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	2021-05-12
Court	District Court, D. Delaware	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Gregory B. Williams
Jury Demand	Both	Referred To
Parties	AVADEL CNS PHARMACEUTICALS, LLC
Patents	10,041,044; 10,046,031; 10,195,168; 10,213,400; 10,272,062; 10,675,258; 10,736,866; 10,864,181; 10,952,986; 10,973,795; 11,253,494; 11,426,373; 11,554,102; 5,008,126; 5,858,398; 6,045,501; 6,228,398; 6,309,663; 6,315,720; 6,419,960; 6,514,531; 6,755,784; 7,268,156; 7,668,730; 7,765,106; 7,765,107; 7,772,209; 7,895,059; 8,022,036; 8,101,209; 8,263,650; 8,324,275; 8,457,988; 8,589,182; 8,591,922; 8,731,963; 8,772,306; 8,901,173; 9,050,302; 9,132,107; 9,486,426
Attorneys	Rose S. Lee; Sarah W. Wang
Firms	DLA Piper LLP (US); McCarter & English LLP
Link to Docket	External link to docket

Biologic Drugs cited in Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC

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

Date Filed	Document No.	Description	Snippet	Link To Document
2021-05-12				External link to document
2021-05-12	1	Complaint	United States Patent Nos. 8,731,963 (the “’963 patent”), 10,758,488 (the “’488 patent”), 10,813,885 … for patent infringement and for a declaratory judgement of patent infringement under the patent laws…PageID #: 2 (the “’956 patent”), and 10,966,931 (the “’931 patent”) owned by Jazz Pharmaceuticals (…’963 patent entitled, “Sensitive Drug Distribution System and Method.” A copy of the ’963 patent is attached…of the ’931 patent is attached hereto as Exhibit E. 27. The claims of the patents-in-suit cover	External link to document
2021-05-12	11	Answer to Complaint	United States Patent Nos. 8,731,963 (the “’963 patent”), 10,758,488 (the “’488 patent”), 10,813,885 (…United States Patent Nos. 8,731,963 (the “’963 patent”), 10,758,488 (the “’488 patent”), 10,813,885 (… for patent infringement and for a declaratory judgement of patent infringement under the patent laws … (the “’885 patent”), 10,959,956 (the “’956 patent”), and 10,966,931 (the “’931 patent”) owned by Jazz… for patent infringement and for a declaratory judgment of patent infringement under the patent laws	External link to document
2021-05-12	117	Motion for Judgment on the Pleadings	counterclaim seeking delisting of U.S. Patent No. 8,731,963 (the “’963 patent”) from the Orange Book (see D.I…submit a request to the FDA to delist the ’963 patent pursuant to 21 U.S.C. § 355(c)(3)(D)(ii)(I). The… 12 May 2021 1:21-cv-00691 830 Patent None District Court, D. Delaware	External link to document
2021-05-12	118	Opening Brief in Support	seeking delisting of Jazz’s U.S. Patent No. 8,731,963 (the “’963 patent”) from the FDA’s Orange Book.1 …the FDA “the patent number and expiration date of each patent for which a claim of patent infringement…Orange Book-listed patents for XYREM. D.I. 1, Exhibit F at 163. Of the seven patents Jazz has accused …only the ’963 patent is listed in the Orange Book and therefore is the only asserted patent that could …26, and 27 of the ’963 Patent, along with all claims of six other issued patents in the family. Only claims	External link to document

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

Introduction

The litigation between Jazz Pharmaceuticals, Inc. and Avadel CNS Pharmaceuticals, LLC is a complex and multifaceted case that involves patent infringement, regulatory compliance, and the intricacies of pharmaceutical law. Here, we will delve into the key aspects of this case, including the background, the main arguments, the court decisions, and the implications of the rulings.

Background

The dispute began in May 2021 when Jazz Pharmaceuticals initiated a patent infringement action against Avadel CNS Pharmaceuticals following Avadel's submission of a new drug application (NDA) for its narcolepsy medication, Lumryz, under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA)[4].

The Patents in Question

Jazz asserted infringement of several patents, including the '963 Patent, which is central to the litigation. The '963 Patent pertains to a system for managing the distribution and use of a drug, rather than the drug or its method of use itself[1][4][5].

Claim Construction and Delisting

Avadel counterclaimed, seeking a declaration to order Jazz to remove the '963 Patent from the FDA's Orange Book, a compilation of approved drug products with therapeutic equivalence evaluations. Avadel argued that the '963 Patent does not claim a drug or an approved method of use, and therefore should not be listed in the Orange Book[1][4][5].

The district court, in its claim construction, found that the '963 Patent indeed claims a system and not an approved method of use. This ruling led to the court ordering Jazz to request the FDA to delist the '963 Patent from the Orange Book[1][4][5].

Appeal and Stay

Jazz appealed the district court's decision and sought a stay of the injunction pending the appeal. The Federal Circuit issued a temporary stay, which was later extended until the appeal could be evaluated on its merits. Despite Jazz's arguments, the Federal Circuit ultimately affirmed the district court's judgment, upholding the decision to delist the '963 Patent[1][4][5].

Regulatory Aspects

A significant aspect of this case involves the FDA's role in patent listing and certification. The FDA does not verify whether submitted patents meet the statutory listing criteria, nor does it proactively remove improperly listed patents. This led Avadel to sue the FDA, alleging a violation of the Administrative Procedure Act (APA) by requiring certification over the '963 Patent despite its improper listing[5].

Jury Verdict in the District of Delaware

In a separate but related development, a jury in the United States District Court for the District of Delaware delivered a mixed verdict in a patent lawsuit concerning Avadel's Lumryz. The jury found that Lumryz infringes on one of Jazz's patents (Patent 782), but the royalty payment was set at 3.5%, significantly lower than the 27% sought by Jazz. Avadel expressed disappointment and indicated plans to appeal the unfavorable aspects of the decision[2].

Implications and Reactions

The Federal Circuit's affirmation of the district court's decision has significant implications for patent listing and regulatory compliance in the pharmaceutical industry. Jazz has expressed confidence in the strength of its patent portfolio and its commitment to protecting innovation, while Avadel is pursuing all available options to overturn the unfavorable aspects of the jury's decision[2][4].

Key Takeaways

• Patent Listing Criteria: The case highlights the importance of ensuring that listed patents meet the statutory criteria for inclusion in the Orange Book.
• Regulatory Compliance: The FDA's passive role in verifying patent listings underscores the need for careful scrutiny by pharmaceutical companies.
• Litigation Strategy: The mixed verdicts and ongoing appeals demonstrate the complexity and strategic considerations in pharmaceutical patent litigation.
• Innovation Protection: The case emphasizes the ongoing battle to protect intellectual property in the pharmaceutical industry.

FAQs

Q: What is the main issue in the litigation between Jazz Pharmaceuticals and Avadel CNS Pharmaceuticals? A: The main issue revolves around the listing and delisting of the '963 Patent in the FDA's Orange Book and whether it claims a drug or method of use.

Q: What was the district court's decision regarding the '963 Patent? A: The district court ordered Jazz to request the FDA to delist the '963 Patent from the Orange Book, finding it does not claim an approved method of use.

Q: How did the Federal Circuit rule on the appeal? A: The Federal Circuit affirmed the district court's decision, upholding the delisting of the '963 Patent.

Q: What was the outcome of the jury verdict in the District of Delaware? A: The jury found that Avadel's Lumryz infringes on one of Jazz's patents, but set a lower royalty payment than what Jazz sought.

Q: What are the implications of this case for the pharmaceutical industry? A: The case emphasizes the importance of careful patent listing, regulatory compliance, and the ongoing need to protect intellectual property in pharmaceuticals.

Sources

1. Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC, 23-1186.OPINION.2-24-2023.
2. Sleep Review Magazine, "Jazz, Avadel Secure Wins in Patent Lawsuit Over Narcolepsy Drug."
3. Justia, "Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, No. 1:2021cv00691."
4. Wilson Sonsini Goodrich & Rosati, "Federal Circuit Affirms Jazz Pharmaceutical's Risk Evaluation and Mitigation Strategy Patent Is Not Listable in Orange Book."
5. Federal Circuit Blog, "Opinion Summary - Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals LLC."