Litigation Details for THERAPEUTICSMD, INC. v. AMNEAL PHARMACEUTICALS, INC. (D.N.J. 2020)

THERAPEUTICSMD, INC. v. AMNEAL PHARMACEUTICALS, INC. (D.N.J. 2020)

Docket		Date Filed	2020-04-29
Court	District Court, D. New Jersey	Date Terminated	2021-02-25
Cause	15:1126 Patent Infringement	Assigned To	Freda L. Wolfson
Jury Demand	None	Referred To	Tonianne J. Bongiovanni
Parties	AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Patents	10,052,386; 10,206,932; 10,639,375; 10,675,288; 10,806,740; 11,033,626; 11,103,513; 11,103,516; 11,110,099; 8,633,178; 8,846,648; 8,846,649; 8,987,237; 8,993,548; 8,993,549; 9,006,222; 9,114,145; 9,114,146; 9,301,920
Attorneys	ALEXANDER LEE CALLO
Firms	Stone Conroy LLC
Link to Docket	External link to docket

Details for THERAPEUTICSMD, INC. v. AMNEAL PHARMACEUTICALS, INC. (D.N.J. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-04-29				External link to document
2020-04-29	1	Complaint	9,301,920 (the “’920 patent”); 10,052,386 (the “’386 patent”); and 10,206,932 (the “’932 patent”) (collectively…of United States Patent Nos. 8,633,178 (the “’178 patent”); 8,846,648 (the “’648 patent”); 8,846,649 (… (the “’649 patent”); 8,987,237 (the “’237 patent); 8,993,548 (the “’548 patent”); 8,993,549 (the “’549…’549 patent”); 9,006,222 (the “’222 patent”); 9,114,145 (the “’145 patent”); 9,114,146 (the “’146 patent… 1. This is an action for patent infringement under the patent laws of the United States, 35 U.S.C	External link to document
2020-04-29	10	Amended Complaint	146 patent”); 9,301,920 (the “’920 patent”); 10,052,386 (the “’386 patent”); 10,206,932 (the “’932 patent…of United States Patent Nos. 8,633,178 (the “’178 patent”); 8,846,648 (the “’648 patent”); 8,846,649 …8,846,649 (the “’649 patent”); 8,987,237 (the “’237 patent); 8,993,548 (the “’548 patent”); 8,993,549 (the “… “’549 patent”); 9,006,222 (the “’222 patent”); 9,114,145 (the “’145 patent”); 9,114,146 (the “’146 …10,639,375 (the “’375 patent”); and 10,675,288 (the “’288 patent”) (collectively, “the patent(s)-in-suit”),	External link to document
2020-04-29	45	Order	,006,222; 9,114,145; 9,114,146; 9,301,920; 10,052,386; 10,206,932; 10,639,375; 10,675,288; 10,806,740…this Consent Judgment, the term “Patents-in-Suit” shall mean U.S. Patent Nos. 8,633,178; 8,846,648; 8,…11,110,099. 4. Until expiration of the Patents-in-Suit, Amneal, including any of its successors… and assigns, is enjoined from infringing the Patents-in-Suit, on its own part or through any third …parties in connection with any infringement of the Patents-in-Suit by any such third parties in connection	External link to document
2020-04-29	9	Amended Complaint	9,301,920 (the “’920 patent”); 10,052,386 (the “’386 patent”); 10,206,932 (the “’932 patent”); and 10,639,375…of United States Patent Nos. 8,633,178 (the “’178 patent”); 8,846,648 (the “’648 patent”); 8,846,649 (… (the “’649 patent”); 8,987,237 (the “’237 patent); 8,993,548 (the “’548 patent”); 8,993,549 (the “’549…’549 patent”); 9,006,222 (the “’222 patent”); 9,114,145 (the “’145 patent”); 9,114,146 (the “’146 patent… 1. This is an action for patent infringement under the patent laws of the United States, 35 U.S.C	External link to document

TherapeuticsMD, Inc. v. Amneal Pharmaceuticals, Inc.: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between TherapeuticsMD, Inc. and Amneal Pharmaceuticals, Inc. revolves around a patent dispute involving TherapeuticsMD's product BIJUVA, a combination of estradiol and progesterone. Here is a detailed summary and analysis of the case.

Background of the Litigation

TherapeuticsMD, Inc. is the owner of several patents related to BIJUVA, a hormone therapy product approved by the FDA. Amneal Pharmaceuticals, Inc. submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of BIJUVA before the expiration of TherapeuticsMD's patents listed in the FDA's Orange Book[4].

Initiation of Litigation

The litigation began in 2020 when TherapeuticsMD filed a patent infringement lawsuit against Amneal in the U.S. District Court for the District of New Jersey. This action was a response to Amneal's ANDA filing, which TherapeuticsMD claimed would infringe on its patents if approved[4].

Key Issues and Claims

The primary issue in the litigation was whether Amneal's generic version of BIJUVA would infringe on TherapeuticsMD's patents. TherapeuticsMD asserted that Amneal's ANDA filing would violate its patent rights, while Amneal argued that its generic product did not infringe on the patents in question.

Settlement and License Agreement

After ongoing litigation, the parties reached a settlement agreement. As part of this settlement, TherapeuticsMD granted Amneal a license to commercialize its generic version of BIJUVA in the United States. The license allows Amneal to market its generic product starting on May 25, 2032, or earlier under certain circumstances. This date is just 180 days before the expiration of the last of TherapeuticsMD’s BIJUVA patents listed in the Orange Book[4].

Terms of the Settlement

The settlement includes a consent judgment that will be filed with the U.S. District Court for the District of New Jersey. This judgment enjoins Amneal from marketing its generic version of BIJUVA before the specified date, except as provided for in the settlement and license agreement. The agreement reflects the strength of TherapeuticsMD's patent estate, as noted by Rob Finizio, CEO of TherapeuticsMD[4].

Analysis of the Settlement

The settlement is significant because it resolves the patent infringement dispute without the need for further litigation. It allows Amneal to enter the market with its generic product at a defined future date, providing a clear timeline for both parties. This type of settlement is common in pharmaceutical patent litigation, where companies often negotiate to avoid lengthy and costly legal battles.

Implications for the Pharmaceutical Industry

This case highlights the importance of patent litigation in the pharmaceutical industry. Companies like TherapeuticsMD and Amneal frequently engage in such disputes to protect their intellectual property and market share. The settlement demonstrates how these disputes can be resolved through licensing agreements, allowing generic manufacturers to enter the market while respecting the original patent holder's rights.

Comparison with Other Pharmaceutical Litigations

This case is similar to other pharmaceutical patent litigations, such as those involving ANDA filings and reverse payment agreements. For example, the case of CVS Pharmacy Inc. v. Forest Laboratories Inc. involved antitrust allegations against generic drug companies and brand-name manufacturers over settlement agreements in ANDA litigation. However, the TherapeuticsMD and Amneal case focuses specifically on patent infringement and licensing agreements rather than antitrust issues[2].

Conclusion and Key Takeaways

• Patent Protection: The case underscores the importance of patent protection in the pharmaceutical industry.
• Licensing Agreements: Licensing agreements can be a viable solution to resolve patent disputes, allowing generic manufacturers to enter the market while respecting original patent rights.
• Litigation Strategy: The settlement highlights the strategic use of litigation and negotiation to protect intellectual property and market share.
• Regulatory Compliance: The case emphasizes the need for compliance with regulatory requirements, such as those related to ANDA filings and patent listings in the Orange Book.

Key Takeaways

• The litigation between TherapeuticsMD and Amneal was resolved through a settlement and licensing agreement.
• The agreement allows Amneal to market its generic version of BIJUVA starting May 25, 2032.
• The settlement reflects the strength of TherapeuticsMD's patent estate.
• Patent litigation is a critical aspect of the pharmaceutical industry, often resolved through licensing agreements.

Frequently Asked Questions (FAQs)

Q: What was the main issue in the litigation between TherapeuticsMD and Amneal?

A: The main issue was whether Amneal's generic version of BIJUVA would infringe on TherapeuticsMD's patents.

Q: How was the litigation resolved?

A: The litigation was resolved through a settlement and licensing agreement that allows Amneal to market its generic product starting May 25, 2032.

Q: What is the significance of the Orange Book in this case?

A: The Orange Book lists approved drug products with therapeutic equivalence evaluations, and in this case, it listed the patents that TherapeuticsMD claimed would be infringed by Amneal's generic product.

Q: How common are licensing agreements in pharmaceutical patent litigation?

A: Licensing agreements are relatively common in pharmaceutical patent litigation as they provide a way to resolve disputes without prolonged legal battles.

Q: What are the implications of this case for the pharmaceutical industry?

A: The case highlights the importance of patent protection and the use of licensing agreements to resolve disputes, allowing generic manufacturers to enter the market while respecting original patent rights.

Cited Sources:

1. TherapeuticsMD Settles U.S. Patent Litigation with Amneal for Bijuva - Biospace[4]
2. Patent Litigation - Patent Docs[2]
3. Attorney General James Secures Over $270 Million Multistate Settlement in Principle with Amneal Pharmaceuticals - New York State Attorney General[5]

Last updated: 2025-01-17