United States District Court

For the Northern District of California

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IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF CALIFORNIA

CHIRON CORPORATION,

Plaintiff,

 v.

SOURCECF, INC., SOURCECF CLINICAL

RESEARCH & DEVELOPMENT, L.L.C.,

MAXOR NATIONAL PHARMACY

SERVICES CORPORATION d/b/a IV

SOLUTIONS, FOUNDATION CARE L.L.C.,

and PHARMACEUTICAL SPECIALTIES,

INC.,

Defendant. /

No. C 05-01938 WHA

ORDER DENYING

DEFENDANTS’ MOTION TO

PERMIT FILING OF FIRST

AMENDED ANSWER AND

COUNTERCLAIM

In this patent-infringement action, defendants now seek leave to amend their answer to

add for the first time the affirmative defenses of non-infringement, prosecution-history estoppel,

patent invalidity for indefiniteness and patent misuse and to assert a counterclaim for

declaratory judgment with respect to non-infringement and patent invalidity. Good cause has

not been shown to allow this eleventh-hour request. Defendants’ motion is DENIED.

STATEMENT

On May 10, 2005, plaintiff initiated this patent-infringement action. Plaintiff alleged

that defendants willfully infringed U.S. Patent No. 6,890,907. The first case-management order

was issued July 14, 2005. Therein, it stated that “any new parties or pleading amendments must

Case 3:05-cv-01938-WHA Document 77 Filed 01/19/06 Page 1 of 3
United States District Court

For the Northern District of California

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be sought by AUGUST 19, 2005” (Case Management Order)(emphasis in original). 

Defendants filed their answer on September 28, 2005 denying infringement. No affirmative

defenses of non-infringement, prosecution-history estoppel, patent invalidity for indefiniteness

or patent misuse were alleged at that time. Nor was there a counterclaim for declaratory

judgment. 

During the hearing on November 30, 2005, it appeared that this case had been fully

resolved except for the issue of whether defendants’ new 50 mg/ml tobramycin formulation

infringes the patent at issue. The parties jointly represented that no claim construction was

necessary. Due to the limited issue to be tried, the schedule was revised. The trial was moved

forward from September 5, 2006 to April 17, 2006. 

Defendants filed the present motion for leave to amend on December 13, 2005. 

ANALYSIS

1. LEGAL STANDARD.

Leave to amend a complaint shall be freely given when justice so requires under Federal

Rule of Civil Procedure 15(a). Rule 15(a), however, does not apply when a district court has

established a deadline for amended pleadings under Rule 16(b). See Johnson v. Mammoth

Recreations, Inc., 975 F.2d 604, 607-08 (9th Cir. 1992). Once a scheduling order has been

entered, subsequent amendments are not allowed without first a request to modify the

scheduling order. Id. at 608-09. A party’s failure to seek modification for the scheduling order

is a ground to deny the untimely motion. Ibid. (citation omitted). Even if sought, any

modification must be based on a showing of good cause. 

Rule 16(b)’s ‘good cause’ standard primarily considers the diligence of the party

seeking the amendment. . . . Although the existence or degree of prejudice to the

party opposing the modification might supply additional reasons to deny a

motion, the focus of the inquiry is upon the moving party’s reasons for seeking

modification. If that party was not diligent, the inquiry should end.

Id. at 609 (citation omitted).

2. FAILURE TO SHOW DILIGENCE.

In the present motion, defendants contend that the reason their answer did not contain

assertions of non-infringement or invalidity was because they agreed to stop filling

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prescriptions at concentrations of 95 mg/ml of tobramycin. Defendants now seek leave to

amend their answer to add the affirmative defenses of non-infringement, prosecution-history 

estoppel, patent invalidity for indefiniteness and patent misuse and to assert a counterclaim for

declaratory judgment.

The deadline for seeking leave for pleading amendment was August 19, 2005. 

Defendants have not asked leave for modification of the scheduling order. This is ground for

denial. Id. at 608-09.

In addition, defendants have not shown diligence in seeking this amendment. The

complaint was filed on May 10, 2005. The complaint clearly identified the ’907 patent as the

patent at issue. Patents are publicly available. There is no reason why defendants, at that time,

could not have alleged non-infringement or invalidity due to indefiniteness of the phrase “about

60 mg/ml to about 200 mg/ml of tobramycin.”

Defendants’ claim of patent misuse is also untimely. At the very least, defendants were

aware on October 20, 2005 that plaintiff would likely consider a concentration of 50 mg/ml of

tobramycin to be infringing. It is unclear why defendants delayed bringing this motion until

December 13, 2005.

Amendment at this stage of the proceedings is not warranted for the additional reason

that it would seriously prejudice plaintiff. For instance, the non-expert discovery cut-off date is

February 24, 2006 and the trial date is quickly approaching. It would be particularly difficult to

complete discovery on all these new issues.

CONCLUSION

For these reasons, this motion is DENIED.

IT IS SO ORDERED.

Dated: January 19, 2006 WILLIAM ALSUP

UNITED STATES DISTRICT JUDGE

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