Jazz loses appeal, will have patent delisted from the Orange Book

2023-02-27

专利侵权

The US Court of Appeals for the Federal Circuit is upholding an injunction that states that a patent related to Jazz Pharmaceuticals’ narcolepsy drug should be delisted from the FDA’s generic drug compendium known as the Orange Book. The patent in question, called the ‘963 patent, is related to Jazz’s “single-pharmacy distribution system” which is designed to control access to drugs prescribed to narcolepsy patients, which can be abused. The patents include a central pharmacy and computer database that can track prescriptions and patients. Avadel CNS Pharmaceuticals originally sought to delist the patent in question, as it related to the system under its REMS. And after listing the patent in the Orange Book, Jazz filed a patent infringement lawsuit against Avadel, dropping a 30-month stay that blocked the final FDA approval of Avadel’s narcolepsy drug. However, in November, the judge in the Delaware case ruled that the FDA should delete the patent from the Orange Book, claiming that the ‘963 patent’s claims were “directed to systems, not methods.” But, in the appeal, Jazz stated that the district court had “abused” its discretion in finding that “the ’963 patent is not a method-of-use patent for listing and delisting purposes under the FDCA,” the appeals court case stated. Jazz also stated that even if the patent was not a method-of-use patent, the court still had abused its “discretion” in determining the delisting. However, the appeals court’s decision noted: Jazz further contended that in 2014, the regulatory environment allowed Jazz to list the patent which fell into a category of patents that were neither required nor forbidden to be listed. And because it listed the patent, that does not provide Avadel with the power to request an order for delisting. However, the court disagrees and finds that the Delaware court’s decision is correct. “As the ’963 patent claims neither and has been asserted in a patent infringement action against Avadel, provides Avadel with a delisting remedy. The district court therefore correctly ordered Jazz to seek delisting of the ’963 patent from the Orange Book,” the court decision said. The decision from the appeals court further stated that it found Jazz’s remaining arguments “unpersuasive” and is asking the FDA to delist the ‘963 patent. In an email to Endpoints News, a Jazz Pharmaceuticals spokesperson said:

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构