Litigation Details for CELGENE CORPORATION v. HETERO LABS LIMITED (D.N.J. 2017)

CELGENE CORPORATION v. HETERO LABS LIMITED (D.N.J. 2017)

Docket		Date Filed	2017-05-11
Court	District Court, D. New Jersey	Date Terminated	2021-08-19
Cause	35:271 Patent Infringement	Assigned To
Jury Demand	None	Referred To
Parties	CELGENE CORPORATION
Patents	10,006,091; 10,555,939; 5,008,126; 6,045,501; 6,281,230; 6,315,720; 6,476,052; 6,555,554; 6,561,976; 6,561,977; 6,755,784; 6,869,399; 7,119,106; 7,141,018; 7,189,740; 7,393,862; 7,468,363; 7,968,569; 8,198,262; 8,315,886; 8,404,717; 8,530,498; 8,626,531; 8,648,095; 8,673,939; 8,735,428; 8,828,427; 8,927,592; 9,024,096; 9,056,120; 9,101,621; 9,101,622; 9,993,467
Attorneys	IRENE ORIA; MONVAN HU
Firms	Quinn Emanuel Uquhart & Sullival LLP; Saul Ewing Arnstein & Lehr LLP
Link to Docket	External link to docket

Biologic Drugs cited in CELGENE CORPORATION v. HETERO LABS LIMITED

Details for CELGENE CORPORATION v. HETERO LABS LIMITED (D.N.J. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-05-11				External link to document
2017-05-11	168	Letter	judgment of non-infringement of U.S. Patent No. 8,828,427 B2 (“’427 patent”). At the …judgment of non-infringement of U.S. Patent No. 8,828,427 (“’427 patent”); WHEREAS, on May 11…summary judgment of non-infringement of the ’427 patent (“Joint Letter concerning summary judgment…5 PageID: 4303 non-infringement of the ’427 patent by May 25, 2018 (17-3159 ECF No. 89, Text Order…summary judgment of non-infringement of the ’427 patent, and wish to join in the joint letter to be submitted	External link to document
2017-05-11	171		antibiotics, collagen, botulinum toxin, inter- Nos. 6,281,230 and 5,635,517; U.S. publication nos. 2004/ … United States Patent (10) Patent No.: … (45) Date of Patent: Sep.9,2014 (54)… U.S. PATENT DOCUMENTS Hopatcong, OH … FOREIGN PATENT DOCUMENTS ( *) Notice: Subject to	External link to document
2017-05-11	211	Statement	Evidence: • U.S. Patent No. 6,045,501 generally, including … • File History of United States Patent No. 6,045,501 …Evidence: • U.S. Patent No. 6,045,501 generally, including … • File History of U.S. Patent No. 6,045,501 at o Claims, Abstract, … • U.S. Patent No. 6,045,501:	External link to document
2017-05-11	227	Exhibits 1-15 (Part 1)	antibiotics, collagen, botulinum toxin, inter- Nos. 6,281,230 and 5,635,517; U.S. publication nos. 2004/ …Claims of U.S. Patent Nos. 8,198,262 (“the ’262 patent”), 8,673,939 (“the ’939 patent”), 8,735,428 …8,735,428 (“the ’428 patent”), and 8,828,427 (“the ’427 patent”) (collectively, “the Patents-in-Suit”). …clients. One of the patents 3 is a formulation patent. It's a very specific…): Patent Asserted Claims ’262 patent [DEFS_POM_	External link to document
2017-05-11	237		antibiotics, collagen, botulinum toxin, inter- Nos. 6,281,230 and 5,635,517; U.S. publication nos. 2004/ …clients. One of the patents 3 is a formulation patent. It's a very specific… United States Patent (10) Patent No.: …. I'm joined by Kyle Musgrove, patent 5 counsel, Haynes and Boone in Washington…active defendants. The 19 number of patents asserted here are between four and nine	External link to document
2017-05-11	250		E is a true and correct copy of U.S. Patent No. 6,045,501. 9. Attached hereto as…correct copy of the prosecution history of U.S. Patent No. 8,198,262 B2. 5. Attached hereto…correct copy of the prosecution history of U.S. Patent No. 8,673,939 B2. 6. Attached hereto…correct copy of the prosecution history of U.S. Patent No. 8,735,428 B2. 7. Attached hereto…correct copy of the prosecution history of U.S. Patent No. 8,828,427 B2. 8. Attached hereto	External link to document

CELGENE CORPORATION v. HETERO LABS LIMITED: A Comprehensive Litigation Summary and Analysis

Introduction

The case of Celgene Corporation v. Hetero Labs Limited is a complex and multifaceted patent infringement litigation under the Hatch-Waxman Act. This article delves into the key aspects of the case, including the parties involved, the patents in dispute, the legal issues, and the outcomes at various stages of the litigation.

Parties and Patents Involved

• Plaintiff: Celgene Corporation
• Defendants: Hetero Labs Limited, Hetero Labs Limited Unit-V, Hetero Drugs Limited, Hetero USA, Inc., Aurobindo Pharma Limited, Aurobindo Pharma USA, Inc., Aurolife Pharma LLC, Eugia Pharma Specialties Limited, Apotex Inc., Apotex Corp., Mylan Pharmaceuticals, Inc., Mylan Inc., Mylan N.V., Breckenridge Pharmaceutical, Inc., and Teva Pharmaceuticals USA, Inc.[2][3].
• Drug Product: Pomalyst® (pomalidomide capsules)
• Patents-in-Suit: U.S. Patents Nos. 8,198,262, 8,673,939, 8,735,428, 8,828,427, and others related to method of treatment and formulation patents[1][2].

Nature of the Case

The case revolves around Celgene's assertion of patent infringement against multiple generic drug manufacturers who filed Abbreviated New Drug Applications (ANDAs) with the FDA for generic versions of Pomalyst®. The defendants collectively filed six ANDAs, prompting Celgene to initiate patent infringement actions under the Hatch-Waxman Act[2].

Venue and Jurisdiction Issues

One of the critical issues in the case was the question of proper venue. Mylan, one of the defendants, moved to dismiss Celgene's complaint for improper venue, lack of subject matter jurisdiction, and failure to state a claim. The court initially denied Mylan's motion but allowed limited venue-related discovery to determine if Mylan had a regular and established place of business in New Jersey and if acts of infringement occurred within the district[1].

Acts of Infringement Under Hatch-Waxman

The court's interpretation of "acts of infringement" under the Hatch-Waxman Act was pivotal. It was determined that acts of infringement include the submission of the ANDA and any non-speculative future acts the ANDA applicant intends to take if the ANDA is approved. However, the court ultimately agreed with the defendants that the submission of the ANDA itself is the primary act of infringement, and it must be tied to a specific location for venue purposes[1][4].

Claim Construction and Consolidation

The case involved extensive claim construction proceedings. The parties stipulated to bifurcate the case, staying claims related to certain Risk Evaluation and Mitigation Strategy (REMS) solutions. The court consolidated multiple cases against the defendants and addressed several disputed terms related to the patents. By the time of the Markman decision, the parties had resolved disputes over some terms, and the court focused on four disputed terms from six patents[2][3].

District Court Rulings

In the district court, Judge Esther Salas made several key rulings:

• Venue-Related Discovery: Allowed limited discovery to determine if Mylan had a regular and established place of business in New Jersey and if acts of infringement occurred there[1].
• Failure to State a Claim: Denied Mylan’s motion to dismiss for failure to state a claim without prejudice, allowing Mylan to raise the issue again after discovery[1].
• Consolidation and Claim Construction: Consolidated multiple cases and addressed claim construction issues, resolving some disputes before the Markman hearing[2][3].

Appellate Court Rulings

On appeal, the Federal Circuit Court of Appeals affirmed the district court's decisions:

• Improper Venue: Agreed that venue was improper in New Jersey for the domestic-corporation defendants (MPI and Mylan Inc.) because Celgene did not show acts of infringement or a regular and established place of business in the district[4].
• Failure to State a Claim: Affirmed that Celgene’s pleadings failed to state a claim upon which relief could be granted for the foreign-corporation defendant (Mylan N.V.) due to speculative and conclusory allegations[4].

Key Takeaways

• Venue Specificity: The Hatch-Waxman Act requires specific and unambiguous venue criteria, focusing on past acts of infringement such as the submission of the ANDA[4].
• Acts of Infringement: The submission of the ANDA is the primary act of infringement, and future conduct is not considered for venue purposes[4].
• Claim Construction: Extensive claim construction is often necessary in Hatch-Waxman cases to clarify patent terms and resolve disputes[2][3].
• Jurisdiction and Pleadings: Clear and non-speculative pleadings are essential to establish jurisdiction and state a claim upon which relief can be granted[4].

FAQs

1. What is the Hatch-Waxman Act, and how does it apply to this case? The Hatch-Waxman Act is a statutory framework that balances the interests of brand and generic drug manufacturers. In this case, it governs the patent infringement actions brought by Celgene against generic drug manufacturers who filed ANDAs for Pomalyst®.

2. Why was venue a critical issue in this case? Venue was critical because the court had to determine if the defendants committed acts of infringement within the District of New Jersey and if they had a regular and established place of business there.

3. What constitutes an act of infringement under the Hatch-Waxman Act? An act of infringement under the Hatch-Waxman Act is primarily the submission of the ANDA. Future conduct intended by the ANDA applicant is not considered for venue purposes.

4. How did the court handle claim construction in this case? The court consolidated multiple cases and addressed several disputed terms related to the patents. The parties resolved some disputes before the Markman hearing, and the court focused on the remaining disputed terms.

5. What was the outcome of the appeal to the Federal Circuit Court of Appeals? The Federal Circuit Court of Appeals affirmed the district court's decisions, agreeing that venue was improper for the domestic-corporation defendants and that Celgene failed to state a claim upon which relief could be granted for the foreign-corporation defendant.

Sources:

1. Robins Kaplan LLP Law Firm - Celgene Corp. v. Hetero Labs Ltd.
2. Vlex - Celgene Corp. v. Hetero Labs Ltd.
3. Justia - CELGENE CORPORATION v. HETERO LABS LIMITED et al
4. Federal Circuit Court of Appeals - CELGENE CORPORATION v. MYLAN PHARMACEUTICALS INC.