IP Law Daily, PATENT NEWS: FTC urges court to delist asthma inhaler patents from Orange Book, (Mar 26, 2024)

By Thomas Long, J.D.

In amicus brief filed in patent infringement suit, FTC argues five Teva patents are not entitled to 30-month block of approval for competing generics because the patents do not mention any drug.

Five patents owned by pharmaceuticals company Teva—relating to asthma inhalers and dose counters—should be removed from the Food and Drug Administration’s “Orange Book” because they do not mention any drug in their claims, the Federal Trade Commission argues in an amicus curiae brief filed in a lawsuit over efforts by drug maker Amneal to obtain approval to market generic versions of the inhalers. According to the FTC, the improper Orange Book listings are allowing Teva to delay entry into the market of less-expensive generic inhalers. The FTC’s involvement in the case is part of its ongoing effort to address what it calls “abusive” Orange Book listings that keep drug prices high by delaying or deterring the introduction of cheaper generics. The lawsuit, Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals Of New York, LLC , is pending in the U.S. District Court for the District of New Jersey

Orange Book. The FDA keeps a list of all federally approved drugs in its publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. The Orange Book identifies approved drug products and patents covering them. Listing a patent related to a brand-name drug in the Orange Book gives its manufacturer the ability to trigger a 30-month stay of approval of a competing generic product, pursuant to provisions of the Hatch-Waxman Act. Statutory and regulatory authority provide that patents eligible for Orange Book listing must consist of either drug substance (active ingredient) patents, drug product (formulation and composition) patents, or method-of-use patents.

Market for generic asthma inhalers. Asthma inhalers use the drug albuterol, which has long been off-patent. According to the FTC, despite the lack of patent protection for the drug, there is little generic competition for inhalers, “in part because brand manufacturers improperly list patents that claim device-related aspects of asthma inhalers, like dose counters, to block competition.”

Patent infringement suit. After Amneal sought FDA approval to market a generic version of asthma inhaler ProAir HFA, Teva sued Amneal for patent infringement. Because the relevant Teva patents associated with the ProAir HFA product were listed in the Orange Book, filing the suit triggered the statutory stay, meaning that the generic inhalers could be kept off the market until February 2026. Amneal filed counterclaims to remove the listings and a motion for judgment on the pleadings, asserting that Teva is using improper Orange Book listings to restrict competition and delay Amneal from marketing its generic products.

Previous efforts to secure delistings. In February of this year, three pharmaceutical companies removed some of their patents from the Orange Book after receiving warnings from the FTC, as detailed in an announcement by Senator Elizabeth Warren (D-Mass.) and Representative Pramila Jayapal (D-Wash.) The affected patents covered epinephrine injectors and inhalers, among other products. The delistings came in response to an FTC communication to 10 drug manufacturers in November 2023 identifying patents that the Commission said were improperly or inaccurately listed. Among the recipients was Teva, which was warned about the five patents at issue in the Amneal lawsuit, along with over three dozen other patent listings on inhalers. Teva did not delist or amend any of the 42 patent-listings disputed by the FTC, including the asserted patents in this case.

FTC’s views. In its brief, the FTC says that “device patents that do not mention any drug in their claims do not meet the statutory criteria for Orange Book listing, and a device patent that is improperly listed in the Orange Book must be delisted.” Teva listed the asserted patents in the Orange Book as “drug product” patents, but it is undisputed that these patents are not “drug substance” or “method of use” patents, the FTC argues. Rather, the FTC asserts, they are device and device component patents “untethered from any drug—much less the ProAir HFA albuterol sulfate formulation.”

The FTC next addresses an argument by Teva that the listing statute “broadly requires” listing all patents that “claim the drug.” In Teva’s view, the patents “read on” the ProAir HFA Inhaler. However, even if the inhaler can be considered part of the “drug,” under the statutory text it is not enough that the patent “claims the drug,” the FTC asserts.

Harms to competition. The FTC then provides information to show that improper Orange Book listings harm competition, including data on price reductions occurring after the introduction of competing generics. Without the 30-month stay for listed patents, Amneal’s generic inhalers could reach the market as early as April 2024, the FTC says, whereas allowing the stay to remain in place would impose a nearly two-year delay. The brief also asserts that the improper Orange Book listings could amount to illegal monopolization under Section 2 of the Sherman Act.

Conclusion. The FTC asks the court to grant Amneal’s motion for a judgment on the pleadings on its counterclaims and to order the five asserted patents delisted.

The case is Civil Action No. 2:23-cv-20964-JXNMAH.

Attorneys: Christine Clark (Walsh Pizzi O'Reilly Falanga LLP) for Teva Branded Pharmaceutical Products R&D, Inc. Rebekah R. Conroy (Stone Conroy LLC) for Amneal Pharmaceuticals of New York, LLC. Bradley J. Vettraino for the Federal Trade Commission.

Companies: Teva Branded Pharmaceutical Products R&D, Inc.; Amneal Pharmaceuticals of New York, LLC

News: Patent NewJerseyNews