12 known cases. View patent page →
Hatch-Waxman ANDA patent infringement action in the District of New Jersey. The multi-patent Xyrem complaint included US 7,668,730 and also asserted the '059, '988, '182, and '963 patents. The case was resolved short of trial and closed.
Federal Circuit appeal from the PTAB IPR decision on U.S. 8,589,182. The court affirmed, holding the FDA Advisory Committee materials were a publicly accessible printed publication and proper prior art; the decision disposed of the family patents together.
Inter partes review of U.S. 8,731,963. The Board held claims 24, 26, and 27 unpatentable on obviousness and on-sale/public-disclosure grounds relating to the Xyrem REMS. Related appeal No. 2017-1671 settled during appeal.
Related appeal from IPR2015-01903 (Jazz/Par appeal). The parties settled during appeal, and on January 9, 2018, Jazz entered a settlement with Par resolving the district court and IPR matters.
D.N.J. Hatch-Waxman/ANDA litigation over Xyrem. Jazz's mandatory notices in IPR2015-01903 identify the '963 patent as asserted in this action.
D.N.J. Hatch-Waxman/ANDA litigation over Xyrem. Jazz's mandatory notices in IPR2015-01903 identify the '963 patent as asserted in this action.
D.N.J. Hatch-Waxman/ANDA litigation over Xyrem. Jazz identified this action as concerning patents related to the '963 patent in its mandatory notices in IPR2015-01903.
First Jazz Complaint in D. Del. over Avadel's FT218/LUMRYZ. The consolidated action asserted five patents, including U.S. 8,731,963. The court held the '963 claims directed to systems, not methods, and ordered Jazz to request delisting from the Orange Book; on March 7, 2023, the '963 infringement claims and related counterclaims were dismissed by stipulation. Other patents, including U.S. 10,758,488 and 11,147,782, proceeded to a 2024 jury verdict.
Fourth Jazz Complaint re-asserting U.S. 8,731,963 after FDA required Avadel to file a Paragraph IV certification. Avadel counterclaimed for non-infringement, invalidity, delisting, and Sherman Act monopolization. The case was dismissed by stipulation on March 7, 2023.
APA challenge to FDA's requirement that Avadel certify against U.S. 8,731,963 (REMS patent). Jazz Pharmaceuticals intervened on July 28, 2022, to defend the FDA decision. The D.D.C. denied Avadel's requested relief, holding Avadel had an adequate remedy at law via its delisting counterclaim in the Delaware action.
Declaratory-judgment action listing the '219 patent among patents in the case, including 10,272,062; 10,736,866; 10,952,986; 7,851,506; and 8,731,963. Final disposition not confirmed.
Jazz Pharmaceuticals sued Ranbaxy Laboratories and Ranbaxy Inc. in a Hatch-Waxman ANDA patent infringement action over generic sodium oxybate referencing Xyrem. The complaint asserted multiple patents including U.S. Patent No. 8,461,203. The case was consolidated for all purposes into Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, No. 13-391-ES-JAD, and administratively terminated.