Amneal, Aided by FTC, Succeeds in Getting Teva Patents Removed from Orange Book
“There is no dispute that the Inhaler Patents contain no claim for the active ingredient at issue, albuterol sulfate. Amneal contends that the Inhaler Patents do not meet the requirement that they claim the relevant drug. The FTC agrees.” – District court opinion
In a significant ruling, the United States District Court for the District of New Jersey has ordered that Teva’s inhaler patents were improperly listed in the Food and Drug Administration’s (FDA) Orange Book, supporting Amneal’s claims that the patents did not cover key drug formulations.
The case is centered around Teva’s New Drug Application (NDA) for the ProAir HFA inhaler. While Teva holds patents related to the inhaler, a product that is used to treat potentially life-threatening respiratory conditions like COPD (chronic obstructive pulmonary disease) and common asthma, Amneal argued that the patents listed in the FDA’s Orange Book can delay or block the approval of competitive generic formulations of the drug until the patents expire. The patents at issue are U.S. Patent Nos. 8,132,712, 9,463,289, 9,808,587, 10,561,808, and 11,395,889.
The Federal Trade Commission (FTC) also filed an amicus brief in the case supporting Amneal.
Improper Listing or Infringement?
Teva asserted that their patents were properly listed in the Orange Book under 21 U.S. Code § 355 – a provision that mandates that the patents must claim the drug for which the applicant submitted the NDA and be directed toward a drug substance or product.
Under the Hatch-Waxman Act, patent owners are required to disclose to the FDA any information or patents that describe the drug, its method of use, formulations, or any other pertinent information related to the product they are aiming to protect.
However, Section 355 also establishes the Abbreviated New Drug Application (ANDA) pathway, allowing generic manufacturers like Amneal to be granted FDA approval of an equivalent drug that already has FDA approval.
In this case, Amneal was responsible for demonstrating that their ANDA product did not infringe on any existing patents. The district court was tasked with determining whether Teva’s patents were indeed improperly listed in the Orange Book, as alleged by Amneal, and whether Teva’s actions reflected anticompetitive behavior, potentially violating antitrust laws.
Judgment and Rationale – District Court Verdict
Amneal sought to enter the market with their own generic version of Teva’s ProAir inhaler. However, Teva sought to block their breakthrough into the commercial space, alleging that Amneal’s generic formulations infringed on their patents. Amneal aimed to dismiss these claims and sought judgment that certain Orange Book patents should be delisted, arguing that Teva’s patents did not actually cover the inhaler’s primary active ingredient, albuterol sulfate.
While Teva argued that delisting their patents would violate antitrust laws, the court disagreed. Teva’s Motion to Dismiss Amneal’s counterclaims was denied. Instead, the court sided with Amneal, granting their Motion for Partial Judgement on the Pleadings and allowing them to continue challenging the validity of Teva’s Orange Book patents and pursue antitrust claims. The court found that Amneal provided sufficient evidence that Teva may have violated antitrust laws by prohibiting low-cost, generic alternatives from entering the market.
By allowing Amneal’s claims to proceed, the court recognized the potential for abuse in the Orange Book listing process and the importance of allowing other companies to enter the market with competing products. The court said:
“There is no dispute that the Inhaler Patents contain no claim for the active ingredient at issue, albuterol sulfate. Amneal contends that the Inhaler Patents do not meet the requirement that they claim the relevant drug. The FTC agrees.”
This ruling is significant as it could set a precedent for similar disputes between brand name pharmaceutical companies and their generic manufacturing counterparts. It also comes after the FTC recently sent letters to 10 pharmaceutical companies disputing the relevancy of more than 300 patents protecting aspects of drugs that have received market approval from the FDA. The court’s decision to support Amneal’s claims highlights a trend toward requiring greater transparency in patents listed in the FDA’s Orange Book and. the decision could encourage other generic manufacturers to challenge similar patents.
Image Source: Deposit Photos
Author: belchonock
Image ID: 149144242
Stephanie Head
Stephanie Head is a Technology Licensing Associate at MIT’s Technology Licensing Office. In her role, she assists with intellectual property and licensing matters, facilitating the transfer of technologies from the […see more]
