*1 it is not all-inclusive and Assignment is if the remedy would ensue
known what protester were sustained.
protest request only required affirmatively monetary minimal in order to relief judicial fashioning “mootness.” The
avoid relief, protest should appropriate
sustained, It is not cor- is not before us. cannot be protest to rule that
rect at all.
made poten- of mootness has
Today’s ruling consequences government
tially broad losing if
contracting, for it holds that insolvency while its pressed into
bidder is right protest
protest pending, disappears. award This is not
wrongful law, poli- legislative and it subverts
correct
cy. respectfully I dissent. LABORATORIES, INC., For-
FOREST Ltd., Holding, and H.
est Laboratories a/s, Plaintiffs-Appellees,
Lundbeck PHARMACEUTICALS, INC. and
IVAX
Cipla, Ltd., Defendants-Appellants.
No. 2007-1059. Appeals, States Court of
United
Federal Circuit.
Sept. 2007.
Rehearing Denied Oct. 2007. *2 Desmarais,
John M. Kirkland & Ellis LLP, York, NY, argued plain- of New for tiffs-appellees. With him on the brief Armenio, Flatt- were Peter J. Gerald J. mann, Jr., Scordino, A. Anne Ellen S. Toker.
Henry Dinger, Proctor C. Goodwin LLP, Boston, MA, argued for defen- of the '712 patent With him on the brief claims are dants-appellants. Lynch. counsel on the infringed by
was Francis C. Of invalid the manu- and/or Ward, Jeffrey facture, use, and Thomas P. brief were S. products sale LLP, Michael Best & Friedrich Heneghan, approval sought. Cipla which is the *3 Madison, of WI. for supplier intended of EO Ivax and con- tributed information for the of the LOURIE, Judge, Before Circuit September ANDA. Forest filed suit on FRIEDMAN, Judge, Senior Circuit and 2003, alleging that Ivax’s filing of the SCHALL, Judge. Circuit infringed patent ANDA the '712 under 35 271(e)(2)(A).1 § Ivax filed its an- U.S.C. by for the court filed Circuit Opinion 15, 2003, in- denying swer on October concurring as to Judge Opinion LOURIE. fringement and counterclaiming for inval- through dissenting I IVA and as to parts idity patent. of the '712 Forest later by part Judge PV.Bfiled Circuit SCHALL. complaint amended its to add as a LOURIE, Judge. Circuit 27,May on 2004. defendant (“Ivax”) Pharmaceuticals, Inc. and patent August The '712 issued on (“Cipla”) from the order Cipla, appeal Ltd. relates, alia, 1994 and inter to a substan- States District Court for the United (+ )-enantiomer tially pure of entering judgment District of Delaware (also “escitalopram”) referred to as and validity upholding the of United States acid nontoxic additional salts thereof. (“the 34,712 patent”) Reissue Patent '712 compounds Stereoisomers are that con- Laboratories, Inc., of Forest For- favor tain the same constituent atoms and the Ltd., H. Holding, est Laboratories and bonding same between those atoms but “Forest”) (collectively Lundbeck A/S En- spatial arrangements. have different infringing from enjoining antiomers are stereoisomers that are non- patent. the '712 affirm the district an- superimposable images mirror of one validity entry judgment court’s of on accordingly Enantiomers exhibit other. entry injunction of an as to both Ivax optical activity; different the enantiomer Cipla, modify injunction we but plane polarized light that rotates a of escitalopram oxalate. apply (+)enan- is the the clockwise direction BACKGROUND tiomer; the enantiomer rotates plane polarized light of the counter- Drug Appli- Ivax filed Abbreviated New (-)-enantiomer. direction is the clockwise (“the ANDA”) cation 76-765 at the Food as may designated Enantiomers also be Administration, pursuant Drug the S-enantiomer and the R-enantiomer (§ U.S.C. of Federal 856® 505© relating according to a different criterion Food, Act), Drug, ap- Cosmetic to the location of the chiral centers. proval generic containing tablets market (+ )-enantiom- citalopram, the case of 5, 10, escitalopram milligrams or 20 (“EO”). A mixture of certified, er also the S-enantiomer. pur- ANDA oxalate The two 355(j)(2)(A)(vii)(IV), equal amounts of enantiomers suant to U.S.C. 271(e)(2)(A) approval to obtain provides: of such submission is 1. 35 U.S.C. engage the commercial such Act to under It be an act of to submit shall manufacture, use, drug veter- 505(j) or sale of application section under Food, Drug, patent and Cosmetic Act or inary biological product Federal claimed in a 505(b)(2) in section of such Act patent described claimed in a or the use of which is for a claimed in a or the use expiration of such before purpose patent if the which is claimed in a racemate, is invalid as prove mixture or a a racemic called anticipated. Specifically, enantiomers from the court found separating the two resolving the is referred to as that an article Donald F. Smith a racemate (“Smith”) also owned the now compound. Stereoselectivity Forest entitled 4,136,193 on the ra- expired U.S. Patent Tissue and Uptake Serotonin in Brain Patent cemic form of and U.S. Topography Blood Platelets: The 4,650,884 a method for mak- (“Smith that claims refer- Uptake Serotonin Area an interme- ing citalopram using racemic ence”) claim 1 of the anticipate did not 1,4 racemic diate because it did not disclose —diol. “substantially pure” eseitalopram as EO, form which is the oxalate salt *4 claimed in claim 1 and it did not enable a compounds en- eseitalopram, is one of the ordinary in person having skill the art to compassed by pat- the claims of the '712 The court compound. obtain found antidepressant by It virtue of ent. reuptake High Liquid inhibi- that chiral Performance
being a selective serotonin Chro- (“HPLC”) in ingredient relatively tor and is the active Forest’s matography Lexapro® drug. branded Forest has al- unpredictable technique new and at the leged Cipla infringed that Ivax and claims of the and that time invention Smith had 1, 3, 5, 7, patent by 9 and 11 of the '712 worked with the founder of the field of Independent the ANDA. claim of separate chiral HPLC to the enantiomers patent '712 as follows: the reads citalopram near the time of the inven- substantially A compound selected from tion, but had failed in his efforts. The pure (+)-l-(3-Dimethylaminopropyl)- court also found that team of chemists at l-(4’-fluorophenyl)-l,3-dihydroisoben- unsuccessfully attempted Lundbeck had zofuran-5-carbonitrile non-toxic citalopram chiral to resolve for use HPLC acid addition salts thereof. years Danishefsky, and that Dr. For- two Dependent col.10 '712 11.31-34. chemistry expert, est’s medicinal had un- preparing claim recites method of the successfully compounds tried resolve by1 compound cyclizing of claim an inter- in with HPLC the mid-1980’s. The court diol. mediate also found that an '712 inventor the patent, Bogeso, Dr. had conducted numer- parties stipulated specific to a claim experiments attempting ous to resolve ra- primary disputed construction for the term and, in '712 patent, citalopram through the on that cemic the method of based agreement, parties stipulated formation, further the diasteriomeric had salt but also proposed products that the included in the Finally, failed. the court found that Dr. 1, 3, 5, 7, infringe
ANDA claims and 9 of Bogeso only attempted to resolve citalo- proposed pro- the '712 and that the intermediate, pram using a diol as recited making products infringes cess for those patent, in claim 11 of the '712 as a last Thus, claim 11. the district court was resort of skill in art others the required to reach a determination with similarly would have hesitated because counterclaims, respect including possibility there was a real the re- asserting those that the claims are invalid solved intermediate would re-racemize obviousness, anticipation and that during attempt it from convert they improperly through were broadened diol intermediate enantiomer to the de- reissue. Thus, citalopram sired enantiomer. trial, attempting separate court found that After a bench the district court 13, 2006, July the enantiomers of based on issued its decision on con- cluding ordinary that Ivax and had failed to in knowledge of one skill process specification, in the required experi- scription have undue the art would change the Smith reference this amounted to correction of a mentation and words, not enabled. typographical was therefore error. In other court found that the mistake would have Next, concluded that the district court ordinary been clear to one of skill prove by clear had failed to reviewing art therefore any convincing evidence change scope that it did not constitute a were asserted claims of the original from the claim. that one of ordi- obvious. The court found art at the time of the nary skill judgment The court entered accor- generally have been moti- invention would opinion dance with its on November develop compounds vated to new rather enjoined 2006 and at the same time both unpredict- than undertake the difficult and mak- commercially “from resolving able task of a known racemate. ing, using, offering to or selling sell within person The court further found that States, importing into the United racem- attempting to resolve any products infringe United States ic would have had no reason- patent, including escitalopram *5 for expectation able of success reasons products oxalate referred to in the Abbre- respect with to similar to those discussed Drug Application viated New No. 76-765 enablement of the Smith reference. With until time '712 patent expires.” such as the claim 11 respect to the method of Cipla timely appealed. Ivax and We have that none of patent, '712 the court found jurisdiction pursuant to 28 U.S.C. upon by the articles relied Ivax and 1295(a)(1). particular types described the of reactions (viz., a serving claimed “a Mosher ester as DISCUSSION a leaving group ring for a closure of Diol Anticipation I. Intermediate,” enantioconserving ring “an appeal, Cipla argue On tertiary a containing closure of a diol clearly anticipates the Smith reference tetrahydrofuran,” amine to form a or “an claim 1 of the '712 because it dis- enantioconserving cyclization reaction of efficacy analyzes cusses and of various tertiary convert a type needed to that one predicts enantiomers and any enantiomerically pure Diol amine like ( )- potent will be more substantially pure citalopram into + enantiomer Intermediate court also found that inhibitor than the citalopram”). reuptake as a serotonin secondary argue considerations of commercial further other. Ivax success, results, unexpected copying in the art would have ordinary one of validity of the supported others to use at the time of the invention known claims. to resolve ci- diasteriomeric salt formation person of skill in talopram. Specifically, addition,
In
court found that
district
the method de-
the art would have used
'712
was not invalid
claim of the
reference to resolve
scribed
the Wilen
broadening during reis-
impermissible
for
diol into its enan-
the racemic intermediate
During
proceeding
sue.
the reissue
in the Jacobus
tiomers and the method
in the '712
claim was
resulted
(Williamson
synthesis) to
ether
reference
converting
claim a method of
corrected to
(by cyclizing
enantiomer
(+
convert the diol
a(-)-diol
)-citalopram,
intermediate
(+
)-diol
ring)
)-citalopram.
a(
the ether
+
intermediate
using
rather
than
ability to
Bogeso’s
add that Dr.
claim. The
original patent
as shown in the
try after
citalopram on his first
that,
specific de-
resolve
given
found
court
is fur-
with Forest that the dis
starting with the diol intermediate
compelling
findings relating
evidence that
routine
trict court’s factual
ther
separate
experimentation
required
was
of the Smith
enablement
reference are not
erroneous, and,
clearly
upon
the enantiomers.
based
those
find no
findings, we
error
the district
argues
Forest
response,
court’s conclusion that the Smith reference
“sub-
Smith reference does
disclose
(+ )-citalo-
respect
is not
with
enabled
(+
stantially pure”
)-citalopram. Forest
pram.
pharma
The Smith reference is a
testimony
argues
also
that the
ex-
cology paper,
paper.
not a chemical
It
failures of Dr.
perts
repeated
and the
describes the effects of various enantiom-
Bogeso
citalopram
to resolve
others
(not
(+ )-
drugs
particular
including
ers of
support
into its enantiomers
the district
citalopram)
uptake
on the
of serotonin in
court’s determination that the Smith refer-
platelets.
brain
It mentions
tissue and/or
(+ )-citalopram.
ence was not enabled for
(“also
interest”)
racemic
Forest also states that the court
cor-
structure,
predicts,
shows its
but
incorrect
person
rect to conclude that a
(the (-)-enan-
ly, that
the R-enantiomer
difficulty
skill would have viewed the
citalopram,
tiomer
not the one claimed
resolving the diol intermediate rather than
patent)
should be far more
significant
as
and deter-
itself
potent
reuptake
as
serotonin
inhibitor.
addition,
argues
rent.
that even
Forest
encompass
Because
racemate does
person
if a
of skill in the art were to
enantiomers,
two
it in effect does state
diol,
using
consider
Wilen
Ja-
)-enantiomer
a(
there is
+
of citalo-
compounds
cobus references do not involve
pram, but it does not tell how to
it.
obtain
with structures similar
to the cital-
enough
*6
A
enabling
reference that
is not
is not
opram diol
that a person
intermediate so
Pharm.,
anticipating.
Mayo
Elan
Inc. v.
ordinary
rely upon
of
skill would
them to
Research,
Found. For Med. Educ. &
predict
a
346
the results of
reaction with that
(Fed.Cir.2003).
1051,
F.3d
1054
specifically,
ar-
compound. More
Forest
reference,
a
gues
cy-
pharmacology paper,
that neither
a
Smith
as
reference discloses
clizing
involving compound,
preparation
reaction
a
like
thus does not enable the
(-t-)-enantiomer
diol,
citalopram
citalopram.
that has a resident
of
tertiary
benzylic
amine
aor
alcohol.
Ivax and
acknowledge that
reference
Smith
itself does not teach one
Anticipation
question
is a
of fact
(
)-citalo-
of
+
ordinary skill how to make
that we
following
review for clear error
pram,
arguments
but their
that
it
en-
Amgen
bench trial.
Inc. v.
Mar
Hoechst
by
largely
abled
other references are
Roussel, Inc.,
1293,
ion
457 F.3d
1304
recounting
testimony
favorable to
(Fed.Cir.2006).
“Under the clear error
theory
their
of the case without explana-
standard,
findings
court’s
will not be
why
tion as to
we should have a definite
overturned
the absence of a
and
definite
and firm
conviction
mistakes were
firm conviction that a mistake has been
made
the district court in its fact-find-
Labs.,
Impax
made.”
Inc. v. Aventis
words,
ing.
they
Inc.,
(Fed.Cir.
other
do not inform us
1366,
Pharm.
468 F.3d
1375
2006)
why
omitted).
the district court was not entitled to
(quotation
“Whether a
rely on the evidence
art
favorable to Forest or
prior
enabling
ques
reference is
is a
tion of law
demonstrate that the evidence favorable to
upon underlying
based
factual
heavily
them
findings.”
(quoting
outweighed
Id. at 1382
Minn.
the evidence fa-
Inc.,
Mining Mfg.
Chemque,
&
Co. v.
303 vorable to Forest. Such evidence includes
(Fed.Cir.2002)).
F.3d
of
failures
various scientists to resolve
having
potency
twice the
of racemic
pram
Given Ivax
as recited above.
the detailed
Cipla’s failure to disturb
citalopram.
argues
Forest also
findings underlying
thorough factual
court
entitled to credit evi-
district
decision, we
no
court’s
see
the district
person
ordinary
that a
of
skill in the
dence
refer-
finding
in the
Smith
error
easily
not
the diol
art would
have turned to
ordinary
of
skill
not enable one
ence does
ra-
attempt
intermediate to
resolution of
(+
that the
)-citalopram and hence
to make
un-
cemic
both because of the
claims
anticipate
does not
Smith reference
certainty involved and because
Wilen
(+ )-citalopram.
compounds
complex
describe
Jacobus
less
necessary
than those
here to resolve the
II. Obviousness
(-)-
diol intermediate and then convert
(+)-citalo-
argue escitalopram.
diol enantiomer to
racemic cital-
light
obvious
of
pram was
techniques
descriptions
opram
law,
question
“Obviousness is
from
separate
enantiomers
available
novo,
underlying
de
upon
reviewed
based
Further,
they argue that
their racemates.
questions which are reviewed for
factual
in the art that one
general expectation
trial.”
following
clear error
bench
than the
potent
would be more
enantiomer
Enter.,
Fisher-Price,
Leapfrog
Inc. v.
person
reason for a
of ordi-
provided
other
(Fed.Cir.2007)
(quot
485 F.3d
nary
in the art to isolate the enan-
skill
Labs., Inc.,
Corp. Mylan
ing Alza
For reasons similar to those dis-
tiomers.
(Fed.Cir.2006)).
1286, 1289
F.3d
respect
argument
to their
cussed with
enabled,
reference was
Ivax
the Smith
that the dis
with Forest
person
contend that a
key
findings underly
trict court’s
factual
had a reason-
in the art would have
are
ing its conclusions on obviousness
expectation
separate
able
that one could
erroneous, and,
clearly
upon
based
those
citalopram.
the enantiomers
findings, we find no error
the court’s
argue
Lexapro’s®
commer-
Cipla also
that the asserted claims of the
conclusion
market-
aggressive
cial
due to
success was
are not invalid for obviousness.
any alleged superiority
than
ing rather
*7
arguments
anticipation,
their
on
As with
not
to alternatives and that it did
the
mainly emphasize the evi
Cipla
Ivax and
unexpectedly superior properties.
possess
that
is favorable to their desired
dence
3, 5,
also
that claims
argue
addressing the evidence
outcome without
7,
variations
represent only
and 9
obvious
latter includes
favorable to Forest. The
1
no elements that are not
on claim with
others to
failure of the inventors and
the
that
chemistry
in medicinal
standard
experi
without undue
resolve
way of
represents
claim 11
the obvious
testimony
Forest’s
and the
mentation
light
in
of the teach-
resolving citalopram
applied
court
the
experts. The district
references.
ing of the Wilen
Jacobus
thorough
a
factors to conduct
Graham
any pri-
response,
argues
Forest
evidence, and we find no
analysis of the
ci-
ma facie obviousness based on racemic
law.
no error of
clear error on facts and
rebutted
the evidence
talopram was
Co.,
1,
Deere
383 U.S.
See Graham John
demonstrating
difficulty
separating
the
(1966).
684,
1270 Broadening necessarily III. clerical does not Reissue scope the of the broaden claims and so argue that claim 11 of Ivax and patent does not render the invalid. The patent repre- it is invalid because question change before us is whether the original claim 11. broadening sents application in the reissue effected here They change in argue optical the the scope merely broadened the of claim 11 or in sign rotation of the diol intermediate original clarified or corrected the claim. during clearly claim 11 reissue was broadening of the claim because the claim Comparison scope of the of the a process beginning now covers with a with origi reissue claims the claims of the different enantiomer. also patent nal is a matter of claim construc argue typographical may that a error tion, it performed perspec from the broadening typo- nonetheless be and that having ordinary tive of one skill in the art. graphical error must be evident Instruments, See Pannu v. Storz general public public in order to serve the 1366, (Fed.Cir.2001); F.3d Phillips v. patents. response, notice function of (Fed.Cir. Corp., AWH 415 F.3d argues Forest that the district court cor- 2005) (en banc). Whether claims of rectly applica- determined that the reissue patent reissue violate 35 U.S.C. 251 is a typographical tion corrected a error that question of law that we review de novo readily apparent to one of underlying based on facts reviewed for in reviewing patent the art Medtronic, clear error. Inc. v. Guidant any therefore did not in in change result (Fed.Cir.2006). Corp., 465 F.3d the scope of the with Forest The reissue statute reads as follows: change optical rotation sign for the is, any patent through Whenever error diol intermediate claim 11 of the '712 any deceptive intention, without deemed patent scope did not broaden the wholly invalid, or partly inoperative or patent specification claim. The supports, by reason of ... the patentee claiming compels, even this conclusion. In Reac more or than right less he had a to claim I, process begins tion Scheme with a the Director shall ... racemic mixture of the diol intermediate. patent reissue the for the invention dis- See '712 original patent diagram closed ... for the col.5 11.41-42.The unexpired part origi- of the term of the I Reaction Scheme reinforces that con patent.... nal No reissued shall clusion it because includes a notation next granted enlarging scope diagram of the diol intermediate original patent ap- claims unless “(+) (-).” (em reads ’712 plied years for within two from the *8 added). phasis patent The then describes grant original of the sequence pro reaction in results 35 U.S.C. 251. duction of “the ester as a diastereomeric at mixture.” Id. col.5 11.47-48.It is the patent The '712 reissue resulted (of diastereomeric an mixture of ester from an application filed more than two monoalcohol) subjected is then years grant original pat after the of the produce an enantiomerically HPLC ent, and the patent claims of reissue filed pure compound that can be converted into they after that date are if enlarge invalid (+ )-citalopram the desired product. end scope the of original the claims. See 35 282; Further, Quantum by Id. at col.5 11.47-59. U.S.C. as found Corp. v. Rodime PLC, (Fed.Cir.1995). court, 65 F.3d the district because Reaction However, a in change application a reissue I begins Scheme with the racemate of the ar- intermediate, infringement. Ivax and further ambiguous the is diol by of the diol inter- gue injunction granted enantiomer the the as to which ( )-cital- + actually is converted mediate in holding court violates our Inter- district opram. Corp. Corp., v. IXYS national Rectifier (Fed.Cir.2004). 1312, 1316 For- 383 F.3d contrast, of Re- description while the injunction the is suffi- responds est with the begins II also action Scheme intermediate, ciently narrowly because of the it is the defined the diol racemate of itself that is resolved of infringement stipulation parties diol intermediate the product enantiomerically pure produce an argues the detailed record. Forest also de- at col.6 11.8-33. The compound: Id. will manufacture and because using describes specifically also scription in import products the EO described the ( )ci- (-)-diol + produce the intermediate approved, Cipla may proper- ANDA if it is 11.29-42. Further Id. at col.6 talopram. enjoined infringe- of ly be for inducement diagram the again provided is support ment. II, includes a which of Reaction Scheme “(-) (+)” to the reads next notation that Scope A. Products of citalopram. of diagram structural scope with the We do not added). Thus, the enan- patent (emphasis injunction that includes the district court’s product for the end labeling tiomeric oxalate. products escitalopram other than starting that of the com- reversed from of review for the ‘(Although the standard and the plain reading this pound. Given scope injunction of an issuance and testimony supporting expert additional discretion, the terms of abuse of whether court, we upon by the district also relied of Fed injunction fulfill the mandates finding court’s no error in the district see 65(d) Procedure is a eral Rule of Civil in the art person that a de question of law that this court reviews would find the error reviewing Vutek, USA, Ltd. v. Signtech novo.” relating optical sign to the in claim (Fed.Cir.1999). 174 F.3d intermediately apparent. The dia- the diol Rectifier, we held that “the International II makes clear of Reaction Scheme gram (-)-diol are injunction may prohibit that is converted to only that it is the acts [an] and that the correction (+)-eitalopram adjudi patent by of the corresponds claim to the disclosure infringement by [products] and cated agree that We therefore specification. eolorably than differ [products] not more sign during reis- change optical adjudicated [products]. 383 from the ent change of claim represent sue does with comply In order to F.3d at 1316. the claim merely a correction of scope, but 65(d), explicitly injunction should Rule with the disclosure to be consistent acts.” specific those proscribe specification. Here, covers a described beyond those range products Injunction Scope IV. statute, 35 U.S.C. ANDA. The language Cipla argue that 271(e)(4)(B), “injunctive provides overly in extend- injunction is broad infringer granted against may relief infringe the '712 *9 “any ing products manufacture, the commercial prevent Also, that the artifi- they arg-ue patent.” use, sell, within the United or sale offer by created 35 infringement act of cial the United into importation or States 271(e)(2)(A) and that is narrow U.S.C. Thus, while drug.” approved of an States to Ivax for of information Cipla’s provision extend to the injunction may properly not an act of of the ANDA is filing “approved drag,” only it should not extend to it pursuing approval, as is FDA products by the remainder of the covered commercially manufacturing selling injunction The is therefore However, infringing product. just as Ivax language “any prod- modified to delete the for, will be liable being hence is en- infringe ucts that the '712 patent, includ- from, joined exploitation the commercial of ing.” escitalopram when it approved by during FDA and life of so Cipla B. Inclusion of enjoined. Cipla They part- should are However, inap- we find that it was not Cipla contributing ners. would be to the propriate the district court to include Ivax, infringement by injunction so the Cipla injunction. within the scope of the partners. should cover both It is true 271(e)(2)may support Section an action for 271(e)(2) that, states, § as the dissent de- infringement. Allergan, induced Inc. v. fines Ivax’s of its ANDA as an in- Labs., Inc., Alcon 324 F.3d fringement, Cipla did not file the (Fed.Cir.2003). “The difference in ANDA; however, question when the of an analysis infringement of a traditional injunction against activity commercial claim infringement claim of under 271(e)(2) arises, section Cipla culpable, is the timeframe under is as and hence enti- which infringement the elements of are enjoined, tled to be as Ivax. inquiry
considered.” Id. An into induced party focuses on the accused CONCLUSION prime of inducement as the mover chain leading infringement. of events stated, For the reasons affirm we Here, we if Cipla ap- do not know first grant district court’s judgment of of no versa, proached Ivax or plan vice but the invalidity of the '712 entry and the manufacture, market, import, and sell injunction, herein, as modified as to both products the EO described in the ANDA Ivax pursuant stipulation to the venture, was undoubtedly cooperative infringement. was to manufacture and sell infringing products EO to Ivax for resale AFFIRMED in the United States. Under the stan- dards for inducement apply which we to 35 SCHALL, Circuit Judge, dissenting-in- 271(b), U.S.C. has ac- therefore part.
tively induced the acts of Ivax that will constitute direct infringement upon ap- (i) join I opinion the court’s insofar as it proval ANDA, and it was thus not judgment non-invalidity affirms the inappropriate for the district court to in- (ii) and modifies the scope clude Cipla injunc- within the scope of the injunction issued the district tion. However, court. I respectfully dissent dissent asserts from opinion the court’s insofar as it af- 271(e)(1) exempts Cipla being from en firms entry the district court’s an in- joined with Ivax. disagree. Cipla junction Cipla. as to information, providing provide and will Ivax filed its ANDA seeking approval to material, that Ivax will use to FDA obtain generic containing market tablets escitalo- approval. Up point, to that there is indeed Labs., And, fact, pram no oxalate. infringement. See Forest Inc. v. Ivax is not currently Pharms., infringement, liable for long as F.Supp.2d
1273 (D.Del.2006). 271(e)(2), statutory § Congress employ Under the frame- chose to by Congress: set forth work infringement clause shall be an act of “[i]t to plain language submit.” The infringement It shall be an act of 271(e)(2) § compels thus the conclusion submit— that an infringement may action for lie (A) 505(j) an under section application based upon filing By of an ANDA. Food, Drug, of the Federal Cosmet- ANDA, filing its Ivax committed an act 505(b)(2) in ic Act or described section constituting infringement under in a drug such Act for a claimed 271(e)(2) and, § infringer, as an prop- was in or the use of which is claimed 271(e)(4)(B). erly enjoined § under patent, or Cipla provided information to Ivax that (B) application an under section 512 of ANDA, included and if the 4, such Act or under the Act of March approved, ANDA were Cipla would manu- 151-158) (21 drug for a 1913 U.S.C. or escitalopram facture the oxalate used in veterinary biological product which is Forest, proposed generic drugs. primarily using manufactured re- F.Supp.2d at In 484. contrast to what DNA, RNA, hy- combinant recombinant case, Cipla’s IVAX did this involve- technology, processes bridoma or other to providing ment—limited information to involving specific genetic manipu- site IVAX that was included in the submission techniques lation and which is claimed activity ANDA—seems akin to the a patent or the use of which is claimed (e)(1) protected by paragraph of the stat- in a ute, provides which that: if purpose of such submission is to It shall not be an act approval infringement obtain under such Act to en- manufacture, make, use, sell, gage the commercial offer to or sell within the use, veterinary or sale of a or import United States or into the United biological product claimed in a or patented solely States a ... invention the use of which is claimed in a reasonably for uses related the devel- expiration before the of such opment and submission of information regulates under a Federal law which 271(e)(2). terms, By 35 U.S.C. manufacture, use, drugs or sale of or infringement statute the act of limits veterinary biological products. an ANDA At application. 271(e)(4)(B) time, pro- same 35 U.S.C. 271(e)(1). Supreme U.S.C. “injunctive may grant- vides that relief 271(e)(l)’s “§ Court has stated ex- against infringer prevent ed emption infringement from extends to all manufacture, use, sell, commercial offer to patented uses of inventions that are rea- or impor- sale within the United States or sonably development related to the ap- tation into the United States of an any submission of information under the proved drug veterinary biological prod- Food, Drug, and Cosmetic [Federal Act].” added). (Emphasis uct.” I, Integra Merck KGaA Lifesciences Ltd., 193, 202, 545 U.S. 125 S.Ct. statute, In interpreting presume we (2005). short, Congress L.Ed.2d 160 Congress give intended to their words made it an act of to file an infringement ordinary meanings. Asgrow Seed Co. v. ANDA,
Winterboer, 179, 187, exempted from but 513 U.S. 115 S.Ct. (1995). reasonably development 130 L.Ed.2d acts related to *11 opinion that affirms ANDA, part of the court’s as those of filing of an such enjoining Cipla. court’s action the district Cipla here. inappropriate In that it was not holding with- to include
for the district court injunction, the court scope
in the Labs., Inc. v. Alcon Allergan, on
relies (Fed.Cir.2003),
Inc.,
for the
proposition Maj. infringement.
an action for induced is distin- Allergan at 1272. I think
op. Allergan, In we
guishable on its facts. 271(e)(2) § general
held as a matter in-
may support an action for induced However, Allergan fringement.1 IN TECHNOLOGIES AUTOMOTIVE that submitted party defendant was the TERNATIONAL, INC., Plaintiff/Counterclaim (“[S]ummary at the ANDA. 324 F.3d t-Appella Defendan non-infringement under sec- judgment of nt, 271(e)(2)[ inappropriate where the ] tion plaintiff can demonstrate the existence of respect fact with genuine issue of material AMERICA, INC., BMW OF NORTH CK claim that the ANDA will to the filer Electronics, Incorporated, Tem Conti infringement patent upon ap- induce of its Microelectronic, GmbH, ic and Temic added)). proval (emphasis of the ANDA.” America, Automotive of North Incor words, presented In other the court was Defendants, porated, 271(e)(2) § question
with the of whether ANDA may support an action where the if infringement
filer would induce DaimlerChrysler Corporation, Mo Ford approved. ANDA were Company, Company Honda Motor tor Allergan sup- I am unable Limited, American Honda Motor that, alone, ports proposition standing Hyundai Company, Incorporated, Mo (providing what did here information Company, Hyundai Amer tor Motor ANDA) in the of an can form used ica, America, Mazda Motor of the basis for a cause of action under USA, Inc., Auto Saab Cars Siemens 271(e)(2). view, my proposition Corporation, Toyota Mo motive 271(e)(2). goes beyond language USA, Inc., tor Sales Defendants/Coun terclaimants-Appellees, Accordingly, I dissent from respectfully manufacturer, 271(e)(2), Allergan, alleging Allergan, drug 1. suit under 35 U.S.C. using who held a for a method of approved and Bausch & if the FDA Alcon’s specified drug particular purpose for a ANDAs, Lomb’s Alcon and Bausch & Lomb brought against action two infringe Allergan's induce doctors to would Lomb, competitors, & Alcon and Bausch who drug patent- patents by prescribing the seeking approval produc- filed for the ANDAs patients ed method of use and would induce drug generic tion of a version of the for use infringe by using drug patented for the different from the method of use of the method of use. patent. Allergan brought claimed in the