The opinion of the court was delivered by: PHYLLIS HAMILTON, District Judge
ORDER GRANTING SUMMARY JUDGMENT IN PART AND DENYING SUMMARY
JUDGMENT IN PART
The parties' cross-motions for summary judgment came on for
hearing on October 26, 2005 before this court. Plaintiff, the
Regents of the University of California (the "UC Regents"),
appeared through its counsel, Gerald Dodson, Erik Olson, and
Erica Wilson. Defendant Monsanto Company ("Monsanto") appeared
through its counsel, Adrian Pruetz, John B. Quinn, Victoria
Maroulis, John D. Van Loben Sels, Irvin E. Tyan, and Robert B.
Wilson. Having read all the papers submitted and carefully
considered the relevant legal authority, the court hereby GRANTS
the motions for summary judgment in part and DENIES the motions
for summary judgment in part, for the reasons stated at the
hearing, and as follows.
The UC Regents is the assignee and owner of U.S. Patent No.
6,692,941 ("the `941 patent"), which covers bovine growth hormone
("bGH"), bovine pre-growth hormone, and the DNA molecules that
allow for expression of bovine growth hormone and pre-growth
The `941 patent was issued in February 2004, and was the result
of four prior patent applications: (1) the `348 application filed
in 1980; (2) the `557 application filed in 1983; (3) the `937
application filed in 1987; and (4) the `745 application filed in
1990. Under the rules espoused by the Patent and Trademark Office
("PTO"), the `941 patent is deemed to relate back to the filing date of the first application, i.e., 1980.
Monsanto makes, uses, and sells POSILAC, a veterinary drug
whose active ingredient is bovine growth hormone. In order to
make POSILAC, Monsanto engages in an extensive production process
that includes the use of two bacterial strains, W3110G[pBGH1] and
LBB557[pXT757]. These strains include the recombinant plasmids
pBGH1 and pXT757, which in turn include the DNA sequences that
allow the bacteria to express commercial levels of sometribove,
the recombinant form of bGH that comprises POSILAC.
A. The `941 Patent Claims
Only claims 1-10 of the `941 patent are at issue here. These
claims are directed to isolated DNA and recombinant DNA molecules
that encode bGH amino acid nos. 2-191; recombinant DNA vectors
that can express a DNA segment encoding bGH amino acid nos.
2-191; and bacteria that contain these DNA vectors. The claims
are also directed to bacteria containing the bGH protein, and
methods for making bGH protein using claimed bacteria or vectors.
Specifically, the `941 patent claims:
1. "A composition of DNA molecules which consists of
DNA molecules encoding bovine growth hormone
comprising the amino acid sequence: [sequence]"
2. "A recombinant DNA molecule which comprises a
segment encoding a protein in a condition
substantially free of DNA encoding bovine pituitary
protein other than bovine growth hormone, wherein
said segment encodes a protein comprising the amino
acid sequence: [sequence]"
3. "The recombinant DNA molecule of claim 2 wherein
said segment comprises the nucleotide sequence:
4. "A microorganism transformed with the DNA molecule
of claim 3"
5. "The recombinant DNA molecule of claim 2 which
further comprises sequences capable of effecting the
expression of said segment when contained in a microorganism"
6. "A microorganism transformed with the DNA molecule
of claim 5"
7. "A method to produce bovine growth hormone which
method comprises culturing the microorganism of claim
6 under conditions wherein said expression is
effected to produce said bovine growth hormone; and
recovering bovine growth hormone from the culture"
8. "A microorganism transformed with the DNA molecule
of claim 2"
9. "A microorganism that contains bovine growth
hormone which hormone has the amino acid sequence:
10. "A method to produce bovine growth hormone which
method comprises recovering the bovine growth hormone
from the microorganism of claim 9"
On March 9, 2005, the court held a hearing on the issue of
claim construction. On March 17, 2005, the court issued its order
construing the disputed terms in the above claims. See Claim
The instant action was filed against Monsanto on February 17,
2004, asserting a claim for patent infringement under
35 U.S.C. § 1 et seq. and seeking damages accordingly. Monsanto answered and
counterclaimed, seeking a declaration that the `941 patent is
invalid, unenforceable, that the UC Regents are guilty of
inequitable conduct, and that no infringement of the `941 patent
has occurred. Monsanto also asserted the affirmative defense of
Both parties now move for summary judgment. Specifically, the
UC Regents move for summary judgment as to: (1) validity; (2)
inequitable conduct; and (3) prosecution laches. Monsanto moves
for summary judgment as to (1) non-infringement; (2) invalidity
and unenforceability; and (3) damages. Monsanto has also moved to
preclude the testimony of the UC Regents' damages expert, Dr.
Jeffrey Leitzinger. DISCUSSION
I. Summary Judgment Standard
Summary judgment is appropriate when the evidence shows there
is no genuine issue of material fact and the moving party is
entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c);
Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986).
Monsanto seeks a declaration that none of the plasmids,
bacteria, or culturing and purification methods it uses in
producing POSILAC infringe claims 1-10 of the `941 patent. It
asserts that no infringement occurs, either literally, or under
the doctrine of equivalents.
The court engages in a two-step process in evaluating a motion
for summary judgment on infringement. First, the court determines
the scope and meaning of the claims via claim construction; then,
the court compares that construction of the patent against the
accused products. See, e.g., Business Objects, S.A. v.
Microstrategy, Inc., 398 F.3d 1366, 1371 (Fed. Cir. 2004)
While claim construction is a matter of law, infringement
itself is a question of fact. See, e.g., Frank's Casing Crew
and Rental Tools, Inc. v. Weatherford International, Inc.,
389 F.3d 1370,1376 (Fed. Cir. 2004) (citations omitted). Therefore, a
plaintiff is only entitled to summary judgment on the question of
infringement "if the facts and inferences, when viewed in the
light most favorable to [defendant], would not persuade a
reasonable jury to return a verdict in favor of . . . the
non-moving party." Business Objects, 398 F.3d at 1371.
Infringement may be proven under two different theories. First,
a claim can be "literally infringed" if each properly construed
claim element directly reads on the accused product or process.
See Jeneric/Pentron Inc. v. Dillon Co., 205 F.3d 1377, 1382
(Fed. Cir. 2000). Second, under the doctrine of equivalents, a
court may find infringement when an accused product or process is
the substantial equivalent of the patented invention i.e.,
where the accused product or process performs substantially the
same function in substantially the same way to accomplish substantially the same result as the claimed
product or process. See Graver Tank & Mfg. Co. v. Linde Air
Prod. Co., 339 U.S. 605, 608 (1950); Optical Disc Corp. v. Del
Mar Avionics, 208 F.3d 1324, 1335-37 (Fed. Cir. 2000).
Preliminarily, there are two distinct issues that must be
resolved prior to resolution of the infringement issue on the
merits. First, whether the infringement analysis requires that
all claims of the `941 patent be construed in light of the
technology that was known and available to one of ordinary skill
in the art as of 1980, when the initial `941 patent application
was filed. Second, whether prosecution history estoppel applies
to prevent application of the doctrine of equivalents.
1. Known and Available Limitation
Monsanto asserts that all claims are to be construed in light
of the technology that was known and available to one of ordinary
skill in the art as of 1980, either by operation of this court's
claim construction order, in which the court construed claim 7 to
require this limitation, or by operation of law via legal
precedent. The UC Regents disputes this assertion, arguing that
this court read the known and available limitation into claim 7
only, and that legal precedent demands otherwise.
The court relied on Bayer AG v. Biovail Corp., 279 F.3d 1340,
1348 (Fed. Cir. 2002), in its claim construction order. See
Claim Construction Order at 13. Bayer AG explicitly sets forth
the proposition that claims must be construed with regards to
"what was known to one of ordinary skill in [the] art . . . at
the time of filing, in addition to the claims, the specification,
and the prosecution history." Bayer AG, 279 F.3d at 1348. In
the Bayer AG case, the claims at issue covered a composition of
pharmaceutical chemicals, and a treatment method involving that
same pharmaceutical composition. Bayer AG held that the "known
and available" limitation on claims construction applied to both
The UC Regents attempts to distinguish Bayer AG by asserting
that it was limited to the issue of collateral estoppel. It also
cites to Bio-Technology Gen. Corp. v. Genentech, Inc., 80 F.3d 1553 (Fed. Cir. 1996) and Amgen Inc. v. Hoescht Marion
Roussel, Inc., 314 F.3d 1313, 1335 (Fed. Cir. 2003) as support
for the fact that no "known and available" requirement should be
mandated. While its written advocacy is persuasive, its legal
arguments are not. A reading of Bayer AG demonstrates that the
court was considering claims construction with respect to the
infringement issue specifically (and even reversed the district
court's grant of summary judgment as to non-infringement), and
held that the known and available limitation applied to product
and process claims alike.
Other case law also supports this notion. See, e.g., Schering
Corp. v. Amgen Inc., 222 F.3d 1347, 1353 (Fed. Cir. 2000)
("th[e] court must determine what the [claim] term meant at the
time the patentee filed the  application"); Markman v.
Westview Instr., Inc., 52 F.3d 967, 968 (Fed. Cir. 1995) ("[T]he
focus in construing disputed terms in claim language is not the
subjective intent of the parties to the patent contract when they
used a particular term. Rather the focus is on the objective test
of what one of ordinary skill in the art at the time of the
invention would have understood the term to mean.").
Moreover, Bio-Technology Gen. Corp. does not directly support
the UC Regents' argument. While true that the court in that case
found infringement of a process claim directed to a recombinant
DNA method for producing hGH, the court made no specific
statement holding that literal infringement or claim
construction is to be decided regardless whether the accused
infringer's methods used later-developed technology. As for
Amgen Inc., the court there construed claims covering DNA
sequences for the protein erythropoietin ("EPO") to include both
exogenous and endogenous DNA. Although the UC Regents is correct
that the accused infringer in that case made exogenous DNA
through a process involving later-developed technology, the
court's actual holding in construing the claims focused only on
the plain meaning of the claims, and found that exogenous DNA was
encompassed by the claims since the claims themselves did not
specify that they covered one or the other. As with
Bio-Technology Gen. Corp., the Amgen Inc. court made no
specific holding that claim construction is to be decided
regardless without reference to what was known and available as
of the time the patent application was filed.
Accordingly, the court finds that, as a matter of law, the
construction of the `941 patent claims as set forth in the
court's claim construction order is made with reference to what
those claims meant as of 1980, when the `941 patent was filed.
In so holding, the court is not unmindful of the policy
arguments made by counsel for the UC Regents at the hearing on
the instant motions. Specifically, counsel pointed out that the
value in seeking pioneering patents such as those that opened
up the biotechnology industry would be rendered worthless, if
the claims of those patents are to be construed in accordance
with what was known and available at the time those patent
applications were filed. To this, however, the court responds
that the proper place to address such a concern is at the second
stage of the infringement analysis i.e., the point at which,
having construed the claims, the court must decide whether the
accused product or process either literally, or under the
doctrine of equivalents, reads on the properly construed claim.
As is made clear by the case law, this question of infringement
itself specifically under the doctrine of equivalents is
measured under a "time of infringement" approach, and does
encompass later-developed technology. See, e.g., Smithkline
Beecham Corp. v. Excel Pharm., Inc., 356 F.3d 1357, 1364 (Fed.
Cir. 2004) (noting "after-arising technology" as the
"quintessential example of an enforceable equivalent"); DeMarini
Sports, Inc. v. Worth, Inc., 239 F.3d 1314, 1333 (Fed. Cir.
2001) ("there is no requirement that equivalents be unknown to
science at the time of the application"); Atlas Powder Co. v.
E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1581 (Fed. Cir.
1984) ("It is not a requirement of equivalence . . . that those
skilled in the art know of the equivalence when the patent
application is filed or the patent issues. That question is
determined as of the time infringement takes place.").
In sum, while the "known and available" limitation is properly
taken into account at the claim construction stage, and can serve
to limit the literal scope of claims to what was known and
available at the time of filing, it does not prevent the court
from taking later-developed technology into account in
determining whether infringement of a claim has occurred. 2. Prosecution History Estoppel
Monsanto also argues that, with respect to claims 1-2 in
particular which cover DNA molecules encoding bGH the UC
Regents cannot succeed in proving infringement under the doctrine
of equivalents. This is because, under the doctrine of
prosecution history estoppel, the UC Regents allegedly
"surrendered" any claims directed to synthetic DNA molecules
encoding bGH. Naturally, the UC Regents disputes this assertion,
and argues that any arguments it made to the PTO examiner
regarding synthetic DNA were directed to whether the prior art
was enabling, not the scope of any patent claims.
Prosecution history estoppel operates when a patent applicant
gives up some limitation or subject matter during the patent's
prosecution to obtain allowance of the patent. Having done so,
the doctrine precludes the patent applicant from recapturing,
through the doctrine of equivalents, what he/she expressly
disclaimed during prosecution. Warner-Jenkinson Co. v. Hilton
Davis Chem. Co., 520 U.S. 17, 20 (1997). As Monsanto correctly
points out, prosecution history estoppel applies to matter
surrendered either as a result of amendments to overcome
patentability rejections, or as a result of argument to secure
allowance of a claim. See, e.g., Deering Precision Instr., LLC
v. Vector Distrib. Sys., Inc., 347 F.3d 1314, 1324-25 (Fed. Cir.
Monsanto offers no proof of amendment based estoppel. As to
argument based estoppel, Monsanto offers into evidence several
written communications that the UC Regents sent to the PTO during
prosecution, which communications show that the UC Regents
addressed several possible rejections on the basis of prior art
references. See Declaration of Van Loben Sels in Support of
Monsanto's Motion for Summary Judgment re Non-Infringement ("Van
Loben Sels Decl."), Exs. AA, BB, CC. The UC Regents, in their
communications, argued that the prior art references did not
support a conclusion that one skilled in the art could have
synthesized a DNA sequence encoding bGH. See id.
These communications, however, are insufficient to establish
prosecution based estoppel. From them, it appears clear that the
UC Regents' arguments to the PTO examiner were directed to specific prior art references and the limited
issue of whether those prior art references rendered the patent
obvious or anticipated. Specifically, the UC Regents argued that
the prior art, which disclosed a complete amino acid sequence
encoding for bGH, as well as methods for chemically synthesizing
DNA, did not render obvious or anticipated the UC Regents' patent
claims to the DNA sequence encoding bGH. This is not the same
as arguing that the claims themselves did not cover any synthetic
DNA sequence encoding bGH, and Monsanto points to no evidence
that the UC Regents actually argued that the claims covering the
DNA sequence encoding bGH were limited to non-synthetic DNA.
Indeed, the proffered evidence actually presumes that the claims
did cover synthetic DNA, for as the UC Regents points out, it
would be non-sensical for the examiner to have initially rejected
claims in view of prior art disclosing synthetic DNA, if the
claims did not actually cover synthetic DNA in the first place.
In short, it cannot be said that Monsanto has affirmatively
proven the existence of subject matter limitations as to the
claims of the `941 patent during prosecution history, such that
prosecution history estoppel could be held to apply. Accordingly,
the court finds that it does not.
Having dispensed with the above preliminary issues, the court
now turns its attention to the merits of the infringement
Claims 1 and 2 cover all DNA and recombinant DNA molecules
encoding bGH. See, e.g., Claim Construction Order at 8. Claim 1
specifically refers to any "composition" of such molecules. See
Van Loben Sels Decl., Ex Z.
Monsanto claims that it does not infringe claims 1 and 2,
literally or under the doctrine of equivalents, because (1) it
does not make, use, or sell any "composition" of its plasmids
pBGH1 or pXT757 and (2) its plasmid pXT757 has a completely
synthetic DNA encoding bGH. a. Use of pBGH1 and pXT757
Monsanto asserts that it has not made, used, or sold any
"composition" of pBGH1 and pXT757 since prior to issuance of the
`941 patent. In so arguing, Monsanto misses the point. The
question is not whether Monsanto has made, used, or sold any
"compositions" of pBGH1 or pXT757. The question is whether
Monsanto has made, used, or sold any cDNA or DNA molecules that
encode for bGH. Since Monsanto admits that the recombinant
plasmids pBGH1 and pXT757 contain the DNA molecules that encode
bGH, see Opening Brief re Non-Infringement at 3:21-22, the
question is simply whether Monsanto has made, used, or sold pBGH1
pBGH1. Monsanto presents evidence that it stopped using pBGH1
altogether in September 2003. See Van Loben Sels Decl., Ex. B.
In response, the UC Regents submits evidence that purportedly
proves Monsanto's use of pBGH1 in the making of "old strain"
powder after September 2003. See Declaration of Timur Engin in
Support of UC Regents' Opposition to Motion for Summary Judgment
re Non-Infringement ("Engin Decl."), Exs. H; I at 261:6-10.
The UC Regents' evidence fails to raise a material disputed
fact. The UC Regents sets forth an alleged "breakdown" of
"formulation batches," with no affirmative proof that any
particular batch set forth in the breakdown pertains to pBGH1
specifically, nor any proof that such a batch, if it exists, was
made after February 2004 which is the relevant date for
infringement purposes. Nor can the deposition testimony relied on
by the UC Regents provide the missing link: that testimony
asserts only that old strain powder was formulated as of February
2004, but provides no corresponding link to whether pBGH1 was an
ingredient of that old strain powder. In short, without more, the
UC Regents cannot assert Monsanto's infringement of claims 1-2 by
virtue of its use of the pBGH1 plasmid, which the evidence
demonstrates was not actually in use as of the time of
Accordingly, summary judgment on the issue of whether
Monsanto's use of pBGH1 infringes claims 1-2 of the `941 patent is GRANTED as to
pXT757. Monsanto also presents evidence that it has not used
its pXT757 plasmid since making its master cell bank prior to
February 2004. See Van Loben Sels Decl., Exs. P at
CA-BST-098427; X at ¶ 94. In response, the UC Regents asserts
that pXT757 is used daily during the fermentation and
manufacturing of bGH, and that the creation of working cell
banks, which occurs every one and a half to two years, involves
the testing of the DNA sequence that is the subject of claims
1-2. See, e.g., Engin Decl., Ex. F; Declaration of Richard
Flavell in support of UC Regents' Oppositions to Motions for
Summary Judgment ("Flavell Opp. Decl."), ¶ 10.
Contrary to the evidence it proffers with respect to pBGH1,
with the above evidence, the UC Regents has presented a disputed
material fact with respect to Monsanto's use of pXT757.
Accordingly, summary judgment on this issue is DENIED as to
Monsanto asserts that, even if it is deemed to make or use
pXT757, it still does not infringe claims 1 and 2 because pXT757
is completely synthetic. According to Monsanto, a completely
synthetic DNA sequence is outside the scope of claims 1 and 2,
literally and under the doctrine of equivalents.
First, Monsanto asserts that pXT757 does not literally infringe
claims 1-2 because synthetic DNA molecules encoding bGH were not
known and available to a person of ordinary skill in the art in
1980; construing the claims to cover only what the ordinary level
of skill in the art covered, Monsanto contends that the literal
scope of claims 1-2 cannot cover synthetic DNA sequences.
As to this, however, the parties have a material dispute, with
the UC Regents asserting that chemical synthesis of small strands
of DNA was known to skilled artisans prior to August 1980,
although the method of making longer DNA molecules developed
afterwards. See Flavell Opp. Decl., ¶¶ 19-20; cf. Van Loben Sels Decl., Ex. X,
¶ 96. In essence, this is a battle of experts and must be decided
by the trier of fact.
Second, Monsanto asserts that no infringement occurs under the
doctrine of equivalents, "in light of the prosecution history
estoppel." Since the court has already determined, however, that
prosecution history estoppel does not apply, Monsanto's argument
to this effect is unpersuasive. Applying, therefore, the doctrine
of equivalents, the issue whether Monsanto's synthetic DNA
molecules infringe on claims 1-2 is a question of fact. See
generally Warner-Jenkinson Co. v. Hilton Davis Chem. Co.,
520 U.S. 17 (1997). Again, the parties dispute whether a synthetic
DNA molecule would have been substantially the same as a
regularly isolated DNA molecule. See Van Loben Sels Decl., Ex.
X; Flavell Opp. Decl., ¶¶ 19-20. As this dispute is material,
summary judgment is inappropriate.
Accordingly, for all the above reasons, summary judgment on the
issue of whether Monsanto's use of pXT757 infringes claims 1-2 of
the `941 patent is DENIED as to Monsanto.
Claim 4 is dependent on claim 3. Together, claims 3 and 4 cover
the recombinant DNA molecules encoding bGH that comprise a
specific nucleotide sequence, as well as any bacteria that
contains those recombinant DNA molecules. Since the nucleotide
sequence in claim 3 is not literally identical to the nucleotide
sequence used by Monsanto in its plasmid pXT757, the UC Regents
does not assert literal infringement of claims 3-4. Rather, it
relies solely on the doctrine of equivalents to prove
The issue, then, is whether pXT757 performs substantially the
same function in substantially the same way, and to accomplish
substantially the same result, as the DNA sequence listed in
claim 3. See Zelinski v. Brunswick Corp., 185 F.3d 1311,
1316-17 (Fed. Cir. 1999) (an accused product is equivalent to a
claimed element if the accused product performs substantially the
same function in substantially the same way to accomplish
substantially the same result as the claimed element). In this,
the parties disagree, and resort to conflicting expert testimony
for support. For example, Monsanto asserts that the function of claim 3 is to require expression of the bGH protein; the UC
Regents disputes this, claiming that the purpose is merely to
provide a blueprint for bGH. See Van Loben Sels Decl., Ex. X;
Flavell Decl. In Support of Regents' Oppositions to Motions for
Summary Judgment, ¶ 12. In addition, Monsanto asserts that the
cDNA sequence of claim 3 does not express at commercial levels;
the UC Regents assert that it does. Id.
Each of these disputes presents a material factual dispute as
to the issue of equivalence, and is enough to defeat summary
judgment on these claims.
Accordingly, summary judgment on the issue of whether
Monsanto's use of pXT757 infringes claims 3 and 4 is DENIED as to
Claim 5 is dependent on claim 2 and covers the recombinant DNA
vectors that can express a DNA segment encoding bGH amino acid
nos. 2-191. Monsanto resurrects its previous arguments as to
claims 1-4 in favor of non-infringement, including the argument
that pXT757 functions in a substantially different way from what
is claimed i.e., it functions to commercially express bGH.
Accordingly, and for the same reasons that there are material
disputed facts with respect to claims 1-4, see above, summary
judgment on the issue of whether Monsanto's use of pXT757
infringes claim 5 is DENIED.
Claim 6 is dependent on claim 5, and covers bacteria that
contain DNA vectors that encode for bGH. Monsanto asserts that it
does not infringe claim 6, either literally or under the doctrine
of equivalents, for the reasons already discussed.
Accordingly, for the same reasons that there are material
disputed facts with respect to the above claims, summary judgment
on the issue of whether Monsanto's ...