “[t]he patent specification 

states that controlled 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[.]” Pls. Ex. 10 at 13. 

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Releases substantially all of said drug [within about eight hours] after such 

immersion (’475 and ’280 Patents) 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

About 100% of the drug has been released 

into gastric fluid 

At least 80% of the drug has been released after 

eight hours of immersion in gastric fluid 

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

drug is maintained in an acidic environment (’475 Patent) 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

Releasing about 100% of the drug in the 

stomach having a pH value of less than 7 

At least 80% of the drug has been released after 

eight hours of immersion in gastric fluid 

Plaintiffs do not dispute that the plain and ordinary meaning of “all” and “substantially 

all” are “100%” and “about 100%,” respectively. Instead, they rely solely on extrinsic 

evidence—i.e., two FDA Guidances for Industry—to contend that “all” and “substantially all” 

mean a value considerably less than 100%, even as low as 80%. But the ’475 and ’280 patents 

do not cite or refer to any FDA documents. 

In fact, the notion that the applicants implicitly were referring the reader to these FDA 

Guidances is a fantasy. Both Guidances were not published until September 1997—after the 

applicants filed their June 6, 1997, priority application for the ’475 and ’280 patents. 

 The applicants thus could not 

have had the FDA Guidances in mind when using the terms “all” and “substantially all.” 

Plaintiffs simply made this up. 

In fact, as explained in Sun’s Opening Brief, there is nothing in the patents suggesting 

anything other than that the plain and ordinary meaning of “all” and “substantially all” should 

apply. On the contrary, the intrinsic record draws a distinction between “substantially all of said 

drug” and “all of said drug,” thus confirming that “all” means what it says and nothing less. See 

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Ex. 2, claim 1; see also id. claim 34; id. col. 9, ll. 32-36. Also, Figure 4 of the patent shows that 

100% of the drug (metformin) is released after eight hours regardless of the type of polymeric 

matrix used in the formulation. Id. Fig. 4. 

Consequently, the Court should not turn to extrinsic evidence to vary the ordinary 

meanings of “all” and “substantially all.” Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc., 334 

F.3d 1294, 1298 (Fed. Cir. 2003) (“In the absence of an express intent to impart a novel meaning 

to the claim terms, the words are presumed to take on the ordinary and customary meanings 

attributed to them by those of ordinary skill in the art.”); see also Advanced Fiber Tech. (AFT) 

Trust v. J&L Fiber Servs., Inc., -- F.3d --, 2012 WL 1088698, at *7 (Fed. Cir. Apr. 3, 2012) 

(reversing because district court “reli[ed] on extrinsic evidence that contradicted the patent’s 

specification.”). 

D. Terms Addressing The Required Drug-To-Polymer Ratios 

There does not appear to be any dispute between the parties for the following terms: 

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 (’475 Patent) 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

A polymeric matrix at a drug to polymer 

weight ratio from 14.4:85.6 to 80.8:19.2 

A medium comprising polymer that surrounds 

drug particles at a drug to polymer weight ratio 

from 14.4:85.6 to 80.8:19.2 

At a weight ratio of drug to polymer of from 15:85 to 80:20 (’280 Patent) 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

The weight of the drug is 15 to 80% relative 

to the total weight of drug and polymer in 

the solid polymeric matrix 

Plain and ordinary meaning 

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At a weight ratio of drug to polymer of from 0.01:99.99 to 80:20 (’280 Patent) 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

The weight of the drug is .01% to 80% 

relative to the total weight of drug and 

polymer in the solid polymeric matrix 

Plain and ordinary meaning 

Plaintiffs’ expert conceded that Sun’s constructions are correct. Ex. 17 at 158:19-159:21; 

160:1-23. And Plaintiffs have never offered any different constructions. Yet, they have not 

agreed to Sun’s request that the parties deem these terms undisputed. Ex. 20 (4/26/12 Ltr. from 

John K. Hsu to Lisa Kobialka and email response from Lisa Kobialka). To be sure, Plaintiffs are 

inexplicably wasting the Court’s time by continuing to dispute these terms.5

II. Disputed Terms In The ’667 Patent 

A. Terms Relating To First Solid Polymeric Matrix 

The parties have construed the two terms below in a manner consistent with similar terms 

(“polymeric matrix” and “solid polymeric matrix with drug dispersed therein”) used in the ’475 

and ’280 patents: 

First solid polymeric matrix 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

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 

Plain and ordinary meaning 

 

5

 In agreeing that Sun’s construction is the plain and ordinary meaning, Dr. Hopfenberg also 

testified that the word “polymer” in these terms really means “polymeric matrix with all of the 

components included thereto.” Ex. 17, 160:8-17. But Plaintiffs never offered a special 

construction for the term “polymer.” And this after-the-fact testimony is contrary to Plaintiffs’ 

construction of “[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,” which draws a distinction between 

“polymeric matrix” and “polymer.” See Phillips, 415 F.3d at 1318 (rejecting usefulness of 

“conclusory, unsupported assertions by experts” in claim construction). 

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

therein 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

The core of a drug dosage form comprising a 

drug dispersed throughout a first solid 

polymeric matrix 

A core comprising a first medium comprising 

polymeric materials that surrounds drug 

particles 

As Plaintiffs’ expert explained: “I think the polymeric matrix, per se, is similar in both” 

patents. Ex. 17 at 242:10-22. Sun agrees. Thus, it incorporates by reference its arguments 

relating to “polymeric matrix” above and in its opening claim construction brief. 

B. 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 

fed mode 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

A second solid polymeric formulation 

comprised of a water-swellable polymer 

that surrounds and fully encases the core, is 

of 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” 

A second medium comprising polymeric 

materials which increase 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 

Only Sun’s construction sufficiently captures the following four limitations of this claim. 

First, Plaintiffs’ construction ignores “swells upon imbibition of water,” which Plaintiffs’ expert 

agrees must occur: 

Q. Okay. You agree that the shell swells when it’s placed in gastric fluid, 

though; right? 

A. Yes. 

Id. at 246:22-24. 

Second, this water-swellable polymer must surround and fully encase the core. Claim 1 

itself describes “a shell encasing said core.” Ex. 6, col. 21, l. 42. Sun’s construction tracks the 

language of the specification, which explains that the shell is comprised of a second “matrix 

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

material that swells upon imbibition of water[.]” Id. col. 7, ll. 11-13 (emphasis added). 

Plaintiffs, in contrast, ignore this limitation, which defines how the “second solid polymeric 

matrix” is incorporated into the formulation. 

Third, as the specification again makes clear, this second solid polymeric formulation 

must be “of sufficient thickness and strength that it is not disrupted by the swelling and remains 

intact during substantially the entire period of drug release.” Id. col. 7, ll. 17-20 (emphasis 

added). Put simply, the shell in the claimed invention cannot dissolve or erode before 

substantially all the drug is released. 

Fourth, this shell must be capable of swelling, while remaining intact, to a size large 

enough to promote gastric retention. This limitation, too, comes directly from the language of 

this claim term, which expressly requires “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 a fed mode.” Id. col. 21, ll. 42-45; see also id. col. 7, ll. 12-14; see also id., Abstract. 

C. Hydroxyalkyl-substituted cellulose 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

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 

Plain and ordinary meaning 

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Plaintiffs construe the term as “plain and ordinary meaning,” but they do not give any 

further explanation. At his deposition, Plaintiffs’ expert testified that Sun’s definition is “close 

but no cigar” because the “R” in Sun’s definition is not properly defined. Ex. 17 at 256:20-23, 

258:5-6. Still, neither Dr. Hopfenberg nor Plaintiffs actually offer a construction for this term. 

In contrast, Sun has set forth a construction and has supported it by extrinsic evidence. See Ex. 

13 at 3. Moreover, in response to Dr. Hopfenberg’s testimony, Sun’s expert, Dr. Umesh 

Banakar, explains that a person of ordinary skill in the art would understand Sun’s construction 

as properly covering a hydroxyalkyl-substituted cellulose. Banakar Decl. ¶¶ 23-25. 

III. Disputed Terms In The ’962 Patent 

A. Terms Requiring A Matrix Capable Of Swelling In An Unrestricted Manner 

When read in the context of claim 1 as a whole, both terms below emphasize that the 

dosage form cannot contain any component that restricts (or hinders) the polymeric matrix from 

freely swelling:

Dosage form consisting essentially of a solid monolithic matrix with said drug 

contained therein 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

Dosage form with a solid monolithic matrix 

containing the drug and no other 

components that restrict swelling of the 

matrix 

See constructions for “solid monolithic matrix” 

and “drug contained therein.” 

Swells in an unrestricted manner along both such axes 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

No component of the dosage form hinders 

swelling of the matrix in any dimension 

(i.e., prevents completely or partially the 

matrix from swelling) 

Imbibition of fluid causes an increase in volume 

of the matrix, wherein the relative length of both 

axes after imbibitions of fluid is substantially the 

same as the relative dimensions of the original 

matrix 

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As Sun explained in its opening brief, and as the applicants repeatedly emphasized, the 

matrix cannot contain any component that restricts swelling of the matrix in any dimension. The 

specification requires the matrix to be “swellable” and that such swelling be “dimensionally 

unrestricted.” Ex. 7, col. 3, ll. 52-53 & col. 4, ll. 48-52 (emphasis added). Even the prosecution 

history relied on by Plaintiffs supports Sun’s construction. There, the applicants represented that 

“the concept of constrained swelling . . . is diametrically opposed to the concept of dimensionally 

unrestricted swelling which is the basis for the creation of the Applicants’ invention.” Pls. Br. 33 

(emphasis added). Simple logic dictates that the matrix cannot be “dimensionally unrestricted” if 

it contains components that restrict swelling of the matrix. Equally important, only Sun’s 

construction gives meaning to the phrase “consisting essentially of,” which is intended to modify 

claim language requiring the “matrix” to “be[] one that swells in an unrestricted manner along 

both [orthogonal] axes upon imbibition of water[.]” Ex. 7, col. 11, ll. 19-20 (emphasis added). 

Plaintiffs nonetheless offer three arguments to support their constructions, each of which 

is plainly wrong, or otherwise misplaced: 

First, Plaintiffs argue that the phrase “and no other components that restrict swelling” in 

Sun’s construction of the first term is “redundant.” Pls. Br. 32. In reality, however, Plaintiffs are 

trying to ignore the claim language “consisting essentially of,” which they cannot do. See 

Becton Dickinson and Co. v. Tyco Healthcare Group, LP, 616 F.3d 1249, 1257 (Fed. Cir. 2010) 

(patent claims must be “interpreted with an eye toward giving effect to all terms in the claim”). 

“Consisting essentially of” is a common patent phase construed by the Federal Circuit to 

preclude unlisted ingredients that “materially affect the basic and novel properties of the patented 

invention.” PPG Indus. v. Guardian Indus. Corp., 156 F.3d 1351, 1354 (Fed. Cir. 1998). To be 

sure, adding a component that restricts swelling of the matrix would materially affect the basic 

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and novel properties of the invention covered by claim 1, which expressly requires a matrix that 

“swells in an unrestricted manner along both . . . axes.” Ex. 7, col. 11, ll. 19-20. 

In fact, the applicants highlighted the importance of this phrase to patentability by filing a 

Certificate of Correction that changed “said dosage form comprising a solid monolithic matrix” 

to “said dosage form consisting essentially of a solid monolithic matrix.” Id., last page 

(emphasis added). This change was necessary to distinguish prior art (the Wong reference) 

where the dosage form included a component (a band) that did restrict swelling of the matrix. 

The applicants represented to the Patent Office that, unlike in the prior art Wong reference, their 

“solid monolithic matrix [must] swell in an unrestricted manner.” Ex. 14 at 10 (emphasis 

added); see also id. (“Applicants . . . recite a solid monolithic matrix swelling in an unrestricted 

manner along both axes.”). Again, the only way the matrix can “swell in an unrestricted 

manner” is if it contains no components that restrict such swelling in any dimension. See, e.g.,

Southwall Tech., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1576 (Fed. Cir. 1995) (“The prosecution 

history limits the interpretations of claim terms so as to exclude any interpretation that was 

disclaimed during prosecution.”).6

Second, Plaintiffs have improperly read “swells in an unrestricted manner along both 

such axes” as requiring the swelling of the matrix to be “substantially the same” along both axes. 

In support, they cite col. 4, lines 7-48 of the specification. Pls. Br. 32. But this section in no way 

supports their construction that “the relative length of both axes after imbibitions of fluid [be] 

substantially the same as the relative dimensions of the original matrix.” Plaintiffs pulled this 

 

6

 To address fully Plaintiffs’ contention of redundancy, if (but only if) the Court were to accept 

Sun’s construction of “swells in an unrestricted manner along both such axes,” Sun would agree 

with Plaintiffs that the term “dosage form consisting essentially of a solid monolithic matrix with 

said drug contained therein” subsumes the definition of “solid monolithic matrix” and there is no 

need to construe the remaining claim language. 

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construction from thin air. The intrinsic record simply focuses on a matrix that is dimensionally 

unrestricted, a term that necessarily precludes components that restrict swelling of the matrix. 

Third, Plaintiffs argue that Sun’s construction excludes a preferred embodiment. Once 

again, however, they have distorted the specification and prosecution history. Plaintiffs point to 

specification language saying that “the dosage form is a multilayered tablet in which one or more 

of the layers swells while others do not.” Pls. Br. 33 (emphasis added). But this does not mean 

that, according to claim 1, the matrix can contain a component that restricts swelling. Such a 

reading would contradict the claim language and the prosecution history. 

To the extent the claims can even cover a multilayered tablet (an issue not before the 

Court), such a tablet would have to consist of a dosage form containing a separate, non-swellable 

layer that is surrounded by the matrix. The non-swellable layer cannot restrict swelling of the 

matrix. If it did, such a formulation would “materially affect the basic and novel properties of 

the patented invention,” PPG Indus., 156 F.3d at 1354, which expressly requires the dosage form 

to consist essentially of a drug-infused matrix and “swell[] in an unrestricted manner along both 

. . . axes.” Ex. 7, col. 11, ll. 19-20. Plaintiffs’ argument thus proves Sun’s point—the matrix (as 

opposed to the dosage form) cannot contain any component that restricts (or hinders) swelling. 

Additionally, even on its face, Plaintiffs’ construction of “Dosage form consisting 

essentially of a solid monolithic matrix with said drug contained therein” makes no sense 

because it includes a reference to “drug contained therein.” The parties have not asked the Court 

to construe that term. 

B. Terms Addressing The Non-Circular Shape Of The Matrix 

There is no dispute that all claims in the ’962 patent require the matrix to be “non-circular 

in shape.” Id. col. 11, l. 14-col. 12, l. 64. Instead, the parties dispute whether the applicants 

were referring to the shape of the face of the tablet (Sun’s position), or the thickness of the tablet 

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(Plaintiffs’ position). To concoct an infringement claim, Plaintiffs are improperly trying to 

convince the Court that the circular tablet depicted below (plainly excluded from the scope of the 

patent) is really non-circular in shape. Ex. 17 at 212:10-215:14; 219:3-220:24. 

The following terms are related, and can be covered in one discussion: 

Said matrix being non-circular in shape and having first and second 

orthogonal axes of unequal length 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

The largest planar projection of the shape 

has first and second orthogonal axes of 

unequal length 

Plain and ordinary meaning 

Said matrix has a shape which when projected onto a plane 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

The largest planar projection of the tablet Plain and ordinary meaning 

Sun explained in its opening brief that its constructions are not only the plain and 

ordinary meanings of these terms, they also come directly from the specification of the ’962 

patent. In fact, the applicants repeatedly emphasized the importance of having a non-circular 

matrix. And they clearly explained that this limitation refers to the shape of the largest, twodimensional planar projection of the matrix: 

 The applicants explained that the matrix, “when projected onto a planar surface, has 

two orthogonal axes of different lengths” and thus is “non-circular.” Ex. 7, col. 3, ll. 

28-31 (emphasis added). 

 The applicants confirmed in their detailed description of the invention that they are 

referring to the largest planar projection of the shape of the claimed dosage form, 

thus excluding a tablet with a round or circular face: “Some of the possible shapes 

[for the dosage forms of the patented invention] are oval, triangle, almond, peanut, 

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‘bow tie,’ parallelogram, trapezoidal, pentagonal, and hexagonal, provided (as stated 

above) that the largest planar projection of the shape has at least orthogonal 

dimensions, one being larger than the other.” Id. col. 4, ll. 8-15 (emphasis added). 

 The applicants then distinguished this largest “planar projection” of the shape of the 

tablet—again, plainly referring to the face of the tablet—from the thickness of the 

tablet: “One example of a tablet that meets these descriptions [of shape limitations] is 

a diamond-shaped tablet (i.e., a tablet whose planar projection is a parallelogram 

with one diagonal dimension shorter than the other) in which the shorter diagonal is 

0.9 cm and the longer diagonal is 1.5 cm. In this example, both of these dimensions 

are substantially greater than the thickness of the tablet.” Id. col. 4, ll. 42-48 

(emphasis added). 

When the applicants referred to the shape of the matrix, therefore, they plainly meant the shape 

of the largest planar projection of the matrix (i.e., the face of the tablet) and not its thickness. As 

Sun’s expert confirms, this is consistent with how a person of ordinary skill in the art would 

understand the claim elements. Such a person would not read “non-circular in shape” to refer to 

the thickness of the tablet. Banakar Decl. ¶¶ 17-22. 

Curiously, Plaintiffs argue that Sun’s construction “is problematic because it attempts to 

incorporate the limitation ‘largest’ into its construction.” Pls. Br. 34. This position is based 

entirely on the following misrepresentation: “There is no support in the intrinsic evidence for 

such a limitation, and Sun does not cite to anything to support the ‘largest’ limitation.” Id.; see 

also id. at 36. Both statements are untrue. 

As explained above and in Sun’s opening brief, the specification expressly emphasizes 

“that the largest planar projection of the shape” of the claimed dosage form must have “at least 

two orthogonal dimensions, one being larger than the other.” Ex. 7, col. 4, ll. 8-15 (emphasis 

added). As the applicants explained, this particular “non-circular” shape of the largest planar 

projection of the tablet is what allows the claimed dosage form to “enhanc[e] gastric retention” 

of the drug and also “render the tablets . . . convenient to swallow.” Id. col. 3, ll. 36-38. 

Moreover, Sun did cite this portion of the specification in the joint claim construction and 

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prehearing statement. Dkt. 43-1 at pp. 55, 57-58 of 59 (pp. 47, 49-50 of document). Plaintiffs’ 

sole objection to Sun’s construction thus is frivolous. 

Finally, Plaintiffs have failed to provide any alternative construction and thus have 

waived their right to do so. 

C. An oval 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

A shape that has a curve that is closed and 

concave towards the center and has an 

overall non-circular shape from all 

dimensions 

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 

There should be no real dispute about what an oval looks like. In fact, both parties have 

relied on the same extrinsic evidence, a tablet design training manual for Elizabeth Companies. 

Ex. 15; Pls. Ex. 34. Instead, the dispute here really turns on whether a person of ordinary skill in 

the art would understand there to be a distinction between a circular and an “oval” tablet. He or 

she most certainly would. 

The Elizabeth Companies’ training manual draws this very distinction and fully supports 

Sun’s constructions relating to the non-circular shape of the matrix required by the ’962 patent. 

The manual describes a tablet as circular (or “round”) if the diameter of the largest planar 

projection of the tablet has first and second orthogonal axes of equal length: 

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Pls. Ex. 34 at 4, 7-8. A circular tablet may or may not be spherical, and it also may have various 

degrees of thickness. See id. at 15 (pictures 1-16). 

The manual draws a stark distinction between a tablet that is circular and one that is oval. 

See id. at 4, 7-10 (distinguishing between “round tablet” nomenclature and dimensioning and an 

“oval” tablet nomenclature and dimensioning). This distinction turns on the shape of the largest 

planar projection of the tablet (i.e., its face), not its “thickness.” For example, the following 

pages of the document depict an oval-shaped tablet based on its “major face radius”: 

Id. at 9. Page 15 of the document also contains a simple picture of an oval, reproduced below, 

where the largest planar projection of the tablet is an oval. 

Id. at 15. 

The Court might think the distinction between a circular and oval-shaped tablet is 

obvious. But Plaintiffs’ expert, Dr. Hopfenberg, has offered an opinion that the following 

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picture—which Elizabeth Companies refers to as a “round tablet,” id. at 4, 7-8—actually depicts 

a non-circular (i.e., oval) dosage form: 

Id. at 15; Ex. 17 at 219:6-222:10. He purports to justify this opinion by relying on the fact that 

the thickness of this admittedly round tablet is non-circular (in fact, it resembles the thickness of 

the “oval” tablet depicted above). Ex. 17 at 220:25-222:10. To support his illusion that a round 

tablet really has an oval shape, Dr. Hopfenberg opines that, at least according to the patent, a 

tablet must be considered “non-circular” unless it is spherical. Id. at 226:19-228:8. 

But this opinion carries no weight because it conflicts directly with the plain language of 

the specification. See AFT Trust, 2012 WL at *5 (“[C]laims must be read in view of the 

specification, of which they are a part. . . . [I]f the specification or prosecution history defines a 

claim term, that definition shall apply even if it differs from the term’s ordinary meaning.”); 

Phillips, 415 F.3d at 1312, 1315-17 (reaffirming “basic principle” that the specification is “the 

single best guide to the meaning of a disputed term,” “usually dispositive,” and “always highly 

relevant” (internal quotations omitted)). As the applicants made clear: “The shape that achieves 

this result [enhancing gastric retention] is a non-circular and non-spherical shape . . . .” Ex. 7, 

col. 3, ll. 28-29, 35-36 (emphasis added). To fall within the scope of this patent, therefore, the 

tablet must be both non-circular (referring to the two-dimensional shape of the largest planar 

projection of the tablet) and non-spherical (referring to the three-dimensional shape of the 

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tablet). Under no stretch of the imagination can a circular (or round) tablet satisfy the limitations 

of claim 1 of the ’962 patent. 

Consistent with this clear distinction, Sun is willing to accept Plaintiffs’ construction of 

oval only if the Court were to adopt Sun’s constructions of “said matrix being non-circular in 

shape and having first and second orthogonal axes of unequal length” or “said matrix has a shape 

which when projected onto a plane.” In that situation, claim 1 would require the largest planar 

projection of the tablet to have a two-dimensional shape that is non-circular, e.g., an oval. If, 

however, the Court were to consider the meaning of “oval” in a three-dimensional context, it is 

clear from the specification that the applicants were referring to a tablet with an overall noncircular shape from all dimensions—i.e., a “non-circular and non-spherical shape[.]” Id. col. 3, 

ll. 28-31, 36 (emphasis added); id. col. 4, ll. 8-16. Plaintiffs’ argument to the contrary is 

gamesmanship that ignores the plain language of the claim and specification. 

IV. Disputed Term In The ’987 Patent: Curing The Coated Oral Dosage Form At A 

Temperature Of At Least 55° C 

Sun’s Proposed Construction Plaintiffs’ Proposed Construction 

The coated oral dosage form is raised to a 

temperature of at least 55° C for curing 

Plain and ordinary meaning 

The deposition of Plaintiffs’ expert has revealed why Plaintiffs refuse to offer a 

construction for this term. They apparently hope to circumvent claim construction under the 

guise of “plain and ordinary meaning” expert testimony that mischaracterizes the patent. 

Specifically, their expert opines that this claim limitation is met as long as the oven used for 

curing is set at a temperature of at least 55° C—regardless of whether the oral dosage form, 

itself, reaches the temperature shown on a dial or a meter. See Ex. 17 at 231:3-232:3. This is 

backwards and contrary to the specification. 

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The applicants repeatedly emphasized in the specification that the dosage form itself must 

reach a temperature of at least 55o Celsius. 

First, the patent plainly requires “a polyglycol having a melting point greater than 55° C.” 

Ex. 8 at Abstract; see also id. at col. 25, ll. 13-16 (claim 1); id. at col. 4, ll. 29-30 (requiring “a 

poly glycol having a melting point greater than 55° C”); id. at col. 4, ll. 42-43 (same); id. at col. 

9, ll. 10-11 (“The coat formulation also comprises a poly gycol [sic] with a melting point of 

greater than 55° C.”). 

Second, the applicants repeatedly required the oral dosage form itself to be raised to a 

temperature equal to or greater than this 55° C melting point. See id. at col. 4, ll. 32-34 

(requiring “said oral pharmaceutical dosage forms [to be] cured at a temperature at least equal 

to or greater than the melting point of the poly glycol”) (emphasis added); id. at col. 4, ll. 45-47 

(same); id. at col. 5, ll. 35-37 (same); id. at col. 10, ll. 46-49 (“The coated tablet cores are placed 

onto a tray and cured . . . in an electrical or steam oven at a temperature above the temperature of 

the melting point of the polyethylene glycol or derivative thereof.”); see also id. at col. 10, ll. 60-

65 (requires “curing the coated tablets at above the melting temperature of the polyethylene 

glycol”); id. at col. 13, ll. 21-23 (discussing curing “in an oven at 62±2° C” and noting that 

“[t]his temperature is above the melting temperature of the polyethylene glycol”). 

Third, the applicants explained that heating the oral dosage form above the 55° C melting 

point for polyethylene glycol is critical to the patented invention. As they put it: “Surprisingly, 

. . . applicants have found that addition of polyethylene glycol or its derivatives in the amounts 

described herein and curing the coated tablets at above the melting temperature of the 

polyethylene glycol provided for a controlled release of the therapeutically active agent.” Id. at 

col. 10, ll. 60-65 (emphasis added). As Sun’s expert explained, a person of ordinary skill in the 

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art would understand that when the poly glycol polymer melts during the curing process, it is 

allowed to form a film that affects the release profile of the drug. Banakar Decl. ¶¶ 27-28. Thus, 

allowing the polymer to reach its melting point is not a mere after-thought but, instead, 

materially affects the ability of the formulation to release the drug in a controlled manner. See 

id. 

The arguments offered by Plaintiffs and their expert are nonsense and have no support in 

the intrinsic evidence. Plaintiffs’ expert takes the far-fetched position that the temperature of the 

oral dosage form is irrelevant. When pointed to the fact that the applicants repeatedly instructed 

the reader to heat the polyglycol above its melting point, he responded by saying this was 

“coincidental.” Ex. 17 at 234:18-236:9 (emphasis added). The Court should discard such 

testimony because it is “conclusory” and “clearly at odds with . . . the written record of the 

patent.” Phillips, 415 F.3d at 1318. Plaintiffs even quibble that Sun states that the dosage form 

is “raised” to at least 55o Celsius. Pls. Br. 40. But any person of ordinary skill in the art would 

understand that the oral dosage form is cured by raising the temperature. 

In sum, the plain and ordinary reading of this claim term is “the coated oral dosage form 

is raised to a temperature of at least 55° C for curing.” As a matter of common sense, if the 

coated oral dosage form is not raised to this temperature, it cannot possibly be “at least equal to 

or greater than the melting point of the poly glycol.” See, e.g., Ex. 8, col. 4, ll. 32-34. 

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CONCLUSION 

For the reasons set forth above, Sun asks the Court to adopt its constructions of the 

disputed claim terms. 

WINSTON & STRAWN LLP 

Attorneys for Defendants 

Sun Pharma Global FZE, Sun Pharmaceutical 

Industries Ltd. and Sun Pharmaceutical Industries, 

Inc. 

By: s/ Melissa Steedle Bogad 

James S. Richter 

jrichter@winston.com 

Melissa Steedle Bogad 

mbogad@winston.com 

Dated: May 4, 2012 

OF COUNSEL

James F. Hurst 

WINSTON & STRAWN LLP 

35 West Wacker Drive 

Chicago, IL 60601 

Charles B. Klein 

John K. Hsu 

WINSTON & STRAWN LLP 

1700 K Street, NW 

Washington, DC 20006

Case 3:11-cv-03553-JAP-TJB Document 54 Filed 05/04/12 Page 34 of 35 PageID: 1689
CERTIFICATION OF SERVICE

I hereby certify that on May 4, 2012, copies of the foregoing Responsive Claim 

Construction Brief and supporting documents were served by electronic filing and electronic 

mail upon all counsel of record. 

I certify that the foregoing statements made by me are true. I am aware that if any of the 

foregoing statements are willfully false, I am subject to punishment. 

By: s/ Melissa Steedle Bogad 

Melissa Steedle Bogad 

mbogad@winston.com 

Date: May 4, 2012 

Case 3:11-cv-03553-JAP-TJB Document 54 Filed 05/04/12 Page 35 of 35 PageID: 1690