News & Analysis as of

Trade Agreements Act Pharmaceutical Industry

Whitcomb Selinsky, PC

Contractor Challenges VA Interpretation of TAA and FAR

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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

Perkins Coie

Federal Circuit Decides Country of Origin Test for Drugs Under Trade Agreements Act

Perkins Coie on

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

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Changes the Game for Selling Single-API Drugs to the Government

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

Sheppard Mullin Richter & Hampton LLP

What Does it Mean to Manufacture? Federal Circuit’s Acetris Decision Fundamentally Alters Trade Agreements Act Compliance

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

K&L Gates LLP

Pharma Ruling Broadens Gov't Drug Procurement Options

K&L Gates LLP on

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

Morgan Lewis

Important Clarifications in the Federal Circuit Acetris Decision

Morgan Lewis on

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

Pillsbury Winthrop Shaw Pittman LLP

Substantial Transformation of the FAR Trade Agreements Clause

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

Faegre Drinker Biddle & Reath LLP

Appellate Court Rules that the Government May Procure U.S. Manufactured Drug Products Despite Use of Foreign Active Pharmaceutical...

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

Morgan Lewis

Federal Circuit Acetris Decision Is Important for Pharmaceutical Manufacturers Planning Sales to US Government

Morgan Lewis on

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

Hogan Lovells

Federal Circuit Acetris Decision Changes Procurement Country of Origin Landscape

Hogan Lovells on

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

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Revolutionizes Country of Origin Analysis for Pharmaceuticals

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

Blank Rome LLP

Federal Circuit Holds Generic Drugs Manufactured in the U.S. from API Produced in India Qualify for Sale to U.S. under Trade...

Blank Rome LLP on

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

Foley & Lardner LLP

Opportunities for Increased Drug Sales to the VA

Foley & Lardner LLP on

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

Morgan Lewis

Trade Agreements Act Compliance Activity Increasing at VA

Morgan Lewis on

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

King & Spalding

Recent False Claims Act Decision Provides Important Guidance To Manufacturers And Resellers About Trade Agreements Act Compliance

King & Spalding on

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

King & Spalding

False Claims Act Update: GSA Contractor Reasonably Relied Upon Distributor Certifications Of Product Origin And Trade Agreements...

King & Spalding on

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

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