Teva Pharmaceuticals will remove over 200 improper patent listings from the Orange Book

On December 10, 2025, the FTC announced that Teva Pharmaceuticals will “[r]emove. . .  Over 200 Improper Patent Listings” to improve generic competition.  The Press Release states:

FTC investigation prompts Teva request for removal of patents from Orange Book, paving the way for generic competition

After a challenge from the Federal Trade Commission, Teva Pharmaceuticals has requested that the Food and Drug Administration (FDA) remove more than 200 improper patent listings from the FDA’s Orange Book. The FTC sent a series of warning letters in May 2025 to Teva and several other pharmaceutical companies, which have also withdrawn most of the disputed listings.

These challenges are part of the FTC’s broader efforts to promote competition and lower drug prices in keeping with President Trump’s Executive Order on Lowering Drug Prices. Improper patent listings can limit competition by preventing generic alternatives from entering the market. This can keep drug prices artificially high and prevent patients from accessing lower-cost alternatives. The removals of more than 200 improper listings will pave the way for greater competition for generic alternatives for more than 30 asthma, diabetes, and COPD drugs and epinephrine autoinjectors.

“President Trump has promised Americans access to prescription drugs at lower costs. The FTC is fighting to help deliver on that promise,” said FTC Chairman Andrew N. Ferguson. “When improper patent listings limit competition from generic alternatives, it hurts Americans’ bank accounts and more importantly, it can endanger their health. The Trump-Vance FTC is working hard to ensure that Americans have access to the affordable prescription drugs they need.”

The FTC’s 2025 challenges followed a decision from the U.S. Court of Appeals for the Federal Circuit decision that affirmed that Teva’s patents were improperly listed, consistent with an amicus brief filed by the FTC. The FTC will continue to monitor the pharmaceutical industry for other improper listings and anticompetitive conduct.

The Federal Trade Commission works to promote competition, and to protect and educate consumers. The FTC will never demand money, make threats, tell you to transfer money, or promise you a prize. You can learn more about how competition benefits consumers, file an antitrust complaint, or comment on a proposed merger. For the latest news and resources, follow the FTC on social media, subscribe to press releases, and read our blog.

Huawei ruling: bad news for SEPs?

From our friend Colm Ahern (Elzaburu, Madrid) comes the following hot-off-the-press comment on today's decision of the Court of Justice of the European Union in Case C-170/13 Huawei v ZTE [noted on the IPKat here].

Standard Essential Patents Lose Ground

The judgment in in Huawei v ZTE (C‑170/13) which was published today largely confirms the Advocate General’s Opinion. It amounts to a significant departure from the very strict conditions laid down by the German Bundesgerichtshof (BGH) in the Orange Book case regarding standard essential patents (SEPs) and antitrust law. It also vindicates the Commission’s position, which has been openly critical of Orange Book.

The Court effectively rejects the rules established by the BGH in the Orange Book case whereby the seeking of a cessation injunction by a patent holder with a dominant position, would only constitute abuse of that position if the alleged infringer had made an unconditional and binding licence offer which could not be limited to cases where patent infringement had been proven. By contrast the Court places the burden on the patent holder to first send a notice letter setting out not only the alleged infringement. Failure to do so before seeking a cessation injunction and removal of infringing products would constitute abuse of dominant position. If the alleged infringer expresses willingness to negotiate, then the patent holder must offer licence terms offer under FRAND conditions specifying, in particular, the amount of the royalty and the way in which that royalty is to be calculated. The alleged infringer could then respond with a counter-offer setting out alternative terms. If this offer is rejected the alleged infringer could provide a bank guarantee or place the amounts necessary on deposit. The patent holder could only avoid the charge of abuse if the counter-offer were held not to be serious and to constitute a mere delaying tactic. The alleged infringer could also reserve the right to later challenge both patent validity and the existence of infringement.

The rights held by owners of SEP patents under the “Orange Book Standard” have been significantly curtailed as a result of this judgment.

Thanks, Colm!