FTC Challenges Teva Orange Book Listings

The Federal Trade Commission has filed an amicus brief calling out Teva Pharmaceuticals for “improperly listed patents” in FDA’s Orange Book and urging the court to order them removed. “Improper Orange Book listings can harm competition by delaying the entry of cheaper generic products,” according to the brief. The filing is in response to a case brought by Teva against drugmaker Amneal after Amneal sought approval of a generic version of asthma inhaler ProAir HFA.

Amneal argues that Teva improperly listed its patents in the Orange Book and therefore should not be able to stay approval of Amneal’s competing generic product. In its brief, FTC says the court should grant Amneal’s motion for judgment to compel de-listing of the patents at issue.

Lately, FTC has been taking a tougher stance against improper patent listings. In November, it challenged over 100 patent-listings as improperly listed, including the five patents at issue in Teva’s case against Amneal, as well as 37 additional Teva patentlistings.