Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-4_04-cv-05429/USCOURTS-cand-4_04-cv-05429-25/pdf.json

Parties Involved:
Celtrix Pharmaceuticals, Inc.
Counter-claimant
Genentech, Inc.
Counter-defendant
Insmed Incorporated
Counter-claimant
Insmed Therapeutic Proteins
Defendant
Tercica, Inc.
Counter-defendant

Document Text:

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

GENENTECH, INC., a Delaware

corporation, and TERCICA, INC., a

Delaware corporation,

Plaintiffs,

v.

INSMED INCORPORATED, a Virginia

corporation; CELTRIX PHARMACEUTICALS,

INC., a Delaware corporation; and

INSMED THERAPEUTIC PROTEINS, a

Colorado Corporation,

Defendants. /

AND RELATED COUNTERCLAIMS.

 /

No. C 04-5429 CW

ORDER ON CLAIM

CONSTRUCTION AND

CROSS-MOTIONS FOR

SUMMARY JUDGMENT 

Plaintiffs and Counterdefendants Genentech, Inc. and Tercica,

Inc. and Defendants and Counterclaimants Insmed Incorporated,

Celtrix Pharmaceuticals, Inc. and Insmed Therapeutic Proteins, Inc.

dispute the meaning of several terms and phrases used in U.S.

Patent No. 6,331,414 ('414 patent), U.S. Patent No. 5,187,151 (the

'551 patent) and U.S. Patent No. 5,258,287 ('287 patent). 

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Plaintiffs and Defendants each ask the Court to adopt their

proposed construction of the disputed terms and phrases. In

addition, Plaintiffs move for partial summary judgment. Defendants

oppose the motion and cross-move for summary judgment. Plaintiffs

oppose that motion. The matter was heard on May 19, 2003. Having

considered the parties' papers, the evidence cited therein and oral

argument, the Court construes the disputed terms and phrases as set

forth below. The Court grants Plaintiffs' motion and grants

Defendants' motion in part and denies it in part.

BACKGROUND

Plaintiffs and Defendants are biotechnology companies

competing to penetrate and serve a market of 6,000 children in the

United States who suffer from a rare disorder known as Severe

Primary Insulin-Like Growth Factor Deficiency (Severe Primary

IGFD). In humans, growth hormone (GH) stimulates the production of

insulin-like growth factor (IGF-I), which then stimulates statural

growth and increases whole-body, lean tissue mass. Most children

who fail to grow normally can be treated with GH. Children who

suffer from Severe Primary IGFD, however, do not respond to

standard GH therapy because GH does not stimulate IGF-I production

in their bodies. These children typically will grow if they are

given an IGF-I based therapy. There are two approved products for

administering IFG-I to treat children with Severe Primary IGFD:

Plaintiff Tercica's IncrelexTM product, comprising "free" IGF-I, and

Defendant Insmed's IPLEXTM product, comprising IGF-I complexed to

IGFBP-3. The Food and Drug Administration (FDA) approved IncrelexTM

on August 27, 2005; IPLEXTM was approved on December 12, 2005.

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At issue are three patents awarded to Plaintiff Genentech: the

'414 patent, "Preparation of Human IGF via Recombinant DNA

Technology"; the '151 patent, "Use of Binding Protein with IGF-I as

an Anabolic Growth Promoting Agent"; and the '287 patent, "DNA

Encoding and Methods of Production of Insulin-like Growth Factor

Binding Protein BP53." Plaintiff Genentech licensed these patents

to Plaintiff Tercica. Plaintiffs claim that Defendants' IPLEXTM

infringes the patents. Defendants assert that, not only do they

not infringe the patents, the patents are invalid and

unenforceable.

DISCUSSION

I. Claim Construction

A. Legal Standard

The construction of a patent is a matter of law for the Court.

Markman v. Westview Instruments, Inc., 517 U.S. 370, 372 (1996). 

"It is a 'bedrock principle' of patent law that 'the claims of a

patent define the invention to which the patentee is entitled the

right to exclude.'" Phillips v. AWH Corp., 415 F.3d 1303, 1312

(Fed. Cir. 2005) (en banc) (quoting Innova/Pure Water, Inc. v.

Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir.

2004)). Accordingly, in construing disputed terms, the Court first

looks to the words of the claims. Vitronics Corp. v. Conceptronic,

Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Generally, the Court

ascribes the words of a claim their ordinary and customary meaning.

Id. The Federal Circuit instructs that "the ordinary and customary

meaning of a claim term is the meaning that the term would have to

a person of ordinary skill in the art in question at the time of

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the invention, i.e., as of the effective filing date of the patent

application." Phillips, 415 F.3d at 1313. Other claims of the

patent in question can also assist in determining the meaning of a

claim term. Id. at 1314. "Because claim terms are normally used

consistently throughout the patent, the usage of a term in one

claim can often illuminate the meaning of the same term in other

claims." Id.

The Federal Circuit also instructs that claims "must be read

in view of the specification, of which they are a part." Id. at

1315 (quoting Markman v. Westview Instruments, Inc., 52 F.3d 967,

979 (Fed. Cir. 1995) (en banc)). The specification must contain a

description of the invention that is clear and complete enough to

enable those of ordinary skill in the art to make and use it, and

thus the specification is "always highly relevant" to the Court's

claim construction analysis. Vitronics, 90 F.3d at 1582. 

"Usually, [the specification] is dispositive; it is the single best

guide to the meaning of a disputed term." Id. In some cases, the

specification may reveal that the patentee has given a special

definition to a claim term that differs from its ordinary meaning;

in such cases, "the inventor's lexicography controls." Phillips,

415 F.3d at 1316. The specification also may reveal the patentee's

intentional disclaimer or disavowal of claim scope. "In that

instance, as well, the inventor has dictated the correct claim

scope, and the inventor's intention, as expressed in the

specification, is regarded as dispositive." Id. However, claims

are not limited to the preferred embodiment described in the

specification. See SRI Int’l v. Matsushita Elec. Corp. of Am., 775

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F.2d 1107, 1121 (Fed. Cir. 1985) (en banc, plurality opinion).

In addition to reviewing the specification, the Court should

consider the patent's prosecution history. Markman, 52 F.3d at

980. The prosecution history is intrinsic evidence that "can often

inform the meaning of the claim language by demonstrating how the

inventor understood the invention and whether the inventor limited

the invention in the course of prosecution, making the claim scope

narrower then it would otherwise be." Phillips, 415 F.3d at 1317;

see also Chimie v. PPG Indus., Inc., 402 F.3d 1371, 1384 (Fed. Cir.

2005) ("The purpose of consulting the prosecution history in

construing a claim is to exclude any interpretation that was

disclaimed during prosecution.") (internal quotations omitted).

While emphasizing the importance of intrinsic evidence in

claim construction, the Federal Circuit has authorized courts to

rely on extrinsic evidence, which consists of "all evidence

external to the patent and prosecution history, including expert

and inventor testimony, dictionaries, and learned treatises." 

Phillips, 415 F.3d at 1317 (quoting Markman, 52 F.3d at 980). 

While extrinsic evidence may be useful to the Court, it is less

significant than intrinsic evidence in determining the legally

operative meaning of claim language. Id; see also C.R. Bard, Inc.

v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004). 

Furthermore, extrinsic evidence is unlikely to lead to a reliable

interpretation of claim language unless considered in the context

of the intrinsic evidence. Phillips, 415 F.3d at 1319.

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B. The '414 Patent

1. Claim 1 

Claim 1 provides, "A process for producing human IGF-I

comprising preparing a replicable expression vector capable of

expressing the DNA sequence encoding human IGF-I in a prokaryotic

host cell, transforming a prokaryotic host cell culture with said

vector to obtain a recombinant host cell, culturing said

recombinant host cell culture under conditions permitting

expression of said human IGF-I-encoding DNA sequence to produce

human IGF-I, and recovering said human IGF-I."

a. Expression

The parties dispute whether this claim covers both fusion and

direct expression of a human IGF-I-encoding DNA sequence. Their

differing constructions of terms in this claim arises out of this

dispute. Plaintiffs contend that claim 1 covers both. 

Defendants, however, claim that claim 1 covers only direct

expression, not fusion. 

Defendants' expert conceded that a person of ordinary skill in

the art understands the term expression to encompass both fusion

and direct expression. See Gaede Dec., Ex. 5 at 79:25-80:3. The

Federal Circuit instructs that the ordinary meaning of a term

governs absent an express disclaimer in the patent. See, e.g.,

NTP, Inc. v. Research In Motion, Ltd., 418 F.3d 1282, 1308-9 (Fed.

Cir. 2005). As Plaintiffs note, here, there is no express

disclaimer. Instead, the patent itself, the specification and the

prosecution history demonstrate that the inventors used the

ordinary meaning of the term "expression."

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1Claim 5 provides, "A method for producing human IGF-I

comprising preparing a replicable expression vector capable of

expressing in prokaryotic cells a DNA sequence encoding a fusion

protein comprising the amino acid sequence of mature human IGF-I

and a bacterial protein, transforming prokaryotic cells with said

vector, culturing said transformed cells under conditions

permitting expression of said DNA sequence to produce the fusion

protein, recovering the fusion protein from the culture, and

cleaving the fusion protein to obtain mature human IGF-I, wherein

the prokaryotic cells are capable of such expression and of

processing the IGF-I." 

7

Although claim 1 uses the term "expression" without the

adjectives direct or fusion, claims 5 and 9 expressly refer to

fusion expression.1 The term "direct expression" is used in the

specification, demonstrating that the inventors were aware of the

two different types of expression and, when appropriate, specified

which form of expression they were discussing. 

In the prosecution history, the Examiner raised an enablement

issue as to claim 1, which was then claim 5: "In addition, claims 5

and 21 encompass direct expression of IGF-I and IGF-II in

prokaryotes in the absence of a fusion partner." Stipulated File

History of the '414 patent, Tab 4 at 7-9. Plaintiffs note the word

"encompass," used by the Examiner, shows that the claims's scope

includes but is not limited to direct expression. Defendants'

argument, that the Examiner's objection was based on the difficulty

of producing IGF-I or IGF-II without regard to whether the protein

was expressed directly or as a fusion protein, is irrelevant in

determining whether claim 1 includes both direct and fusion

expression. During the prosecution, Plaintiff Genentech confirmed

its belief that expression was not limited to direct expression

when it wrote: "The Examiner also urges that claims 5 and 21

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encompass direct expression of human IGF-I and IGF-II in

prokaryotes, as well as fusion proteins and secreted proteins, with

no guidance model." Id, Tab 8 at 15.

In light of the claims, the specification and the patent

history, Defendants' arguments that claim 1 entails only direct

expression are not convincing. Accordingly, the Court construes

the term "expression" used in claim 1 as covering both fusion and

direct expression.

b. Human IGF-I

The parties also dispute the construction of the term "human

IGF-I." Plaintiffs contend that human IGF-I means "a polypeptide

that corresponds in amino acid sequence to mature human insulinlike growth factor-I (IGF-I) naturally occurring in human blood,

and optionally can include an additional amino acid at the N

terminal end." Defendants construe this term to mean a polypeptide

having the same amino acid sequence and disulfide bond

configuration as human IGF-I isolated from human blood or serum and

to exclude IGF-I fusion proteins. The Court agrees that this term

excludes IGF-I fusion proteins, but it will not use the term

Defendants propose. Instead, it will use the definition provided

in the patent. Thus, the Court construes the term "human IGF-I" as

comprising the amino acid sequence corresponding to human IGF

native to human tissue; human IGF-I does not include fusion

proteins. See col. 4:64-2. 

2. Claim 9

Claim 9 discloses, "A process for producing mature human IGF-I

comprising culturing a recombinant prokaryotic host cell,

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transformed with a replicable expression vector capable of

expressing in a suitable host cell a DNA sequence encoding a fusion

protein comprised of human IGF-I fused at the N-terminus of the

IGF-I to amino acid sequence exogenous to human IGF-I, under

conditions permitting expression of the DNA sequence, and cleaving

the fusion protein to release mature human IGF-I having the proper

amino terminus (gly)."

The parties dispute the construction of the term "fusion

protein comprised of human IGF-I fused at the N-terminus to amino

acid sequence exogenous to human IGF-I." Plaintiffs contend that

the terms means a non-natural protein encompassing an amino acid

sequence that corresponds to the mature human IGF-I sequence linked

at its N-terminus to an amino acid sequence from any other source

other than the human IGF-I sequence. Defendants contend that the

term means "'a fusion protein' composed of an amino acid sequence

taken from a prokaryotic cell attached to the N-terminus of a

domain with the amino acid sequence of 'Human IGF-I.'" Defendants

separately construe the term "a fusion protein." According to

Defendants, "a fusion protein" means "a final translation product

that is a single polypeptide chain composed of amino acid sequences

from two or more distinct proteins." At the hearing, however, the

parties agreed that the Court need not construe the term "fusion

protein," nor any other term except "exogenous to human IGF-I."

Plaintiffs point out that Defendants' experts conceded that

the ordinary meaning of the term "exogenous" does not convey a

specific source for the amino acids, and encompasses anything

outside of that which is endogenous. See, e.g., Gaede Dec., Ex. 9

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at 195-97. Defendants do not, however, show a clear disclaimer of

the ordinary meaning through "redefining the term or by

characterizing the invention in the intrinsic record using words or

expressions of manifest exclusion or restriction, representing a

clear disavowal of claim scope." Teleflex, Inc. v. Ficosa North

Am. Corp., 299 F.3d 1313, 1327 (Fed. Cir. 2002). 

As Plaintiffs note, the claim language defines the fusion

protein in reference to only one source, the human IGF-I amino acid

sequence, and requires only that the fusion partner be an amino

acid sequence not derived from that source. Unlike in claim 5, no

other source limitations are recited, and the language encompasses

any amino acid sequences, not just portions from proteins. Claim 5

expressly restricts the fusion partner source by reciting that it

comes from a bacterial protein, a limitation not present in

claim 9. During prosecution, the Examiner required Plaintiff

Genentech to limit claim 5 to "bacterial protein" fusions, but did

not impose such a requirement on claim 9, leaving its scope

undisturbed.

The Court construes the term "exogenous to human IGF-I" to

mean any other source other than the human IGF-I sequence. 

3. Bioactivity

Defendants assert that the human IGF-I, in claim 1, and the

mature human IGF-I, in claim 9, require proper disulfide

configuration. Plaintiffs contend that Defendants are reading

additional limitations into claims 1 and 9. According to

Plaintiffs, human IGF-I and mature human IGF-I are defined by their

primary amino acid sequence and do not require any disulfide bond

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configuration. 

The patent does not include the phrase "disulfide bond

configuration." But it does stress bioactivity, and, according to

Defendants' expert, IGF-I that does not have proper disulfide bonds

formed are likely to be inactive. Defendants contend that the only

utility disclosed in the '414 patent for human IGF-I is its use as

a therapeutic agent, and thus bioactivity is required. In

discussing the present invention, the patent states, "All such

products have been found to be biologically active, hence useful as

intended." '414 patent, col. 1:44-53. The goal of the invention

was to produce human IGF as a product of recombinant DNA technology

from a host organism: "Such materials would exhibit bioactivity

admitting of their use clinically in the treatment of various

growth affect conditions." Id. at col. 2:226-32. In addition to

the specification, Defendants point to the prosecution history,

which reinforces the bioactivity requirement.

Plaintiffs point to other parts of the specification. They

note that the specification teaches that the claimed IGF proteins

are "defined by means of DNA, gene and deductive sequencing," not

only bioactivity. Id. at col. 5:2-5. The specification further

describes the invention as "directed to the preparation of

polypeptides comprising the amino acid sequence of IGF." Id. at

3:56-61. The parts of the specification Plaintiffs cite, however,

do not show that there is no bioactivity requirement. And

Plaintiffs fail to address the portions of the specification

emphasizing the need for bioactivity. Nor do Plaintiffs adequately

address the prosecution history. For example, in response to an

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office action, Plaintiff Genentech stated that undue

experimentation would not be required "to determine whether a given

IGF-I or IGF-II protein, expressed directly, secreted or as a

fusion protein, is biologically active and thus falls within the

scope of the present claims." '414 Patent Stipulated File History,

Tab. 8 at 18. 

The Court construes the term "human IGF-I," in claim 1, and

term "mature human IGF-I," in claim 9, to refer to bioactive

material.

C. The '151 Patent

Claim 1 provides, "A method for producing an anabolic state in

a mammal comprising co-administering to the mammal by subcutaneous

bolus injection effective amounts of IGFBP-3 and IGF-I in a molar

ratio of IGFBP-3 to IGF-I of about 0.5:1 to about 3:1 so as to

produce a greater anabolic state in the mammal than that achieved

using an equivalent dose of IGF-I alone, wherein growth hormone is

not also administered to the mammal." 

1. "produce a greater anabolic state"

Plaintiffs contend that this term means "promoting a greater

gain of total body weight or statural growth." According to

Plaintiffs, here, Plaintiff Genentech acted as its own

lexicographer; the patent’s specification contains an explicit

definition of producing an anabolic state, and that definition must

be followed. Defendants disagree, arguing that the term should be

given its common and ordinary meaning. Defendants state the term

means "characterized by or promoting constructive metabolism." 

Defendants contend that the intrinsic evidence, including the

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specification, is consistent with the common and ordinary meaning

of the term. 

The specification provides, 

As used herein, the words "producing an anabolic state" refer

to promoting total body weight gain as well as the dynamics of

statural growth experienced by an individual during infancy,

childhood, and adolescence as depicted by a normal growth

curve, i.e., growth of linear-producing bone plate driven by

chondrocytes, as well as growth of osteoblast cells, derived

from a different part of the bone. Restoration of normal

growth patterns would allow the patient to approach a more

satisfactory growth curve. Examples of patients that are

relatively resistant to GH but require treatment to induce an

anabolic effect include those with Turner's Syndrome,

GH-deficient children who grow poorly in response to GH

treatment, children who experience a slowing or retardation in

their normal growth curve about 2-3 years before their growth

plate closes, so that GH administered alone would no longer

increase growth of the children, so-called short normal

children, and patients where the IGF-I response to GH has been

blocked chemically (i.e., by glucocorticoid treatment) or by a

natural condition such as in adult patients where the IGF-I

response to GH is naturally reduced. In addition, the method

herein is useful for treating pregnant women who are in a

catabolic state and/or experience loss of bone mass, for

treating women with osteoporosis, and for repairing bone. 

'151 patent, col. 6:38-68.

Plaintiffs focus on the first sentence of the above paragraph;

Defendants focus on the last sentence. Defendants also highlight

other parts of the specification that they contend support their

definition. As they note, the Field of the Invention states, "This

invention relates to a method for producing an anabolic or growth

promoting state in a mammal. More specifically, this invention is

directed to the use of a complex of IGF-I and one or more of its

binding proteins to produce an anabolic state, including enhancing

whole body and bone growth." '151 patent, col. 1:7-12. The

specification also states, "Efficacious results are measured by

increases in body weight gain, lean body mass, bone growth, or

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statutory [sic] growth approximating the normal range, or by other

criteria for measuring the anabolic state of a mammal, as defined

herein, as are deemed appropriate by the practitioner." '151

patent, col. 8:2-7. These statements and the last sentence in the

paragraph quoted above, however, do not support Defendants'

definition. The patent and its history do not contain the term

"constructive metabolism." The last sentence of the quoted

paragraph, stating that the method described is useful for treating

pregnant women and for repairing bone, is not part of the

definition; it does not broaden the definition beyond what the

patent explicitly states that it is. Rather, that sentence

provides examples of patients and conditions that can also benefit

from the method for producing an anabolic state as claimed in the

patent.

Plaintiffs are correct that the specification's definition of

"produce a greater anabolic state" controls. Therefore, the Court

construes the term "produce a greater anabolic state" to mean

promoting greater total body weight gain as well as statural

growth.

2. "greater anabolic state in the mammal than achieved

using an equivalent dose of IGF-I"

Plaintiffs contend that this phrase means to "promote total

body weight gain or statural growth that is greater than whatever

total body weight gain or statural growth would be observed if the

same amount of IGF-I as present in the IGF-I/IGFBP-3 mixture were

administered by the same route, regimen, and schedule of

administration as is used in the administration of the IGF-I/

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IGFBP-3 mixture." In short, Plaintiffs state that it requires

"that the doses compared, i.e., complexed IGF-I/IGFBP-3 versus 

IGF-I alone, must contain the same quantity of IGF-I and they must

be administered following the same dosing regimen." Defendants

contend that this phrase means that "a greater state of

constructive metabolism is produced in the mammal when an IGFI/IGFBP-3 complex is administered than when an 'equivalent dose' of

'IGF-I' is administered alone." Defendants separately define

equivalent dose as a dose of IGF-I alone which has, within the

measurement error, the same number of molecules of IGF-I as the

dose of IGFBP-3/IGF-I complex to which it is being compared. 

Plaintiffs believe that no separate construction of equivalent dose

is necessary because it should be construed as part of the phrase.

Both parties rely on the specification to support their

constructions. Plaintiffs point to language, under the heading

"Modes for Carrying Out the Invention," stating that the "amounts

administered will promote a greater anabolic state in the treated

patient over the anabolic effect obtained using the same amount of

IGF-I administered by the same protocol, regimen, and route, but

without IGFBP being also administered." '151 patent, col. 7:20-25. 

As Plaintiffs note, the '151 patent does not purport to teach, or

claim, benefits based on different amounts of IGF-I, different

protocols, different doses, or different routes of administration. 

Defendants note that the language Plaintiffs quote from the

specification relates to the term "effective amounts," which the

parties have stipulated means "the amounts of IGF-I and IGFBP-3 coadministered produce a 'greater anabolic state in the mammal than

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that achieved using an equivalent dose of IGF-I alone.'" 

Regardless, the specification language quoted above is not to be

ignored just because it concerns a different phrase. See ACTV,

Inc. v. Walt Disney Co., 346 F.3d 1082, 1088 (Fed. Cir. 2003). The

specification language Plaintiffs quote concerning the "same

protocol, regimen, and route" is more useful in construing the

phrase "greater anabolic state in the mammal than achieved using an

equivalent dose of IGF-I" than the language to which Defendants

point. For example, in their section on equivalent doses,

Defendants contend that the patent refers to dose as the amount

delivered per day, not per injection. Although this is true, the

patent provides how many injections are to be given daily, e.g.,

"IGF-I delivery at 0.3 mg/kg/day (two injections of 15 μg per

day)." '151 patent, col. 12:4-5. The experiments described in the

patent illustrate that the '151 patent compares forms of the drug,

not different doses or numbers of injunctions. 

Defendants' other two arguments in support of their

construction are based on their expert's report and English

grammar. Neither argument is persuasive. Their expert states

that, when making comparisons between two different treatments,

"clinicians often compare total daily dosage of a drug, without

regard to whether the drug is administered in one injection per day

or two injections per day" and "comparison of daily dosages is

scientifically relevant." 2d Spencer Report at ¶ 47. This is

extrinsic evidence, regarding what clinicians often compare, does

not pertain to the patent at issue and is not useful. Defendants

further argue that the phrase uses a past participle -- the word

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achieved -- and thus requires that a direct comparison have been

made between the effect "achieved" using a complex of IGF-I and

IGFBP-3 and that "achieved" using IGF-I alone. According to

Defendants, Plaintiffs seek to rewrite the claim by adding the

words "if" "were" and "would," to change the claim to require only

a theoretical comparison of the effects of the complex and IGF-I

alone that has not yet occurred and that may never occur. This

argument is unavailing as well.

 Based on the intrinsic evidence presented, the Court

construes the phrase "greater anabolic state in the mammal than

achieved using an equivalent dose of IGF-I" to mean promote total

body weight gain or statural growth that is greater than whatever

total body weight gain or statural growth would be observed if the

same amount of IGF-I as is present in the IGF-I/IGFBP-3 mixture

were administered by the same route, regimen, and schedule of

administration as used in the administration of the IGF-I/IGFBP-3

mixture. The Court will not separately construe the term

"equivalent dose" because it is construed as part of the above

phrase.

D. The '287 Patent

Claim 1 provides, "An isolated DNA molecule comprising a

sequence that hybridizes, under stringent conditions of 50%

formamide with 0.75M NaCl and 0.075M sodium citrate, at 42N C., to

the portion of the DNA sequence of FIG. 3 coding for mature BP53 or

the preprotein for BP53 and which encodes a BP53 protein that binds

to IGF-I or IGF-II, excluding BP28, PP12, and HEP-G2."

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1. "hybridizes, under stringent conditions"

Plaintiffs state that the parties largely agree to the

construction of this term. Defendants contend that it means

"single strands of DNA from two sources form a stable doublestranded structure that remains intact during manipulation in the

following conditions: Hybridizing in 50% formamide at 5XSSC at a

temperature of 42N C. and washing the filters in 0.2XSSC at 60N C. 

These conditions are intended to exclude sequences that hybridize

to the BP28 sequence." According to Plaintiffs, the difference

between the parties' constructions is Defendants' attempt to add

the sentence on intent. 

Plaintiffs argue that the intent sentence is from the

specification and should not be imported to the definition of this

term. Defendants contend that the intent sentence is an

affirmative limitation that Plaintiff Genentech added to claim 1

during prosecution to overcome an enablement rejection. They note

that the Examiner initially rejected claim 1 for lack of enablement

because the specification did "not enable all DNAs which would

hybridize to the DNA of Fig. 3 under stringent conditions." '287

Patent Stipulated File History, Tab 12 at 3. But Defendants

include only a portion of the Examiner's sentence. The sentence in

full reads: "The specification does not enable all DNAs which would

hybridize to the DNA of Fig. 3 under stringent conditions wherein

the sequence is at least 10 nucleotides in length as set forth in

claim 1." Id. According to Plaintiffs, Plaintiff Genentech

overcame this rejection by replacing the minimum length limitation

with a limitation that the DNA molecules must encode a protein with

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specific biological activity that is not the BP28 protein. 

Furthermore, as Plaintiffs note, the intrinsic evidence also

contradicts Defendants' interpretation. The words of the claim and

the prosecution history demonstrate that the final phrase of claim

1 -- excluding BP28, PP12, and HEP-G2 -- is meant to exclude

certain proteins from the claim, not to exclude DNA sequences that

hybridize to certain other DNA sequences. 

The Court construes the term "hybridizes, under stringent

conditions" to mean that single strands of DNA from two sources

form a stable double-stranded structure that remains intact during

manipulation in the following conditions: Hybridizing in 50%

formamide at 5XSSC at a temperature of 42N C. and washing the

filters in 0.2XSSC at 60N C. 

II. Summary Judgment

A. Legal Standard

Summary judgment is properly granted when no genuine and

disputed issues of material fact remain, and when, viewing the

evidence most favorably to the non-moving party, the movant is

clearly entitled to prevail as a matter of law. Fed. R. Civ.

P. 56; Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986);

Eisenberg v. Ins. Co. of N. Am., 815 F.2d 1285, 1288-89 (9th Cir.

1987).

The moving party bears the burden of showing that there is no

material factual dispute. Therefore, the court must regard as true

the opposing party's evidence, if supported by affidavits or other

evidentiary material. Celotex, 477 U.S. at 324; Eisenberg, 815

F.2d at 1289. The court must draw all reasonable inferences in

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favor of the party against whom summary judgment is sought. 

Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574,

587 (1986); Intel Corp. v. Hartford Accident & Indem. Co., 952 F.2d

1551, 1558 (9th Cir. 1991). 

Material facts which would preclude entry of summary judgment

are those which, under applicable substantive law, may affect the

outcome of the case. The substantive law will identify which facts

are material. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248

(1986).

Where the moving party does not bear the burden of proof on an

issue at trial, the moving party may discharge its burden of

production by either of two methods. Nissan Fire & Marine Ins.

Co., Ltd., v. Fritz Cos., Inc., 210 F.3d 1099, 1106 (9th Cir.

2000). 

The moving party may produce evidence negating an

essential element of the nonmoving party’s case, or,

after suitable discovery, the moving party may show that

the nonmoving party does not have enough evidence of an

essential element of its claim or defense to carry its

ultimate burden of persuasion at trial. 

Id. 

If the moving party discharges its burden by showing an

absence of evidence to support an essential element of a claim or

defense, it is not required to produce evidence showing the absence

of a material fact on such issues, or to support its motion with

evidence negating the non-moving party's claim. Id.; see also

Lujan v. Nat’l Wildlife Fed’n, 497 U.S. 871, 885 (1990); Bhan v.

NME Hosps., Inc., 929 F.2d 1404, 1409 (9th Cir. 1991). If the

moving party shows an absence of evidence to support the non-moving

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party's case, the burden then shifts to the non-moving party to

produce "specific evidence, through affidavits or admissible

discovery material, to show that the dispute exists." Bhan, 929

F.2d at 1409. 

If the moving party discharges its burden by negating an

essential element of the non-moving party’s claim or defense, it

must produce affirmative evidence of such negation. Nissan, 210

F.3d at 1105. If the moving party produces such evidence, the

burden then shifts to the non-moving party to produce specific

evidence to show that a dispute of material fact exists. Id.

If the moving party does not meet its initial burden of

production by either method, the non-moving party is under no

obligation to offer any evidence in support of its opposition. Id.

This is true even though the non-moving party bears the ultimate

burden of persuasion at trial. Id. at 1107.

Where the moving party bears the burden of proof on an issue

at trial, it must, in order to discharge its burden of showing that

no genuine issue of material fact remains, make a prima facie

showing in support of its position on that issue. UA Local 343 v.

Nor-Cal Plumbing, Inc., 48 F.3d 1465, 1471 (9th Cir. 1994). That

is, the moving party must present evidence that, if uncontroverted

at trial, would entitle it to prevail on that issue. Id.; see also

Int’l Shortstop, Inc. v. Rally's, Inc., 939 F.2d 1257, 1264-65 (5th

Cir. 1991). Once it has done so, the non-moving party must set

forth specific facts controverting the moving party's prima facie

case. UA Local 343, 48 F.3d at 1471. The non-moving party's

"burden of contradicting [the moving party's] evidence is not

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negligible." Id. This standard does not change merely because

resolution of the relevant issue is "highly fact specific." Id.

B. Plaintiffs' Motion for Partial Summary Judgment

Plaintiffs move for summary judgment that Defendants' process

for making IPLEXTM literally meets every element of claims 2 and 9

of the '414 patent. In addition, they move for summary judgment of

validity as against Defendants' anticipation and obvious defenses

to the '151 patent.

1. '414 patent

Plaintiffs note that Defendants' non-infringement position as

to claim 2, which depends on claim 1, and claim 9 rests on

Defendants' claim construction of the terms "expression" and

"exogenous to human IGF-I." Indeed, Defendants do not dispute

that, if the Court adopts Plaintiffs' constructions, they literally

infringe claims 1, 2 and 9. The Court has adopted Plaintiffs'

constructions regarding these terms and grants Plaintiffs summary

judgment that Defendants literally infringe claims 1, 2 and 9 of

the '414 patent.

2. '151 patent

Plaintiffs contend that no reasonable jury would find that the

Maack and Sommer abstracts qualify as prior art under 35 U.S.C.

§ 102(a). According to Plaintiffs, the inventions asserted were

reduced to practice in September, 1990, before the January, 1991

publication of the abstracts, and thus the abstracts are not prior

art. Reduction to practice occurs when the inventors perform a

process that satisfies all of the limitations of the claim, and

determine it will work for the intended purpose. See SlipTrack

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Sys., Inc. v. Metal-Lite, Inc., 304 F.3d 1256, 1266 (Fed. Cir.

2002). 

Plaintiffs provide evidence, including corroborating evidence,

showing that Plaintiff Genentech's scientists reduced claims 1, 4,

5 and 7 to practice approximately four months prior to the

abstracts' publication. They meet their "burden of production to

present evidence of its asserted actual reduction to practice prior

to the filing date of its patent application." Loral Fairchild

Corp. v. Matsushita Elec., 266 F.3d 1358, 1361 (Fed. Cir. 2001). 

They point out that Defendants bear the burden of showing by clear

and convincing evidence that the Maack and Sommer abstracts are

prior art. See id. (noting that, because of the statutory

presumption of patent validity, at trial defendants would bear the

burden of proving by clear and convincing evidence that a reference

was published prior to plaintiff's reduction to practice). 

Plaintiffs note that Defendants did not submit expert testimony on

reduction to practice.

Defendants respond that there are genuine issues of material

fact as to whether the asserted claims of the '151 patent were

reduced to practice before the Maack and Sommer abstracts were

published. But Defendants provide no evidence to rebut Plaintiffs'

prima facie showing that the claims were reduced to practice prior

to publication of the abstracts. Instead, Defendants criticize

Plaintiff's corroborating evidence. That criticism, however, is

not sufficient to create an issue of fact. It is Defendants'

burden to prove that the Maack and Sommer references were published

prior to Plaintiff's reduction to practice. They cannot produce

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evidence of a triable issue of fact by relying only upon attorney

argument. Thus, the Court grants Plaintiffs summary judgment that

the patent is not invalidated by prior art. 

C. Defendants' Motion for Summary Judgment

Defendants move for summary judgment that they do not infringe

claims 1 through 4 and 9 and 10 of the '414 patent, that the

asserted claims of the '414 patent are invalid under 35 U.S.C.

§ 101 and § 112, that they do not infringe claims 1, 4, 5, and 7 of

the '151 patent, and that they are not liable for activities that

occurred more than six years before the filing of this suit and/or

which are covered by the safe harbor doctrine.

1. '414 patent

a. Infringement

Defendants conceded at the hearing that if the Court construes

the term expression to cover both direct and fusion expression then

summary judgment of no infringement cannot be granted. As

explained above, the Court did construe expression to cover both

direct and fusion expression, and it granted Plaintiffs summary

judgment that Defendants infringe claims 1, 2 and 9 of the '414

patent. Thus, the Court denies Defendants summary judgment that

they did not infringe claims 1 through 4 and 9 and 10 of the '414

patent.

b. Invalidity

Defendants contend that, if the Court adopts Plaintiffs'

construction of "human IGF-I," in claim 1, and "mature human IGFI", in claim 9, which does not require a disulfide bond

configuration or bioactivity, then the claims at issue are invalid

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for lack of utility. See 35 U.S.C. § 101. The Court adopted the

patent's definition of "human IGF-I" and construed that term, and

the term mature human IGF-I, to refer to bioactive material. The

claims are not invalid as a matter of law for lack of utility.

Defendants further contend that, if the Court rejects their

construction of the asserted claims, the claims are invalid because

they do not comply with the written description requirement of 35

U.S.C. § 112. Section 112 requires, "The specification shall

contain a written description of the invention, and of the manner

and process of making and using it, in such full, clear, concise,

and exact terms as to enable any person skilled in the art to which

it pertains, or with which it is most nearly connected, to make and

use the same, and shall set forth the best mode contemplated by the

inventor of carrying out his invention." The Federal Circuit

explains, "The adequate written description requirement, which is

distinct from the enablement and best mode requirements, serves 'to

ensure that the inventor had possession, as of the filing date of

the application relied on, of the specific subject matter later

claimed by him; how the specification accomplishes this is not

material.'" In re Alton, 76 F.3d 1168, 1172 (Fed. Cir. 1996)

(quoting In re Wertheim, 541 F.2d 257, 262 (C.C.P.A. 1976)). To

meet the adequate written description requirement, “the description

must clearly allow persons of ordinary skill in the art to

recognize that [the inventor] invented what is claimed.” In re

Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989) (citation omitted).

Plaintiffs respond that there are genuine issues of fact on

this issue, pointing to their experts' reports that conclude the

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asserted claims are not invalid under section 112. Defendants

contend that Dr. Keith Backman's report, in particular, is

irrelevant or inconsistent with the facts and law. That is

incorrect. Dr. Backman's report demonstrates that there are

disputed issues of fact, making summary judgment inappropriate. 

Dr. Backman concludes that the specification conveys to one of

skill in the art that the inventors were in possession of the

claimed invention. His report is not based solely upon his

interpretation of what a person of ordinary skill would have

thought was obvious based upon a combination of the '414 patent's

specification and other art. Nor is it dispositive that the patent

does not contain an express description of a heterologous/

heterologous fusion protein. Because there is a disputed issue of

fact as to whether the patent's description clearly allows persons

of ordinary skill in the art to recognize that the inventors

invented what is claimed, the Court denies summary judgment.

2. '151 Patent

Defendants contend that Plaintiffs fail to meet their burden

to show that they infringe claims 1, 4, 5 and 7 of the '151 patent. 

But, as both parties note, this contention depends upon the Court

accepting Defendants' proposed construction of the claims. The

Court did not adopt Defendants' construction. Rather, the Court

adopted Plaintiffs' construction of the disputed terms. The Court

will not summarily adjudicate that Defendants did not infringe the

asserted claims of the '151 patent.

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3. Defendant Celtrix's liability

Plaintiffs accuse Defendant Celtrix of infringing, inducing

and/or contributing to infringement of the '151 and '287 patents. 

Defendants contend that all of Defendant Celtrix's activities

allegedly infringing the patents fall outside the statute of

limitations and fall within the safe-harbor provided by 35

U.S.C. § 271(e)(1). 

a. Statute of limitations

Title 35 U.S.C. § 286, entitled "Time limitation on damages,"

provides that "no recovery shall be had for any infringement

committed more than six years prior to the filing of the complaint

or counterclaim for infringement in the action." As Plaintiffs

noted, for the first time, at the hearing, § 286 is not a statute

of limitations in the sense of barring a suit for infringement;

rather, it limits recovery to damages for infringing acts committed

within six years of the date of the filing of the infringement

action. A.C. Aukerman Co. v. R.L. Chaides Const. Co., 960 F.2d

1020, 1030 (Fed. Cir. 1992).

Plaintiffs' original complaint was filed on December 23, 2004;

therefore, any recovery based on activities pre-dating December 23,

1998 is time-barred. Relying on the declaration of Dr. Andreas

Sommer, the Chief Scientific Officer of Insmed Incorporated,

Defendants contend that, prior to December, 1998, Celtrix ceased to

perform any activities that could be alleged to have infringed, or

contributed to or induced infringement of Plaintiff Genentech's

patents. Dr. Sommer notes that, due to financial difficulties,

Celtrix closed its manufacturing facility and laid off its 

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manufacturing employees in September, 1998; between December 28,

1998 and May 31, 2000, when Defendant Celtrix was acquired by

Defendant Insmed, Defendant Celtrix did not produce any form of

what was to become IPLEXTM.

Plaintiffs respond that Dr. Sommer's recollection is

unreliable, noting that Dr. Sommer states that to "the best of his

recollection" neither Defendants Celtrix nor Defendant Insmed

provided Dr. Martin Zdanowicz with IPLEXTM after December 23, 1998. 

Plaintiffs point to an article by Dr. Zdanowicz, published in 2003,

that states that the complex, IPLEXTM, was "kindly provided by

Celtrix Pharmaceuticals." According to Plaintiffs, the reasonable

inference is that the drug used in Dr. Zdanowicz's study, discussed

in his 2003 article, probably was supplied after December, 1998. 

Plaintiffs contend that a jury should be able to weigh the evidence

of this recent article against the credibility of Dr. Sommer's

recollection. This 2003 article, however, is not enough to create

a material dispute of fact, especially because Plaintiffs do not

rebut Defendants' claim that Defendant Celtrix did not produce

IPLEXTM from December, 1998, to May, 2000, when Defendant Insmed

acquired Defendant Celtrix. As Defendants note, Plaintiffs did not

take any discovery from Dr. Zdanowicz. Because Plaintiffs fail to

provide evidence that Defendant Celtrix infringed, or induced

others to infringe, after December 28, 1998, the Court grants

Defendant Celtrix summary judgment that no recovery can be had

against it based on Plaintiffs' allegations regarding Dr.

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2

In their moving papers, Defendants sought summary judgment

that all Celtrix activities infringing the '151 and '287 patents

fall outside § 286. But in their reply, they seek summary

adjudication only as to the allegations regarding Celtrix and Dr.

Zdanowicz.

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Zdanowicz.2

b. Safe-harbor 

Defendants contend that even if Defendant Celtrix had engaged

in any activities that would infringe, induce or contribute to

infringement of the patents at issue after December 23, 1998, those

activities would fall within the safe-harbor provided by 35 U.S.C.

§ 271(e). Under this safe-harbor doctrine, it is not an act of

infringement to make, use or sell a patented invention solely for

purposes reasonably related to the development and submission of

information under a federal law which regulates the manufacture,

use or sale of drugs. As the Supreme Court recently instructed,

"the use of patented compounds in preclinical studies is protected

under § 271(e)(1) as long as there is a reasonable basis for

believing that the experiments will produce the types of

information that are relevant to an IND or NDA." Merck KGaA v.

Integra Lifesciences I, Ltd., 545 U.S. 193, 125 S.Ct. 2372, 2383-84

(2005).

Plaintiffs argue that Defendants have not met their burden of

proving a section 271(e) safe harbor as an affirmative defense. 

They contend that Protegan, a consultant company to which Defendant

Insmed supplied IGFBP-3 made by Celtrix, conducted infringing

experiments for commercial activities, which are not exempted by

section 271(e)(1) because they are not reasonably related to any

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FDA submission. But, as discussed at the hearing, any research

conducted by Protegan, was for FDA purposes. Without FDA approval,

Defendants could not sell their drug on the market. The Court

finds that, even if the allegedly infringing experiments were

conducted, in part, for commercial reasons, the experiments would

produce information that would be given to the FDA in order to get

FDA approval. Thus, research conducted by Protegan would be

protected under the safe harbor doctrine. Accordingly, the Court

grants Defendants summary judgment on this ground. 

CONCLUSION

For the foregoing reasons, the Court construes the disputed

terms and phrases in the foregoing manner. The Court GRANTS

Plaintiffs' Motion for Partial Summary Judgment (Docket No. 412). 

The Court grants Plaintiffs summary judgment that Defendants

infringe claims 1, 2 and 9 of the '414 patent and that the '151

patent is not invalidated by the Maack and Sommer abstracts. The

Court GRANTS Defendants' Motion for Summary Judgment (Docket

No. 426) IN PART and DENIES it IN PART. The Court denies

Defendants summary judgment that they did not infringe claims 1

through 4 and 9 and 10 of the '414 patent and that the '414 patent

is invalid. There are disputes of fact regarding claims 3, 4 and

10. The Court will not summarily adjudicate that Defendants did

not infringe claims 1, 4, 5 and 7 of the '151 patent. The Court,

however, does grant Defendants summary judgment that no recovery

can be had against Defendant Celtrix based on Plaintiffs'

allegations regarding Dr. Zdanowicz and that research conducted by

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3To the extent that the Court relied upon evidence to which

there is an objection, the parties' objections are overruled. To

the extent that the Court did not rely on such evidence, the

parties' objections are overruled as moot. 

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Protegan is protected under the safe harbor doctrine.3 

IT IS SO ORDERED.

Dated: 6/30/06

 

CLAUDIA WILKEN

United States District Judge

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