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

AZURITY PHARMACEUTICALS, INC. v. BIONPHARMA INC. (D.N.J. 2021)

Docket		Date Filed	2021-06-22
Court	District Court, D. New Jersey	Date Terminated	2021-09-10
Cause		Assigned To	Michael Andre Shipp
Jury Demand		Referred To	Douglas Arpert
Patents	10,039,745; 10,154,987; 10,772,868; 10,786,482; 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. BIONPHARMA INC. (D.N.J. 2021)

Date Filed	Document No.	Description	Snippet	Link To Document
2021-06-22				External link to document
2021-06-22	29		-1067, which relates to asserted U.S. Patent No. 10,154,987, should also be included herein with …Judge Stark's Revised Procedures fo r Managing Patent Cases (which is posted at 1 …www.ded.uscourts.gov; see Chambers, Judge Leonard P. Stark, Patent Cases), and the parties having determined…Identification of Accused Product(s) and Asserted Patent(s). By December… and the asserted patent(s) they alleged infringe, and produce the	External link to document
2021-06-22	45	Reply Brief to Opposition to Motion	Shrestha Decl. Ex. M) ’745 patent U.S. Patent No. 10,039,745 B2 (ECF No. 9-5, 7/13/21… Decl. Ex. C) ’023 patent or patent-in-suit U.S. Patent No. 11,040,023 B2 (ECF No. 1-1,…PTO or Patent Office United States Patent and Trademark Office Second Wave Patents …the ’023 patent is “patentably indistinct” from the claims of the First and Second Wave Patents, which… ’023 patent are patentably indistinct from the claims of the First and Second Wave Patents, which	External link to document
2021-06-22	46		of U.S. Patent Nos. 9,669,008 (“the ’008 patent”); 9,808,442 (“the ’442 patent”); 10,039,745 (“the ’… ’745 patent”); and 10,154,987 (“the ’987 patent”) (collectively, “patents-in-suit”). Bionpharma has…II. The Patents-in-Suit. A. The ’008 Patent. The ‘008 patent, entitled …assignee on the face of the patent. The patent issued with 20 claims. ’008 patent at cover. …assignee on the face of the patent. The patent issued with 30 claims. ’442 patent at cover. The	External link to document
2021-06-22	60	Redacted Document	10,154,987 ’745 Patent U.S. Patent No. 10,039,745 ’868 Patent U.S. Patent No. 10,772,868…ABBREVIATIONS ’023 Patent U.S. Patent No. 11,040,023 ’008 Patent U.S. Patent No. 9,669,…9,669,008 ’442 Patent U.S. Patent No. 9,808,442 ’987 Patent U.S. Patent No. 10,154,987…10,772,868 ’482 Patent U.S. Patent No. 10,786,482 ’621 Patent U.S. Patent No. 10,918,621…to U.S. Patent Application No. 15/081,603 (now U.S. Patent No. 9,669,008, or “the ’008 Patent”). D.I	External link to document
2021-06-22	63	Redacted Document	’745 Patent U.S. Patent No. 10,039,745 ’868 Patent U.S. Patent No. 10,772,868 ’482 Patent…ABBREVIATIONS ’023 Patent U.S. Patent No. 11,040,023 (D.I. 1-1) ’008 Patent U.S. Patent No. 9,669,008…9,669,008 ’442 Patent U.S. Patent No. 9,808,442 ’987 Patent U.S. Patent No. 10,154,987 … Patent U.S. Patent No. 10,786,482 ’621 Patent U.S. Patent No. 10,918,621 ACE … infringes the ’023 Patent. Instead, Bionpharma contends that the ’023 patent (which is presumed valid	External link to document
2021-06-22	65	Redacted Document	Shrestha Decl. Ex. M) ’745 patent U.S. Patent No. 10,039,745 B2 (ECF No. 9-5, 7/13/21… Decl. Ex. C) ’023 patent or patent-in-suit U.S. Patent No. 11,040,023 B2 (ECF No. 1-1,…PTO or Patent Office United States Patent and Trademark Office Second Wave Patents …asserting a continuation patent—the ’023 patent—with claims that are patentably indistinct from the claims…023 patent are patentably indistinct from the claims of the First and Second Wave Patents that	External link to document

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

Overview of the Dispute

The litigation between Azurity Pharmaceuticals, Inc. and Bionpharma Inc. revolves around patent infringement claims related to Bionpharma's generic version of Azurity's enalapril oral liquid medication, marketed under the trade name Epaned®. This dispute is part of an ongoing series of lawsuits, referred to as the "First Wave," "Second Wave," and "Third Wave" of litigation.

First Wave of Litigation

The First Wave involved lawsuits (Nos. 18-cv-1962 and 19-cv-1067) concerning Azurity's patents '008, '442, '745, and '987. In April 2021, Judge Leonard Stark of the District of Delaware held a bench trial and entered a judgment in favor of Bionpharma. Key findings included:

• Prosecution History Estoppel: Azurity was estopped from claiming that the active ingredient in Bionpharma's ANDA, enalapril maleate, was equivalent to the citrate buffer limitation in the asserted claims due to amendments and arguments made during patent prosecution[1][3][4].
• Buffer Claim Limitations: Azurity failed to prove that enalapril maleate acted as a buffer, and the proposed maleic acid buffer was not equivalent to the citric acid buffer[1][3][4].
• Preservative Claim: Azurity could not claim parabens as equivalent to the claimed preservative sodium benzoate because parabens were disclosed in the specification but not claimed[3].

The Federal Circuit affirmed Judge Stark's findings without an opinion[3].

Second Wave of Litigation

The Second Wave involved the '868, '482, and '621 patents (No. 20-cv-1256). After the Federal Circuit's affirmance in the First Wave suits, Azurity stipulated to the dismissal of the Second Wave lawsuit[3].

Third Wave of Litigation

The Third Wave includes ongoing lawsuits (Nos. 21-cv-1286 and 21-cv-1455) involving the '023 and '405 patents. One of these lawsuits was originally filed in the District of New Jersey and was transferred to the District of Delaware[3].

Antitrust Counterclaims

Bionpharma asserted antitrust "sham litigation" claims 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 delay Bionpharma's market entry and incur litigation costs[3].

Motion to Dismiss Antitrust Counterclaims

Azurity moved to dismiss these antitrust counterclaims, but the motion was denied. The court found that Bionpharma's allegations were sufficient to state a claim for relief that was plausible on its face[3].

Attorney Fees and Exceptional Case Determination

Bionpharma moved for attorney fees under Section 285 of the US Code, arguing that Azurity's lawsuit was exceptionally meritless and that Azurity engaged in exceptionally unreasonable conduct. Bionpharma contended that Azurity:

• Lacked a Plausible Infringement Theory: Azurity never had a plausible way to satisfy the "buffer" limitation and repeatedly shifted its infringement theories[1][4].
• Failed to Conduct Pre-Suit Investigation: Azurity refused to review Bionpharma’s ANDA before filing suit, despite being offered access under confidentiality conditions[1][4].
• Pursued Excessive Discovery: Bionpharma alleged that Azurity sought an unreasonable amount of discovery, although the court found this argument unpersuasive[1].

The district court denied Bionpharma's motion for attorney fees, concluding that Azurity's rejection of the offer of confidential access (OCA) to Bionpharma's ANDA was reasonable, and that the mere assertion of a statutory patent right based on a reasonable belief in infringement did not render the case exceptional[1][4].

Legal and Procedural Implications

• Hatch-Waxman Framework: The litigation highlights the complexities of the Hatch-Waxman framework, particularly the requirements for pre-filing investigations and the use of offers of confidential access (OCAs) to review ANDAs[4].
• Prosecution History Estoppel: The case emphasizes the importance of prosecution history estoppel in patent litigation, where amendments and arguments made during patent prosecution can significantly limit the scope of patent claims[1][3][4].

Market and Competitive Impact

The ongoing litigation has significant implications for the market and competition in the pharmaceutical sector. Bionpharma's allegations suggest that Azurity's actions were aimed at delaying market entry and maintaining a monopoly, which could have broader antitrust implications[3].

Key Takeaways

• Patent Litigation Strategy: The case underscores the importance of thorough pre-suit investigations and the careful consideration of prosecution history estoppel in patent litigation.
• Antitrust Considerations: It highlights the potential antitrust implications of aggressive patent litigation strategies aimed at delaying generic competition.
• Hatch-Waxman Compliance: The litigation emphasizes the need for compliance with the Hatch-Waxman framework, including the use of OCAs and the conduct of reasonable pre-filing investigations.

Frequently Asked Questions (FAQs)

What is the central issue in the Azurity Pharmaceuticals, Inc. v. Bionpharma Inc. litigation?

The central issue revolves around patent infringement claims related to Bionpharma's generic version of Azurity's enalapril oral liquid medication, with a focus on the "buffer" limitation in Azurity's patents.

What was the outcome of the First Wave of litigation?

The First Wave resulted in a judgment in favor of Bionpharma, with the court finding that Azurity was estopped from claiming certain equivalences due to prosecution history and that Azurity failed to prove key claims.

Why did Bionpharma assert antitrust counterclaims?

Bionpharma asserted antitrust counterclaims alleging that Azurity brought the lawsuits in bad faith to stifle competition and maintain a monopoly in enalapril liquids.

Was Azurity's rejection of the OCA reasonable?

Yes, the district court found that Azurity's rejection of the offer of confidential access (OCA) to Bionpharma's ANDA was reasonable.

What are the implications of this litigation for the pharmaceutical industry?

The litigation has significant implications for market competition and antitrust considerations, highlighting the need for careful patent litigation strategies and compliance with the Hatch-Waxman framework.

Cited Sources:

1. Memorandum Opinion - District of Delaware. (2024, October 4). Retrieved from https://www.ded.uscourts.gov/sites/ded/files/opinions/19-1067.pdf
2. Azurity Pharm. v. Bionpharma Inc., No. 2021-1926. (2022, March 9). Retrieved from https://casetext.com/case/azurity-pharm-v-bionpharma-inc
3. Azurity Pharm. v. BionPharm., 650 F. Supp. 3d 269. (2023, January 11). Retrieved from https://casetext.com/case/azurity-pharm-v-bionpharm-2
4. Silvergate Pharmaceuticals v. Bionpharma: The relevance of offers of confidential access. (2024, November 21). Retrieved from https://www.dlapiper.com/en-us/insights/publications/synthesis/2024/silvergate-pharmaceuticals-v-bionpharma-relevance-of-offers-of-confidential-access
5. AZURITY PHARMACEUTICALS, INC. v. BIONPHARMA INC. DC. Retrieved from https://insight.rpxcorp.com/litigation/njdce-476077-azurity-pharmaceuticals-v-bionpharma