Request for a preliminary injunction preventing the agency from proceeding with a contract for Hepatitis B medication is denied, where the solicitation’s description of acceptable products did not conflict with the Trade Agreement Act, and where the court did not have jurisdiction to consider challenges to the agency’s administration of the current contract for the medication.
Acetris Health LLC challenged the terms of a Department of Veterans Affairs solicitation for Entecavir tablets for the treatment of chronic Hepatitis B.
Acetris alleged a patent ambiguity between the solicitation provision requiring an offeror to certify that its proposed end product is Trade Agreements Act compliant and the FAR provision indicating that government purchases are restricted to U.S. made or designed end country products.
The Trade Agreements Clause requires the awardee to “deliver only U.S.-made or designated country end products,” and defines a “U.S.-made end product” as “an article that is manufactured in the United States or that is substantially transformed in the United States.” According to Acetris, VA’s interpretation of this clause would prohibit the purchase of its tablets, which are manufactured in the U.S.
Next, Acetris challenged the inclusion of a separate solicitation provision requiring manufacturers to certify whether or not the end product offered is Trade Agreements Act compliant. According to Acetris, this provision improperly restricts offerors to proposing products from Trade Agreements Act countries, thereby precluding offerors from proposing products manufactured in the United States—a non-Trade Agreements Act country.
Finally, Acetris alleged that VA improperly deferred to the United States Customs and Border Protection (CBP) to interpret the clause and argued that the agency should make its own determination regarding whether a product is manufactured in the U.S. such that it qualifies as a U.S.-made end product.
Acetris moved the court for a temporary restraining order and a preliminary injunction enjoining VA from proceeding with the procurement using its current interpretation of the Trade Agreements clause.
In response, the government maintained that VA properly interpreted the Trade Agreements Clause for the forthcoming procurement. The government argued that Acetris cannot challenge its administration of the existing contract for Entecavir tablets in this bid protest. The government explained that during the administration of the incumbent contract, it requested and received CBP’s determination that the country of origin for Acetris’ supply was India, and it advised Acetris of a possible default termination if the contractor did not obtain another source.
The court concluded that Acetris was unlikely to succeed on the merits of its claims. First, the court explained that VA’s administration of the current contract for Entecavir tablets did not fall within the court’s bid protest jurisdiction, and therefore it could not consider arguments challenging VA’s possible default termination.
Next, the court found no ambiguity in the solicitation, noting that the description of acceptable products in the Trade Agreements Act regulations mirrored the description of acceptable products in the solicitation’s Trade Act Agreements Clause and Trade Agreements Certificate. Therefore, the solicitation’s requirement that products comply with Trade Agreements Act limitations did not conflict with either.
The court acknowledged that Acetris’ lost opportunity to compete for the new contract could constitute irreparable harm, but found this concern was outweighed by the adverse effects to patient health that could occur should the procurement be delayed.
Acetris Health LLC is represented by Stephen E. Ruscus. The government is represented by Daniel B. Volk of the United States Department of Justice.
