Court Orders Patents Delisted from Orange Book: Is FTC’s Newly Aggressive Posture Having an Impact?
June 11, 2024, 9:40 AM
By: Ross E. Blau
Over the past year, FTC has placed two sets of Orange Book listings in its crosshairs, but, to date, FTC has not actually begun any litigation on its own. Instead, the Commission has decided to file amicus briefs supporting FTC's policy statement that it would “scrutinize improper Orange Book listings” and “use its full legal authority” to “tak[e] actions against companies and individuals that improperly list patents in the Orange Book that do not meet the statutory listing criteria.”
One of the products identified by FTC as having improperly listed patents was Teva's ProAir HFA product. Amneal filed an ANDA to make and sell a generic version of ProAir HFA and was sued on various Orange Book-listed patents, including five “Inhaler Patents” that FTC had originally deemed improperly listed.
Amneal brought a motion for judgment on the pleadings that these Inhaler Patents were improperly listed, and FTC supported the motion as amicus curiae. Yesterday, Judge Chesler in the District of New Jersey agreed that these Inhaler Patents were improperly listed and needed to be corrected or deleted from the Orange Book. Judge Chesler's opinion concluded that the Inhaler Patents did not claim “the drug for which the applicant submitted the application” (albuterol sulfate), nor did the Inhaler Patents claim the “finished dosage form” that is the subject of the NDA.
So far, FTC has managed to obtain some success with two sets of Orange Book patents delisted voluntarily, and now another set of Orange Book patents delisted due to a generic applicant's litigation efforts. Time will tell if FTC will take on a more direct role in patent delistings, but it's clear that the FTC intends to remain active in this area.
[T]he Inhaler Patents do not claim the drug for which the applicant submitted the application.

To subscribe to our publications, click here.
Tags
News & Insights
News & Insights
NJSBA Annual Meeting and Convention 2025
Speaking Engagement
Intellectual Property
CompLaw Antitrust West Coast Conference 2025
Speaking Engagement
Antitrust
AHLA Health Care Transactions Program 2025
Sponsorship
Antitrust
ACI 21st Annual Paragraph IV Conference
Speaking Engagement
Intellectual Property
ABA 73rd Annual Section of Antitrust Law Spring Meeting
Speaking Engagement
Antitrust
AIPLA CLE Web Series: Hot Topics in Chemical & Biotech Patent Practice
Speaking Engagement
17th Annual Practitioners' Think Tank on ITC Litigation & Enforcement
Speaking Engagement
Intellectual Property
Antitrust Enforcement Trends and Policies in 2025: Unfair Competition, Merger Policies, Premerger Procedures
Webinar
Antitrust
CompLaw Nordic 2025
Speaking Engagement
Antitrust
Compounding Problems: Recent Decisions on Tirzepatide Highlight Interplay Between FDA Anti-Compounding Enforcement and Private Intellectual Property Rights
Axinn Viewpoints
Intellectual Property