Litigation Details for Arbor Pharmaceuticals, LLC v. Lupin Limited (D. Del. 2020)

Arbor Pharmaceuticals, LLC v. Lupin Limited (D. Del. 2020)

Docket		Date Filed	2020-07-08
Court	District Court, D. Delaware	Date Terminated	2022-04-18
Cause	35:271 Patent Infringement	Assigned To	Maryellen Noreika
Jury Demand	None	Referred To
Parties	LUPIN PHARMACEUTICALS, INC.
Patents	7,157,584; 7,572,920; 9,066,936
Attorneys	Bruce M. Wexler
Firms	Phillips, Goldman, McLaughlin & Hall, P.A.
Link to Docket	External link to docket

Details for Arbor Pharmaceuticals, LLC v. Lupin Limited (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-07-08				External link to document
2020-07-08	4	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 7,157,584 ;7,572,920 ;9,066,936…2020 18 April 2022 1:20-cv-00922 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2020-07-08	67	Order - -Memorandum and Order	three patents but only one term in one of those patents, U.S. Patent No. 9,066,936 (“the…the disputed claim term of U.S. Patent No. 9,066,936 (“the ’936 Patent”) is construed as follows: …reading the entire patent.” Id. at 1321 (internal quotation marks omitted). The patent specification…have reviewed the ’936 Patent and the excerpts of the ’936 Patent prosecution history submitted…ultimate question of the proper construction of the patent [is] a question of law,” although subsidiary fact-finding	External link to document
2020-07-08	93	Notice of Service	Ph.D., D.Sc. Regarding the Validity of U.S. Patent No. 9,066,936; (2) [HIGHLY CONFIDENTIAL] Expert Report…2020 18 April 2022 1:20-cv-00922 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2020-07-08	97	Notice of Service	Ph.D., D.Sc. Regarding Infringement of U.S. Patent No. 9,066,936 filed by Lupin Limited, Lupin Pharmaceuticals…2020 18 April 2022 1:20-cv-00922 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2020-07-08	101	Notice of Service	Fisher, Ph.D. Regarding Invalidity of U.S. Patent Nos. 7,157,584 & 7,572,920 filed by Lupin Limited, Lupin…Buckton, Ph.D., D.SC. Regarding Invalidity of U.S. Patent No. 9,066,936; and (3) [HIGHLY CONFIDENTIAL-OUTSIDE…2020 18 April 2022 1:20-cv-00922 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Arbor Pharmaceuticals, LLC v. Lupin Limited: A Comprehensive Litigation Summary and Analysis

Introduction

The lawsuit between Arbor Pharmaceuticals, LLC, and Takeda Pharmaceutical Company Limited (collectively, "Plaintiffs") against Lupin Limited and Lupin Pharmaceuticals, Inc. (collectively, "Defendants") is a significant case in the pharmaceutical industry, involving patent infringement and the approval of generic drugs. Here, we will delve into the key aspects of this litigation.

The Parties Involved

• Plaintiffs: Arbor Pharmaceuticals, LLC, and Takeda Pharmaceutical Company Limited. Arbor is a limited liability company based in Atlanta, GA, while Takeda is a global pharmaceutical company[1].
• Defendants: Lupin Limited and Lupin Pharmaceuticals, Inc., both part of the Lupin group, a major generic pharmaceutical company.

Background of the Case

The lawsuit revolves around the Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of a drug protected by several patents held by the Plaintiffs. Specifically, the patents in question are U.S. Patent Nos. 9,066,920 and 9,066,936[1].

Claims and Allegations

Patent Infringement

The Plaintiffs allege that the Defendants' ANDA filing and the subsequent certification under 35 U.S.C. § 271(e)(2)(A) constitute an act of patent infringement. They argue that the commercial manufacture, use, offer for sale, or import of the generic product, if approved by the FDA before the expiration of the patents, would infringe the Plaintiffs' patents[1].

Infringement of Specific Patents

• U.S. Patent No. 9,066,920: The Plaintiffs claim that Lupin’s ANDA filing and certification do not provide any factual basis or opinion for noninfringement of claims 1-4, 7, and 8 of this patent[1].
• U.S. Patent No. 9,066,936: Similar allegations are made regarding this patent, with the Plaintiffs asserting that Lupin’s actions constitute infringement under 35 U.S.C. § 271(e)(2)(A)[1].

Relief Sought

The Plaintiffs seek several forms of relief, including:

• An order that the effective date of the FDA approval for Lupin’s ANDA be no earlier than the expiration of the patents or any later expiration of exclusivity.
• An injunction to prevent Lupin from commercially manufacturing, using, offering for sale, or selling the generic product in the United States before the patents expire.
• Monetary relief for any infringement that occurs before the patents expire, including prejudgment interest.
• Attorneys’ fees and costs[1].

Defendants' Position

While the provided documents do not extensively detail Lupin's defense, it is common in such cases for the defendants to argue that their generic product does not infringe the patents or that the patents are invalid. However, in this specific case, Lupin’s Notice Letter did not identify any factual bases for noninfringement of the specified claims[1].

Legal Framework

The case is governed by the Hatch-Waxman Act, specifically 35 U.S.C. § 271(e)(2)(A), which allows generic drug manufacturers to file ANDAs with the FDA while the original drug is still under patent. This provision also allows the patent holder to sue the generic manufacturer for patent infringement based on the ANDA filing[1].

Industry Implications

This litigation highlights the ongoing battles between brand-name pharmaceutical companies and generic manufacturers over patent rights. The outcome of this case can have significant implications for the pharmaceutical industry, affecting the timing and cost of bringing generic drugs to market.

Key Takeaways

• The lawsuit centers on patent infringement claims related to Lupin’s ANDA filing for a generic drug.
• The Plaintiffs seek to prevent early market entry of the generic product and seek monetary relief for any infringement.
• The case is critical for understanding the legal framework governing generic drug approvals and patent protections in the pharmaceutical industry.

FAQs

What is the main issue in the Arbor Pharmaceuticals, LLC v. Lupin Limited case?

The main issue is the alleged patent infringement by Lupin Limited and Lupin Pharmaceuticals, Inc. due to their submission of an ANDA for a generic version of a drug protected by patents held by Arbor Pharmaceuticals and Takeda Pharmaceutical Company.

Which patents are involved in the lawsuit?

The patents involved are U.S. Patent Nos. 9,066,920 and 9,066,936.

What relief are the Plaintiffs seeking?

The Plaintiffs are seeking an injunction to prevent early market entry of the generic product, monetary relief for any infringement, and attorneys’ fees and costs.

How does this case impact the pharmaceutical industry?

The case impacts the timing and cost of bringing generic drugs to market and highlights the ongoing legal battles between brand-name and generic pharmaceutical companies over patent rights.

What is the significance of the Hatch-Waxman Act in this case?

The Hatch-Waxman Act, specifically 35 U.S.C. § 271(e)(2)(A), allows generic manufacturers to file ANDAs while the original drug is still under patent and permits patent holders to sue for infringement based on the ANDA filing.

Sources:

1. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ARBOR PHARMACEUTICALS, LLC and TAKEDA PHARMACEUTICAL COMPANY LIMITED, v. LUPIN LIMITED and LUPIN PHARMACEUTICALS, INC. [PDF]
2. Case 1:20-cv-00922-JDB Document 26 Filed 01/12/21 [PDF]
3. Case 1:20-cv-05747-PAE Document 227 Filed 06/23/23 [PDF]
4. H. LUNDBECK A/S v. LUPIN LTD [PDF]
5. Abbott Laboratories v. Lupin Limited [Casetext]