*1 LABORATORIES, ABBOTT
Plaintiff-Appellant,
and Pharma, Inc., Plaintiff- Astellas
Appellant,
v. INC., Defendant-Appellee, SANDOZ,
and Defendant, GMBH, Sandoz and USA, Inc. and Teva Pharmaceuticals Industries, Teva Pharmaceutical Ltd., Defendants-Appellees,
and Laboratories, Ranbaxy Ltd. Defendants, Ranbaxy, Inc., Companies, Inc. Par Pharmaceutical Pharmaceutical, Par Defendants. Limited, Lupin Plaintiff/Counterclaim
Defendant-Appellee, Inc., Pharmaceuticals, Lupin Defendant- Counterclaim Appellee,
v. Laboratories, Abbott Defendant/Counterclaimant-Appellant, Pharma, Inc.,
Astellas Defendant/Counterclaimant-Appellant. 2007-1400, 2007-1446.
Nos. Appeals, United States Court Federal Circuit.
May
Hurst, & Strawn
James F. Winston IL,
LLP, argued plain- for all Chicago, in 2007-1400 and defen- tiffs-appellants dants/counterclaimants-appellants 2007- him the briefs for Abbott 1446. With Ehlman, Kath- were Todd J. Laboratories Poullaos, Ivan M. Barry, B. leen Johnson, Washington, N. DC. Of Steffen brief for Abbott Laborato- counsel on the Jr., Cavanaugh, Jef- were F. ries William Pollack, Lewis, E. frey I.D. and Stuart LLP, Tyler & Belknap Patterson Webb York, counsel was John C. New NY. Of for Astellas Phar- Knapp. On the briefs ma, Inc., Kelly, Stephen were Richard D. Obion, West, Spi- Frank G. Baxter and J. Neustadt, P.C., vak, McClelland, Maier & Alexandria, VA.
Brinks, Hofer, Addy, Martin Meredith IL, Lione, for Chicago, argued &
Gilson Sandoz, her defendant-appellee Inc. With Filarski, Thomas J. on the brief were Remus, Kaman, and Lau- Mark H. C. Noel L. Lydigsen. ra A. Of counsel was Rashad Morgan. Meloro, Jr., Farr &
Thomas J. Wilkie LLP, York, NY, argued New Gallagher defendants-appellees Teva Pharmaceu- USA, Inc., al. him on the ticals et With counsel was Neal K. Feivelson. Of brief and Alexander were Michael W. Johnson H. Swirnoff. Mazzochi, nial of motion Rakoczy preliminary Molino Abbott’s
Deanne M. LLP, IL, Siwik, Chicago, ar- injunction, in large part Mazzochi based on the same defendant- plaintiff/counterclaim gued correct claim construction. counterclaim Lupin Limited and
appellee Lupin Pharmaceuti- defendant-appellee, I. cals, her on the Inc. in 2007-1446. With Laboratories, Abbott the exclusive licen Rakoczy, Paul A. J. brief were William patent, crystalline see of the '507 markets Molino, Brody. D. Amy according cefdinir to the '507 under Virginia trade name Omnicef. The RADER, PLAGER, and
Before Lupin sought case arose when a declarato MICHEL, BRYSON, Judges. Circuit *4 ry RADER, BRYSON, judgment noninfringement against Judge, and Chief GAJARSA, LINN, DYK, PROST, and Abbott Laboratories and Astellas Pharma (collec MOORE, joined Judges, Inc., have Circuit the owner of the '507 opinion. Dissenting Abbott). Section III.A.2 of tively The Drug Food and Ad as to Section III.A.2 filed opinion previously ministration approved had Lu- NEWMAN, Judge, Circuit pin’s Drug Application Abbreviated New LOURIE, Judges, MAYER and Circuit (ANDA) generic market a version of join. Dissenting opinion filed Omnicef. Lupin’s generic product con LOURIE, SCHALL, Judge. Circuit exclusively B Crystal tains almost form Judge, participate as a Circuit did (cefdinir crystalline monohyd cefdinir court. member of the en banc rate), whereas Abbott’s Omnicef Crystal crystalline contains the A form of RADER, Judge. Circuit (cefdinir anhydrate). Further, cefdinir case, Pat- patent, In this the same U.S. Lupin processes makes its with (the 4,935,507 '507 occa- patent), ent No. other than those claimed in pat the '507 litigation sions both United States reasons, Lupin brought ent. For these for the Eastern District of District Court Virginia clarify pro action to that its Virginia and the States District United posed product infringe would not a valid for the Northern District of Illinois. Court patent. Abbott counterclaimed for in granted the Virginia District Court fringement. The Eastern District Vir Lupin Lupin motion of Ltd. and Pharma- claims, ginia Lupin construed the Ltd. v. (collectively Lupin) ceuticals Inc. for sum- Laboratories, F.Supp.2d Abbott 448 noninfringement. mary judgment of (E.D.Va.2007) Order), (Lupin CC and ulti case, the other the Illinois District Court mately granted-in-part Lupin’s motion for injunction to preliminary denied a Abbott summary judgment noninfringement, Laboratories, the exclusive licensee of the equivalent infringement both literal and patent, based on the claim construc- '507 equivalent for claims 2-5 and as to in Virginia. District of tion from the Eastern fringement for claim v. Ab Lupin Ltd. Virginia Because the Eastern District of Labs., (E.D.Va.2007) F.Supp.2d bott correctly construed the claims of the '507 Order). (L parties stip upin SJ correctly genuine discerned no prejudice ulated to the dismissal without infringe- of material fact on literal issues remaining (invalidity) claims and coun infringement ment of claims 2-5 or (literal 1). infringement terclaims of claim 1-5, af- equivalents of claims this court action, In the Illinois Abbott sued San- partial summary judgment its firms doz, (collectively Inc. GmbH Likewise, and Sandoz noninfringement. this court af- USA, Sandoz), Teva Pharmaceuticals Inc. firms the Northern District Illinois’ de- Industries, X-ray powder pat- and Teva Pharmaceuticals Ltd. table diffraction Teva), Laboratories, (collectively Ranbaxy tern:
Ltd., Inc., Ranbaxy, Par Pharmaceutical (°) angle diffraction Inc., and Par Pharmaceutical Companies, 14.7° about about 17.8° about 21.5° (all defendants, collectively, Sandoz and Teva) infringement patent. of the '507 Lupin, previ
Like Sandoz and Teva had about 22.0° ANDAs, ously seeking ge filed to market about 23.4° about 24.5° sought Abbott neric versions Omnicef. about 28.1° injunction in preliminary the Illinois motion, purposes case. For contrast, patent, '507 col.16 11.13-27. parties agreed adopt the Eastern Dis crystalline cefdinir, 2-5 with- Virginia’s trict of claim construction from limitations, PXRD any peak out Sandoz, Lupin case. Abbott Labs. v. descriptions processes used to obtain Inc., (N.D.Ill.2007) F.Supp.2d crystalline cefdinir. Claims and 5 (Sandoz Order). Despite agree PI independent: ment, parties to the Sandoz case disa *5 7-[2-(2-a 2. Crystalline minothiazol-4- greed interpret as to how to some of the yl)-2-hydroxyiminoacetamido] -3-vinyl- Virginia’s Eastern District of construc 3-cephem-4-carboxylic (syn acid iso- tions, necessitating some clarification mer) which is acidifying obtainable a the Northern District of Illinois. 486 7-[2-(2-aminothia- containing solution F.Supp.2d (disputing “Crystal 770-71 zol-4~yl)-2-hydroxyiminoacetamido]-3- A,” “about,” “peaks,” seeking and con vinyl -3-cephem-4-carboxylie (syn acid “powder X-ray pat struction of diffraction isomer) temperature at room or under tern,” Virgi which the Eastern District of warming. defined). nia Ultimately, had not 7-[2-(2~aminothiazol-4- Crystalline 5. Illinois, Northern District based on the - yl)-2-hydroxyiminoacetamido]-3-vinyl claim Virginia, construction from denied 3-cephem-4-carboxylic (syn acid iso- injunction. preliminary mer) which by dissolving is obtainable Both ap- cases arrived at this court on 7-[2-(2-aminothiazol-4-yl)-2 -hydroxy- peal. This court together heard the cases iminoacetamido]-3-vinyl-3-cephem-4- together and decides them with this deci- isomer) carboxylic (syn acid in an alco- sion. hol, continuing slowly to stir the solution warming, under then cooling the solution II. to room temperature allowing claims, patent The '507 has five all of solution to stand. against which Abbott asserts Lupin as well 11.29-34, Id. at col. 16 43-50. crys- Sandoz and Teva. Claim 1 claims cefdinir, name, way talline These claims use PXRD as a using its chemical defining unique the structure and characteristics characteristics of (PXRD) powder X-ray angle unique crystalline diffraction form. PXRD is a peaks: method for identifying distinguishing 7-[2-(2-a crystalline compounds. different Crystalline
1. minothiazol-4- X-rays method beams a powdered toward yl)-2-hydroxyiminoacetamido]-3-vinyl- chemical. The 3-cephem.-4-carboxylic (syn acid iso- method then measures the mer) ways rays which the peaks upon shows at the dif- reflect or bend contact angles fraction shown in the following with the chemical. The angles diffraction vary type with the and which the context of this case means and intensities varying hydration. A compound. graph of the test levels purity angle on one axis plots then the diffraction Virginia District of Eastern con- intensity on another. These “crystalline,” strued the claim terms unique “fingerprint” a graphs yield “shows,” “peaks,” and “about” as follows: A crystalline form of a chemical. each 1) “crystalline” “Crystal means A as X-ray more sensitive form diffraction specification”; outlined in the (SCXRD). crystal X-ray diffraction single 2) requires display “shows” aof suggests, this name this method uses As powder X-ray pattern diffraction only single crystal sample. a as a SCXRD demonstrates the existence of the rele- intensity, a produces does not detect peaks scientifically acceptable vant precise angle more diffraction measure- degree certainty visually either ment. appropriate display; other means of data The '507 was not the first cefdi- 3) “peaks” the plural “peak;” Rather, nir art patent. Astellas’ “peak powder X-ray exists at a diffrac- (the 4,559,334 patent) Patent No. '334 U.S. angle corresponds tion to an inten- discovery describes the of cefdinir as sity greater measurement than meas- compound demonstrating high antimicrobi- urements attributable to “noise” if that col. 11 11.18-24. activity. patent, al '334 angle immediately preceded by and 6,May patent expired The '334 by powder X-ray followed diffraction an- measurement; priority Japa- gle intensity The '507 with lower Application portions nese Patent No. 62-206199 “noise” refers to those of a (the produced by which claimed PXRD application), pattern JP '199 intrinsic *6 cefdinir, error, crystalline “Crystal forms of measurement which two and cannot “Crystal A” B.” The '199 applica- scientifically signifi- and JP be associated with very A B Crystals specifi- quantity tion claimed and cant of the material which is test; cally, defining Crystal subject A three infrared of the PXRD (IR)-absorption wavelengths and sixteen 4) encompasses “about” measurement contrast, angles PXRD and intensities. In inherently pow- errors associated with Crystal IR-absorption B featured five X-ray testing. der diffraction twenty-one PXRD an- wavelengths and Order; 459, Lupin CC 484 F.Supp.2d gles/intensities. Virginia 466. The Eastern District of also Despite using application the JP '199 concluded that claims 2-5 were product- priority, patent’s specification by-process the '507 dif- claims. Id. Later the district (ac- significantly. Specifically, Abbott fers court concluded terms of Co., Ltd., Fujisawa 2-5, tually phrase Pharmaceutical indicated “ob interest) jettisoned predecessor by,” speci Astellas’ tainable limit the claims to the Crystal B processes process steps. disclosure found the JP fied conclusion, application reaching '199 and crafted broader claims the trial court prosecution patent. opinion of the '507 Be- followed this court’s Atlantic applications Thermoplastics Faytex Corp., cause the JP '199 defines v. 970 Co. (Fed.Cir.1992). Order, Crystal Crystal Lupin A B physiochemically F.2d 834 SJ 567-68; structurally, actually F.Supp.2d Lupin than forms 491 Ltd. v. rather (E.D.Va. Labs., represent subgenuses crystalline cefdi- Abbott No. 3:06-CV-400 Order). 2007) 10, Crystals May (Lupin PbyP A B comprise nir. Thus structures, challenges only crystalline varying Lupin appeal, forms of Abbott 1288 Virginia’s specification practically District of construc- offers incontro-
the Eastern
“crystalline”
by.”
and “obtainable
meaning.
tions of
vertible directions about claim
example,
may
For
inventors
act as their
III.
lexicographers
give a specialized
own
summary judgment
of a
Evaluation
claim
definition of
terms. See id. at 1316.
nonmfringement requires
steps:
two
claim Likewise,
in-
applicants may
inventors and
construction, which this court
reviews
disclaim,
disavow,
tentionally
subject
deference, Cybor Corp.
without
v. FAS matter that would
fall within
otherwise
Inc.,
1448, 1451
Technologies,
138 F.3d
scope of the claim. See id.
(Fed.Cir.1998) (en banc),
comparison
consulting
specification
When
properly
construed claims to the
clarify
terms,
meaning
of claim
product, process,
composition
accused
import
courts must take care not to
limita
matter,
summary
the context of
tions into the
specification.
claims from the
deference,
judgment also occurs without
recognized
This court has
the “fine line
Inc.,
Corp. Align Technology,
v.
see Ormco
encouraged
prohibit
between”
and the
(Fed.Cir.2007).
498 F.3d
Al
ed use of the specification. Comark
though infringement by equivalency
ais
Commc’ns,
v.
Corp.,
Inc. Harris
156 F.3d
fact,
question
this court
affirm
(Fed.Cir.1998).
1182, 1186
the spec
When
summary judgment “where no reasonable
single
ification describes a
embodiment to
equivalence.” Sage
fact finder could find
Prods.,
Indus.,
Inc.,
invention,
Inc. v. Devon
enable
this court will not
(Fed.Cir.1997)
F.3d
limit
(citing
language
broader claim
to that single
Warner-Jenkinson Co. v. Hilton Davis
application
patentee
“unless the
has dem
Co.,
Chemical
520 U.S.
39 n.
117 onstrated a clear intention to limit the
(1997)).
1040, 137
S.Ct.
L.Ed.2d
scope using
‘words or expressions of
”
manifest exclusion or restriction.’
Lie
A. Claim Construction
Medrad,
Inc.,
bel-Flarsheim Co. v.
pat
Because the claims define the
(Fed.Cir.2004)
F.3d
(quoting Tele
Water,
right,
ent
see
Inc. v.
Innova/Pure
flex, Inc. v.
N.
Corp.,
Ficosa Am.
Inc.,
Systems,
Water Filtration
381 1313,
(Fed.Cir.2002)). By
Safari
the same
*7
1111,
(Fed.Cir.2004), naturally
F.3d
1115
token, the
“enlarge
claims cannot
what is
provide
“the claims themselves
substantial
patented beyond what
the inventor has
guidance
meaning
particular
as to the
as the
Biogen,
described
invention.”
Inc.
claim terms.” Phillips
Corp.,
v. AWH
415
Labs., Inc.,
1132,
v. Berlex
318 F.3d
1140
(Fed.Cir.2005) (en banc).
1303,
F.3d
1314
(Fed.Cir.2003)
Netword,
(quoting
v.
LLC
But the claims “must be read in
view
(Fed.
1347,
Centraal
242
Corp.,
F.3d
1352
specification,
they
part.”
are a
Cir.2001)).
Thus this court
reach a
Instruments,
Inc.,
Markman v. Westview
construction,
narrower
limited
the em
(Fed.Cir.1995) (en
967,
banc),
52 F.3d
979
bodiment(s)
specification,
disclosed in the
370,
aff'd,
1384,
517 U.S.
116 S.Ct.
themselves,
specifica
when the claims
(1996).
patent’s specifica
L.Ed.2d 577
A
tion,
prosecution history
or the
clearly in
provides necessary
tion
context for under
encompasses
dicate that the invention
no
standing
claims,
always highly
and “is
than that
more
confined structure or meth
relevant
to the claim
analy
construction
Liebel-Flarsheim,
od. See
358 F.3d at
sis.” Phillips,
(quoting
Unlike to U.S. claim peaks expressly PXRD Ltd., the seven associat- Ranbaxy Inc. v. Labs. Pfizer Crystal specification. ed with A in the '507 1284, 1290(Fed.Cir.2006), F.3d in this case Nonetheless, of Virgi- the Eastern District '199 application part pros JP of the A” in “crystalline” “Crystal nia limited to history ecution patent the '507 itself. well, gave The trial court these claims as patent Indeed the '507 priority claims First, for this limitation. two reasons application. from the JP '199 Further steps detailed in those “[t]he more, the trial court rely did not on attor correspond with 2-5] claims [claims ney argument during or amendments making Crystal A disclosed processes foreign prosecution Pfizer, as in but con under the specification heading ‘The only sulted foreign the contents of the Preparing Crystal For A of The Process priority application. applica JP '199 ” (I).’ Id. at 457 Compound (quoting '507 strongly suggests tion patent that the '507 11.13-14). Second, col.2 patent, parent intentionally Crystal excluded B com application steps JP '199 recited these “to above, pounds. As discussed the JP '199 distinguish preparations Crys- between application unequivocally establishes Crystal tal A (citing B.” Id. JP '199 Abbott knew and could describe both 11.1-25). application, col.6 Crystal A Crystal B. Abbott could “crystalline” A” limiting “Crystal have Crystal retained the disclosure of B 1-5, Eastern District of Vir- support the broader claims of the '507 ginia improperly import pre- did not patent, but instead disclosed and claimed ferred embodiment into the Ini- claims. A alone. tially, Crystal A only is the embodiment Furthermore, the prosecution history of specification. described As dis- patent the '507 shows a clear and inten- above, cussed specification’s recitation tional scope beyond disavowal of claim Crystal A as its sole embodiment does Crystal A. Co-inventor Takaya, Takao who justify not alone the trial court’s limitation prepared samples according Examples of claim scope single to that disclosed em- Liebelr-Flarsheim, prior bodiment. and 16 of the art patent See '334 and a (“[T]his sample of “Crystal F.3d court A of the expressly present appli- has rejected cation,” if patent contention' that offered a Crystal declaration that embodiment, single describes the A was more stable than the art sam- claims of the must be construed ples patent. from the '334 An analytical embodiment.”). being limited to that chemist, Okamato, Yoshihiko corroborated case, however, this the rest of the intrinsic Beyond evidence. J.A. 501-04. these evidence, including prosecution history declarations, applicant specifically lim- priority and the application, JP '199 evince Crystal ited the invention to A: “the meth- a clear intention to limit the '507 od preparation crystalline form of Crystal A as defined the seven PXRD presently compounds claimed is not peaks in specification and in claim 1. considered the present heart of the inven- crystalline tion. The form of the com-
Initially, the Virginia Eastern District of pound represents concept inventive properly applica- considered the JP '199 *9 hereof, tion and is clear that objective patent] [the as relevant '334 evidence of the does not knowledge anticipate suggest crystal- inventor’s at said filing patent. '507 line form.” (Response While statements made J.A. 511 dur- Office ing prosecution 11, 1989, of a foreign counterpart May to Action of received October 6). U.S. application 27,1989, have a narrow at
1291
at
Crystal
infringed
A theless
26. Id.
838. This
focus on
the exclusive
Given
rejected
patentee’s
prosecu-
position.
as the
court
as well
specification
in the
in
patent,
Thermoplastics
'507
the Eastern This court Atlantic
con-
history of the
tion
“crys-
limited
limit-
Virginia properly
product-by-process
strued
claims as
District of
“Crystal
process.
1-5 to
A.”
at
by
in claims
ed
Id.
846-47.
talline”
in
support
This rule finds extensive
Su
product-
of
interpretation
proper
2.
preme
opinions
Court
that have addressed
claims1
reading
product-by-process
proper
Part III.A.2 of this
addresses
This court
Goodyear
v.
claims. See Smith
Dental
banc,
prop-
addresses the
opinion en
which
Co.,
486, 493,
L.Ed.
Vulcanite
93 U.S.
23
interpretation
product-by-process
er
(“The
(1877)
process detailed is there
952
determining infringement.
in
claims
part
made as much a
of the invention as
patent begin by
2-5 of the '507
are the materials of which the
Claims
cefdinir,
crystalline
reciting
product,
composed.”); Goodyear
Dental Vulcanite
Davis,
224,
this
steps
222,
a series of
102
then recite
Co. v.
U.S.
26 L.Ed.
(“[T]o
(1880)
Eastern Dis-
“obtainable.” The
infringement
149
constitute
correctly categorized
Virginia
patent,
trict
both the material of which the
product-by-process
2-5 as
claims.
claims
...
plate
dental
is made
and the
that the Eastern
appeal,
argues
Abbott
On
constructing
plate
... must be em
construing
in
Yeomans,
District erred
ployed.”); Merrill v.
94 U.S.
in
2-5 under the rule At-
steps of claims
568,
(1877);
they
product prepared
are not limited to
(1938);
Thermoplastics,
see also Atl.
claims.”).
by the
set forth in the
(discussing
F.2d
839-42
each of these
opportunity
clarify
this
This court takes
cases).
cases,
In
the Supreme
these
Court
scope
product-by-process
en banc the
consistently
noted that
terms that
by adopting
the rule
Atlantic
product in product-by-process
define the
Thermoplastics.
In
claim serve as enforceable limitations.
addition,
binding
case law
Thermoplastics,
this court
Atlantic
courts,
predecessor
court’s
the United
scope
product-by-process
considered
Ap
States Court
Customs and Patent
claim 26
issue: “[t]he
(see
peals
Hughes,
re
produced by
innersole
the method
molded
(CCPA 1974) (acknowledging
patentee
of claim 1.”
and the United Court of Claims but “artificial States alizarines” available States, v. Tri-Wall Containers United 187 in the litigation market the time of the 748, (1969)), 408 F.2d fol Ct.Cl. completely pure varied from almost aliza- lowed the same rule. rine, to combinations alizarine and an- thrapurpurine, pure purpurine contain-
This court’s sister circuits also followed ing 309-10, no alizarine whatsoever. Id. at general defining process rule that the 455. The product S.Ct. defendant’s con- limit product-by-process terms claims. See, Prods., approximately sixty percent tained e.g., Hide-Ite Leather v. Fiber anthra- (1st Cir.1915) (“It F. purpurine. is also a Thus both alizarine and artifi- that, well-recognized although prod rule cial alizarines were known art. by uct has definite characteristics which it Supreme clearly Court articulated apart process, be identified from the scope validity problems some of the still, if in a claim for the it product is not that arise when limitations of described, so but is set forth in the terms ignored: claims are of the process, nothing can be held to product] by [The defendant’s is claimed infringe the claim by which is not made the plaintiff to be the artificial alizarine Paeco, process.”); Applied Inc. v. 4,321, described No. physi- and to be Inc., (3d Moldings, 562 F.2d Cir. cally, chemically, coloring and in proper- 1977) (“A patent granted on a ties similar to that. But what that is is claim describing one process grants no 4,321, except defined No. that it is monopoly as to identical manu of the described in by process.”). Indeed, factured a different 4,321. Therefore, No. unless it is shown this court itself had articulated that rule: 4,321 of No. was fol- reason, “For though product-by- even produce article, lowed the defendant’s process claims are limited and defined or unless it is shown that that article process, patentabil determination of produced by any could not be pro- other ity is based itself.” In re cess, the defendant’s article cannot be (Fed.Cir.1985) Thorpe, identified as the added). (emphasis 4,321. of No. Nothing of the kind Supreme Court long empha has shown. limiting requirement
sized the BASF, the lating to artificial steps in product-by-process claims. Court considered a claimed “[a]rtificial alizarine. Specifically, alizarine, re If the words of the claim are to be construed [*] cover all artificial [*] [*] alizarine, ingredients, whatever its produced from produced from anthracine or its deriva anthracine or its derivatives methods tives either of the methods herein de invented since Graebe and Liebermann scribed, by any or other method which will process, invented the bromine we then produce a like result.” 111 U.S. at a patent have for a composi- or (quoting S.Ct. 455 U.S. Pátent Reissue No. tion of matter which gives no informa- 4,321). RE turn, specification gen tion as to how it is to be identified. erally described a making method for arti Every patent composi- involving ficial alizarine anthracine or its tion matter identify derivatives. Alizarine must it so that had been use for years recognized thousands of can dye, red textile aside the de- from from, traditionally it, scription process making extracted madder root.
Pure alizarine has the chemical formula nothing else can be to infringe held *11 uct-by-process claims. To the extent that by pro- not made that which is
patent Scripps Clinic is inconsistent with this cess. rule, hereby expressly court this overrules added). (emphasis at S.Ct. Id. Scripps Clinic. BASF, con- Supreme Court After importance dissenting opinions The lament the loss emphasize
tinued to
evaluating
infringe-
in
steps
prac-
of a
that has never
in
“right”
existed
See,
claims.
product-by-process
ment
precedent
right
tice or
to assert a
—the
Plummer,
at
120 U.S.
S.Ct.
e.g.,
against
claim
a defen-
product-by-process
(“[W]hatever
may ap-
likeness that
practice
express
dant who does not
between the
pear
limitations of the claim. This court’s en
article
in the
and the
described
way
an
abridges
banc decision
no
inven-
defendants,
identity
their
by the
made
right
product-by-
to stake
tor’s
claims
unless it is shown
not established
terms.
Instead this decision
same
they
by
process.”);
are made
merely restates the rule that the defining
Co.,
Elec.
304 U.S.
58 S.Ct.
Gen.
a claim—in this
limitations of
case
(“[A]
not distin-
patentee who does
in-
terms —are also
terms that show
except
from what is old
guish
his
fringement.
constructive,
reference, express or
question
Thus this court does not
at all
it,
produced
he
can-
process by
product-by-process
whether
claims are le-
monopoly
on the
not secure
gitimate
legiti-
as a matter of form. The
(footnote
produced.”
means
whatever
macy
of this
form was indeed a
omitted)).
century
relevant
the nineteenth
issue
Thus,
Supreme
Court
based
Painter,
parte
when Ex
1891 C.D.
product-
and the treatment of
precedent
(Comm’r
1891),
200-01
Pat.
some later
throughout
years by
by-process claims
cases
before the
were
Commissioner
decisions,
binding
other
court
the PTO and
However, this court need not
Patents.
“process
this court now restates
address that settled issue. The issue here
serve
product-by-process
terms in
claims
only
infringed
whether such a claim is
determining infringe
limitations in
than
by products
by processes
made
other
970 F.2d at
Thermoplastics,
ment.” Atl.
one claimed. This court holds that it
earlier,
holding fol
As noted
this
846-47.
is not.
in In re
lows this court’s clear statement
jurisprudence
of the Court of Cus-
Thorpe
“product by process
claims
Appeals
toms and Patent
court with
—a
process.”
are limited
and defined
in-
virtually
jurisdiction
no
to address
in the
courts
out
defining
reference to its
terms would
ings
uniformly
....
courts
hold that
[T]he
alleged infringer
mean that an
pro-
who
by the claim-
only
product produced
compound
by process
duces
X
Z is still
designated process may
infringe
be held to
liable for infringement. But how would
claim.”)
Co.,
(citing
Gen. Elec.
304 U.S.
the courts ascertain that
in-
alleged
the inventor would invention, his distinctly infringement urge, purposes, claim[ed]” there ¶ § 112 6. 35 U.S.C. nothing would then be to differentiate in- independent claim from dependent Thus, Virginia District of the Eastern *13 all, if 5. After those claims are not bound rule that the correctly applied the recited by process terms but “define” the steps limit the process compound, basic cefdinir then each of the analysis. any infringement claims 2-5 for
thing, claims recite the same over and over Though that again. argues Abbott it by”
3. “obtainable merely give meaning intends to to the case, plain In this Abbott’s lan “obtainable,” it word instead seeks to have by” that “obtainable in guage argument, meaningless this court render the explicit even if optional process, troduces an process applicant limitations that the chose by” limiting introduce “obtained would to define its invention. steps, unavailing. is also The case, analogous an situation to BASF The intrinsic evidence in this case fur- case, above, As noted controls. ther rebuts Abbott’s contention its in BASF considered the Supreme Court claims not limited to those language: claim “Artificial ali following actually by processes obtained recited. zarine, produced from anthracine or its 2 patent, column of the '507 under the by derivatives either of the methods heading title “The Process for Preparing described, by any herein other meth (I),” Crystal Compound A of paten- produce will a like result.” od which tee specific language used to describe the (emphasis 455 U.S. S.Ct. very processes two that are mirrored in added). patentee argued that even claims 2 and 5. '507 col.2 11.13-51. not make arti though the defendant did language open-ended, This is not nor does by ficial alizarine “either of the methods it description constitute mere described,” cap the claim should herein product by reference to the manner in by because of the “or ture made, argues. which it can be as Abbott language. another method” Id. at By drafting incorporate claims and 5 to Supreme S.Ct. 455. The Court refused specific processes, these Abbott made a importance expansive to attach to those place process require- conscious choice to 4,321 by no words: “No. furnishes test product. ments on its claimed If Abbott covers, identify it which coverage had wanted to obtain broader except such crystalline any process cefdinir devoid of result of the describes.” Id. here, limitations, as it seeks to do it could 455. claims 2- S.Ct. Abbott’s (if indeed, ar- simply have done so as it product- like those BASF and like gues, really it is that is the by-process general, claims in do not fur invention, process). heart of the not the any by identify which to nish test crystals But it did not. The of claims crystals except they cefdinir are the simply and 5 are not identifiable other respectively pro claimed result their BASF, by processes than disclosed column per cesses. As Abbott’s ways court must enforce the This capture obtained cannot that a chooses to define its party than terms obtainable other those processes in the claims. invention. explicitly recited prosecution history limiting prod- also does not 2-5 as the asserted claims to contention that “obtain-
support Abbott’s
ucts made
those
steps.
by”
merely
optional
an
set of
able
offers
Summary Judgment
B.
During
definitional
conditions.
Abbott faced obviousness re-
prosecution,
case,
Lupin
In the
the Eastern District
6-9,
jections
application
based on
claims
Virginia granted summary
judgment of
that mirrored
were
claims
2-5,
noninfringement of claims
both literal
very process
limitations of issued
by equivalents,
of claim 1
claims 2-5. The PTO refused to issue the
equivalents. Lupin
in-
SJ Order. Literal
claims until
can-
duplicates
one set
1, i.e.,
fringement
Lupin’s
of claim
whether
in cancelling
celled. Abbott’s action
generic
any
cefdinir
contains
acquiescence
6-9
demonstrates
A,
Crystal
is therefore not a live issue on
*14
PTO’s view
the
elements of
2-5,
appeal.
forAs
claims
the Eastern
parts
claims 2-5 are critical
of those
District noted that “Abbott and Astellas
addition,
claims.
In
in a response to the
have conceded that
infringement
literal
action,
PTO’s office
Abbott chose to differ-
Claims 2-5 cannot be
if
established
reference,
§
Takaya,
entiate a cited
product-by-process analysis
performed
the basis that
processes
Abbott’s claimed
pursuant to Atlantic Thermoplastics,” giv-
reasons,
are different.
ap-
For these
en that
present-
“Abbott and
have
Astellas
plicant’s
wrapper
statement in the file
ed no
Lupin
practicing
evidence that
preparation
“the method of
...
is not con-
process steps
sidered
set forth in Claims 2-5.”
present
the heart of the
invention”
Order,
should
gravitas. Lupin
not be afforded undue
F.Supp.2d
SJ
at 568.
The
limitations
haphaz-
cannot be
Because the Eastern District correctly ap-
ardly jettisoned
infringement analy-
for an
plied the rule from
Thermoplas-
Atlantic
they
sis
important
when
were so
in the
properly
tics and likewise
construed the
patentability analysis.
limiting process
2-5, only
terms in claims
infringement by equivalents
sum,
of claims 1-5
patentee’s
use of the word
remains before this court.
by”
“obtainable” rather
than “obtained
cannot give
pass
escape
it a free
Infringement
analysis under
ambit of the
claiming
equivalents
doctrine of
proceeds ele
doctrine.
that include such ambig-
Claims
ment-by-element;
generalized
showing
language
uous
extremely
should be viewed
of equivalency between the claim as a
narrowly.
If
require,
this court does not
allegedly
whole and the
infringing product
precondition
as a
infringement,
that an
or
is not
in
sufficient to show
infringer actually
accused
use
recited
fringement.
Warner-Jenkinson,
See
process, simply
patentee’s
because of the
29,
(“the
U.S.
identified or and/or IV. of the '334 enable cefdinir monoh- ydrate, Crystal type crystals. B i.e. grant This court reviews the injunction preliminary denial of a for abuse Beyond attempt to reinf Amazon.com, of discretion. Inc. v. Barn encompass Crystal B late the claims esand.noble.com, Inc., 1343, 1350 239 F.3d comparisons mathematical of the based on (Fed.Cir.2001). A district court enter Crystal A peak patterns PXRD injunction a preliminary based on its con B, Crystal Lupin Abbott also asserts that “(1) of four sideration factors: the likeli effectively infringement admitted patentee’s hood of the success on the mer equivalents when it before the claimed (2) its; irreparable injunction harm if the Drug Food and Administration that (3) granted; is not the balance of hard bioequivalent generic cefdinir Ab (4) ships parties; between the bioequiva bott’s product. Omnicef While public Erico v. Corp. interest.” Int’l Vutec lency may be relevant to the function (Fed.Cir. Corp., 516 F.3d 1353-54 test, prong function-way-result bioe 2008) Techs., (quoting PHG LLC v. St. quivalency equivalent infringement Cos., (Fed. Inc., inquiries. Bioequivalency John are different Cir.2006)). regulatory and medical aimed at concern establishing compounds that two are effec generic Sandoz and Teva’s Omnicef tively pharmaceutical pur the same for products, Lupin’s, like are also at least contrast, poses. equivalency pur monohydrate, cefdinir primarily Crystal *16 poses patent infringement requires an Order, B compound. Sandoz PI element-by-element comparison of pat F.Supp.2d at 769. Before the Northern product, requir ent claim and the accused Illinois, parties District to the San- ing only equivalent function but also litigation disputed doz whether Sandoz and equivalent way and result. Different at Teva’s also contained small given product may tributes of a thus be i.e., anhydrate, Crystal of cefdinir amounts bioequivalency relevant to not equiva A, which would fall within the literal scope infringement, lent and vice versa. theAs patent. Working of claim of the '507 Northern in District of Illinois observed primarily from the Eastern District of Vir- case, bioequivalency Sandoz “[i]f construction, ginia’s claim to which the per meant infringement, se no alternative parties to the litigation agreed Sandoz patented to a medicine could ever be of would litigation pur- bind their as well for public during fered to the the life of a motion, poses of preliminary injunction Order, patent.” Sandoz PI 486 F.Supp.2d the Northern District of Illinois denied Thus, relevant, potentially while injunc- a preliminary Abbott’s motion for bioequivalency of an accused tion, finding unlikely that Abbott was with a product produced patent from the prevail on the merits trial. at issue is not in sufficient to establish fringement by equivalents. court detects no abuse of dis This cretion in the Northern District of Illinois’ Crystal equivalent
Because B not an A, injunction Crystal preliminary denial. As de Virgi- the Eastern District of above, properly nia did the '507 granting summary judg- not err scribed 2-5, B, ment of noninfringement Crystal of claims construed to exclude both as to Thus, primarily based on trial court’s discretion infringement. equivalent literal claim con- proper into the Northern of the not delve its administration court need of the clarifications Illinois’ finding that Abbott was District and its struction con- Virginia’s claim District Eastern prod- Sandoz and Teva’s likely to show Illi- District of Northern structions. Crystal A at all. any ucts contained that know succinctly “[w]e concluded: nois be- plaintiffs to the B was known Crystal CONCLUSION Japanese included in the had been cause it Virginia District of correct- The Eastern that the we conclude Thus patent. '199 patent’s the '507 recitation ly construed from the deliberately excluded plaintiffs in each of the asserted “crystalline” A, monohyd- Crystal cefdinir definition A, Crystal as outlined limited to rate, B.” Id. at 775. Crystal scrubbed all specification. Because Abbott of small alleged presence to the As B in Crystal patent’s the '507 references and Teva’s A in Sandoz Crystal amounts present which were specification, per- did not Abbott’s evidence products, foreign application, patent’s parent '507 Illinois. Northern District suade clearly demonstrated its intent to Abbott that decision perceives This court Id. Crystal A. This limit the '507 As court’s discretion. the trial well within was further underscored com- District intent the Northern support, additional such, during prosecution. was no evidence As that there ments made observed anhydrate, cefdinir Crystal trace amounts of B any recapture unable to Abbott is A, prod- and Teva’s Crystal Sandoz i.e. language under the through broad factor in the contributing ucts “could be equivalents. The Eastern Dis- doctrine “if is a small efficacy” that even there Virginia properly therefore con- trict of anhydrate in defen- cefdinir amount of Lupin’s summary judgment cluded do not conclude products, we dants’ infringe did not claims 1-5 cefdinir infringement.” literal Id. cause this could by equivalency. literally or claims 2-5 misstatements these While District of Illinois Similarly, the Northern infringement can law, de minimis because declining its discretion did not abuse U.S.C. infringement, see 35 still be injunction against San- preliminary enter a 271(a); v. SunTiger, Inc. Sci. § see also products. cefdinir doz and Teva’s *17 Funding Group, Res. AFFIRMED (“If (Fed.Cir.1999) merely reads a claim device, enough that is a of an accused part COSTS this court need infringement.”),
for injunction in preliminary that issue a reach party shall bear its own costs. Each trial court broad which affords the context success.” leeway a “likelihood of to discern NEWMAN, Judge, Circuit with whom may court have over- Likewise the district Judges MAYER and LOURIE Circuit efficacy, because the relevance stated from en banc Section join, dissenting limita- no claim patent the '507 contains III.A.2. efficacy. But these mis- relating to tions today acts en banc to overturn The court they harmless because statements were and practice, and century precedent a for the an alternative basis merely formed product a new that is difficult holds that of Illinois’ reasonable Northern District to how it was without reference describe proffered of the evidence assessment made, a new and that is nonetheless injunction mo- preliminary Abbott for protected as product, cannot be noted, unobvious this court sustains tion. As product description if its property rights is aided may be diminished. In so reference to how it was made. Heretofore doing, statute, the court departs from product new whose structure precedent, practice. and change This is as fully readily known or not described could unnecessary flawed, as it is gratuitously patented product be by including affecting inventions past, present, and fu- product description sufficient reference ture. I respectfully dissent. made, it can distinguish how be product products. new from art Pat- DISCUSSION entability was product, determined as a product inventions, For most pro- independent any process reference made, cess which the product was claim, validity and infringement whether or not the is itself a pat- were based on the itself. This invention, entable is not stated in prod- expedient patenting for products whose However, uct claims. variety as the structure fully was not known at the time complexity of invention technology filing application has been increased, have various forms of called necessity.” the “rule of It was claims with terms have been used fair, pragmatic, just, for it attuned circumstances, in specific depending on the practice law and to the realities of nature of the invention.1 The form here at invention. issue relates to product claims for new and Today rejects the court expedient unobvious whose structure is not practice, discards this ruling that all known, fully and for process param- containing process term under the eters are used to aid in defining prod- necessity construed, rule of now must be uct. claiming expedient This has been rec- purposes of infringement, as limited to ognized since least 1891. any use of process term that was used to today The court overturns this expedient assist in defining product. is, That circumstances, for all brooking no excep- such a patented is not prod- as a tion. uct, Acting en banc for the produced, purpose, however it is but is limited court rules that if process by any process which it was term or obtained. This is a new patents descriptive aspect restraint on included in a product new products, particularly today’s complex to aid in distinguishing a prod- new chemical and biological products uct, whose the claim cannot be infringed by the structure analyze difficult to identical unless the same precision. It is a change of law with un- aspect is used in making the prod- accused consequences known patent-based in- uct. The court holds that it is irrelevant novation. whether the known, is new or was irrelevant whether could have court acts sua sponte, without ex- *18 fully been by planation of described policy what structure the is intended to be by served time of the change, application, this without irrelevant consider- ation of the technologies may particular whether the be ad- invention ais new versely by affected elimination of this ex- or is actually process.
pedient, without notice to those whose court adopts simplistic rule, universal Mirabel, 1. by claims, As discussed Eric P. Product- claims with a limita- By-Process Perspective, tion, Claims: A Practical process-derived claims with a (1986), J. Pat. & Soc'y Trademark Off. 3-4 element, structural and claims with the various forms of functional terms. include "true” product-by-process (C) legal arguments facts and are significant thereby targeting a small adequately presented of this deci- in the briefs and inventions. The effect class of record, complex fields decisional on innovation sion significantly by is unknown to the be technology would not aided science advice court, we have had no on oral argument. for My change of law.
consequences this standards, Rule 34 it is clear Applying the much to the court’s is directed as dissent (A) (B) appeal this is not frivolous and as to the substance procedure, dispositive issue has not been authori- decision. court’s decided, tatively currently being for (C) no addressed en banc. There has been
I court, briefing record and no to the this is a case in which the decisional PROCEDURE argu- not be aided oral would has no notice of this given The court no ment. The en banc court has heard action, contrary en banc impending argument, and has neither writ- received Appellate Rules of Procedure and Federal exploration ten nor oral of the diverse contrary oper- to the own Federal Circuit’s long-established aspects claiming of this The en banc has ating procedures. court practice. no briefing argument, no and held received Appellate Federal Rule Procedure 35 although require. the Federal Rules so compliance. has failed of That rule also inventors, innovators, The communities recognizes exceptional nature of en may affected this public who be hearing rehearing, banc or and identifies change opportunity of law have had no warranting the two circumstances such has received no infor- be heard. court procedure: on concerning patents mation the effect 35(a)... Rule An en hearing banc or granted long-es- on this
that were based rehearing ordinarily is not favored practice, no advice what kinds tablished will be ordered unless: lie fallow of inventions now because (1) unprotected. Nor does the court they necessary en banc consideration suspension explain its standards uniformity or maintain secure decisions; judicial process. the court’s or (2) proceeding question involves The Federal Rules have force of importance. exceptional § Federal Rules of law. 28 U.S.C.
Appellate Procedure 34 and 35 are here rehearing is hearing When an en banc or court, that “oral implicated. provides Rule 34 sponte ordered sua whether every must allowed in case” argument be uniformity question of decision or on a specific exceptions hearing unless certain exist: exceptional importance, 34(a)(2) pro- receive rehearing appellate must argu- Rule Oral Standards. cess Rules. set in every ment must allowed case panel judges unless a of three who have agree appropri- I banc that en review is and record unani- examined briefs ate, prece- apparent conflict our mously agrees argument that oral is un- that the dent has existed since 1992. Now necessary any following rea- con- court undertaken resolve the has sons: flict, notice, withholding of public
(A) frivolous; appeal case, the parties even to the to this notice (B) question is of justification. or devoid of dispositive the issue issues decided; there no asser- authoritatively importance, been has been have require by- urgency disqualified. tion of sufficient to recused Additional the passing appellate procedures. standard and oral briefing argument be or- will ruling, breadth of the en banc court’s appropriate. dered as solidity precedent of the now over- the Appeals United States Court the of ruled, importance technologies Circuit, Federal Internal Operating Pro affected, patents and the untold issued cedures at available at http://www.cafc. limbo, placed require now this that are uscourts.gov/pdf/IOPsl22006.pdf. This IOP compliance court’s with Federal Rules 34 has not been followed. No notice was and 35. given, to parties, even court that the recognized that The Federal Circuit has question had ordered this en to be reheard benefit can from the advice those banc; parties nor did the court advise the knowledgeable purposes, in the law and its or the as to public aspects being ad responsibil- the areas of our nation-wide dressed for en banc court decision. The ity. impact Patent law has a direct on acting sponte, sua without notice and with innovation, industry, technological and ad- argument out and opportunity without an vance, and when an ruling may en banc for participation. By bypassing this change affecting law areas of some court’s operating procedure, standard technology and the industries there- based violating well as the Federal of Ap Rules on, routinely sought this court has to be Procedure, pellate deprived the court has informed, curiae, by the parties amici input concerning itself of experience impact of relevant concerns. When precedent, of change advice as to how this sponte change a sua of law transcends the may innovation, of law affect future and of case, parties interests specific guidance existing as to the effect prop to the public, notice interested as well as erty rights. parties, is fundamental to due and process. fair The Federal Circuit’s Inter- II (IOP) Operating nal Procedure was adopted implement principles: these PRECEDENT AND PRACTICE 14.3(c)If sponte IOP the sua petition opinion The court’s does not mention hearing en granted, banc is a committee long-established precedent that it is over- judges appointed by judge, the chief turning. This is simple not a be- conflict normally shall judge include rulings tween isolated of the Federal Cir- poll, who initiated the shall within seven cuit; a change it is practice law and (fourteen working days working days century-old with I roots start decisions. 11) between June 21 September precedent, expedient on a judges transmit vote sheet what to be came called the neces- “rule of will setting who sit en banc an order sity” originated in the recognition, the questions forth to be proposed ad- Office, courts Patent that not all by the court dressed en banc. The clerk products new fully could be described provide shall majority notice that a structure, their due to the state scienti- judges regular service has acted knowledge fic or available tech- analytical § under U.S.C. Fed. R.App. niques. recognized, It also over a 35(a)
P. to order the appeal to heard century ago, sufficient distinction banc, en any indicate questions from art could sometimes parties court wish the and amici to prod- be achieved reference to how the given address. Notice shall be that the court en banc uct shall consist all circuit was made. Thus the courts and judges regular service who exception administrators established the *20 in ample exception, this the claim product in a claim Globe inclusion that permitted Co., F. how the Nail Horse Nail recitation of Co. v. U.S. of sufficient (C.C.D.Mass.1884) made, identifying the product (sustaining validity to aid in was prior art. it from the distinguishing claim to nail claimed directed horse-shoe called loosely “prod- a claim form was manufacture, This process its by reference to form, although term that uct-by-process” infringed the accused finding by it nail situations, n. 1 variety see includes having only a “trivial and unsubstantial legal having consequences. diverse supra, product). from the claimed variation” at issue is that only form here contrast, application the patent where its new and structure which the be made clear that could de- known, readily such that its fully or is not structure, Patent by its Office scribed by as a is aided refer- definition exception not apply. ruled that did it made. Since before ring to how was See, Scheckner, e.g., parte Ex 1903 C.D. accepted way to this has been an (Comm’r Pat.1903) (sustaining 315-16 recognizing products, rejection of claim to an directed etched general rule exception this is an that “specifies certain printing-plate steps ref- products are claimed without that new by etching means of which the is accom- by they which to the erence plished” other claims “define because produced. structure”). plate in of its terms exception discussed This was has expedient This been discussed in Painter, the Commissioner of parte Ex judicial various decisions. In all cases the explaining that when there is enti- Patents expedient issue not been has whether a new patent to a on article of tlement available, availability was for its was not manufacture, by it claimed refer- can be simply appli- the issue challenged; it, when producing to the ence particular cation to the facts. For exam- language “de- lacks other the inventor appeals it ple, at a time when heard direct the invention: fine and discriminate” rulings, from Office the D.C. Cir- Patent no to establish the requires argument It exception” this “only cuit remarked an that as a rule claim for proposition general product claiming, rule of stat- de- article of manufacture should not be ing: producing by fined law It is a well-settled rule hand, when a man article. On other claims for de- right an his to a has made invention producing fined will it, right his to a claim allowed; only exception and the be it, is not to deter- defining be properly in cases to this rule seems to be where English the limitations of the mined involves invention can- an When the case arises that language. except not be used defined thing, manufacture is a new article of In extreme cases of this its creation. invention, thing, and embodies useful character, allowed; product may be properly de- and that article cannot case, especially not this but that and discriminated from art fined appel- the broad claims allowed view of pro- than reference otherwise copending lant in his application.... it, presented a case is producing cess (D.C.Cir. Brown, re F.2d exception an to the which constitutes 1928) added). (emphasis rule. (Comm’r 1891). Patent Ap- of Customs and The Court Pat.
1891 C.D. 200-01 cited, precedent involving peals an ex- discussed earlier The Commissioner *21 1304 plied, in various processes recognized fac- was nonetheless both situations,
tual
summarized that:
by
the
and the
courts
Patent Office. Deci
sions of
Patent
possible
the
Office Board of Ap
Where it is
to define
characteristics,
by
practice
peals
See,
practice.
its
illustrate the
e.g., Ex
clearly
that this should be done.
(Pat.Off.
settled
parte Pfenning,
These
times
inquiries
into the
called a
warranting
facts
claim,
application
exception
supra
see n. 1
repeatedly
demonstrate
—and
that the rule
necessity
ap-
was seldom
ruled that such claims
properly
viewed
*22
justified
necessity
product
full
The court
rule
process,
not
claims.
product,
as
the
scope
where
for the invention at
issue. The
such claims
also disallowed
patents
not novel and unobvious.
that
are con-
itself was
CCPA’s observation
product
claim,
a
confirmed that such
inconsistently
The court
courts can-
strued
other
unobvious
justified
a novel and
for
taken,
my
when
col-
apparently
not be
do
encom
construed as
properly
product,
by
the
To the
leagues,
error
CCPA.
a
claim.
scope
product
the full
passing
inconsistency
contrary,
among
the
courts
Bridgeford,
In re
53
example, in
For
to consolidation.2
eventually
led
(1966),
1182,
the
F.2d
357
679
C.C.P.A.
Brown,
1036,
59
Again
In re
C.C.P.A.
that a new
again explained
court
(1972),
explained
the
F.2d 531
CCPA
459
making it
process
may be defined
claims are
product-by-process
that
way
is no other
describe
if there
claims,
claims,
not
and that
so
stressing that “the invention
product,
be estab-
patentability of
must
not
id.
process,”
and
a
defined
independently
lished
the'
Bridgeford
court relied
(“[I]n
it is
See id. at 535
identified.
scope
product-by-
of the
this view of the
of the
that the claim
spite
fact
recite
patent,
in a related
process claims
limitations, it
only process
patenta-
is the
patenting
unpatentable for double
held
bility of the
not of
product claimed and
per se.”
“product
that
claims
defined
steps which
be estab-
recited
must
prod
that
explained
court
Id. at 680. The
lished.”).
claims are true
uct-by-process
discussing
application
Other decisions
in In
claims,
the suggestion
and overruled
expedient to claims
to com
directed
178,
Freeman,
920, 166F.2d
35 C.C.P.A.
re
Pilking
include
re
plex new
In
(1948),
claims
product-by-process
181
that
ton,
56 C.C.P.A.
F.2d
limita
... on
“dependent]
(“While
(1969)
we are
that
pro
with
satisfied
coextensive
tions”
therefore
anticipate ap
do
Bridgeford,
ception
on sale
continuously by
though
product
the Patent Office
that was
had
lowed
than
and the Courts.
a different
been made
in the claim. The Court of
process stated
approv-
F.2d
1218 (quoting
Hughes,
showed
stated that
evidence
Claims
argument). The court
ingly
Solicitor’s
art
the claimed
“the
the fact that
spite
that “in
reaffirmed
identical,” id. at
only product
structurally
may recite
limitations,
a known
explained
‘it is
not the recited
patented
including
covered
claim and
cannot be
”
col-
Contrary my
process steps.’
Id.
terms in the claim:
statement, Hughes
elimi-
did not
leagues’
It
well established that
claim,
change
its role
nate this form
claimed as made
new
Indeed, the Hughes
claim.
as a
patentable
unless the
itself is
*24
exception
reversed
applied
court
Patent,
Wood-Paper
new. The
90 U.S.
rejection of product-by-pro-
a
the Board’s
(23 Wall.)
596,
566,
(1874),
L.Ed. 31
23
claim, stating:
cess
v.
Anilin
Cochrane
Badische
& Soda
[gen-
that
agree
appellant
We
[“BASF”],
293, 311, 4
Fabrik
111 U.S.
applied
rule should not be
to
eral]
(1984)....
455,
S.Ct.
ples. re F.2d with DNA Cir.1985), transformed transfected explained prod the court sequence according claim 2 or 3 in uct-by-process claims are anticipated when art, allowing manner the host cell to ex- existed in the even if press erythropoietin. pro was made a different My colleagues cess. are mistaken stat Id. at 108. The district court found claim ing Thorpe held that all such claims 4 “ambiguous,” explaining that while claims, are to construed even a new product directed to host cell— —this *25 product when the new and the rule of the words or “transformed transfected” necessity justifies describing this mode of appear a process. to invoke The district Thorpe invention. product the In the was court recognized that' the traditional “[i]n new; developer not a known was color framework, product wholly sep copy for paper systems, carbonless and process.” arate and from a Id. at distinct this court held that the correctly PTO 107. The court that product observed “[a] rejected the claim to “the product of the patent gives patentee the the to right re 1,” process of claim that explaining since strict of product the use and sale the re the was it could old not claimed gardless of how and it was manu whom as a product, process steps whether factured,” while process patentee’s “[a] in are recited the claim. power extends to those Thorpe patented (quot
The facts of
did
made
the
process.”
not concern the
Id.
exception
expedient
ing
Studiengesellschaft
and
States v.
where
United
Kohle,
(D.C.Cir.
prod-
terms
invoked
describe a new
F.2d
670
1127-28
1981)).
court,
complex
uct of
structure.
exception
This
district
The
affirmed
the
impugns
3. The era banc
predecessor's legal
scholarly
court
the CCPA’sex-
Our
and
dis-
law,
perience. Maj.
(stating
op.
1293
the
tinction in the field of
the
and
“virtually
jurisdiction
had
high regard
Congress
CCPA
no
to ad-
in which
inno-
and the
infringement litigation”).
jurisprudence
dress
The CCPAfor
vation communities held
years
many
infringement litigation,
addressed
were
CCPA
a critical foundation
for-
for
appeals
from the
charge
International Trade Com-
mation of the Federal Circuit and its
predecessor
E.g.,
and
reinvigorate
patent system
mission
its
tribunals.
the role of
Comm’n,
Corp.
Sealed Air
Int’l
technological
v.
Trade
service to the nation’s
innova-
(1981) (issues
23,462 (1979)
Cong.
C.C.P.A.
645 F.2d
tion.
See
Rec.
(statement
validity
DeConcini) ("It
infringement);
Pump
and
Fire
Hale
of Sen.
a reflec-
Tokai, Ltd.,
high
Congress
Co. v.
67 C.C.P.A.
tion of
esteem which
has for
(1980) (issues
validity, scope,
sitting
judges
and
the Court of Claims
Orion,
infringement); In
Appeals
re
C.C.P.A.
of Customs and
Court
Patent
(issues
(1934)
jurisdiction
(e)
highly
and
recovering
purified
1.
of claim
method
concentrated VIILC.
turn,
as
1 was
follows:
disputed
that
a
It was not
was
manufacturing
1.
In a method of
purified
and
product,
“highly
new
that
innersole for
shock-absorbing, molded
Factor
clotting
concentrated” blood
VIII: C
footwear, which
insertion in
method
obtained,
been
and that
previously
had not
comprises:
structural identification
Fac-
complete
(a)
an
introducing
expandable, poly-
The
tor
was not available.
defen-
VIILC
mold;
into a
urethane
dant Genentech had made its commercial
(b)
from the mold an in-
recovering
by the
set forth
Factor VIILC not
method
comprises a
nersole which
contoured
using
sample
of the
claim but
composed of a
heel and arch section
“clone” Factor VIII: C
product to
Scripps
substantially open-celled polyurethane
DNA
using recombinant
tech-
protein
material, the
improvement
foam
presented in the
niques.
question
One
comprises:
claim 13
whether claims such
case was
(i)
insert ma-
placing an elastomeric
product pro-
same
infringed by the
were
mold,
into
method,
terial
the insert materi-
or whether
by a different
duced
infiringed only
having greater
shock-absorbing
if
ac-
al
such claims were
being
properties
particularly
pharmaceutical
less resilient
manu-
molded, open-celled polyure-
than the
facturers.
material,
thane foam
and the insert
J.,
(Rich,
Id. at 1280
from
dissenting
denial
having
material
tack
sufficient surface
banc).
rehearing
en
to
placed position
remain
in the
Most trial
recognize
courts continued to
mold on the introduction of the ex-
necessity.
the rule of
For example, in
pandable polyurethane
so
material
as Trustees
University
Columbia
v. Roche
permit
the expandable polyure-
GmbH,
Diagnostics
whether the
was new or known.
adopted
the rule that
decisions of a
necessity,
The court stated that the rule of
panel
precedent
the court are binding
applied
Scripps,
contrary
Su-
subsequent
panels
and until
unless
preme
rulings.
panel
Court
stated
banc.”),
applied
overturned in
Scripps
the decision in
is incorrect.
Scripps ruling, holding that the new cell
A majority of the Federal Circuit declined
limited
which it
banc,
to resolve the conflict
resulting
en
was made.
opinions.
several further
E.g., Atlantic
The PTO also
apply
continued to
Thermoplastics
Faytex Corp.,
Co. v.
necessity.
instructing
rule
examin-
(dissents
(Fed.Cir.1992)
F.2d 1279
of Chief
possible
ers
should whenever
Judge
Rich, Newman,
Judges
Nies and
be described without reference to how
from
Lourie
denial of
en
rehearing
*27
they
made,
were
the PTO continued to
banc).
Judge Rich wrote:
point
exception
out the
that patentability
[T]his whole
unnecessary
excursion was
product
as a
is not foreclosed when inde-
patentee
because the
admitted that
pendent description is not available. The
24,
claim,
claim
the
Manual of
Examining
Patent
Procedure
was
to
process.
limited
the
The claim
(MPEP) instructs the
to
examiner
consider
read: “The
produced
molded innersole
implied by any
the structure
process steps
was,
the method of claim 1.” There
in the claim:
therefore, no
occasion
review the law
implied
The
structure
the
to determine how the claim
be
should
steps should be considered when assess-
pro-
construed....
not
We are
here to
ing
patentability
the
product-by-pro-
vide restatements of the law. Such re-
art,
claims
the
especially
cess
over
statements should not be made without
the
opportunity
product
only
an
where
can
be
parties
for all affected
defined
process steps by
be
from.
the
the prod-
heard
The affected
parties
made,
here are not the vendors of
uct is
the manufacturing
inner soles
where
the
largely
industry,
entire chemical
process steps
expected
be
to im-
would
old article.
a new
It was an
While
characteristics
structural
part distinctive
it
product.
producing
patentable,
was
to the final
for
patented,
could
be
product itself
rev.).
the
(8th ed., July 2008
§ 2113
MPEP
product
it was a
made arti
though
even
at least
practice
the
since
been
This has
time, in
surprised
ficially
I am
the first
contradis
Painter in 1891.
parte
Ex
casual misstatement
being
the en banc court’s
eliminated from the
at
tinction from
product-by-pro-
treatment of
“the
Calling
about
it artificial aliza
madder root.
years by the
the
throughout
claims
cess
it a
composition
rine did not make
new
PTO,”
maj. op. at
statement
matter,
such, by
patentable
contrary to the treatment of
directly
having been
arti
prepared,
reason of its
years by the
throughout
such
time,
from anthra
ficially, for
first
PTO.
alizarine,
cite, if
it was set forth as
insistence that one
banc court’s
en
Wood-Paper
well-known substance.
applied
rule should now
universal
Patent,
[23
23 Wall.
L.Ed.
body
the entire
of decisional
contrary to
(1874) There was
no foun
].
therefore
law,
Supreme Court cases
including the
4,321,
No.
dation for reissue
discuss,
I
by my colleagues. As next
cited
because,
description giv
product,
product
cases the
was
in most of
cited
en,
have
no
for the
could
pat-
and thus was not
not a new
originally.
been taken out
any
product,
or not
as a
whether
entable
311-12,
Every patent composi- for a or vulcanite, plate of hard rubber or or identify so it tion of matter must that teeth, equivalent, holding its for artificial the de- recognized can be aside from substantially or gums, teeth and as de- it, scription process making scribed. held the nothing infringe else can be (12 Otto) Davis, at 102 U.S. 223. The patent pro- which is not made claim in was written the then-standard cess. incorporating description format of 310, 4 Id. at S.Ct. 455. This statement is specification through phrase “sub- rule, general indeed the as stated stantially as described.” This was not a Patent years Commissioner several later product-by-process or product-of-the-pro- However, parte Ex Painter. BASF did all, cess claim for the claim contains no present not for which situation limitation, process simply distinction but created, expedient of necessity was for as description specifica- refers to the stated, the Court the invention was “a Nonetheless, tion. majority the en banc alizarine, process preparing aas appears to state these cases mean time, new prepared substance for the first Supreme requires that the Court that all as the already substance known as pro- claims for whose method alizarine, however, by to be prepared, specification duction is set forth —as process,
new
is to be the
required by
description
and enable-
subject of
patent,
and is
requirement
ment
be infringed
—cannot
preparing the known
alizarine unless that method is used.
308-09,
from
anthraeine.” Id.
S.Ct.
That
Goodyear
what the
Dental
cases said. The Court referred to the
This was not an instance of
prod-
a new
position Goodyear
Dental Vulcanite that
uct
only in
describable
terms of its
patent
all
plates
covered
dental
made of
of manufacture. The BASF decision lends
held,
rubber,
upon
vulcanized
review-
today’s
no
support
en banc rule that
art,
ing
specification
prior
and the
every product claim
pro-
that mentions a
of manufacture was what dis-
always
cess step is
that pro-
restricted to
tinguished
plate
this dental
from
cess,
exception,
expedient,
with no
no
no
plates,
art dental
and concluded: “The in-
preservation
among
of the distinctions
vention, then,
is a
or manufacture
forms
claim
based on the nature of the
made
It
defined manner.
is not a
invention.
alone,
separated
from the
Goodyear
Dental cases
Smith,
(3
by which it is created.”
93 U.S.
Otto)
The en banc court also states that its
at 493. Were the claim not limited
ruling
new
supported by
two
process,
cases relat-
to this
the Court concluded that
ing
to a
use
of vulcanized
would not have
patentable.
been
rubber to form a plate
holding
(holding
den- See id. at 492
that if the
tures,
Goodyear
Smith v.
Dental Vulcanite were for a “mere substitution of vulcanite
Co.,
(3 Otto) 486,
materials,
93 U.S.
its product,” and held this reissue void limiting about a product it how was because claimed a different invention specification, made but to sustain original than in the patent. The Court also validity of the in view of the Brock- patents discussed several other directed to sieper prior art. The decision Plummer produce paper-pulp, boilers used to and to is to any unrelated rule of claim construc- a process bleaching Nothing straw. tion based on whether terms are this case concerns the claim. included in the issue today acting. on which the court is nineteenth-century These do cases why I cannot discern the en banc court relate to en banc court’s new universal Wood-Paper relies Patent case as construction, rule of claim whereby all invalidating Saripps, and court has product claims having process terms are attempted explain. claims, treated as whatever the nature of Sargent product, whatever the need Plummer v. for process descriptors, any other factor court also en banc relies on Plum- that precedent shows to be relevant to the Sargent, mer v. U.S. S.Ct. exception that is here at issue to the use (1887), again L.Ed. 737 provides of and construction such Nor claims. do support my no colleagues’ thesis. This any more recent Court cases. again case practice illustrates Court’s General Electric v. Wabash of reviewing patentee what the stated he forth specification invented set in the in My colleagues also cite General Electric light art. The claim Plum- Co. v. Appliance Corp., Wabash 304 U.S.
1315
(1938),
assuming that definiteness
be
899,
Even
L.Ed.
364,
58 S.Ct.
to
claim
that
imparted
the
is,
of this case
relevance
although the
specification
purport-
the
part of
no
for it
involved
apparent,
not
again,
edly
making
a method of
the
details
claims,
rather
product-by-process
pro-
of the Pacz
product,
description
properties of
that recite the
to the nature
cess is likewise silent as
of
25,
is claim which
typical
A
product.
product.
the filament
lamp filament com-
electric
an
describes
at
899.
Court held
Id.
S.Ct.
a size and
tungsten grains of
posed of
patent
invalid for lack of a “distinct
the fila-
sagging of
prevents
that
shape
invention,
description
definite”
of
ment:
one
court “doubted whether
who
incandescent
A
for electric
25.
filament
he knows to
discovers or invents
devices, composed sub-
lamps or other
it
to
impossible
new will ever find
de-
be
up
and made
stantially
tungsten
of
novelty.”
aspect
scribe some
Id.
comparatively
mainly of a number
inadequacies
in the
Whatever
Pacz
as
size and contour
large grains
such
invention,
description of his
the Court’s
off-
sagging and
prevent substantial
to
capability
optimistic view of scientific
can-
commercially
setting during a normal or
have
all
not be deemed to
barred
recourse
or
lamp
other
life
such
useful
necessity
the rule of
when
is warrant-
to
device.
ed,
ensuing seventy-
or
have
to
voided the
judicial
years of Patent Office and
one
The Court held
Id. at
Court stated
lawby
inappropriate, unsupported
It is
contour as to
as
such size and
grains
“of
contrary
purposes
to the
precedent,
offsetting”
sagging and
prevent substantial
systems, for this court now rule
description
“inadequate
was
as
patented
that such
cannot be
the grains.”
characteristics of
structural
products.
The Court also
criticized the use
claim, stating
such terms were too
My colleagues
rely
also
on some deci-
guidance.
clear
Id.
provide
indefinite to
regional
preceding
of the
circuits
sions
no
899. There was
issue
S.Ct.
formation, announcing that “our
court’s
in the claims were
steps
whether
general
sister circuits also followed the
no
limiting, for there were
regarded as
limit
defining
rule that the
terms
Instead,
process steps
the claims.
claims,”
citing
two
inclu-
implicit
cases,
Court stated
even
and one in 1977.
one decided
process steps could
save
do
en
support
sion of
These cases
banc
claim,
no
description
pro-
opinion,4
and raised
issue
an
because
court’s
necessity.
expedient based on
specification
inadequate:
cess
regional
questions from the
circuit courts.
en banc court
It is curious
observe this
96-1300,
("Direct-
(1980)
extolling
regional
Rep.
circuits
decisions of
See H.R.
at 20
authoritative,
disregards the
while it
decisions
appeals
ing patent
court will have
new
predecessor
court.
courts and of this
of our
removing
these unusu-
the beneficial effect
law
court was created
remove
This
*32
In Hide-Ite Leather Co. v. Fiber Prod
these two
inaptly
addition to
cases
Co.,
(1st
court,
Cir.1915),
regional
ucts
Applied Moldings,
Corp.,
Buono v. Yankee
Dress
Maid
(3d Cir.1977),
(2d Cir.1935) (L.Hand, J.),
in which the court
the
used
Act 1979: Subcomm. Before decisions, regional jettison- two circuit while Improvements Machinery in Judicial ing precedents uniquely quali- of the court Comm, Senate, Judiciary, on the U.S. 96th patent questions fied to address and selected (statement (1979) Cong. 197 Henry of Hon. J. circuits, regional supplant puzzling. to ("What Friendly) group is needed ais absolutely process steps free to use not mean when does lished law product” define this if its “structure is and useful and unob- itself new product is fully complex known or too either vious, as a claimed cannot be analyze,” maj. op. at but eliminate tied the machine that made must be thereby that the inventor ob- premise it. claim, not claim. tains *33 that this exam- emphasized Judge Hand majority, patentee the a can According to the only to situations where ple related using product continue to obtain claims opinion not product new. itself process descriptors, but such product product, to as a be claimed explained for process are treated as claims claims such, is, as be new product the “must applicant would still infringement. machine which the or regardless process of the patentability to of have demonstrate it; upon its it must stand own makes and (independent a of product product new invention, independently of the ma- again process), pat- the while enforcement the it.” Id. This which makes process chine identical against ent an would the view was also CCPA’s to of the infringer’s limited use claims, carried precedent providing descriptor. used For first steps to, binding upon the Federal and forward time, differently are for claims construed Circuit.5 validity infringement. for and Ill has an rule that It been inviolate way for claims are construed same EN BANC THE RULING See, infringement. e.g., for validity and en court precedent, banc Defying Roussel, Amgen Inc. v. Hoechst Marion “the basic rule all situations adopts for (Fed.Cir.2003) Inc., 1313, 314 F.3d 1330 product-by- limit terms (“It axiomatic that is construed claims,” 1293, maj. op. whether at infringement.”); invalidity way for and the same both known, is and wheth- novel n.com, Inc. v. Bar Amazo nesandnoble.com, Inc., not could have er or not new 1343, 1351 239 F.3d structure alone. fully described been (Fed.Cir.2001) (“Because the claims long-accepted ex- The court eliminates issue, patent measure the invention products new whose structure pedient for given interpreted claims must be Scripps fully known. While is validity meaning for of both purposes same is only decision that men- decision is Bard, analyses.”); C.R. infringement overruled,” maj. op. “expressly tioned as Inc., 1340, Systems, 157 F.3d Inc. v. MS many is one of cases Smpps (Fed.Cir.1998) (“Claims in must be now discarded. way determining terpreted the same their infringement as was done to sustain majority’s response to the The en banc Technologies, Inc. v. validity.”); Southwall to that “the inventor is is state dissenters commentary terms is made. 5. There has been extensive See, product-by-process exception is be dis e.g., to Jon S. Saxe & This this class of claim. Levitt, tinguished terminolo Product-by-Process from the use Claims Julian S. being.”); descriptive a state Brian gy as Status in Chemical Patent and Their Current Tomko, Practice, Scripps Federal or Atlantic: The Soc’y S. 42 J. Pat. Off. Office (1960) arts, Scope Product- Squares Over ("Except a claim Circuit in the chemical Off Patents, L.Rev. product's by-Process 60 Brook. must be terms (the (1995) "pared Atlantic decision objective physical and chemical characteris- tics; impos- scope to that of a are unknown or but where these process patent”). glorified may of a express, a claim define sible Co., (Fed. development today’s complex F.3d sci- Cardinal IG Cir.1995) (“Claims ences, simple. not be construed The en banc court’s X, way order obtain their allowance “simple” hypothetical “compound one about way Y,” accused against by process simply a different obtained irrele- Beachcombers, infringers.”); Internation vant to the issues must we resolve. Scien- Products, al, Inc. v. WildeWood Creative know that it often tists easier to show Inc., (Fed.Cir.1994) same, products that two are the than (“We already interpreted have the claims decipher biological their chemical or struc- purposes assessing validity. their ture; bar, example, the ease at claim interpretation The same of course X-ray comparing patterns diffraction infringement applies analysis.”); to the absorption spectra show that the could Scripps v. Clinic & Research Foundation same, although are the ex- their *34 Inc., (Fed. Genentech, 1565, 927 F.2d crystal act structure is undefined. Howev- Cir.1991) (“claims must be construed the er, my colleagues that announce way validity infringe for for same way to establish whether the accused com- ment”); Diagnostics, SmithKline Inc. v. pound is the as the com- patented same Corp., Helena Laboratories by inquiring pound they whether were (Fed.Cir.1988) (“The claims of the '970 prepared Maj. op. the same method. at issue; patent measure the at invention (“[Wjhat analytical 1293-94 tools can con- thus, interpreted the claims must be alleged infringer’s firm that the compound given meaning purposes the same for of inis fact other a infringing, compari- than validity infringement analyses.”); both infringing son the claimed and accused § see also 5A Chisum on Patents 18.01 question processes?”). That has an- many (2007) (“A fundamental law tenet swers, now stated to be irrelevant. that a interpreted claim must be consis While opinion the section this decided tently infringement for purposes and by the en banc court is largely directed to validity.”); § (collecting id. 18.03[2][h] of precedent, implementa- its reversal eases). ruling tion remains with the original As interpreted validity, the claims panel panel. enlarges The en decision expedient necessity obtained under the ruling, banc binding further this court. claims, subject are and are to the The at processes by claims issue state requirements unobviousness, novelty, “obtainable,” crystal which the new form is and all requirements other prod- for new although specification states that other ucts, independent products of how can might panel methods be used. The rules My colleagues be made. hold that these that a capture claim “cannot a are validity, by processes obtained obtainable infringement. claims for Departure from explicitly other than those recited in the rule that forbids such re- deviation maj. op. claims.” finding authority at reason, quires exploration sound and fuller BASF, which I have discussed ante. cursory than the dispensed brush-off My colleagues thus to misapply continue my colleagues. BASF, the Court’s ruling where the agree my repeatedly
I do
Court stated
that the
colleagues that their
BASF,
logic
“simple.” Maj.
in that
was a
op.
product.
at 1294. How-
case
known
ever,
(“It
today’s
simple.
inventions are not
111 U.S. at
S.Ct.
was an old
article.”).
The
past
needs
inventions of the
responded
BASF the Court
future,
present, and more
patentee’s argument
so
to the
that
it was
simple.
public
The
interest
invention
entitled to cover all artificial alizarine
en
to
by observing
appears misjudge
that
The
banc court
by any process,
made
of its
implications
ruling,
the in-
the court
not shown how
patentee
had
making
now
“can be
states that it is
available to
patented products
fringing and
right
freely practice process
an “others the
at
S.Ct.
recognized,” id.
may produce
process]
Z
a
opposite
[a
from the case
different
aspect
pole
at the
bar,
way.” Maj. op.
in better
patentee provided elabo- better
where the
If
indeed
patented and
others can
make
as to how the
rate details
product,
expedient presents
better
this
no
recognized.
forms can be
crystal
accused
impediment. That is
issue of
appli-
that “the
panel
The
also states
right
case.
is the
make the
issue
wrapper
the file
cant’s statement
product, by
change
making process
same
...
preparation
is not con-
‘the method of
change
By now
product.
that does not
present
heart of the
invention’
sidered the
assuring
right,
exclusionary
value
gravitas.”
undue
should not be afforded
of the claim to
new
is lost.
too is an aberration
Maj. op. at 1296. This
necessity
purpose
rule
is to
many
contrary
and is
precedent,
allow inventors of
new
complex
Supreme Court and this
rulings of the
patent scope to which their
obtain the
appli-
to the
gravitas
court that afford due
*35
scope
invention
of
nov-
is entitled —the
the
of
has been invent-
cant’s statement what
invented,
product they
no
no
el
more and
See,
BASF,
111 U.S. at
e.g.,
ed.
majority’s change
less. The
of
simply
law
(“It
very
specifi-
that the
plain
is
S.Ct. 455
as
imposes
legal
unfairness
well
error
95,465,
original patent,
of the
No.
cation
patent-supported
advances.
process
a
invention to be
states the
alizarine,
as a new substance
preparing
not
SUMMARY
time,
the
the
but as
prepared for
first
alizarine,
already
to
Precedent establishes that
the correct
known
substance
however,
claims
recite
by
process,
the
construction of
that
prepared,
be
new
construction,
subject
steps depends,
to
the
of the
like all claim
process is
be
which
No
rule
single
v.
on what has been invented.
Sargent,
Plummer
patent....”);
must
specifica-
fits all inventions. The construer
(quoting
the en banc court’s
as well as the
And there
differing
be
results de-
procedure
they
were reached.
upon
pending
of a
wording
exact
claim
LOURIE,
example,
issue. For
reading
claim
Judge, dissenting
Circuit
by”
from
III.
“when made
might
infringed
en banc Section
A. 2.
when the recited process is used
I respectfully dissent from the
en
court’s
accused,
itas
is situational.
theOn
other
holding
banc
III.
prod-
Section
A.
hand,
reading
by”
a claim
“obtainable
re-
uct-by-process
always require
use
capability,
fers to
it might
require
so
the recited
to be in-
order
use of
infringe.
“Obtained
fringed.
by”
ambiguous. Bright
have
lines
their
I agree that
there is substantial Su-
uses,
judging
should take account of
preme
precedent
Court
that holds that
addition,
differing circumstances.
product-by-process claims require use of
course, in order
any
to sustain
recited
there
be in-
infringement, a patent
prove
owner must
However,
fringement.
many of those
an accused
is the same as
applied overly
cases
broad language to fact
covered
an
If
asserted claim.
involving
situations
old
or used
*36
product
by
reason a
was
pro-
claimed
its
vague language that makes it difficult to
cess
unknown,
its structure was
products
determine whether the
were old
then, if,
infringement
time
is assert-
however,
Clearly,
or new.
when
ed, there still is no means to ascertain
old,
a product-by-process claim cannot
structurally
whether the accused
be interpreted
as a claim to the
claimed,
is the same as that
any
infringe-
by
made
means. The
is old
However,
ment
claim fails.
unpatentable per se.
that should
BASF
fact
an
product.
involved
old
mean that a
See Cochrane v.
new
claimed
Fabrik,
Badische Anilin
preparation
& Soda
U.S.
cannot
be in-
ever
(1884)
4 S.Ct.
dissent CORPORATION, Appellant, EPISTAR
v. TRADE INTERNATIONAL COMMISSION,
Appellee, Lighting Company, Philips Lumileds LLC, Intervenor. 2007-1457.
No. of Appeals, Court United States Federal Circuit.
May