ACETRIS HEALTH, LLC v. USA

Filing 54

REPORTED OPINION reissuing 49 **SEALED**OPINION and ORDER for publication. Signed by Chief Judge Margaret M. Sweeney. (kb1)

In the United States Court of Federal Claims
No. 18-433C
(Filed Under Seal: July 10, 2018)
(Reissued for Publication: July 16, 2018) *
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ACETRIS HEALTH, LLC,
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Plaintiff,
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v.
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THE UNITED STATES,
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Defendant.
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Preaward Bid Protest; Motion to Dismiss;
Standing; Motion to Supplement the
Administrative Record; Cross-Motions for
Judgment on the Administrative Record;
Declaratory and Injunctive Relief; Buy
American Statute; Trade Agreements Act of
1979; Proper Construction of Solicitation’s
Trade Agreements Clause; Conflicting
Solicitation Provisions; Reliance on
Customs and Border Protection’s Countryof-Origin Determination

Stephen E. Ruscus, Washington, DC, for plaintiff.
Daniel B. Volk, United States Department of Justice, Washington, DC, for defendant.
OPINION AND ORDER
SWEENEY, Judge
In this preaward bid protest, plaintiff Acetris Health, LLC challenges the United States
Department of Veterans Affairs’ (“VA”) construction and application of the Trade Agreements
clause included in a solicitation to purchase Entecavir Tablets, one of the few medications
approved by the United States Food and Drug Administration to treat chronic hepatitis B.
Plaintiff contends that under the VA’s erroneous construction of the clause, the VA would not
accept the Entecavir Tablets that plaintiff had been supplying to the VA under the incumbent
contract. Presently before the court are defendant’s renewed motion to dismiss on standing
grounds, plaintiff’s motion to supplement the administrative record, and the parties’ crossmotions for judgment on the administrative record. As explained in more detail below, the court
concludes that plaintiff has standing to protest, that supplementation of the administrative record
is not necessary for the court to effectively review plaintiff’s claims, and that plaintiff is entitled
to some of the declaratory and injunctive relief it requests.

*

This reissued Opinion and Order incorporates the agreed-to redactions proposed by the
parties on July 13, 2018, and two other redactions in conformance with the parties’ proposed
redactions. The redactions are indicated with bracketed ellipses (“[. . .]”).

I. BACKGROUND
A. Statutory and Regulatory Context
This bid protest concerns the construction and application of the Trade Agreements Act
of 1979 (“Trade Agreements Act”), 19 U.S.C. §§ 2501-2582 (2012), its implementing
regulations, and its associated contract clauses. 1
In general, the Buy American statute restricts the goods that can be acquired by the
federal government to “manufactured articles, materials, and supplies that have been
manufactured in the United States substantially all from articles, materials, or supplies mined,
produced, or manufactured in the United States . . . .” 41 U.S.C. § 8302(a) (2012); accord
Federal Acquisition Regulation (“FAR”) 25.101(a) (2018) (“The Buy American statute restricts
the purchase of supplies that are not domestic end products.” 2). The Trade Agreements Act
allows the federal government to waive the Buy American restriction “with respect to eligible
products of any foreign country or instrumentality designated under [the Act], and suppliers of
such products,” 3 such that those products and suppliers would be treated as favorably as “United
States products and suppliers.” 19 U.S.C. § 2511(a); accord FAR 25.402(a)(1) (indicating that
“[t]he Trade Agreements Act . . . provides the authority for the President to waive the Buy
American statute and other discriminatory provisions for eligible products from [designated]
countries,” such that those “eligible products receive equal consideration with domestic offers”).
As reflected in FAR part 25 (“Foreign Acquisition”), the federal government has
exercised its Trade Agreements Act authority and waived the Buy American restriction for
acquisitions covered by the World Trade Organization Government Procurement Agreement
(“WTO GPA”) or a Free Trade Agreement (“FTA”). FAR 25.402(a)(1); see also FAR 25.402(b)
(reflecting that the waiver of the Buy American restriction for products from WTO GPA
countries only applies if the “value of the acquisition” is $180,000 or greater). For “acquisitions
covered by the WTO GPA,” federal government purchases are restricted to “U.S.-made or
designated country end products . . . , unless offers for such end products . . . are either not
received or are insufficient to fulfill the requirements.” FAR 25.403(c). A “designated country
end product” is an end product from one of four groups of countries–WTO GPA countries, FTA
countries, least developed countries, or Caribbean Basin countries. FAR 25.003; see also id.
(reflecting, as relevant here, that the United States and India are not included in any of the four
groups and that [. . .] and [. . .] are WTO GPA countries). A “U.S.-made end product” is “an
article that is mined, produced, or manufactured in the United States or that is substantially
transformed in the United States into a new and different article of commerce with a name,
1

The court derives the information in the background section from the administrative
record (“AR”), relevant statutes and regulations, and publicly available court filings.
2

The term “domestic end product” does not appear in the Buy American statute, see 41
U.S.C. ch. 83, but, as described below, is defined in FAR 25.003.
3

Pursuant to FAR 25.003, an “eligible product” is “a foreign end product,” and a
“foreign end product” is “an end product other than a domestic end product.”
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character, or use distinct from that of the article or articles from which it was transformed.” Id.
Offers of a “U.S.-made end product” can be “domestic” offers or “not domestic” offers. FAR
25.502(b)(2); FAR 25.504-2; accord Federal Acquisition Regulation; Foreign Acquisition (Part
25 Rewrite), 63 Fed. Reg. 51,642, 51,642 (Sept. 28, 1998) (indicating that “[t]he Trade
Agreements Act does not specifically address the treatment of U.S. made end products that do
not qualify as domestic end products” and that the FAR was being amended–in accordance with
an administrative decision holding “that the Trade Agreements Act does not prohibit the
purchase of U.S. products”–“to permit the purchase of all U.S. made end products, whether or
not they are domestic end products” 4). A domestic offer is “an offer of a domestic end product,”
and a domestic end product is “[a]n end product manufactured in the United States, if–(i) [t]he
cost of its components mined, produced, or manufactured in the United States exceeds 50 percent
of the cost of all its components . . . or (ii) [t]he end product is a [commercially available off-theshelf (“COTS”)] item.” 5 FAR 25.003. It follows that a U.S.-made, nondomestic offer is an offer
of a product that is substantially transformed in the United States. See also Int’l Bus. Machines,
GSBCA No. 10532-P, 90-2 BCA ¶ 22,824 (holding that the then-existing Trade Agreements
clause, which only allowed contractors to supply “domestic end products” or “foreign end
products,” impermissibly prevented the federal government from procuring “United States
products”–in other words, products substantially transformed in the United States).
B. Plaintiff and Its Entecavir Tablets
Plaintiff, a domestic corporation with its principal place of business in Allendale, New
Jersey, is a generic pharmaceutical distributor that specializes in providing pharmaceuticals to
the federal government. Notice of Issuance of Final Determinations Concerning Certain
Pharmaceutical Products, 83 Fed. Reg. 5118, 5132 (Feb. 5, 2018). Plaintiff obtains the
pharmaceuticals it distributes from Aurolife Pharma LLC (“Aurolife”), a manufacturer of generic
pharmaceuticals. See generally id. at 5118-39. Aurolife manufactures the pharmaceuticals it
4

In its cross-motion for judgment on the administrative record, defendant misconstrues a
phrase in this Federal Register notice–“when a U.S. made end product that is not a domestic end
product,” 63 Fed. Reg. at 51,642–to mean that “not every domestic end product is a U.S.-made
end product,” Cross-Mot. 22. To the contrary, the phrase–and the remainder of the Federal
Register notice–reflects that all domestic end products qualify as U.S.-made end products, and
that there is a subset of U.S.-made end products that do not qualify as domestic end products.
5

As relevant here, a COTS item is a commercial item (an item “that is of a type
customarily used by the general public or by non-governmental entities for purposes other than
governmental purposes, and” is either sold or offered for sale “to the general public”) that is
“[s]old in substantial quantities in the commercial marketplace” and “[o]ffered to the
Government, under a contract or subcontract at any tier, without modification, in the same form
in which it is sold in the commercial marketplace.” FAR 2.101. Plaintiff alleges that Entecavir
Tablets are COTS items, Am. Compl. ¶¶ 2, 32, and the solicitation at issue reflects the VA’s
intent to acquire a commercial item, see generally AR 52-123. However, the administrative
record does not indicate whether plaintiff’s Entecavir Tablets were sold commercially in
“substantial quantities.” The court need not decide whether plaintiff’s Entecavir Tablets are
COTS items.
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supplies to plaintiff in a facility located in Dayton, New Jersey. See generally id.; AR 145-47,
573, 849.
To make Entecavir Tablets, Aurolife combines a number of active and inactive
ingredients in a process that “converts the[] ingredients into finished, medically effective dosage
tablets . . . .” 83 Fed. Reg. at 5132. Aurolife obtains the ingredients for its Entecavir Tablets
from domestic and foreign suppliers; the active pharmaceutical ingredient (“API”)–entecavir–is
sourced from India and the remaining ingredients are sourced from five other countries,
including the United States. Id.
Plaintiff supplied the VA with Entecavir Tablets under a national contract set to expire on
April 12, 2018. AR 33, 125, 847; see also id. at 847 (indicating that the contract was terminated
on April 5, 2018 6). The VA could also obtain Entecavir Tablets using Federal Supply Schedule
contracts or on the open market. Id. at 33-35, 847; see also id. at 841-42 (reflecting that the VA
could obtain a lower price on the open market than it could using a Federal Supply Schedule
contract).
C. Customs and Border Protection’s Country-of-Origin Determination
On July 7, 2017, plaintiff requested final determinations from Customs and Border
Protection (“CBP”) regarding the country of origin of eleven of the pharmaceuticals it
distributes, including its Entecavir Tablets. 7 See generally 83 Fed. Reg. at 5118-39. CBP issued
its final determinations on January 30, 2018. 8 Id.; accord AR 941-68 (containing CBP’s final
determinations). In its final determination pertaining to plaintiff’s Entecavir Tablets, CBP
described the relevant facts and then set forth the legal standard under which it would make its
determination. 83 Fed. Reg. at 5132. With respect to the applicable legal standard, CBP noted
that pursuant to 19 U.S.C. § 2515(b)(1), it was required to determine whether the Entecavir
Tablets were products of a foreign country under the rule of origin. Id. The rule of origin
provides:
An article is a product of a country or instrumentality only if (i) it is wholly the
growth, product, or manufacture of that country or instrumentality, or (ii) in the
case of an article which consists in whole or in part of materials from another
6

A contract modification submitted by defendant with its cross-motion for judgment on
the administrative record reflects that plaintiff and the VA agreed to a no-cost termination of the
contract. Cross-Mot. App. 4-5.
7

Although the administrative record does not reflect the reason why plaintiff made such
a request, plaintiff alleges that it was advised by the VA that CBP was “‘the sole federal entity
with authority to make county of origin determinations for [Trade Agreements Act] purposes.’”
Am. Compl. ¶ 49 (quoting a VA cure notice); accord Acetris Health, LLC v. United States, No.
18-433C, 2018 WL 2123461, at *3-4 (Fed. Cl. May 8, 2018).
8

The final determinations were subsequently published in the Federal Register on
February 5, 2018. 83 Fed. Reg. at 5118-39.
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country or instrumentality, it has been substantially transformed into a new and
different article of commerce with a name, character, or use distinct from that of
the article or articles from which it was so transformed.
19 U.S.C. § 2518(4)(B); accord 19 C.F.R. § 177.22(a) (2017).
CBP then noted that it was required to apply the rule of origin “consistent with” the FAR,
83 Fed. Reg. at 5132 (citing 19 C.F.R. § 177.21), and in that regard, it recognized that the FAR
“restrict[s] the U.S. Government’s purchase of products to U.S.-made or designated country end
products for acquisitions subject to the [Trade Agreements Act],” id. at 5132-33 (citing FAR
25.403(c)(1)). After reciting the definition of the term “U.S.-made end product,” CBP defined
the term “substantial transformation” and explained how it applied that definition in prior cases:
A substantial transformation occurs when an article emerges from a
process with a new name, character or use different from that possessed by the
article prior to processing. A substantial transformation will not result from a
minor manufacturing or combining process that leaves the identity of the article
intact.
In determining whether a substantial transformation occurs in the
manufacture of chemical products such as pharmaceuticals, CBP has consistently
examined the complexity of the processing and whether the final article retains
the essential identity and character of the raw material. To that end, in cases
concerning pharmaceutical products, CBP has considered whether the API
retained its chemical and physical properties as a result of the processing
performed and whether the processing changed the medicinal use of the API.
Id. at 5133 (citations omitted). Focusing on whether a substantial transformation occurred in the
manufacture of plaintiff’s Entecavir Tablets, CBP analyzed the relevant facts and found that
because “the API does not undergo a change in name, character or use[,] . . . no substantial
transformation occurs in United States, and the Entecavir tablets would be considered a product
of India, where the API was produced, for purposes of U.S. government procurement.” Id. CBP
then addressed plaintiff’s question of “whether the Entecavir tablets are ‘manufactured in the
United States’ within the meaning of the term ‘U.S.-made end products’, as set forth in” the
FAR. Id. CBP responded in the negative:
As stated in 19 C.F.R. § 177.21, subpart B is intended to be applied consistent
with the [FAR]. The definition of country of origin in subpart B, 19 C.F.R.
§ 177.22(a) has two rules . . . as does [FAR] 25.003. The term “manufactured in
the United States” in [FAR] 25.003 correlates to the first rule of 19 C.F.R.
§ 177.22(a) which provides that an article is a product of a country or
instrumentality if “it is wholly the growth, product, or manufacture of that country
or instrumentality”. Since the production of Entecavir tablets partially occurs in
India, we do not find that they are manufactured in the United States.

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Id. Based on these findings, CBP held that “[t]he country of origin of the Entecavir tablets for
U.S. Government procurement purposes is India.” Id. Plaintiff appealed this determination, as
well as CBP’s final determinations on the other ten pharmaceuticals, at the United States Court
of International Trade (“CIT”). 9 See Acetris Health, LLC v. United States, No. 1:18-cv-00040RWG (Ct. Int’l Trade Apr. 10, 2018) (consent motion for test case designation and suspension);
Acetris Health, LLC v. United States, No. 1:18-cv-00047-RWG (Ct. Int’l Trade Mar. 7, 2018)
(complaint regarding CBP’s Entecavir Tablets country-of-origin determination).
D. The Current Procurement
1. Solicitation
On March 14, 2018, the VA issued a solicitation for proposals to supply Entecavir
Tablets to the VA and the United States Department of Defense through their Pharmaceutical
Prime Vendor Programs. 10 AR 52-53, 57. The VA provided in the solicitation that the resulting
contract would be subject to the Trade Agreements Act. See id. at 81.
To implement the Trade Agreements Act’s requirements, the solicitation incorporated by
reference the Trade Agreements clause found at FAR 52.225-5, id., and included a Trade
Agreements Certificate (as part of the FAR contract clause that sets forth the representations and
certifications that each offeror must make), id. at 112. The Trade Agreements clause contained
the VA’s determination “that the WTO GPA and FTAs appl[ied] to” its acquisition of Entecavir
Tablets, and indicated that the awardee would be required to supply “only U.S.-made or
designated country end products” under the contract. FAR 52.225-5(b); see also FAR 52.2255(a) (reflecting that the Trade Agreements clause’s definitions of the terms “U.S.-made end
product” and “designated country end product” mirror those set forth in FAR part 25). The
Trade Agreements Certificate required offerors to certify that “each end product . . . is a U.S.made or designated country end product, as defined in the” Trade Agreements clause. 11 AR 112.

9

One of the eleven cases has been designated as a test case, with proceedings in the
remaining ten cases suspended pending the outcome of the test case. See Acetris Health, LLC v.
United States, No. 1:18-cv-00040-RWG (Ct. Int’l Trade Apr. 25, 2018) (order granting motion
for test case designation and suspension).
10

Other agencies that procure pharmaceuticals through the Pharmaceutical Prime
Vendor Programs include the Indian Health Service, the Federal Bureau of Prisons, the Federal
Health Care Center, and certain State Veteran Homes. AR 57-58.
11

Offerors were also required, “[f]or statistical purposes only,” to “indicate whether the
place of manufacture” of their Entecavir Tablets was “predominantly . . . [i]n the United States
. . . or . . . “[o]utside the United States.” AR 114; see also id. at 105 (defining “place of
manufacture” as “the place where an end product is assembled out of components, or otherwise
made or processed from raw materials into the finished product that is to be provided to the
Government”).
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The VA advised offerors that it intended to award a single firm-fixed-price requirements
contract, id. at 121-22, for one base year and four option years, “to the responsible offeror that
submit[ted] an offer meeting the solicitation requirements, and [was] the lowest price technically
acceptable offer,” id. at 122. It further advised offerors, in the Trade Agreements Certificate and
elsewhere in the solicitation, that:
The Government will evaluate offers in accordance with the policies and
procedures of FAR Part 25. For line items covered by the WTO GPA, the
Government will evaluate offers of U.S.-made or designated country end products
without regard to the restrictions of the Buy American statute. The Government
will consider for award only offers of U.S.-made or designated country end
products unless the Contracting Officer determines that there are no offers for
such products or that the offers for such products are insufficient to fulfill the
requirements of the solicitation.
Id. at 112; accord id. at 56, 123. To aid its FAR part 25 evaluation, the VA directed offerors to
include in their proposals an additional certification not required by the FAR, as well as certain
country-of-origin information:
Manufacturers must also certify whether or not the end product offered in
response to this solicitation is [Trade Agreements Act] compliant. Offers that fail
to meet this requirement before contract award shall be rejected and shall receive
no further consideration.
In addition to identifying Country of Origin for the end product offered
under this solicitation in accordance with contract clause 52.212-3 Offeror
Representation and Certifications, the offeror shall also identify the Country of
Origin for all [APIs]. Offerors shall certify whether or not the end product(s)
offered in response to this solicitation are from the United States or a [Trade
Agreements Act] qualifying or designated country.
Id. at 102. The VA set a March 28, 2018 deadline for submitting proposals. Id. at 52.
2. Questions and Answers
Before the proposal submission deadline, plaintiff sent the VA five questions concerning
the solicitation. Id. at 126-27. The VA responded on March 21, 2018. Id. at 124-25. The
questions and answers are as follows:
1. The solicitation states . . . that the Government will evaluate offers in
accordance with the policies and procedures of FAR Part 25, and will only
consider offers of “U.S.-made or designated country end products” for award.
FAR 25.003 defines “U.S.-made end product” for purposes of FAR Part 25 as a
product that is manufactured in the U.S. or is substantially transformed in the U.S.
into a new article of commerce. Will the VA consider offers of [Entecavir
Tablets] to be offers of “U.S.-made end products” under the first criterion if the
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Entecavir Tablets are manufactured in the U.S. from an active chemical ingredient
manufactured in India?
[Answer:] Under the rule of origin set forth under 19 U.S.C. § 2518(4)(B): An
article is a product of a country or instrumentality only if (i) it is wholly the
growth, product, or manufacture of that country or instrumentality, or (ii) in the
case of an article which consists in whole or in part of materials from another
country or instrumentality, it has been substantially transformed into a new and
different article of commerce with a name, character, or use distinct from that of
the article or articles from which it was so transformed.
2. The solicitation states . . . that offerors that are not manufacturers must submit
a letter of commitment from the manufacturer, and that the manufacturer must
also certify whether or not the product offered in response to the solicitation is
“[Trade Agreements Act] compliant.” By “[Trade Agreements Act] compliant”
does the VA mean the product offered is either a U.S.-made or designated country
end product as both terms are defined in FAR Part 25?
[Answer:] The letter must disclose the country of origin of the API and the[n]
confirm it is [Trade Agreements Act] compliant.
3. The solicitation states . . . that the offeror must not only identify country of
origin of the offered end products in accordance with [the Trade Agreements
Certificate], but also must identify country of origin of all [APIs] in the end
products, and must “certify whether or not the end product(s) offered are from the
United States or a Trade Agreement[s] Act . . . qualifying or designated country.”
Does the phrase “end product(s) offered are from the United States” mean that
end products offers are “U.S.-made end products” as defined in FAR Part 2[5]
and if a manufacturer identifies the country of origin of API as a non-designated
country, will the VA still consider an offer of Entecavir Tablets compliant if the
tablets are manufactured in the United States?
[Answer:] In [the Trade Agreements Certificate] there is a section to disclose the
country of origin. Also, the interested company that is not the manufacture[r]
must produce a Letter of Commitment prior to award.
4. The solicitation states . . . that the Government will evaluate offers in
accordance with the policies and procedures of FAR Part 25. FAR subpart 25.5
governs evaluation of foreign offers in supply contracts, and FAR 25.504-2
“WTO GPA/Caribbean Basin Trade Initiative/FTAs” states there are two
categories of offers of “US-made end products”: those that offer domestic end
products and those that offer products that are not domestic end products but
otherwise meet the definition of U.S.-made end product, and both may be
considered in an acquisition covered by the WTO-GPA. Will the VA consider
offers of products manufactured in the U.S. that qualify as domestic end products
as defined in FAR Part 25 to be “U.S.-made end products” for purposes of the
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solicitation, whether or not they qualify as U.S.-made end products under the
substantial transformation criterion?
[Answer:] If the manufacture of the drug is not [Trade Agreements Act]
compliant and there are no [Trade Agreements Act] offers received then the
Government may take Non-[Trade Agreements Act] offers. The substantial
[transformation] determination is determined by [CBP]. The Buy American Act
is under $190,000 and the Trade Agreement[s] Act is $190,000 and above. 12
5. Will the VA consider “Entecavir Tablets” currently offered under [plaintiff’s
then-existing contract] that are manufactured in the U.S. to be US-made end
products as defined in FAR Part 25, even if [CBP] has determined under its rules
for determining if a product is a product of a designated country that the tablets
are a product of India?
[Answer:] [CBP’s] determination is final and cannot be overturned. The API was
manufactured in India and India is deemed Non-[Trade Agreements Act]
compliant.
Id. (footnote added). Notwithstanding the VA’s responses to its questions, plaintiff submitted a
proposal in response to the solicitation on March 28, 2018. Id. at 129-202. Two other
companies also submitted proposals: [. . .] and Golden State Medical Supply, Inc. (“Golden
State”). Id. at 276-348, 422-95.
3. Discussions
The VA initiated written discussions with all three offerors on April 6, 2018, requesting
that the offerors submit final proposal revisions addressing specific issues. Id. at 749-54. The
VA raised the following issues with all three offerors:
•

“Per the solicitation’s Scope of Contract . . . , ‘The contract effective date
shall be no later than 60 days but no earlier than 04/13/2018.’ The current
contract expires 04/12/2018. If awarded a contract, state when [you] will be
able to meet the contract effective date.”

•

“The Government requests that [you] certify whether the offer[ed] end
product meets one of the definitions in FAR 52.225-5 of either ‘U.S.-made
end product’ or ‘Designated country end product.’”

•

“The Government is requesting price consideration on line items 1 and 2.
Your best and final offer should be stated in the Final Proposal Revision.”

12

Effective January 1, 2018, the threshold for applying the Trade Agreements Act to
procurements covered by the WTO GPA is $180,000. Procurement Thresholds for
Implementation of the Trade Agreements Act of 1979, 82 Fed. Reg. 58248 (Dec. 11, 2017).
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Id. at 749-53. In addition, the VA asked plaintiff to address “whether there has been any change
to [CBP’s] final ruling dated January 30, 2018,” id. at 749, and suggested that [. . .] submit a
letter of commitment that “state[d] whether or not the end product is [Trade Agreements Act]
compliant and disclose[d] the country of origin of the API and the final country of the end
product,” id. at 751.
In its response to the VA’s inquiries, plaintiff (1) asserted that it would be able provide
certain quantities of Entecavir Tablets immediately upon award and full contract quantities
within [. . .] days of award; (2) stated that the API of its Entecavir Tablets is manufactured in
India; (3) certified that its Entecavir Tablets “meet[] the definition of ‘U.S.-made end product’
set forth in FAR 52.225, notwithstanding the determination by CBP, now on appeal, that the
country of origin under its rules is India”; and (4) confirmed that there had been no change to
CBP’s final determination regarding the Entecavir Tablets. Id. at 757. [. . .], in turn, responded
to the VA’s inquiries by (1) indicating that it could provide its Entecavir Tablets [. . .] days after
award, (2) providing a letter of commitment that did not include the requested country-of-origin
information, and (3) certifying that its Entecavir Tablets were Trade Agreements Act compliant.
Id. at 762-63. And, Golden State responded to the VA’s inquiries by (1) providing an updated
letter of commitment that indicated that for its Entecavir Tablets, the API’s country of origin is
[. . .] and the end product’s country of origin is [. . .]; and (2) indicating that it could provide its
Entecavir Tablets within sixty days of award. Id. at 768. None of the three offerors changed its
proposed prices. Id. at 851-53; see also id. at 132 (indicating that plaintiff offered a price of
$[. . .] per bottle for [. . .] Entecavir Tablets), 277 (indicating that [. . .] offered prices of $[. . .]
per bottle of the 0.5 mg Entecavir Tablets and $[. . .] per bottle of the 1.0 mg Entecavir Tablets),
425 (indicating that Golden State offered prices of $50.60 per bottle of the 0.5 mg Entecavir
Tablets and $53.70 per bottle of the 1.0 mg Entecavir Tablets).
4. Proposal Evaluation and Contract Award
On April 12, 2018, the VA informed plaintiff that it had rejected plaintiff’s proposal
“because the manufacturing location” of plaintiff’s Entecavir Tablets–India–“is not a Trade
Agreements Act designated country.” Id. at 770. Thereafter, the VA prepared a Price
Negotiation Memorandum that contained its source selection decision. Id. at 847-57. In that
document, the VA noted that it had received three proposals, all of which it found to be
technically acceptable. Id. at 848-49. In describing plaintiff’s proposal, the VA noted that the
API of plaintiff’s Entecavir Tablets was from India, and that “CBP’s ruling dated January 30,
2018 stated that [plaintiff’s] offered product (also the product on their recently terminated
contract) was not considered to be substantially transformed in a [Trade Agreements Act]
designated country.” Id. at 849. The VA then summarized its discussions with the three
offerors. With respect to its discussions with plaintiff, the VA remarked:
The [. . .] days of products availability is an exception to the solicitation terms,
thereby rendering the proposal unacceptable. . . . The CBP decision has been
appealed, and the appeal before the [CIT] is pending. The CBP decision is valid,
and as a result [plaintiff’s] offer will not receive further consideration. Although
[plaintiff] was found to be technically acceptable, [its] products are not [Trade
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Agreements Act] compliant. A letter of rejection was sent to [plaintiff] on
04/12/2018. Two other companies submitted technically acceptable offers for
[Trade Agreements Act]-compliant products.
Id. at 851. The VA proceeded to evaluate the two remaining proposals. Id. at 853. It noted that
[. . .] proposed a total price (base year plus four option years) of $[. . .], and Golden State
proposed a total price (base year plus four option years) of $6,465,583.50. Id.; see also id. at 838
(indicating that plaintiff proposed a total price (base year plus four option years) of $[. . .]). It
then commented:
Although [[. . .]’s letter of commitment] did not state the country of origin[ of the]
API and the final country of the end product as requested in the Final Proposal
Revision, the Contract Specialist made the determination to not re-open
discussions. This determination was made after comparing the prices of both
technically acceptable offers. Re-opening discussions with both offerors in order
to obtain this clarification from [. . .] would constitute an undu[e] delay in the
procurement, as [. . .] offer was approximately $[. . .] higher than that of the next
best offeror’s prices.
Id.; see also id. at 847 (noting that the VA’s estimated price for the contract was $20,659,900,
which was based on the prices in its contract with plaintiff), 853 (noting that Golden State’s
proposed price of $6,465,583 would result in cost savings of $32,422,899 over the prices it
would obtain on the open market). In short, because Golden State submitted the lowest-priced,
technically acceptable proposal, the VA, upon concluding that Golden State was a responsible
offeror, recommended that Golden State be awarded the contract. Id. at 856. Indeed, on May 9,
2018, the VA notified Golden State that it had been awarded the contract. Id. at 860; see also id.
at 859 (indicating that [. . .] was notified that it was an unsuccessful offeror on May 9, 2018),
861-932 (containing the executed contract). The effective date of the contract was July 8, 2018.
Id. at 860-61.
II. PROCEDURAL HISTORY
Five days before the March 28, 2018 proposal submission deadline, plaintiff filed a
protest in this court challenging the solicitation on three grounds. In its first claim for relief,
plaintiff contends that the VA improperly construed the Trade Agreements clause as
(1) prohibiting the purchase of plaintiff’s Entecavir Tablets unless the VA determined that there
are no Trade Agreements Act compliant products available to purchase, and (2) excluding the
purchase of products that qualify as both domestic end products under the Buy American statute
and U.S.-made end products under the Trade Agreements clause. Compl. ¶¶ 74-75. In its
second claim for relief, plaintiff contends:
The VA Solicitation requirement that “[m]anufacturers must also certify whether
or not the end product offered in response to this solicitation is [Trade
Agreements Act] compliant” and statement that “[o]ffers that fail to meet this
requirement before contract award shall be rejected and shall receive no further
consideration” unduly restrict[] offers to products of [Trade Agreements Act]
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countries, [and] excludes products manufactured in the U.S., which is not a [Trade
Agreements Act] country . . . .
Id. ¶ 82 (first and third alterations in original). In its third claim for relief, plaintiff contends that
the VA improperly relied on CBP to make a country-of-origin determination rather than
independently determining whether plaintiff’s Entecavir Tablets qualify as U.S.-made end
products under the Trade Agreements clause incorporated into the solicitation. Id. ¶¶ 88-90. To
remedy these purported errors, plaintiff seeks both declaratory and injunctive relief. Compl.
Prayer for Relief ¶¶ 1-7. Specifically, it seeks declarations that
•

“the [Trade Agreements] Clause permits purchase of U.S.-made end products
that are manufactured in the U.S. even if CBP has stated that the [API] used,
along with inactive ingredients, in the manufacture of the products, is from
India and not ‘substantially transformed’ in the manufacturing process,” id.
¶ 1;

•

“the VA’s Solicitation is defective, arbitrary and capricious and violates the
FAR,” id. ¶ 3;

•

“the [Trade Agreements] Clause’s standard for determining a U.S.-made end
product based on the ‘manufactured in the United States’ criterion is separate
and different from the standard in CBP’s regulation, and permits the
government to purchase U.S.-made end products manufactured in the U.S.
from foreign components,” id. ¶ 5; and

•

“the VA’s refusal to interpret and give full effect to the U.S.-made end
product provision of the [Trade Agreements] Clause, in complete reliance on
CBP, is an abdication of its responsibility to interpret the contract terms,
arbitrary and capricious, an abuse of discretion and contrary to [the] FAR,” id.
¶ 6.

And, it seeks an injunction prohibiting the VA from
•

“interpreting the [Trade Agreements] Clause of the Solicitation as prohibiting
purchase of U.S.-made products manufactured in the U.S., including [its]
Entecavir Tablets,” id. ¶ 2;

•

“proceeding with the contemplated procurement through a Solicitation that
mandates rejection of any offer for which the manufacturer has not certified
[Trade Agreements Act] compliance where the offered product is a U.S.-made
product manufactured in the United States,” id. ¶ 4; and

•

“relying solely on CBP to interpret the [Trade Agreements] Clause and
refusing to interpret and give full effect to the definition of U.S.-made end
product in the [Trade Agreements] Clause and the first alternative criterion
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under that definition: the product is manufactured in the United States,” id.
¶ 7.
Plaintiff amended its complaint only to clarify its allegation of standing, Am. Compl. ¶ 15; it has
not sought to supplement its complaint with allegations pertaining to the VA’s rejection of its
proposal for the Entecavir Tablets contract or the VA’s award of the Entecavir Tablets contract
to Golden State, both of which occurred after plaintiff lodged this preaward protest.
With its complaint, plaintiff filed a motion for a temporary restraining order and
preliminary injunction. In its response to plaintiff’s motion, filed four days later, defendant
moved to dismiss the bid protest pursuant to Rules 12(b)(1) and 12(b)(6) of the Rules of the
United States Court of Federal Claims (“RCFC”). The court denied plaintiff’s motion in a
March 28, 2018 Opinion and Order and then denied defendant’s motion in a May 8, 2018
Opinion and Order. Thereafter, the court adopted a schedule proposed by the parties for the final
resolution of the bid protest. Defendant moved to dismiss plaintiff’s bid protest for lack of
standing, plaintiff moved to supplement the administrative record, and both parties moved for
judgment on the administrative record. Briefing concluded on June 29, 2018, and the court heard
argument on July 9, 2018. The court is now prepared to rule.
III. DEFENDANT’S MOTION TO DISMISS FOR LACK OF STANDING
A. Legal Standard
As a threshold matter, defendant moves to dismiss plaintiff’s bid protest for lack of
standing. “[T]he question of standing is whether the litigant is entitled to have the court decide
the merits of the dispute or of particular issues.” Warth v. Seldin, 422 U.S. 490, 498 (1975). In
bid protests, standing “is framed by 28 U.S.C. § 1491(b)(1), which . . . imposes more stringent
standing requirements than Article III.” Weeks Marine, Inc. v. United States, 575 F.3d 1352,
1359 (Fed. Cir. 2009). Under §1491(b)(1), bid protests may only be brought by “interested
parties.” Interested parties are those “actual or prospective bidders or offerors whose direct
economic interest would be affected by the award of the contract or by failure to award the
contract.” Am. Fed’n of Gov’t Emps. v. United States, 258 F.3d 1294, 1302 (Fed. Cir. 2001)
(citing 31 U.S.C. § 3551(2)(A) (2000)). Therefore, to have standing, a protestor must establish
that it (1) is an actual or prospective offeror and (2) possesses a direct economic interest in the
award of (or failure to award) the contract. CGI Fed. Inc. v. United States, 779 F.3d 1346, 1348
(Fed. Cir. 2015); see also Lujan v. Defenders of Wildlife, 504 U.S. 555, 561 (1992) (noting that
the burden of establishing standing is on “[t]he party invoking federal jurisdiction”). In other
words, a protestor must show that it is prejudiced by the procuring agency’s conduct. 13 See Diaz
v. United States, 853 F.3d 1355, 1358 (Fed. Cir. 2017) (explaining that to demonstrate a “direct
economic interest,” a protestor must “‘show that it was prejudiced by a significant error in the
procurement process.’” (quoting Labatt Food Serv., Inc. v. United States, 577 F.3d 1375, 1378
13

A protestor must also demonstrate prejudice to succeed on the merits of its protest.
See Data Gen. Corp. v. Johnson, 78 F.3d 1556, 1562 (Fed. Cir. 1996) (“[T]o prevail in a protest
the protester must show not only a significant error in the procurement process, but also that the
error prejudiced it.”).
-13-

(Fed. Cir. 2009))); Info. Tech. & Applications Corp. v. United States, 316 F.3d 1312, 1319 (Fed.
Cir. 2003) (“[B]ecause the question of prejudice goes directly to the question of standing, the
prejudice issue must be reached before addressing the merits.”); Myers Investigative & Sec.
Servs., Inc. v. United States, 275 F.3d 1366, 1370 (Fed. Cir. 2002) (“[P]rejudice (or injury) is a
necessary element of standing.”).
B. Plaintiff Has Standing to Pursue Its Preaward Protest Claims
There is no question that plaintiff qualifies as an actual or prospective offeror with
respect to the Entecavir Tablets procurement–plaintiff was a prospective offeror when the VA
issued the solicitation and then became an actual offeror when it submitted its proposal. Rather,
the parties’ dispute focuses on whether plaintiff has a direct economic interest in the
procurement. “Generally, to prove the existence of a direct economic interest, a [protestor] must
show that it had a ‘substantial chance’ of winning the contract.” Orion Tech., Inc. v. United
States, 704 F.3d 1344, 1348 (Fed. Cir. 2013) (quoting Rex Serv. Corp. v. United States, 448 F.3d
1305, 1307 (Fed. Cir. 2006)). “An exception to that standard is when a prospective bidder
challenges the terms of the solicitation itself, prior to actually submitting a bid. In that
circumstance, the protestor can establish standing by demonstrating that it suffered a ‘non-trivial
competitive injury which can be redressed by judicial relief.’” Id. (quoting Weeks Marine, Inc.,
575 F.3d at 1361).
In its motion to dismiss, defendant argues that plaintiff cannot demonstrate that it was
prejudiced by the VA’s conduct because plaintiff did not submit the lowest-priced proposal, 14
14

Defendant also advances an argument that appears contrary to the evidence in the
administrative record. Specifically, defendant contends that the VA would have found plaintiff
to be a nonresponsible offeror because plaintiff “represented in its final proposal revision that it
was unable to comply with the solicitation’s stated delivery schedule.” Cross-Mot. 9. The
solicitation provision upon which defendant relies– “1.4 Contract Effective Date” –provides:
The contract effective date shall be 60 days but no earlier than 04/13/2018.
Before the contract effective date, the [Pharmaceutical Prime Vendors] will begin
placing orders with the contractor for delivery . . . . The contractor shall ensure
that sufficient inventory of contract items awarded under this solicitation is
available . . . to permit the [Pharmaceutical Prime Vendors] to begin timely
distribution of Government orders by the contract effective date. Payment terms,
time and place of delivery to [Pharmaceutical Prime Vendor] distribution centers
and other business-to-business agreement terms shall be agreed upon between the
[Pharmaceutical Prime Vendor] contractors and the contractor awarded a contract
from this solicitation.
AR 57; accord id. at 74 (“Delivery order requirements such as product quantities, time and place
of delivery, and method of delivery for product(s) awarded on resultant contract(s) will be
determined between the awarded contractor(s) and Government Prime Vendor contractors.”),
121 (indicating that the VA “contemplate[d] an award of a Firm Fixed Price, Requirements
contract,” which, pursuant to FAR 16.501-2(a), is a type of indefinite-delivery contract that “may
be used to acquire supplies and/or services when the exact times and/or exact quantities of future
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and therefore had no chance to be awarded the contract. In response, plaintiff contends that
defendant incorrectly applies the “substantial chance” standard to its preaward allegations, and
that under the proper standard, it has suffered a nontrivial competitive injury from the VA’s
conduct that can be redressed by the court. In its reply, defendant expands on the position it
advanced in its motion, arguing that plaintiff has never had standing to pursue its claims in this
court, even before it submitted a proposal. The court finds no merit in either of defendant’s
arguments.
With respect to defendant’s first argument, the court notes, as a preliminary matter, that it
is obliged to assess standing based on the allegations in the complaint. See Gwaltney of
Smithfield, Ltd. v. Chesapeake Bay Found., Inc., 484 U.S. 49, 65 (1987) (“[A]llegations of
injury are sufficient to invoke the jurisdiction of a court. . . . [A] suit will not be dismissed for
lack of standing if there are sufficient ‘allegations of fact’–not proof–in the complaint or
supporting affidavits.” (quoting Warth, 422 U.S. at 501)); Warth, 422 U.S. at 501 (“For purposes
of ruling on a motion to dismiss for want of standing, both the trial and reviewing courts must
accept as true all material allegations of the complaint, and must construe the complaint in favor
of the complaining party.”); Tech Sys., Inc. v. United States, 98 Fed. Cl. 228, 244 (2011)
(“[Prejudice] is . . . assessed based on the cumulative impact of the well-pled allegations of
agency error (which are assumed true at this juncture of proceedings).”); see also Distributed
Sols., Inc. v. United States, 539 F.3d 1340, 1343 (Fed. Cir. 2008) (explaining that the allegations
in the complaint confirmed that the protestors were challenging the procuring agency’s decision
to outsource the award of subcontracts, and not the award of the subcontracts by the outside
entity); cf. CGI Fed. Inc., 779 F.3d at 1350 (rejecting the government’s contention that the
protestor’s “prospective bidder status dissolved on the day bidding ended in the middle of its
[Government Accountability Office] protest”). The complaint in this bid protest contains no
allegations concerning plaintiff’s submission of a proposal, the VA’s evaluation of proposals, or
the VA’s award of the contract to Golden State (nor could it have, given that those events
occurred after plaintiff filed its complaint).

deliveries are not known at the time of contract award”). This provision does not set a delivery
schedule or require that offerors be able to supply full contract quantities by the contract
effective date. See also id. at 35 (noting, in the VA’s acquisition plan, that “[t]here are no
specific scheduling constraints for this procurement; this will be an indefinite delivery type
contract and just-in-time delivery will be provided through the . . . Pharmaceutical Prime Vendor
contractors”). Rather, it only (1) advises offerors when they should be prepared to begin
supplying Entecavir Tablets under the contract and (2) requires offerors to ensure that they can
meet demand as of that date. In its final proposal revision, plaintiff indicated that it would be
able to supply [. . .] bottles of the 0.5 mg Entecavir Tablets and [. . .] bottles of the 1.0 mg
Entecavir Tablets immediately upon award, and “full contract quantities [. . .] days after award
notification.” Id. at 757; see also id. at 53 (reflecting that offerors were directed, for the base
year of the contract, to propose prices for 19,308 bottles of the 0.5 mg Entecavir Tablets and
5887 bottles of the 1.0 mg Entecavir Tablets–these quantities were classified elsewhere in the
solicitation as “estimated quantities”). Plaintiff did not represent that it could not satisfy orders
for Entecavir Tablets by the contract effective date.
-15-

Based on the allegations set forth in plaintiff’s complaint, this protest falls squarely
within the factual scenario presented in Weeks Marine, Inc. In that case, the United States Court
of Appeals for the Federal Circuit (“Federal Circuit”) observed:
[I]n a case such as this, where a prospective bidder/offeror is challenging a
solicitation in the pre-award context . . . , it is difficult for a prospective
bidder/offeror to make the showing of prejudice that we have required in postaward bid protest cases. The reason of course is that, in a case such as this, there
have been neither bids/offers, nor a contract award. Hence, there is no factual
foundation for a “but for” prejudice analysis.
575 F.3d at 1361 (citation omitted). Several years later, in Orion Technology, Inc., the Federal
Circuit reiterated that the “substantial chance” test does not apply “when a prospective bidder
challenges the terms of the solicitation itself, prior to actually submitting a bid.” 448 F.3d at
1307. Certainly, as defendant notes, there are cases in which the “substantial chance” test has
been applied in preaward bid protests. See, e.g., CS-360, LLC v. United States, 94 Fed. Cl. 488,
495 (2010); DMS All-Star Joint Venture v. United States, 90 Fed. Cl. 653, 661 (2010); Med.
Dev. Int’l, Inc. v. United States, 89 Fed. Cl. 691, 701 (2009). However, in all of those cases, the
protestors challenged either the evaluation of bids/proposals or the award of the contract to
another bidder/offeror, and the protests were filed after the submission of bids/proposals but
before the procuring agency awarded the contract. See CS-360, LLC, 94 Fed. Cl. at 493-94 (bid
submitted June 17, 2010, bid protest challenging rejection of bid filed July 13, 2010, contract
award postponed until September 7, 2010); DMS All-Star Joint Venture, 90 Fed. Cl. at 659-60
(final revised proposals due February 3, 2009, bid protest challenging price realism analysis and
proposed award filed October 28, 2009); Med. Dev. Int’l, Inc., 89 Fed. Cl. at 701 (“[The
protestor] lodged its protest before the contract was awarded, but after the competitive range had
been determined. . . . The factual record in this case is fully developed regarding the disputed
issue: the competitive range determination.”); see also Magnum Opus Techs., Inc. v. United
States, 94 Fed. Cl. 512, 530 n.13 (2010) (“Occasionally pre-award cases arise in which proposals
have been submitted and evaluated such that the competition can be assessed using a more
stringent prejudice standard.”); cf. Golden Mfg. Co. v. United States, 107 Fed. Cl. 264, 273
(2012) (holding, where the procuring agency amended the solicitation after it had eliminated the
protestor’s proposal from the competition, that the protestor’s standing to contend that the
amendment rendered the entire evaluation process invalid and that a new solicitation was
necessary should be assessed under the “nontrivial competitive injury” test). In contrast, plaintiff
lodged its protest before it submitted a proposal, and is not challenging the evaluation of
proposals or the award of the contract to Golden State. Accordingly, the appropriate test to
determine whether plaintiff has standing to pursue its claims is the “nontrivial competitive
injury” test.
Defendant’s second argument—that plaintiff never had standing to pursue its claims in
this court—is equally unconvincing. Specifically, defendant contends that “[a]t the time
[plaintiff] filed its original complaint, it could not have suffered any injury, having neither
submitted a proposal nor had such a proposal rejected,” and that “[t]hroughout the pendency of
this protest, [plaintiff] has never been able to demonstrate that the errors it alleges were the cause
of any injury it claims to have suffered.” Reply 2-3. As an initial matter, it is well settled that a
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protestor need not submit a proposal or have a proposal rejected to challenge an aspect of a
procurement. See 28 U.S.C. § 1491(b)(1) (2012) (providing that the United States Court of
Federal Claims has “jurisdiction to render judgment on an action by an interested party objecting
to a solicitation . . . or any alleged violation of a statute or regulation in connection with a
procurement or proposed procurement”); CGI Fed. Inc., 779 F.3d at 1348-52 (reflecting that a
company that did not submit a bid in response to a solicitation had standing to protest because it
was a prospective bidder and had a direct economic interest affected by the award of the
contract); Weeks Marine, Inc., 575 F.3d at 1362-63 (“[I]n some cases the injury stemming from
a facially illegal solicitation may in and of itself be enough to establish standing; in such a case a
bidder should not have to wait until the solicitation is applied unfavorably to establish injury.”);
Distributed Sols., Inc., 539 F.3d at 1344-45 (reflecting that the contractors that responded to a
Request for Information and alleged that they were prepared to submit bids in response to the
anticipated solicitation had standing to protest because they were prospective bidders with a
direct economic interest in the award of the contract). Indeed, the first prong of the bid protest
standing inquiry adopted by the Federal Circuit expressly contemplates the filing of bid protests
by prospective bidders and offerors.
Moreover, the allegations set forth in plaintiff’s complaint are more than sufficient to
establish that it had a direct economic interest in the award of a contract flowing from the
Entecavir Tablets solicitation. Plaintiff generally alleges that the VA improperly (1) construed
and applied the solicitation’s Trade Agreements clause, (2) included a provision in the
solicitation that was contrary to the Trade Agreements clause, and (3) relied on CBP’s countryof-origin determination rather than independently construing and applying the solicitation’s
Trade Agreements clause. Plaintiff further alleges that as a result of this conduct, its ability to be
awarded the Entecavir Tablets contract was greatly diminished because the VA would not
consider its Entecavir Tablets to be U.S.-made end products in accordance with the Trade
Agreements clause (it could only be awarded the contract if the VA received no proposals for
U.S.-made or eligible Entecavir Tablets). Such an injury is nontrivial and competitive since
plaintiff “has a definite economic stake in the solicitation being carried out in accordance with
applicable laws and regulations.” Weeks Marine, Inc., 575 F.3d at 1362; accord CGI Fed. Inc.,
779 F.3d at 1351; see also Distributed Sols., Inc., 539 F.3d at 1344-45 (indicating that the
protestors were prospective bidders that had “a direct economic interest in the government action
at issue in that they were both deprived of the opportunity to compete” and “lost significant
business opportunities amounting to approximately ten million dollars”). Further, such an injury
can be redressed by the court through the award of declaratory and injunctive relief.
Accordingly, plaintiff has standing to pursue its claims.
IV. PLAINTIFF’S MOTION TO SUPPLEMENT THE ADMINISTRATIVE RECORD
Before addressing the merits of plaintiff’s claims, the court must resolve plaintiff’s
motion to supplement the administrative record. Generally, “the focal point for judicial review
should be the administrative record already in existence, not some new record made initially in
the reviewing court.” Camp v. Pitts, 411 U.S. 138, 142 (1973). An administrative record
typically contains the materials developed and considered by an agency in making a decision
subject to judicial review. See id. at 142-43 (remarking that an agency’s finding must be
“sustainable on the administrative record made” by the agency at the time of its decision); Cubic
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Applications, Inc. v. United States, 37 Fed. Cl. 345, 349-50 (1997) (“[T]he primary focus of the
court’s review should be the materials that were before the agency when it made its final
decision.”). The administrative record “should be supplemented only if the existing record is
insufficient to permit meaningful review consistent with the” applicable standard. Axiom Res.
Mgmt., Inc. v. United States, 564 F.3d 1374, 1381 (Fed. Cir. 2009); accord id. at 1380
(“[S]upplementation of the record should be limited to cases in which the ‘omission of extrarecord evidence precludes effective judicial review.’” (quoting Murakami v. United States, 46
Fed. Cl. 731, 735 (2000), aff’d, 398 F.3d 1342 (Fed. Cir. 2005))).
As set forth in its motion, plaintiff seeks to supplement the administrative record with six
documents: (1) search results for Entecavir Tablets from the VA’s online Pharmaceutical
Catalog; (2) four documents related to, and generated during the pendency of, plaintiff’s nowterminated contract to supply Entecavir Tablets to the VA (two cure notices, a cure notice
extension letter, and a Contract Disputes Act claim letter); and (3) a declaration memorializing a
telephone conversation regarding plaintiff’s now-terminated contract. Alternatively, plaintiff
requests that the court admit these six documents into the court’s record.
With respect to all but the first document, plaintiff contends that the material at issue is
relevant to the merits of its claims and that the court would not be able to effectively review its
claims without including those documents in the administrative record. The court disagrees. As
noted above, plaintiff asserts three claims: that the VA improperly (1) construed and applied the
solicitation’s Trade Agreements clause, (2) included a provision in the solicitation that was
contrary to the Trade Agreements clause, and (3) relied on CBP’s country-of-origin
determination rather than independently construing and applying the solicitation’s Trade
Agreements clause. The administrative record, as currently constituted, contains evidence
indicating (1) how the VA construed and applied the solicitation’s Trade Agreements clause, (2)
that the solicitation contained the provision challenged by plaintiff, and (3) that the VA relied
upon CBP’s country-of-origin determination. These facts are the same as those contained within
the documents that plaintiff seeks to add to the administrative record. Thus, there is no need to
supplement the administrative record with the documents identified by plaintiff.
With respect to the first document–the VA Pharmaceutical Catalog search results–
plaintiff contends that the search results are relevant to assessing the harm it suffered from the
VA’s conduct. The court is permitted to consider extrarecord evidence in assessing the harm that
a party to a bid protest–whether it be the protestor, the procuring agency, or the successful
offeror–would suffer from the imposition of, or failure to impose, an injunction:
Standing apart from evidence supplementing the administrative record . . . are
evidentiary submissions that go to the prospective relief sought in this court. The
latter relate to an issue wholly within the court’s purview. Accordingly, “[i]t is
the responsibility of this [c]ourt, not the administrative agency, to provide for
factual proceedings directed toward, and to find facts relevant to, irreparability of
harms or prejudice to any party or to the public interest through grant or denial of
injunctive relief.” PGBA, LLC v. United States, 60 Fed. Cl. 567, 568 n.1 (2004).
. . . Evidence respecting relief . . . “necessarily would not be before an agency
decision-maker effecting a procurement decision such as a source selection
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award, . . . but would necessarily post date and flow from such agency decision.”
AshBritt, Inc. v. United States, 87 Fed. Cl. 344, 367 (2009). Accordingly, such
evidence is admitted, not as a supplement to the administrative record, but as part
of this court’s record.
PlanetSpace, Inc. v. United States, 90 Fed. Cl. 1, 5 (2009) (alterations in original) (citation
omitted); accord CBY Design Builders v. United States, 105 Fed. Cl. 303, 328 n.19 (2012)
(remarking that “the issue of prejudice . . . often cannot rest on matters in an administrative
record”); E.W., Inc. v. United States, 100 Fed. Cl. 53, 57 (2011) (“[A] bid protester’s entitlement
to relief may often turn on considerations of injury that spring from the challenged actions, and
to that extent could not be reflected in the agency record underlying those actions.”).
Accordingly, the court will consider the VA Pharmaceutical Catalog search results, to the extent
necessary, when considering plaintiff’s allegations of prejudice and harm.
In sum, the court denies plaintiff’s motion to the extent that plaintiff seeks to supplement
the administrative record with documents related to its now-terminated contract to supply the VA
with Entecavir Tablets, and grants plaintiff’s motion to the extent that plaintiff requests that the
court entertain extrarecord evidence of the harm it would suffer from the VA’s conduct.
V. THE PARTIES’ CROSS-MOTIONS FOR JUDGMENT ON THE ADMINISTRATIVE
RECORD
Finally, the court turns to the parties’ cross-motions for judgment on the administrative
record. In ruling on such motions, “the court asks whether, given all the disputed and undisputed
facts, a party has met its burden of proof based on the evidence in the record.” A & D Fire Prot.,
Inc. v. United States, 72 Fed. Cl. 126, 131 (2006) (citing Bannum, Inc. v. United States, 404 F.3d
1346, 1356 (Fed. Cir. 2005)). Because the court makes “factual findings . . . from the record
evidence,” judgment on the administrative record “is properly understood as intending to provide
for an expedited trial on the administrative record.” Bannum, 404 F.3d at 1356.
A. Legal Standard
The court reviews challenged agency conduct pursuant to the standards set forth in 5
U.S.C. § 706. 28 U.S.C. § 1491(b)(4). Specifically, “the proper standard to be applied in bid
protest cases is provided by 5 U.S.C. § 706(2)(A): a reviewing court shall set aside the agency
action if it is ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with
law.’” Banknote Corp. of Am. v. United States, 365 F.3d 1345, 1350 (Fed. Cir. 2004). Under
this standard, the court
may set aside a procurement action if “(1) the procurement official’s decision
lacked a rational basis; or (2) the procurement procedure involved a violation of
regulation or procedure.” A court reviews a challenge brought on the first ground
“to determine whether the contracting agency provided a coherent and reasonable
explanation of its exercise of discretion, and the disappointed bidder bears a
heavy burden of showing that the award decision had no rational basis.” “When a

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challenge is brought on the second ground, the disappointed bidder must show a
clear and prejudicial violation of applicable statutes or regulations.”
Centech Grp., Inc. v. United States, 554 F.3d 1029, 1037 (Fed. Cir. 2009) (citations omitted)
(quoting Impresa Construzioni Geom. Domenico Garufi v. United States, 238 F.3d 1324, 133233 (Fed. Cir. 2001)); accord Advanced Data Concepts, Inc. v. United States, 216 F.3d 1054,
1058 (Fed. Cir. 2000) (“The arbitrary and capricious standard . . . requires a reviewing court to
sustain an agency action evincing rational reasoning and consideration of relevant factors.”).
In addition to showing “a significant error in the procurement process,” a protestor must
show “that the error prejudiced it.” Data Gen. Corp., 78 F.3d at 1562; see also Bannum, 404
F.3d at 1351 (holding that if the procuring agency’s decision lacked a rational basis or was made
in violation of the applicable statutes, regulations, or procedures, the court must then “determine,
as a factual matter, if the bid protester was prejudiced by that conduct”). In a preaward bid
protest, a protestor with standing to protest satisfies the prejudice requirement:
Given the nature of a protest brought prior to the award of a contract or issuance
of a solicitation, there is no meaningful way to further assess the prejudice to the
plaintiff after examination of the merits–if the failure to hold a competition was
wrongful or there was a material error in the solicitation, then the plaintiff has
been wrongfully deprived of the opportunity to fully and fairly compete, which
suffices to establish prejudicial injury on the merits.
Magnum Opus Techs., Inc., 94 Fed. Cl. at 531; accord BINL, Inc. v. United States, 106 Fed. Cl.
26, 36 (2012); Distributed Sols., Inc. v. United States, 104 Fed. Cl. 368, 380 (2012).
B. Plaintiff Has Established Prejudicial Agency Error
In its motion for judgment on the administrative record, plaintiff reasserts the three
claims set forth in its complaint: that the VA improperly (1) construed and applied the
solicitation’s Trade Agreements clause, (2) included a provision in the solicitation that was
contrary to the Trade Agreements clause, and (3) relied on CBP’s country-of-origin
determination rather than independently construing and applying the solicitation’s Trade
Agreements clause. The court addresses each claim in turn.
1. The VA Misconstrued the Trade Agreements Clause as Preventing the Purchase of
Domestic End Products
Plaintiff first contends that the VA misconstrues the Trade Agreements clause included in
the solicitation as preventing the purchase of products that qualify as domestic end products.
Specifically, plaintiff argues, the Trade Agreements clause allows the VA to purchase U.S.-made
or designated country end products, and that all domestic end products qualify as U.S.-made end
products. Defendant disagrees with plaintiff, asserting that both the text and regulatory history
of the relevant FAR provisions (including the Trade Agreements clause) reflect that whether a
product is a domestic end product has no bearing on whether the product is a U.S.-made end

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product, and that the proper test for determining whether an offered product is a U.S.-made or
designated country end product is the Trade Agreements Act’s rule of origin.
To resolve the parties’ dispute, the court must first determine the proper construction of
the Trade Agreements clause. As reflected in Part I, supra, the court finds that plaintiff’s
construction is the correct one.
The Trade Agreements clause contains the VA’s determination “that the WTO GPA and
FTAs apply to” its acquisition of Entecavir Tablets, and indicated that the awardee would be
required to supply “only U.S.-made or designated country end products” under the contract. 15
FAR 52.225-5(b). The term “U.S.-made end product” is defined as “an article that is mined,
produced, or manufactured in the United States or that is substantially transformed in the United
States into a new and different article of commerce with a name, character, or use distinct from
that of the article or articles from which it was transformed.” FAR 52.225-5(a). In other words,
a U.S.-made end product can either be (1) “mined, produced, or manufactured in the United
States” or (2) “substantially transformed in the United States . . . .” Id. As reflected by other
provisions of the FAR, the former type of product is a domestic end product and the latter type of
product is a nondomestic end product. See FAR 25.003; FAR 25.502(b)(2); FAR 25.504-2. 16
15

Defendant relies on Klinge Corp. v. United States, 82 Fed. Cl. 127 (2008), to support
its contentions that whether a product is a domestic end product has no bearing on whether the
product is a U.S.-made end product, and that the Trade Agreements Act’s rule of origin is the
proper test to be applied. The court in Klinge Corp. remarked:
When an acquisition meets the [Trade Agreements Act] threshold, the article to be
acquired must be either “wholly the growth, product, or manufacture of [a
signatory or designated] country” or, in cases where the article “consists in whole
or in part of materials from another country . . . , it has been substantially
transformed into a new and different article of commerce with a name, character,
or use distinct from that of the article or articles from which it was so
transformed.”
Id. at 135 (quoting 19 U.S.C. § 2518(4)(B) (2000)). However, the court made this statement
without acknowledging that the solicitation at issue incorporated the United States Department of
Defense’s trade agreements clause that allowed for the procurement of U.S.-made end products,
id. at 128, and that the definition of the term “U.S.-made end product” is broader than the rule of
origin because it allows for the procurement of products that are “manufactured in the United
States,” rather than “wholly” manufactured in the United States.
16

FAR 25.504-2 provides:

If the agency gives the same consideration given eligible offers [in other words,
offers from a WTO GPA country] to offers of U.S.-made end products that are not
domestic offers, it is unnecessary to determine if U.S.-made end products are
domestic (large or small business). No further analysis is necessary. Award on
the low . . . offer [as between eligible offers and offers of U.S.-made end
products].
-21-

This conclusion is reinforced by the stated rationale for adding a class of products designated as
“U.S.-made end products” to the FAR: allowing the federal government to procure, when a trade
agreement applies to a procurement, products that were substantially transformed in the United
States in addition to domestic end products and foreign end products. See 63 Fed. Reg. at 51,642
(explaining that the then-current FAR prohibited a contractor from supplying “U.S. made end
products that do not qualify as domestic end products”–in other words, products substantially
transformed in the United States–when the Trade Agreements Act applied). Indeed, to accept
defendant’s construction of the FAR would be to prevent the federal government from procuring
a class of products–domestic end products–that it has always had the ability to purchase when
the Trade Agreements Act applied to the procurement. See FAR 25.402(a)(1) (indicating that
the federal government can give eligible products of designated countries “equal consideration
with domestic offers”); Int’l Bus. Machines, GSBCA No. 10532-P, 90-2 BCA ¶ 22,824
(explaining that the then-existing Trade Agreements clause allowed for the acquisition of
domestic end products but not products substantially transformed in the United States); see also
19 U.S.C. § 2511(a) (allowing the federal government to give equal treatment to eligible
products of designated foreign countries and “United States products”). The fact that a trade

Accord FAR 25.502(b)(2). Defendant argues that this language indicates that the VA, which
gives equal consideration to eligible offers and offers of U.S.-made end products, need not
inquire into whether an offered product is a domestic end product. Defendant is only partially
correct. This language indicates that the VA need not discriminate between types of U.S.-made
end products when determining the lowest-priced proposal. However, it does not excuse the VA
from allowing offers of both domestic and nondomestic end products in the first instance. Cf. 63
Fed. Reg. at 51,642 (explaining that some procuring agencies “provide an evaluation preference
to domestic end products, when such products are competing with other U.S. made end products
that do not qualify as domestic end products”).
Defendant’s reliance on FAR 25.001(c)–which provides that “[t]he test to determine the
country of origin for an end product under the Buy American statute . . . is different from the test
to determine the country of origin for an end product under the trade agreements” and that
“[u]nder the trade agreements, the test to determine country of origin is ‘substantial
transformation’”–is similarly misplaced. As plaintiff notes, the trade agreements do not prohibit
the United States from purchasing its own domestic end products, but instead “only require the
United States to determine which foreign products should receive non-discriminatory treatment
so as to receive equal consideration with domestic offers . . . .” Reply & Resp. 9. Indeed, FAR
25.001 was included in rewrite of FAR part 25 as “an overview to help readers understand the
part,” 63 Fed. Reg. at 51,643, and specifically refers to FAR subpart 25.4 for the policies and
procedures relating to acquisitions covered by trade agreements, FAR 25.001(b). FAR subpart
25.4, in turn, provides that “[o]ffers of eligible products receive equal consideration with
domestic offers,” FAR 25.402(a)(1), and that “in acquisitions covered by the WTO GPA,
[procuring agencies are to] acquire only U.S.-made or designated country end products,” FAR
25.403. And, as noted previously, a U.S.-made end product can be either “manufactured in the
United States” or “substantially transformed in the United States . . . .” FAR 52.225-5(a). Thus,
defendant takes FAR 25.001(c) out of context.
-22-

agreement applies to a procurement does not prevent the federal government from procuring
domestically sourced products.
Having determined that the term “U.S.-made end product,” as used in the Trade
Agreements clause, includes domestic end products, the court must next ascertain whether the
VA construed the term in this manner. The primary evidence of the VA’s construction of the
Trade Agreements clause is in its March 21, 2018 responses to plaintiff’s questions concerning
the solicitation. Plaintiff asked the VA:
Will the VA consider offers of products manufactured in the U.S. that qualify as
domestic end products as defined in FAR Part 25 to be “U.S.-made end products”
for purposes of the solicitation, whether or not they qualify as U.S.-made end
products under the substantial transformation criterion?
AR 125. The VA responded: “If the manufacture of the drug is not [Trade Agreements Act]
compliant and there are no [Trade Agreements Act] offers received then the Government may
take Non-[Trade Agreements Act] offers.” Id. Moreover, in response to a different question, the
VA stated that the Trade Agreements Act’s rule of origin is used to determine whether a product
qualifies as a U.S.-made end product under the Trade Agreements clause. 17 The VA’s responses
clearly indicate that the VA did not consider the term “U.S.-made end product” to include
domestic end products. Consequently, the VA misconstrued the Trade Agreements clause. The
VA’s failure to properly construe the Trade Agreements clause was arbitrary, capricious, and
contrary to law.
2. The VA Improperly Required Offerors to Certify Compliance With the Trade
Agreements Act
Plaintiff next claims that the VA improperly included the following provision in the
solicitation:
Manufacturers must also certify whether or not the end product offered in
response to this solicitation is [Trade Agreements Act] compliant. Offers that fail
to meet this requirement before contract award shall be rejected and shall receive
no further consideration.
17

This statement is curious, given that the definition of the term “U.S.-made end
product” differs from the rule of origin in a significant respect: a U.S.-made end product can be
“manufactured in the United States,” FAR 25.003; FAR 52.225-5(a), while the rule of origin
refers to products that are “wholly the . . . manufacture” of the United States, 19 U.S.C.
§ 2518(4)(B). The omission of the word “wholly” from the definition of “U.S.-made end
product” must be intentional since other definitions in the Trade Agreements clause (of “Free
Trade Agreement country end product,” “Least developed country end product,” and “WTO
GPA country end product”) all include the word “wholly.” See FAR 52.225-5(a). Indeed, if the
authors of the FAR wanted to use the rule of origin to determine what products qualify as U.S.made end products (as defendant argues), they would have ensured that the two definitions were
identical.
-23-

In addition to identifying Country of Origin for the end product offered
under this solicitation in accordance with contract clause 52.212-3 Offeror
Representation and Certifications, the offeror shall also identify the Country of
Origin for all [APIs]. Offerors shall certify whether or not the end product(s)
offered in response to this solicitation are from the United States or a [Trade
Agreements Act] qualifying or designated country.
Id. at 102. Plaintiff objects both to the requirement that offerors “certify whether or not the end
product offered in response to this solicitation is [Trade Agreements Act] compliant” and the
requirement that offerors identify the country of origin for the offered end product’s API.
Defendant contends that both requirements were proper.
Pursuant to the challenged certification requirement, by directing manufacturers to certify
that the offered products were “[Trade Agreements Act] compliant,” the VA was directing
offerors to affirmatively represent that their Entecavir Tablets were “wholly” manufactured or
substantially transformed in the United States or a designated country in accordance with the
Trade Agreements Act’s rule of origin. This requirement conflicts with other provisions
included in the solicitation (and taken directly from the FAR): the Trade Agreements clause and
the Trade Agreements Certificate. Specifically, the Trade Agreements Certificate required
offerors to certify that “each end product . . . is a U.S.-made or designated country end product,
as defined in the” Trade Agreements clause, id. at 112, and the Trade Agreements clause defined
the term “U.S.-made end product” as a product “manufactured in the United States” or
“substantially transformed in the United States,” FAR 52.225-5(a). In other words, there was no
requirement that the end product be “wholly” manufactured in the United States. Thus, it was
arbitrary and capricious for the VA to require manufacturers to certify that the offered products
were “[Trade Agreements Act] compliant.”
In contrast, because it was the VA’s responsibility to ensure that all of the offered
Entecavir Tablets qualified as U.S.-made or designated country end products, see also infra
Section V.B.3, the VA was entitled to direct offerors to identify the country of origin of their
Entecavir Tablets’ APIs. Such information is relevant (even if not sufficient) to determining
whether the Entecavir Tablets qualified as U.S.-made end products of a domestic nature
(manufactured in the United States), U.S.-made end products of a nondomestic nature
(substantially transformed in the United States), or designated country end products. Thus, the
VA’s request of such information was not arbitrary, capricious, an abuse of discretion, or
contrary to law.
3. The VA Was Responsible for Determining, in the First Instance, Whether Plaintiff’s
Entecavir Tablets Qualified as U.S.-Made End Products
In its third and final claim, plaintiff contends that the VA should have analyzed, for itself,
whether plaintiff’s Entecavir Tablets qualified as U.S.-made end products, rather than relying on
CBP’s country-of-origin determination. In response, defendant argues that the VA was entitled
to rely on CBP’s final determination because CBP had “relevant expertise.” Cross-Mot. 26. The
court agrees with plaintiff that the VA erred in not assessing whether plaintiff’s Entecavir
-24-

Tablets qualified as U.S.-made end products under the Trade Agreements clause for three
reasons.
First, there can be no question that procuring agencies generally, and contracting officers
in particular, are responsible for ensuring compliance with all pertinent laws and regulations
when procuring goods and services. See FAR 1.602-1(b) (“No contract shall be entered into
unless the contracting officer ensures that all requirements of law, executive orders, regulations,
and all other applicable procedures, including clearances and approvals, have been met.”). These
laws and regulations include the Trade Agreements Act and the FAR. See also Klinge Corp., 82
Fed. Cl. at 135 (explaining that when a procuring agency has reason to believe that an offeror’s
Trade Agreements Act certification is inaccurate, “the agency has a duty to make reasonable
inquiry and satisfy itself that the product offered meets the terms of the [A]ct”). There is no
evidence in the administrative record reflecting that the VA assessed whether plaintiff’s
Entecavir Tablets qualified as U.S.-made end products in accordance with the Trade Agreements
clause and FAR part 25 as a whole. Accord Veterans Contracting Grp., Inc. v. United States,
135 Fed. Cl. 610, 618-19 (2017) (holding that the VA’s failure to “look beyond the fact of a
ruling by [the Small Business Administration] to determine whether it was based on grounds
consistent with or contrary to VA’s eligibility regulations” was arbitrary and capricious). Rather,
as set forth in its March 21, 2018 responses to plaintiff’s questions, the VA merely stated its
intent to apply the Trade Agreements Act’s rule of origin.
Second, the Trade Agreements Act lacks any provision specifying that CBP, and not
procuring agencies, is responsible for determining whether an offered product qualifies as a U.S.made end product under the Trade Agreements clause. The Trade Agreements Act contains a
subchapter titled “Government Procurement.” See 19 U.S.C. §§ 2511-2518. Section 2511(a)
provides that “the President may waive, in whole or in part, with respect to eligible products of
any foreign country or instrumentality designated under subsection (b) of this section, . . . the
application of any law, regulation, procedure, or practice regarding Government procurement”
such that those products are accorded the same treatment as “United States products . . . .”
(Emphasis added). Pursuant to § 2515(b)(1), CBP is authorized to determine whether “an article
is or would be a product of a foreign country or instrumentality designated pursuant to section
2511(b),” and in making such a determination, is required to apply the rule of origin set forth in
§ 2518(4)(B). (Emphasis added). And, the rule of origin provides that
[a]n article is a product of a country or instrumentality only if (i) it is wholly the
growth, product, or manufacture of that country or instrumentality, or (ii) in the
case of an article which consists in whole or in part of materials from another
country or instrumentality, it has been substantially transformed into a new and
different article of commerce with a name, character, or use distinct from that of
the article or articles from which it was so transformed.
Id. § 2518(4)(B). Reading these provisions together, it is apparent that CBP is empowered to
determine whether a product is “wholly” manufactured in a foreign country in accordance with
the Trade Agreements Act’s rule of origin, but is not empowered to determine the threshold
question of whether an offered product is a U.S.-made end product (particularly, whether an

-25-

offered product is a domestic end product) pursuant to the Trade Agreements clause. 18 Rather,
the procuring agency is responsible to make that determination.
Third, defendant has not identified, and the court has not located, any provision in the
FAR that directs procuring agencies to refer Trade Agreements clause compliance issues to CBP.
In fact, CBP regulations reflect that the only parties that may request a country-of-origin
determination from CBP are:
(a) A foreign manufacturer, producer, or exporter, or a United States importer of
merchandise,
(b) A manufacturer, producer, or wholesaler in the United States of a like
product,
(c) United States members of a labor organization or other association of workers
whose members are employed in the manufacture, production, or wholesale in the
United States of a like product, or
(d) A trade or business association a majority of whose members manufacture,
produce, or wholesale a like product in the United States.
19 C.F.R. § 177.23. In contrast, the FAR describes other circumstances in which referral to
another executive agency is necessary. See, e.g., FAR 19.301-1(b) (“The contracting officer
shall accept an offeror’s representation in a specific bid or proposal that it is a small business
unless (1) another offeror or interested party challenges the concern’s small business
representation or (2) the contracting officer has a reason to question the representation.
Challenges of and questions concerning a specific representation shall be referred to the [Small
Business Administration] . . . .”); FAR 22.404-3(c)(2) (“Agencies should promptly submit to the
Department of Labor an offeror’s request for a project wage determination for a secondary site of
the work.”); FAR 26.103(a)-(b) (“Contracting officers and prime contractors, acting in good
faith, may rely on the representation of an Indian organization or Indian-owned economic
enterprise as to its eligibility, unless an interested party challenges its status or the contracting
officer has independent reason to question that status. In the event of a challenge . . . , the
contracting officer shall refer the matter to the [United States Department of Interior, Bureau of
Indian Affairs].”). Similarly, the decision upon which defendant relies to support its contention
that the VA was entitled to rely on CBP’s expertise–NCL Logistics Co. v. United States–reflects
that the procuring agency’s referral of an issue to another agency was mandated by regulation.
See 109 Fed. Cl. 596, 608 (2013) (indicating that “[t]he Acquisition Instruction requires
contracting officers to vet all non-U.S. vendors operating in Afghanistan as directed by [the]
18

The court does not opine on whether CBP properly applied the rule of origin to
plaintiff’s Entecavir Tablets, as it has no authority to do so. See 28 U.S.C. § 1581(e) (providing
the CIT with “exclusive jurisdiction” to review CBP’s final country-of-origin determinations).
Indeed, the court need not undertake such an analysis since this bid protest concerns only the
VA’s conduct. Cf. Klinge Corp., 82 Fed. Cl. at 135-38 (reviewing a procuring agency’s
application of the Trade Agreements Act’s rule of origin).
-26-

Fragmented Order,” and that “the contracting officer submits all non-U.S. vendors for vetting
by” the Joint Contingency Contracting System); id. at 618 (“[T]he contracting officer not only
was entitled to rely upon [the vendor vetting assessment] in her nonresponsibility evaluation, she
was required to do so.”).
In sum, the VA’s failure to independently assess whether plaintiff’s Entecavir Tablets
qualified as U.S.-made end products under the Trade Agreements clause was arbitrary,
capricious, and contrary to law.
4. Plaintiff Was Prejudiced by the VA’s Errors
The court has concluded that the VA erred in (1) construing the term “U.S.-made end
product,” as used in the Trade Agreements clause, to not include “domestic end products,” as
that term is defined in the FAR; (2) requiring manufacturers to certify that the offered products
were “[Trade Agreements Act] compliant”; and (3) failing to independently assess whether
plaintiff’s Entecavir Tablets qualified as U.S.-made end products under the Trade Agreements
clause. Plaintiff was prejudiced by these errors because they severely diminished plaintiff’s
ability to be awarded the Entecavir Tablets contract. See Magnum Opus Techs., Inc., 94 Fed. Cl.
at 531; see also Caddell Constr. Co. v. United States, 125 Fed. Cl. 30, 51 (2016) (“[P]rejudice is
presumed when the Government acts irrationally. . . . The crux of the inquiry on whether
violation of statute or regulation was prejudicial should be focused on the magnitude and
materiality of error to the procurement at hand–not on the plaintiff’s chances for securing
award.”).
C. Plaintiff Is Entitled to Declaratory and Injunctive Relief
In accordance with 28 U.S.C. § 1491(b)(2), “[t]o afford relief” in a bid protest, the United
States Court of Federal Claims “may award any relief that [it] considers proper, including
declaratory and injunctive relief except that any monetary relief shall be limited to bid
preparation and proposal costs.” Accord Turner Constr. Co. v. United States, 645 F.3d 1377,
1388 (Fed. Cir. 2011) (holding that “once jurisdiction attaches [under 28 U.S.C. § 1491(b)], the
Court of Federal Claims has broad equitable powers to fashion an appropriate remedy”).
Plaintiff requests both declaratory and injunctive relief. With respect to the latter, plaintiff seeks
a permanent injunction prohibiting the VA from (1) construing the term “U.S.-made end
product” in the Trade Agreements clause as excluding products manufactured in the United
States (in other words, a domestic end product), (2) continuing the Entecavir Tablets
procurement using a solicitation that results in the rejection of offers of U.S.-made end products
manufactured in the United States because the offeror does not certify Trade Agreements Act
compliance, and (3) relying on CBP rather than independently ascertaining whether an offered
product is manufactured in the United States pursuant to the definition of the term “U.S.-made
end product.”
1. Declaratory Relief
As an initial matter, the court concludes that plaintiff is entitled to declaratory relief in
accordance with the analysis set forth above. Specifically, the court declares:
-27-

•

The term “U.S.-made end product,” as used in the Trade Agreements clause,
includes “domestic end products,” as that term is defined in the FAR.

•

The VA’s failure to construe the term “U.S.-made end product,” as used in the
Trade Agreements clause, to include “domestic end products,” as that term is
defined in the FAR, was arbitrary, capricious, and contrary to law.

•

It was arbitrary and capricious for the VA to require manufacturers to certify
that the offered products were “[Trade Agreements Act] compliant.”

•

The VA’s failure to independently assess whether plaintiff’s Entecavir Tablets
qualified as U.S.-made end products under the Trade Agreements clause was
arbitrary, capricious, and contrary to law.
2. Injunctive Relief

Plaintiff is also entitled to some, but not all, of its requested injunctive relief. In
determining whether to award a permanent injunction, the court must consider whether (1) the
plaintiff has succeeded on the merits, (2) the plaintiff will suffer irreparable harm if the court
withholds injunctive relief, (3) the balance of hardships favors the grant of injunctive relief, and
(4) it is in the public interest to grant injunctive relief. PGBA, LLC v. United States, 389 F.3d
1219, 1228-29 (Fed. Cir. 2004). The protestor bears the burden of establishing the factors by a
preponderance of the evidence. Lab. Corp. of Am. Holdings v. United States, 116 Fed. Cl. 643,
654 (2014); Textron, Inc. v. United States, 74 Fed. Cl. 277, 287 (2006). None of the four factors,
taken individually, is dispositive, and a “weakness of the showing regarding one factor may be
overborne by the strength of the others.” FMC Corp. v. United States, 3 F.3d 424, 427 (Fed. Cir.
1993). 19 Conversely, “the absence of an adequate showing with regard to any one factor may be
sufficient, given the weight or lack of it assigned the other factors, to justify the denial” of
injunctive relief. Id. The award of injunctive relief is within the discretion of the court. See
Turner Constr. Co., 645 F.3d at 1388 (“We give deference to the Court of Federal Claims’
decision to grant or deny injunctive relief, only disturbing its decision if it abused its
discretion.”).
Because plaintiff has established the existence of significant, prejudicial procurement
errors, it has succeeded on the merits of its protest. Thus, the court addresses the remaining
factors.

19

Although FMC Corp. concerns the award of a preliminary injunction, 3 F.3d at 427,
“[t]he standard for a preliminary injunction is essentially the same as for a permanent injunction
with the exception that the plaintiff must show a likelihood of success on the merits rather than
actual success,” Amoco Prod. Co. v. Vill. of Gambell, 480 U.S. 531, 546 n.12 (1987).
-28-

a. Irreparable Injury
With respect to the irreparable injury factor, “a lost opportunity to compete for a contract
on a level playing field” can be sufficient, on its own, to constitute an irreparable injury. Hosp.
Klean of Tex., Inc. v. United States, 65 Fed. Cl. 618, 624 (2005), cited in Sys. Application &
Techs., Inc. v. United States, 691 F.3d 1374, 1383 (Fed. Cir. 2012). The court has found that
plaintiff’s ability to compete for the Entecavir Tablets contract was severely diminished by the
VA’s improper conduct. Nevertheless, with respect to the Entecavir Tablets procurement
specifically, plaintiff has not been irreparably injured by the VA’s misconduct. The
administrative record reflects that plaintiff submitted a proposal in response to the Entecavir
Tablets solicitation, but did not offer the lowest price. 20 Thus, even if the VA had properly
construed the Trade Agreements clause to permit the purchase of domestic end products and then
determined that plaintiff’s Entecavir Tablets qualified as domestic end products, plaintiff could
not have prevailed in the competition. In short, while the VA’s improper conduct diminished
plaintiff’s ability to compete for the Entecavir Tablets contract, it ultimately would not have
prevented the VA from awarding plaintiff the contract. Therefore, requiring the VA to issue a
new solicitation and reevaluate proposals would have no benefit for plaintiff.
In contrast, the administrative record reflects that plaintiff’s ability to compete for other
national contracts that the VA might award would be severely diminished in the same manner it
was diminished in the Entecavir Tablets procurement. See AR 941-68 (containing eleven CBP
country-of-origin determinations for pharmaceuticals that plaintiff supplied to the VA under
national contracts–manufactured by Aurolife in Dayton, New Jersey–in which CBP concluded,
20

During oral argument, plaintiff’s counsel contended that plaintiff would have offered a
lower price for its Entecavir Tablets had its product been considered among those deemed to be
Trade Agreements Act compliant. However, plaintiff’s complaint contains no such allegations
and the administrative record lacks any evidence that plaintiff could or would offer a lower price
in such circumstances. Indeed, the administrative record reflects that the price plaintiff actually
offered was lower than the price set forth in its now-terminated contract, and that both of those
prices are substantially higher than the price offered by Golden State. Compare AR 132
(indicating that plaintiff offered a price of $[. . .] per bottle in response to the solicitation), with
id. at 10 (indicating that plaintiff provided the VA with Entecavir Tablets under its nowterminated contract at a price of $164.00 per bottle), and id. at 862 (indicating that Golden State
will be providing the VA with Entecavir Tablets for either $50.60 or $53.70 per bottle).
Attorney argument is insufficient to establish an irreparable injury. See, e.g., Intelligent Waves,
LLC v. United States, 135 Fed. Cl. 299, 314 (2017) (noting that the protestors, rather than
submitting evidence in support of their claims of irreparable injury, relied on the averments of
counsel, and holding that neither protestor “provided the court with the evidence necessary to
carry its burden”); Totolo/King v. United States, 87 Fed. Cl. 680, 693 (2009) (“Nor can a court
evaluate the parties’ factual showings regarding the three equitable findings for injunctive relief
without accepting post-final-agency-action evidentiary submissions.”), appeal dismissed and
remanded sub nom. Totolo/King Joint Venture v. United States, 431 F. App’x 895 (Fed. Cir.
2011) (per curiam); Ashbritt, Inc. v. United States, 87 Fed. Cl. 344, 367 (2009) (holding that
evidence “pertaining to . . . the factors governing injunctive relief . . . is crucial to assess whether
relief is warranted”).
-29-

pursuant to the Trade Agreements Act’s rule of origin, that the country of origin of each
pharmaceutical was India); see also KWR Constr., Inc. v. United States, 124 Fed. Cl. 345, 362
(2015) (agreeing that “the lost opportunity to compete on future task orders and other contracts
[would] cause irreparable harm” to the protestor); Miles Constr., LLC v. United States, 108 Fed.
Cl. 792, 806 (2013) (“The real harm suffered by [the protestor] is the denial of the opportunity to
compete for the Solicitation award and for future [service-disabled, veteran-owned small
business] set-aside contracts. Denial of the opportunity to compete for a contract can constitute
irreparable harm.”). Thus, with respect to plaintiff’s request for a permanent injunction
prohibiting the VA from (1) construing the term “U.S.-made end product” in the Trade
Agreements clause as excluding products manufactured in the United States (in other words,
domestic end products) and (2) relying on CBP rather than independently ascertaining whether
an offered product is manufactured in the United States (in other words, a domestic end product)
pursuant to the definition of the term “U.S.-made end product,” the court finds that plaintiff has
been irreparably injured.
b. Balance of Harms
In addition to considering whether a protestor would suffer an irreparable injury absent a
permanent injunction, “the court must weigh the irreparable harm plaintiff would suffer without
an injunction against the harm an injunction would inflict on defendant . . . .” Progressive
Indus., Inc. v. United States, 129 Fed. Cl. 457, 485 (2016). Defendant offers no evidence
regarding the harm that the VA would suffer if it were prohibited from (1) construing the term
“U.S.-made end product” in the Trade Agreements clause as excluding products manufactured in
the United States (in other words, domestic end products) and (2) relying on CBP rather than
independently ascertaining whether an offered product is manufactured in the United States (in
other words, a domestic end product) pursuant to the definition of the term “U.S.-made end
product.” Indeed, the VA will likely benefit from properly, and independently, construing the
Trade Agreements clause in future procurements because it would be able to entertain more, and
potentially lower-priced, offers (in other words, offers it would have rejected previously for not
being “Trade Agreements Act compliant”)–competition would be enhanced. Thus, the balance
of harms tilts in plaintiff’s favor.
c. Public Interest
Finally, when “employing the extraordinary remedy of injunction,” a court “should pay
particular regard for the public consequences” of doing so. Weinberger v. Romero-Barcelo, 456
U.S. 305, 312 (1982). There is no dispute that “[t]here is an overriding public interest in
preserving the integrity of the procurement process by requiring the Government to follow its
procurement regulations.” Bona Fide Conglomerate, Inc. v. United States, 96 Fed. Cl. 233, 242
(2010). Although “there is a countervailing public interest in minimizing disruption” to the
procuring agency, Heritage of Am., LLC v. United States, 77 Fed. Cl. 66, 80 (2007), defendant
has not explained how the VA would be disrupted by properly, and independently, construing the
Trade Agreements clause in future procurements. Thus, the public interest favors the award of a
permanent injunction.

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d. Summary
In addition to prevailing on the merits of its protest, plaintiff has established that it will
suffer some irreparable harm if the court withholds injunctive relief, that the balance of harms
tips in its favor, and that an award of injunctive relief is in the public interest. Thus, an award of
a permanent injunction is warranted.
VI. CONCLUSION
For the reasons set forth above, the court DENIES defendant’s motion to dismiss on
standing grounds, GRANTS IN PART and DENIES IN PART plaintiff’s motion to
supplement the administrative record, and GRANTS IN PART and DENIES IN PART the
parties’ cross-motions for judgment on the administrative record. 21 Plaintiff is entitled to
declaratory and injunctive relief. Specifically, the court DECLARES that:
•

The term “U.S.-made end product,” as used in the Trade Agreements clause,
includes “domestic end products,” as that term is defined in the FAR.

•

The VA’s failure to construe the term “U.S.-made end product,” as used in the
Trade Agreements clause, to include “domestic end products,” as that term is
defined in the FAR, was arbitrary, capricious, and contrary to law.

•

It was arbitrary and capricious for the VA to require manufacturers to certify
that the offered products were “[Trade Agreements Act] compliant.”

•

The VA’s failure to independently assess whether plaintiff’s Entecavir Tablets
qualified as U.S.-made end products under the Trade Agreements clause was
arbitrary, capricious, and contrary to law.

In addition, the court ENJOINS the VA, in future procurements, from
•

construing the term “U.S.-made end product” in the Trade Agreements clause
as excluding products manufactured in the United States (in other words,
domestic end products), and

•

relying on CBP rather than independently ascertaining whether an offered
product is manufactured in the United States (in other words, a domestic end
product) pursuant to the definition of the term “U.S.-made end product.”

The clerk is directed to enter judgment accordingly.
21

Additionally, the court GRANTS defendant’s May 18, 2018 motion for leave to file a
declaration. Plaintiff did not file a response in opposition to defendant’s motion and, in fact,
relied on the declaration attached to motion in its motion for judgment on the administrative
record.
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The court has filed this ruling under seal. The parties shall confer to determine agreed-to
proposed redactions. Then, by no later than Wednesday, July 18, 2018, the parties shall file a
joint status report indicating their agreement with the proposed redactions, attaching a copy of
those pages of the court’s ruling containing proposed redactions, with all proposed
redactions clearly indicated.
Further, the court reminds the parties of their obligation under paragraph 12 of the
protective order filed on May 10, 2018, to file redacted versions of protected documents for the
public record. If the parties have not already filed redacted versions of their motions and
supporting briefs, they shall file a joint status report by no later than Wednesday, August 1,
2018, explaining the reason for the delay.
IT IS SO ORDERED.
s/ Margaret M. Sweeney
MARGARET M. SWEENEY
Judge

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