FTC Backs Amneal on Unlawful Orange Book Listings


Update: Teva Granted 30-Day Stay on Inhaler Patents’ Orange Book Delisting Last week, a federal judge in New Jersey granted Teva a 30-day stay during a hearing on their request.

Amneal, supported by the FTC, has achieved a significant legal victory against Teva by successfully removing Teva’s inhaler patents from the FDA’s Orange Book. Amneal argued that Teva’s patents, listed under the Orange Book for the ProAir HFA inhaler, did not meet the statutory requirement of claiming the drug in question. This led to a court dispute over whether Teva’s actions constituted anticompetitive behavior. The FTC filed an amicus brief in support of Amneal’s claims, marking this as a significant antitrust and intellectual property case.

The United States District Court for the District of New Jersey ruled that Teva’s patents were improperly listed in the FDA’s Orange Book, allowing Amneal to challenge their validity and pursue antitrust claims. This decision sets a precedent for future disputes over the Orange Book listing process and promotes competition in the pharmaceutical market.

The ruling emphasizes the importance of transparent patent listings and may encourage other generic manufacturers to challenge similar patents. It also aligns with recent FTC actions questioning the relevance of numerous patents protecting various drug aspects.

As part of its ongoing effort to ensure accurate patent listings and promote fair competition in the pharmaceutical industry, the FTC issued a press release and warning letters to ten pharmaceutical companies on April 30, 2024. These letters challenged over 300 patents listed in the Orange Book for various drug products, including treatments for diabetes, asthma, COPD, and weight loss.

In response to these letters, some manufacturers withdrew listed patents, while others re-certified that their patents were properly listed.

This legal victory highlights the significance of FTC efforts to enforce antitrust laws and promote fair competition.

Leave a Reply