Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC
Authored by: Jeremy J. Gustrowsky
A recent decision in Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC provides important guidance on how far patent owners can go in blocking competitors from conducting clinical trials or seeking new drug approvals. The case centered on Jazz’s U.S. Patent No. 11,147,782, which covers a specific formulation of gamma-hydroxybutyrate (GHB). Jazz sought to stop Avadel from expanding its Lumryz product into new medical uses, including treating idiopathic hypersomnia, by obtaining a broad injunction after Avadel’s product was found to infringe the patent.
The Federal Circuit made clear that not all activities related to drug development and approval can be enjoined, even if a patent is being infringed. Specifically, the court ruled that Avadel could not be blocked from starting new clinical trials or offering open-label extensions to trial participants, because these activities are protected by the “safe harbor” provision of the Hatch-Waxman Act (35 U.S.C. § 271(e)(1)). This law allows companies to conduct research and submit information to the FDA without it being considered patent infringement, as long as the activities are reasonably related to obtaining regulatory approval.
The court also addressed whether Avadel could be stopped from submitting new applications to the FDA for additional indications of Lumryz. The judges explained that simply applying for FDA approval is not “use” of a patented invention under the general infringement statute (35 U.S.C. § 271(a)), but it may be considered an “artificial” act of infringement under a special provision (35 U.S.C. § 271(e)(2)) if the application seeks approval for a drug or use claimed in a patent. However, the court left this issue unresolved, sending it back to the district court to decide whether Avadel’s FDA application would actually constitute infringement under this provision.
This decision highlights the careful balance courts must strike between protecting patent rights and encouraging the development of new medicines. Patent owners cannot use their rights to block competitors from engaging in legitimate clinical research or from seeking regulatory approval, unless those activities clearly cross the line into infringement. The ruling is a reminder that the scope of patent injunctions in the pharmaceutical space is limited by both statutory “safe harbor” protections and the need for a direct connection between the alleged harm and the enjoined activity.