John E. Flaherty

Partner 

T. 973.639.7903 

F. 973.297.3971 

jflaherty@mccarter.com 

McCarter & English, LLP 

Four Gateway Center 

100 Mulberry Street 

P.O. Box 652 

Newark, NJ 07102 

T. 973.622.4444 

F. 973.624.7070 

www.mccarter.com 

BOSTON

HARTFORD 

NEW YORK 

NEWARK 

PHILADELPHIA 

STAMFORD 

WILMINGTON 

July 6, 2012 

VIA ECF 

Hon. Tonianne J. Bongiovanni, U.S.M.J. 

U.S. District Court for the District of New Jersey 

Clarkson S. Fisher Building & U.S. Courthouse 

402 East State Street 

Trenton, New Jersey 08608 

Re: Takeda Pharmaceutical Company Limited, et al. v. Mylan Inc. et al.

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

Dear Judge Bongiovanni: 

We, along with Hogan Lovells, represent Plaintiffs Takeda and Ethypharm1

in this action. We write to seek an Order from this Court striking new arguments 

raised by Defendant Mylan Pharmaceuticals Inc. ("Mylan") for the first time in its 

responsive claim construction brief (D.I. 81) and supplemental expert declaration 

(D.I. 80). By improperly introducing new non-rebuttal arguments in its responsive 

brief, Mylan has effectively prevented Plaintiffs from responding to those arguments 

and severely prejudiced Plaintiffs. 

For the first time in its responsive brief, Mylan advanced a claim construction 

for the '994 patent2 term "enteric coating layer." In flagrant disregard of the 

disclosure requirements set forth in L. Pat. R. 4.2 and 4.3, Mylan never disclosed to 

Plaintiffs its newly proposed construction or any supporting evidence. (See, e.g.,

Joint Claim Construction Chart and Prehearing Statement (D.I. 59), which is silent 

as to Mylan's new construction and cites to no supporting intrinsic or extrinsic 

evidence.) And yet, the "local patent rules are created to further the goal of full, 

timely discovery and provide all parties with adequate notice and information with 

which to litigate their cases" to prevent "litigation by ambush." APP Pharms. LLC v. 

Ameridose, LLC, Civil Action No. 10-4109, 2011 WL 6325975, at *1 (D.N.J. Dec. 6, 

2011) (quotation omitted). 

Mylan also articulated for the first time two new indefiniteness arguments as 

to the '632 patent3 terms "permits to obtain reduced pH influence in the digestive 

tract" and "permits to obtain . . . reduced influence of viscosity." But it is Mylan's 

burden to prove, by clear and convincing evidence, that the claim terms are invalid 

for indefiniteness. It is not Plaintiffs' burden to prove the contrary. Mylan should 

 

1

 "Plaintiffs" refers to Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals 

North America, Inc., Takeda Pharmaceuticals LLC, Takeda Pharmaceuticals America, Inc. 

(collectively, "Takeda"), and Ethypharm, S.A. 

2

 United States Patent No. 6,328,994 

3

 United States Patent No. 5,464,632 

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Hon. Tonianne J. Bongiovanni, U.S.M.J. 

July 6, 2012 

Page 2 

have presented its indefiniteness arguments, at the minimum, in its opening brief. 

Likewise, Mylan argues for the first time that the '994 file history supports its 

proposed construction that the "enteric coating agent" and "sustained-release 

agent" must be separate and distinct. 

Accordingly, Plaintiffs request that the Court strike the following new 

arguments by Mylan: 

• Mylan's argument that "enteric coating layer" 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 ("Mumper Supp. Decl.") ¶¶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); Mumper Supp. 

Decl. ¶¶50-53; 

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

influence of viscosity" (Def.'s Resp. Br. at 29-30); Mumper Supp. Decl. ¶¶50, 

54-56; and 

• 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); Mumper Supp. 

Decl. ¶¶32-34, 45; Exhibits 23-25. 

See Pall Corp. v. Cuno Inc., No. 03-CV-0092 (JS)(ETB), 2007 WL 2363019, *1 n.1

(E.D.N.Y. Aug. 14, 2007) ("Any arguments raised for the first time in reply [claim 

construction] briefs or letters filed subsequent to the briefs will not be considered by 

this Court in rendering its decision."); see also SPX Corp. v. Bartec USA, LLC, No. 

06-14888, 2008 WL 1749479, at *1-4 (E.D. Mich. April 11, 2008) (finding the Court 

would have struck defendants’ expert declaration, which was filed for the first time 

with their responsive claim construction brief and introduced new arguments, had 

the defendants not withdrawn the declaration themselves). 

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

Plaintiffs respectfully request that the Court level the playing field by permitting 

Plaintiffs to file a reply brief and supplemental expert declaration to rebut Mylan's 

new arguments. Biovail Labs. Int'l SRL v. Cary Pharm. Inc., No. 09-605, 2010 WL 

2132021, at *2-3 (D. Del. May 26, 2010) (permitting plaintiff to file reply brief in 

response to new expert opinions introduced by defendants in answering claim 

construction papers to avoid prejudice to plaintiff); Server Tech., Inc. v. Am. Power 

Conversion Corp., No. 06-00698, 2010 WL 1610395, at *11 n.5 (D. Nev. April 19, 

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Hon. Tonianne J. Bongiovanni, U.S.M.J. 

July 6, 2012 

Page 3 

2010) (granting defendant's motion for a surreply because plaintiff's reply claim 

construction brief raised new arguments to which defendant would otherwise be 

unable to respond). 

For the Court's consideration, Plaintiffs' reply brief is attached hereto as 

Exhibit A and the Supplemental Declaration of Plaintiffs' expert, Dr. Stephen R. 

Byrn, is attached hereto as Exhibit B. The parties have met and conferred about 

Plaintiffs' submitted papers; although Plaintiffs requested Mylan's permission to file 

the attached papers, Mylan has not consented. 

If the Court wishes to discuss the matters raised above in a teleconference, 

Plaintiffs are available at the Court's convenience. 

 

Respectfully, 

s/John E. Flaherty

John E. Flaherty 

cc: Counsel of Record (via email) 

Enclosures: Exhibits A-B 

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