Litigation Details for Azurity Pharmaceuticals, Inc. v. CoreRx, Inc. (M.D. Fla. 2021)

Azurity Pharmaceuticals, Inc. v. CoreRx, Inc. (M.D. Fla. 2021)

Docket		Date Filed	2021-10-26
Court	District Court, M.D. Florida	Date Terminated	2021-11-30
Cause		Assigned To	Virginia Maria Hernandez Covington
Jury Demand		Referred To	Sean P. Flynn
Patents	10,039,745; 10,154,987; 10,772,868; 10,786,482; 11,141,405; 6,028,222; 6,977,257; 8,568,747; 8,778,366; 9,463,183; 9,616,096; 9,669,008; 9,808,442; 9,855,214; 9,968,553
Link to Docket	External link to docket

Details for Azurity Pharmaceuticals, Inc. v. CoreRx, Inc. (M.D. Fla. 2021)

Date Filed	Document No.	Description	Snippet	Link To Document
2021-10-26				External link to document
2021-10-26	1	Exhibit A	6/2012 Nov. 2, 2017, now Pat. No. 10,039,745, which is a WO WO-2014055667 …Reference-based pricing of prescription drugs: 10,039,745 B2 8/2018 Mosher … O U.S. Pat. No. 10,039,745, issued Aug. 7, 2018), which is a …) United States Patent (10) Patent No.: US …preservative that is 65 All publications, patents, and patent applications men- sodium benzoate; and (	External link to document
2021-10-26	5	Exhibit A	6/2012 Nov. 2, 2017, now Pat. No. 10,039,745, which is a WO WO-2014055667 …Reference-based pricing of prescription drugs: 10,039,745 B2 8/2018 Mosher … O U.S. Pat. No. 10,039,745, issued Aug. 7, 2018), which is a …) United States Patent (10) Patent No.: US …preservative that is 65 All publications, patents, and patent applications men- sodium benzoate; and (	External link to document
2021-10-26	21		Products (Nov. 2003, Rev. 2; and (5) U.S. Patent No. 8,568,747 B1. A POSA would be motivated to combine…Products (Nov. 2003, Rev. 2; and (5) U.S. Patent No. 8,568,747 B1. A POSA would be motivated to combine…for patent infringement of United States Patent Nos. 11,040,023 (the “’023 patent”) and…“’405 patent”) (collectively the “Patents-in-Suit”) and damages under the patent laws …infringement of U.S. Patent Nos. 11,040,023 (the “’023 patent”) and 11,141,405 the “’405 patent”) under Title	External link to document

Azurity Pharmaceuticals, Inc. v. CoreRx, Inc.: A Comprehensive Litigation Summary and Analysis

Background and Context

The litigation between Azurity Pharmaceuticals, Inc. and CoreRx, Inc. is intricately linked with another ongoing dispute involving Bionpharma Inc. Here’s a brief overview of the key parties and their roles:

• Azurity Pharmaceuticals, Inc.: The plaintiff asserting patent infringement claims.
• CoreRx, Inc.: The defendant, a contract manufacturer for Bionpharma Inc.
• Bionpharma Inc.: A generic pharmaceutical company selling an enalapril maleate oral solution, which is a generic version of the branded drug "Epaned."

Initial Patent Infringement Claims

In October 2021, Azurity filed two lawsuits against CoreRx, alleging that CoreRx's actions in manufacturing the enalapril maleate oral solution for Bionpharma infringed two patents that Azurity had previously asserted against Bionpharma[1][3].

Settlement Agreement and Its Implications

Azurity and CoreRx subsequently entered into a confidential Settlement Agreement. Under this agreement, Azurity released any claims for patent infringement against CoreRx in exchange for CoreRx's commitment not to manufacture and supply the product for Bionpharma. Additionally, Azurity agreed to indemnify CoreRx for any resulting litigation[1].

CoreRx's Compliance and Counterclaims

Despite the Settlement Agreement, CoreRx complied with a preliminary injunction to deliver outstanding orders for the product to Bionpharma. CoreRx also filed an answer to Bionpharma's claims and asserted counterclaims against Bionpharma for breach of the contractual covenant of good faith and fair dealing, and for unjust enrichment[1].

Reassertion of Patent Infringement Claims

On April 1, 2022, Azurity filed a new suit against CoreRx in the Middle District of Florida (the "Florida Action"), reasserting its claims for patent infringement and asserting a claim for breach of the Settlement Agreement. This action was part of Azurity's ongoing efforts to halt the production and supply of Bionpharma's product[1].

Motion to Stay the Florida Action

Azurity and CoreRx jointly filed a motion to stay the Florida Action pending the resolution of the Delaware Actions. This motion was granted on May 20, 2022, indicating that the court found it prudent to wait for the outcome of related cases before proceeding with the Florida Action[1].

Key Legal Decisions and Rulings

Preliminary Injunction

The United States District Court for the Southern District of New York granted Bionpharma's motion for a preliminary injunction, compelling CoreRx to supply Bionpharma with the enalapril maleate oral solution in accordance with their Master Manufacturing Supply Agreement. This decision was crucial as it ensured Bionpharma could continue fulfilling its contractual obligations[3].

Stay and Security Bond

In a subsequent ruling, the court denied CoreRx's motion to stay the preliminary injunction pending appeal but granted an interim stay. The court also required Bionpharma to post a $200,000 security bond to maintain the preliminary injunction. Azurity's motion to intervene permissively was granted, allowing them to appeal the court's opinion and order[4].

Irreparable Harm and Likelihood of Success

The court emphasized that Bionpharma had demonstrated a strong likelihood of success on the merits of its breach-of-contract claim against CoreRx. It also highlighted that CoreRx's claims of potential harm were speculative and that Bionpharma would suffer substantial injury if a stay were granted, including damage to its reputation and goodwill[4].

Analysis of the Litigation

Contractual Obligations and Patent Law

The litigation underscores the complex interplay between contractual obligations and patent law. CoreRx's decision to cease manufacturing the product due to Azurity's patent infringement claims led to a breach of contract dispute with Bionpharma. The court's rulings emphasized the importance of honoring contractual agreements despite ongoing patent disputes[3][4].

Strategic Maneuvering

Azurity's repeated assertions of patent infringement and its efforts to intervene in the Bionpharma-CoreRx dispute indicate a strategic attempt to protect its intellectual property rights. However, the court's decisions suggest that such actions must be balanced against the contractual obligations and the potential harm to other parties involved[1][4].

Impact on the Parties

For Bionpharma, the ability to continue supplying its product is crucial for maintaining its market presence and customer trust. For CoreRx, complying with the preliminary injunction while navigating the Settlement Agreement and potential litigation costs is a significant burden. Azurity's actions aim to protect its patents but also risk being seen as overly aggressive and potentially harmful to other stakeholders[3][4].

Key Takeaways

• Contractual Compliance: The importance of adhering to contractual agreements, even in the face of patent disputes.
• Patent Protection: The aggressive measures companies may take to protect their intellectual property.
• Judicial Balancing: Courts must balance the interests of all parties involved, considering potential harm and the likelihood of success on the merits.
• Strategic Litigation: The strategic use of litigation to achieve business objectives, such as protecting market share and intellectual property.

FAQs

What was the basis of Azurity's lawsuits against CoreRx?

Azurity's lawsuits against CoreRx were based on allegations that CoreRx's manufacturing of Bionpharma's enalapril maleate oral solution infringed Azurity's patents[1][3].

What was the outcome of the preliminary injunction in the Bionpharma-CoreRx case?

The court granted the preliminary injunction, compelling CoreRx to supply Bionpharma with the enalapril maleate oral solution in accordance with their Master Manufacturing Supply Agreement[3].

Why did the court deny CoreRx's motion to stay the preliminary injunction?

The court denied the motion because CoreRx's claims of potential harm were speculative, and Bionpharma had demonstrated a strong likelihood of success on the merits of its breach-of-contract claim. Additionally, the court found that a stay would cause substantial injury to Bionpharma's reputation and goodwill[4].

What was the significance of the Settlement Agreement between Azurity and CoreRx?

The Settlement Agreement required CoreRx to cease manufacturing the product for Bionpharma in exchange for Azurity releasing its patent infringement claims against CoreRx. Azurity also agreed to indemnify CoreRx for any resulting litigation[1].

How did the court's decision affect the ongoing litigation in the Florida Action?

The court's decision to grant a stay in the Florida Action pending the resolution of the Delaware Actions allowed the parties to await the outcome of related cases before proceeding, potentially streamlining the litigation process[1].

Cited Sources

1. Bionpharma Inc. v. CoreRx, Inc., No. 21-CV-10656 - Casetext
2. Bionpharma Inc. v. CoreRx Inc. | New York Law Journal - Law.com
3. Bionpharma Inc. v. CoreRx, Inc., 582 F. Supp. 3d 167 - Casetext
4. Bionpharma Inc. v. CoreRx, Inc., 21-CV-10656 (JGK)(VF) - Casetext