The Federal Trade Commission (FTC) has lodged an amicus brief in a case initiated by Teva against Amneal, elucidating that Teva incorrectly listed patents in the Food and Drug Administration’s (FDA) Orange Book. The brief further implores the court to mandate the elimination of those listings.
An FTC press release reveals that Teva instituted a lawsuit against Amneal, alleging patent infringement after Amneal sought FDA approval for a generic version of ProAir HFA, an asthma inhaler. Teva had catalogued the patents for its ProAir HFA in the FDA’s "Approved Drug Products with Therapeutic Equivalence Evaluations," colloquially known as the "Orange Book." As a result of these listings, Teva's patent infringement complaint triggered a statutory stay, effectively stalling the approval process for Amneal’s drug for up to 30 months.
According to the same press release, besides asserting that Teva incorrectly listed the patents in the Orange Book—thereby it has no right to delay approval of Amneal’s generic inhaler—Amneal also alleges that Teva's incorrect listings have negatively impacted competition.
The press release further states that over 40 Teva patents—including those under dispute in the lawsuit—were among more than 100 patents challenged by FTC last fall as being improperly listed in the Orange Book.
As per the press release, this amicus brief was filed in the U.S. District Court for the District of New Jersey in relation to the case titled "Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al."
