Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-3_05-cv-01938/USCOURTS-cand-3_05-cv-01938-12/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 35:271 Patent Infringement

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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

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.,

Defendants. /

No. C 05-01938 WHA

ORDER RE DEFENDANTS’

MOTIONS IN LIMINE 

NOS. 1 AND 2

INTRODUCTION

In this patent dispute, defendants bring two motions in limine which both essentially

seek to prevent plaintiff Chiron Corporation from arguing infringement via the doctrine of

equivalents. At this juncture, plaintiff will be allowed to present evidence on the doctrine of

equivalents, but defendants are free to re-raise these arguments in the context of a motion under

Federal Rule of Civil Procedure 50. Accordingly, defendants’ first and second motions in

limine are DENIED WITHOUT PREJUDICE.

STATEMENT

Plaintiff Chiron Corporation is the owner of United States Patent No. 6,890,907

(“the ’907 patent”). The ’907 patent discloses a method of treating lung infections, namely an

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inhaled tobramycin formulation used with a high efficiency nebulizer, particularly for patients

suffering from cystic fibrosis. Defendants are alleged to infringe, induce infringement of and/or

contributorily infringe one or more claims of the ’907 patent by (1) selling a product called the

eFlow® inhaler and (2) instructing doctors and patients how to use it.

On December 1, 2006, this Court granted plaintiffs the following stipulated permanent

injunction (December Order at 6):

Defendants are preliminarily and permanently enjoined from

making, using, offering for sale, selling, promoting or importing

into the United States any tobramycin formulation in an aqueous

solution comprising from 60 to 200 mg/ml of tobramycin in a

physiologically acceptable carrier in a nebulized unit dose volume

of 4.0 ml or less for use in the eFlow® Electronic Inhaler by

PARI or a similar inhalation device having a rate of aerosol

output of not less than about 4:l/sec, releases at least about 75%

of the loaded dose, and produces aerosol particles having particle

sizes between about 1 :m to about 5:, for a duration of

nebulization of less than about 10 minutes. Defendants are

further enjoined from instructing doctors or patients in such use.

Still in dispute after the injunction was whether defendants’ product, which purportedly

allows for effective treatment of CF with 40 mg/ml and 50 mg/ml concentrations of tobramycin,

infringed plaintiff’s patent. As the December order explained (id. at 5) (emphasis in original):

The remaining dispute, however, is not one of claim construction. 

It is a question of infringement that remains to be decided another

day. As plaintiff correctly points out, even if a 50 mg/ml

tobramycin formulation does not literally infringe, a jury could

still find defendants liable under a doctrine of equivalents theory,

(assuming that no prosecution history estoppel applies). In other

words, reasonable jurors could find that a person of ordinary skill

in the art would know that a lower dosage performs substantially

the same function, in substantially the same way, to reach

substantially the same result.

In defendants’ first motion in limine, they seek to prevent evidence that defendants

infringed the’907 patent by duplicating the total volume of tobramycin, regardless of the fact

that defendants’ product accomplishes the desired results with concentrations of tobramycin of

less than 60 mg/ml. Plaintiff maintains that defendants have merely modified an earlier

infringing product (which contained 100 mg/ml of tobramycin) by adding a higher volume of

saline. This, it is argued, is like taking a 600 mg headache reliever, dividing it into two caplets,

and representing the two 300 mg tablets as an advance. Essentially, this is a claim for

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infringement under the doctrine of equivalents. Defendants counter that as long as they avoid

one limitation of the claim language, the limitation for concentrations of “about” 60 mg/ml,

they are not infringing the ’907 patent. According to defendants, the argument regarding total

volume vitiates the claim language, and thus they seek to bar this particular application of the

doctrine of equivalents.

In defendants’ second motion in limine, they attempt to remove the doctrine of

equivalents from the picture completely. According to defendants, the ’907 patent incorporated

by reference United States Patent No. 5,508,269 (“the ’269 patent”). In the ’269 patent, it is

argued, formulations containing less than 60 mg/ml of tobramycin were disclaimed. On

defendants’ view, this estops plaintiff from proving that defendants’ products, which involve

such lower concentrations, infringe plaintiff’s patent under the doctrine of equivalents.

ANALYSIS

“The standard for infringement under the doctrine of equivalents has often been

articulated: infringement may be found if an accused device performs substantially the same

function in substantially the same way to achieve substantially the same result.” London v.

Carson Pirie Scott & Co., 946 F.2d 1534, 1538 (Fed. Cir. 1991). “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) (citing Warner-Jenkinson Co. v. Hilton

Davis Chem. Co., 520 U.S. 17 (1997)).

1. TOTAL VOLUME.

Defendants rely on the “element by element” test for the proposition that plaintiff cannot

argue infringement based on the total volume of tobramycin in defendants’ products. 

Defendants argue that the only issue remaining is concentration—whether or not defendants’

products with concentrations below 60 mg/ml tobramycin violated the concentration limitation

in plaintiff’s patent. Any evidence regarding total volume, it is argued, is irrelevant.

Plaintiff, however, maintains that when applying the doctrine of equivalents, a court

must not take a myopic view of the claim, but rather must look to the totality of circumstances. 

“[C]ourts must consider the totality of circumstances of each case and determine whether the

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This term apparently was coined by defendants, but it accurately captures the legal argument so this

order adopts the term.

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alleged equivalent can be fairly characterized as an insubstantial change from the claimed

subject matter without rendering the pertinent limitation meaningless.” Pfizer, Inc. v. Teva

Pharms. USA, Inc., 429 F.3d 1364 (Fed. Cir. 2005).

Without knowing more about defendants’ products, it is premature to assess whether the

products should be characterized as an insubstantial change from the subject matter of the ’907

patent. After hearing evidence at the bench trial, the Court will be in a better position to assess

the legal sufficiency of defendants’ argument. Defendant will at that time be able to raise this

issue again via a Rule 50 motion.

2. SPECIFICATION DISCLAIMER ESTOPPEL.

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Moreover, under certain circumstances a plaintiff is barred from relying on the doctrine

of equivalents. “A particular structure can be deemed outside the reach of the doctrine of

equivalents because that structure is clearly excluded from the claims whether the exclusion is

express or implied.” SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d

1337, 1345 (Fed. Cir. 2001); see also Gaus v. Conair Corp., 363 F.3d 1284, 1291 (Fed. Cir.

2004) (“[T]he patentee cannot reclaim that surrendered claim coverage by invoking the doctrine

of equivalents”); Astrazeneca AB, Aktiebolaget Hassle, KBI-E, Inc. v. Mutual Pharmaceutical

Co., Inc., 384 F.3d 1333, 1342 (Fed. Cir. 2004) (“The specification’s clear disavowal of

nonsurfactant solubilizers precludes the application of the doctrine of equivalents to recapture

the disavowed solubilizers”). The test for “specification disclaimer estoppel” thus is whether

the patentee clearly disclaimed the contested structure.

It is important to note that application of such estoppel is a legal question, not a question

of fact. “A patent applicant may limit the scope of any equivalents of the invention by

statements in the specification that disclaim coverage of subject matter. Such limitations on the

scope of equivalents are legal determinations . . . .” Frank’s Casing Crew & Rental Tools, Inc.

v. Weatherford Int’l, Inc., 389 F.3d 1370, 1376 (Fed. Cir. 2004) (citing J & M Corp. v.

Harley-Davidson, Inc., 269 F.3d 1360, 1366 (Fed. Cir. 2001)).

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A. INCORPORATION BY REFERENCE.

As an initial matter, a determination must be made as to whether and to what extent the

purported disclaimers in the earlier ’269 patent were incorporated by reference in the ’907

patent. “To incorporate material by reference, the host document must identify with detailed

particularity what specific material it incorporates and clearly indicate where that material is

found in the various documents.” Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d

1272, 1282 (Fed. Cir. 2000). See also Manual of Patent Examining Procedure, § 2163.07(b)

(8th ed. 2006). “Whether and to what extent material has been incorporated by reference into a

host document is a question of law.” Advanced Display, 212 F.3d at 1283.

Here, the ’907 patent contained the following language (col. 3, lines 18–33) (emphasis

added):

A preservative-free, stable and convenient formulation of

tobramycin (TOBI® tobramycin solution for inhalation; 60

mg/mL tobramycin in 5 mL of 1/4 normal saline) for administration via jet nebulizer was developed by PathoGenesis

Corporation, Seattle, Wash. (now Chiron Corporation,

Emeryville, Calif.). The combination of a 5 mL BID TOBI dose

(300 mg tobamycin) and the PARI LC PLUS/PalmoAide

compressor delivery system was approved under NDA 50-753,

December 1997, for the management of P. aeruginosa in CF

patients, and remains the industry standard for this purpose. The

aerosol administration of a 5ml dose of a formulation containing

300 mg of tobramycin in quarter normal saline for the suppression

of P. aeruginosa in the endobronchial space of a patient is

disclosed in U.S. Pat. No. 5,508,269, the disclosure of which is

incorporated herein in its entirety by this reference.

This language was sufficient to incorporate the earlier patent by reference in its entirety. 

Plaintiff does not really dispute this conclusion (Opp. 3). Rather, plaintiff disputes the import

and extent of such incorporation.

Plaintiff argues that materials incorporated by reference should not be read to limit

claims in subsequent patents. It is certainly the case that where a patentee so clearly

incorporates materials by reference, however, that the patent is to be interpreted with those

materials in mind. “When a document is ‘incorporated by reference’ into a host document, such

as a patent, the referenced document becomes effectively part of the host document as if it were

explicitly contained therein.” Telemac Cellular Corp. v. Topp Telecom, Inc., 247 F.3d 1316,

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Contrary to plaintiff’s argument, it does not matter that the ’269 patent is a different patent with

different inventors. A patentee may, in fact, incorporate by reference any source “which is available to the

public.” In re Howarth, 654 F.2d at 106.

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1329 (Fed. Cir. 2001). Indeed, the whole point of incorporation by reference is to make the

material part of the patent:

Instead of repeating some information contained in another

document, an application may attempt to incorporate the content

of another document or part thereof by reference to the document

in the text of the specification. The information incorporated is

as much a part of the application as filed as if the text was

repeated in the application, and should be treated as part of the

text of the application as filed.

 Manual of Patent Examining Procedure, § 2163.07(b) (8th ed. 2006) (emphasis added). 

Accordingly, there are several circumstances in which courts have considered materials

incorporated by reference. Such materials have been considered when determining whether a

patent is invalid due to anticipation. See, e.g., Advanced Display, 212 F.3d at 1282 (“Material

not explicitly contained in the single, prior art document may still be considered for purposes of

anticipation if that material is incorporated by reference into the document”). The materials

have been considered for purposes of determining sufficiency of enablement. See, e.g., In re

Howarth, 654 F.2d 103, 106 (C.C.P.A. 1981). Finally, materials incorporated by reference have

been considered in construing patent terms. See, e.g., Neutrino Dev. Corp. v. Sonosite, Inc., 410

F. Supp. 2d 529, 537 (S.D. Tex. 2006) (“Ambiguous terms within the patent can sometimes be

interpreted in light of disclosures made in the materials incorporated by reference”); Intel Corp.

v. Altima Commc’ns, Inc., 275 F. Supp. 2d 1236, 1253 (E.D. Cal. 2003).2

B. SPECIFICATION DISCLAIMER IN THE ’269 PATENT.

Even so, it remains to be determined whether the ’269 patent clearly disclaimed

equivalent products containing concentrations of tobramycin of less than 60 mg/ml.

Here, the ’269 patent contained the following language (col. 6, lines 38–47):

Typically, two to four, preferably 300 mg of tobramycin is

dissolved in 5 ml solution of a diluted quarter normal saline,

preferably containing 0.225% NaCl.

The most preferred aerosol tobramycin formulation

according to the invention contains 300 mg of tobramycin sulfate

per 5 ml of the quarter normal saline. This corresponds to 60

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mg/ml of tobramycin which is minimal yet efficacious amount of

tobramycin to suppress the Pseudomonas aeruginosa infection in

endobronchial space.

The ’269 patent further provided (col. 8, lines 3–41) (emphasis added):

The formulated dose of 60 mg/ml of one quarter diluted

saline has been found to be optimal for the most efficacious

delivery. Although in some instances both lower or higher doses,

typically from 40–80 mg/ml may be advantageously used, the 60

mg/ml dose of tobramycin is preferred. A more concentrated

tobramycin solution has three disadvantages. First, if the solution

approaches the solubility of tobramycin, 160 mg/ml, precipitation

on storage is expected. Second, a higher concentration of

tobramycin than is clinically needed is economically

disadvantageous. Thirdly, a more concentrated solution will

increase the osmorality of the solution, thus decreasing the output

of the formulation with both jet and ultrasonic nebulizers. The

alternative of a more concentrated solution in a smaller total

volume is also disadvantageous. Most nebulizers have a dead

space volume of 1 ml, i.e., that of the last 1 ml of solution is

wasted because the nebulizer is not performing. Therefore, while

for example, a 2 ml solution would have 50% wastage, the 5 ml

solution (the capacity of the nebulizer) has only 20% wastage. 

Additionally, since there is no sufficient aerosolization of the drug

into the small particles, the drug in large particles or as a solution

is deposited in the upper airways and induces cough and may also

cause bronchospasm. Large aerosol particles also limit the drug

delivery.

The dose lower than 60 mg of tobramycin 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. This is due to

variability of sputum tobramycin levels caused by anatomical

variability among patients as observed in Examples 4 and 5, and

also because the minimum inhibitory concentration of

Pseudomonas aeruginosa also varies. As seen in Table 4, a dose

of 300 mg total has been found to be optimal. Previously studied

doses 80 mg, Pedia Pulmonol., 6:91–8 (1989) were reported

effective, however, the dose would be predicted to be efficacious

in approximately sixty to seventy percent of patients initially. If

any degree of drug resistance developed, only a small percentage

of patients would be effectively treated.

Plaintiff argues that this was not sufficient to disclaim tobramycin concentrations of less

than 60 mg/ml. Plaintiff emphasizes the language that “in some instances both lower or higher

doses, typically from 40–80 mg/ml may be advantageously used.” (’269 patent, col. 8,

lines 3–4).

The remainder of the above quoted language, though, seems to be a critique of

formulations less than 60 mg/ml and above 200 mg/ml. The patent described the 60mg/ml

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It is also worth noting that, in order to estop reliance on the doctrine of equivalents, the disclaimer

need not be in response to an action by the United States Patent Office. While defendants have not pointed to

any aspect of the prosecution history of the ’269 patent suggesting office action, neither was such a fact

suggested in SciMed.

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concentration as the formulation “which is minimal yet efficacious,” “optimal,” and

“preferred.” Lower concentrations were deemed “not sufficient to suppress the bacterium and

to treat the infection”and “will not be sufficiently effective in at least 90% of patients.”

This critique is similar to that found to estop the patentee in SciMed, supra. That

opinion explained that the patentee:

As noted above, the common specification of SciMed's patents

referred to prior art catheters, identified them as using the dual

lumen configuration, and criticized them as suffering from the

disadvantages of having “larger than necessary shaft sizes” and

being “stiffer in their distal regions than would be desired.” That

criticism of the dual lumen configuration was consistent with the

evidence from SciMed witnesses and documents, which noted the

advantages of the coaxial lumen configuration in increasing the

flexibility of catheters and their ability to track through the

coronary arterial system. The disclaimer of dual lumens was made

even more explicit in the portion of the written description in

which the patentee identified coaxial lumens as the configuration

used in “all embodiments of the present invention.

SciMed, 242 F.3d at 1345 (internal citations omitted). In SciMed, just as in the instant case, the

patentee did not state that the dual lumen configuration was completely useless, but did describe

in detail the disadvantages of that alternative configuration. Accordingly, the opinion ruled that

“[h]aving specifically identified, criticized, and disclaimed the dual lumen configuration, the

patentee cannot now invoke the doctrine of equivalents to ‘embrace a structure that was

specifically excluded from the claims.’” Ibid. (quoting Dolly, Inc. v. Spalding & Evenflo Cos.,

16 F.3d 394, 400 (Fed. Cir.1994)).3

Likewise, a similar result was reached in Dawn Equip. Co. v. Kentucky Farms Inc.,

140 F.3d 1009, 1016 (Fed. Cir. 1998). The Federal Circuit there overturned a jury verdict

finding infringement under the doctrine of equivalents. The opinion explained that:

The patent teaches that such mechanisms are time-consuming to

adjust and are prone to misadjustment by inserting the pin in the

wrong holes, and furthermore the loose pins in such mechanisms

are easily lost. Kentucky Farms’ multiple-hole, pinned

height-adjustment mechanism is such a mechanism and shares

these same problems.

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Ibid. (internal citations omitted). Accordingly, “[t]hese statements in the patent alone strongly

suggest, if not mandate, judgment in Kentucky Farms’ favor.”

Nevertheless, at hearing on the instant motions, plaintiff presented persuasive authority

that simply critiquing the prior art in the context of a later patent is not sufficient to clearly

disavow those claims in the later patent. In Micro Chemical v. Great Plains Chemical Co.,

194 F.3d 1250, 1260 (Fed. Cir. 1999), the Federal Circuit ruled that inclusion of a prior art

reference that contained certain limitations could not be translated as a disclaimer for purposes

of the later patent. The decision stated:

[T]he district court read the patentee’s statements about the

Brewster prior art as a clear disavowal of the weigh dump

method. To the contrary, although the applicant noted certain

inefficiencies in the Brewster system, the patent never clearly

disavows the weigh dump method as being incapable of

performing the claimed functions. The statements relied on by

the district court in both the background section and the

prosecution history were directed to a particular prior art device,

the Brewster machine, not to the weigh dump method in general .

. . .

* * *

The prosecution history also does not disavow the weigh

dump method. The prosecution history merely described the

Brewster system to facilitate a comparison by the patent

examiner.

Accordingly, plaintiff argues that the purported disclaimers in the ’269 patent are

irrelevant because that patent involved a “low efficiency nebulizer and not the high efficiency

eFlow® device used by Defendants and covered by the patent in suit” (Opp. 4) (emphasis in

original). The disclaimers in the earlier patent were reflective of the limitations of nebulization

at the time of that patent. The ’907 patent purportedly advanced on that prior art by utilization

of high efficiency nebulization and so, it is argued, the critiques must be read in that light.

As with the issue of total volume versus concentration, this is an issue that will benefit

from the trial process. This order allows plaintiff to present evidence on the theory of doctrine

of equivalents, but defendants may challenge that theory again on a Rule 50 motion.

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CONCLUSION

For the foregoing reasons, defendants’ first and second motions in limine are DENIED

WITHOUT PREJUDICE to defendants to raise these arguments again in a motion under FRCP 50.

IT IS SO ORDERED.

Dated: April 4, 2006 WILLIAM ALSUP

UNITED STATES DISTRICT JUDGE

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