UNITED STATES DISTRICT COURT

DISTRICT OF NEW JERSEY

__________________________________________

:

SHIRE, LLC et al., :

:

Plaintiffs, : Hon. Stanley R. Chesler, U.S.D.J.

: Civil Action No. 11-3781 (SRC)

v. : (Consolidated)

:

AMNEAL PHARMACEUTICALS, LLC et al., : OPINION & ORDER

:

Defendants. :

__________________________________________:

:

SHIRE, LLC et al., :

:

Plaintiffs, :

:

v. : Civil Action No. 12-83 (SRC)

:

WATSON LABORATORIES, INC. et al., :

:

Defendants. :

__________________________________________:

CHESLER, U.S.D.J.

This matter comes before the Court on Defendants’ appeal of the non-dispositive order by

Magistrate Judge Waldor, entered on December 26, 2013, denying Defendants’ motion to amend

their invalidity contentions to include an “on-sale bar” claim. For the reasons set forth below, the

order will be affirmed.

A Magistrate Judge’s non-dispositive order may be set aside if it is clearly erroneous or

contrary to law. 28 U.S.C. § 636(b)(1)(A). Here, Defendants contend that Magistrate Judge

Waldor’s decision should be reviewed under a de novo standard “because it is based upon a

misinterpretation or misapplication of law.” (Defs.’ Br. 4.) Defendants are clearly incorrect. A

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careful review of Magistrate Judge Waldor’s decision indicates that it neither misinterprets nor

misapplies this district’s local civil rules. Magistrate Judge Waldor correctly and cogently

explained that the precedent governing the interpretation of the local patent rules is set by the law

of the Federal Circuit, and that the Local Patent Rules are designed to encourage parties to

provide early notice of their infringement and invalidity contentions, and to proceed with

diligence in amending those contentions when new information comes to light in the course of

discovery. O2 Micro Int'l, Ltd. v. Monolithic Power Sys., 467 F.3d 1355, 1364-66 (Fed. Cir.

2006). Moreover, as the opinion indicates, the Local Patent Rules emphasize “ultra early

disclosure of infringement and invalidity contentions for patent cases arising under the

Hatch-Waxman Act.” Sanofi-Aventis v. Barr Labs., 598 F. Supp. 2d 632, 637 (D.N.J. 2009)

(emphasis added). 

Here, Magistrate Judge Waldor balanced the factors governing applications to amend

contentions carefully and deliberately. Her conclusion that Defendants’ application to amend

was not timely brought is amply supported by the evidence of record before her. She properly

concluded that Defendants did not seek to amend their contentions until months after they

concededly had all the information which they needed. She likewise properly concluded that the

Defendants had not been diligent in seeking information relating to the on-sale bar. In fact, the

record reflects no real diligence in pursuing information concerning this issue. 

Finally, Magistrate Judge Waldor properly reviewed the prejudicial impact the

amendment would have. Defendants moved to amend their contentions just nine days before fact

discovery closed. Granting this application would have required major adjustments to the pretrial schedule – clearly to Plaintiffs’ prejudice, given the time-sensitive nature of Hatch-Waxman

2

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cases. 

Magistrate Judge Waldor is clearly correct in concluding that Defendants’ explanations

for the proposed amendment were too little and too late, given the stage of the litigation. This

Court is satisfied that Magistrate Judge Waldor’s decision was neither clearly erroneous nor

contrary to law, and that she correctly and fairly applied our local rules in reaching her decision. 

Her decision will be affirmed.

For the reasons stated above,

IT IS on this 12th day of May, 2014 

ORDERED that Defendants’ appeal (Docket Entry No. 461) of Magistrate Judge

Waldor’s order issued on December 27, 2013 is DENIED; and it is further 

ORDERED that Magistrate Judge Waldor’s order issued on December 27, 2013 (Docket

Entry No. 457) is hereby AFFIRMED. 

 s/ Stanley R. Chesler 

Stanley R. Chesler, U.S.D.J.

3

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