Litigation Details for Novo Nordisk Inc. v. Aurobindo Pharma USA, Inc. (D. Del. 2022)

Novo Nordisk Inc. v. Aurobindo Pharma USA, Inc. (D. Del. 2022)

Docket		Date Filed	2022-03-04
Court	District Court, D. Delaware	Date Terminated	2022-03-28
Cause	35:271 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	None	Referred To
Patents	10,220,155; 10,335,462; 10,357,616; 10,376,652; 11,097,063; 7,762,994; 8,114,833; 8,129,343; 8,536,122; 8,579,869; 8,684,969; 8,920,383; 9,108,002; 9,132,239; 9,457,154; 9,616,180; 9,687,611; 9,775,953; 9,861,757; RE46,363
Link to Docket	External link to docket

Biologic Drugs cited in Novo Nordisk Inc. v. Aurobindo Pharma USA, Inc.

Details for Novo Nordisk Inc. v. Aurobindo Pharma USA, Inc. (D. Del. 2022)

Date Filed	Document No.	Description	Snippet	Link To Document
2022-03-04				External link to document
2022-03-03	1	Complaint	the “’953 patent”), 9,861,757 (the “’757 patent”), 10,220,155 (the “’155 patent”), 10,335,462 (the “’… COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 10,220,155 128. Novo Nordisk re-alleges … United States Patent Nos. 7,762,994 (the “’994 patent”), 8,114,833 (the “’833 patent”), 8,129,343 (the…(the “’343 patent”), 8,536,122 (the “’122 patent”), 8,579,869 (the “’869 patent”), 8,684,969 (that “’…“’969 patent”), 8,920,383 (the “’383 patent”), 9,108,002 (the “’002 patent”), 9,132,239 (the “’239 patent	External link to document
2022-03-03	8	Patent/Trademark Report to Commissioner of Patents	; 9,132,239 B2; 9,457,154 B2; 9,687,611 B2; 10,335,462 B2. (Attachments: # 1 Notice of Voluntary Dismissal… Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,129,343 B2; …2022 28 March 2022 1:22-cv-00295 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Novo Nordisk Inc. v. Aurobindo Pharma USA, Inc.: A Comprehensive Litigation Summary and Analysis

Introduction

Novo Nordisk Inc. and Novo Nordisk A/S (collectively, "Novo Nordisk") have been engaged in a significant patent infringement lawsuit against Aurobindo Pharma USA, Inc., Aurobindo Pharma Ltd., and Eugia Pharma Specialties Ltd. (collectively, "Aurobindo"). This litigation, filed in the District of Delaware (Case No. 1:22-cv-00295), revolves around the alleged infringement of Novo Nordisk's patents related to the diabetes medication semaglutide.

Nature of the Action

The lawsuit is an action for patent infringement under the patent laws of the United States, specifically Title 35 of the United States Code. Novo Nordisk alleges that Aurobindo's submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of semaglutide infringes on Novo Nordisk's patents[1].

Patents-in-Suit

The complaint focuses on two specific patents:

U.S. Patent No. 8,129,343

This patent encompasses semaglutide and pharmaceutical compositions comprising semaglutide. It also includes methods of treating type 2 diabetes by administering an effective amount of semaglutide. Novo Nordisk claims that Aurobindo's actions would infringe claims 1-6 of this patent[1].

U.S. Patent No. 8,536,122

This patent covers GLP-1 compounds and pharmaceutical compositions comprising these compounds, as well as methods of treating type 2 diabetes using these compounds. Novo Nordisk alleges that Aurobindo's ANDA submission would infringe claims 1-16 of this patent[1].

Infringement Allegations

Novo Nordisk alleges that Aurobindo's submission of the ANDA constitutes an act of infringement under 35 U.S.C. § 271(e)(2)(A). This section allows for infringement claims when a generic drug manufacturer submits an ANDA before the expiration of the relevant patent. Novo Nordisk also claims that Aurobindo's actions would intentionally induce others to use the generic product, thus inducing infringement of the method claims in both patents[1].

Harm and Remedies

Novo Nordisk argues that it will suffer substantial and irreparable harm if Aurobindo is not enjoined from infringing the patents and if the FDA approves Aurobindo's ANDA before the patents expire. Novo Nordisk asserts that it has no adequate remedy at law and is entitled to an injunction and attorney's fees under 35 U.S.C. § 285[1].

Awareness and Intent

Novo Nordisk claims that Aurobindo was aware of the patents when it submitted its ANDA, which supports the argument for an exceptional case and the award of attorney's fees[1].

Litigation Outcome

The case was initially filed on March 4, 2022, but it was dismissed on March 28, 2022. The dismissal details are not explicitly stated in the available documents, but it is part of a broader series of litigations by Novo Nordisk against various generic drug manufacturers[2][4].

Broader Context

This litigation is part of Novo Nordisk's broader efforts to protect its intellectual property related to semaglutide, a key component of its diabetes medication Ozempic. Similar cases have been filed against other generic drug manufacturers, highlighting the ongoing battles in the pharmaceutical industry over patent rights and generic drug approvals[2][3].

Key Takeaways

• Patent Infringement Claims: Novo Nordisk alleges that Aurobindo's ANDA submission infringes on its patents related to semaglutide.
• Substantial Harm: Novo Nordisk claims it will suffer irreparable harm if the infringement continues.
• Awareness and Intent: Aurobindo was aware of the patents when it submitted its ANDA.
• Dismissal: The case was dismissed on March 28, 2022, but the reasons are not detailed in the available documents.
• Broader Litigation: This case is part of a larger legal campaign by Novo Nordisk to protect its intellectual property.

FAQs

Q: What is the main issue in the Novo Nordisk v. Aurobindo Pharma USA, Inc. litigation? A: The main issue is the alleged infringement of Novo Nordisk's patents related to the diabetes medication semaglutide by Aurobindo's submission of an ANDA.

Q: Which patents are involved in this litigation? A: The patents involved are U.S. Patent No. 8,129,343 and U.S. Patent No. 8,536,122.

Q: Why did Novo Nordisk file this lawsuit? A: Novo Nordisk filed the lawsuit to prevent Aurobindo from manufacturing, using, offering to sell, or selling a generic version of semaglutide before the patents expire.

Q: What was the outcome of the case? A: The case was dismissed on March 28, 2022.

Q: Is this litigation part of a larger legal campaign by Novo Nordisk? A: Yes, this litigation is part of Novo Nordisk's broader efforts to protect its intellectual property related to semaglutide.

Sources

1. Novo Nordisk Inc. and Novo Nordisk A/S v. Aurobindo Pharma USA, Inc., et al., Case 1:22-cv-00295-UNA, Document 1, Filed 03/04/22.
2. Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S, IPR2023-00724, Patent 10,335,462 B2.
3. The Interplay: Key Decisions at the Intersection of Antitrust and Life Sciences, WilmerHale Client Alert, October 2024.
4. Novo Nordisk Inc. et al v. Aurobindo Pharma USA, Inc. et al, Litigation Tracker, RPX Corporation.