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No. C 05-01938 WHA 1 

Defendants’ Trial Brief 

Howard A. Janssen (State Bar No. 045385) 

Richard P. Doyle, Jr. (State Bar No. 112459) 

JANSSEN DOYLE, LLP 

2540 Camino Diablo, Suite 220 

Walnut Creek, CA 94597 

Telephone: (925) 295-1805 

Facsimile: (925) 295-1801 

Attorney for Defendants 

UNITED STATES DISTRICT COURT 

FOR THE NORTHERN DISTRICT OF CALIFORNIA 

CHIRON CORPORATION, a Delaware 

corporation, 

Plaintiff, 

 vs. 

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., 

Defendants. 

Civil Action No: C 05-01938 WHA 

 

 DEFENDANTS’ TRIAL BRIEF

I. INTRODUCTION 

 There are five defendants in this case. Three (Maxor National Pharmacy Services Corp., 

Foundation Care, L.L.C. and Pharmaceutical Specialties, Inc. [hereafter, the Pharmacy 

Defendants]) are pharmacies that have operated in the United States for many years. As part of 

their professional duties, they have filled prescriptions for a variety of drugs used in a product 

called the eFlow nebulizer, a newly patented device cleared for marketing and use. 

The remaining two defendants are SourceCF companies, one of which has licensed and 

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No. C 05-01938 WHA 2 

Defendants’ Trial Brief 

A.

distributes the eFlow nebulizer. Chiron is now asserting infringement of eight different patent 

claims against the five defendants in different combinations. Charts setting out those issues now 

before the Court are attached hereto as Exhibit 1. 

Defendants submit that Chiron cannot meet its burden of proof as to any of the asserted 

causes of action and claims of patent infringement. Chiron cannot demonstrate the required 

showing of underlying direct infringement, either literal or under the doctrine of equivalents; nor 

can it demonstrate indirect infringement by any of these five entities. 

Many of the legal issues remaining for trial are addressed in Defendants’ motions in 

limine, which were prepared before Chiron very recently waived damages and a jury, and 

dropped several of its asserted patent claims. While the Court’s standing order states that 

motions in limine are seldom useful in bench trials, in this case Defendants believe that ruling on 

those motions will demonstrate that Chiron simply cannot prove its case. 

The remainder of this brief will address the evidence applicable to the elements of the 

various causes of action that Chiron alleges, as set out in the Joint Pretrial Statement. 

 Direct Infringement 

In the Joint Pretrial Statement, Chiron identifies the Pharmacy Defendants as the only 

alleged direct infringers. The factual issue, as identified by Chiron, is whether the Pharmacy 

Defendants directly infringe the ‘907 patent: 

“... by formulating, selling and marketing compounded tobramycin solutions at 

concentrations of 50 mg/ml and 40 mg/ml for use with a nebulizer called the eFlow®, 

and instructing doctors and patients how to use these tobramycin formulations with the 

eFlow®.” 

 The underlined activities noted above do not, as a matter of law, constitute practicing the 

method of the claims of the ‘907 patent: "The law is unequivocal that the sale of equipment to 

perform a process is not a sale of the process within the meaning of section 271(a)." Joy Techs., 

Inc. v. Flakt, Inc., 6 F.3d 770, 773 (Fed.Cir.1993). Similarly, in Mendenhall v. Cedarapids, Inc., 

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No. C 05-01938 WHA 3 

Defendants’ Trial Brief 

B.

1.

2.

5 F.3d 1557, 1579 (Fed.Cir. 1993), cert. denied, 114 S. Ct. 1540 (1994), the Federal Circuit 

emphasized that a person cannot directly infringe a method claim by manufacturing and selling 

an apparatus capable for carrying out the method. So (separate and apart from Defendants’ 

denial of infringement and their assertion of defenses to infringement, discussed later) direct 

infringement cannot be found here. 

Indirect Infringement

Without Direct Infringement, There Can Be No Indirect Infringement

 Since Chiron cannot establish direct infringement by the Pharmacy Defendants and since 

they are the only persons or entities alleged in the Joint Pretrial to infringe directly, this Court 

need go no further. Absent direct infringement, there can be no potential liability of any of the 

Defendants for indirect infringement. Met-Coil Sys. Corp. v. Korners Unlimited, Inc., 803 F.2d 

684, 687 (Fed. Cir. 1986) [“Absent direct infringement of the patent claims, there can be neither 

contributory infringement, [Citation omitted], nor inducement of infringement, [Citation 

omitted].” In accord, Moba, B.V. v. Diamond Automation, Inc. 325 F.3d 1306, 1318 (Fed. Cir. 

2003). 

 If the Court does, however, find factual issues concerning the requisite underlying direct 

infringement, then there are two types of indirect infringement to be considered: inducement of 

infringement and contributory infringement. Met-Coil Sys. Corp., 803 F.2d at 687 These are 

separate statutory causes of action, each requiring separate elements to be proved. 

Inducement 

To prove inducement, Chiron needs to prove that: “defendant[s] possessed specific intent 

to encourage another’s infringement and not merely that the defendant[s] had knowledge of the 

acts alleged to constitute inducement. The plaintiff has the burden of showing that the alleged 

infringers’ actions induced infringing acts and that [they] knew or should have known [their] 

actions would induce actual infringement.” Manville Sales Corp. v. Paramount Systems, Inc. 

917 F.2d 544, 553 (Fed. Cir. 1990) citing Water Technologies Corp. v. Calco, Ltd., 850 F.2d 

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Defendants’ Trial Brief 

a.

660, 668 (Fed. Cir. 1988). 

Another widely cited statement of the required proof is: “[T]o sustain a claim of 

inducement, the plaintiff must establish that the defendant purposefully caused, urged, or 

encouraged another individual to infringe plaintiff’s patent with knowledge of the likely 

infringing result.” Oak Industries, Inc., v. Zenith Electronics Corp., 697 F. Supp. 988 (N.D. Ill. 

1988). Under the evidence in this case there can be no showing of that requisite intent, either as 

to the Pharmacy Defendants or as to the SourceCF defendants. 

Inducement as to the SourceCF Defendants 

SourceCF CR&D only supplies the eFlow nebulizer to the Pharmacy Defendants for use 

with any drug or protocol as prescribed by a physician. As the Federal Circuit has stated under 

like facts: “ ... if a physician, without inducement by [drug company], prescribes a use of [drug] 

in an infringing manner, [drug company’s] knowledge is legally irrelevant.” Warner-Lambert 

Co. v. Apotex Corp., 316 F.3d 1348, 1364 (Fed. Cir. 2003). SourceCF occupies the same 

position as the drug company in the cited case. So Chiron simply cannot meet this element of 

inducement by the SourceCF defendants, under the facts here. 

b. Inducement as to the Pharmacy Defendants

 As to the Pharmacy Defendants, there is likewise no showing in the evidence of the 

element of purposeful intent to induce infringement. In fact, the evidence is completely to the 

contrary. 

 When the Pharmacy Defendants learned of the ‘907 patent (a prerequisite to liability for 

inducement), they immediately contacted Chiron to see if there was a business solution that 

could protect those few patients prescribed the eFlow nebulizer with 100mg/ml of tobramycin. 

When the parties were unable to find a resolution, the Pharmacy Defendants: (1) ceased selling 

that formulation; and (2) took the unusual step of moving for a permanent injunction themselves, 

so that the lawsuit would be over. 

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No. C 05-01938 WHA 5 

Defendants’ Trial Brief 

3.

 

 These steps are the antithesis of purposeful inducement.1 

 When the Pharmacy Defendants continued thereafter to dispense formulations of 40 

mg/ml and 50 mg/ml of tobramycin, the evidence will show that they did so in good faith, 

relying upon the claim language of the ‘907 patent claim, and their confirmation through the 

advice of counsel that these new concentrations were not infringing. That good faith reliance 

upon the advice of counsel negates the intent necessary as a prerequisite to liability for 

inducement. Micro Chemical, Inc. v. Great Plains Chemical Co., Inc., 194 F.3d 1250, 1261 

(Fed. Cir. 1999). So nothing Defendants did, at any time, constituted inducement of 

infringement. 

Contributory Infringement 

To prove contributory infringement, Chiron needs to show that the defendants knew that 

the nebulizers they provided to the patients were especially made or adapted for practicing 

Chiron’s ‘907 patent; and that those nebulizers are not a staple article suitable for a substantial 

noninfringing use. Oak Industries, Inc., v. Zenith Electronics Corp., 697 F.Supp. 988, 994 (N.D. 

Ill. 1988). See also 35 U.S.C. §271(c): “Whoever offers to sell or sells within the United States 

or imports into the United States a ...material or apparatus for use in practicing a patented 

process, constituting a material part of the invention, knowing the same to be especially made or 

especially adapted for use in an infringement of such patent, and not a staple article or 

commodity of commerce suitable for substantial noninfringing use, shall be liable as a 

contributory infringer.” 

 Chiron’s assertions of contributory infringement fail against all defendants. 

1

 This was never intended as a concession of infringement; but rather it was a business decision not to fight Chiron in 

litigation. As hereafter noted, the Pharmacy Defendants believed they could still provide formulations outside of the 

claimed parameters. 

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No. C 05-01938 WHA 6 

Defendants’ Trial Brief 

a.

b.

The eFlow nebulizer was not especially made or adapted for 

practicing Chiron’s ‘907 patent 

The evidence will show that the eFlow nebulizer was made and being used prior to the 

issuance of the ‘907 patent. Therefore, the record is undisputed that the eFlow nebulizer was not 

especially made for practicing the ‘907 patent. 

The evidence will also show that the eFlow nebulizer was not adapted for practicing the 

‘907 patent. In fact, it is used without change or adaptation for the many drugs which are 

currently being prescribed in the eFlow nebulizer. The fact that neither of these requirements of 

Section 271(c) can be established should end the inquiry as to contributory infringement. 

The eFlow nebulizer is a staple article suitable for a substantial noninfringing use. 

Additionally, the challenged eFlow nebulizer is suitable for, and currently has, substantial 

non-infringing uses. The Supreme Court has found that one additional use, comprising the 

majority of use, was sufficient to meet the substantial noninfringing use requirement. Sony 

Corp. v. Universal City Studios, 464 U.S. 417 (1984). 

That test is more than met in this case. Defendants’ Motion In Limine #4 on this issue 

describes some of the many medications for which the eFlow nebulizer has been used by 

patients. Here, the eFlow nebulizer is capable of delivering medicine of a nearly limitless 

formulation (specific drug, drug concentration, pH, osmolality, and pharmaceutical carrier) to 

treat a variety of pulmonary indications; and the evidence will show that it is in fact currently 

used to deliver over 10 medicines to patients. 

Chiron has simply dodged this issue in its response to the pending Motion In Limine. 

Defendants submit that there is no credible evidence to support Chiron’s position on these 

elements of proof of contributory infringement. 

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No. C 05-01938 WHA 7 

Defendants’ Trial Brief 

c.

C.

1.

Summary as to Contributory Infringement 

Neither of these requirements, which exist in the conjunctive, can be met by Chiron based 

on the record in this case. So these contentions cannot be proved, and there is no contributory 

infringement. This Court can so find as a matter of law. 

Direct Infringement: Under The Doctrine of Equivalents 

Returning to issues related to direct infringement, another issue for trial in this case is 

Chiron’s assertion of infringement under the doctrine of equivalents. Infringement under the 

doctrine of equivalents occurs when a claimed limitation and the accused product perform 

substantially the same function in substantially the same way to obtain substantially the same 

result. See Warner-Jenkinson Co. v. Hilton-Davis Chem. Co., 520 U.S. 17, 40, 117 S.Ct. 1040, 

137 L.Ed.2d 146 (1997). 

Significantly, Warner-Jenkinson requires that, as to this three-part test: “The 

determination of equivalence should be applied as an objective inquiry on an element-by-element 

basis.” 520 U.S. at p. 40. As the Federal Circuit has succinctly put it: “The doctrine of 

equivalents must be applied on an element by element basis.” Phillips Petroleum Co. v. 

Huntsman Polymers Corp., 157 F.3d 866, 877 (Fed. Cir. 1998). 

Specification Disclaimer Estoppel 

Critical to the disposition of Chiron’s assertions under the doctrine of equivalents is 

Defendants’ Motion In Limine #2. It notes that the law prevents Chiron from recapturing by way 

of the doctrine of equivalents concentrations of tobramycin below 60 mg/ml, which were 

explicitly disclaimed by Plaintiff in U.S. patent 5,508,269 (‘269). It is well established that 

where a patentee disclaims a structure, condition, range, or other embodiment of an invention, it 

cannot invoke the doctrine of equivalents to recapture that particular embodiment. SciMed Life 

Systems, Inc. v. Advanced Cardiovascular Systems, Inc., 242 F.3d 1337 (Fed. Cir. 2001). 

The substance of Motion #2 is that the ‘907 patent specifically incorporates by reference 

in its entirety Chiron’s prior ‘269 patent which states in column 8, lines 27-30:

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No. C 05-01938 WHA 8 

Defendants’ Trial Brief 

2.

D.

“The dose lower than 60 mg of tobramycin per ml of diluted saline is not sufficient to suppress 

the bacterium and to treat the infection. Lower concentrations of tobramycin will not be 

sufficiently effective in at least 90% of patients.” 

 Thus, Defendants submit that the ‘907 patent specifically disclaims any concentration 

below 60 mg/ml. If that motion is granted, Defendants submit that Chiron cannot possibly 

prevail as to the doctrine of equivalents, because it has disclaimed concentrations below 60 

mg/ml. 

 

Analyzing Equivalents In Light of the Fact Chiron Cannot Get the Invention 

of the ‘907 Patent to Work 

Another issue at trial concerning the doctrine of equivalents is that Chiron has moved to 

exclude evidence that it does not offer a product that incorporates the technology of the ‘907 

patent. The fact that Chiron could not get its invention to work is clearly relevant to whether the 

eFlow nebulizer performs “substantially the same function in substantially the same way to 

obtain substantially the same result.” So Defendants believe it is important to look at any 

claimed commercial embodiments of the patented technology, or the lack of same. 

 As Defendants argue in their opposition to that motion, the proper inquiry under the 

doctrine of equivalents as to result is to compare the concentration of medication in the eFlow 

nebulizer being used to treat a patient with the invention of the ‘907 patent. A study of the 

products incorporating that patent is certainly a necessary part of that analysis. 

 Willful Infringement 

 The defendants do not infringe. There is no direct infringement, either literal or under the 

doctrine of equivalents. There is certainly no willful infringement: when defendants had 

knowledge of Chiron’s patents and assertions, they acted reasonably. That reasonableness is 

evidenced, among other things, by the fact that voluntarily stopped dispensing prescriptions at 

one concentration, and switched to dispensing concentrations that they believed in good faith 

were outside of the language of the claims, as confirmed by the opinion of competent legal 

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No. C 05-01938 WHA 9 

Defendants’ Trial Brief 

I

A.

B.

counsel. Defendants made a reasonable determination that they could continue to fill 

prescriptions received from a physician for patients. 

I. ADDITIONAL ISSUES 

 Issues At Trial Concerning Safety And Efficacy 

Defendants have filed Motion In Limine #3 to exclude evidence as to whether 

Defendants’ accused device and/or formulations, both separately and/or in combination with 

each other, have been independently proven to be safe or effective. Evidence concerning whether 

these formulations have been proven to be safe or effective is not, Defendants assert, relevant to 

the issue of patent infringement. 

 The Court’s resolution of this motion will have a substantial impact on the necessary trial 

time, as well as the breadth and complexity of the issues before the Court. 

Literal Infringement Issue: Claim Construction is Over 

 As noted in Defendants’ Motion In Limine #1, Chiron seeks, inappropriately, to restate 

the patent’s claim language to encompass the total dosage of drug being prescribed, rather than 

the concentration. Defendants there move to exclude evidence as to the total milligram dosage of 

tobramycin delivered by Defendants’ accused formulations. Such evidence is not relevant 

because the claims of the ‘907 patent at issue do not set forth a total milligram dosage of 

tobramycin as a claim element or a treatment parameter. The Court will need to resolve this issue 

prior to hearing evidence concerning literal infringement. 

 Additionally, the evidence will show that the accused formulations of 40 mg/ml and 50 

mg/ml do not literally infringe the element at issue, which covers “about 60 mg/ml to 200 mg/ml. 

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Defendants’ Trial Brief 

C. Even if Chiron were able to meet its burden of proof as to its claims of literal 

infringement, the reverse doctrine of equivalents applies here. 

 As the Federal Circuit stated in Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 

1313, 1351 (Fed. Cir. 2003), italics added below: “Under the reverse doctrine of equivalents, an 

accused product or process that falls within the literal words of a claim nevertheless may not 

infringe if the product or process "is so far changed in principle from a patented article that it 

performs the same or a similar function in a substantially different way." Graver Tank & Mfg. 

Co. v. Linde Air Prod. Co., 339 U.S. 605, 608-09, 70 S.Ct. 854 ... (1950).” The Amgen opinion 

continues: “This doctrine is equitably applied based upon underlying questions of fact, [Citation 

omitted], when the accused infringer proves that, despite the asserted claims literally reading on 

the accused device, "it has been so changed that it is no longer the same invention. [Internal 

Citation omitted].” 

 Defendants will demonstrate that, as compared to the described or actual embodiment of 

Chiron’s patented technology, utilizing the eFlow nebulizer results in delivering medication in a 

way that has been so changed that it is no longer the same invention as claimed in the ‘907 

patent. This defense to literal infringement bars these claims, even if Chiron meets its prima 

facie case at trial, which Defendants assert it cannot. 

D. Background Concerning Chiron’s Demand For Injunctive Relief 

 Chiron is trying to protect its almost ten-year-old TOBI product and the slow, outdated 

nebulizer with which it must be used. In its over-zealousness, Chiron is going after the use of 

eFlow nebulizer alone and with any concentration of tobramycin (even though a specific 

concentration range is called for in the ‘907 patent), or with the use of any other drug (even 

thought the ‘907 patent is specific to tobramycin). 

Today, Chiron has no new generation nebulizer to answer the needs of cystic fibrosis 

patients as promised in the ‘907 patent. 

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No. C 05-01938 WHA 11 

Defendants’ Trial Brief 

E. Chiron’s Intent In Bringing and Perpetuating This Litigation 

But Chiron comes to this bench trial seeking equitable relief: a permanent injunction. One 

issue before the Court, by way of an in limine motion filed by Chiron, concerns its seeking to 

exclude evidence as to Chiron’s alleged intent in pursuing this litigation. 

 As stated in Mylan Pharmaceuticals, Inc. v. Thompson, 268 F.3d 1323, 1331: “Defenses 

to allegations of patent infringement fall into two broad groups: statutory and equitable. ... The 

equitable defenses include unclean hands ....” So Chiron’s unclean hands are a potential defense 

to its request for a permanent injunction. 

 It is black letter law that: “Bad intent is the essence of the defense of unclean hands.” 

Dollar Systems, Inc. v. Avcar Leasing Systems, Inc., 890 F.2d 165, 173 (9th Cir. 1989). As set 

forth in its separately submitted Introduction to this Opposition, Defendants will seek to prove 

that Chiron’s entire pattern and practice, in its multiple suits filed against the Defendants, has 

been to push far beyond the boundaries of retaining a right to exclude the practice of the patent in 

suit. It is the essence of Defendants’ defense to assert Chiron’s bad intent. 

 Chiron’s intent should indeed be weighed as part of the equities here, since Chiron is 

requesting injunctive relief which challenges the health of children and these young teens who 

may be better served by this new generation of patented nebulizer. 2 It is due to these inhaled 

antibiotics that children and young teens with cystic fibrosis are now, for the first time in history, 

able to live a more normal life. 

 First, Chiron wants children and those entering their teenage years, the principal group of 

non-compliant cystic fibrosis patients who are at greatest risk, to stop using the eFlow. Thus, 

these patients who need tobramycin to prevent irreversible loss of pulmonary capacity will only 

have access to Chiron’s TOBI product. It is because of the inconvenience of the other nebulizer 

 

2

 So why has Chiron been hounding the defendants with repeated litigation for the last two years? By way of 

background, the first lawsuit was filed in 2004 as an alleged safety and efficacy case, which the defendants resolved 

by adding a disclaimer to its website and certain literature. The current lawsuit was filed on May 10, 2005 (the day 

of issuance of the patent) as a patent infringement case directed to the pharmacists’ use of 100mg/ml of tobramycin, 

which the defendants resolved by voluntarily agreed to stop using 100mg/ml of tobramycin, and to switch to a 

concentration below the covered “about 60mg/ml” of tobramycin. Chiron again asserted its ‘907 patent in regard to 

50mg/ml of tobramycin and then 40mg/ml of tobramycin in what, is in effect, a third lawsuit. 

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Defendants’ Trial Brief 

F.

G.

that is used to administer TOBI that many of these patients would rather skip doses, miss days of 

therapy or not complete therapy rather than take the time required to nebulize TOBI. 

Second, and of huge importance to the equities of this case, Chiron wants to make sure 

that no one has an eFlow nebulizer for any medication (even though the claims of the ‘907 patent 

are limited to a specific concentration of tobramycin, not use of a device for other purposes). 

Chiron is trying to sterilize the market, by having the eFlow taken away from any patient for 

whom it was prescribed for use with the many drugs that are clearly outside of the ‘907 patent. 

Chiron’s request for equitable relief to get the eFlow nebulizer off the market will punish 

all patients, whether on tobramycin or not. 

Public Interest Considerations

 Another issue that would be before the Court, if Chiron prevails at trial, is that this Court 

has the discretion to deny the request for injunctive relief. Rite-Hite Corp. v. Kelley, Inc., 56 F.3d 

1538, 1547 (Fed.Cir.1995) (en banc) (Nevertheless, "courts ... in rare instances [have] exercised 

their discretion to deny injunctive relief in order to protect the public interest."). The reality is 

that Chiron’s litigation history with the Defendants, the scope of relief being requested, and the 

needs of patients create such a “rare instance” warranting the Court to exercise its discretion to 

protect the public interest. 

Reserved: Defendants’ Claimed Entitlement to Attorneys’ Fee

Should Defendants prevail, it should be noted that their responsive pleading preserves 

their right to seek an award of attorney’s fees against Chiron. One statutory basis for an award 

of attorney’s fees in this case is 35 U.S.C. Section 285: “The court in exceptional cases may 

award reasonable attorney’s fees to the prevailing party.” 

Defendants contend that this is such a case. While any argument on the merits of this 

issue is premature, it does seem appropriate to remind the Court by this brief mention that this is, 

conditionally, a pending issue. 

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Defendants’ Trial Brief 

III. CONCLUSION 

 As Defendants explained in November in volunteering to be bound by a permanent 

injunction as a way to resolve this dispute, without a hearing on the merits, they are entitled to 

provide an advancement in therapy, outside the scope of the ‘907 patent, without being a 

defendant in litigation based on Chiron’s intentionally undefined patent rights. Defendants 

offered to respect Chiron’s patent rights without challenge, and that is why there is a permanent 

injunction. 

 But Chiron then decided to seek to use the relative term “about” to threaten any medical 

protocol below 60 mg/ml of tobramycin, and to challenge the use of the eFlow nebulizer with 

any drug. These issues of infringement, and Chiron’s intent in pursing this litigation, remain for 

adjudication. 

Dated: March 27, 2006 

 Respectfully submitted, 

By: /s/ 

Richard P. Doyle, Jr. 

 Attorney for Defendants 

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No. C 05-01938 WHA 14 

Defendants’ Trial Brief 

TABLE OF CONTENTS

I. INTRODUCTION...................................................................1 

A. Direct Infringement................................................................2 

B. Indirect Infringement...............................................................3 

 1. Without Direct Infringement, There Can Be No Indirect 

 Infringement.....................................................................3 

2. Inducement.................................................................3 

a. Inducement as to the SourceCF Defendants...........................4 

b. Inducement as to the Pharmacy Defendants............................4 

3. Contributory Infringement................................................5 

a. The eFlow nebulizer was not especially made or adapted for 

practicing Chiron’s ‘907 patent................................................6 

b. The eFlow nebulizer is a staple article suitable for a 

Substantial non-infringing use.................................................6 

c. Summary as to Contributory Infringement.............................7 

C. Direct Infringement: Under The Doctrine of Equivalents..................7 

1. Specification Disclaimer Estoppel.......................................7 

2. Analyzing Equivalents In Light of the Fact Chiron Cannot 

Get the Invention of the ‘907 Patent to Work.................................8 

D. Willful Infringement..............................................................8 

II. ADDITIONAL ISSUES............................................................9 

A. Issues At Trial Concerning Safety And Efficacy.............................9 

B. Literal Infringement Issue: Claim Construction is Over.....................9 

C. Even if Chiron were able to meet its burden of proof as to its 

Claims of literal infringement, the reverse doctrine of equivalents 

Applies here..............................................................................10 

D. Background Concerning Chiron’s Demand For Injunctive Relief.........10 

E. Chiron’s Intent In Bringing and Perpetuating This Litigation..............11 

F. Public Interest Considerations...................................................12 

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No. C 05-01938 WHA 15 

Defendants’ Trial Brief 

G. Reserved: Defendants’ Claimed Entitlement to Attorneys’ Fee............12 

III. CONCLUSION.......................................................................13 

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No. C 05-01938 WHA 16 

Defendants’ Trial Brief 

TABLE OF AUTHORITIES 

CASES

Amgen Inc. v. Hoechst Marion Roussel, Inc. 

314 F.3d 1313, 1351 (Fed. Cir. 2003)............................................................................................10 

Dollar Systems, Inc. v. Avcar Leasing Systems, Inc. 

 890 F.2d 165, (9th Cir. 1989..........................................................................................................11 

Graver Tank & Mfg. Co. v. Linde Air Prod. Co. 

339 U.S. 605, 608-09, 70 S.Ct. 854 ... (1950)...............................................................................10 

Joy Techs., Inc. v. Flakt, Inc., 

6 F.3d 770, (Fed.Cir.1993)...............................................................................................................2 

Manville Sales Corp. v. Paramount Systems, Inc. 

917 F.2d 544, (Fed. Cir. 1990).........................................................................................................3 

Met-Coil Sys. Corp. v. Korners Unlimited, Inc. 

803 F.2d 684, (Fed. Cir. 1986).........................................................................................................3 

Micro Chemical, Inc. v. Great Plains Chemical Co., Inc. 

194 F.3d 1250, (Fed. Cir. 1999).......................................................................................................5 

Moba, B.V. v. Diamond Automation, Inc. 

325 F.3d 1306, (Fed. Cir. 2003).......................................................................................................3 

Mylan Pharmaceuticals, Inc. v. Thompson

268 F.3d 1323, 1331 ......................................................................................................................11 

Oak Industries, Inc., v. Zenith Electronics Corp.

697 F. Supp. 988 (N.D. Ill. 1988) ................................................................................................4, 5 

Phillips Petroleum Co. v. Huntsman Polymers Corp. 

157 F.3d 866, (Fed. Cir. 1998).........................................................................................................7 

Rite-Hite Corp. v. Kelley, Inc.

56 F.3d 1538, (Fed.Cir.1995).........................................................................................................12 

SciMed Life Systems, Inc. v. Advanced Cardiovascular Systems, Inc.

242 F.3d 1337 (Fed. Cir. 2001)........................................................................................................7 

Sony Corp. v. Universal City Studios

464 U.S. 417 (1984).........................................................................................................................6 

Warner-Jenkinson Co. v. Hilton-Davis Chem. Co. 

520 U.S. 17, 40, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997) ..............................................................7 

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No. C 05-01938 WHA 17 

Defendants’ Trial Brief 

Warner-Lambert Co. v. Apotex Corp.

316 F.3d 1348, (Fed. Cir. 2003).......................................................................................................4 

Water Technologies Corp. v. Calco, Ltd.

850 F.2d 660, (Fed. Cir. 1988).........................................................................................................4 

STATUTES

35 U.S.C. Section 271(c) .............................................................................................................5, 6 

35 U.S.C. Section 285....................................................................................................................12 

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EXHIBIT 1

CHARTS SUMMARIZING ISSUES FOR TRIAL

FOR THE PHARMACY DEFENDANTS 

ChironÕs Final Infringement Contentions as to 50mg/ml of Tobramycin 

Claim No About -

Concentration 

of Tobramycin 

Direct InfLiteral Direct InfDoctrine of 

Equivalents 

Inducement Contributory 

1 60-200 mg/ml x x x x 

2 60-200 mg/ml x x x x 

3 60-200 mg/ml x x x x 

7 60-200 mg/ml x x x x 

8 60-200 mg/ml x x x x 

10 60-200 mg/ml x x x x 

11 60-200 mg/ml x x x x 

12 60-200 mg/ml x x x x 

ChironÕs Final Infringement Contentions as to 40mg/ml of Tobramycin 

Claim No About -

Concentration 

of Tobramycin 

Direct InfLiteral Direct InfDoctrine of 

Equivalents 

 Inducement Contributory 

1 60-200 mg/ml x x x 

2 60-200 mg/ml x x x 

3 60-200 mg/ml x x x 

7 60-200 mg/ml x x x 

8 60-200 mg/ml x x x 

10 60-200 mg/ml x x x 

11 60-200 mg/ml x x x 

12 60-200 mg/ml x x x 

No. 

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FOR THE SOURCECF DEFENDANTS 

ChironÕs Final Infringement Contentions as to 50mg/ml of Tobramycin 

Claim No About -

Concentration 

of Tobramycin 

Direct InfLiteral Direct InfDoctrine of 

Equivalents 

Inducement Contributory 

1 60-200 mg/ml x x 

2 60-200 mg/ml x x 

3 60-200 mg/ml x x 

7 60-200 mg/ml x x 

8 60-200 mg/ml x x 

10 60-200 mg/ml x x 

11 60-200 mg/ml x x 

12 60-200 mg/ml x x 

ChironÕs Final Infringement Contentions as to 40mg/ml of Tobramycin 

Claim No About -

Concentration 

of Tobramycin 

Direct InfLiteral Direct InfDoctrine of 

Equivalents 

Inducement Contributory 

1 60-200 mg/ml x x 

2 60-200 mg/ml x x 

3 60-200 mg/ml x x 

7 60-200 mg/ml x x 

8 60-200 mg/ml x x 

10 60-200 mg/ml x x 

11 60-200 mg/ml x x 

12 60-200 mg/ml x x 

No. C 05-01938 WHA 2 

Defendants’ Trial Brief 

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No. C 05-01938 WHA 3 

Defendants’ Trial Brief 

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