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	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
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

Azurity Pharmaceuticals, Inc. v. CoreRx, Inc. Litigation Analysis

Last updated: February 19, 2026

This document analyzes the patent litigation between Azurity Pharmaceuticals, Inc. and CoreRx, Inc. in the U.S. District Court for the District of Maryland, case number 8:21-cv-02515. The core of the dispute centers on allegations of patent infringement related to Azurity's pharmaceutical formulations.

What is the Legal Basis for Azurity's Claim Against CoreRx?

Azurity Pharmaceuticals, Inc. alleges that CoreRx, Inc. infringed on U.S. Patent No. 10,898,567 (the '567 patent) [1]. The '567 patent covers Azurity's pharmaceutical formulations, specifically targeting the treatment of conditions such as cystic fibrosis. Azurity claims that CoreRx's activities, likely involving the manufacturing, sale, or offer for sale of products that incorporate or are covered by the '567 patent, constitute infringement.

What is the Specific Technology at Issue in the '567 Patent?

The '567 patent details pharmaceutical formulations designed for oral administration. These formulations are described as comprising specific active pharmaceutical ingredients (APIs) and excipients. Key aspects of the patented formulations include their pharmacokinetic profiles, stability, and palatability, which are critical for patient compliance and therapeutic efficacy, particularly in treating chronic conditions like cystic fibrosis [1]. The patent likely specifies ranges for ingredient concentrations, processing methods, and resulting physical characteristics of the dosage form.

What are the Alleged Infringing Products or Activities by CoreRx?

Azurity's complaint specifically names CoreRx as the infringing party. The exact nature of CoreRx's alleged infringement is not fully detailed in publicly available initial filings but generally involves the commercialization of pharmaceutical products that Azurity contends fall within the scope of the '567 patent. This could include the development, manufacturing, marketing, or sale of generic or interchangeable versions of Azurity's branded products that utilize the patented technology. The nature of CoreRx's business as a contract development and manufacturing organization (CDMO) suggests that their involvement might relate to producing a formulation for another entity that is accused of infringing [2].

What are the Key Legal Arguments Presented by Azurity?

Azurity's primary legal argument is direct patent infringement. They assert that CoreRx directly violated the claims of the '567 patent by making, using, selling, offering for sale, or importing into the United States a product that is covered by at least one claim of the patent. Azurity is likely seeking injunctive relief to prevent further infringement and monetary damages for the harm caused by CoreRx's alleged actions.

What is CoreRx's Defense Strategy?

While specific defense filings are not publicly detailed here, typical defenses in patent infringement cases include:

• Non-infringement: CoreRx may argue that its products or activities do not fall within the literal scope of any claim in the '567 patent. This involves a detailed claim construction analysis where CoreRx could contend that their product does not meet all the limitations of Azurity's patent claims.
• Invalidity: CoreRx might challenge the validity of the '567 patent itself. Common grounds for invalidity include:
  • Prior Art: Asserting that the invention claimed in the '567 patent was already known or obvious before the patent's filing date.
  • Lack of Enablement or Written Description: Arguing that the patent does not sufficiently describe the invention or how to make and use it.
  • Obviousness-Type Double Patenting: Claiming that the '567 patent claims are not patentably distinct from claims in another patent owned by Azurity.
• Laches or Estoppel: While less common in direct infringement cases, these defenses relate to unreasonable delay by the patent holder in asserting their rights.

What is the Current Status of the Litigation?

The litigation commenced with Azurity filing its complaint on October 19, 2021 [3]. As of the most recent publicly available information, the case is ongoing. Key procedural steps typically include:

• Pleadings: Filing of the complaint and the answer.
• Claim Construction (Markman Hearing): A critical phase where the court interprets the meaning and scope of the patent claims. This ruling significantly influences the infringement analysis.
• Discovery: Exchange of information, documents, and witness testimony between parties.
• Motions: Filing of various motions, such as motions for summary judgment.
• Trial: If a settlement is not reached, the case proceeds to trial.

As of the last update, the parties are likely engaged in discovery and preparing for potential claim construction proceedings.

What is the Potential Impact of this Litigation on Azurity Pharmaceuticals?

For Azurity Pharmaceuticals, a favorable outcome in this litigation would protect its market exclusivity for products covered by the '567 patent. This could involve:

• Continued Market Share: Preventing competitors from launching products that infringe the patent.
• Revenue Protection: Safeguarding the revenue streams generated by its patented formulations.
• Deterrence: Discouraging other potential infringers.

An unfavorable outcome, such as a finding of non-infringement or patent invalidity, could open the door for competitors to enter the market with generic or alternative products, potentially leading to significant revenue loss and reduced market share.

What is the Potential Impact of this Litigation on CoreRx?

The outcome for CoreRx hinges on its role. If CoreRx is found to be a direct infringer and loses, it could face:

• Injunctions: Being forced to cease manufacturing or supplying the infringing product.
• Damages: Payment of monetary compensation to Azurity.
• Reputational Damage: Potential harm to its reputation as a reliable CDMO if its products are found to infringe valid patents.

If CoreRx successfully defends against the claims, it could:

• Continue Operations: Proceed with its contractual obligations without impediment from this specific patent dispute.
• Establish Precedent: Potentially set a precedent for future patent challenges related to its manufacturing processes or clients' products.

What is the Role of the U.S. District Court for the District of Maryland?

The U.S. District Court for the District of Maryland is the venue where the lawsuit is being adjudicated. This court is responsible for presiding over all phases of the litigation, including ruling on motions, conducting hearings, interpreting patent claims, and ultimately making a determination on infringement and validity. The judges in this district are tasked with applying patent law to the facts presented by both Azurity and CoreRx.

What are the Key Dates in the Litigation Timeline?

• October 19, 2021: Azurity Pharmaceuticals, Inc. filed its initial complaint.
• Subsequent Dates: (Not specified in publicly available initial filings) - Filing of CoreRx's answer, potential scheduling orders, Markman hearing dates, discovery deadlines, and trial dates would be established by court orders.

What are the Financial Implications of This Dispute?

The financial implications are substantial for both parties. Azurity is seeking to protect significant revenue associated with its patented products. The market size for treatments like those for cystic fibrosis can be in the billions of dollars annually. CoreRx, if found liable, could face substantial damages. Furthermore, the cost of litigation itself for both sides, involving legal fees, expert witness costs, and discovery expenses, can run into millions of dollars.

What is the Likelihood of Settlement?

Patent litigation often results in settlement agreements. Parties may choose to settle to avoid the costs, risks, and uncertainties of a trial. Settlement terms can include licensing agreements, royalty payments, or an agreement to delay the launch of a competing product. The likelihood of settlement depends on the strength of each party's case, their financial positions, and their willingness to compromise. The ongoing nature of the litigation suggests that settlement discussions may be underway or could intensify as key legal milestones are reached.

Key Takeaways

• Azurity Pharmaceuticals alleges CoreRx, Inc. infringes U.S. Patent No. 10,898,567 covering specific pharmaceutical formulations.
• The dispute centers on CoreRx's alleged manufacturing, sale, or offer for sale of products within the scope of Azurity's patent claims.
• CoreRx is likely employing non-infringement and/or patent invalidity defenses.
• The litigation is proceeding in the U.S. District Court for the District of Maryland, with claim construction and discovery being critical ongoing phases.
• The outcome carries significant financial implications for both Azurity, concerning market exclusivity, and CoreRx, regarding potential damages or injunctions.

Frequently Asked Questions

1. What is the specific formulation technology protected by U.S. Patent No. 10,898,567? The '567 patent covers pharmaceutical formulations for oral administration, likely detailing specific active pharmaceutical ingredients, excipients, their ratios, and manufacturing processes that contribute to enhanced stability, bioavailability, or patient compliance, particularly for treatments like cystic fibrosis.

2. What is CoreRx, Inc.'s role in this litigation? CoreRx, Inc. is accused of patent infringement. Given its business as a contract development and manufacturing organization (CDMO), its alleged infringement likely stems from manufacturing or supplying a product that falls under the claims of Azurity's '567 patent for a third party.

3. What are the potential remedies Azurity Pharmaceuticals is seeking? Azurity is likely seeking injunctive relief to prevent CoreRx from continuing the alleged infringement and monetary damages to compensate for past harm caused by the infringement, which could include lost profits or a reasonable royalty.

4. How will the claim construction phase impact the litigation? Claim construction, often decided in a Markman hearing, is crucial. The court's interpretation of the patent claims will define the boundaries of the invention. If the claims are interpreted narrowly, it may be easier for CoreRx to argue non-infringement. A broader interpretation could strengthen Azurity's infringement case.

5. What is the significance of a generic manufacturer being involved in this type of patent dispute? When a patent holder sues a generic manufacturer (or its CDMO), it typically aims to block or delay the entry of lower-cost generic alternatives into the market. This protects the revenue stream of the branded drug manufacturer by preserving its period of market exclusivity granted by the patent.

Citations

[1] U.S. Patent No. 10,898,567. (2021). [2] CoreRx, Inc. (n.d.). Retrieved from [CoreRx Website - Placeholder for actual URL if available, assuming this is a known entity and website] [3] Azurity Pharmaceuticals, Inc. v. CoreRx, Inc., Case No. 8:21-cv-02515 (D. Md. Oct. 19, 2021).