Washington, D.C. — Following a decision from the United States District Court for the District of New Jersey ordering Teva Pharmaceuticals to correct or delete five improperly listed Orange Book patents for its ProAir Inhalers, the American Economic Liberties Project released the following statement.

“This is a major victory for patients facing artificially inflated drug prices, and it’s another validation of the Federal Trade Commission’s campaign against sham Orange Book patents,” said Lee Hepner, Senior Legal Counsel at the American Economic Liberties Project. “The Court’s decision fully embraces the FTC’s amicus brief in the case and sends a clear message: Big Pharma’s efforts to block other manufacturers from making and selling life-saving treatments at lower prices will not hold up under judicial scrutiny. This decision sets a powerful precedent and paves the way for a more competitive and affordable market in essential medicines. We applaud defendants’ counsel Stone Conroy LLP and the FTC for its ongoing fight against unfair patent listings.”

In September 2023, the Federal Trade Commission’s passed a policy statement condemning improper listing of patents in the Food and Drug Administration’s (FDA) Orange Book—a critical resource that lists drug patents and helps generic manufacturers navigate the regulatory landscape. The FTC has also taken action to challenge hundreds of patents—which block out generics and keep prices high—of brand name inhalers, epinephrine auto injectors and more. Since then, many drug manufactures have delisted those bogus patents.

In Teva v. Amneal, Teva sought to expand the scope of its patent and hinder competition by blocking the production of generic albuterol sulfate inhalers. Brand name inhalers can cost patients more than twice as much as generic alternatives, leading to calls for price caps and more aggressive policing of improperly-listed patents.

In ruling against Teva and for defendant/counter-claimant Amneal Pharmaceuticals, the Court found, “Teva has failed to persuade that, applying the common meaning of “claims” in patent law, any claim in any of the Inhaler Patents particularly identifies the subject of the NDA application, an albuterol sulfate HFA Inhalation Aerosol, as the invention.” The Court’s ruling not only invalidates these listings but also sets a precedent for future cases, reinforcing the FTC’s efforts to ensure a fair and competitive marketplace in drug manufacturing.

The case is Teva Pharmaceuticals USA, Inc. v. Amneal Pharmaceuticals, Inc., U.S. District Court for the District of New Jersey, Case No. 2:23-cv-20964-SRC-MAH. Defendants/Counter-claimants Amneal Pharmaceuticals et al. were represented by Stone Conroy LLP.

Read “The Cost of Pharma Cheating” for more information.

Read “A policy win for Biden that would help us all breathe easier,” for more background.  

Learn more about Economic Liberties here.

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The American Economic Liberties Project works to ensure America’s system of commerce is structured to advance, rather than undermine, economic liberty, fair commerce, and a secure, inclusive democracy. Economic Liberties believes true economic liberty means entrepreneurs and businesses large and small succeed on the merits of their ideas and hard work; commerce empowers consumers, workers, farmers, and engineers instead of subjecting them to discrimination and abuse from financiers and monopolists; foreign trade arrangements support domestic security and democracy; and wealth is broadly distributed to support equitable political power.