United States District Court, D. New Jersey
September 17, 2004.
AVENTIS Pharmaceuticals, Inc., MERRELL Pharmaceuticals, Inc., and CARDERM CAPITAL L.P., Plaintiffs, BARR LABORATORIES, INC., Defendant. IMPAX LABORATORIES, INC., Defendant. TEVA PHARMACEUTICALS, USA, INC., Defendant. MYLAN PHARMACEUTICALS, INC., Defendant. DR. REDDY'S LABORATORIES, LTD. and DR. REDDY'S LABORATORIES, INC., Defendants.
The opinion of the court was delivered by: JOSEPH GREENAWAY, District Judge
This matter comes before the Court on the motion of Barr
Laboratories, Inc. ("Barr"), Impax Laboratories, Inc. ("Impax"),
Teva Pharmaceuticals USA, Inc. ("Teva"), Mylan Pharmaceuticals, Inc. ("Mylan"), Dr. Reddy's Laboratories, Ltd.,
and Dr. Reddy's Laboratories, Inc. ("Reddy"), (collectively
"Defendants"), seeking summary judgment on their claim that U.S.
Patent No. 5,738,872 ("the '872 patent") is invalid as
anticipated, and that the '872 patent, as well as U.S. Patent
Nos. 6,113,942 ("the '942 patent"), 5,855,912 ("the '912
patent"), 5,932,247 ("the '247 patent"), and 6,039,974 ("the '974
patent") are not infringed.*fn1 For the reasons set forth
below, the summary judgment motion of non-infringement of the
'912, '942, and '247 patents is granted. The motion as to the
'974 patent is denied. A ruling on the '872 patent is reserved
pending a Markman hearing to assist this Court in construing
the patent's product-by-process claims. The scope of the
Markman hearing shall be set forth below.
This dispute concerns patents owned by Aventis Pharmaceuticals,
Inc., Merrell Pharmaceuticals Inc., and Carderm Capital L.P.
(collectively "Plaintiffs" or "Aventis") disclosing solid dosage
fexofenadine formulations sold in the United States by Aventis
under the tradenames ALLEGRA® and ALLEGRA-D® These antihistamine
allergy medication products have achieved substantial commercial
success in the United States. Between May 2001 and November 2002,
Defendants each filed Abbreviated New Drug Applications ("ANDA")
seeking the Federal Drug Administration's ("FDA") approval to
market generic drug products containing the same active
ingredients (fexofenadine hydrochloride ("fexofenadine") and
pseudoephedrine hydrochloride) as Aventis' ALLEGRA® and ALLEGRA-D®
products.*fn2 In connection with their ANDA submissions,
Defendants filed so-called "Paragraph IV Certifications"
asserting that the Aventis patents*fn3 were invalid,
unenforceable, or would not be infringed by the commercial
manufacture, use, or sale of their drug products.*fn4 In
response to notice of Defendants' Paragraph IV Certifications,
and acting pursuant to statutorily prescribed
procedures,*fn5 Plaintiffs commenced these, now consolidated, patent infringement actions.
Defendants have filed the instant motions for summary judgment
arguing that their accused products do not literally infringe the
'942, '912, '274, and '974 patents, and further, that there can
be no finding of infringement under the doctrine of equivalents.
Defendants contend that Plaintiffs are barred from asserting the
doctrine of equivalents by prosecution history estoppel, and in
the alternative, are precluded from relying on the doctrine of
equivalents because Plaintiffs' patents have dedicated inert
ingredients or excipients used by Defendants in their accused
products to the public. With respect to the '872 patent,
Defendants argue that their accused products do not infringe, and
that the '872 patent is invalid, as anticipated by the prior art.
This Court will address infringement issues initially with
respect to the '942, '912, '274, and '974 patents, followed by a
focus on the inquiry into the validity of the '872 patent.
APPLICABLE LEGAL STANDARDS
I. FED. R.Civ. P. 56(c)
Summary judgment is appropriate under FED. R.CIV.P.56(c) when
the moving party demonstrates that there is no genuine issue of
material fact and the evidence establishes the moving party's
entitlement to judgment as a matter of law. Celotex Corp. v.
Catrett, 477 U.S. 317, 322-23 (1986); Orson, Inc. v. Miramax
Film Corp., 79 F.3d 1358, 1366 (3d Cir. 1996). In making this
determination, the Court must draw all reasonable inferences in
favor of the non-movant. Hullett v. Towers, Perrin, Forster &
Crosby, Inc., 38 F.3d 107, 111 (3d Cir. 1994); Nat'l State Bank v. Fed. Reserve Bank of N.Y., 979 F.2d 1579, 1581
(3d Cir. 1992).
Once the moving party has satisfied its initial burden, the
party opposing the motion must establish that a genuine issue as
to a material fact exists. Jersey Cent. Power & Light Co. v.
Lacey Township, 772 F.2d 1103, 1109 (3d Cir. 1985). The party
opposing the motion for summary judgment cannot rest on mere
allegations and instead must present actual evidence that creates
a genuine issue as to a material fact for trial. Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 248 (1986); Siegel Transfer,
Inc. v. Carrier Express, Inc., 54 F.3d 1125, 1130-31 (3d Cir.
1995). "[U]nsupported allegations . . . and pleadings are
insufficient to repel summary judgment." Schoch v. First Fid.
Bancorporation, 912 F.2d 654, 657 (3d Cir. 1990); see also
FED. R.Civ.P. 56(e) (requiring nonmoving party to "set forth
specific facts showing that there is a genuine issue for trial").
If the nonmoving party has failed "to make a showing sufficient
to establish the existence of an element essential to that
party's case, and on which that party will bear the burden of
proof at trial, . . . there can be `no genuine issue of material
fact,' since a complete failure of proof concerning an essential
element of the nonmoving party's case necessarily renders all
other facts immaterial." Katz v. Aetna Cas. & Sur. Co.,
972 F.2d 53, 55 (3d Cir. 1992) (quoting Celotex,
477 U.S. at 322-23). In determining whether there are any issues of material
fact, the Court must resolve all doubts as to the existence of a
material fact against the moving party and draw all reasonable
inferences including on issues of credibility in favor of the
non-moving party. Watts v. Univ. of Del., 622 F.2d 47, 50 (3d
The test for patent infringement requires a two step analysis:
"First, the claim must be properly construed to determine its scope and meaning. Second,
the claim as properly construed must be compared to the accused
device or process." Carroll Touch, Inc. v. Electro Mech. Sys.,
Inc., 15 F.3d 1573, 1576 (Fed. Cir. 1993). "In order for a court
to find infringement, the plaintiff must show the presence of
every limitation or its substantial equivalent in the accused
device." KX Industries v. PUR Water Purification Products, 2001
WL 902507 *3 (Fed. Cir. 2001) (citing Wolverine World Wide, Inc.
v. Nike, Inc., 38 F.3d 1192, 1199 (Fed. Cir. 1994)). Although
claim construction is an issue of law, the determination of
infringement is a question of fact. Id.
"A district court should approach a motion for summary judgment
on the fact issue of infringement with great care." Cole v.
Kimberly-Clark Corp., 102 F.3d 524, 528 (Fed. Cir. 1996).
Nonetheless, summary judgment of infringement may be granted when
a rational jury could only conclude that infringement has
occurred. See Karlin Tech. Inc. v. Surgical Dynamics, Inc.,
177 F.3d 968, 974-75 (Fed. Cir. 1999).
INFRINGEMENT UNDER THE DOCTRINE OF EQUIVALENTS
A product may infringe a patent either literally or
equivalently. Cybor Corp. v. FAS Techs., 138 F.3d 1448, 1459
(Fed. Cir. 1998). Plaintiffs cannot argue that each limitation of
the claims at issue in patents '942, '912, '274, and '974, are
satisfied exactly by the accused products, as required to prove
literal infringement. Instead, they rely on the doctrine of
equivalents which "prevents an accused infringer from avoiding
liability for infringement by changing only minor or
insubstantial details of a claimed invention while retaining the
invention's essential identity." Festo Corp. v. Shoketsu Kinzoku
Kogyo Kabushiki Co., 234 F. 3d 558, 564 (Fed. Cir. 2000)
("Festo VI"). Infringement under the doctrine of equivalents is
found "only when a patentee shows by a preponderance of the
evidence that the accused product or process contain[s] elements identical or equivalent to each
claimed element of the patented invention." Warner-Jenkinson Co.
v. Hilton Davies Chem. Co., 520 U.S. 17, 40 (1997).
Application of the doctrine of equivalents requires a fact
intensive analysis to determine whether or not differences
between a claim limitation of the patent, and the corresponding
element of the accused device, are merely insubstantial or
unimportant substitutions. In certain cases, however, the law
restricts application of the doctrine of equivalents without
further fact finding. This occurs when a patentee is found to
have dedicated equivalent subject matter to the public, or where
prosecution history estoppel bars application of the doctrine of
The '912, '942, '974, and '247 patents generally claim
fexofenadine formulations with certain combinations of
excipients, including pregelatinized starch, croscarmellose
sodium, and microcrystalline cellulose. These excipients are not
present in Defendants' accused product formulations.*fn6 For
the purposes of this motion, it is assumed that defendants Barr,
Impax, Teva, and Mylan's accused tablets substitute povidone, and
Reddy substitutes mannitol as an equivalent for pregelatinized
starch as a binder; Barr and Mylan substitute crospovidone, and
Impax substitutes sodium starch glycolate for croscarmellose
sodium as a disintegrant; and Barr and Reddy substitute powdered
cellulose for microcrystalline cellulose as a diluent.
PROSECUTION HISTORY ESTOPPEL
I. Standard for the Bar of Prosecution History Estoppel to
Availability of the Doctrine of Equivalents in an Infringement
Prosecution history estoppel may bar a patentee from asserting
infringement under the doctrine of equivalents:
[T]here are limits to the application of the doctrine
of equivalents aside from the question of
insubstantiality of the differences . . .
[P]rosecution history estoppel can prevent a patentee
from relying on the doctrine of equivalents when the
patentee relinquishes subject matter during the
prosecution of the patent, either by amendment or
Eagle Comtronics, Inc. v. Arrow Commun. Labs., Inc.,
305 F.3d 1303
, 1315 (Fed. Cir. 2002). There are thus two different kinds
of prosecution history estoppel: that based on amendment, and
that based on argument.
A. Amendment-Based Estoppel
The Supreme Court established the standard for amendment-based
estoppel in Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki
Co., 535 U.S. 722 (2002) ("Festo VIII"). The basic principle
is: "[a] narrowing amendment made to satisfy any requirement of
the Patent Act may give rise to an estoppel." Id. at 736. A
patentee making such an amendment is presumed to have surrendered
the territory for purposes of the doctrine of equivalents, and
bears the burden of rebutting this presumption.
[W]e hold here that the patentee should bear the
burden of showing that the amendment does not
surrender the particular equivalent in question. The
patentee, as the author of the claim language, may be
expected to draft claims encompassing readily known
equivalents. A patentee's decision to narrow his
claims through amendment may be presumed to be a
general disclaimer of the territory between the
original claim and the amended claim.
Id. at 740. The Court held that there are three ways in which a
patentee may rebut this presumption:
The equivalent may have been unforeseeable at the
time of the application; the rationale underlying the
amendment may bear no more than a tangential relation
to the equivalent in question; or there may be some
other reason suggesting that the patentee could not
reasonably be expected to have described the
insubstantial substitute in question.
Id. Even if estoppel applies, however, the patentee may
demonstrate that the narrowing amendment did not surrender the particular equivalents at issue.
Id. at 741. "The standard for determining whether particular
subject matter was relinquished is an objective one that depends
on what a competitor reasonably would conclude from the patent's
prosecution history." Mark 1 Marketing, Corp. v. R.R. Donnelley
& Sons Co., 66 F.3d 285
, 291 (Fed. Cir. 1995).
The issue of whether prosecution history estoppel bars the
availability of the doctrine of equivalents in an infringement
action is a matter of law. "We have stated on numerous occasions
that whether prosecution history estoppel applies, and hence
whether the doctrine of equivalents may be available for a
particular claim limitation, presents a question of law." Festo
Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359,
1367 (Fed. Cir. 2003) ("Festo IX"). Any resolution of factual
issues underlying these questions of law may be decided by the
court, not the jury. Id. at 1369.
B. Argument-Based Estoppel
The Federal Circuit has extended the principles of prosecution
history estoppel to arguments made by an applicant during patent
prosecution, producing a second category of estoppel:
argument-based estoppel. "Clear assertions made during
prosecution in support of patentability, whether or not actually
required to secure allowance of the claim, may also create an
estoppel." Southwall Techs., Inc. v. Cardinal IG Co.,
54 F.3d 1570, 1583 (Fed. Cir. 1995). "To invoke argument-based estoppel,
the prosecution history must evince a clear and unmistakable
surrender of subject matter." Eagle Comtronics,
305 F.3d at 1316. Thus, the legal standards for amendment-based estoppel and
argument-based estoppel differ greatly.
II. Prosecution History Estoppel Does Not Bar Availability of
the Doctrine of Equivalents in Plaintiffs' Action for
Infringement of the '974 Patent
The '974 patent is for a two-layer tablet, with one layer of
antihistamine (from the genus of which fexofenadine is one
species) and another layer of decongestant. Defendants make only one argument relating to the examiner's statements in the office
action allowing the claims: "[h]aving failed to contest the
P.T.O.'s stated reasons for allowance, Plaintiffs have disallowed
any broader constructions." (Impax Br. at 20). That single
sentence contains Defendants' entire argument on this
matter.*fn7 Defendants propose no legal theory to explain
why Plaintiffs have disallowed any broader constructions. They
cite no case law, and their reply brief does not even discuss the
'974 patent. Non-response to a statement in an office action does
not qualify for consideration as either amendment-based estoppel
or argument-based estoppel. Defendants have failed to show a
basis for their claim.
III. Prosecution History Estoppel Bars Availability of the
Doctrine of Equivalents in Plaintiffs' Actions for Infringement
of the '942 and '912 Patents
Both Plaintiffs and Defendants agree that the written
descriptions of the '942 and '912 patents are virtually
identical, and do not differ materially for the purposes of this
summary judgment motion. Plaintiffs and Defendants have argued
the two patents together, and they are considered together in
A. Prosecution History of the '942 and '912 Patents
The '942 and '912 patents descended from three related
applications: 1) application 08/395,952 was filed on February 28,
1995, and abandoned, but continued in part by 2) application
08/552,287, filed on December 12, 1995, and abandoned, but
continued in part by 3) application 08/943,460 for the present
patents, filed October 3, 1997. The '912 patent was granted
directly from the last-mentioned application, and the '942 patent
is a divisional offspring of that application. The claims in the first application, 08/395,952, are all
pharmaceutical composition claims for a combination of an active
ingredient and one or more inert ingredients. The record shows
that the P.T.O. response to the first application, the first
office action, was directed to the generic nature of the claims,
finding that they encompassed a plurality of species, and seeking
restriction or election of species. (Gresalfi Decl. at A270-272.)
Applicants responded by electing the species of
fexofenadine, with a group of specific inert ingredients
(croscarmellose sodium, microcrystalline cellulose, lactose,
pregelatinized starch, gelatin and magnesium stearate), for a
group of the claims. (Gresalfi Decl. at A274.) The P.T.O. then
responded by reiterating the restriction requirement for the
claims that did not involve the elected formulation, and it
rejected the claims involving the elected formulation as
anticipated and/or obvious. (Gresalfi Decl. at A278-281).
The applicants then filed the second application, 08/552,287,
as a continuation-in-part of the first. The claims in the second
application were of two types: most were pharmaceutical
composition claims which varied from very broad and generic
formulations to very specific formulations, while some were
product-by-process claims. The P.T.O. responded by again seeking
restriction/election for some claims and rejecting others under
35 U.S.C. §§ 102(b) and 103 (Gresalfi Decl. at A385-A390). The
examiner's comments in this first office action are nearly
identical to the comments in the first office action for the
first application. Applicants then cancelled all claims except
for the product-by-process claims, and added new composition
claims for fexofenadine formulations with specific inert
ingredients (croscarmellose sodium, microcrystalline cellulose,
lactose, pregelatinized starch, and gelatin; some formulations
also included magnesium stearate). (Gresalfi Decl. at A392-A394.) At this point, a significant change occurred in the
specification of inert ingredients. As originally filed, claims
in the second application referred specifically to the inert
ingredients croscarmellose sodium, lactose, microcrystalline
cellulose, pregelatinized starch, gelatin, calcium carbonate,
magnesium stearate, and sodium starch glycolate. (Gresalfi Decl.
at A355-A366.) The applicant cancelled all claims which specified
the inert ingredients calcium carbonate and sodium starch
glycolate, and added claims not specifying those two inert
ingredients. Those two inert ingredients did not appear in the
third application (08/943,460), nor are they specified in the
claims in either the '942 or '912 patents. This is a crucial
point in the prosecution history for this dispute, and the
discussion below will focus on those events.
The P.T.O. next reexamined this group of old and new claims and
rejected all of them as obvious over prior art, focusing on the
particular inert ingredients croscarmellose sodium,
microcrystalline cellulose, lactose, pregelatinized starch, and
gelatin. (Gresalfi Decl. at A404.) Applicants filed a reply to
this rejection, arguing, in brief, that the combinations of
fexofenadine with the particular inert ingredients were not
obvious from the prior art. (Gresalfi Decl. at A407-410.) The
P.T.O. responded by reversing its rejection and allowing the
previously rejected claims. Nonetheless, the applicants abandoned
The applicants then filed the third application as a
continuation of the second, adding some new claims, but
essentially restricting the patent to the specific formulations
claimed in the amended second application. These claims were
allowed. The '912 patent was granted directly from the third
application, and the '942 patent is a divisional offspring of
that application. B. Narrowing Amendments Were Made for Reasons of Patentability
of the '942 and '912 Patents
The parties do not dispute that the applicant made narrowing
amendments during the prosecution history of the '942 and '912
patents. The applicant had previously eliminated most claims with
generic formulations when, in response to the first office action
to the second application, the applicant cancelled the claims
with the remaining generic references to inert ingredients. From
this point on, the application contained only claims with
combinations of specific inert ingredients. At this point, then,
the claim amendments narrowed their scope.
The focus of the parties' dispute here is the actual reason for
the narrowing amendments. Plaintiffs argue that the applicants
made narrowing amendments not for reasons of patentability, but
to comply with the examiner's election/restriction requirements.
Defendants argue that the narrowing amendments were made for
reasons of patentability.
Plaintiffs argue that they cancelled the claims in response to
the election/restriction requirements, not in response to the
rejections for patentability. This argument must fail for several
reasons, but the simplest is that it does not match the facts. In
the first office action to the second application, the examiner
rejected claims 1-10, 14-17, 22-24, 29, and 31-35 under
35 U.S.C. §§ 102(b) and 103; the examiner determined that claims
11-13, 18-21, 25-28, 30, and 36-43 were subject to
restriction/election requirements. (Gresalfi Decl. at A385.)
Claims 1 and 3 were the broadest claims. The examiner rejected
Claims 1 and 3 and the applicant then cancelled the claims.
Plaintiffs cannot maintain that they cancelled these broad claims
in response to a restriction requirement. The prosecution history
clearly shows that they were cancelled due to a rejection, and thus necessarily for reasons of
patentability. This analysis alone defeats Plaintiffs' argument.
In addition, the Federal Circuit has held that a series of
narrowing applications may form the basis for a finding of
surrender of claim coverage. In Mark I Mktg. Corp. v. R.R.
Donnelley & Sons Co., 66 F.3d 285, 292 (Fed. Cir. 1995), cert.
denied, 516 U.S. 1115 (1996), the patentee "chose to file
continuing applications with successively narrower claims in lieu
of otherwise responding to the P.T.O.'s rejections," and the
Court held that the patentee had surrendered claim coverage. To
argue here that the patentees filed a series of narrowing claims,
in the context of repeated rejections for reasons of
patentability, but that the narrowing claims were not filed for
reasons of patentability, is far-fetched.
Moreover, even if one were to assume, arguendo, that the
changes were made only because of the restriction/election
requirements, Plaintiffs assert incorrectly that such an action
would preclude the application of prosecution history estoppel.
Plaintiffs argue, in effect, for a per se rule that restriction
requirements and requests for election of species cannot invoke
prosecution history estoppel. Yet the Federal Circuit has not
established a per se rule; rather, it has held that whether
restriction requirements invoke prosecution history estoppel
depends on the prosecution context in which they occur. Merck &
Co. v. Mylan Pharms., Inc., 190 F.3d 1335 (Fed. Cir. 1999).
Plaintiffs erroneously cite Merck as authority for its
argument, but, in Merck, the Federal Circuit rejected Merck's
argument that an election of species cannot invoke prosecution
history estoppel. Considering the entire prosecution context in
which the election of species occurred, the Court held that the
election of species was actually in response to a patentability
rejection, and it found narrowing amendments giving rise to prosecution
history estoppel. Id. at 1341. Thus, this Court may consider
whether the amendments stemming from the restriction requirements
and requests for election of species give rise to prosecution
This, however, is not the basis for this Court's finding of
prosecution history estoppel; rather, as discussed above, the
history shows clearly a narrowing amendment made to avoid a
rejection under 35 U.S.C. §§ 102(b) and 103. Given that the
applicant made a narrowing amendment for reasons of
patentability, under Festo VIII, this gives rise to the
rebuttable presumption that the patentee surrendered the
equivalents in question.
C. Plaintiffs Have Failed to Rebut the Presumption of
Surrender of the Equivalents in Question
1. Sodium Starch Glycolate
Examination of the history of the second application reveals
that the applicant did obviously surrender one of the equivalents
at issue, sodium starch glycolate. As noted above, this inert
ingredient was specified in claims initially made in the second
application, but, after those claims were cancelled, never
appeared in any claims again. This is an umistakable surrender of
an equivalent in question, sodium starch glycolate.
At oral argument, Plaintiffs made one argument in an attempt to
show that the applicant had not surrendered this equivalent:
Plaintiffs argued that, because sodium starch glycolate and
calcium carbonate always appeared together in the prosecution
history, they surrendered only the combination of sodium starch
glycolate and calcium carbonate. (Nov. 3, 2003, Tr. at 68-69.)
Plaintiffs offered no cases or logic to sustain this argument.
Sodium starch glycolate and calcium carbonate are clearly two discrete chemicals. The prosecution
history manifests a clear surrender of the two chemicals
individually; Plaintiffs have offered no persuasive justification
for viewing them as a combination.
2. Povidone, Corn Starch, Mannitol, Crospovidone, and Powdered
The prosecution history does not manifest this same kind of
clear surrender of the other inert ingredients at issue. At no
point in the entire prosecution history do any claims mention
povidone, corn starch, mannitol, crospovidone, or powdered
cellulose. Nor does the rationale for claim rejection in the
first office action make explicit reference to these ingredients
or to the topic of inert ingredients. While the March 27, 1997,
office action does reject claims for reasons involving
obviousness of particular inert ingredient formulations, the
applicant's reply convinced the P.T.O. to reverse this rejection,
and so it should not figure into this analysis.
The burden is on Plaintiffs to rebut the presumption that the
applicant surrendered these equivalents. Plaintiffs have
attempted rebuttal of this presumption using two of the kinds of
arguments articulated in Festo VIII, tangential relation and
The recent ruling by the Federal Circuit in Festo IX raises
the possibility that Plaintiffs are foreclosed from successfully
arguing tangential relation. The Court held that "an amendment
made to avoid prior art that contains the equivalent in question
is not tangential; it is central to allowance of the claim."
Festo IX, 344 F.3d at 1369. Because there is no further
discussion of this point, it is unclear whether this represents an absolute
rule, or a holding tailored to the facts of the case.
This principle speaks directly to this prosecution history
because the prior art references do contain four of the exact
equivalents in question (povidone, crospovidone, corn starch, and
mannitol).*fn9 Amendments made to avoid that prior art
therefore could not be considered tangentially related to the
equivalents in question. While it does sound like an absolute
rule, such a view is not consistent with the approach the Federal
Circuit has generally taken, nor is it consistent with the case
that the court cites as authority for the principle, Pioneer
Magnetics, Inc. v. Micro Linear Corp., 330 F.3d 1352 (Fed. Cir.
2003). In general, and in Pioneer, the Federal Circuit has
examined the prosecution history in detail in order to comprehend
the rationale for amendments made to avoid prior art. In
Pioneer, the court held: "The amendment was clearly not
tangential to the equivalent in question; the amendment was made
to avoid the very prior art that contained the equivalent." Id.
at 1357. Because Plaintiffs have not persuaded this Court of a
tangential relation, however, this Court need not decide whether
this principle from Festo IX poses an insurmountable obstacle
Plaintiffs make five arguments to persuade the Court that the
amendments were only tangentially related to the equivalents in
question, but none is convincing:
1) The examiner did not reject any claims because the prior
art disclosed Defendants' equivalents. This argument fails for two reasons. First, the examiner did
not explain exactly how the claims were anticipated by, or
obvious over, the prior art, so the Court cannot rule out the
possibility that the examiner made the rejection on this basis.
Second, and more importantly, this is not the test established by
the Federal Circuit in Festo IX: the test does not refer to
whether an equivalent is mentioned in the office action, but
whether it is mentioned in the prior art references.
2) The applicants did not mention the equivalents in
prosecuting the application.
Again, as above, this argument fails because it is irrelevant
to the test established in Festo IX.
3) None of the prior art references discloses a solid
This argument simply makes no sense, as it is not directed at
the issue of the equivalents used in prior art references.
4) While prior art references describe using povidone as a
binder, none do so in fexofenadine formulations, and so this fact
was not germane to the stated reasons for rejection.
This argument actually works against Plaintiffs. The fact that
the examiner listed quite a few prior art references which did
not contain fexofenadine suggests that the examiner may have been
concerned not with the active ingredient, but with the inert
ingredient components of these references. Thus, the examiner may
well have rejected claims to avoid the specific inert ingredients
in the prior art. The choice of inert ingredient could have been
central to the examiner's rejection. 5) Powdered cellulose is not listed in any of the prior art
references, and mannitol is not used as a wet granulation binder
in those formulations, so the amendments could only be
tangentially related to those equivalents.
While it is true that the Gowan reference European Patent
Application No. 0,636,364,A1 (Suppl. Kambic Decl. at Ex. 11),
explicitly lists cellulose, rather than powdered cellulose, not
finding the equivalent in a prior art reference is not sufficient
to rebut the presumption of surrender. The argument fails with
regard to mannitol because, even if the reference uses the
mannitol in a different way, this does not meet the burden of
showing a tangential relation.*fn10
Plaintiffs next try to further argue that discovery should be
allowed in order to develop a factual record on foreseeability.
This argument has no basis in law and runs contrary to the
principles of Festo IX. In Festo IX, the Federal Circuit held
that determining whether an equivalent was unforeseeable
"presents an objective inquiry." Festo IX, 344 F.3d at 1369.
The Federal Circuit makes plain that such an objective inquiry
looks into the state of the art, not into the facts of the
case. As such, this is not a matter for which discovery is
D. The Prosecution History Does Not Support a Finding of
Defendants did not offer a specific argument-based estoppel
analysis, but mixed prosecution arguments with narrowing
amendments in one general analysis. In doing so, they overlook
that the analyses involve very different legal standards.
Defendants must show that the arguments made during prosecution manifest a clear and
unmistakable surrender of subject matter. The arguments
Defendants point to do not manifest any surrender of subject
matter, no less a clear and unmistakable one. (Impax Br. at 7.)
Given that Plaintiffs have failed to rebut the presumption of
surrender in the amendment-based estoppel inquiry, this Court
need not address in detail Defendants' points on argument-based
In sum, the prosecution history of the '942 and '912 patents
shows narrowing amendments made for reasons of patentability.
Plaintiffs have failed to rebut the presumption of surrender of
the equivalents in question, and are barred from using the
doctrine of equivalents in their present actions for infringement
of the '942 and '912 patents.
IV. Prosecution History Estoppel Bars Availability of the
Doctrine of Equivalents in Plaintiffs' Actions for Infringement
of the '247 Patent.
A. Prosecution History of the '247 Patent
The '247 patent shares the beginning prosecution history of the
'942 and '912 patents: all three began with first application
08/395,952 ("'952 application") and second application
08/552,287 ("'287 application"). The history for this patent
then branches off: applicant filed third application 08/742,166
("'166 application") as a division of the second application. A
division of the third application resulted in the fourth
application 08/948,005 ("'005 application), which matured into
the '247 patent.
The prosecution history of the '247 patent has many
similarities to that of the '942 and '912 patents, as it began
with a common application with broad generic formulation claims
and ended with a patent claiming like the '942 and '912 patents
defined formulations of fexofenadine and specific inert
ingredients. As with the '942 and '912 histories, the parties do not dispute that the '247 prosecution history shows narrowing
B. Narrowing Amendments Were Made for Reasons of Patentability
of the '247 Patent
Plaintiffs argue that the prosecution history of the '247
patent differs crucially from the histories of the '942 and '912
patents in that the '247 patent resulted from divisional
applications of the original applications, while the '942 and
'912 patents resulted from continuation applications.
Plaintiffs cite Biogen, Inc. v. Berlex Labs., 318 F.3d 1132,
1141 (Fed. Cir. 2003) for the proposition that estoppel from the
history of a parent application does not generally arise in
regard to a divisional application with claims that differ from
those of the parent. This argument suffers from two major flaws.
First, Biogen concerns argument-based estoppel, not
amendment-based estoppel. Its holding is inapplicable in the
present analysis of amendment-based estoppel. Second, even
setting aside Plaintiffs' lack of basis in law for their
argument, the claims in the divisional applications were not for
inventions that differed from those of the parent. The '247
history began with generic pharmaceutical formulation claims for
the present invention and ended with specific formulation claims.
Any argument based on the proposition that these claims represent
different inventions must fail.
The prosecution history reveals narrowing amendments made for
reasons of patentability. One notable feature of this patent's
history is that the applicant submitted its third application,
'166, on the same day, November 1, 1996, that it submitted a
request to cancel and amend claims in that application. Thus, the
history shows that it received the first office action for the
'287 application on October 8, 1996, and then promptly filed the
third '166 application as a division of the second '287
application, simultaneously canceling claims. The Federal Circuit
dealt with a similar history in Mark I, 66 F.3d at 285, and
held that an applicant cannot avoid the application of estoppel
by filing a continuation application instead of responding to
rejections. The court reasoned that:
Mark I chose to file continuing applications with
successively narrower claims in lieu of otherwise
responding to the P.T.O.'s rejections, but an
estoppel is not avoided by failing to respond to a
rejection and instead meeting the substance of the
rejection by filing a narrower continuing
application. Rather, the prosecution history must be
viewed as a whole to determine whether and what
subject matter was surrendered to procure issuance of
Id. at 292.
In the present case, the applicant filed a series of
applications with successively narrower claims in the context of
multiple interrelated applications with multiple rejections.
Viewing the prosecution history as a whole, the applicant clearly
made narrowing amendments to secure the patent. Moreover, the
Federal Circuit has considered the prosecution history of related
patents and applications broadly. Most importantly, it has
specifically applied the holding of Mark I to prosecution
histories involving divisional applications. See Desper Prods.
v. Qsound Lab., 157 F.3d 1325, 1339 (Fed. Cir. 1998). It has
even found estoppel from the prosecution history of one patent to
apply to a different patent stemming from the same original
application. See Jonsson v. Stanley Works, 903 F.2d 812, 817
(Fed. Cir. 1990). In Elkay Mfg. Co. v. Ebco Mfg. Co.,
192 F.3d 973, 980 (Fed. Cir. 1999), the court held that "[w]hen multiple
patents derive from the same initial application, the prosecution
history regarding a claim limitation in any patent that has
issued applies with equal force to subsequently issued patents
that contain the same claim limitation." These cases manifest an
approach that considers the prosecution histories of related
applications and patents broadly and inclusively, avoiding purely
formalistic distinctions such as that between a continuation and
a divisional application.
C. Plaintiffs Have Failed to Rebut the Presumption of
Surrender of the Equivalents in Question
The equivalents in question in the action for infringement of
the '247 patent are powdered cellulose, mannitol, crospovidone,
and povidone. Plaintiffs made no new arguments to rebut the
presumption of surrender of the equivalents in question in their
action for infringement of the '247 patent, relying on the arguments made with regard to the
'942 and '912 patents. The Court has considered those arguments
above and determined that Plaintiffs have failed to rebut the
presumption of surrender. Because the amendment-based estoppel
analysis results in a finding that prosecution history estoppel
bars use of the doctrine of equivalents in the action for
infringment of the '247 patent, the Court need not address the
parties' argument-based estoppel dispute.
As an alternative ground for their summary judgment motion,
Defendants contend that subject matter that was disclosed but not
claimed in the '942, '912, '974 and '247 patents is "dedicated to
the public" and therefore cannot fall within the scope of
equivalency. This Court is satisfied that prosecution history
estoppel bars Plaintiffs from asserting sodium starch glycolate,
povidone, mannitol, crospovidone, powdered cellulose, and corn
starch as equivalents for excipients in the '912, '942 and '247
patents. However, this Court will consider Defendants' dedication
arguments in full to determine the application of the doctrine of
equivalents to the '974 patent, to which prosecution history
estoppel does not apply, and as further support for a finding
that the equivalents in question have been surrendered in the
'912, '942, and '247 patents.
I. Standard for the Bar of Dedication to Availability of the
Doctrine of Equivalents in an Infringement Action (The Johnson &
In March 2002, the Federal Circuit issued an en banc, per
curiam opinion in Johnson & Johnston v. R.E. Service Co. Inc.,
285 F.3d 1046 (Fed. Cir. 2002). In Johnson & Johnston, the
plaintiff held a patent for a component used in the manufacture
of printed circuit boards. The patent described a laminate
comprised of copper foil adhered to a stiffer substrate of
aluminum. The substrate served to make the copper foil easier to handle
without damage in the manufacturing process. The patent
specification described the preferred composition of the
substrate material as aluminum, but noted that, "[w]hile aluminum
is currently the preferred material for the substrate, other
metals, such as stainless steel or nickel alloys, may be used."
Id. at 1050. The claims, however, only recited the use of a
substrate sheet of aluminum.
The defendant made a similar product that used steel as the
substrate sheet, and not aluminum. The defendant argued that
their product was not infringing because the plaintiff had
dedicated the use of steel to the public, by describing it in the
patent specification as an alternative to aluminum, but not
claiming it in the claims. The Federal Circuit agreed, and held
that "when a patent drafter discloses but declines to claim
subject matter . . . this action dedicates unclaimed subject
matter to the public." Id. The Johnson & Johnston decision
imposes a strict application of the dedication rule in its
articulation of the primacy of the claims in defining the scope
of a patentee's exclusive rights. Johnson & Johnston affirmed
the principle that "[o]ut of all the possible permutations of
elements which can be made from the specifications, [a patentee]
reserves for himself only those contained in the claims." Id.
(citing Milcor Steel Co. v. George A. Fuller Co., 122 F.2d 292,
294 (2nd Cir. 1941)).
II. The Instant Case
The '942 and '912 patents both claim a pharmaceutical
composition consisting of a piperidinoalkanol compound and
certain inert ingredients including croscarmellose sodium (a
superdisintegrant), pregelatinized starch (a binder), and
microcrystalline cellulose (a cellulose diluent). (Gresalfi Decl.
at A18, A53). The "written description" of the patent
specifications identify inert ingredients that can be present in
amounts of up to 95% of the total pharmaceutical composition weight.
As used herein the term "inert ingredient" refers to
those therapeutically inert ingredients that are well
known in the art of pharmaceutical science which can
be used singly or in various combinations . . . as
are disclosed in The United States Pharmacopeia,
XXII, 1990 . . . pages 1857-1859, which is
incorporated herein by reference. For example, the
following inert ingredients can be utilized singly or
in various combinations; binders such as . . .
pregelatinized starch, povidone . . .; disintegrants
such as microcrystalline cellulose, croscarmellose
sodium . . . sodium starch glycolate . . .
pregelatinized starch and the like; preferred
disintegrants are croscarmellose sodium . . .
pregalatinized starch and sodium starch glycolate
with croscarmellose sodium being the most preferred
disintegrant. . . . The above inert ingredients can
be present in amounts up to about 95% of the total
composition by weight. (Gresalfi Decl at
While identified in the specifications, the inert ingredients
povidone, crospovidone, and sodium starch glycolate are not
claimed. Mannitol and powdered cellulose are not expressly cited
in the specifications, but are listed in the U.S. Pharmacopeia
incorporated in the specification by reference.
The '974 patent claims a bilayer tablet, with one layer
containing a formulation of a decongestant such as
pseudoephedrine, and the other layer containing a formulation of
an antihistamine such as fexofenadine. Each claim of the patent
sets forth a composition containing a cellulose diluent,
pregelatinized starch, a "suitable disintegrant," and a "suitable
lubricant" in varying amounts by weight. (Gresalfi Decl. at 33.)
The patent specifications state that the composition "optionally"
may contain one or more other pharmaceutically acceptable
excipients. Povidone as well as crospovidone are listed as
examples. (Gresalfi Decl. at 27.)
The '247 patent claims a capsule formulation of a
piperidinoalkanol compound and certain inert ingredients
including pregelatinized starch, croscarmellose sodium, and microcrystalline cellulose. The patent specifications set forth
povidone and crospovidone with identical language as that used in
the '912, and '942 patents. These excipients are not claimed.
III. The Parties' Contentions
Defendants argue that the '942, '912, '974 and '247 patents
(variously) disclose the inert ingredients sodium starch
glycolate, povidone, crospovidone, mannitol, corn starch, and
powdered cellulose in their specifications, but do not claim
them. The patents, therefore, have dedicated those ingredients to
the public, and under Johnson & Johnston, Plaintiffs cannot now
reclaim subject matter which has been disclosed.
Plaintiffs make several arguments in an attempt to distinguish
the present case from Johnson & Johnston. First, Plaintiffs
argue that the dedication to the public doctrine only applies
when a patentee fails to claim an alternative embodiment of the
patentee's invention that is disclosed in the patent
specifications, not individual elements in isolation. Plaintiffs
claim that the specifications for the patents at issue merely
recite a list of excipients, some of which are contained in the
accused products, but do not disclose the accused products in
their entirety as a discrete embodiment. In support of their
proposition, Plaintiffs cite Maxwell v. Baker, 86 F.3d 1098
(Fed. Cir. 1991), a Federal Circuit case in which a plaintiff was
barred from asserting the doctrine of equivalents where they had
disclosed an alternate embodiment of their shoe attachment system
invention in the written specifications, but did not recite the
embodiment in the claims.
Plaintiffs' argument fails because the dedication doctrine
encompasses unclaimed subject matter, which includes not only
unclaimed embodiments, but also unclaimed elements and
limitations. The Johnson court held that the plaintiff could
not invoke the doctrine of equivalents to extend its claimed limitation of the substrate material,
namely aluminum, to also encompass steel, where the use of steel
as a substitute for aluminum had been disclosed but not claimed.
"Having disclosed without claiming the steel substrates, Johnston
cannot now invoke the doctrine of equivalents to extend its
aluminum limitation to encompass steel." Id. at 1055. Moreover,
the Federal Circuit in Johnson overruled YBM Magnex Inc. v.
Int'l Trade Comm'n, 145 F.3d 1317 (Fed. Cir. 1998), a case which
purported to limit the application of the dedication rule to
instances where a patent disclosed an unclaimed alternative
embodiment distinct from the claimed invention. By overruling
YBM Magnex, the Johnson and Johnston court rejected this
narrowing of the dedication doctrine.*fn12 See also PSC
Computer Products Inc. v. Foxconn International Inc.,
355 F.3d 1353, 1356 (Fed. Cir. 2004) (affirming district court finding of
dedication where patentee disclosed alternative "parts" of
invention, while failing to claim them).
In an extension of the embodiment argument, Plaintiffs claim
that in order for the dedication rule to apply, the patents at
issue must describe Defendants' accused products' specific
formulations (i.e., combinations and amounts of ingredients),
citing to district court cases (namely, Astra v. Andrx,
222 F. Supp. 2d 433 (S.D.N.Y. 2002) and Upjohn v. Mova,
951 F. Supp. 333 (D.P.R. 1997), aff'd in part and rev'd in part,
225 F.3d 1306 (Fed. Cir. 2000)), in which courts failed to find that
dedication occurred where the patent specifications for biochemical formulations did not disclose the specific
combination and amounts of ingredients used in the accused
products. The cases cited by Plaintiffs which this Court is not,
in any event, bound to follow, at most stand for the narrow
proposition that where patent specifications have disclosed
alternative subject matter (here, ingredients) in specific
amounts and combinations without claiming them, dedication is
limited to subject matter within the parameters (e.g., amounts)
set forth in the specifications. There is no apparent conflict
between this premise, and a finding of dedication in this
instance. The '912, '942, and '247 patent specifications describe
the excipients povidone, crospovidone, and sodium starch
glycolate as ingredients that may be present in the
pharmaceutical composition in an amount up to 95% by weight.
Assuming Defendants' products contain any one or a combination of
these excipients in amounts equal to or less than 95%,
Defendants' accused products' formulations have in fact been
described by the Aventis patent specifications. This Court sees
no reason to read limitations into what subject matter has been
dedicated beyond what is plainly disclosed in the specifications.
The Federal Circuit's recent opinion in PSC Computer Products
Inc., provides further guidance. In PSC, the patentee argued
that its disclosure of plastic in the written description section
of its patent for a heat assembly clip, as an alternative
material for the strap portion of the clip, was neither as
precise nor clear as the disclosure in Johnson, and
consequently, should be distinguished from that case. The written
description in the patent at issue stated, "[o]ther prior art
devices use molded plastic and/or metal parts that must be cast
or forged which again are more expensive metal forming
operations." Id. at 1360. The Federal Circuit affirmed the
district court's finding that this disclosure was in fact
sufficiently `specific' to constitute dedication of the
alternative use of plastic parts to the public. This language was
distinguished from the `generic' disclosure, "other resilient materials may be suitable for the
strap," which was also written in the description section of the
patent. The court rejected the patentee's argument that only
language as clear as the Johnson or the Maxwell disclosures
is sufficient to dedicate subject matter to the public. Id. at
1358. In so ruling, the court underscored the public notice
function of patent claims and stated,
The ability to discern both what has been disclosed
and what has been claimed is the essence of public
notice. It tells the public which products or
processes would infringe the patent and which would
not. Were the patentee allowed to reclaim some
specifically-disclosed-but-unclaimed matter under the
doctrine of equivalents, the public would have no way
of knowing which disclosed matter infringed and which
Id. (citing Festo IX).
Under PSC and Johnson, Plaintiffs' argument that the mere
listing of excipients in the patents' specifications do not teach
substituting Defendants' specific excipients for those set forth
in the claimed formulations must also fail.*fn13 The proper
inquiry is whether one of ordinary skill in the art could
identify which subject matter has been disclosed and which
subject matter has been claimed. Id. ("We thus hold that if one of ordinary skill in
the art can understand the unclaimed disclosed teaching upon
reading the written description, the alternative matter disclosed
has been dedicated to the public."); see also Maxwell v. J.
Baker, Inc., 86 F.3d 1098, 1108 (Fed. Cir. 1996) (finding
dedication where a person of ordinary skill in the art would
conclude that the patentee dedicated to the public an alternative
to the subject matter that was claimed). The excipient povidone
is set forth in the '912, '942, and '247 patents' specifications
in a list of excipients described as "binders," along with the
claimed excipient pregelatinized starch, as an example of an
ingredient that can be used in the composition. Crospovidone and
sodium starch glycolate are similarly disclosed as disintegrants,
in the same list as the claimed excipient croscarmellose sodium,
designated as the "most preferred" disintegrant. The plain
language of the patent specifications makes clear that the
unclaimed excipients belong to the same class of therapeutically
inert ingredients as those claimed, and moreover, that they can
be used in the composition. The facts presented are analogous to
those in Johnson and Johnston, and this Court must reach the
same conclusion as did the Federal Circuit in that case. By
disclosing but not claiming povidone, crospovidone, and sodium
starch glycolate, the patents have dedicated these ingredients to
the public, and cannot now reclaim these excipients through
application of the doctrine of equivalents.
The Court's analysis differs, however, with respect to the
ingredients mannitol, corn starch, and powdered
cellulose.*fn14 These ingredients are not expressly recited
in any of the patents' specifications. Rather, mannitol and
powdered cellulose are listed on page 1858 of the U.S. Pharmacopeia, incorporated in the patent specifications by
reference.*fn15 These ingredients are not cited in the list
of excipients following the sentence, "[f]or example, the
following inert ingredients can be utilized . . ." (Gresalfi
Decl. at A43.) Rather, the pharmacopeia reference appears in the
sentence, "As used herein the term `inert ingredient' refers to
those therapeutically inert ingredients that are well known in
the art of pharmaceutical science which can be used singly, or in
various combinations . . . as are disclosed in the United States
Pharmacopeia. . . ." Id.*fn16 As compared to the
ingredients that are expressly cited, there is no explicit
language specifying that mannitol, powdered cellulose, or corn
starch can be present in the invention in a particular
compositional amount (e.g. up to 95% of the composition by
weight). It appears to this Court that the ingredients
incorporated by reference are set forth to define the term "inert
ingredient."*fn17 The mere description of ingredients
belonging to the class "inert ingredient," without a clearer
indication that any ingredients so described are equivalents to
the claimed excipients, does not constitute a clear or specific
disclosure of subject matter such that a person of ordinary skill
in the art would conclude, by reading the specification, that the
patentee has dedicated the use of these ingredients to the public
as alternatives to those claimed.
The '974 patent disclosure of excipients which can "optionally"
be included in addition to the claimed excipients, similarly
fails to give rise to the conclusion that these excipients were dedicated as equivalents to those claimed. The '974 patent
states, "Formulation (A) and (B) of the pharmaceutical
compositions of the present invention optionally may contain one
or more other pharmaceutically acceptable excipients." (Gresalfi
Decl. at A27.) Povidone and crospovidone are listed as such
"other" excipients. In Johnson & Johnston, the disclosed
element was clearly identified as an alternative to the claimed
element, although a disfavored one. This Court is not presented
with analogous facts in this instance.
For these reasons, the Court finds that the '912, '942, and
'247 patents have dedicated the excipients povidone,
crospovidone, and sodium starch glycolate to the public. On this
basis, and because of prosecution history estoppel, Plaintiffs
cannot now claim these ingredients as equivalents to those
claimed. Although this Court finds that mannitol, corn starch,
and powdered cellulose have not been dedicated to the public by
any of the patents at issue, Plaintiffs are precluded from
relying on the doctrine of equivalents by prosecution history
estoppel, and cannot now assert these excipients as equivalents
to claimed excipients in the '912, '942, and '247 patents.
Finally, this Court finds that the '974 patent does not dedicate
the excipients povidone and crospovidone to the public. As there
has been no finding of prosecution history estoppel, Plaintiffs
may assert these excipients against Barr, Impax, and
Mylan*fn18 as equivalents to those claimed.
THE '872 PATENT
The '872 patent describes a fexofenadine hydrochloride drug
formulation. Plaintiffs allege that claims 1 and 2 of the '872
patent are infringed by Defendants' accused products. These independent claims are product-by-process claims.
Product-by-process claims are not specified in the statutes
governing patents. This category of claims is a judicial
construct that evolved from a recognition that, due to the
limitations of language, some products may be described only by
the process used to make them.*fn19
The composition of claims 1 and 2 of the '872 patent include a
diluent, a disintegrant, and a binding agent, while the
composition of claim 2 also includes a lubricant.
Claim 1 reads:
Claim 1: A pharmaceutical composition prepared by a
wet granulation process comprising, preparing the wet
granulation wherein a compound of formula: [graphic]
wherein X is a number ranging from about zero to 5,
and the individual optical isomers thereof, a diluent
and a disintegrant are mixed with a solution of a
binding agent; the wet granulation is screened, the
wet granulation is dried, and the dry granulation is
(Gresalfi Decl. at A72.)
Claim 2 is identical to Claim 1, except instead of reciting
that "the dry granulation is screened," it recites that "the dry
granulation is combined with a lubricant." Id.
Defendants argue that their products do not infringe, and that
claims 1 and 2 of the '872 patent are invalid for anticipation by
the prior art under 35 U.S.C. § 102 (b).*fn20 Defendants
assert that U.S. Patent Nos. 4,929,605 ("the '605 patent"),
4,996,061 ("the '061 patent"), 6,037,353 ("the '353 patent),
5,375,693 ("the '693 patent"), and 4,254,129 ("the '129 patent")
are anticipating prior art references. Plaintiffs argue that the '872 patent is
valid because the prior art references do not disclose each
limitation of claims 1 and 2 of the '872 patent, as they must to
anticipate, and that Defendants' products infringe the claims,
either literally or under the doctrine of equivalents.
I. Legal Standards
A. Claim Construction
In Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed.
Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996), the Federal
Circuit articulated the basic legal principles of claim
construction. Claim construction is a matter of law and is
exclusively the province of the court. Id. at 976-77. "[T]he
focus in construing disputed terms in claim language . . . 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." Id. at 986.
"To ascertain the meaning of claims, we consider three sources:
the claims, the specification, and the prosecution history.
Expert testimony, including evidence of how those skilled in the
art would interpret the claims, may also be used." Id. at 979
(internal citations omitted). A hearing on issues of claim
construction is known as a Markman hearing.
A claim is invalid for anticipation if a single prior art
reference published more than a year before the patent
application was filed discloses each and every limitation set
forth in a claim, either expressly or inherently. In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Patents are
presumed valid under 35 U.S.C. § 282. Consequently, when
challenging the validity of a patent, the burden is on the
defendant to establish each element of invalidity by clear and
convincing evidence. "[A] moving party seeking to invalidate a
patent at summary judgment must submit such clear and convincing evidence of invalidity so that no
reasonable jury could find otherwise." Eli Lilly & Co. v. Barr
Labs., Inc., 251 F.3d 955, 962 (Fed. Cir. 2001).
In Scripps Clinic & Research Foundation v. Genentech, Inc.,
927 F.2d 1565 (Fed. Cir. 1991), the Federal Circuit articulated
the basic legal rules for establishing anticipation to invalidate
a patent. "Invalidity for anticipation requires that all of the
elements and limitations of the claim are found within a single
prior art reference. There must be no difference between the
claimed invention and the reference disclosure, as viewed by a
person of ordinary skill in the field of the invention." Id. at
1576 (internal citations omitted).
Anticipation is a question of fact. To make such
finding on summary judgment, the court must determine
that no facts material to the question are disputed;
or that even if all material factual inferences are
drawn in favor of the non-movant, there is no
reasonable basis on which the non-movant can prevail.
The standard of proof that would have to be met at
trial must be considered.
Id. (citations omitted).
Thus, to invalidate the '872 patent for anticipation by prior
patents, this Court must find that even if all material factual
inferences are drawn in favor of Plaintiffs, there is no
reasonable basis on which Plaintiffs can prevail.
A prior art reference must be enabling to anticipate. Amgen
Inc. v. Hoechst Marion Roussel, 314 F.3d 1313, 1355 (Fed. Cir.
2003). The accused infringer is entitled to a presumption of
enablement of claimed and unclaimed material in a prior art
patent. Id. The patentee bears the burden of presenting
evidence to convince the court that the prior art patent did not
enable the invention, and thus, that it is not anticipating.
Id. In the instant case, then, Plaintiffs bear the burden of
presenting evidence that the prior art patents do not enable the
'872 inventions. Determination of whether a prior art reference is enabling "is
a legal conclusion based upon underlying factual inquiries."
Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1354 (Fed.
Cir. 1998). "[T]o be enabling, the specification of a patent must
teach those skilled in the art how to make and use the full scope
of the claimed invention without undue experimentation." In re
Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). In Johns
Hopkins, the Federal Circuit performed a detailed analysis of
the evidentiary requirements for succeeding at summary judgment
on enablement. The evidence must be viewed in the light most
favorable to the non-moving party (in this case, Plaintiffs.)
Id. at 1359. At trial, Plaintiffs would have "to prove by clear
and convincing evidence facts establishing a lack of enablement."
See id. Plaintiffs must present evidence that does more than
simply raise doubt regarding enablement; they must show "that a
material factual dispute existed, i.e., a dispute upon which a
reasonable jury could have resolved enablement in [the non-moving
party's] favor after a review of the entire record." See id.
If the evidence presented is not "significantly probative,
summary judgment may be granted." See id.
As an initial matter, this Court must address the threshold
question of whether product-by-process claims are limited to the
product prepared by the process set forth in the claims. In other
words, do the process limitations of claims 1 and 2 of the '872
patent limit the scope of the claims? In Scripps,
927 F.2d at 1583, the Federal Circuit held that "the correct reading of
product-by-process claims is that they are not limited to product
prepared by the process set forth in the claims."*fn21 See also In re
Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985) ("The patentability
of a product does not depend on its method of production. If the
product in a product-by-process claim is the same as or obvious
from a product of the prior art, the claim is unpatentable even
though the prior product was made by a different
While product-by-process claims are not limited to the product
prepared by the process set forth in the claims, process steps
may establish product characteristics which are claim
limitations. In an infringement or validity analysis,
characteristics or product properties imparted by process steps
recited in product-by-process claims are only relevant, however,
to the extent that the resulting characteristics are claimed.
Claims cannot be "saved" from invalidity by reading extraneous limitations not present in the claims. E.I. du Pont
de Nemours & Co. v. Phillips Petroleum Co., 849 F.2d 1430, 1433
(Fed. Cir. 1988); see also SmithKline Beecham Corp. v. Geneva
Pharms., Inc., 2002 U.S. Dist. LEXIS 25275 (E.D. Pa. 2002).
A. Incorporation by Reference in the '605 and '061 Patents
In their initial briefs, Defendants asserted that the '872
patent was anticipated by prior art patents '605 and '061. The
'605 and '061 patents disclose a piperidinoalkanol formulation
used in SELDANE® and SELDANE D®, antihistamine products once sold
by Aventis. Plaintiffs argue that these prior art references do
not anticipate patent '872, because they do not disclose
fexofenadine compositions, a claimed element of the '872
patent.*fn23 Rather, both prior art references claim
compositions of a piperidinoalkanol compound, and identify
terfenadine, a type of piperidinoalkanol compound, as the
preferred active ingredient. Although both prior art patents
incorporate by reference patents which describe fexofenadine, or
alternatively piperidinoalkanol compounds, Plaintiffs argue that
this general incorporation by reference fails to meet requirements for a description necessary
Whether the prior art patents incorporate by reference the
fexofenadine formulation, such that the '872 patent is
anticipated, is a question of law for the court to decide. See
Advanced Display Systems v. Kent State University,
212 F.3d 1272, 1283 (Fed. Cir. 2000) ("Whether and to what extent material
has been incorporated by reference into a host document is a
question of law.") (citing Quaker City Gear Works, Inc. v. Skil
Corp. 747 F.2d 1446 (Fed. Cir. 1984)).
The '605 patent provides that "[t]he present invention relates
to a pharmaceutical composition for oral administration of
various piperidinoalkanol derivatives which are disclosed in U.S.
patents Nos. 3,878,217, 4,254,129, and 4,285,957, the full
disclosures of each patent being incorporated by reference."
(Gresalfi Decl. at A115.) The '061 patent states that
"[p]iperidinoalkanol derivatives which are useful as
antihistamines are disclosed in U.S. Patents Nos. 3,878,217,
4,254,129, and 4,285,957 and these patents are incorporated
herein by reference." (Gresalfi Decl. at A78.)
Defendants argue that the Court may consider the patents
referred to in the quoted passage as incorporated into the '605
and '061 patents for purposes of the anticipation
analysis.*fn24 This Court agrees. By their express language,
these references bring within the four corners of the
anticipatory reference the relevant elements of the prior art.
"Consideration of a reference within a reference is consistent
with the established standards for determining anticipation."
Rheox, Inc. v. United Catalysts, Inc., 1995 WL 526542, *4
(D.N.J. 1995); see also 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."). Atari Games
Corp. v. Nintendo, 1993 WL 214886 (N.D. Cal. 1993) and In Re
Saunders, 444 F.2d 599 (C.C.P.A. 1971), two cases cited by
Plaintiffs which held that the asserted anticipating reference
did not expressly incorporate another reference, are
distinguishable. In those cases, the portions of the references
claimed to be incorporated were not contained within the
particular portions of the reference specified in the prior art.
Here, the referenced patents are incorporated in their entirety.
Moreover, the '605 and '061 patents refer specifically to these
references for purposes of incorporating "piperidinoalkanol
derivatives," fexofenadine being one such derivative.
B. Plaintiffs Cannot Defeat Summary Judgment by Arguing that
the Prior Art Does Not Enable a Bioavailable Formulation
Plaintiffs further argue that even if patents '605 and '061
described the substitution of fexofenadine for terfenadine, they
are not enabling because a person of ordinary skill in the field,
directed to the prior art by the anticipatory reference, could
not produce the invention. As described by Plaintiffs, the
inventors of the '872 patent attempted to develop a fexofenadine
tablet using the formulations set forth in the '605 and '061
patents, by substituting fexofenadine for terfenadine, and
omitting a pseudoephedrine decongestant. The formulation that was
produced contained, but for the substitutions described, the same
combination of excipients as the formulations set forth in the
'605 and '061 patents. When the formulation was administered to
patients it was shown that the bioavailability*fn25 of the
formulation was unacceptably poor. Plaintiffs claim that the '605 and '061 patents, therefore,
cannot be said to enable the "novel" fexofenadine formulations of
the '872 patent which have excellent bioavailability.
Bioavailibility, a desirable characteristic in a biochemical
formulation, is not set forth either expressly or inherently as a
limitation in the '872 patent claims. For this Court to accept
Plaintiffs' argument that the prior art need enable a
bioavailable formulation in order to anticipate, we would have to
disregard the clear warnings of the Federal Circuit against
importing claim limitations based on terms not mentioned in the
It is improper for a court to add extraneous
limitations to a claim, that is limitations added
wholly apart from any need to interpret what the
patentee meant by particular words or phrases in the
claim. The danger of improperly importing a
limitation is even greater when the purported
limitation is based upon a term not appearing in the
claim. "If we once begin to include elements not
mentioned in the claim in order to limit such claim
. . ., we should never know where to stop."
Amgen Inc. v. Hoechst Marion Roussel, 314 F.3d 1313
, 1325 (Fed.
Cir. 2003) (citations omitted).
In short, the prior art need not enable a bioavailable
fexofenadine formulation in order to be deemed anticipating.
C. Plaintiffs Cannot Defeat Summary Judgment by Arguing that
the '129, '353, and '693 Patents do not Disclose the '872
Hydrochloride Salt Formulation
In the event that the Court does not find that the '872 patent
is anticipated by prior art patents '605 and '061, Defendants
have also asserted the '353 patent, the '693 patent, and the '129
patent, as anticipating prior art references. (Def. Joint Reply
Br. at 35-36.) Plaintiffs argue that the '129, '353 and '693
patents cannot anticipate claims 1 and 2 of the '872 patent
because claims 1 and 2 of '872 require a form of fexofenadine
called the hydrochloride salt, also called fexofenadine
hydrochloride, while the '129, '353 and '693 patents do not
disclose fexofenadine hydrochloride formulations. Plaintiffs admit that, while the '129 and '693 patents do not
claim the hydrochloride salt, they do disclose the hydrochloride
salt in the specifications. (Aventis Supp. Br. on New References
at 15 n. 8, p. 16 n. 10). Plaintiffs also admit that the '353
patent incorporates the '129 patent by reference. (Aventis Supp.
Br. on New References at 15 n. 9.) Plaintiffs argue that the
'129, '353, and '693 patents cannot anticipate '872, however;
while they may disclose the individual ingredients, they do not
disclose them together as fexofenadine hydrochloride
formulations. This is, in essence, an argument about enablement:
do the prior art patents enable the formulations of the '872
inventions? Do they teach one skilled in the art how to make and
use the fexofenadine hydrochloride formulations claimed in '872?
Plaintiffs have failed to meet the evidentiary burden specified
by Amgen to defeat summary judgment on the issue of whether the
prior art patents are enabling. They rely only on the second
declaration of Dr. Zak T. Chowhan, which does not squarely
address the enablement issue. Dr. Chowhan states that the '129,
'353, and '693 patents do not describe the fexofenadine
formulation of the '872 patent, but this does not speak to the
question of whether each prior art patent would enable one of
ordinary skill in the art to make the '872 fexofenadine
hydrochloride formulation. At oral argument, Plaintiffs could
point to no other evidence which could be used to persuade a
reasonable jury to resolve the enablement issue in Plaintiffs'
favor. Plaintiffs thus fail in arguing that the '129, '353, and
'693 patents do not anticipate '872 because they do not disclose
the same fexofenadine hydrochloride formulation.
D. Plaintiffs Cannot Defeat Summary Judgment by Arguing that
the '872 Claim Language States a Limitation of Reduced
Plaintiffs argue that claims 1 and 2 of the '872 patent require
that the wet granulation be screened, and that this "imparts a distinguishing structural
difference in the product of the claims," as compared to the
product of patents '129, '353, and '693. (Aventis Supp. Br. on
New References at 11.) Plaintiffs argue that the effect of this
process step is to "reduce the size of large wet granulation
agglomerates," and that this states a product limitation absent
in the prior art patents (Aventis Supp. Br. on New References at
18, 19, 21.) Plaintiffs' argument is unpersuasive because the
claim language of '872 says nothing about the size of particles
or agglomerates; it has no express reference to the size of
anything. Plaintiffs' "separate disintegrant" argument addressed
below is worthy of consideration because the claim expressly
states the use of a disintegrant, and so it is conceivable that
the patent has claimed a product limitation involving a
disintegrant; here, however, there is no such express claim
language regarding size, and so there is no language in the claim
on which to base an inference that the patentee has claimed a
Plaintiffs admitted at oral argument that the claim language
did not express a clear or specific limitation:
The Court: Right. So if I look at 19 and 20, what's
the and I'm obviously reading the claim, how would
I read the claim to that particular size
specification? It says physically reduce the size of
larger agglomerates of the granule. I'm just looking
at Dr. Chowhan.
Mr. Barr: That's one skilled in the art. The
pharmaceutical formulator makes a decision on whether
the wet granulation is has agglomerates in it and
to reduce the size. And that's something defendants
each do in the way by using
The Court: So any notion of particularized sizes is
not relevant to this, it's just the fact through that
process you can reduce the size? Mr. Barr: Yes, your Honor. (Dec. 8, 2003, Tr. at
Plaintiffs cannot reasonably argue that the claim language
states a product limitation of reduced size, but without
limitation as to size. Under Amgen, this Court is not permitted
to import a limitation that does not appear in the claims.
E. Plaintiffs Have Raised an Issue of Claim Construction: Do
Claims 1 and 2 of the '872 Patent State a Product Limitation of a
Separate Intragranular Disintegrant?
Finally, Plaintiffs argue that claims 1 and 2 of the '872
patent "require that the claimed product contain a separate
disintegrant incorporated into the granules," and that the claim
language thus states a product characteristic absent from any of
the prior art references. (Aventis Br. at 37, Aventis Supp. Br.
on New References at 10.) Plaintiffs have offered as evidence the
second declaration of Dr. Zak T. Chowhan, which states that, in
essence, in his expert opinion, claims 1 and 2 of the '872 patent
state this product limitation. (See Chowhan Decl. at ¶¶ 13, 16,
20, 24.) Defendants argue the insufficiency of this declaration,
but offer no evidence to counter it.
Plaintiffs argue that the process step quoted above establishes
a product characteristic of a separate intragranular
disintegrant, and offer the second Chowhan declaration as
evidence that one of ordinary skill in the art would understand
the claim language to mean this. This raises an issue of claim
construction: do claims 1 and 2 state a limitation requiring that
the product have the structural characteristic of a separate
disintegrant incorporated into the granules? This Court must
decide, as a matter of law, whether one of ordinary skill in the
art would understand the claim phrase "a diluent and a
disintegrant are mixed with a solution of a binding agent" to
state a product limitation of a separate intragranular
Understanding the meaning of the claim language in regard to
the chemical properties of the pharmaceutical product specified in claims 1 and 2 of the
'872 patent requires technical expertise in pharmaceutical
chemistry. To construe the claim language, this Court requires a
Markman hearing directed to the question of whether claims 1
and 2 of the '872 patent require that the product have the
structural characteristic of a separate disintegrant incorporated
into the granules. After the Markman hearing, this Court will
rule on the issue of claim construction, and proceed to address
the motion for summary judgment of patent invalidity.
Based on the above reasoning, this Court GRANTS Defendants'
motion for summary judgment of noninfringement of the '912, '942,
and '247 patents. Defendants' motion for summary judgment of
noninfringement of the '974 patent is DENIED. A ruling on the
'872 patent is reserved pending a Markman hearing to assist
this court in construing the patent's product-by-process claims.