04-1100
ASTRAZENECA
AB, AKTIEBOLAGET HASSLE,
KBI-E, INC., KBI INC., and ASTRAZENECA LP,
Plaintiffs-Appellees,
v.
MUTUAL
PHARMACEUTICAL COMPANY, INC.,
Defendant-Appellant.
Lisa B. Pensabene, Fitzpatrick, Cella,
Harper & Scinto, of
H.
Michael Hartmann, Leydig, Voit
& Mayer, Ltd., of
Appealed from:
Judge Michael M. Baylson
04-1100
ASTRAZENECA
AB, AKTIEBOLAGET HASSLE,
KBI-E,
INC., KBI, INC., and ASTRAZENECA LP,
Plaintiffs-Appellees,
v.
MUTUAL PHARMACEUTICAL COMPANY, INC.,
Defendant-Appellant.
___________________________
DECIDED:
___________________________
Before MICHEL, Circuit Judge, ARCHER, Senior
Circuit Judge, and BRYSON, Circuit Judge.
MICHEL, Circuit Judge.
Astrazeneca
AB, Aktiebolaget Hassle, KBI-E, Inc., KBI, Inc., and Astrazeneca LP
(collectively, “Astrazeneca”) sued Mutual Pharmaceutical Co., Inc. (“Mutual”)
pursuant to 35 U.S.C. § 271(e)(2), under which it is an “act of infringement”
to submit an Abbreviated New Drug Application (“ANDA”) to the Food and Drug
Administration (“FDA”) to obtain approval to market a drug that is claimed in a
nonexpired patent. Astrazeneca alleged that Mutual infringed U.S. Patent No.
4,803,081 (the “’081 patent”), titled “New Pharmaceutical Preparations With
Extended Release,” by submitting an ANDA to the FDA seeking approval of
extended-release felodipine tablets.
After construing the asserted claims of the ’081 patent, the United
States District Court for the Eastern District of Pennsylvania granted Astrazeneca’s
motions for summary judgment on infringement and validity.
BACKGROUND
Astrazeneca
markets extended-release felodipine tablets under the trade name PLENDIL®, for use in
treating hypertension. Astrazeneca has obtained two patents related
to PLENDIL®: U.S. Patent No. 4,264,611 (the “’611 patent”)
and the ’081 patent. The ’611 patent was
directed to certain chemical compounds -- including felodipine -- having
antihypertensive qualities. The
application that matured into the ’611 patent was filed on
Mutual
hopes to market generic felodipine tablets for treating hypertension. To this end, on
On
Mutual
timely appealed to our court, which has jurisdiction pursuant to 28 U.S.C. §
1295(a)(1). We heard oral argument on
DISCUSSION
On appeal, Mutual challenges the district court’s rulings on
claim construction, infringement, and validity.
Mutual’s challenge to the district court’s rulings on validity is
contingent on our affirming the district court’s claim construction; Mutual
concedes that if our court were to accept Mutual’s position as to the proper
scope of the asserted claims -- and reverse the district court’s broader
construction -- the claims as narrowed would not be invalid. We thus begin with claim construction.
The ’081 patent has sixteen product claims and one process
claim, of which Astrazeneca asserts product claims 8, 12, 14, and 15, and
process claim 17. The asserted product
claims are dependent directly or indirectly on claim 1:
1. A solid preparation providing extended
release of an active compound with very low solubility in water comprising a
solution or dispersion of an effective amount of the active compound in a
semi-solid or liquid nonionic solubilizer, wherein the amount by weight of
the solubilizer is at least equal to the amount by weight of the active compound,
and a release controlling system to provide extended release.
’081 patent, col. 8, ll. 43-51 (emphasis added). Claim 17 is the process claim:
17. A
process for making a solid preparation that provides extended release of an
active compound with very low solubility in water comprising dissolving or
dispersing an effective amount of the active compound in a semi-solid or
liquid nonionic solubilizer, the amount by weight of said solubilizer being
at least equal to the amount by wight [sic] of the active compound, and
incorporating the resulting solution or dispersion into a suitable release
controlling system to form a pharmaceutical dosage unit.
The claim construction dispute centers on the term “solubilizer,”
which is common to all asserted claims.
The parties agree that as a general matter, artisans would understand
the term “solubilizer” to embrace three distinct types of chemicals: (1)
surface active agents (also known as “surfactants”), (2) co-solvents, and (3)
complexation agents.[1] But Mutual has contended that in the context
of the ’081 patent’s specification and prosecution history, “solubilizer”
comprehends only surfactants. Because it
is undisputed that Mutual’s ANDA sought approval for extended-release
felodipine tablets that use a co-solvent, not a surfactant, as a solubilizer,
Mutual has argued that filing its ANDA was not an act of infringement under §
271(e)(2). The district court rejected
Mutual’s argument. Relying on the
parties’ agreement as to artisans’ general understanding of “solubilizer,” and
on certain general-usage dictionary definitions of “solubilizer” and
“solubility,” the district court held that the “ordinary meaning” of
“solubilizer” embraced the three types of chemicals noted above. See Astrazeneca, 221 F. Supp.
2d at 543-44. The district court held
that the evidence intrinsic to the patent did not curtail this ordinary
meaning. See id. at
543-48. The district court’s lengthy and
careful opinions relied extensively on our recent case law, which is
unfortunately complex and inconsistent.
I. Applicable
Law
We review the district court’s claim construction de novo. E.g., Cybor Corp. v. FAS Techs.,
Inc., 138 F.3d 1448, 1454-56 (Fed. Cir. 1998) (en banc). It is axiomatic that the claims mark the
outer boundaries of the patent right to exclude. The critical challenge is to determine the
meaning of the claims, i.e., their scope.
A long line of cases indicates that evidence intrinsic to
the patent -- particularly the patent’s specification, including the inventors’
statutorily-required written description of the invention -- is the primary
source for determining claim meaning. We
have embraced that proposition frequently.
See, e.g., Bell Atl. Network Servs., Inc. v. Covad
Communications Group, Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001); Vitronics
Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Indeed, that proposition has been accepted
doctrine in patent law for many years. See,
e.g., Autogiro Co. of Am. v. United States, 384 F.2d 391, 397-98
(Ct. Cl. 1967) (“The use of the
specification as a concordance for the claim is accepted by almost every court,
and is a basic concept of patent law.
Most courts have simply stated that the specification is to be used to
explain the claims; others have stated the proposition in different terms, but
with the same effect.”); Musher Found., Inc. v. Alba Trading Co., 150
F.2d 885, 888 (2d Cir. 1945) (Hand, J.) (“As in the case of any other claim, a
product claim may, and indeed must, be read upon the specifications: its terms are no more than a shorthand from
the fuller explanation which the specifications should contain.”). On this view, the patent is an integrated
document, with the claims “pointing out and distinctly claiming,” 35 U.S.C. §
112, the invention described in the rest of the specification[2]
and the goal of claim construction is to determine what an ordinary artisan
would deem the invention claimed by the patent, taking the claims together with
the rest of the specification. See,
e.g., United States v. Adams, 383 U.S. 39, 49 (1966) (“[I]t is
fundamental that claims are to be construed in the light of the specifications
and both are to be read with a view to ascertaining the invention.”). Under this approach to claim construction, evidence extrinsic
to the patent is useful insofar as it “can
shed useful light on the relevant art -- and thus better allow a court to place
itself in the shoes of a person of ordinary skill in the art” reading the
claims alongside the rest of the specification.
Language in some of our recent cases suggests that the
intrinsic record, except for the claims, should be consulted only after the
ordinary and customary meaning of claim terms to persons skilled in the
pertinent art is determined. See,
e.g., Tex. Digital Sys., Inc. v. Telegenix, Inc., 308 F.3d 1193,
1204 (Fed. Cir. 2002) (“[T]he presumption in favor of a dictionary definition
[of a claim term] will be overcome where the patentee, acting as his or her own
lexicographer, has clearly set forth an explicit definition of the term
different from its ordinary meaning.
Further, the presumption also will be rebutted if the inventor has
disavowed or disclaimed scope of coverage, by using words or expressions of
manifest exclusion or restriction, representing a clear disavowal of claim
scope.”) (citations omitted). The
language in these cases emphasizes the use of technical and general-usage
dictionaries in determining the ordinary meaning.
Against this backdrop, the question becomes whether the
intrinsic evidence takes priority in our construction of the claim term
“solubilizer,” or if instead the ordinary meaning of the term, as determined
from sources such as treatises and dictionaries, controls our construction in
the absence of intrinsic evidence of clear lexicography or disavowal. Given that the parties agree that the
extrinsic meaning of solubilizer is broad, Astrazeneca unsurprisingly urges the
latter approach to claim construction.
We need not decide which approach is proper as a matter of
law,[3]
as even under Astrazeneca’s preferred methodology, the district court’s claim
construction must be reversed. The
intrinsic evidence, we hold, clearly binds Astrazeneca to a narrower definition
of “solubilizer” than the extrinsic evidence would support.
II. Specification
of the ’081 Patent
The
specification of the ’081 patent begins by stating that
[t]he present invention is related
to pharmaceutical extended release preparations of active compounds with very
low solubility, especially substituted dihydropyridines, and to methods of
preparing such preparations.
The object of this invention is to
obtain a solid preparation with high extent of bioavailability and extended
release of an active compound which normally has very low solubility.
’081 patent, col. 1, ll. 6-15. The specification continues with a
“Background of the Invention” section, which states that
[p]harmaceuticals with very poor
water solubility present formulation problems due to their slow rate of
dissolution. Their efficacy can by [sic]
severely limited and large interindividual variations of absorption can occur. Examples of drugs with very low solubility
are some substituted dihydropyridine compounds such as nifedipine and
felodipine. The mentioned
dihydropyridines are commonly classified as calcium antagonists, which are
widely used for the treatment of cardiovascular disorders such as ischaemic
heart disease and arterial hypertension.
One of the mentioned dihydropyridines, namely felodipine, has a
solubility of only .5 mg/l in water. . . .
Several ways to increase drug
absorption have been described in the prior literature. . . . Of particular relevance to the present
invention is that surfactant solubilizing agents may be employed in order to
increase the bioavailability of the drugs with very low solubility.
[i]t is the object of the present
invention to provide a preparation of a drug with very low solubility that
shows prolonged and nearly constant rate of drug absorption for a long period
of time and concurrently maintains a high extent of bioavailability. The object is reached by using a solubilizer
which is mixed with the drug with very low solubility. The solubilizers suitable according to the
invention are defined below. The
active compound is preferably dissolved or dispersed in the solubilizer. The mixture of active compound (drug) and
solubilizer can be diluted with water or intestinal juice without significant
precipitation of the dissolved drug. In
the solution the drug is included in a micelle-structure formed by the
solubilizer. With other commonly used
solubilizers or co-solvents dilution may cause precipitation of the drug. The mixture of the drug and the solubilizer
is incorporated into a pharmaceutical formulation, which gives prolonged release.
Drugs suitable for the extended
release preparation according to the inventions are compounds characterized by
their very low solubility, that is less than 0.1 per cent by weight in water. .
. .
The solubilizers suitable for the
preparations according to the invention are semi-solid or liquid non-ionic
surface active agents, especially such containing polyethyleneglycols as
esters or ethers. They are preferably
chosen from polyethoxylated fatty acids, hydroxylated fatty acids and fatty
alcohols. It is especially preferred to
choose the solubilizer from the group polyethoxylated castor oil,
polyethoxylated hydrogenated castor oil, polyethoxylated fatty acid from castor
oil or polyethoxylated fatty acid from hydrogenated castor oil. Commercially available solubilizers, which
can be used are known under the trade names Cremophor, Myrj, Polyoxyl 40
stearate, Emerest 2675, Lipal 395 and HCO 50.
A specially preferred solubilizer is Cremophor®RH
40 (BASF).
The active compound mixed with the
solubilizer is incorporated into different kinds of known controlled release
systems, e.g. a hydrophilic gel system, beads coated with a rate controlling
membrane, which can be a diffusion retarding coating or a disintegrating
coating or tablets with an inert porous matrix.
According to the invention the solubilized drug is preferably combined
with a hydrophilic gel system, namely a hydrophilic swelling matrix e.g.
HPMC. This form of controlled release
mechanism is a suitable way to control the release of the micelles of drug
and solubilizer.
Id. at col. 2, ll.
67-68, col. 3, ll. 1-20, 33-58 (emphases added). The specification then provides five detailed
working examples of drug formulations embraced by the invention.
Mutual
contends that the specification limits the scope of the claim term
“solubilizer” to surfactants, and we agree.
First, we hold that the inventors deliberately acted as their own
lexicographers. The “Description of the
Invention” states that “[t]he solubilizers suitable according to the invention are
defined below” (emphasis added), and two paragraphs later, states that
“[t]he solubilizers suitable for the preparations according to the invention
are semi-solid or liquid non-ionic surface active agents” (emphasis
added). Astrazeneca maintains that these
statements simply refer to preferred embodiments of “suitable”
solubilizers. We might agree if the
specification stated, for example, “a solubilizer suitable for the
preparations according to the invention,” but in fact, the specification definitively
states “the solubilizers suitable for the preparations according to the
invention” (emphasis added). Astrazeneca
seems to suggest that lexicography requires a statement in the form “I define
____ to mean ____,” but such rigid formalism is not required. See, e.g., Bell Atl. Network
Servs., Inc., 262 F.3d at 1268 (“[A] claim term may be clearly redefined
without an explicit statement of redefinition. . . . [T]he specification may
define claim terms ‘by implication’ such that the meaning may be ‘found in or
ascertained by a reading of the patent documents.’” (citation omitted)). Certainly the ’081
specification’s statement that “[t]he solubilizers suitable according to the
invention are defined below” provides a strong signal of lexicography.
Second, we
hold the specification clearly disavows nonsurfactant solubilizers. The inventors’ lexicography alone works an
implicit disavowal of nonsurfactant solubilizers, but the rest of the
specification goes further. The
“Description of the Invention” twice describes micelle structures as a feature
of the novel formulation structure conceived by the inventors. See ’081 patent, col. 3, ll. 11-12
(“In the solution the drug is included in a micelle-structure formed by the
solubilizer.”); id. at col. 3, ll. 56-58 (“This form of controlled
release mechanism is a suitable way to control the release of the micelles of
drug and solubilizer.”). It is
undisputed that surfactants are the only solubilizers believed to form micelle
structures in watery environments. Indeed, immediately after the reference to the
“micelle-structure formed by the solubilizer” of the invention, the
specification criticizes other types of solubilizers -- and specifically
co-solvents -- as leading to undesirable precipitation. See id. at col. 3, ll. 12-14
(“With other commonly used solubilizers or co-solvents dilution may cause
precipitation of the drug.”).
Again, Astrazeneca contends that these statements in the
specification simply address the features of preferred embodiments. Astrazeneca seems to suggest that clear
disavowal requires an “expression of manifest exclusion or restriction” in the
form of “my invention does not include ____.”
But again, such rigid formalism is not required: Where the general summary or description of the
invention describes a feature of the invention (here, micelles formed by the
solubilizer) and criticizes other products (here, other solubilizers, including
co-solvents) that lack that same feature, this operates as a clear disavowal of
these other products (and processes using these products). See, e.g., SciMed Life Sys., Inc.
v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1340-45 (Fed. Cir.
2001) (construing claims to be limited to catheters with coaxial lumens where
written description emphasized coaxial lumens as a feature of the invention and
criticized catheters using other types of lumens). Indeed, Teleflex, Inc. v. Ficosa North
America Corp., 299 F.3d 1313 (Fed. Cir. 2002), the first case to use the
formulation “expressions of manifest exclusion or restriction, representing a
clear disavowal of claim scope,” cited as authority our decision in SciMed,[4]
where we held the claims-in-suit were limited by written-description statements
-- none of which was in the form “my invention does not include ______.” See SciMed, 242 F.3d at 1342-44
(discussing the content of the written description at issue).
Third,
while it is of course improper to limit the claims to the particular preferred
embodiments described in the specification, the patentee’s choice of preferred
embodiments can shed light on the intended scope of the claims. After defining the term “solubilizer,” the
“Description of the Invention” section goes on to list a number of solubilizers
that are preferred or even “especially preferred”:
The
solubilizers suitable for the preparations according to the invention are
semi-solid or liquid non-ionic surface active agents, especially such
containing polyethyleneglycols as esters or ethers. They are preferably chosen from
polyethoxylated fatty acids, hydroxylated fatty acids and fatty alcohols. It is especially preferred to choose the
solubilizer from the group polyethoxylated castor oil, polyethoxylated
hydrogenated castor oil, polyethoxylated fatty acid from castor oil or
polyethoxylated fatty acid from hydrogenated castor oil. Commercially available solubilizers, which
can be used are known under the trade names Cremophor, Myrj, Polyoxyl 40
stearate, Emerest 2675, Lipal 395 and HCO 50.
A specially preferred solubilizer is Cremophor®RH
40 (BASF).
’081 patent, col. 3, ll. 33-47. At oral argument, Astrazeneca conceded that
every one of these preferred solubilizers is a surfactant. Similarly, it is uncontested that in each of
the five detailed working examples that follow the “Description of the
Invention,” the listed solubilizer is a nonionic surfactant identified by its
commercial trade name (either “Cremophor” or “Myrj”). The fact that all of the solubilizers listed
in the specification and used in the working examples were surfactants adds
further support to the conclusion that the term “solubilizer” in the claims
should be limited, according to the definition employed in the specification,
to surfactants.
In sum, we hold that the specification of the ’081 patent
overcomes any “ordinary meaning” of “solubilizer” derived from extrinsic
evidence, limiting the claim term to surfactants.
III. Prosecution
History of the ’081 Patent
Although the specification, by itself, compels the above
claim construction, we briefly discuss additional confirmation for this
construction: the patent applicants’ remarks during the prosecution history of
the ’081 patent. On
The
second reference cited by the Examiner is U.S. Patent No. 4,673,564 to Kawata
et al. (“Kawata”). Kawata discloses
preparations in which an amorphous medical material such as amorphous
nifedipine is combined with a “basic substance” and a solvent, mixed and then
dried to form an amorphous powder which is then mixed with polyethylene
oxide. Only one component of these
formulations could be a “nonionic solubilizer” in the context of the present
invention, however, in view of the definition on Page 4, line 33 – Page 5, line
6 of the specification, i.e., Kawata’s optional 2nd component of the basic
substance.
(Underlined emphasis added, italicized emphases in
original.) This passage is notable for
two reasons. First, the reference to the
“definition” in the specification includes a citation to the sentence in the
specification stating that “[t]he solubilizers suitable for the preparations according
to the invention are semi-solid or liquid non-ionic surface active
agents.” The applicants’
characterization of this sentence in the specification as a “definition”
confirms that the applicants acted as their own lexicographers to redefine
“solubilizer” differently from its ordinary meaning. Second, the applicants highlighted the second
component of the composition taught by the Kawata patent as the only component
that “could be a ‘nonionic solubilizer’ in the context of the present
invention.” In its brief to our court,
Astrazeneca concedes that “Kawata emphasizes surfactants for the second
component.” See also U.S. Patent No. 4,673,564, col. 2, ll. 56-61
(“As the surface active agent of 2nd substance, there are anionic
surface active agents such as sodium alkylsulfate, nonionic surface active
agents such as polyoxyethylene sorbitan fatty acid ester, polyoxyethylene
castor oil derivative, etc.”) (emphasis added).
Finally, we note that near the end of the above-excerpted
remarks to the examiner, the applicants stated:
“Thus, none of the references disclose materials in which solutions or
dispersions of the active material in a nonionic surfactant are formed
into a solid preparation with extended release.” (Emphasis added.) This general description of the applicants’
invention substitutes the term “surfactant” for the term “solubilizer,” further
evidence that, in the context of the application, “solubilizer” embraced only
surfactants.
IV. Conclusion
as to Infringement and Invalidity
For the
foregoing reasons, we conclude that the district court erred in its claim
construction, and that properly construed, the claim term “solubilizer” must be
limited to surfactants. Because all
asserted claims include the term “solubilizer,” and because Mutual’s
extended-release felodipine tablets use a co-solvent, not a surfactant, as a
solubilizer, Mutual’s tablets could not literally infringe the ’081 patent.
Astrazeneca
contends that even under this construction, the case should be remanded for
further proceedings to address the doctrine of equivalents. We disagree.
The specification’s clear disavowal of nonsurfactant solubilizers
precludes the application of the doctrine of equivalents to recapture the disavowed
solubilizers. See, e.g., Gaus
v. Conair Corp., 363 F.3d 1284, 1291 (Fed. Cir. 2004) (“Having disavowed
coverage of [particular] devices . . . the patentee cannot reclaim that
surrendered claim coverage by invoking the doctrine of equivalents.”); SciMed,
242 F.3d at 1345 (“A particular structure can be deemed outside the reach of
the doctrine of equivalents because that structure is clearly excluded from the
claims whether the exclusion is express or implied.”).
Thus, we must reverse the judgment of infringement and
remand for entry of judgment of noninfringement. Mutual concedes that the ’081 patent is not
invalid if the term “solubilizer” is construed to include only
surfactants. Because we hold that the
term “solubilizer” is limited to surfactants, we affirm the district court’s
judgment in favor of Astrazeneca on invalidity.
AFFIRMED-IN-PART, REVERSED-IN-PART, and REMANDED
COSTS
Costs to appellant.
[1] Doubtless
because the parties agreed as to artisans’ general understanding of “solubilizer,”
the parties decided not to introduce expert testimony as to the meaning of this
claim term at the Markman hearing at the district court.
[2] I.e.,
the invention vel non taught by the specification, as distinct from
particular, idiosyncratic embodiments disclosed in the specification. See, e.g., Alloc, Inc. v. Int’l
Trade Comm’n, 342 F.3d 1361, 1370 (Fed. Cir. 2003) (“[T]his court
recognizes that it must interpret the claims in light of the specification, yet
avoid impermissibly importing limitations from the specification. That balance turns on how the specification
characterizes the claimed invention. In
this respect, this court looks to whether the specification refers to a
limitation only as a part of less than all possible embodiments or whether the
specification read as a whole suggests that the very character of the invention
requires the limitation to be a part of every embodiment.” (citations omitted)).
[3] Resolution
of this question may be approaching. See
Phillips v. AWH Corp., __ F.3d __, Nos. 03-1269, 03-1286, 2004 WL
1627271 (Fed. Cir.
[4] Teleflex
stated: “The patentee may demonstrate an
intent to deviate from the ordinary and accustomed meaning of a claim term by
including in the specification expressions of manifest exclusion or
restriction, representing a clear disavowal of claim scope.” Teleflex, 299 F.3d at 1325 (citing SciMed,
242 F.3d at 1344).