United States Court of Appeals for the Federal Circuit 

2007-1014 

AMGEN, INC., 

Appellant, 

v. 

INTERNATIONAL TRADE COMMISSION, 

Appellee, 

and 

ROCHE HOLDING LTD., F. HOFFMANN-LA ROCHE LTD., ROCHE 

DIAGNOSTICS GMBH, and HOFFMAN-LA ROCHE INC., 

 Intervenors. 

Linda A. Sasaki-Baxley, Day Casebeer Madrid & Batchelder LLP, of Cupertino, 

California, argued for appellant. On the brief was Lloyd R. Day, Jr. Of counsel were 

David M. Madrid and Katie J.L. Scott. Of counsel on the brief were Cecilia H. Gonzalez

and Margaret D. Macdonald, Howrey LLP, of Washington, DC. 

Christal A. Sheppard, Attorney, Office of the General Counsel, United States 

International Trade Commission, of Washington, DC, argued for appellee. With her on 

the brief were James M. Lyons, General Counsel, and Wayne W. Herrington, Assistant 

General Counsel. 

Michael P. Dougherty, Morgan & Finnegan, LLP, of New York, New York, 

argued for intervenors. With him on the brief were Bartholomew Verdirame, Tony V. 

Pezzano, and John C. Vassil, of New York, New York; and Kent R. Stevens, of 

Washington, DC. Of counsel on the brief were Leora Ben-Ami, Patricia A. Carson, 

Thomas F. Fleming, Howard S. Suh, and Manvin Mayell, Kaye Scholer LLP, of New 

York, New York; and V. James Adduci II, Adduci, Mastriani & Schaumberg, LLP, of 

Washington, DC. Of counsel were Tom M. Schaumberg and Maureen F. Browne, of 

Washington, DC. 

Appealed from: United States International Trade Commission 
United States Court of Appeals for the Federal Circuit 

 

2007-1014 

 AMGEN, INC., 

Appellant, 

 v. 

INTERNATIONAL TRADE COMMISSION, 

Appellee, 

 and 

ROCHE HOLDING LTD., F. HOFFMANN-LA ROCHE LTD., 

 ROCHE DIAGNOSTICS GMBH, and HOFFMANN-LA ROCHE INC., 

Intervenors. 

 

Appeal from the United States International Trade Commission in Investigation 

No. 337-TA-568. 

 __________________________ 

DECIDED: April 30, 2009 

 __________________________ 

Before NEWMAN, LOURIE, and LINN, Circuit Judges. 

PER CURIAM.1

 Dissenting opinion filed by Circuit Judge LINN as to Section I.A. 

By complaint to the International Trade Commission under Section 337 of the 

Tariff Act of 1930 as amended, 19 U.S.C. '1337, Amgen, Inc. charged that certain 

importations of recombinant human erythropoietin and derivatives thereof (collectively 

 1

 A petition for rehearing en banc was granted for the limited purpose of 

authorizing the panel to revise part II of its previous opinion, reported at 519 F.3d 1343 

and now withdrawn. 
"EPO") are in violation of Section 337. Amgen charged that the imported EPO and the 

process by which it is produced in Europe are covered by one or more claims of the 

following Amgen United States patents: Patent No. 5,411,868 (claims 1 and 2); Patent 

No. 5,547,933 (claims 3, 4, 5, and 11); Patent No. 5,618,698 (claims 4-9)2

; Patent No. 

5,621,080 (claims 4 and 6); Patent No. 5,756,349 (claim 7); and Patent No. 5,955,422 

(claim 1). The Intervenors Roche Holding Ltd., F. Hoffmann-La Roche, Ltd., Roche 

Diagnostics GmbH, and Hoffmann-La Roche, Inc. (collectively "Roche") are producers 

and importers of the accused EPO. 

 Roche moved for summary determination of noninfringement as to all claims, on 

the ground that the imported EPO is exempt from infringement by operation of 35 

U.S.C. '271(e)(1), the "safe harbor" statute, because the imported EPO is used only for 

the statutorily exempt purpose of the development and submission of information under 

a federal law regulating the manufacture, sale, and use of drugs. The Commission 

granted the motion for noninfringement, holding that all of Roche's activities are within 

the safe harbor, including the foreign production of the imported product. Amgen 

appeals this ruling, on the principal ground that the safe harbor statute does not apply to 

Tariff Act violations based on foreign practice of patented processes, and also on the 

ground that not all of the imported EPO was used for the statute's exempt purposes. 

We affirm the Commission's ruling that the safe harbor provided by '271(e)(1) 

applies in proceedings under the Tariff Act relating to process patents as well as 

product patents, for imported product that is used for exempt purposes. In part II, we 

reverse the Commission’s ruling that Roche was entitled to summary determination, 

 2

 Claims 4 and 5 of Patent No. 5,618,698 were removed from the case 

2007-1014 2
because there was a genuine dispute of material fact concerning whether all of Roche’s 

activities fell within this safe harbor. Accordingly, we affirm in part, reverse in part, and 

remand. 

I 

The Commission's statutory interpretations and rulings of law receive plenary 

review, applying the standards of the Administrative Procedure Act. See 19 U.S.C. 

'1337(c); 5 U.S.C. '706; e.g., Jazz Photo Corp. v. United States Int'l Trade Comm'n, 

264 F.3d 1094, 1099 (Fed. Cir. 2001). Plenary review is given to the Commission's 

summary determinations, which are governed by the criteria of summary judgment and 

are reviewed accordingly. See 19 C.F.R. '210.18(b) (authorizing summary 

determination by the Commission if there is no genuine issue of material fact and the 

moving party is entitled to prevail as a matter of law); Hazani v. United States Int'l Trade 

Comm'n, 126 F.3d 1473, 1476 (Fed. Cir. 1997) (reviewing the Commission's summary 

determinations in accordance with the standards for summary judgment). 

A

Section 337 assigns to the Commission the authority and obligation to investigate 

and prohibit importation based on unfair competition derived from patent, trademark, 

and copyright infringement, including: 

19 U.S.C. '1337(a)(1) Subject to paragraph (2), the following are unlawful, and when 

found by the Commission to exist shall be dealt with, in addition to any other provision 

of law, as provided in this section: 

* * * 

(B) The importation into the United States, the sale for importation, 

or the sale within the United States after importation by the owner, 

importer, or consignee, of articles that-- 

 

during the pendency of this appeal. 

2007-1014 3
(i) infringe a valid and enforceable United States patent or 

a valid and enforceable United States copyright under title 17, 

United States Code; or 

(ii) are made, produced, processed, or mined under, or by 

means of, a process covered by the claims of a valid and 

enforceable United States patent. . . . 

* * * 

(b)(1) The Commission shall investigate any alleged violation of this 

section on complaint under oath or upon its initiative. . . . The 

Commission shall conclude any such investigation and make its 

determination under this section at the earliest practicable time . . . . 

The issues on this appeal center on the safe harbor statute for drug products, on 

application to the imported EPO of the following provisions of Title 35: 

35 U.S.C. '271(e)(1) It shall not be an act of infringement to make, use, 

offer to sell, or sell within the United States or import into the United States 

a patented invention . . . solely for uses reasonably related to the 

development and submission of information under a Federal law which 

regulates the manufacture, use, or sale of drugs or veterinary biological 

products. 

 

* * * 

'271(e)(3) In any action for patent infringement brought under this 

section, no injunctive or other relief may be granted which would prohibit 

the making, using, offering to sell, or selling within the United States or 

importing into the United States of a patented invention under paragraph 

(1). 

The Commission held that the safe harbor statute applies to products produced offshore 

by a process patented in the United States. Amgen argues that this statute does not bar 

the exclusion of such importation, reasoning that the '271(e)(1) reference to importing "a 

patented invention" is necessarily limited to importation of product, for a process cannot 

be imported. Amgen states that it is incorrect to assume that Congress, by silence, 

changed the long-standing Section 337 right and obligation of the Commission to reach 

importation based on offshore practice of a United States patented process. Amgen 

argues that the 1988 enactment of 35 U.S.C. '271(g), whereby the Patent Act provided 

2007-1014 4
remedy in the district courts for offshore practice of a patented process but explicitly 

applied the safe harbor to '271(g), shows congressional intent to limit the safe harbor to 

process patents that would be enforced under '271(g): 

35 U.S.C. '271(g) Whoever without authority imports into the United States 

or offers to sell, sells, or uses within the United States a product which is 

made by a process patented in the United States shall be liable as an 

infringer, if the importation, offer to sell, sale, or use of the product occurs 

during the term of such process patent. . . . A product which is made by a 

patented process will, for purposes of this title, not be considered to be so 

made after-- 

(1) it is materially changed by subsequent processes; or 

(2) it becomes a trivial and nonessential component of another 

product. 

Amgen states that the enactment of '271(g) makes clear that the Commission's 

authority under Section 337 was not changed by enactment of '271(g), because in 

adding '271(g) to Title 35 when Congress enacted the Process Patent Amendments of 

1988, Congress stated that "[t]he amendments made by this subtitle shall not deprive a 

patent owner of any remedies available under subsections (a) through (f) of section 271 

of title 35, United States Code, under Section 337 of the Tariff Act of 1930, or under any 

other provision of law." Pub. L. 100-48, §9006(c) (1988). That is, Congress preserved 

both the safe harbor, 35 U.S.C. '271(e)(1), and the Tariff Act's Section 337, in enacting 

'271(g). Amgen states that this means that process patent infringement would give 

way to the safe harbor when enforced in the district courts under '271(g), while remedy 

is retained for process patent infringement enforced under Section 337. Amgen 

stresses that Section 337 was enacted several decades before '271(g) was added to 

the Patent Act, and that the legislative record is clear that the Tariff Act remedy was 

intended to continue undiminished. 

2007-1014 5
The Commission rejected these arguments, and held that the safe harbor statute 

fully applies to process patent liability under the Tariff Act. In support the Commission 

cited Glaxo Inc. v. Novopharm Ltd., 110 F.3d 1562 (Fed. Cir. 1997) and Bio-Technology 

General Corp. v. Genentech, Inc., 80 F.3d 1553 (Fed. Cir. 1996). Novopharm related to 

determinations of infringement based on the filing of an ANDA for product produced 

offshore; and this court remarked that the "artificial" acts of infringement that are created 

by '271(e)(2) – concerning the conditions under which the patentee can sue for 

infringement during the pendency of the ANDA – relate only to "a drug claimed in a 

patent or the use of which is claimed in a patent" but not to the process for making the 

drug. However, the issues in that case did not relate to exclusion under the Tariff Act, 

but to the right to sue when the charged infringements arose under sections 271(e)(2) 

and 271(g). In Bio-Technology General this court held that the safe harbor statute 

applied in the district court as to product produced offshore after '271(g) was enacted; 

the district court did not rule on the safe harbor for process patents under the Tariff Act, 

although the court apparently assumed that the safe harbor would apply on the same 

terms. 80 F.3d at 1563-64 (explaining that although the ITC dismissed the patentee’s 

Section 337 complaint with prejudice for violation of discovery orders, this ruling cannot 

have claim preclusive effect on the case at bar involving the same transactional facts 

because “the ITC does not have the power to award damages for patent infringement” 

which was the form of relief sought by the patentee). 

In Kinik v. United States International Trade Commission, 362 F.3d 1359 (Fed. 

Cir. 2004) this court explained that '271(g) provided a new right and remedy in the 

district court, but held that the Tariff Act remedy of exclusion based on practice of a 

2007-1014 6
patented process was unchanged, and that the exceptions set forth in '271(g)(1) and 

(2), shown supra, did not apply in Section 337 cases. Id. at 1362. Amgen argues that 

Kinik confirmed that no change whatsoever was made in the Commission's authority 

under the Tariff Act to exclude products made offshore by an infringing process, and 

that this was not changed by the enactment of either '271(g) or '271(e)(1). Amgen 

also argues that Congress intentionally included only product patents when enacting 

'271(e)(1), for the reference therein to "importation" and "patented invention" tracks the 

language of '271(a), which does not concern processes practiced abroad. Thus Amgen 

argues that an importation that is exempt under '271(e)(1) of the Patent Act may 

nonetheless be unlawful under Section 337 of the Tariff Act. 

The Commission did not accept Amgen's distinction, and ruled that the safe 

harbor statute insulates the Roche EPO from Section 337 exclusion not only as to 

infringement of Amgen's product patents but also as to Amgen's process patents. We 

conclude that the Commission's ruling is in consonance with congressional policy as set 

forth in enactment of '271(g), and as elaborated by the Supreme Court in its 

applications of the safe harbor statute. 

In enacting '271(g) the legislative history included the policy statement that: 

Specifically, the Committee does not intend that it shall be an act of 

infringement to import a product which is made by a process patented in 

the United States “solely for uses reasonably related to the development 

and submission of information under a Federal law which regulates the 

manufacture, use, or sale of drugs.” See 271(e)(1) of title 35, United 

States Code. Congress previously decided that certain actions do not 

constitute patent infringements and this Act does not change that prior 

policy decision. 

S. Rep. No. 100-83, 48 (1987). Implementing in other contexts this broadly stated 

congressional policy, in Merck KgaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005) 

2007-1014 7
the Court explained that Congress intended that the immunity of regulatory activity not 

be inhibited, stating that "'271(e)(1)'s exemption from infringement extends to all uses 

of patented inventions that are reasonably related to the development and submission 

of any information under the FDCA." Id. at 202 (emphasis in original). And in Eli Lilly & 

Co. v. Medtronic, Inc., 496 U.S. 661 (1990) the Court held that '271(e)(1) includes 

medical devices, although the statute mentions only drugs and veterinary products; the 

Court stated that "[t]he phrase 'patented invention' in '271(e)(1) is defined to include all 

inventions, not drug-related inventions alone." Id. at 665. In both Merck and Eli Lilly the 

Court stressed the congressional purpose of removing patent-based barriers to 

proceeding with federal regulatory approval of medical products. This purpose and its 

application in precedent weigh heavily against selectively withholding the '271(e)(1) 

exemption depending on whether the infringement action is in the district court or the 

International Trade Commission. We thus affirm the Commission's ruling that the safe 

harbor statute applies to process patents in actions under Section 337, when the 

imported product is used for the exempt purposes of '271(e)(1). 

B

Amgen argues that even on the Commission's interpretation of the safe harbor 

statute, at least some of the imported Roche EPO is not exempt because its actual use 

was not "reasonably related to the development and submission of information under 

[the FDCA]," §271(e)(1). Amgen points out that while '271(e)(1) is directed to the 

development of information for submission to the FDA, Amgen did not bring this action 

for exclusion of imports until after Roche had completed its submission to the FDA. 

2007-1014 8
Amgen states that Roche had entered the "post-BLA" (Biologics License Application) 

stage, which is the stage at which complete data have been obtained, analyzed, and 

presented to the FDA. See 21 C.F.R. '601.2(a) (requiring that the BLA contain "data 

derived from nonclinical laboratory and clinical studies which demonstrate that the 

manufactured product meets prescribed requirements of safety, purity and potency”). 

Amgen states that by the time this action was brought Roche had shifted its 

attention in the United States to infringement analysis experiments, market-seeding 

trials, and litigation-related activity. Amgen states that these activities are not shielded 

by the safe harbor, for they do not "contribute, relatively directly, to the generation of the 

kinds of information that are likely to be relevant to the processes by which the FDA 

would decide whether to approve the product in question," a general definition of 

exempt activity endorsed by the Court in Merck as "consistent with, if less detailed than, 

the construction of '271(e)(1) that we adopt today." 545 U.S. at 208. Amgen argues 

that Roche's post-BLA activities are not exempt from infringement of either product or 

process patents. 

The Commission appears to have assumed that all otherwise infringing activities 

are exempt if conducted during the period before regulatory approval is granted. That 

assumption is incorrect, for the Court in Merck confirmed that "[e]ach of the accused 

activities must be evaluated separately to determine whether the exemption applies." 

Id. at 200. The studies at issue in Merck were presented as scientific studies, and it is 

apparent that commercial and marketing studies are more clearly subject to separate 

evaluation for application of the exemption. 

2007-1014 9
The ALJ denied most of Amgen's requests for discovery of Roche's post-BLA 

activities, with the exception of the experiments conducted by Dr. Veng-Pedersen, and 

perhaps some others - the briefs dispute what was disclosed in discovery. However, as 

to Dr. Veng-Pederson's work, Amgen asserts that these experiments were conducted 

for marketing purposes, with the objective of trying to distinguish Roche's EPO from that 

of Amgen. The evidence on this aspect was conflicting and required closer analysis 

than it received, in light of the distinctions drawn by the Court in Merck. For example, 

an email from Roche's Program Director for Oncology asked Dr. Veng-Pedersen to 

"explore the metabolism (uptake in the bone marrow vs. liver uptake) and to see if there 

are differences between CERA and EPO," a communication that Amgen states is 

directed to future marketing plans to distinguish the Roche and Amgen products, 

whereas the Roche position was that it contacted Dr. Veng-Pedersen because Roche 

was "currently studying CERA and EPO in terms of receptor interaction by using an invitro cellular model system only and would need to move into a more physiological 

situation." The Amgen position is that since this study was conducted after the BLA 

information had been submitted to the FDA, by definition this study was not directed to 

obtaining information for submission for federal approval of the Roche product, as 

required for exemption under '271(e)(1). 

The ALJ held that all of the imported EPO, including that used after the 

application for federal approval was completed, is exempt. However, the Court in Merck

set careful boundaries to the exemption, requiring separate review of all studies for 

which the exemption was claimed. Roche does not appear to dispute that some 

imported product was used to conduct Roche's marketing department's recommended 

2007-1014 10
studies for purposes of brand recognition and not for FDA approval, and the record 

does not discuss whether any of the post-BLA work was supplemental to the BLA and 

intended for submission to the FDA, thereby subject to exemption. See 21 C.F.R. 

§601.12 (entitled “Changes to an approved application” and requiring an applicant to 

inform the FDA “about each change in the product, production process, quality controls, 

equipment, facilities, responsible personnel, or labeling established in the approved 

license application(s)”). 

To the extent that the Commission held all importation and all uses exempt while 

FDA approval was pending, the safe harbor statute does not so provide. The factual 

questions of the purposes of the post-BLA and other challenged activities were 

improperly summarily decided adversely to Amgen. On remand the Commission shall 

consider the exempt status of each study for which question has reasonably been 

raised. 

II

On appeal, the parties dispute whether, under 19 U.S.C. § 1337, the Commission 

has jurisdiction to address “imminent importations” in the absence of a contract for sale. 

The Commission argues that it has jurisdiction “only when there is an importation, sale 

for importation, or sale within the United States after importation.” Br. of Appellee Int’l 

Trade Comm’n at 18; see also Combined Pet. for Reh’g & Reh’g En Banc of Appellee 

Int’l Trace Comm’n at 5 (“Nothing in the statute suggests that the ITC may investigate 

an alleged violation when the particular accused article has not been imported or sold or 

even when infringing acts are reasonably likely to occur.”). Amgen responds that, 

pursuant to the ITC’s own precedent, “an imminent importation will violate Section 337.” 

2007-1014 11
Appellant’s Reply Br. at 5; see also Appellant Amgen Inc.’s Response to Combined Pet. 

for Panel Reh’g and Reh’g En Banc at 8 (“[T]he ITC has jurisdiction to prevent imminent 

irreparable damage to a patentee.”). 

It is not necessary for us to resolve the parties’ dispute concerning “imminent 

importations” to decide this case. In this case, Amgen asserted that Roche imported 

EPO into the United States. See Amended Complaint of Amgen Inc. ¶ 7.1, In re Certain 

Prods. & Pharm. Compositions Containing Recombinant Human Erythropoietin, No. 

337-TA-568 (Int’l Trade Comm’n Apr. 27, 2006) (“On information and belief, Roche is 

currently importing for use and imminent sale in the United States pharmaceutical 

compositions containing PEG-EPO.”) (emphasis added); id. ¶ 7.2 (“On information and 

belief, Roche is offering for sale or imminently preparing to sell in the United States after 

importation pharmaceutical compositions containing PEG-EPO.”) (emphasis added); id.

¶ 7.16 (“On information and belief, Roche has imported and is importing products 

containing glycosylated human EPO manufactured in Europe, as well as 

pharmaceutical compositions containing glycosylated human EPO, into the United 

States. In addition, Roche has used and is using the imported PEG-EPO and 

pharmaceutical compositions containing PEG-EPO in the United States to treat anemic 

patients under the auspices of clinical trials.”) (emphasis added). On Roche’s motion 

for summary determination, the Commission in fact found that “CERA has been 

imported into the United States”—albeit for purposes that, in the view of the 

Commission, broadly fell within the safe harbor of § 271(e)(1). In re Certain Prods. & 

Pharm. Compositions Containing Recombinant Human Erythropoietin, No. 337-TA-568 

(Int’l Trade Comm’n July 7, 2006). 

2007-1014 12
There is no dispute that Roche has imported EPO. The parties’ main disputes 

are whether the safe harbor of § 271(e)(1) applies as a matter of law, and whether all of 

the EPO that Roche imported was entitled to the protection of the safe harbor. That 

dispute goes to the merits of Amgen’s complaint, not to the Commission’s jurisdiction to 

hear it. As we have stated (in a case nearly twenty years ago involving the same 

complainant): 

As is very common in situations where a tribunal’s subject matter 

jurisdiction is based on the same statute which gives rise to the federal 

right, the jurisdictional requirements of section 1337 mesh with the factual 

requirements necessary to prevail on the merits. In such a situation, the 

Supreme Court has held that the tribunal should assume jurisdiction and 

treat (and dismiss on, if necessary) the merits of the case. 

* * * 

Amgen’s complaint alleged that Chugai was importing rEPO and that the 

rEPO was made by a process covered by the ’008 patent; thus, on its face 

the complaint came within the jurisdiction of the Commission. The fact 

that Amgen was later unable to sustain these allegations is not material to 

the issue of jurisdiction. We hold that the Commission should have 

assumed jurisdiction, and, if the facts indicate that Amgen cannot obtain 

relief under section 1337(a)(1)(B)(ii), the Commission should have 

dismissed on the merits. 

Amgen Inc. v. Int’l Trade Comm’n, 902 F.2d 1532, 1536 (Fed. Cir. 1990) (citing Bell v.

Hood, 327 U.S. 678, 682 (1946) and Jackson Transit Auth. v. Local Div. 1285, 

Amalgamated Transit Union, AFL-CIO-CLC, 457 U.S. 15, 21 (1982)) (footnotes 

omitted). 

In this case, the Commission had jurisdiction as a result of Amgen’s allegation 

that Roche imported an article made by a process covered by the claims of a valid and 

enforceable United States patent. See 19 U.S.C. § 1337(a)(1)(B)(ii). The Commission 

therefore was correct to reach the merits of Amgen’s claim. We need not and do not 

address whether the Commission would have had jurisdiction if Amgen had not 

2007-1014 13
2007-1014 14

asserted actual importation and relied instead entirely on its “imminent importation” 

theory. 

SUMMARY 

Applying the safe harbor exemption of 35 U.S.C. '271(e)(1), the imported EPO is 

not subject to exclusion based on infringement of either product or process patents, to 

the extent that the imported EPO is used to develop information that is reasonably 

related to the development and submission of information to the federal regulatory 

authority. The Commission's holding to this effect is affirmed. However, Roche's uses 

of imported EPO unrelated to obtaining FDA approval are not shielded by the 

exemption. We therefore reverse the Commission's summary determination in favor of 

Roche and remand for further proceedings consistent with this opinion. 

 AFFIRMED IN PART, REVERSED IN PART, AND REMANDED 
United States Court of Appeals for the Federal Circuit 

2007-1014 

AMGEN INC., 

 Appellant, 

v. 

INTERNATIONAL TRADE COMMISSION, 

 Appellee, 

 and 

ROCHE HOLDING LTD., F. HOFFMANN-LA ROCHE LTD., 

ROCHE DIAGNOSTICS GMBH, and HOFFMANN-LA ROCHE INC., 

 Intervenors. 

Appeal from the United States International Trade Commission in Investigation 

No. 337-TA-568. 

LINN, Circuit Judge, concurring-in-part and dissenting-in-part. 

I am pleased to join Parts I.B and II of the majority opinion insofar as they relate 

to the asserted product claims, but I respectfully dissent from Part I.A, which holds that 

the safe harbor from infringement liability provided by 35 U.S.C. § 271(e) extends to the 

exclusion by the Commission of pharmaceutical products produced abroad by means of 

a patented process. Like the majority, I do not find persuasive Amgen’s arguments that 

the term “patented invention” in § 271(e)(1) was intended to exclude process patents. 

See Majority Op. at 7-8. Nor do I disagree that § 271(e)(1) is to be construed broadly. 

See id. at 8. My conclusion, rather, follows from the fact that § 271(e)(1) declares that 

certain activities “shall not be an act of infringement,” while the plain language of the 
statute governing process claims before the Commission, 19 U.S.C. § 1337(a)(1)(B)(ii), 

does not require an act of infringement for the Commission to issue an exclusion order. 

Specifically, § 1337(a)(1)(B)(ii) declares unlawful the importation, inter alia, of 

articles that “are made, produced, processed, or mined under, or by means of, a 

process covered by the claims of a valid and enforceable United States patent.” 

Assuming, arguendo, that Amgen prevails as to its infringement and validity contentions 

on the merits, the EPO at issue in this case would be “produced . . . by means of[] a 

process covered by the claims of a valid and enforceable United States patent”—

regardless of whether the use to which the EPO is put is shielded from liability for 

infringement by § 271(e)(1). The thrust of the majority’s position is that Congress 

probably intended § 271(e)(1) to apply in section 337 proceedings the same way it 

applies in patent infringement litigation under Title 35. While I agree that it would make 

sense for section 337 to apply that way, the problem remains that if that is what 

Congress intended, it is not what Congress unambiguously said. 

The language of § 1337(a)(1)(B)(ii) contrasts with the language of 

§ 1337(a)(1)(B)(i), the corresponding provision governing proceedings regarding 

patented products. Section 1337(a)(1)(B)(i) declares unlawful the importation of articles 

that “infringe a valid and enforceable United States patent.” Thus, there is no dispute 

that the safe harbor of § 271(e) applies to product claims before the Commission; the 

unlawfulness under section 337 of the importation of a patented product hinges on 

whether the importation is itself an act of infringement. 

It appears that this difference in language is not accidental. Although Title 35 

and section 337 are ordinarily coextensive, their scope has differed with respect to 

2007-1014 2 
imported goods made by patented processes for almost seventy years. In 1940, 

Congress enacted § 1337a—the predecessor to today’s § 1337(a)(1)(B)(ii) and the 

origin of its “covered by the claims” language—in response to a decision by our 

predecessor court that the importation of an article produced abroad by a process 

covered by a U.S. patent was not an unfair trade practice forbidden by section 337. 

See In re Amtorg, 75 F.2d 826 (CCPA 1935) (observing that it was not the “purpose of 

the Congress in enacting section 337 of the Tariff Act of 1930 to broaden the field of 

substantive patent rights”). Such importations were not acts of infringement until 

Congress enacted 35 U.S.C. § 271(g) in 1988. Even under the present statutory 

scheme, as the majority acknowledges, we have held that the defenses enumerated in 

§ 271(g) do not apply in actions under § 1337(a)(1)(B)(ii). See Kinik v. Int’l Trade 

Comm’n, 362 F.3d 1359, 1362–63 (Fed. Cir. 2004). This is because the language of 

the two provisions differs and because the legislative history of § 271(g) indicates that 

Congress did not intend for it to narrow the scope of pre-existing remedies before the 

Commission. 

It is important to recognize that the former § 1337a was recodified into 

§ 1337(a)(1)(B)(ii) as part of the same statute that created 35 U.S.C. § 271(g). 

Omnibus Trade and Competitiveness Act of 1988, Pub. L. 100-418. In enacting 

§ 1337(a)(1)(B)(ii), Congress reaffirmed its choice of language that required only that a 

process be “covered by the claims of a valid and enforceable United States patent,” 

even though § 271(e) had by this time been enacted. Congress easily could have 

referred to the newly-created § 271(g), which for the first time extended “liab[ility] as an 

infringer” to those who import products made abroad by processes patented in the 

2007-1014 3 
United States, or it could have used the same language in § 1337(a)(1)(B)(ii) as in 

§ 1337(a)(1)(B)(i) if it intended those sections to correspond exactly to § 271(g) and 

§ 271(a), respectively. Instead, it chose to recodify language that had deliberately 

broadened the scope of section 337 proceedings beyond the scope of infringement 

liability under § 271. Thus, with respect, I do not find persuasive the majority’s 

conclusion that we should ignore the language of § 1337(a)(1)(B)(ii) based on 

“congressional policy as set forth in enactment of § 271(g).” Majority Op. at 7. Whether 

deliberately or through oversight, when Congress passed § 271(g), it enacted statutory 

text that is not consistent with the majority’s interpretation of congressional policy. 

In short, I see no basis for concluding that Congress did not intend what it said. I 

do not disagree with the majority’s policy judgment that § 1337 and § 271 should be 

brought into synchrony. But that is not a decision for a court to make, particularly in 

light of the legislative history. “[I]t is not our function to eliminate clearly expressed 

inconsistency of policy and to treat alike subjects that different Congresses have chosen 

to treat differently.” W. Va. Univ. Hosps., Inc. v. Casey, 499 U.S. 83, 101 (1991). 

Indeed, it is worth noting that there are also potential policy arguments in support of the 

textual reading of the statute. Congress may not have intended to extend the same 

benefits of § 271(e)(1) to foreign pharmaceutical companies as it extended to domestic 

ones, or it may have intended to discourage the importation of pharmaceuticals that 

have not yet been approved by the FDA. But “[i]t is not our job to speculate upon 

congressional motives.” Riegel v. Medtronic, Inc., No. 06-179 (U.S. Feb. 20, 2008). 

Accordingly, I would reverse and remand to the Commission for consideration of 

the merits of Amgen’s complaint with respect to the process claims, without regard to 

2007-1014 4 
2007-1014 5 

the use to which the imported EPO is put. I join the majority’s disposition as to the 

product claims.