In February 2020, Acetris Health, LLC, a generic pharmaceutical distributor, challenged the VA’s interpretation of the Trade Agreements Act of 1979 (TAA) and the Federal Acquisition Regulation (FAR) in the United States Court...more
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
Selling drugs to the Government just got a lot simpler. In Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020), the Federal Circuit opened the Government door to all drugs “manufactured”—that is, measured,...more
On February 10, 2020, the U.S. Court of Appeals for the Federal Circuit issued its long-awaited decision in Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020). In Acetris, the Federal Circuit was asked to...more
A recent Federal Circuit court decision promises to significantly impact and broaden the scope of the types of foreign-produced pharmaceutical products companies can sell to the U.S. government. ...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 February 10, 2020, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a decision clarifying the interpretation of the Trade Agreements Act (TAA) and the Federal Acquisition Regulations (FAR) with respect to...more
The US Court of Appeals for the Federal Circuit’s February 10 decision in Acetris Health, LLC v. United States provides important guidance regarding the determination of a product’s country of origin, which is a gating issue...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
Earlier today, the United States Court of Appeals for the Federal Circuit issued a decision that is sure to send shockwaves through the generic drug industry....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
Companies should include internal TAA compliance reviews in their overall manufacturing compliance programs. Every manufacturer of medical devices and pharmaceuticals that offers a product for sale to the federal...more
The United States Court of Appeals for the District of Columbia Circuit recently upheld a District Court's dismissal of a False Claims Act (FCA) complaint against a federal government contractor in a case that will be of...more
The United States Court of Appeals for the District of Columbia Circuit recently upheld a District Court’s dismissal of a False Claims Act (FCA) complaint against a federal government contractor in a case that will be of...more