Introduction
The litigation between Ferring Pharmaceuticals Inc. and Serenity Pharmaceuticals, LLC, along with its affiliates Reprise Biopharmaceutics LLC and Avadel Specialty Pharmaceuticals LLC, is a complex and longstanding dispute centered around patents related to the treatment of nocturia, a condition characterized by frequent nighttime urination. Here, we delve into the key aspects of this litigation, including the background, major motions, and significant court rulings.
Background
The dispute began in April 2017 when Ferring Pharmaceuticals Inc. filed a declaratory judgment action against Serenity Pharmaceuticals, LLC, and Reprise Biopharmaceutics LLC in the District of Delaware. Ferring sought a declaration that certain patents held by Reprise, exclusively licensed to Serenity, were invalid, unenforceable, and not infringed by Ferring's product NOCDURNA, which treats nocturia using desmopressin[3][5].
Key Patents in Dispute
The patents at the heart of this litigation are U.S. Patent Nos. 7,405,203, 7,579,321, and 7,779,761, which cover the sublingual application of desmopressin. Reprise owns these patents, and Serenity is the exclusive licensee, while Avadel is the exclusive sublicensee[3][5].
FDA Approval and Market Dynamics
A significant turning point came when Ferring received FDA approval for NOCDURNA on June 21, 2018. This approval prompted Serenity and Reprise, along with Avadel, to assert counterclaims for patent infringement and seek a preliminary injunction to block the commercial release of NOCDURNA. The defendants argued that Ferring's product would undermine their "first mover advantage" and cause significant damages[1].
Preliminary Injunction Motion
Serenity and its affiliates moved for a preliminary injunction to prevent the commercial release of NOCDURNA. This motion was denied by the court, citing the interrelatedness of the factual issues and the need for further proceedings, including a Markman hearing and a trial on the merits. The court emphasized that detailed findings of fact would be deferred until after these proceedings[1].
Claim Construction and Markman Hearing
The court scheduled a Markman hearing to construe the terms of the patents, specifically "transmucosal delivery" and "transmucosal administration" of desmopressin. In January 2019, the court ruled that these terms did not require transmucosal absorption of desmopressin, a decision crucial for determining infringement and validity[5].
Motions to Strike and Preclude
Throughout the litigation, various motions were filed to strike or preclude certain arguments and evidence. For instance, Serenity and Reprise moved to preclude Ferring from presenting arguments related to untimely disclosed claim construction positions and sought sanctions for alleged deposition misconduct. These motions were denied by the court, which allowed Ferring to continue presenting its arguments and ordered additional depositions[3][4].
Deposition Conduct and Sanctions
A notable issue arose during the deposition of Ferring's expert, Dr. Jennifer Dressman, where counsel for Ferring instructed her not to answer certain questions. Serenity and Reprise alleged deposition misconduct and sought sanctions, but the court denied their motion while ordering a continued deposition to address the disputed questions[3][4].
Motions in Limine
In March 2020, U.S. District Judge Colleen McMahon ruled on several motions in limine filed by Serenity and Reprise. She denied their motions to exclude testimony and argument related to Ferring's failed claim construction positions and the inventor's statements before the European Patent Office (EPO). These rulings were significant as they allowed Ferring to present relevant evidence and arguments at trial[5].
Trial and Current Status
The case is currently set for a bench trial, which was scheduled to begin on May 26, 2020. The trial will determine the validity and enforceability of the patents, as well as whether Ferring's NOCDURNA infringes on these patents[5].
Economic and Market Implications
The outcome of this litigation has significant economic and market implications. The "first mover advantage" claimed by Serenity and its affiliates could be substantially impacted if Ferring is allowed to market NOCDURNA. Additionally, the ruling on patent validity and infringement will influence the competitive landscape in the treatment of nocturia[1].
Key Takeaways
- Patent Dispute: The litigation revolves around the validity, enforceability, and infringement of patents related to the sublingual application of desmopressin.
- FDA Approval: Ferring's NOCDURNA received FDA approval in June 2018, prompting counterclaims from Serenity and its affiliates.
- Preliminary Injunction: The motion for a preliminary injunction to block NOCDURNA's release was denied.
- Claim Construction: The court has ruled on the construction of key patent terms, which will be crucial for determining infringement.
- Deposition and Sanctions: Issues related to deposition conduct and sanctions have been addressed, with the court allowing further depositions.
- Motions in Limine: Rulings on motions in limine have set the stage for the trial by allowing relevant evidence and arguments.
FAQs
What is the primary issue in the Ferring Pharmaceuticals Inc. v. Serenity Pharmaceuticals, LLC litigation?
The primary issue is a dispute over the validity, enforceability, and infringement of patents related to the sublingual application of desmopressin for treating nocturia.
Which patents are at the center of this litigation?
The patents in dispute are U.S. Patent Nos. 7,405,203, 7,579,321, and 7,779,761, owned by Reprise Biopharmaceutics LLC and exclusively licensed to Serenity Pharmaceuticals, LLC.
What is the significance of the FDA approval of NOCDURNA?
The FDA approval of NOCDURNA in June 2018 was a critical event that prompted Serenity and its affiliates to assert counterclaims for patent infringement and seek a preliminary injunction.
What was the outcome of the preliminary injunction motion?
The court denied the motion for a preliminary injunction to block the commercial release of NOCDURNA, citing the need for further proceedings.
What are the key court rulings related to claim construction and motions in limine?
The court has ruled on the construction of key patent terms and denied motions to exclude testimony and argument related to Ferring's failed claim construction positions and the inventor's statements before the EPO.
Cited Sources:
- Ferring B.V. v. Serenity Pharm., LLC - Federal Cases - Case Law
- Ferring Pharmaceuticals Inc. et al v. Serenity Pharmaceuticals, LLC et al - Justia Law
- Ferring Pharmaceuticals Inc. v. Serenity Pharmaceuticals, LLC - Casetext
- Ferring Pharmaceuticals Inc. et al v. Serenity Pharmaceuticals, LLC et al - Justia Law
- Judge McMahon's Motions in Limine Rulings Clear Way for Ferring v. Serenity - JD Supra
