Avadel CNS Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.: A Comprehensive Litigation Summary and Analysis
Background of the Case
The litigation between Avadel CNS Pharmaceuticals, LLC and Jazz Pharmaceuticals, Inc. revolves around patent disputes related to sodium oxybate products, specifically Avadel’s Lumryz and Jazz’s Xyrem. Here is a detailed overview of the key points and developments in this case.
Avadel’s Product and FDA Approval Process
Avadel developed Lumryz, a sodium oxybate product designed to be administered once nightly, contrasting with Jazz’s Xyrem which requires a second dose in the middle of the night. Avadel submitted a 505(b)(2) New Drug Application (NDA) referencing Xyrem in December 2020. However, Avadel proposed using its own Risk Evaluation and Mitigation Strategy (REMS) rather than Jazz’s patented system, leading to a section viii statement asserting that the ‘963 patent did not claim a use for which Avadel was seeking approval[4].
Jazz’s Patent Infringement Claims
Despite Avadel’s section viii statement, the FDA ordered Avadel to certify to the ‘963 patent in May 2022, citing the overlap between Lumryz’s REMS and the U-1110 use code. Avadel certified to the ‘963 patent “under protest” in June 2022. Jazz subsequently initiated a lawsuit against Avadel for infringement of the ‘963 patent on July 15, 2022. This lawsuit triggered a thirty-month stay, effectively delaying Lumryz’s market entry until the expiration of the ‘963 patent and its associated pediatric exclusivity in June 2023[4].
District Court Rulings
During the litigation, Avadel responded to Jazz’s infringement claims with a counterclaim seeking the delisting of the ‘963 patent for failure to claim a drug or method of use. The District Court of Delaware agreed with Avadel, construing the ‘963 patent claims as directed to systems rather than methods. This ruling led to an order for the delisting of the ‘963 system patent on November 18, 2022[4].
Appeal to the Federal Circuit
Jazz appealed the district court’s decision to the Court of Appeals for the Federal Circuit. On February 24, 2023, the Federal Circuit upheld the district court’s decision, affirming that the ‘963 patent claims were for systems and not methods. The court emphasized that the patent specification and prosecution history supported this construction, and that the system claims did not qualify as “an approved method of using the drug” under 21 U.S.C. § 355(c)(2) and § 355(c)(3)(D)(ii)(I)[1][4].
Legal Analysis and Implications
Claim Construction
The Federal Circuit’s decision was pivotal in clarifying the distinction between system and method claims in patent law. The court reiterated that the ‘963 patent’s claims to a system comprising computer memory and a data processor were not method claims, even though the system could be used to treat patients[4].
FDA Regulations and Patent Law
Jazz argued that FDA regulation 21 C.F.R. § 314.53(b)(1) required a broader definition of the term “method” that would encompass the claims of the ‘963 patent. However, the court rejected this argument, stating that the patent still needed to claim a method of use to be eligible for listing. Since the ‘963 patent did not claim a method of use, the FDA regulation was deemed inapplicable[4].
Impact on Market Entry
The litigation and subsequent rulings significantly impacted Avadel’s ability to bring Lumryz to market. The thirty-month stay triggered by Jazz’s lawsuit delayed Lumryz’s entry until the patent and its associated exclusivity expired. However, with the delisting of the ‘963 patent, Avadel argued that its 505(b)(2) NDA was entitled to final approval without waiting for the expiration of the patent or the stay period[4].
Current Status and Future Implications
Ongoing Litigation
As of January 2025, the case continues with Avadel CNS Pharmaceuticals, LLC and Flamel Ireland Limited suing Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited in the US District Court for the District of Delaware. The lawsuit filed on January 3, 2025, alleges patent infringement under 35 U.S.C. § 271 and seeks a jury trial[3].
Market and Regulatory Implications
The outcome of this litigation has significant implications for both companies and the broader pharmaceutical industry. It sets a precedent for how system and method claims are construed and how they interact with FDA regulations. For Avadel, a favorable outcome could expedite the market entry of Lumryz, while for Jazz, it could protect their existing market share and intellectual property rights.
Key Takeaways
- Patent Claim Construction: The Federal Circuit clarified that the ‘963 patent claims are for systems, not methods, which is crucial for determining patent infringement and FDA listing.
- FDA Regulations: The court’s decision highlights the importance of aligning FDA regulations with patent law, particularly in defining what constitutes a “method of use.”
- Market Impact: The litigation has delayed Lumryz’s market entry but could pave the way for its approval once the patent issues are resolved.
- Regulatory Precedent: This case sets a precedent for future disputes involving system and method claims in the pharmaceutical industry.
FAQs
What is the main dispute in Avadel CNS Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.?
The main dispute revolves around whether the ‘963 patent claims a system or a method of using the drug, and whether this affects Avadel’s ability to bring its product Lumryz to market.
Why did the FDA order Avadel to certify to the ‘963 patent?
The FDA ordered Avadel to certify to the ‘963 patent because it determined that Lumryz’s REMS overlapped with the U-1110 use code, despite Avadel’s initial assertion that the patent did not claim a use for which they were seeking approval.
What was the outcome of the Federal Circuit’s decision?
The Federal Circuit upheld the district court’s decision, affirming that the ‘963 patent claims are for systems and not methods, and thus do not qualify as “an approved method of using the drug” under relevant statutes.
How has the litigation affected Avadel’s product Lumryz?
The litigation triggered a thirty-month stay, delaying Lumryz’s market entry until the expiration of the ‘963 patent and its associated pediatric exclusivity. However, with the delisting of the ‘963 patent, Avadel argues that its NDA is entitled to final approval without waiting for the stay period.
What are the broader implications of this case for the pharmaceutical industry?
This case sets a precedent for how system and method claims are construed and how they interact with FDA regulations, which can impact future patent disputes and market strategies in the pharmaceutical industry.
Cited Sources
- Jazz Pharms., Inc., v. Avadel CNS – Court of Appeals for the Federal Circuit, February 24, 2023.
- Florida Northern District Court Information Page – PacerMonitor.
- Avadel CNS Pharmaceuticals, LLC et al v. Jazz Pharmaceuticals, Inc., et al. – Justia Dockets.
- Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC – FDLI, June 22, 2023.