Teva Pharmaceutical Industries Ltd. is pushing for the U.S. Supreme Court to review its ongoing patent dispute over asthma inhaler patents, after the U.S. Court of Appeals for the Federal Circuit denied the company’s request to reconsider a decision ordering Teva to delist five patents related to its ProAir HFA asthma inhaler from the FDA’s Orange Book.
On March 4, Teva informed the Federal Circuit that it will seek Supreme Court intervention. That same day, the Federal Circuit affirmed its earlier ruling, which mandated Teva to remove the patents because they do not cover the active ingredient, albuterol sulfate, used in the inhaler. The court also denied Teva’s motion to delay enforcement of this decision while it seeks high court review. Without a stay, Teva argues it will lose significant statutory rights that protect its patents.
The issue stems from the FDA’s Orange Book, which lists patents tied to FDA-approved drugs. If a patent is listed, drugmakers can block generic competition for 30 months if a patent infringement suit is filed. The Federal Trade Commission (FTC) has raised concerns that some drugmakers improperly list patents that do not directly relate to the drug, such as device patents. Teva’s delisting of its patents could potentially set a precedent, leading to further challenges on similar drug-device patents.
Teva described its motion as “highly time-sensitive” because it must submit a request to the FDA by March 17 to delist the patents, with Teva arguing that any permanent delisting would result in irreparable harm, even if the patents are later reinstated.
Legal Experts Weigh In
Mark Lemley, a professor at Stanford University, stated that Teva’s case is unlikely to succeed at the Supreme Court, as it aligns with prior legal precedents and does not present a circuit split. “There is no clear legal error, and the decision seems correct,” Lemley said. He added, however, that Teva stands to make significant financial gains if it can delay the enforcement for several months.
Industry groups have been vocal on both sides of the dispute. Teva’s appeal has garnered support from major pharmaceutical companies like Sanofi and AstraZeneca, who argue that the ruling could help clarify standards for listing patents in the Orange Book. Additionally, trade groups like the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) filed briefs calling for a rehearing or revised opinion focused on device-related patents.
On the other side, Amneal Pharmaceuticals and supporters, including medical and law professors, argue that the ruling benefits patients by preventing improperly listed patents from blocking generic drug competition. “This ruling can help reduce barriers to generic entry and, ultimately, lower drug prices,” said William B. Feldman, a physician at Harvard Medical School.
Broader Implications for Drug-Device Patents
The case touches on broader issues within the generic-drug approval process, particularly around the listing of drug-device patents in the Orange Book. Legal experts say that while the Teva case is narrowly focused, it could have significant implications for how drug-device patents are treated in the future.
Robin Feldman, a professor at the University of California College of the Law, San Francisco, described the case as part of a “chessboard of moves” that drug companies use to protect their market share. If the Supreme Court takes the case, it could provide clarity on whether and how drug-device patents should be listed in the Orange Book.
Kevin Noonan, a partner at McDonnell Boehnen Hulbert & Berghoff LLP, suggested that the case is more about statutory interpretation than broader legal principles, and he expects that drugmakers will continue to find ways to list patents that meet the necessary criteria.
Future Outlook
Even if the Supreme Court declines to hear the case, the ruling could still prompt changes in how patents are listed in the Orange Book. For example, Teva or other drugmakers could seek to amend their patents to cover methods of treatment rather than just devices. If granted, these patents could then be re-listed in the Orange Book.
Legal analysts also predict that other companies could join the Supreme Court battle, especially if they are concerned about the potential for broader challenges to their drug-device patents. The outcome of this case could set a significant precedent for how the industry handles the listing of device-related patents in the future.
The case is Teva Branded Pharm. Products R&D Inc. v. Amneal Pharms. of NY LLC, Fed. Cir., No. 24-1936.
