Litigation Details for Ferring Pharmaceuticals Inc. v. Serenity Pharmaceuticals, LLC (S.D.N.Y. 2017)

Ferring Pharmaceuticals Inc. v. Serenity Pharmaceuticals, LLC (S.D.N.Y. 2017)

Docket		Date Filed	2017-12-20
Court	District Court, S.D. New York	Date Terminated	2020-08-21
Cause	28:2201dj Declaratory Judgment	Assigned To	Colleen McMahon
Jury Demand	None	Referred To	Stewart D. Aaron
Parties	REPRISE BIOPHARMACEUTICS, LLC
Patents	7,405,203; 7,560,429; 7,579,321; 7,799,761; 7,947,654; 8,802,624; 9,220,747; 9,504,647; 9,539,302
Attorneys	Nicholas Verna
Firms	Womble Bond Dickinson LLP (GA)
Link to Docket	External link to docket

Details for Ferring Pharmaceuticals Inc. v. Serenity Pharmaceuticals, LLC (S.D.N.Y. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-12-20				External link to document
2017-12-20	1	Complaint	United States Patent No. 7,405,203, United States Patent No. 7,579,321, and United States Patent No. 7,799,761…Certificate, No. US 7,405,203 C1 (collectively, “the ’203 patent”). The ’203 patent bears the title, “…Application”), which matured into United States Patent No. 7,405,203, and U.S. Application No. 10/706,100 (“… issued United States Patent No. 7,579,321 (“the ’321 patent”). The ’321 patent bears the title, “Pharmaceutical… issued United States Patent No. 7,799,761 (“the ’761 patent”). The ’761 patent bears the title, “Pharmaceutical	External link to document
2017-12-20	12	Response/Reply - Miscellaneous	joint inventor of two patents assigned to Ferring -- U.S. Patent Nos. 7,560,429 and 7,947,654 (collectively…Defendants’ patents -- U.S. Patent Nos. 7,405,203; 7,579,321; and 7,799,761 (collectively, “the patents in suit…Fein’s three patents in suit. In that regard, Ferring contended that Dr. Fein’s patents included “significant…was the rightful owner of the three patents in suit; (2) those patents include “significant” and “inventive…the patents in suit, Ferring filed its DJ complaint in this Court asserting now that the patents in suit	External link to document
2017-12-19	101	Answer to Amended Complaint	, United States Patent No. 7,405,203 (the “’203 patent”); 7,579,321 (the “’321 patent”); and 7,799,761…United States Patent Nos. 7,405,203 (the “’203 patent”), and 7,579,321 (the “’321 patent”) (collectively… (INFRINGEMENT OF U.S. PATENT NO. 7,405,203) 55. Counterclaimants incorporate…the ’203 patent on April 12, 2011 by issuing Ex Parte Reexamination Certificate No. US 7,405,203 C1. … (WILLFUL INFRINGEMENT OF U.S. PATENT NO. 7,405,203) 70. Counterclaimants incorporate	External link to document
2017-12-19	115	Answer to Counterclaim	United States Patent Nos. 7,405,203 (“the ’203 patent”) and 7,579,321 (“the ’321 patent”). 9. … (INFRINGEMENT OF U.S. PATENT NO. 7,405,203) 55. Ferring incorporates by… (WILLFUL INFRINGEMENT OF U.S. PATENT NO. 7,405,203) 70. Ferring incorporates by…Certificate No. US 7,405,203 C1 on April 12, 2011. Ferring states that the claims of the ’203 patent are invalid…issued Ex Parte Reexamination Certificate No. US 7,405,203 C1 on April 12, 2011. Ferring denies the remaining	External link to document
2017-12-19	201	Declaration	version of the original filed claims for U.S. Patent No. 7,405,203, # 2 Exhibit 18 - certified version of the… the original filed claims for U.S. Patent No. 7,579,321, # 3 Exhibit 19 - certified version of the Preliminary…December 2017 21 August 2020 1:17-cv-09922 Patent None District Court, S.D. New York	External link to document

Ferring Pharmaceuticals Inc. v. Serenity Pharmaceuticals, LLC: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between Ferring Pharmaceuticals Inc. and Serenity Pharmaceuticals, LLC, along with its affiliates, is a complex and lengthy dispute involving patent infringement, validity, and other intellectual property issues. This article provides a detailed summary and analysis of the key events, legal arguments, and outcomes in this significant pharmaceutical patent case.

Background and Initial Proceedings

The dispute began in April 2017 when Ferring Pharmaceuticals Inc. filed a lawsuit in the District of Delaware against Serenity Pharmaceuticals, LLC, Reprise Biopharmaceutics LLC, and Allergan, Inc. Ferring sought a declaratory judgment of patent invalidity, unenforceability, and non-infringement regarding several patents related to the treatment of nocturia, a condition characterized by excessive nighttime urination[1].

Transfer and Jurisdiction

The case was later transferred to the Southern District of New York, where it was designated as related to a previous 2012 action. Allergan was voluntarily dismissed from the case, and Avadel Specialty Pharmaceuticals LLC joined as a defendant and patent licensee of Serenity and Reprise[1].

FDA Approval and Counterclaims

On June 21, 2018, Ferring received FDA approval for its New Drug Application (NDA) for NOCDURNA, a drug treating nocturia. Following this approval, Serenity and Reprise, along with Avadel, asserted counterclaims against Ferring, including allegations of patent infringement and willful patent infringement of the '203 and '321 Patents[1].

Preliminary Injunction

Serenity and Reprise moved for a preliminary injunction to block the commercial release of NOCDURNA. The motion was denied after a six-day hearing, during which various experts and exhibits were presented. The court deferred detailed findings of fact until after the scheduled Markman hearing and trial[1].

The Patents in Suit

The patents at issue, U.S. Patent Nos. 7,405,203, 7,579,321, and 7,799,761, cover sublingual applications of desmopressin, a drug used to treat symptoms of diabetes insipidus, including nocturia. These patents are owned by Reprise and exclusively licensed to Serenity for the marketing of NOCTIVA, a competing drug[3].

Motions in Limine and Trial Preparations

In March 2020, Judge Colleen McMahon ruled on several motions in limine filed by Serenity and Reprise. She granted their motion to exclude Ferring's theory of indefiniteness of the term "about" in the patents' claims, as Ferring had not raised this argument earlier. However, she denied their motion to exclude testimony and argument regarding Ferring’s failed claim construction positions and the inventor’s statements before the European Patent Office (EPO)[3].

Remote Trial Due to COVID-19

The trial was scheduled to proceed remotely due to the COVID-19 pandemic. Judge McMahon issued detailed procedures for the remote trial, ensuring that it would proceed despite the pandemic[2].

Findings of Fact, Conclusions of Law, and Verdict

After the trial, the court issued its findings of fact, conclusions of law, and verdict. The court detailed the ownership and licensing agreements involving the patents, the roles of the parties, and the commercial agreements with Avadel. The verdict addressed the validity and infringement issues, concluding the trial phase of the litigation[5].

Key Legal Arguments and Rulings

• Indefiniteness Argument: Ferring's late-raised argument of indefiniteness regarding the term "about" was rejected by Judge McMahon, as it was not included in their initial or final invalidity contentions[3].
• Claim Construction: The court construed the terms "transmucosal delivery" and "transmucosal administration" of desmopressin, finding they did not require transmucosal absorption of desmopressin. This construction was crucial for determining the scope of the patents[3].
• Inventor’s Testimony: The court allowed testimony from the inventor regarding sublingual absorption, which was relevant to the determination of whether the inventor had invented what was claimed in the patents[3].

Impact and Implications

The outcome of this litigation has significant implications for the pharmaceutical industry, particularly in the treatment of nocturia. The denial of the preliminary injunction allowed Ferring to launch NOCDURNA, potentially impacting the market share of Serenity's NOCTIVA. The trial's findings on patent validity and infringement will set precedents for future disputes involving similar technologies.

Bankruptcy and Commercial Agreements

Avadel, the exclusive sublicensee of the patents, filed for Chapter 11 bankruptcy in February 2019, which added another layer of complexity to the case. The commercial development agreements and licensing arrangements between the parties were central to the dispute[5].

Conclusion

The litigation between Ferring Pharmaceuticals Inc. and Serenity Pharmaceuticals, LLC, is a prime example of the intricate and often protracted nature of pharmaceutical patent disputes. The case highlights the importance of thorough legal preparation, the significance of claim construction, and the impact of external factors such as the COVID-19 pandemic on trial proceedings.

Key Takeaways

• Patent Disputes: Pharmaceutical patent disputes can be highly complex and involve multiple parties and counterclaims.
• Claim Construction: The interpretation of patent claims is crucial and can significantly affect the outcome of infringement and validity arguments.
• Legal Preparation: Timely and thorough legal preparation is essential, as late-raised arguments may be rejected.
• Market Impact: The outcome of such disputes can have substantial market implications, affecting the launch and sales of competing products.
• External Factors: External factors like the COVID-19 pandemic can influence trial procedures and scheduling.

Frequently Asked Questions (FAQs)

Q: What was the primary issue in the Ferring v. Serenity Pharmaceuticals case?

A: The primary issue was a dispute over patent infringement, validity, and non-infringement related to drugs treating nocturia.

Q: Which patents were at the center of the dispute?

A: The patents at issue were U.S. Patent Nos. 7,405,203, 7,579,321, and 7,799,761, covering sublingual applications of desmopressin.

Q: Why was the preliminary injunction denied?

A: The preliminary injunction was denied because the court deferred detailed findings of fact until after the scheduled Markman hearing and trial.

Q: How did the COVID-19 pandemic affect the trial?

A: The trial was conducted remotely due to the pandemic, with detailed procedures issued by Judge McMahon to ensure its continuation.

Q: What was the outcome of the trial regarding the patents?

A: The trial concluded with findings of fact, conclusions of law, and a verdict that addressed the validity and infringement issues, but specific details on the outcome are not provided in the sources.

Cited Sources:

1. Ferring B.V. v. Serenity Pharm., LLC - Federal Cases - Case Law - VLEX.
2. Some Judges Press Forward Scheduling Remote Patent Bench Trials - Wolf Greenfield.
3. Judge McMahon's Motions in Limine Rulings Clear Way for Ferring v. Serenity - JD Supra.
4. Ferring Pharmaceuticals Inc. et al v. Serenity Pharmaceuticals, LLC et al - Justia Law.
5. Ferring Pharm. Inc. v. Serenity Pharm., LLC - Casetext.