UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF NEW JERSEY 

SHIRE LLC, et al., 

Plaintiffs, 

v. 

AMNEAL PHARMACEUTICALS, LLC, et al., 

Defendants. 

C.A. No.: 2:11-cv-03781(SRC)(CLW) 

(CONSOLIDATED) 

SHIRE LLC, et al., 

Plaintiffs, 

v. 

WATSON LABORATORIES, INC. et al., 

Defendants. 

C.A. No.: 12-CV-83 

DOCUMENT FILED ELECTRONICALLY 

REPLY BRIEF IN SUPPORT OF 

DEFENDANTS’ NOTICE OF APPEAL PURSUANT TO L. CIV. R. 72.1(c)(1) 

Case 2:11-cv-03781-SRC-CLW Document 473 Filed 01/29/14 Page 1 of 9 PageID: 106936
TABLE OF AUTHORITIES 

 Page(s) 

Cases 

AS Am., Inc. v. Masco Corp. of Indiana, 

CIV. 13-05 (JBS/JS), 2013 WL 4084237 (D.N.J. Aug. 13, 2013) ........................................ 4, 5 

Dole v. Arco Chem. Co., 

921 F.2d 484 (3d Cir. 1990) .................................................................................................... 5 

Helsinn Healthcare S.A. v. Dr. Reddy’s Laboratories, Inc., 

CIV. A. 11-3962 (MLC), 2013 WL 3336859 (D.N.J. July 2, 2013) .................................. 2, 4, 5 

Jazz Pharm., Inc. v. Roxane Labs., Inc., 

CIV. No. 10-6108, 2013 WL 785067 (D.N.J. Feb. 28, 2013) .................................................. 4 

Jazz Pharm., Inc. v. Roxane Labs., Inc., 

 CIV. No. 10-6108, 2012 WL 3133943 (D.N.J. July 30, 2012) ................................................. 4 

Linear Tech. Corp. v. Micrel, Inc., 

275 F.3d 1040 (Fed. Cir. 2001) ............................................................................................... 2 

Oy Ajat, Ltd. v. Vatech Am., Inc., 

CIV. No. 10-cv-48, 2012 WL 1067900 (D.N.J. Mar. 29, 2012) ................................................ 4 

Symantec Corp. v. Veeam Corp., 

No. C 12-00700 SI, 2013 WL 3490392 (N.D. Cal. July 11, 2013) ........................................... 4 

Statutes 

21 U.S.C. § 355(j)(5)(B)(iii) ........................................................................................................... 4 

Other Authorities 

Fed. R. Civ. P. 11 .......................................................................................................................... 1 

Local Patent Rule 3.7 .................................................................................................................... 1 

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Shire’s opposition to Defendants’ appeal seeks to prevent this Court from deciding the 

on-sale bar of the ‘253 Patent on the merits. Relying on Local Rule 3.7, Shire argues that 

Defendants were not sufficiently diligent in discovering the prior sale evidence, and then not 

quick enough to file a motion. Of course, Shire makes no mention of the fact that Shire took 

from February 2012 until the end of June 2013 to produce some of the documents at issue. 

If Shire is considered to have been diligent and fair in taking over a year to produce the relevant 

documents, it cannot be concluded that Defendants were dilatory in moving to amend their 

invalidity contentions within months of receiving those documents. 

 Moreover, the issue of diligence must be viewed in the context of a single fundamental 

economic reality: Shire enjoys monopoly profits on a drug for which no competition is allowed. 

For Shire, the only thing better than indefinite delay would be a ruling that preserves Shire’s 

monopoly on the product at issue without ever having to defend that monopoly on the merits. In 

contrast, Defendants – which cannot sell a competing product – have nothing to gain by delay. 

 Any perceived lack of “diligence” can only be explained by the fact that Defendants were 

moving as fast as reasonably could be expected given the enormous volume of discovery 

material, the complexity of the issues, and the obstacles to discovery put in place by Shire. 

There is a great difference between acting with diligence and acting precipitously. Defendants’ 

own economic self-interest dictates that they move as fast as possible, recognizing that they 

have many complex issues and mountains of material to digest, as well as obligations to the 

Court pursuant to Rule 11, and obligations to prove their invalidity defenses by clear and 

convincing evidence. 

 Shire presents even the simplest of issues in a misleading fashion. For example, in 

Defendants’ opening brief, Defendants observed that AMRI was represented by the Frommer 

firm in responding to discovery requests. As if to challenge that fact, Shire offers a sentence in 

a footnote: “Moreover, third party AMRI had its own counsel from the LeClair Ryan law firm.” 

(Shire Br. at 1, fn 2.) But even that seemingly simple statement is misleading because it fails to 

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2 

explain that LeClair Ryan was co-counsel along with Frommer, which was Defendants’ point all 

along: “Please be advised that Frommer Lawrence & Haug, LLP (“FLH”), along with LeClair 

Ryan, represent AMRI with respect to all matters related to this litigation, including this 

subpoena.” (Ex. J to D.I. 462, April 17, 2012 letter from S. Kuzmich at FLH, responding to 

Defendants’ April 2012 document subpoena to AMRI (emphasis added).)1

 

Shire was likewise misleading in its discussion of the information available to Defendants 

prior to the motion to amend their invalidity contentions. Contrary to Shire’s argument, 

Defendants did not have sufficient information to assert the on-sale bar for the ‘253 Patent after 

receiving the documents identified below – because critical information was missing: 

 8K and 10Q documents: The 8K and 10Q documents merely identified the existence of 

contracts with various potential manufacturers. (Shire Br. at 5-6.) The 8K and 10Q not 

only fail to identify any dates on which the suppliers actually sold or offered to sell 

lisdexamphetamine dimesylate, they also fail to even identify the drug by its chemical 

name. (D.I. 396 at 6-7; D.I. 425, Oct. 22, 2013 Oral Argument Tr. at 28: 9-19.) 

 Shire’s New Drug Application: The cited pages from Shire’s NDA disclosed only the 

names and addresses of potential manufacturers. (Shire Br. at 6.) 

 AMRI Purchase Requisition Form: The AMRI requisition form did not mention 

lisdexamphetamine dimesylate by name, and did not reflect a commercial sale of this 

compound. At best, the form represents an offer to buy, not an offer to sell, which 

cannot support an on-sale bar. Linear Tech. Corp. v. Micrel, Inc., 275 F.3d 1040, 1052 

(Fed. Cir. 2001) (reversing on-sale bar; entry of purchase orders into an order tracking 

system did not constitute acceptance of an offer to buy). Nor did the form identify the 

highly specific requirements of certain claims of the ‘253 Patent (e.g., particle size). 

Like the first few pieces of a puzzle, these earlier documents might have indicated that there 

was a picture of something; but they were not enough to determine what the picture was. 

Helsinn Healthcare S.A. v. Dr. Reddy’s Laboratories, Inc., CIV. A. 11-3962 (MLC), 2013 WL 

 

1

 Similarly misleading is Shire’s statement that Defendants relied on new evidence in their 

appeal brief. (Shire Br. at 3-4.) Shire is mistaken. All evidence cited in the appeal brief was 

before Judge Waldor (Exs. B, D-F are cited in the Proposed Amendment to Invalidity 

Contentions, which appears as Ex. D to D.I. 383; Ex. B also appears as Ex. F to D.I. 396; Ex. C 

is an exact copy of Ex. B; Ex. G is referenced in D.I. 383 at 5; Ex. I is referenced in D.I. 383 at 5 

and D.I. 396 at 6; Ex. J is referenced in D.I. 383 at 5 and D.I. 396 at 5; Ex. K is referenced in 

D.I. 396 at 5; Ex. L is referenced in D.I. 383 at 10 and D.I. 396 at 1; and Ex. M is incorporated 

by reference in D.I. 383 at 4.) 

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3 

3336859, at *4 (D.N.J. July 2, 2013) (“That pieces of the puzzle might have been revealed at 

earlier times does not mean that a complete picture was likewise available.”) Additional 

documents and depositions were, therefore, necessary to elucidate the basis of and support for 

the on-sale bar defense. Even Judge Waldor recognized the possibility that additional 

information beyond these documents might have been required to seek amendment of 

Defendants’ contentions. (D.I. 456 at 5, referring to documentation that “should have led” 

Defendants to the information needed to support the on-sale bar.)2

 

But contrary to Shire’s arguments, Defendants did not wait eight months after receipt of 

the first of the additional documents to seek to amend their contentions. (Shire Br. at 9.) 

Rather, after being requested in early 2012, the additional documents were withheld for close to 

a year and then haltingly produced by Shire (in some cases, never produced by Shire), and third 

parties (as shown below), despite Defendants’ extensive diligence and follow-up over many 

months. (See, e.g., Opening Br., Ex. J.) 

Document Third Party Production Date Shire’s Production Date 

AMRI/New River API Supply 

Agreement 

May 30, 2013 June 28, 2013 

Cambrex/New River API Quality 

Agreement 

Jan. 11, 2013 Never produced by Shire 

Patheon Batch Production Report Mar. 29, 2013 

Patheon Quality Operations 

Report 

 Mar. 29, 2013 

AMRI Invoices Sept. 17, 2013 Never produced by Shire 

Thus, Defendants were diligent in pursuing leads and seeking discovery. But Shire – 

which had an economic interest to delay – did not provide the necessary documents until nearly 

a year later. Therefore, the timing of the Defendants’ requested amendment was not “within the 

 

2

 Shire’s citations to the patents in-suit are unavailing. Defendants could not presume that 

terms and codes used by the patents were consistent with how third parties used them. 

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reasonable control of the party responsible for it,” which is a key factor in demonstrating good 

cause to amend. Helsinn, 2013 WL 3336859, at *3 (citing Oy Ajat, Ltd. v. Vatech Am., Inc., CIV. 

No. 10-cv-48, 2012 WL 1067900, at *20-21 (D.N.J. Mar. 29, 2012)); see also Symantec Corp. v. 

Veeam Corp., No. C 12-00700 SI, 2013 WL 3490392, at *2-3 (N.D. Cal. July 11, 2013) (granting 

motion to amend where plaintiffs delayed production for ten months, and rejecting plaintiffs’ 

argument that the documents cited in the proposed contentions were publicly available, instead 

finding that defendant “needed non-public documents to determine whether it could claim in 

good-faith that the [plaintiffs’] products invalidated the patent.”); AS Am., Inc. v. Masco Corp. of 

Indiana, CIV. 13-05 (JBS/JS), 2013 WL 4084237, at *2-3 (D.N.J. Aug. 13, 2013) (granting 

motion and not requiring “perfect diligence” because Defendant did not “simply sit on its 

hands”).3

 

As the Court observed in Helsinn, “It is reasonable to conclude . . . that [Defendant] was 

not able to formulate a ‘comprehensive story of Plaintiffs’ . . . violation of the on-sale bar’ . . . 

until Plaintiffs had completed their document production.” 2013 WL 3336859, at *4. Here, 

Defendants were able to put the new pieces together on July 30, 2013, and continued to 

request confirming invoices from AMRI.4

 Defendants then asked for Shire’s consent to amend 

on August 23, 2013.5

 

 

3

 Here, unlike the circumstances in Jazz Pharm., Inc. v. Roxane Labs., Inc., CIV. No. 10-6108, 

2013 WL 785067 (D.N.J. Feb. 28, 2013) and Jazz Pharm., Inc. v. Roxane Labs., Inc., CIV. No. 

10-6108, 2012 WL 3133943 (D.N.J. July 30, 2012), in which the Court found lack of diligence as 

it pertained to a prior art search that was fully in the hands of Defendants, Shire controlled the 

timetable and withheld key documents, thereby preventing Defendants from asserting the onsale bar defense earlier in the case. 

4

 Judge Waldor’s opinion noted that: “The parties appeared before this Court on August 1, 2013, 

an event in between Defendants’ newly discovered information and their formal request to 

supplement their invalidity contentions.” (D.I. 456 at 6.) Defendants had just formulated their 

on-sale bar position two days before on July 30, 2013. Further, because Defendants were 

continuing to seek invoices from AMRI to confirm the on-sale bar, Defendants did not raise the 

amendment with the Court. 

5 Shire also argues that Defendants should not have included the on-sale bar defense in their 

expert reports. (Shire Br. at 2.) Defendants included that defense in their expert reports to 

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 With respect to undue prejudice, it is undisputed that Judge Waldor made no finding as 

to any prejudice suffered by Shire. While Shire now claims “undue prejudice,” it has not 

presented specific facts supporting that claim. Shire cannot say that it would be prejudiced if 

the litigation – and Shire’s monopoly – continued longer. And Shire cannot say that the trial 

date – which has not yet been set – would be pushed back to its prejudice while it continues to 

enjoy a monopoly. 

In contrast to Shire’s murky claim of undue prejudice, denying the motion to amend 

Defendants’ contentions would severely prejudice Defendants, and the public, by allowing the 

validity of the ‘253 Patent to be determined without consideration of the merits of the on-sale bar 

defense. Dole v. Arco Chem. Co., 921 F.2d 484, 487 (3d Cir. 1990) (explaining that the court 

should use strong liberality in considering whether to grant leave to amend in order to ensure 

that a particular claim will be decided on the merits rather than on technicalities); AS Am., 2013 

WL 4084237, at *4 (granting motion to amend and citing to Chief Judge Brown’s decision to 

grant a motion to amend on the eve of trial because “the [Federal Rules of Civil Procedure and 

Local Patent] Rules should be construed to further the interests of justice.”); Helsinn, 2013 WL 

3336859, at *6 (granting motion to amend because “preventing [Defendants] from presenting all 

of its defenses would not facilitate resolution on the merits.”). 

CONCLUSION 

For the foregoing reasons, Defendants respectfully ask the Court to reverse D.I. 456 

denying Defendants’ Motion to Amend with respect to the on-sale bar defense. 

Dated: January 28, 2014 

Respectfully submitted, 

 

maintain the schedule entered by Judge Waldor on October 3, 2013 (D.I. 403), and to comply 

with their statutory obligation to expedite the action, pursuant to 21 U.S.C. § 355(j)(5)(B)(iii). 

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By: s/Stuart D. 

Sender 

Stuart D. Sender 

Ellen T. Lowenthal 

Kenneth E. Crowell 

BUDD LARNER, PC 

150 John F. Kennedy 

Parkway 

Short Hills, NJ 

07078-2703 

H. Keeto Sabharwal 

Daniel E. Yonan 

Jeremiah B. Frueauf 

STERNE, KESSLER, 

GOLDSTEIN & FOX 

P.L.L.C. 

1100 New York 

Avenue, NW 

Washington, DC 

20005 

Attorneys for 

Defendant 

Amneal 

Pharmaceuticals LLC

By: s/Diane Ragosa 

Diane Ragosa 

Saira B. Haider 

AXINN, VELTROP & 

HARKRIDER LLP 

114 West 47th Street 

New York, NY 

10036 

Jonathan A. Harris 

AXINN, VELTROP & 

HARKRIDER LLP 

900 State House Square 

Hartford, CT 

06103 

Attorneys for Defendants 

Actavis Elizabeth LLC 

and Actavis LLC

By: s/Rachel Blitzer 

Gregory R. Haworth 

DUANE MORRIS LLP 

1037 Raymond 

Boulevard, Suite 1800 

Newark, NJ 07102-5429 

Douglas R. Nemec 

Stacey L. Cohen 

Rachel Blitzer 

SKADDEN, ARPS, 

SLATE, MEAGHER & 

FLOM LLP 

Four Times Square 

New York, NY 10036- 

6522 

Attorneys for Defendants 

Johnson Matthey Inc. 

and Johnson Matthey 

Pharmaceutical 

Materials.

By: s/Eric I. Abraham 

Eric I. Abraham 

Christina L. Saveriano 

HILL WALLACK LLP 

202 Carnegie Center 

Princeton, NJ 08540 

M. Andrew Woodmansee 

Matthew M. D’Amore 

Eric C. Pai 

MORRISON & 

FOERSTER LLP 

12531 High Bluff Drive 

Suite 100 

San Diego, CA 92130-

2040 

Attorneys for Defendant 

Sandoz Inc. 

By: s/Arnold B. Calmann 

Arnold B. Calmann 

Jeffrey Soos 

Geri L. Albin 

SAIBER LLC 

One Gateway Center 

10th Floor, Suite 1000 

Newark, NJ 07102 

Matthew R. Reed 

Katherine Hasper 

WILSON SONSINI 

GOODRICH 

& ROSATI 

650 Page Mill Road 

Palo Alto, CA 94304 

Wendy L. Devine 

WILSON SONSINI 

GOODRICH 

& ROSATI 

12235 El Camino Real 

San Diego, CA 92130 

Attorneys for Defendants 

Mylan Pharmaceuticals 

Inc. and Mylan Inc.

By: s/Mark S. Olinsky 

Mark S. Olinsky 

Theodora McCormick 

SILLS CUMMIS & GROSS 

P.C. 

The Legal Center 

One Riverfront Plaza 

Newark, NJ 

07102 

Alan B. Clement 

Peter Fallon 

LOCKE LORD LLP 

3 World Financial Center 

New York, NY 

10281 

Scott B. Feder 

Myoka Kim Goodin 

Amanda K. Kelly 

LOCKE LORD LLP 

111 South Wacker Drive 

Chicago, IL 60606 

Attorneys for Defendant 

Roxane Laboratories, Inc.

 

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CERTIFICATE OF SERVICE 

I hereby certify that on January 28, 2014, true and correct copies of Reply Brief in 

Support of Defendants’ Notice of Appeal Pursuant to L. Civ. R. 72.1(c)(1) was served on all 

counsel of record via the Court’s ECF System and electronic mail. 

Dated: January 28, 2014 

/s/ Diane C. Ragosa 

Diane C. Ragosa 

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