Orange Book concerns become another problem for pharmaceutical manufacturers | Insights

Pharmaceutical manufacturers are increasingly having to contend with listing patents they believe are related to their products in the U.S. Food and Drug Administration’s (FDA) Orange Book. The Federal Trade Commission (FTC) issued a policy statement in September 2023 announcing an investigation into whether improper listings in the Orange Book “could constitute unfair competition in violation of Section 5 of the FTC Act.” Two months later, the FTC sent letters to pharmaceutical manufacturers identifying more than 100 patents it believed were improperly listed, and added concerns about more than 300 patents in another round of letters in April 2024.

In addition to the questions from the federal government, the pharmaceutical manufacturers were forced to defend themselves in court. On June 10, 2024, Judge Stanley Chesler of the U.S. District Court for the District of New Jersey ruled in Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New YorkGMBHNo. 2:23-cv-20964 (DNJ), denied a motion to dismiss Teva’s lawsuit and granted Amneal’s motion for judgment. Teva was ordered to correct or delist five asthma inhaler patents that the court found Teva had incorrectly listed in the FDA’s Orange Book. This decision is not only a blow to Teva, but also a significant victory for the FTC, which had intervened in the dispute via an amicus curiae brief.

Listing requirements

Drug manufacturers are required to list in the Orange Book, for each product they manufacture, all patents that the manufacturer believes would be infringed if a generic manufacturer manufactured the drug. Teva listed in the Orange Book a number of patents that it believed were necessary to manufacture its ProAir HFA Inhalation Aerosol inhaler. After Amneal attempted to manufacture and sell a generic version of the ProAir HFA, Teva filed suit against Amneal, claiming to have infringed those patents. Amneal, in turn, filed countersuits under Section 2 of the Sherman Act challenging Teva’s improper assertion of those patents in an attempt to prevent its listing and compel Teva to remove patents from the Orange Book.

In deciding the lawsuits, the court initially denied Teva’s motion to dismiss Amneal’s antitrust claims. Teva relied on the U.S. Supreme Court’s decision in Verizon Communications, Inc. v. Trinko, LLP540 U.S. 398 (2004), which dismissed a Section 2 suit against Verizon alleging that Verizon had failed to comply with its obligation under the Telecommunications Act of 1996 to share its network with a competitor. Teva argued that just as a violation of the Telecommunications Act was not grounds for an antitrust suit, its alleged improper listings in the Orange Book were not grounds for a Sherman Act suit by its competitor Amneal. The court rejected Teva’s argument, holding that the law requiring the company to list its patents in the Orange Book “says nothing about competitors or other pharmaceutical companies; it speaks only of certain information that” must be submitted to the FDA with a new drug application.

Next, the Court agreed with Amneal’s claim that Teva’s Orange Book registrations were inadmissible. The Court found that Teva’s patents did not “claim the drug” for which Teva had filed the Orange Book registrations because the patents “were directed to components of a metered dose inhaler but did not claim or even mention albuterol sulfate or ProAir® HFA.” Because the Court found that “a patent claims only The plaintiff referred to the subject matter which he expressly designated as an invention and nothing more,” he found Teva’s entries in the Orange Book inadmissible and ordered Teva to correct or delete the entries.

Diploma

Pharmaceutical manufacturers should consider this decision and its impact on their patents and Orange Book listings. Not only are they dealing with an FTC ready and willing to act on its belief that improper Orange Book listings may violate Section 5 of the FTC Act, but they also face litigation headwinds.