Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-3_04-cv-03327/USCOURTS-cand-3_04-cv-03327-61/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 28:2201 Declaratory Judgement

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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

THERASENSE, INC.,

Plaintiff,

 v.

BECTON, DICKINSON AND COMPANY,

Defendant. /

AND CONSOLIDATED CASES. 

 /

No. C 04-02123 WHA

Consolidated with

No. C 04-03327 WHA

No. C 04-03732 WHA

No. C 05-03117 WHA

OMNIBUS ORDER ON MOTIONS

FOR FINAL PRETRIAL

CONFERENCE SUBMITTED

WITHOUT ORAL ARGUMENT

INTRODUCTION

This group of now-consolidated patent infringement actions was re-assigned to the

undersigned earlier this year. Since the cases had been set for trial three times (and then

continued), the Court has now given them priority on the trial calender and set them for trial

starting May 27, 2008. All sides filed numerous motions in preparation for the final pretrial

conference. All of the motions have been carefully considered and oral argument is

unnecessary as to the following. This omnibus order resolves all pending motions except those

for which oral argument will be allowed.

BAYER MOTION FOR SUMMARY JUDGMENT (INVALIDITY ’551 PATENT)

DENIED. This motion is not as simple and straightforward as counsel promised. On this

voluminous summary-judgment record, the Court is not yet convinced of the impact of the nowCase 3:04-cv-03327-WHA Document 155 Filed 05/12/08 Page 1 of 8
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controverted sentence in the ’382 patent on the ’551 claims asserted herein. Among other

things, plaintiffs draw a distinction between a membrane being used for whole blood versus

other fluids and how that distinction informs the meaning of the ’382 patent. On this record, the

Court is not yet convinced that the distinction is meritless. Moreover, if the statement made to

the ’551 patent examiner turns out to have been true, could invalidity (as opposed to inequitable

conduct) be found merely because a contradictory (and erroneous) statement made in a different

proceeding was not also revealed to the ’551 examiner?

Bayer has not carried its burden to eliminate all possible issues. This ruling does not

mean that Abbott’s supposed distinction is valid. This ruling is without prejudice to a Rule 50

motion at the close of the evidence, when the matter may be clearer. 

ROCHE MOTION FOR SUMMARY JUDGEMENT (’745 INVALID)

DENIED. As an initial matter, Roche has already made and lost a motion for summary

judgment of non-infringement of the ’745 patent. The present motion is nothing more than an

attempt to get a second bite at the apple and should therefore be denied on that ground alone. In

addition, the Court finds the motion confusing except for pages 9–11. As to the issue on those

pages, Roche has not met its summary-judgment burden to show by clear and convincing

evidence that amperometry is a small genus. Roche primarily relies on the ’745 specification

which discloses that amperometrey includes chronoamperometry and Cottrell-type 

measurements. But nowhere in the ’745 specification or the prior art references relied on by

Roche for its anticipation and obvious arguments does it state that the amperometrey genus is

small or limited. The trial record may be better and clearer so that a verdict of invalidity could

be sustained. 

PLAINTIFFS’ MOTIONS FOR RECONSIDERATION OF JUDGE JENKINS’ SUMMARY JUDGMENT

ORDER

DENIED IN PART. Plaintiffs’ opening memorandum made no effort whatsoever to justify

the motions under Local Rule 7-9(b). In their replies, plaintiffs maintained that such a showing

was not required because the Court had already given them leave to file two motions for

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reconsideration. This is not an accurate statement. During a long hearing on many issues,

plaintiffs’ counsel stated that she wished to file two motions for reconsideration of Judge

Jenkins’ summary judgment order. This came out of the blue. The Court tried to dissuade any

such effort but relented and said plaintiffs could try. The Court assumed that counsel would

justify the motions under our local rule restricting motions for reconsideration. There is no way

the undersigned was in a position to know whether those requirements were satisfied. At no

time did counsel as the Court to waive the requirements. It is unfair for counsel to blame the

judge for their own failure to justify the motions under our local rule. 

BAYER MOTION IN LIMINE NO. 2 (WILLFULNESS)

DENIED. Material fact issues must be resolved by jury. Seagate eliminated an

affirmative obligation to obtain an opinion of counsel. This change in the law occurred in 2007. 

Plaintiffs should be permitted to prove willfulness through ordinary evidence using the new

standard of objective recklessness, assuming the evidence has been disclosed properly or late

disclosure is excused. Bayer raises plausible arguments why the other evidence cited by

plaintiffs is inadmissible. Nonetheless, the Court believes it best to rule on the hearsay and

foundation problems at trial in the traditional manner. Bayer also raises issues of expert

disclosure. Experts will be limited on direct examination to the four corners of their reports. 

Even then, some expert material may be excluded as inadmissible. If a party failed to ask Judge

Jenkins for leave to file a supplemental expert report after Seagate, August 20, 2007, that is its

own fault. It is too late to do so now. Expert opinion, moreover, is not necessarily needed to

prove willfulness.

ROCHE MOTION IN LIMINE NO. 1 (LOST PROFITS)

DENIED AS TO THE ’745 PATENT. Roche’s request to strike Abbott’s entire lost-profits

claim for the ’745 patent is unreasonable. Federal Circuit law makes clear that a patentee must

be permitted to recover any damages it suffered as a result of infringement. Abbott Diabetes

Care, Inc. (“ADC”) is the owner of the ’745 patent. Even assuming that ADC cannot recover

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damages for lost profits of Abbott Diabetes Care Sales Corporation (“ADCSC”), Abbott would

still be entitled to show any lost profits suffered by ADC directly. Eliminating ADC’s entire

lost-profits claim because plaintiffs’ damage expert included ADCSC’s lost profits in his

analysis is a drastic move when ADC’s lost profits are easily ascertainable from the damage

experts’ calculations. At trial, the damage expert will be asked to break up his analysis to

separate ADC’s lost profits from ADCSC’s. Roche maintains that Abbott’s damage expert. Dr.

Ugone, admitted that he was not sure whether he could break up his analysis with the

information he was provided. Dr. Ugone will be permitted to give a supplemental report

including any adjustments needed to separate ADC’s lost profits from ADCSC’s. These

adjustments must be limited to this one change. Defendants may then depose Dr. Ugone up to

two hours by May 21, 2008. The Court will then decide whether ADCSC’s lost profits should

be considered. This ruling only applies to the ’745 patent.

ROCHE MOTION IN LIMINE NO. 3 (JOHNSON)

DENIED. The deposition quote is subject to interpretation and should be laid before the

jury. This is without prejudice to a Rule 50 motion if Johnson performs poorly on

cross-examination and other evidence fails to fill the gap. 

PLAINTIFFS’ UNNUMBERED MOTION IN LIMINE

TO EXCLUDE IMPROPER LEGAL TESTIMONY FROM PATENT LAW EXPERTS

DENIED. Of course, it is the Court’s job to determine the governing law. Since,

however, both side’s views of the inequitable conduct issue rests on a mix of fact and duty, it

would be useful to hear the precise statement of the alleged duty so that the Court may discount

the experts’ opinions if excessive views of the legal duty have been assumed. This issue is for

the judge, so no harm will be done in hearing out the legal regulatory framework supposedly

behind the experts’ testimony. To the extent the jury also hears the testimony, curative

instructions will eventually correct any misstatement of the law by the experts. 

In a separate argument, Abbott contends the law experts should not be permitted to say

what was and was not material since they are not persons of ordinary skill in the art, that is, that

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they should stick to PTO practice points and not veer off into science. While this argument has

considerable appeal and would be true in many contexts, it is not always true. Some issues of

materiality may be so independent of scientific complexity that even patent lawyers can

understand them. If, for example, a inventor swears in a later application that a given formula

was always true, he would normally be obligated to reveal that he had sworn in an earlier

separate application that the same formula was never true. When the contradiction is manifest,

scientists are not needed to explain it. On the other hand, if scientists are needed to explain or

set up the contradiction, then mere lawyers should refrain from purporting to explain the science

part. 

The present case is as follows. Abbott contends that in 1983 persons of ordinary skill in

the art believed that a membrane around the active electrode was essential to perform accurate

measurements using whole blood. The ’551 patent, it seems, revealed a way to conduct tests in

whole blood without a membrane. An earlier patent also controlled by Abbott — the ’382

patent — supposedly (says Abbott) disclosed tests without a membrane but only in cases other

than whole blood. The only ’382 tests with whole blood used a membrane. Supposedly, the

only sensors described in the ’382 patent in which membranes were optional were for fluids

other than whole blood and for whole blood where a filtering member was used in place of a

membrane. The non-controverted sentence in the ’382 patent specification stated:

Optionally, but preferably when being used on live blood, a

protective membrane surrounds both the enzyme and the

mediator layers, permeable to water and glucose molecules. 

Abbott contends that this did not mean that a membrane was optional to surround the active

electrode when used with whole blood. Nonetheless, in the ’551 prosecution, this sentence

troubled the examiner and the applicant had a hard time getting around it. According to a 1997

interview summary, Abbott eventually convinced the examiner that the ’382 patent required a

membrane with whole blood and that the sentence in question was not to the contrary. To

convince him, Abbott’s Sanghera gave a sworn statement to the PTO stating that at the time of

the ’382 patent

one skilled in the art would have felt that an active electrode

comprising an enzyme and a mediator would require a

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protective membrane if it were to be used with a whole

blood sample. 

The patent in suit then issued. 

Trouble was, as to the very same sentence, Sanghera evidently knew all along that his

company had earlier stated as follows to the European Patent Office: 

It is submitted that this disclosure is unequivocally clear. 

The protective membrane is optional, however, it is

preferred when used on live blood in order to prevent the

larger constituents of the blood, in particular erythrocytes

[red blood cells] from interfering with the electrode sensor. 

This statement had been made by Abbott’s predecessor to save the European counterpart to the

’382 patent from an invalidity challenge, a circumstance in which the patent applicant had an

incentive to put the opposite meaning on the sentence. Defendants now say the last two

constructions of the sentence in question flatly contradict each other. One of the central issues

is whether Sanghera violated a duty of candor by submitting one such statement without

disclosing the other, all bearing on the meaning of the very sentence that had troubled the

examiner. 

This issue turns on a single sentence and two interpretations of it. For the most part, the

sentence and the two interpretations can be understood without resort to science, for a crucial

issue is whether the two interpretations were at war with one another. Therefore, lawyers

skilled in practice before the PTO and familiar with how the duty of candor works in practice

should be allowed to opine on whether both should have been revealed to the PTO. The lawyer

witnesses, however, should stop short of trying to explain the underlying science. 

It bears repeating that no expert of any kind will be allowed to speculate as to anyone’s

subjective intent or knowledge. The experts can point to evidence bearing on these issues, such

as a deposition admission or smoking-gun memo to file, but they cannot submit speculation or

argument on subjective intent and knowledge. It will be helpful and allowed for the experts to

explain why they think the earlier “contradictory” statement needed to be disclosed to the PTO

(or not) and to explain PTO practice and procedure. 

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PLAINTIFFS’ UNNUMBERED MOTION IN LIMINE

TO EXCLUDE UNRELIABLE TESTIMONY FROM DEFENSE PATENT LAW EXPERTS

DENIED. As to Smegal, the Court would like to hear the pros and cons from both side’s

experts on whether the PTO duty of candor required Abbott, Sanghera, or Pope to disclose the

“contradictory” statement made earlier to the EPO about the meaning of the sentence in

question, given that Sanghera with Pope’s blessing made allegedly contradictory statements to

the PTO. The immediately preceding sentence is subject to the more paramount rule that all

experts will be limited on direct examination to the four corners of their report. If an expert

failed to include a theory in his or her report, then, the expert may not testify on direct

examination to the new theory. If opposing counsel, however, “opens the door” on cross

examination, however, then the expert may address issues beyond those in the report. 

Contrary to plaintiff the Smegal report (¶¶ 101–102) does argue that Pope and Sanghera

had a duty under Rule 56 to disclose the prior inconsistent statement (assuming it was

inconsistent). Plaintiff argues that Bayer is resorting to a new theory but the undersigned does

not detect a new theory. Again, as the experts testify, the undersigned will follow along with

the expert report and will sustain any objection that the expert is adding a new point not in the

report, at least on direct examination. 

The Court will sort out what the duty of candor does and does not require and what the

word “cumulative” means or does not mean after it hears out both side’s experts. To the extent

the jury hears it as well, the Court will override any incorrect statements of the law by the

experts with curative instructions. 

As to Kunin, it is for the Court, not the expert, to apply the proper standard of proof. As

to whether the ’465 publication is cumulative of other prior art, the Abbott submission is too

sketchy to grasp the issue. As to the ’745 patent, no expert will be allowed to testify as to

knowledge and/or intent. Expert Kunin, therefore, cannot be faulted for not alleging that Liepa

or Black knew of the ’465 publication or its materiality. Knowledge and intent must be decided

by the judge based on all the facts and circumstances. Kunin can testify as to why he thinks the

duty of candor required disclosure of the ’745 and why. The Court will like to hear the analysis 

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as well as the counter-analysis. The submission has not carried its burden to show that the line

of testimony is inadmissible. 

IT IS SO ORDERED.

Dated: May 12, 2008. WILLIAM ALSUP

UNITED STATES DISTRICT JUDGE

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