EXHIBIT A

Case 3:11-cv-02506-JAP-TJB Document 83-1 Filed 07/06/12 Page 1 of 17 PageID: 1781
 

John E. Flaherty 

Jonathan M. H. Short 

MCCARTER & ENGLISH, LLP

Four Gateway Center 

100 Mulberry Street 

Newark, New Jersey 07102 

T (973) 622-4444 

F (973) 624-7070 

Attorneys for all Plaintiffs 

 

Of Counsel: 

Eric J. Lobenfeld 

Arlene L. Chow 

Dillon Kim 

HOGAN LOVELLS US LLP 

875 Third Avenue 

New York, New York 10022 

(212) 918-3000 

Philippe Y. Riesen 

HOGAN LOVELLS HORITSU 

JIMUSHO

Gaikokuho Kyodo Jigyo 

15th Floor Daido Seimei 

Kasumigaseki Building 

1-4-2 Kasumigaseki 

Chiyoda-ku, Tokyo 100-0013 

Japan 

(81) 3-5157-8200 

Attorneys for all Plaintiffs 

Paul A. Ragusa 

Lisa Kole 

BAKER BOTTS LLP 

30 Rockefeller Plaza 

New York, NY 10112 

(212) 408-2588 

Attorneys for Plaintiff 

Ethypharm, S.A.

IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF NEW JERSEY 

TAKEDA PHARMACEUTICAL 

COMPANY LIMITED, TAKEDA 

PHARMACEUTICALS NORTH AMERICA, 

INC., TAKEDA PHARMACEUTICALS 

LLC, TAKEDA PHARMACEUTICALS 

AMERICA, INC., and ETHYPHARM, S.A., 

Plaintiffs and Counterclaim-Defendants, 

 

v. 

MYLAN PHARMACEUTICALS INC., 

Defendant and Counterclaim-Plaintiff. 

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Civil Action No. 3:11-CV-02506-JAP-TJB 

PLAINTIFFS' REPLY CLAIM 

CONSTRUCTION BRIEF 

 

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TABLE OF CONTENTS 

Page 

PRELIMINARY STATEMENT .................................................................................................... 1 

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

I. The Court Should Reject Mylan's New Argument That "An Enteric 

Coating Layer" ('632) Is Limited To An Admixture ............................................................ 2 

A. During Prosecution, The Patentee Did Not Limit "Enteric Coating Layer" To An 

Admixture Of "Enteric Coating Agent" And "Sustained-Release Agent" ........................ 3 

B. Plaintiffs' Expert Testified That "Enteric Coating Layer" Is Not Limited To An 

Admixture Of "Enteric Coating Agent" And "Sustained-Release Agent" ........................ 4 

II. The Court Should Reject Mylan's New Arguments That The '632 Claim Terms 

"Permits To Obtain Reduced pH Influence In The Digestive Tract" And "Permits To 

Obtain . . . Reduced Influence Of Viscosity" Are Indefinite................................................ 5 

A. The Term "Permits To Obtain . . . Reduced Influence Of Viscosity" Means "The 

Formulation Influences Viscosity Less Than the Prior Art Formulations Of Record 

That Have Excipients Increasing Viscosity" ..................................................................... 5 

B. The Term "Permits To Obtain Reduced pH Influence In The Digestive Tract" Means 

"The Active Ingredient In The Tablet Is Less Influenced By Stomach pH (i.e., 

The Drug Is Coated)" ........................................................................................................ 7 

C. The Terms "Permits to Obtain Reduced pH Influence In The Digestive Tract" And 

"Permits To Obtain . . . Reduced Influence Of Viscosity" Are Permissible Functional 

Limitations In A Composition Claim ................................................................................ 8 

III. The Court Should Reject Mylan's New Argument Based On The '994 File History: The 

"Enteric Coating Agent" And "Sustained-Release Agent" Need Not Have Separate and 

Distinct Claim Constructions ............................................................................................... 9 

IV. Plaintiffs' Expert Did Not Concede That A 10% Standard Of Error Was Not Universally 

Accepted During The 1998-1999 Timeframe .................................................................... 11 

CONCLUSION ............................................................................................................................. 12 

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TABLE OF AUTHORITIES 

Page(s) 

CASES

Alcon Research Ltd. v. Barr Labs. Inc., 

No. 09-CV-0318-LDD, 2011 WL 6180032 (D. Del. Dec. 13, 2011) ........................................8 

Allergan, Inc. v. Watson Labs., Inc.-Fla., 

No. 09-cv-511 (GMS), 2012 WL 1133684 (D. Del. Mar. 31, 2012) .........................................6 

Exxon Research & Eng'g Co. v. U.S., 

265 F.3d 1371 (Fed. Cir. 2001)..................................................................................................7 

Pfizer Inc. v. Teva Pharm. USA, Inc., 

Nos. 08-1331, 08-2137, 10-3246, 10-3250 (DMC)(JAD), 2012 WL 1232302 (D.N.J. 

Apr. 12, 2012) ............................................................................................................................6 

Ricoh Co., Ltd. v. Katun Corp., PNA, 

486 F. Supp. 2d 395 (D.N.J. 2007) ............................................................................................9 

Vanguard Prods. Corp. v. Parker Hannifin Corp., 

234 F.3d 1370 (Fed. Cir. 2000)..................................................................................................4 

Young v. Lumenis, Inc., 

492 F.3d 1336 (Fed. Cir. 2007)..................................................................................................7 

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PRELIMINARY STATEMENT 

Scrambling to strengthen its claim construction case, Mylan introduces new arguments in 

its responsive claim construction brief that should have been set forth, if anywhere, in its opening 

papers. In relation to "enteric coating layer" ('994), Mylan advances a claim construction (and 

cites to intrinsic and extrinsic evidence) that it never previously disclosed – in the claim 

construction exchanges required by the Local Patent Rules, the Joint Claim Construction 

Statement and/or its opening Markman brief. Likewise, with respect to "enteric coating agent" 

and "sustained-release agent" ('994), Mylan now identifies purported support in the file history 

for its contention that those terms must have "separate and distinct" constructions. As for 

"permits to obtain reduced pH influence in the digestive tract" ('632) and "permits to obtain . . . 

reduced influence of viscosity" ('632), Mylan articulates, for the very first time, its rationale as to 

why those terms are purportedly indefinite; oddly enough, Mylan ignores the clear dictates of the 

intrinsic evidence and applies a "one size fits all" approach that advances the same indefinite 

argument for both limitations. 

Mylan's gamesmanship should not be countenanced. Accordingly, Plaintiffs respectfully 

request that the Court strike1

 the following new arguments from Mylan's responsive brief (and 

supplemental expert declaration in support thereof): 

• Mylan's argument that "enteric coating layer" ('994) must be an admixture of an 

enteric coating agent and sustained-release agent (Def.'s Resp. Br. at 14-20) and 

supporting paragraphs and exhibits from the Supplemental Declaration of Dr. Russell 

J. Mumper (¶¶35-44, 46-47; Exhibits 22-28); 

• Mylan's indefiniteness argument regarding "permits to obtain reduced pH influence in 

the digestive tract" (Def.'s Resp. Br. at 26-28) and supporting paragraphs from the 

Supplemental Declaration of Dr. Russell J. Mumper (¶¶50-53); 

 

1

Plaintiffs direct the Court to the cover letter submitted herewith in relation to its motion to 

strike.

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• Mylan's indefiniteness argument regarding "permits to obtain . . . reduced influence of 

viscosity" (Def.'s Resp. Br. at 29-30) and supporting paragraphs from the 

Supplemental Declaration of Dr. Russell J. Mumper (¶¶50, 54-56); 

• Mylan's argument that the '994 file history purportedly supports that the "enteric 

coating agent" and "sustained-release agent" must have "separate and distinct" claim 

constructions (Def.'s Resp. Br. at 14) and supporting paragraphs and exhibits from the 

Supplemental Declaration of Dr. Russell J. Mumper (¶¶32-34, 45; Exhibits 23-25). 

In the event that the Court decides to entertain Mylan's new arguments, Plaintiffs 

respectfully request that the Court level the playing field by considering Plaintiffs' rebuttals to 

Mylan's new arguments, as set forth in further detail below.2 

ARGUMENT 

I. The Court Should Reject Mylan's New Argument That "An Enteric Coating Layer" 

('994) Is Limited To An Admixture 

 Until its responsive Markman brief, Mylan at no point advanced a claim construction for 

"an enteric coating layer." (See e.g., Joint Claim Constr. Chart (D.I. 59) at 11 (no proposed 

construction by Mylan and no citation to supporting intrinsic/extrinsic evidence).) Mylan did not 

even bother to address this term in its opening brief. But now, with five pages of briefing and 12 

paragraphs of supporting expert opinion, Mylan seeks to unilaterally inject a limitation into 

"enteric coating layer" such that it is required to be an admixture of an enteric coating agent and 

sustained-release agent. The Court should reject Mylan's belated attempt to manufacture a claim 

construction dispute where there is none.3 

 

2

Plaintiffs also include a Second Supplemental Declaration from its expert, Dr. Stephen R. Byrn, 

to support Plaintiffs' Reply Claim Construction Brief and to rebut new opinions made by Mylan's 

expert, Dr. Mumper, in his Supplemental Declaration. 

3

See Pls.' Resp. Br. at 8-9 ("Since Mylan does not even address Takeda's proposed construction 

of this term in its opening brief, it is reasonable to assume that there is no meaningful dispute on 

this issue.")

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A. During Prosecution, The Patentee Did Not Limit "Enteric Coating Layer" To An 

Admixture Of "Enteric Coating Agent" And "Sustained-Release Agent" 

In purported support of its newly-minted construction that the "enteric coating layer" 

must be an admixture of the "enteric coating agent" and "sustained release agent," Mylan points 

to the file history. In particular, Mylan focuses on a declaration submitted by the named inventor 

Shimizu to the PTO that demonstrated the superior qualities of the '994 invention; in that 

declaration, Shimizu compared Example 9 from the '994 patent with a prior art tablet. (See Ex.

14.) Mylan argues that the inventor "represented to the PTO that the claimed invention consisted 

of fine granules coated with a blend of an 'enteric coating agent' and 'sustained release agent' to 

form an 'enteric coating layer.'" (Def.'s Resp. Br. at 17 (emphasis added).) Mylan 

mischaracterizes the file history. 

 Contrary to Mylan's assertion, neither the patentee nor the inventor limited the "enteric 

coating layer" to an admixture during prosecution. It is significant that Mylan can point to no 

express representation made by Shimizu or the patentee that (1) limits the invention to Example 

9 (with its blend of an enteric coating agent and sustained-release agent); or (2) requires the 

"enteric coating layer" of the invention be an admixture or blend of an "enteric coating agent" 

and a "sustained-release agent." Indeed, since the prior art tablet only included an enteric coating 

agent, there was no need for Shimizu or the patentee to limit the invention as Mylan suggests in 

order to overcome that prior art. Instead, during prosecution, the patentee and Shimizu required 

only that the "enteric coating layer" comprise an enteric coating agent and a sustained-release 

agent. 

 Given that the patentee and inventor did not limit the "enteric coating layer" to any 

specific process or method by which it is made, Mylan's attempt to limit the "enteric coating 

layer" to just a blend is improper. The Federal Circuit has held that "[t]he method of 

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manufacture, even when cited as advantageous, does not of itself convert product claims into 

claims limited to a particular process" and that "[a] novel product that meets the criteria of 

patentability is not limited to the process by which it was made." Vanguard Prods. Corp. v. 

Parker Hannifin Corp., 234 F.3d 1370, 1372-73 (Fed. Cir. 2000). The Court should reject 

Mylan's proposed construction. 

B. Plaintiffs' Expert Testified That "Enteric Coating Layer" Is Not Limited To An 

Admixture Of "Enteric Coating Agent" And "Sustained-Release Agent" 

Mylan next argues that Plaintiffs' expert, Dr. Byrn, admitted that the "enteric coating 

layer" must be an admixture of an enteric coating agent and sustained-release agent. (Def.'s 

Resp. Br. at 15-16.) Not only does Mylan mischaracterize Dr. Byrn's Declaration, but Mylan 

also conveniently ignores Dr. Byrn's deposition testimony to the contrary. 

Mylan identifies a purported admission in Dr. Byrn's declaration: "[T]he '994 patent 

teaches an enteric coat made from a blend of enteric-coating agent and sustained-release agent . . 

. ." (Byrn Decl. at ¶ 20.) Yet, nowhere in his declaration – or during his deposition – did Dr. 

Byrn state that the '994 patent claims are limited to an enteric coating layer that consists of such 

a blend or admixture. (Byrn Second Supp. Decl. at ¶16.) 

In fact, although Mylan attempts to pitch Dr. Byrn's deposition as favorable to it, Mylan 

ignores Dr. Byrn's unambiguous deposition testimony making clear that the enteric coating layer 

is not limited to a blend or admixture. (Ex. 35, Byrn Dep. Tr. 253:3-6 ("The combination of 

coatings, two compositions, like are said in the claims, avoid the problems. So the claims say 

they don't require an admixture."); Byrn Dep. Tr. 254:6-9 ("Well, in the examples he used one 

method of doing the claim. But that doesn't mean that there aren't other methods, and the 

examples are not limiting.").) 

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In short, Mylan's attempt to manufacture a claim construction dispute in relation to 

"enteric coating layer" – based on mischaracterizations of the file history and Takeda's expert's 

testimony – should be rejected. 

II. The Court Should Reject Mylan's New Arguments That The '632 Claim Terms 

"Permits To Obtain Reduced pH Influence In The Digestive Tract" And "Permits 

To Obtain . . . Reduced Influence Of Viscosity" Are Indefinite 

It is Mylan's burden to prove, by clear and convincing evidence, that the claims are 

invalid for indefiniteness. It is not Plaintiffs' burden to prove the contrary. And yet, Mylan did 

not articulate any indefiniteness arguments in its opening brief. This fact, in and of itself, is 

indicative of how much weight this Court should give to Mylan's new indefiniteness arguments, 

which Plaintiffs nonetheless rebut below. 

A. The Term "Permits To Obtain . . . Reduced Influence Of Viscosity" Means "The 

Formulation Influences Viscosity Less Than the Prior Art Formulations Of Record 

That Have Excipients Increasing Viscosity" 

This Court has already concluded in Zydus that the file history dictates a construction for 

"permits to obtain . . . reduced influence of viscosity"; thus, the Court construed that term to 

mean "the formulation influences viscosity less than prior art formulations of record that have 

excipients increasing viscosity." (Ex. 27, Claim Constr. Op. at 12-13.) 

 Based on Dr. Mumper's conclusory opinions, Mylan insists that this limitation is 

indefinite. But Dr. Mumper's opinions are inherently flawed; he recognized the significance of 

critical intrinsic evidence (upon which the Court based its construction) but, nevertheless, 

rejected it. Thus, Dr. Mumper admitted at his deposition that the patentee incorporated this 

limitation to distinguish over prior art formulations that contained excipients which increased 

viscosity. (Ex. 34, Mumper Dep. Tr. 110:16-21 ("Yes, I recall in the prosecution history that this 

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claim term was included to differentiate the '632 claim from prior art that . . . included an 

excipient that increased the viscosity.").) 

Mylan argues that the phrase is indefinite because a person of ordinary skill in the art 

would not know "what the starting and end points are" and because the "'reduced influence of 

viscosity' must be relative to some initial viscosity." (Def.'s Resp. Br. at 29-30.) And yet, a 

claim is not required to quantify the "amount" or "degree" of the reduction for it to be definite, 

especially where, as here, there is a clear point of comparison. Pfizer Inc. v. Teva Pharm. USA, 

Inc., Nos. 08-1331, 08-2137, 10-3246, 10-3250 (DMC)(JAD), 2012 WL 1232302, at *11-12 

(D.N.J. Apr. 12, 2012) (rejecting argument that the term "reduced undesirable side effects" is 

indefinite because it is unclear as to the amount of reduction required and whether the reduction 

must be made to the number of side effects, to the degree of side effects, or both, especially 

where "proposed construction . . . provide[s] a clear point of comparison for the 'reduced side 

effects,' in that they are reduced in comparison to the immediate release formulation of the 

invention") (emphasis added); Allergan, Inc. v. Watson Labs., Inc.-Fla., No. 09-cv-511 (GMS), 

2012 WL 1133684, at *34-35 (D. Del. Mar. 31, 2012) (finding disclosure of a point of 

comparison sufficient to render the claim term "minimizing the occurrence of side effects" 

definite, rejecting contention that the claim term is indefinite because it did not quantify the 

amount of minimization). Indeed, the '632 prosecution history identified that point of 

comparison by establishing that the claimed tablet influences the viscosity of water less than 

certain prior art formulations that require excipients to increase the viscosity of water. (Byrn 

Decl. at ¶¶63-70.) 

In sum, Mylan's indefiniteness argument has no merit and should be rejected. 

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B. The Term "Permits To Obtain Reduced pH Influence In The Digestive Tract" 

Means "The Active Ingredient In The Tablet Is Less Influenced By Stomach pH 

(i.e., The Drug Is Coated)" 

Mylan fails to meet its burden to prove that the phrase "permits to obtain reduced pH 

influence in the digestive tract" is indefinite. "[T]he definiteness of claim terms depends on 

whether those terms can be given any reasonable meaning." Young v. Lumenis, Inc., 492 F.3d 

1336, 1346 (Fed. Cir. 2007) (emphasis added) (citation omitted). "If the meaning of the claim is 

discernible, even though . . . the conclusion may be one over which reasonable persons will 

disagree . . . the claim [is] sufficiently clear to avoid invalidity on indefiniteness grounds." 

Exxon Research & Eng'g Co. v. U.S., 265 F.3d 1371, 1375 (Fed. Cir. 2001) (emphasis added). 

As discussed at length in Plaintiffs' claim constructions briefs, and as explained by 

Plaintiffs' expert, Plaintiffs' proposed construction ("the active ingredient in the tablet is less 

influenced by stomach pH (i.e., the drug is coated)") is reasonable given the '632 patent's clear 

teaching of a tablet that contains coated, gastroresistant drug granules. In stark contrast, Mylan 

submits its expert's conclusory opinion that there is "no correlation . . . between reduced pH 

influence in the digestive tract and gastroresistance." (Mumper Supp. Decl. at ¶53.) 

Applying a "one size fits all" approach, Mylan advances an indefiniteness argument for 

"permits to obtain reduced pH influence in the digestive tract" that is the same as its 

indefiniteness argument for "permits to obtain . . . reduced influence of viscosity." (Compare, 

e.g., Def.'s Resp. Br. at 27, with Def.'s Resp. Br. at 29 (critiquing limitations because there is no 

"starting point and ending point").) This approach is consistent with Mylan's general disregard 

of the intrinsic evidence. Mylan makes no allowances for the fact that each term is associated 

with a distinct file history that bears on claim construction – indeed, the Court adopted a claim 

construction for "permits to obtain . . . reduced influence of viscosity" based on the file history. 

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Mylan's arguments that the phrase is indefinite (1) because a person of skill in the art 

would not know the "starting point and ending point" of the influence of pH to the granule and 

(2) because the specification is purportedly silent as to the specific influence on pH (increase, 

decrease, neutral) and the specific place within the digestive tract that the pH effect takes place 

are meritless. (Def.'s Resp. Br. at 27-28.) The fact that a claim does not identify a comparator 

does not mean that a term is indefinite. Alcon Research Ltd. v. Barr Labs. Inc., No. 09-CV0318-LDD, 2011 WL 6180032, at *18-19 (D. Del. Dec. 13, 2011) (rejecting argument that the 

term "enhancing the chemical stability" is indefinite because there is no appropriate comparator 

("enhanced [chemical stability] over what?"); finding that one of ordinary skill in the art would 

understand the term to mean "using the invention must increase the chemical stability . . . as 

compared to not using the invention."). 

In any event, one of skill in the art would understand that "permits to obtain reduced pH 

influence in the digestive tract" describes a fundamental characteristic of the tablet – that the 

tablet contains coated drug granules to protect the drug (i.e., reduce the influence) from the 

acidic pH of the stomach. This limitation does not require any measurement of pH as suggested 

by Mylan. (Byrn Second Supp. Decl. at ¶4.) 

In sum, Mylan fails to meet its burden that the term is indefinite, and this Court should 

adopt Plaintiffs' proposed construction. 

C. The Terms "Permits To Obtain Reduced pH Influence In The Digestive Tract" And 

"Permits To Obtain . . . Reduced Influence Of Viscosity" Are Permissible 

Functional Limitations In A Composition Claim 

Mylan also rehashes an indefiniteness argument already considered and rejected by this 

Court in Zydus. Specifically, Mylan contends that the limitations at issue are indefinite because 

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they improperly import "method" limitations into a claim directed to a "composition." (Def.'s 

Resp. Br. at 28-29.) 

As previously explained by Plaintiffs in Zydus, however, this Court has rejected this 

strategy of accused patent infringers to characterize claims as invalid "hybrid" claims. In Ricoh 

Co., Ltd. v. Katun Corp., PNA, 486 F. Supp. 2d 395, 402 (D.N.J. 2007), this Court noted that 

"[i]n almost all cases [where the accused infringer claims that the patent claim is invalid because 

it is an improper hybrid claim under IPXL], district courts have held that the suspect claims did 

not cover both an apparatus and a method, but rather were apparatus claims containing functional 

limitations." Mylan's argument suffers from the same fatal flaws. 

Mylan does not dispute that the claim as a whole is directed to a composition, similar to 

the apparatus claims addressed in Ricoh. (Def.'s Resp. Br. at 28.) But the limitations "permits to 

obtain reduced pH influence in the digestive tract and reduced influence of viscosity" are not 

directed to methods. To the contrary, these limitations describe the functionality of the 

composition. Since it is permissible for claim language to define a composition by what it does 

rather than by what it is, this Court should reject Mylan's argument, just as it did in Zydus. See 

id. (citing In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997)). 

III. The Court Should Reject Mylan's New Argument Based on the '994 File History: 

The "Enteric Coating Agent" And "Sustained-Release Agent" Need Not Have 

Separate And Distinct Claim Constructions 

Mylan's responsive brief cites to newly-identified intrinsic evidence with respect to the 

relationship between the "enteric coating agent" and "sustained-release agent." (Def.'s Resp. Br. 

at 14.) Mylan now argues that, when the patentee distinguished the '212 prior art from the '994 

invention during prosecution (because that prior art did not disclose the use of an "enteric coating 

agent" in combination with "a sustained-release agent"), the patentee somehow took the position 

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that "both of these agents mean different things." (See id.) There is no support for Mylan's reinterpretation of the file history; Mylan cannot point to any express statements by the patentee 

that reflect this purported position. 

Mylan critiques Takeda's claim constructions (that are lifted directly from the 

specification) because they allow for both the "enteric coating agent" and the "sustained-release 

agent" to be methacrylate copolymers. As Mylan would have it, no given methacrylate 

copolymer can ever act as both an "enteric coating agent" and a "sustained-release agent" – i.e., 

Mylan's position that "both of these agents mean different things." But Mylan fails to take into 

account the fact that excipients can have multiple functions depending on the context in which 

the excipients are used. (Byrn Second Supp. Decl. at ¶19.) For example, as explained in 

Plaintiffs' responsive claim construction brief, scientific references expressly teach that Eudragit 

L30D-55 – a methacrylate copolymer that Mylan contends can only be an "enteric coating agent" 

– can be a "sustained-release agent." (Pls.' Resp. Br. at 7-8; Byrn Second Supp. Decl. at ¶20.) 

Stated differently, a specific methacrylate copolymer can act as both an "enteric coating agent" 

and a "sustained-release agent." 

In essence, it is Mylan's contention that Takeda's proposed claim constructions do not 

allow one of skill in the art to distinguish between an "enteric coating agent" and a "sustainedrelease agent." Mylan is wrong. One of skill in the art would know if any given methacrylate 

copolymer is known (1) just as an enteric coating agent; (2) just as a "sustained-release agent" 

and/or (3) as both. Thus, Takeda's proposed claim constructions do not collapse "enteric coating 

agent" and a "sustained-release agent" into a "generic class of compounds" without "proffering 

any distinguishing meaning between the two," as Mylan argues. (Def.'s Resp. Br. at 14.) 

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IV. Plaintiffs' Expert Did Not Concede That A 10% Standard Of Error Was Not 

Universally Accepted During The 1998-1999 Timeframe

Not content to mischaracterize Dr. Byrn's testimony as to "enteric coating layer," see

supra, Mylan likewise butchers his deposition testimony as to "average particle size." In an 

attempt to overturn this Court's construction of that term in Zydus, Mylan asserts that Dr. Byrn 

conceded there was no universally accepted deviation for laser diffraction in the 1998-1999 

timeframe. (Def.'s Resp. Br. at 7; Mumper Supp. Decl. at ¶¶12-13.) Not so. 

Dr. Byrn did testify that the known standard of error for particle size measurement was 

much larger than 10% prior to 1999. But Dr. Byrn's testimony was not limited to the 1998-1999 

timeframe, as Mylan would have it. (Byrn Second Supp. Dec. at ¶¶27-28.) Because Mylan's 

questions relating to measurement error were open-ended as to time (i.e., "prior to 1999"), Dr. 

Byrn's testimony captured his understanding of those skilled in the art from time periods well 

before 1999 (e.g., 1980s, early 1990s). (Id.; see also Byrn Second Supp. Decl. at ¶23 (Dr. Byrn 

has expertise in average particle size measurements since the early 1980s).) 

Instead, as made clear during Dr. Byrn's deposition, the 10% standard of error disclosed 

in the Snorek article and the USP reflects the general understanding that a person of ordinary 

skill in the art had during the relevant 1998-1999 time period. (Ex. 35, Byrn Dep. Tr. 179:10-16 

("Although [persons skilled in the art] couldn't go to [the USP or Snorek], they would come out 

with the same analysis . . . my opinion is that 10 percent is a conservative number based on all 

of my analysis. I think that's what a person skilled in the art would come up with."); see also

Byrn Second Suppl. Decl. ¶29.) 

In short, just as with "enteric coating layer," Dr. Byrn's testimony in relation to "average 

particle size," when placed in proper context, is utterly consistent with his prior testimony and 

Takeda's proffered claim constructions. 

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CONCLUSION 

 Should the Court choose to entertain Mylan's new arguments introduced in its responsive 

brief, Plaintiffs submit that this Court should adopt Plaintiffs' proposed constructions, which are 

consistent with the intrinsic evidence and based on the ordinary meanings of the disputed claim 

terms, as understood by those of skill in the art. 

 Respectfully submitted, 

Dated: July 6, 2012 By: s/John E. Flaherty 

 John E. Flaherty 

 Jonathan M.H. Short 

 MCCARTER & ENGLISH, LLP 

 Four Gateway Center 

 100 Mulberry Street 

 Newark, New Jersey 07102 

 (973) 622-4444 

 Attorneys for all Plaintiffs 

OF COUNSEL: 

Eric J. Lobenfeld Paul A. Ragusa 

Arlene L. Chow Lisa Kole 

Dillon Kim BAKER BOTTS LLP

HOGAN LOVELLS US LLP 30 Rockefeller Plaza

875 Third Avenue New York, NY 10112 

New York, New York 10022 (212) 408-2588 

(212) 918-3000 

 Attorneys for Plaintiff

Philippe Y. Riesen Ethypharm, S.A.

HOGAN LOVELLS HORITSU JIMUSHO

Gaikokuho Kyodo Jigyo 

15th Floor Daido Seimei 

Kasumigaseki Building 

1-4-2 Kasumigaseki 

Chiyoda-ku, Tokyo 100-0013 Japan 

(81) 3-5157-8200 

Attorneys for all Plaintiffs 

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CERTIFICATE OF SERVICE

 The undersigned hereby certifies that true copies of the foregoing Plaintiffs' Reply Claim 

Construction Brief and all supporting documents were caused to be served on July 6, 2012 via 

email and the ECF system upon all counsel of record. 

By: s/ John E. Flaherty_____ 

 John E. Flaherty 

 

Case 3:11-cv-02506-JAP-TJB Document 83-1 Filed 07/06/12 Page 17 of 17 PageID: 1797