*1 against confusing subject jurisdic- matter claim).
tion and the merits of the
CONCLUSION request judicial
Gerdau’s review of
the Sixth Review was not rendered moot
by liquidation subject entries Review,
Sixth for there remains issue
having ongoing legal consequences: if
Commerce erred in calculating a de min-
imis dumping margin ICDAS Review,
Sixth this could affect the future
lifting of the 1997 Antidumping Order.4 ju- Court International Trade has matter, subject
risdiction of the in accor-
dance with statute. The dismissal is va-
cated and the case is remanded for further
proceedings.
VACATEDand REMANDED
AMGEN, INC., Appellant, Commission,
International Trade
Appellee, LTD.,
ROCHE HOLDING F. Hoffmann- Ltd., Diagnostics
La Roche Roche
GmbH, Inc., and Hoffman-La Roche
Intervenors.
No. 2007-1014.
United States Court of Appeals,
Federal Circuit.
March 2008. 4. We stay proceedings need not decide in this case respect whether to the Sixth Sixth Review determination, determination would be review- pending Review a revocation antidumping able absent revocation in order to determine whether the outcome of Review, whether, order in the Seventh proceeding the Sixth Review would have circumstances, reviewable in such the Court practical consequences. required of International Trade would be
CA, appellant. for On the brief argued Lloyd Day, R. Of counsel were Jr. M. and Katie J.L. Scott. Of David Madrid H. Gon- counsel on the brief were Cecilia Macdonald, Howrey Margaret D. zalez LLP, Washington, of DC. Attorney, Sheppard, A. Office
Christal Counsel, In- of the General United States Commission, of Wash- ternational Trade DC, argued appellee. With her ington, Lyons, were James M. Gener- on brief Counsel, Wayne Herrington, al W. General Counsel. Assistant Dougherty, Morgan P. & Finne- Michael LLP, York, NY, argued New gan, of him on the brief were intervenors. With Verdirame, Pezzano, Tony Bartholomew Y. Vassil, York, NY; and of New John C. Stevens, Washington, R. DC. Of Kent Ben-Ami, counsel on the brief were Leora Carson, Fleming, Patricia A. Thomas F. Suh, Mayell, Kaye Howard S. and Manvin NY; LLP, York, of New and V. Scholer II, Adduci, & James Adduci Mastriani LLP, Schaumberg, Washington, Of DC. Schaumberg Tom counsel were M. Browne, Washington, Maureen F. DC. NEWMAN, LOURIE, and Before LINN, Judges. Circuit Opinion for the court filed Circuit Opinion concurring-in- Judge NEWMAN. part dissenting-in part Circuit Judge LINN.
NEWMAN, Judge. Circuit Trade By complaint to the International 337 of the Tar- Section amended, 19 iff Act of 1930 as charged that certain Amgen, Inc. eryth- human importations of recombinant (collec- and derivatives thereof ropoietin Sasaki-Baxley, Day A. Casebeer Linda “EPO”) LLP, tively violation Cupertino, & Batchelder Madrid Amgen charged 337. The Commission also ruled that it did process by pro- EPO and the which it is not have to investigate and Europe duced in are covered one or charges resolve the infringement, rea- following Amgen more claims of the Unit- soning that the subject to the safe *3 5,411,868 patents: ed States Patent No. harbor had not been sold in the United (claims 2); 5,547,933 1 and Patent No. subject and was not the of an exist- (claims 4, 5, 11); 5,618,- and Patent No. ing sale, contract for and ruling that sale (claims 4-9);1 5,621,080 698 Patent No. as well required is for Sec- (claims 6); 5,756,349 4 and Patent No. jurisdiction. tion 337 Amgen appeals this (claim (claim 7); 5,955,422 and Patent No. ruling, arguing that Roche’s announced im- 1). Ltd., The Holding Intervenors Roche minent FDA approval imported of the Roche, Ltd., F. Hoffmann-La Diag- Roche EPO and the accompanying end of safe GmbH, Roche, and nostics Hoffmann-La protection, as well as Roche’s ex- “Roche”) (collectively Inc. producers arrangements tensive to sell in and to the importers of the accused EPO. upon United States market FDA approval, jurisdic- suffice to establish Commission summary Roche moved for determina- tion. this connection Amgen complains claims, tion of noninfringement as to all on about the discovery Commission’s denial of that ground imported the EPO is ex- marketing of Roche’s arrangements, there- empt infringement by operation from of 35 by preventing Amgen meeting from U.S.C. the “safe harbor” stat- requirement Commission’s proving sale ute, imported because the is EPO used or contract for sale. statutorily exempt purpose for the submission of infor- We reverse the ruling Commission’s mation under a regulating federal law had no to determine viola- manufacture, sale, drugs. and use of tion of Section posture 337 of this granted the motion for nonin- case. fringement, holding that all of Roche’s ac- harbor, are within the safe tivities includ- statutory The Commission’s in ing foreign production imported terpretations rulings of law receive product. Amgen appeals ruling, on review, plenary applying the standards principal ground that the safe harbor the Administrative Procedure Act. See 19 apply statute does not to Tariff Act viola- 1337(c); 706; e.g., 5 U.S.C. foreign practice tions based on Comm’n, Corp. Jazz Photo v. Int’l Trade processes, ground on also that not (Fed.Cir.2001). 264 F.3d 1099 Ple imported all of the EPO was used for the nary given review is to the Commission’s exempt purposes. statute’s determinations, summary gov which are summary judg erned the criteria of ruling We affirm the Commission’s See accordingly. ment and are reviewed provided by the safe harbor 210.18(b) (authorizing 19 sum applies proceedings under the Tariff Act C.F.R. mary relating process patents as well as determination the Commission prod- patents, imported product genuine uct there is no issue of material fact purposes. moving party used for exempt prevail and the entitled 5,618,698 dency appeal. 1. Claims 4 and 5 of Patent No. of this during pen- were removed from the case make its de- law); investigation such Hazani v. United as a matter Comm’n, at under this section Trade termination States Int’l (Fed.Cir.1997) (reviewing the Com- practicable time.... earliest in ac- summary determinations mission’s on the appeal on this center The issues summary the standards for cordance on drug products, statute for safe harbor judgment). EPO of application
following provisions of Title 35: A It not be an shall make, use, infringement to offer act of assigns to the Commis *4 sell, the United States or obligation to investi or sell within authority sion the patented on a importation import based into the United States gate prohibit patent, from competition solely unfair derived ... for uses invention trademark, in copyright infringement, and submis- related to the cluding: under a Federal law sion of information use, manufacture, or regulates which 1337(a)(1) Subject para- § to 19 U.S.C. veterinary biological drugs sale of or unlawful, (2), following are
graph products. by to found the Commission and when with, in to dealt addition exist shall be law,
any provided provision other in this section: in- patent action for section, brought under this
fringement
may be
injunctive
no
or other relief
mak-
granted
prohibit
which would
(B)
into the United
importation
sell,
using, offering
selling
to
or
ing,
States,
or the
importation,
the sale for
importing
or
within the United States
im-
after
sale within
United States
patented
into the
States of a
United
owner,
by
importer,
or
portation
(1).
paragraph
invention under
of articles that—
consignee,
(i)
that the safe harbor
The Commission held
infringe a valid and enforceable
applies
products produced
to
off-
statute
or a valid and
United States
by process patented
a
in the
shore
United
copyright
States
enforceable United
Code;
Amgen argues
or
this statute
under title
United States
States.
impor-
bar the exclusion of such
does not
(ii)
made,
processed,
produced,
tation,
ref-
reasoning that the
of,
under,
means
a
or mined
“a
invention”
importing
patented
to
erence
by the claims of a
process covered
necessarily
limited to
and enforceable United States
valid
imported.
for a
cannot be
product,
patent....
as-
Amgen states that
it is incorrect
silence,
changed
Congress,
sume that
* * %
right
long-standing
to reach im-
obligation of the Commission
(b)(1)
investigate
shall
The Commission
a
practice of
portation based on offshore
any alleged violation of this section on
Amgen
process.
patented
United States
initia-
upon
under oath or
its
complaint
the 1988 enactment of
argues
conclude
tive .... The
shall
271(g), whereby
271(g),
the Patent Act under
while
is retained
remedy in the district courts for
provided
process patent
infringement enforced
process but
practice
of a
under
offshore
Section 337.
stresses that
applied the safe harbor
explicitly
Section 337 was enacted several decades
congressional
intent
271(g),
271(g)
shows
before
was added to the Patent
process patents Act,
limit the safe harbor to
legislative
and that the
record is clear
§ 271(g):
enforced under
that would be
that the Tariff Act remedy was intended to
continue undiminished.
au-
Whoever without
thority imports into the
States or
United
rejected
The Commission
argu-
these
sell, sells,
offers to
or uses within the ments, and held that the safe
stat-
product
a
which is made
United States
fully applies
process patent
ute
liability
process patented
the United
Tariff Act. In support
the Com-
infringer,
shall
liable as an
be
mission cited Glaxo Inc. v. Novopharm
sell, sale,
importation,
offer to
or use Ltd.,
(Fed.Cir.1997)
case at bar
infringe-
“the
does not have
an act of
al
because
ITC
tend that
shall be
facts
damages
power
to award
a
which is made
import
product
ment to
form of relief
which was the
infringement”
in the
process patented
a
United
sought by
patentee).
“solely
for uses
relat-
ed to the
and submission of
International Trade Com-
In Kinik v.
information
a Federal
law which
(Fed.Cir.2004)
mission,
manufacture, use, or
regulates the
sale
§ 271(g) provided
that
explained
court
drugs.”
See
title
court,
remedy in
the district
right
new
previous-
Congress
United States Code.
Tariff Act
that
but held
ly
not
decided that certain actions do
practice
of a
based on
exclusion
patent infringements and this
constitute
that
ex-
unchanged, and
process was
change
prior policy
Act
not
that
does
(2),
271(g)(1)
§in
ceptions set forth
decision.
apply
in Section 337
supra,
shown
did
argues that
Id. at 1362.
cases.
(1987).
100-83,
S.Rep.
Implement-
No.
change whatsoev-
Kinik confirmed that no
ing
broadly
in other contexts this
stated
authority
in the
er was made
Commission’s
congressional policy, in Merck
KGaA
products
Tariff Act to exclude
under the
I, Ltd.,
Integra
U.S.
Lifesciences
infringing process,
made offshore
(2005)
125 S.Ct.
B appears to have as- sumed that all infringing otherwise activi- Amgen argues that even on the ties exempt during conducted Commission’s interpretation of the safe period regulatory before approval grant- is statute, at import least some of the ed. That assumption incorrect, for the ed Roche EPO is not exempt because its Court in Merck confirmed that “[e]aeh of actual use was not “reasonably related to the accused activities must be evaluated and submission of infor separately to determine 271(e)(1). whether the ex- FDCA],” mation [the emption applies.” Id. at 125 S.Ct. Amgen points out that while 2372. The at studies issue in Merck were directed to the development of information presented studies, as scientific and it is FDA, Amgen submission to the did not apparent that commercial marketing bring this imports action exclusion of studies are more clearly subject to sepa- until completed after Roche had its sub rate application evaluation for of the ex- mission to the FDA. states that emption. (Bio Roche had “post-BLA” entered the logies Application) License stage, which is The ALJ denied most Amgen’s re-
the stage at which complete data have quests for discovery of post-BLA Roche’s obtained, analyzed, been presented activities, with exception experi- 601.2(a) the FDA. (requir See C.F.R. ments conducted Dr. Veng-Pedersen, ing that the BLA contain “data derived and perhaps some others —the briefs dis- *7 from laboratory nonclinical and clinical pute what discovery. was disclosed in studies which demonstrate that the manu However, work, as Dr. Veng-Pederson’s to factured product prescribed meets require Amgen asserts experiments these safety, purity ments of potency”). and marketing were conducted for purposes, objective with the of trying distinguish to
Amgen by states that the time this ac- Roche’s EPO from that of Amgen. The tion was brought Roche had shifted its evidence on aspect conflicting was and attention in the United States to infringe- required analysis received, closer than it in analysis experiments, ment market-seed- trials, light of the ing by distinctions drawn litigation-related activity. and Court in Merck. Amgen example, states that For an email these activities are not harbor, from by Program shielded the safe Roche’s Director for Oncol- they for do “contribute, relatively directly, ogy Veng-Pedersen asked Dr. to “explore to the generation (uptake of the the metabolism kinds of information the bone mar- likely that are uptake) to be relevant to the row vs. liver to pro- and see there are EPO,” cesses which the FDA would decide differences between CERA and approve whether to ques- communication that states is di- purposes post- of the of the questions to tual marketing plans distin- rected to future challenged and other activities were BLA Amgen products, and the Roche guish summarily adversely decided improperly was that position the Roche whereas Amgen. remand the Commission to On Veng-Pedersen Dr. because contacted exempt status of each shall consider the “currently studying CERA and was Roche has study question for which receptor interaction in terms of EPO raised. been system cellular model using an in-vitro move into a more need to only and would Amgen posi- situation.” The
physiological II study was conducted is that since this tion full The Commission sustained had sub- BLA information been after the does holding ALJ’s FDA, study definition this mitted to investigate to and not have obtaining to information was not directed respect to im infringement with approval of the for submission for federal harbor, subject to the safe portation that is product, required exemption Roche as actual in the unless there is also sale Unit 271(e)(1). im ed States or contract for sale of the the imported held that all of ALJ ported product. The Commission held EPO, applica- that used after the including that Roche’s announced imminent FDA approval completed, tion for federal EPO, immi approval and However, the Court in Merck set exempt. harbor, nent end of the safe do not suffice exemption, re- careful boundaries jurisdiction to to establish Commission de all quiring separate review of studies termine the facts of unless was claimed. Roche exemption which the actual sale or contract for sale is also im- appear dispute to that some does shown. used to conduct ported product was Amgen argues that actual sale and use marketing department’s recom- Roche’s FDA prohibited approval, are without rec- purposes mended studies for brand poten- that when the FDA ognition approval, and not for real, injury industry tial domestic the record does not discuss whether imminent, and sale the United States is post-BLA supplemental work was requires Section 337 authorizes and Com- BLA intended for submission to precedent, mission action. This court’s FDA, subject thereby exemption. prior well as the Commission’s own rul- (entitled “Changes See C.F.R. 601.12 position. In the ings, support Amgen’s application” requiring approved “Clearly, words: the Com- Commission’s *8 FDA applicant an to inform the “about remedy mission’s is ineffectual after the product, production in the change each entered the imported product accused has controls, facili- process, quality equipment, stream of domestic commerce.” In the ties, responsible personnel, labeling or es- Tri- Matter Certain Low-Nitrosamine of approved applica- in the license tablished Herbicides, 337-TA-245, Inv. No. fluralin tion^)”). 1986) 14, at *4 (Sept. 1986 ITC LEXIS 91 (“In To extent that the held the Commission purpose view of the remedial of Sec- exempt all importation 337, all and uses while prospective tion and the nature of afforded, pending, may FDA the safe har- the immi- approval was that be importation by party respondent fac- nent provide. bor statute does not so The 1351 broad, ongoing of a new and that 337 investigation an is a remedial infringe alleged complainant’s to statute which authorizes the which Commission tendency injure to patent “prevent and have the unfair acts in incipien- their clearly industry, cy.” domestic falls within the jurisdiction.”). In In re
the Commission’s
1986 ITC Lexis
at *4 (quoting
91
Copper
the
Apparatus
Continuous
Certain
Rod,
895).
214 USPQ
precedent
at
This
Rod, 1980
Copper
Production
WL
of
has
Co.,
its foundation
In re
Orion
(Int’l
42046,
892,
U.S.P.Q.
Tr.
C.C.P.A.
termining what constitutes
unfair
into the
of
country,
commerce
the
the
act,
of
or unfair
competition
method
it is
may
American manufacturer
his
assert
jurisdiction
that our
is not limited
clear
rights against anyone who has posses-
analogous
the strict
of
application
of,
sells,
However,
goods.
sion
the
Commission,
under the au-
laws.
be,
is,
this method of control must
thority granted
may
to it in section
ineffective,
of
because
of
multiplicity
their
prevent
incipiency.
unfair acts in
necessarily
suits which must
be institut-
Speed
re
In In
Certain Variable
Wind
rights
ed to enforce
the domestic
Components Thereof,
Turbines and
Inv.
phase
manufacturer. This
of the matter
30, 1996),
(May
No. 337-TA-376
sub
aff'd
obviously was in the minds of the Con-
Enercon
nom
GmbH
Int’l Trade
gress at
preparation
the time
Comm’n,
(Fed.Cir.1998)
infringement during the safe period
of regulatory approval; this court recog- SUMMARY nized the propriety declaratory of a action Applying the safe harbor exemption of infringement, directed to future although imported EPO inquiries “the hypothetical now are be- subject is not to exclusion based on in- allegedly infringing cause the product has fringement of either product yet been marketed.” Id. at 1366. patents, to the extent imported purposes Thus the of the safe harbor stat- EPO is used to develop information that is met, ute are while safeguarding rights related to the patentee that come into effect when submission of information to the federal the safe harbor has ended. regulatory authority. The Commission’s assignment Commission’s pre- is to holding to this effect is affirmed. Howev- vent unfair flowing acts from er, Roche’s uses of EPO unrelat- infringement. explained As in In re Or- ed obtaining FDA approval are not ion, provision “the relating to unfair meth- exemption. shielded *10 injury merits, infringement The issues of on the at EPO issue in this properly “produced by were before the Commission for ease would be ... means of process a by [] resolution. We reverse the Commission’s covered the claims of a valid and jurisdictional grounds, dismissal on and re- enforceable United pat- regardless of proceedings for further consistent whether mand use to ent” — which put the EPO is is shielded from opinion. with this liability 271(e)(1). infringement by § PART, AFFIRMED IN REVERSED The majority’s position thrust of the is that PART, IN AND REMANDED 271(e)(1) Congress probably § intended to
apply section 337 proceedings the same LINN, Judge, eoncurring-in-part Circuit way applies patent infringement liti- dissenting-in-part. gation under agree Title 35. While I that it would make sense for section 337 to pleased join I am Parts I.B and II of apply way, problem remains that majority opinion they insofar as relate Congress intended, that is what it is not claims, product to the asserted but I re- Congress what unambiguously said. I.A, spectfully dissent from Part which infringe- holds that the safe harbor from 1337(a)(l)(B)(ii) language § con- liability provided by ment trasts language 271(e) § by extends to the exclusion 1337(a)(1)(B)®, the corresponding provi- pharmaceutical products Commission of governing sion proceedings regarding pat- produced by abroad means of a 1337(a)(1)(B)® products. ented process. majority, Like the I do not find importation declares unlawful the of arti- persuasive Amgen’s arguments that cles that “infringe a valid and enforceable 271(e)(1) term “patented invention” in Thus, patent.” United States there is no process was intended to exclude patents. 271(e) dispute that the safe harbor of See Majority Op. at 1348. I Nor do dis- applies claims before the Com- agree that is to be construed mission; the unlawfulness under section See id. broadly. at My 1348-49. conclu- importation 337 of the patented prod- of a sion, rather, follows from the fact uct hinges importation on whether the declares that certain activities infringement. itself an act of “shall not be an act infringement,” while It appears that this difference in lan- plain language governing of the statute guage Although accidental. Title 35 Commission, process claims before the ordinarily coextensive, and section 1337(a)(l)(B)(ii), require does not scope their has respect differed with an act of infringement for the Commission imported goods by patented process- made to issue an exclusion order. seventy years. es for almost Con- 1337(a)(l)(B)(ii)
Specifically, § declares gress predecessor enacted 1337a—the alia, importation, unlawful the inter arti- 1337(a)(l)(B)(ii) today’s § origin and the made, produced, cles that “are processed, by language its “covered the claims” —in under, of, by mined or means a response by to a predecessor decision our covered the claims of a valid and en- court that of an article patent.” forceable United States Assum- produced by process abroad covered a ing, arguendo, Amgen prevails as to an unfair prac- U.S. trade section 337. See In re validity its contentions tice forbidden *11 1354 558, 22
Amtorg,
C.C.P.A.
75 F.2d
persuasive
826
the majority’s conclusion that
(1935)
it
we
should
(observing
ignore
that was not the
“pur-
language
1337(a)(l)(B)(ii)
§
“congressional
based on
pose of
Congress
enacting
section
policy as set
forth in enactment of
337 of the Tariff Act of 1930 to broaden
§ 271(g).” Majority Op. at 1348^49.
field of substantive
rights”).
deliberately
Whether
through
oversight,
importations
Such
were not acts of in-
when Congress passed § 271(g), it enacted
fringement until Congress enacted 35
statutory text that is not consistent with
§ 271(g)
U.S.C.
in 1988. Even under the
majority’s
interpretation of congres-
scheme,
present statutory
majority
as the
sional policy.
acknowledges, we have held that the de-
short,
In
I see no basis for concluding
§
fenses
271(g)
enumerated
do
ap-
that Congress did not intend what it said.
1337(a)(l)(B)(ii).
ply in
§
actions under
I do
disagree
with
majority’s policy
Comm’n,
See Kinik v. Int’l Trade
judgment
§
§
1337 and
271 should be
1359,
(Fed.Cir.2004).
1362-63
This is be-
brought
synchrony.
into
But that is not a
cause the language of the
provisions
two
make,
decision for a court to
particularly
differs and
legislative history
because the
in light of the legislative history.
“[I]t
§ 271(g)
Congress
indicates that
did not
not our function to
clearly
eliminate
ex-
intend for it to
scope
narrow the
pre-
pressed inconsistency
policy
and to treat
existing remedies before the Commission.
subjects
alike
that different Congresses
have
It
chosen to treat
important
differently.”
to recognize that
W. Va.
Hosps.,
Univ.
Inc. v. Casey,
83,
499
§
U.S.
former
1337a was
recodified into
(1991).
S.Ct.
113 L.Ed.2d
1337(a)(l)(B)(ii)
part
of the same stat-
Indeed, it is worth noting that there are
ute that created 35
271(g).
Om-
potential
also
policy arguments in support
nibus Trade and Competitiveness Act of
of the textual reading of the statute. Con-
1988, Pub.L.
100-418.
enacting
gress may not have intended to extend the
§ 1337(a)(l)(B)(ii), Congress reaffirmed its
same benefits of
to foreign
choice
language
that required only that
pharmaceutical companies as it extended
process
be
“covered
the claims of a
ones,
to domestic
may
or it
have intended
valid and enforceable United
pat-
discourage
pharma-
ent,”
271(e)
even though
had
ceuticals that
yet
have not
approved
been
time been enacted. Congress easily could
by the FDA. But
job
is not our
“[i]t
have
referred
newly-created
speculate upon congressional motives.”
§ 271(g), which for the first time extended
—
Riegel Medtronic, Inc.,
-,
U.S.
“liability] as an infringer” to those who
(2008).
128 S.Ct.
the scope of infringement liability under Thus,
§ 271. I respect, do not find