US Court of Appeals upheld Injunction Patent: Jazz Pharmaceuticals’ Narcolepsy Drug to be Delisted

US Court of Appeals upheld Injunction Patent: Jazz Pharmaceuticals’ Narcolepsy Drug to be Delisted

The US Court of Appeals for the Federal Circuit upheld an injunction with respect to a patent related to Jazz Pharmaceuticals’ narcolepsy drug should be delisted from the Food and Drug Administration (FDA) generic drug compendium known as the Orange Book.

The patent in issue, known as ‘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 initially had 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, winning 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.”

The Jazz filed an appeal stating 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. Jazz additionally 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 observed, “as the district court correctly analyzed in its Markman Order, these claims recite ‘an assemblage of components,’ defining a system. Jazz has not identified any description in the patent specification or prosecution history to alter that conclusion. The claims to a system comprising computer memories and a data processor are not claims to a method.”

Jazz further argued 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 had listed the patent, that does not provide Avadel with the power to request an order for delisting.

However, the Court disagreed and found that the Delaware Court’s decision stood 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,” stated the Court.

The decision from the Appeals Court further stated that it found Jazz’s remaining arguments “unpersuasive” and ordered the FDA to delist the ‘963 patent.