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	2021-11-09
Court	District Court, D. Delaware	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Gregory B. Williams
Jury Demand	None	Referred To
Patents	6,228,398; 6,309,663; 6,419,960; 6,514,531; 6,913,768; 7,268,156; 8,101,209; 8,731,963
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
2022-11-04	142	Decision C.A. No. 22-2159 (D.D.C.)	Distribution System and Method, U.S. Patent No. 8,731,963 (“the ‘963 Patent”). Jazz’s oxybate drugs are distributed…2) a “Patent Statement,” which represents that no existing patents listed in the FDA’s patent database…existing patent or why the existing patent is invalid. Id. § 355(b)(2)(A)(i)–(iv). 3 A Patent Certification…submitting a Patent Statement. On May 24, 2022, the FDA rejected Avadel’s Patent Statement. It…claimed by an existing method-of-use patent held by Jazz (the “Patent Decision”). On June 6, 2022, Avadel	External link to document
2022-11-18	146	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 ("…quot;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
2022-12-27	166	Letter	discovery deadlines related to U.S. Patent No. 8,731,963 (“the ʼ963 patent”) while this Court’s Order and … seven patents-in-suit from three different patent families. The ʼ963 patent is the only patent asserted…infringement or validity of the ʼ963 patent from either a patent or regulatory law perspective. …expected to opine on the ʼ963 patent is expected to opine on the formulation patents. Therefore, staying discovery…related to the ’963 patent, including the regulatory exclusivity relating to that patent, but regardless	External link to document

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

Background of the Litigation

The litigation between Jazz Pharmaceuticals, Inc. and Avadel CNS Pharmaceuticals, LLC revolves around patent infringement and the listing of patents in the FDA's Orange Book. The dispute began in May 2021 when Jazz initiated a patent infringement action against Avadel 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].

Key Patents and Claims

Jazz asserted infringement of several patents, including the '963 Patent, which is central to the dispute. Avadel countered with a motion seeking delisting of the '963 Patent from the Orange Book, arguing that it does not claim a drug or method of use as required by FDA regulations[4][5].

District Court Rulings

The U.S. District Court for the District of Delaware played a crucial role in this litigation. The court evaluated Avadel's counterclaim and determined that the '963 Patent claims a system rather than an approved method of use. This ruling was based on claim construction, which found that the patent does not meet the criteria for listing in the Orange Book under 21 U.S.C. § 355(c)(3)(D)(ii)(I)[1][5].

Delisting of the '963 Patent

Following the district court's decision, Jazz was ordered to request the FDA to delist the '963 Patent from the Orange Book. Jazz appealed this 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[1][5].

Federal Circuit Appeal

The Federal Circuit affirmed the district court's decision, upholding the delisting of the '963 Patent from the Orange Book. The court agreed that the '963 Patent claims a system and not an approved method of use, thereby not meeting the statutory criteria for listing[1][4].

Jury Verdict on Patent Infringement

In a separate but related development, a jury from the United States District Court for the District of Delaware delivered a mixed verdict in the patent infringement lawsuit. The jury found that Avadel's Lumryz infringes on one of Jazz's patents (Patent 782) related to Jazz's Xyrem, but ruled in Avadel's favor on another contested patent. The court determined a royalty payment of 3.5% to Jazz, significantly lower than the 27% sought by Jazz[2].

Avadel's Response and Next Steps

Avadel expressed satisfaction with the favorable ruling on one patent but was disappointed with the unfavorable outcome on the other. Avadel indicated its intention to vigorously defend its position through an appeal to overturn the unfavorable aspect of the jury's decision. Despite the legal battles, Avadel does not expect the jury's decision to impact the commercial launch of Lumryz, which received FDA approval in May 2023[2].

Jazz Pharmaceuticals' Stance

Jazz Pharmaceuticals respected the jury's verdict and reaffirmed its commitment to protecting its innovation and supporting patients with serious sleep disorders. Jazz remains confident in the strength of its patent portfolio and will continue to defend it while expanding its product offerings[2].

Regulatory and Legal Implications

The case highlights the complexities of patent law and FDA regulations. The FDA does not verify that submitted patents meet statutory listing criteria, nor does it proactively remove improperly listed patents. This gap can lead to legal disputes, as seen in this case, where the courts must intervene to determine the validity of patent listings[5].

Impact on Pharmaceutical Industry

This litigation has significant implications for the pharmaceutical industry, particularly in the context of patent protection and FDA regulations. It underscores the importance of precise claim construction and adherence to regulatory requirements for patent listing. Companies must be diligent in ensuring that their patents meet the necessary criteria to avoid legal challenges and potential delisting from the Orange Book[4][5].

Key Takeaways

• Patent Claims and FDA Regulations: The '963 Patent was delisted from the Orange Book because it claims a system rather than an approved method of use.
• Jury Verdict: A mixed verdict was delivered, with Avadel infringing on one Jazz patent but not another.
• Regulatory Compliance: The case emphasizes the need for pharmaceutical companies to ensure their patents comply with FDA regulations.
• Legal Strategies: Both companies are pursuing legal avenues to protect their interests, with Avadel planning an appeal and Jazz defending its patent portfolio.
• Market Impact: The litigation does not expect to impact the commercial launch of Avadel's Lumryz.

Frequently Asked Questions (FAQs)

Q: What is the main dispute between Jazz Pharmaceuticals and Avadel CNS Pharmaceuticals?

A: The main dispute revolves around patent infringement and the listing of the '963 Patent in the FDA's Orange Book.

Q: Why was the '963 Patent delisted from the Orange Book?

A: The '963 Patent was delisted because it claims a system rather than an approved method of use, which does not meet the statutory criteria for listing.

Q: What was the outcome of the jury verdict in the patent infringement lawsuit?

A: The jury found that Avadel's Lumryz infringes on one of Jazz's patents but ruled in Avadel's favor on another contested patent, with a royalty payment of 3.5% to Jazz.

Q: How does this litigation impact the pharmaceutical industry?

A: It highlights the importance of precise claim construction and adherence to FDA regulations for patent listing, and it underscores the complexities of patent law and regulatory compliance.

Q: What are the next steps for Avadel and Jazz Pharmaceuticals?

A: Avadel plans to appeal the unfavorable aspect of the jury's decision, while Jazz will continue to defend its patent portfolio and support patients with serious sleep disorders.

Cited Sources

1. Jazz Pharms., Inc., v. Avadel CNS - Federal Circuit Opinion[1]
2. Jazz, Avadel Secure Wins in Patent Lawsuit Over Narcolepsy Drug - Sleep Review Magazine[2]
3. Jazz Pharmaceuticals, Inc. et al v. Avadel CNS Pharmaceuticals, LLC - Justia Dockets[3]
4. Federal Circuit Affirms Jazz Pharmaceutical's Risk Evaluation and Mitigation Strategy Patent Is Not Listable in Orange Book - Wilson Sonsini Goodrich & Rosati[4]
5. Opinion Summary - Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC - Federal Circuit Blog[5]