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 GRANTING

PERMANENT INJUNCTION

INTRODUCTION

In this patent case, the parties appear to agree that at least some products previously

made or sold by defendants were infringing the patent-in-suit. Apparently hoping to avoid the

costs of litigation, they have represented that the only remaining dispute is the proper scope of

injunctive relief and have filed cross-motions on this issue. This order GRANTS a limited

permanent injunction. In addition, the phrase “about 60 to about 200 mg/ml” is construed to

mean “approximately 60 to approximately 200 mg/ml.”

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

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

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 Tobramycin is an antibiotic. A nebulizer is a medical device used to turn liquid solutions into a fine

mist for inhalation.

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suffering from cystic fibrosis (“CF”).* 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. Defendants

challenge the validity of the ’907 patent, but prefer not to litigate. Defendants’ answers, filed

on September 28, 2005, raised no counterclaims of patent invalidity; a reexamination

proceeding before the United States Patent and Trademark Office, however, is pending.

An earlier complaint, filed on October 5, 2004, accused defendants of unfair competition

and false advertising (Compl. ¶ 2). That lawsuit was settled to the mutual satisfaction of the

parties (id. ¶¶ 3–4). In this action, the parties have been engaged in ongoing settlement

discussions. As a result, defendants have agreed that certain tobramycin formulations infringe

’907 patent and have voluntarily stopped using dosages between 60 to 200 mg/ml. They now

move for the entry of the following permanent injunction.

Defendants are preliminarily and permanently enjoined from:

(1) Making, using, offering for sale, or selling in the United States a

compounded tobramycin formulation specifically for use in the

eFlow Electronic Inhaler by PARI or any other inhalation device

which is prescribed to operate within the parameters set forth in

the claims of the patent.

(2) inducing infringement of, or contributorily infringing the ’907

patent by promoting the prescription of a compounded tobramycin

formulation specifically for use in the eFlow Electronic Inhaler by

PARI or any other inhalation device which is to be prescribed to

operate within the parameters set forth in the claims of the patent.

Plaintiff also moves for entry of judgment and a permanent injunction, but proposes the

following language instead:

Defendants are infringing, inducing infringement of and/or contributorily

infringing U.S. Patent No. 6,890,907 (“the ‘907 patent”).

Defendants are preliminarily and permanently enjoined from infringing,

inducing infringement of, or contributorily infringing the ‘907 patent.

Defendants are preliminarily and permanently enjoined from:

(1) Inducing infringement of or contributorily infringing the ‘907

patent by making, using, offering for sale, selling, or promoting in

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the United States or importing into the United States any

tobramycin formulation in an aqueous solution with a

concentration of about 60 to about 200 mg/ml of tobramycin in a

physiologically acceptable carrier in a nebulized unit dose volume

of 4.0 ml or less for use with the eFlow Electronic Inhaler by PARI

or any other inhalation device which, like the eFlow Electronic

Inhaler by PARI, has a rate of aerosol output of not less than about

4 :l/sec, delivers said tobramycin formulation with a duration of

nebulization of less than about 10 minutes, releases at least about

75% of the loaded dose, and produces aerosol particles having

particle sizes between about 1 :m to about 5 :m;

(2) Inducing infringement of the ‘907 patent by using, offering for

sale, selling, or promoting in the United States or importing into

the United States the eFlow Electronic Inhaler by PARI or any

other inhalation device which, like the eFlow Electronic Inhaler by

PARI, has a rate of aerosol output of not less than about 4 :l/sec,

delivers said tobramycin formulation with a duration of

nebulization of less than about 10 minutes, releases at least about

75% of the loaded dose, and produces aerosol particles having

particle sizes between about 1 :m to about 5 :m for use with

tobramycin formulations in an aqueous solution at concentrations

of about 60 to about 200 mg/ml of tobramycin in a physiologically

acceptable carrier in nebulized unit dose volumes of 4.0 ml or less; 

and

(3) Instructing doctors and patients how to administer tobramycin

formulations in an aqueous solution at concentrations of about 60

to about 200 mg/ml of tobramycin in a physiologically acceptable

carrier in nebulized unit dose volumes of 4.0 ml or less using the

eFlow Electronic Inhaler by PARI or any other inhalation device

which, like the eFlow Electronic Inhaler by PARI, has a rate of

aerosol output of not less than about 4 :l/sec, delivers said

tobramycin formulation with a duration of nebulization of less than

about 10 minutes, releases at least about 75% of the loaded dose,

and produces aerosol particles having particle sizes between about

1 :m to about 5 :m.

As indicated below, neither proposal is adopted.

ANALYSIS

There is apparently no dispute that at least some products previously made or sold by

defendants used tobramycin formulations within the range of 60 to 200 mg/ml. It is conceded

that plaintiff is entitled to permanent injunctive relief with respect to those products. Yet, while

the parties have agreed that defendants should be permanently enjoined from infringing the ’907

patent, they dispute the precise scope of the claim language. This order thus rejects the

proposed language proffered by the parties. Instead, a permanent injunction limited to the

precise range of 60 to 200 mg/ml is GRANTED.

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The sole remaining issue to be decided by the Court is presented as one of claim

construction. Claim 1 of the ’907 patent is reproduced below, with the disputed phrase

italicized.

1. A method of treatment of a patient having an endobronchial infection comprising administering to the patient

for inhalation a nebulized unit dose of 4.0 ml or less of an

aqueous solution comprising from about 60 to about 200

mg/ml of tobramycin in a physiologically acceptable carrier

for a duration of nebulization less than about 10 minutes,

using an inhalation device having a rate of aerosol output of

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

of the loaded dose, and that produces aerosol particles 

having particle sizes between about 1 :m to about 5:m.

Specifically, defendants ask the Court to find that an aqueous solution of 50 mg/ml of

tobramycin in a physiologically acceptable carrier would be excluded from the range “about 60

to about 200 mg/ml.” In the alternative, it argues that if plaintiff cannot precisely determine the

range of tobramycin concentrations that would infringe, then the ’907 patent should be deemed

invalid as indefinite.

Plaintiff contends that “about 60 to about 200 mg/ml” should be construed as

“approximately 60 to approximately 200 mg/ml.” Plaintiff asserts that any further definition of

the outer limits of this range would be inappropriate because it would be up to a jury to decide

the factual issue of whether 50 mg/ml (or any other amount) reads on the phrase “about 60 to

about 200 mg/ml” either literally or under the doctrine of equivalents. It also argues that

defendants do not currently make or sell any product containing 50 mg/ml of tobramycin and

improperly seek an advisory opinion.

Although the issue has been framed as a pure question of claim construction, defendants

essentially seek a declaratory-judgment that a 50 mg/ml tobramycin solution would not infringe

the ’907 patent. It is true that without an actual controversy, the Court would lack

subject-matter jurisdiction to decide that question. 28 U.S.C. 2201. Yet, despite plaintiff’s

assertions to the contrary, there is an actual controversy in this case because at least one

defendant has sold a 50 mg/ml dosage (Birdsong Decl. ¶ 12).

As for the proper construction of “about 60 to about 200 mg/ml,” defendants argue that

this range excludes any concentration less than 60 mg/ml. In short, they seek to limit this

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phrase to mean “between exactly 60 and about 200 mg/ml.” That interpretation is rejected. 

Defendants attempt to improperly read in limitations from the patentee’s examples in the

specification. The arguments about what was or was not described as the “minimal yet

efficacious” concentration of tobramycin in the prior art are also unpersuasive, at least for claim

construction purposes, because “minimal yet efficacious” does not appear in the claims.

Nowhere did the inventor expressly define “about 60 mg/ml” to mean “at least

60 mg/ml” or “exactly 60 mg/ml” or anything other than the ordinary and customary meaning

as understood by a person of ordinary skill in the art. Here, claim construction “involves little

more than the application of the widely accepted meaning of commonly understood words.” 

Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed.Cir. 2005) (en banc). The Federal Circuit has

held that the word “about” should be given its ordinary meaning of “approximately.” Merck &

Co v. Teva Pharms. USA, 395 F.3d 1364, 1369 (Fed. Cir. 2005). Accordingly, this order finds

that the proper construction of this phrase is “approximately 60 to approximately 200 mg/ml.”

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. Compare Hilton Davis Chem. Co. v. WarnerJenkinson Co., Inc., 114 F.3d 1161, 1164 (Fed. Cir. 1997) (affirming the jury’s finding “that a

pH of 5.0 is equivalent to a pH of ‘approximately 6.0’ in the context of the claimed process”). 

As such, this order declines to rule as a matter of law that using a 50 mg/ml tobramycin solution

with the eFlow® inhaler would not infringe the ’907 patent.

CONCLUSION

With respect to concentrations of tobramycin within the range of exactly 60 to exactly

200 mg/ml, the parties agree that such products infringe the ‘907 patent. The cross-motions for

permanent injunctive relief are GRANTED as to those dosages:

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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.

The Court retains jurisdiction for three years to enforce this injunction or to modify it as

necessary, depending on the outcome of the pending reexamination proceedings.

This order further construes “about 60 to about 200 mg/ml” to mean “approximately 60

to approximately 200 mg/ml.” Because whether any particular concentration of tobramycin

outside the range of exactly 60 to exactly 200 mg/ml, (such as 50 mg/ml), would infringe the

‘907 patent is a question of fact that remains to be decided, such dosages are not included in the

permanent injunction granted by this order. Rather, this issue shall be reserved for further

adjudication at trial.

IT IS SO ORDERED.

Dated: December 1, 2005 

WILLIAM ALSUP

UNITED STATES DISTRICT JUDGE

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