USA Trends and Developments Contributed by: Ed Haug, Andrew Wasson and Wan Chieh (Jenny) Lee, Haug Partners LLP
Just weeks after the FTC issued its policy state - ment, Teva sued Amneal in the District of New Jersey for patent infringement of six patents list - ed in the Orange Book for ProAir® HFA (albuterol sulfate) inhalation aerosol. The patents generally were directed to the dose counter component of an inhaler – all patents that were challenged by the FDA just a few weeks later as improperly list - ed. In response, Amneal availed itself of Hatch- Waxman’s counterclaim delisting provisions to seek an order requiring Teva to delete the patent information on the ground that the patents do not claim the drug for which the application was approved (see 21 USC Section 355(j)(5)(c)(ii)(II)). Teva moved to dismiss Amneal’s delisting coun - terclaims and Amneal cross-moved for judgment on the pleadings. At the district court level, Judge Chesler denied Teva’s motion to dismiss and granted Amneal’s cross motion, finding that the Orange Book pat - ents were not listable. Judge Chesler found that the case turned on whether the patent claimed the drug for which the applicant submitted the application, as required by the Hatch-Waxman statute. Judge Chesler found that the drug for which Teva submitted its application was albuter - ol sulfate inhalation aerosol. Thus, according to Judge Chesler, patents claiming a dose counter component of an inhaler did not claim the drug for which Teva submitted the application – rath - er, it only claimed a component. On appeal, Teva warned of far-reaching con - sequences if the Federal Circuit allowed Judge Chesler’s opinion to stand. For example, Teva contended that Judge Chesler’s logic would result in the delisting of many patents that are commonly accepted as properly listable, includ - ing patents claiming chemical genera, novel inactive ingredients or dosage forms, or patents claiming one of multiple active ingredients. To
the extent that the Federal Circuit does not reach the listability of these types of patents, we may see that generic applicants become increasingly aggressive in asserting delisting counterclaims. Thus, the authors expect to see generic appli - cants seek to delist not only the types of patents that the FTC has challenged recently (eg, device patents) but also for any patent that does not expressly recite the active ingredient, such as for chemical genera and formulation platform patents. In December 2024, the Federal Circuit affirmed the district court order delisting the challenged Orange Book patents (Teva Branded Pharm. Prods. R&D v Amneal Pharms. of NY, LLC, 124 F.4th 898 (Fed Cir 2024)). A unanimous panel rejected Teva’s principal arguments. The Federal Circuit rejected Teva’s argument that the statuto - ry term “claims” was effective coterminous with an infringement analysis as well as Teva’s argu - ment that the definition of “drug” in the Federal Food Drug and Cosmetic Act contemplated that components of a drug were individually consid - ered “drugs” under the statute. As of the time of submission, Teva has petitioned the Federal Circuit for en banc review of the panel’s deter - mination. Innovators should anticipate challenges to Orange Book listing and prepare in advance. Such preparation should include a critical evalu - ation of the basis for listing all patents in the Orange Book. For many patents, the justifica - tion for listing is likely relatively straightforward. Special care should be taken to justify patents that are listed relating to device components of drug–device combination products. In addition, innovators should confirm the basis of listability for any patent that does not expressly claim the active ingredient, even if that patent is a type that has been commonly accepted as listable, such
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