Litigation Details for Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC (D. Del. 2021)

Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC (D. Del. 2021)

Docket		Date Filed	2021-08-04
Court	District Court, D. Delaware	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Gregory B. Williams
Jury Demand	Both	Referred To
Patents	10,272,062; 10,952,986; 8,101,209; 8,731,963
Link to Docket	External link to docket

Details for Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC (D. Del. 2021)

Date Filed	Document No.	Description	Snippet	Link To Document
2021-08-04				External link to document
2021-08-04	147	Letter	ordering Avadel to submit a patent certification for Jazz’s U.S. Patent No. 8,731,963. During that hearing, …relief—namely, the ongoing, statutorily prescribed patent infringement and counterclaim proceedings in the… 4 August 2021 1:21-cv-01138 830 Patent None District Court, D. Delaware	External link to document
2021-08-04	151	Opinion - Memorandum Opinion	alleges infringement of U.S. Patent Nos. 8,731,963 ("the '963 patent"), 10,758,488 ("…quot;the ' 488 patent"), 10,813 ,885 ("the ' 885 patent"), 10,959,956 ("the…;the ' 956 patent"), 10,966,931 ("the ' 931 patent"), 11 ,077,079 ("the …the ' 079 patent"), and 11,147,782 ("the '782 patent"). 1 Before the Court is …quot; It is a bedrock principle of patent law that the claims of a patent define the invention to which	External link to document
2021-08-04	179	Redacted Document	discovery related to Jazz’s U.S. Patent No. 8,731,963 (the “REMS System Patent”) (D.I. 276). In its request…System Patent regardless of the outcome of its appeal. As Jazz explained, the REMS System Patent “expired…infringement or validity of the [REMS System Patent] from either a patent or regulatory law perspective.” (D.I…Request to Stay Expert Discovery Related to the '963 Patent by Avadel CNS Pharmaceuticals LLC, Avadel CNS Pharmaceuticals… STAY EXPERT DISCOVERY RELATED TO THE ’963 PATENT ME1 43841951v.1 Case 1:21-cv-01138-GBW Document	External link to document
2021-08-04	182	Notice of Service	Kevin C. Almeroth Regarding Patent Ineligibility of U.S. Patent No. 8,731,963, (3) Opening Expert Report…Jeffrey Gudin Regarding Invalidity of U.S. Patent 8,731,963, (9) Expert Report of Dr. Martin Scharf, and… 4 August 2021 1:21-cv-01138 830 Patent Both District Court, D. Delaware	External link to document
2021-08-04	462	Redacted Document	an Avadel patent application, No. 10/826,690 (Ex. 3) that issued as U.S. Patent No. 8,101,209 on its proprietary…in this case. Rather, the Court found “that the patent cases and the trade secrets case do not share enough…support for Avadel’s argument here that Jazz’s patents are invalid for failing to name true inventors,…to Jazz on Invalidity of the Sustained Release Patents for Improper Inventorship” and is not a separate…issues; Avadel will be asking the jury to decide patent invalidity based on improper inventorship. Avadel	External link to document

Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC: A Comprehensive Litigation Summary and Analysis

Background and Context

The litigation between Jazz Pharmaceuticals, Inc. and Avadel CNS Pharmaceuticals, LLC revolves around patent disputes and regulatory challenges related to narcolepsy treatments, specifically involving Avadel's drug Lumryz and Jazz's drug Xyrem (also known as Xywav).

Patent Litigation

Patent Infringement Claims

The core of the dispute involves patent infringement claims. Jazz Pharmaceuticals alleged that Avadel's Lumryz infringes on one of its patents, specifically patent 782 related to Xyrem. A jury in the United States District Court for the District of Delaware delivered a mixed verdict, finding that Lumryz does indeed infringe on Jazz's patent but ordering a significantly lower royalty payment of 3.5% compared to the 27% sought by Jazz[1].

Counterclaims and Delisting

Avadel responded to Jazz's infringement assertions with a counterclaim seeking the delisting of the '963 patent, arguing that it does not claim a drug or method of use. The district court found that the '963 patent claims a system rather than a method, and thus it does not meet the criteria for listing under the Federal Food, Drug, and Cosmetic Act (FDCA). The court ordered Jazz to request the FDA to delist the '963 patent[2][4].

Regulatory Challenges

FDA Certification and Administrative Procedure Act (APA)

Avadel sued the FDA, alleging that the agency violated the APA by requiring certification over the '963 patent. Avadel argued that the FDA improperly listed the patent, which does not meet statutory listing criteria. The court's decision supported Avadel's position, leading to an order for Jazz to request the FDA to delist the patent[2][4].

Orphan Drug Exclusivity (ODE) and Clinical Superiority

Jazz Pharmaceuticals filed a complaint against the FDA in the District Court of D.C., challenging the FDA's decision to grant clinical superiority to Lumryz, which allowed it to break Jazz's orphan drug exclusivity for Xywav. Jazz argued that the FDA's decision was arbitrary and capricious, and that the agency lacked statutory authority to use clinical superiority to override ODE. Jazz also claimed that the FDA ignored relevant scientific considerations and prior determinations that Lumryz did not represent a significant improvement over existing therapies[5].

Court Decisions and Appeals

District Court Rulings

The district court in Delaware ruled in favor of Avadel on the issue of the '963 patent, finding it to be a system patent rather than a method patent, and ordered its delisting. However, the court also found that Lumryz infringes on one of Jazz's patents, leading to a royalty payment order[1][4].

Appeals and Stays

Jazz appealed the district court's decision regarding the '963 patent, and the Federal Circuit Court issued a temporary stay pending the resolution of the appeal. The stay was extended until the issues could be evaluated on the merits[4].

Impact and Reactions

Commercial Launch of Lumryz

Despite the mixed verdict, Avadel stated that the jury's decision would not impact the ongoing commercial launch of Lumryz, which received FDA approval in May 2023[1].

Company Statements

Jazz Pharmaceuticals expressed respect for the jury's verdict and confidence in the strength of its patent portfolio. Avadel expressed disappointment but vowed to defend its position through all available options, including an appeal[1].

Key Takeaways

• Patent Infringement: Avadel's Lumryz was found to infringe on one of Jazz's patents, but with a lower royalty payment than sought.
• Regulatory Challenges: Avadel successfully argued for the delisting of the '963 patent, and Jazz challenged the FDA's clinical superiority determination for Lumryz.
• Court Decisions: Mixed verdicts in the district court, with ongoing appeals.
• Commercial Impact: The litigation has not halted the commercial launch of Lumryz.

FAQs

1. What is the main issue in the litigation between Jazz Pharmaceuticals and Avadel CNS Pharmaceuticals?

   • The main issue revolves around patent infringement claims and regulatory challenges related to narcolepsy treatments.

2. What was the outcome of the jury verdict in the patent lawsuit?

   • The jury found that Avadel's Lumryz infringes on one of Jazz's patents but ordered a 3.5% royalty payment, significantly lower than the 27% sought by Jazz.

3. Why did Avadel sue the FDA?

   • Avadel sued the FDA alleging that the agency violated the Administrative Procedure Act by requiring certification over the '963 patent.

4. What is the basis of Jazz's complaint against the FDA regarding orphan drug exclusivity?

   • Jazz argues that the FDA's decision to grant clinical superiority to Lumryz was arbitrary and capricious and lacked statutory authority.

5. How has the litigation affected the commercial launch of Lumryz?

   • The litigation has not impacted the ongoing commercial launch of Lumryz, according to Avadel.

Cited Sources

1. Sleep Review Magazine: "Jazz, Avadel Secure Wins in Patent Lawsuit Over Narcolepsy Drug"[1].
2. Federal Circuit Blog: "Opinion Summary - Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC"[2].
3. Justia: "Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, No. 1:2021cv00691 - Document 229 (D. Del. 2022)"[3].
4. Federal Circuit Court of Appeals: "Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC"[4].
5. The FDA Law Blog: "No Sleep 'Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination"[5].