Litigation Details for AZURITY PHARMACEUTICALS, INC. v. BIONPHARMA INC. (D. Del. 2021)

AZURITY PHARMACEUTICALS, INC. v. BIONPHARMA INC. (D. Del. 2021)

Docket		Date Filed	2021-09-10
Court	District Court, D. Delaware	Date Terminated
Cause	15:1126 Patent Infringement	Assigned To
Jury Demand	Plaintiff	Referred To
Parties	NOVITIUM PHARMA LLC
Patents	10,039,745; 10,154,987; 10,772,868; 10,786,482; 11,141,405; 11,173,141; 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
Attorneys	Megan C. Haney
Firms	Phillips, McLaughlin & Hall, P.A.
Link to Docket	External link to docket

Details for AZURITY PHARMACEUTICALS, INC. v. BIONPHARMA INC. (D. Del. 2021)

Date Filed	Document No.	Description	Snippet	Link To Document
2021-09-10				External link to document
2021-09-10	103		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…. Del.). 5 U.S. Patent Nos. 11,040,023 (“’023 patent”) and 11,141,405 (“’405 patent”) (collectively, …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	External link to document
2021-09-10	109		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 …action for patent infringement of United States Patent Nos. 11,040,023 (the “’023 patent”) and 11,141,405…11,141,405 (the “’405 patent”) (collectively the “Patents-in-Suit”) and damages under the patent laws of the	External link to document
2021-09-10	137	Redacted Document	Thereafter, U.S. Patent Nos. 9,808,442 B2 (“’442 patent,” 18-1962 D.I. 1-1, Compl. Ex. B), 10,039,745 B2 (“’745… or more claims of U.S. Patent No. 11,040,023 (the “’023 patent”) (the “Patent- In-Suit”). Upon information….S. Patent Application No. 17,228,024, which issued as U.S. Patent No. 11,141,405 (“’405 patent”) on…and ’987 patents are patentably indistinct from, and cover essentially the same patentable subject matter…, the ’008 patent. 123. The claims of the Second Wave Patents are patentably indistinct	External link to document
2021-09-10	149	Opening Brief in Support	U.S. Patent No. 10,039,745 (Aug. 7, 2018) ’442 Patent U.S. Patent No. 9,808,442… for Patents) ’008 Patent U.S. Patent No. 9,669,008 (Jun. 6, 2017) ’745 Patent … ’008 Patent, ’745 Patent, ’442 Patent, and ’987 Patent First Suits 18-1962 and 19….S. Patent No. 11,141,405 (Oct. 12, 2021) Third Patents ’023 Patent and ’405 Patent Third…2017) ’987 Patent U.S. Patent No. 10,154,987 (Dec. 18, 2018) First Patents	External link to document
2021-09-10	155	Answering Brief in Opposition	Decl. Ex. M) ’745 patent U.S. Patent No. 10,039,745 B2 (D.I. 9-5, 7/13/21 Shrestha…405 patent U.S. Patent No. 11,141,405 B2 (D.I. 1, Compl. Ex. A) ’442 patent … PTO or Patent Office United States Patent and Trademark Office Second Wave Patents … Abbreviation ’008 patent U.S. Patent No. 9,669,008 B1 (D.I.1 9-3, 7/13… Decl. Ex. C) ’023 patent U.S. Patent No. 11,040,023 B2 (D.I. 89-1, First	External link to document

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

Introduction

The litigation between Azurity Pharmaceuticals, Inc. and Bionpharma Inc. is a complex and multifaceted dispute centered around patent infringement claims related to generic enalapril oral liquid products. Here, we will delve into the key aspects of this litigation, including the background, legal arguments, court decisions, and the broader implications.

Background

Azurity Pharmaceuticals, Inc. holds a family of patents related to the medication enalapril, specifically enalapril oral liquids. Bionpharma Inc. filed an Abbreviated New Drug Application (ANDA) with the FDA to market a generic version of enalapril oral liquid, which prompted Azurity to initiate a series of lawsuits alleging patent infringement[3][5].

The First Wave of Litigation

The initial lawsuits, referred to as the "First Wave," involved U.S. Patents Nos. 9,669,008, 9,808,442, 10,039,745, and 10,154,987. These patents required specific buffer and preservative components. In February 2021, Judge Leonard Stark of the District of Delaware held a bench trial and subsequently entered a judgment in favor of Bionpharma. The court found that:

• Prosecution history estoppel precluded Azurity from claiming that the active ingredient in Bionpharma's ANDA, enalapril maleate, was equivalent to the citrate buffer limitation in the asserted claims.
• Azurity failed to prove that enalapril maleate acted as a buffer.
• Azurity could not claim parabens as equivalent to the claimed preservative sodium benzoate because parabens were disclosed in the specification but not claimed[3][5].

The Second Wave of Litigation

Following the First Wave, Azurity filed another lawsuit involving U.S. Patents Nos. 10,772,868, 10,786,482, and 10,918,621, known as the "Second Wave" patents. However, after the judgment in the First Wave litigation became final on appeal, Azurity stipulated to the dismissal of the Second Wave lawsuit[5].

The Third Wave of Litigation

The current litigation, often referred to as the "Third Wave," involves U.S. Patents Nos. 11,040,023 and 11,141,405. Bionpharma moved for a judgment on the pleadings, arguing that the previous judgments of non-infringement in the First and Second Wave cases were preclusive of Azurity's new infringement claims. However, the court denied Bionpharma’s motion, finding that the claims in the Third Wave patents differed sufficiently from the earlier patents to avoid claim preclusion[5].

Antitrust Counterclaims

Bionpharma has also asserted antitrust counterclaims under the Sherman Act, alleging that Azurity brought these lawsuits in bad faith to stifle competition and maintain a monopoly in enalapril liquids. Bionpharma claims that Azurity's lawsuits were objectively baseless and intended to force Bionpharma to incur significant litigation costs and delay market entry. Azurity's motion to dismiss these antitrust counterclaims was denied, allowing Bionpharma to proceed with its claims[3].

Litigation Conduct and Attorneys’ Fees

Bionpharma argued that Azurity's litigation conduct was exceptionally unreasonable and meritless, warranting the award of attorneys’ fees. Bionpharma contended that Azurity changed its infringement theories repeatedly and refused to review Bionpharma’s ANDA pre-suit, indicating a lack of interest in the merits of the case. However, the court denied Bionpharma’s motion for attorneys’ fees, finding that while Azurity likely benefited from the automatic stay, this alone did not render the case exceptional[1].

Transfer of Venue

In related proceedings, Novitium Pharma, LLC, Bionpharma's contract manufacturer, moved to transfer the case to the District of Delaware to consolidate with other ongoing litigations involving the enalapril patent family. The court recognized the District of Delaware's comprehensive familiarity with the issues and the potential for preclusive effects from previous decisions, supporting the transfer[2].

Key Findings and Decisions

• Infringement Claims: The court has consistently found that Bionpharma's ANDA product does not infringe Azurity's patents due to the absence of the required buffer and preservative components.
• Antitrust Claims: Bionpharma's antitrust counterclaims have been allowed to proceed, alleging that Azurity's lawsuits were part of a strategy to stifle competition.
• Litigation Conduct: Despite Bionpharma's arguments, the court did not find Azurity's litigation conduct to be exceptionally unreasonable or meritless to the extent of awarding attorneys’ fees.

Broader Implications

This litigation highlights the complexities and challenges in pharmaceutical patent disputes, particularly under the Hatch-Waxman Act. It underscores the importance of careful patent prosecution, the potential for antitrust implications in aggressive litigation strategies, and the need for courts to balance the interests of innovator companies with those of generic manufacturers.

Key Takeaways

• Patent Infringement: The absence of specific buffer and preservative components in Bionpharma's ANDA product has been a critical factor in the non-infringement findings.
• Antitrust Concerns: Allegations of sham litigation and anticompetitive behavior are significant and can lead to additional legal consequences.
• Litigation Strategy: The case emphasizes the importance of consistent and well-founded infringement theories and the potential consequences of changing positions during litigation.
• Venue and Consolidation: The transfer of cases to a single venue can help avoid duplication of effort and ensure consistent rulings in related litigations.

Frequently Asked Questions (FAQs)

Q: What is the main dispute between Azurity and Bionpharma?

A: The main dispute revolves around Azurity's allegations that Bionpharma's generic enalapril oral liquid infringes Azurity's patents.

Q: What were the key findings in the First Wave of litigation?

A: The court found that Bionpharma's ANDA product did not infringe Azurity's patents due to the absence of the required buffer and preservative components.

Q: Why did Bionpharma assert antitrust counterclaims?

A: Bionpharma alleged that Azurity's lawsuits were brought in bad faith to stifle competition and maintain a monopoly in enalapril liquids.

Q: Was Azurity's motion to dismiss the antitrust counterclaims successful?

A: No, the court denied Azurity's motion to dismiss the antitrust counterclaims, allowing Bionpharma to proceed with its claims.

Q: Did the court award attorneys’ fees to Bionpharma?

A: No, the court denied Bionpharma’s motion for attorneys’ fees, finding that Azurity's conduct did not render the case exceptional.

Cited Sources:

1. Memorandum Opinion - District of Delaware: Bionpharma argues these facts demonstrate that Azurity brought this lawsuit solely to obtain a stay and exclude Bionpharma from the market[1].
2. Azurity Pharm. v. Novitium Pharma, LLC: The case involves a transfer motion to the District of Delaware and discusses the broader context of the enalapril patent family litigations[2].
3. Azurity Pharm. v. BionPharm.: This source details the antitrust counterclaims and the ongoing patent infringement dispute between Azurity and Bionpharma[3].
4. AZURITY PHARMACEUTICALS, INC. v. BIONPHARMA INC.: This document provides additional context on the court proceedings and decisions in the District of Delaware[4].
5. Azurity Pharms., Inc. v. Bionpharma Inc. | Robins Kaplan LLP Law Firm: This article summarizes the key aspects of the litigation, including the patents-in-suit and the court's findings[5].