08/28/2024 | Press release | Distributed by Public on 08/28/2024 12:28
Item 8.01. |
Other Events. |
As previously disclosed, in May 2021, affiliates of Jazz Pharmaceuticals plc (the "Company") filed a patent infringement suit against Avadel Pharmaceuticals plc ("Avadel"), and several of its corporate affiliates, in the United States District Court for the District of Delaware (the "Court") alleging, among other things, that Avadel's Lumryz infringed certain of the Company's patents related to controlled release formulations of oxybate and the safe and effective distribution of oxybate. Following a jury verdict finding the Company's '782 patent valid and awarding damages for infringement for Avadel's past sales of Lumryz, the Company filed a motion for a permanent injunction and ongoing royalties.
On August 27, 2024, the Court granted the Company's motion in part, preventing Avadel from seeking approval from the U.S. Food and Drug Administration or marketing Lumryz for the treatment of idiopathic hypersomnia or other indications not already a part of Lumryz's product labeling as of March 4, 2024, and enjoining Avadel from infringing in any way Claim 24 of the Company's '782 patent by making, using or selling Lumryz through and including the February 2036 expiration date of the '782 patent, subject to certain exclusions including, among other things (i) for the treatment of narcolepsy, (ii) for the treatment of patients who have been prescribed Lumryz as of the effective date of the injunction conditioned on the payment of an amount to be determined and (iii) in clinical trials and studies ongoing as of the effective date of the injunction. The Court also granted the Company's motion for an ongoing royalty for any future sale of Lumryz to patients with narcolepsy at a rate to be determined based upon further briefing by the parties on the appropriate ongoing rate above 3.5%. The Company cannot predict the ultimate outcome of this litigation, including with respect to any royalty rate.