What is a thing? On February 10, 2020, the U.S. Court of Appeals for the Federal Circuit gave us a new answer to this old philosophical question. In the case of pharmaceuticals, the U.S. Department of Veterans Affairs (VA)...more
In addition to standing behind the plain language of the definition of a “US-made end product,” the court in Acetris Health, LLC v. United States provided new guidance regarding limits on Customs and Border Protection...more
The Court found the disqualification of an offeror from a pharmaceutical procurement was in error based on a U.S. Customs and Boarder Protection (CBP) interpretation of the Trade Agreements Act of 1979 (TAA)....more
On Monday, in the much-anticipated decision in Acetris Health, LLC v. U.S. 18-2399, the Court of Appeals for the Federal Circuit (the “Federal Circuit”) ruled that U.S. manufacture of a drug is sufficient to confer U.S....more
The Federal Circuit Court of Appeals has just rejected the longstanding U.S. government position that the country of origin of pharmaceuticals in the context of U.S. government procurement is determined by where the active...more
It’s not always clear where the applicability of one law or rule should stop and the applicability of another should begin. Recently, the Government Accountability Office (GAO) decision in Becton, Dickinson and Company,...more
On Thursday, August 8, 2019, the Department of Justice (“DoJ”) announced that Danish medical device company Ambu, Inc. (“Ambu”) will pay $3.3 million to settle False Claims Act (“FCA”) allegations that it violated the Trade...more
Two recent judicial decisions involving the Trade Agreements Act (“TAA”) build on a trend reflecting a more favorable enforcement climate for contractors grappling with domestic preference regimes. ...more
On July 16, 2018, the U.S. Court of Federal Claims (“Court”) issued a decision in the bid protest of Acetris Health, LLC v. United States, Case No. 18-433C, that will likely have far-reaching implications on other...more
Pharmaceutical manufacturers that produce drugs in non-designated countries under the Trade Agreements Act (TAA) may now have an opportunity to increase their sales to the United States government. The Department of Veterans...more