Litigation Details for RECKITT BENCKISER LLC v. AMNEAL PHARMACEUTICALS LLC (D.N.J. 2015)

RECKITT BENCKISER LLC v. AMNEAL PHARMACEUTICALS LLC (D.N.J. 2015)

Docket		Date Filed	2015-03-26
Court	District Court, D. New Jersey	Date Terminated	2017-08-22
Cause	35:271 Patent Infringement	Assigned To	Renee Marie Bumb
Jury Demand	None	Referred To	Joel Schneider
Patents	6,372,252; 6,955,821; 7,838,032
Link to Docket	External link to docket

Details for RECKITT BENCKISER LLC v. AMNEAL PHARMACEUTICALS LLC (D.N.J. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-03-26	1		THE PATENTS-IN-SUIT 15. United States Patent No. 6,372,252 (the “’252 patent,” copy… which are protected by Plaintiff’s U.S Patent Nos. 6,372,252, 6,955,821, and 7,838,032. … INFRINGEMENT OF U.S. PATENT NO. 6,372,252 28. Plaintiff repeats… (10) Patent N0.: US 6,372,252 B1 Blume et al. …PageID: 17 U.S. Patent Apr. 16, 2002 Sheet 1 0f 11 US 6,372,252 B1	External link to document
2015-03-26	129		STIPULATION AND ORDER REGARDING U.S. PATENT NOS. 6,955,821 AND 7,838,032. Signed by Judge Renee Marie…March 2015 22 August 2017 1:15-cv-02155 Patent None District Court, D. New Jersey	External link to document
2015-03-26	130		STIPULATION AND ORDER REGARDING U.S. PATENT NO. 7,838,032. Signed by Judge Renee Marie Bumb on 4/4…March 2015 22 August 2017 1:15-cv-02155 Patent None District Court, D. New Jersey	External link to document
2015-03-26	214		infringe U.S. Patent Nos. 6,372,252 (the “’252 Patent”), 6,955,821 (the “’821 Patent”), and 7,838,032…infringe the Patents-in-Suit. A. The ’821 Patent The ’821 Patent is entitled “Sustained…embodiment in the Patents-in-Suit. Tr. 235:13-15; see also ’821 Patent col. 12:46-56; ’032 Patent col. 17:45… ’252 Patent as to both Defendants [Docket Nos. 64, 65] and its claims under the ’821 Patent against…The ’821 Patent was filed on April 15, 2002, as Application No. 10/121,706. The ’821 Patent expires	External link to document

Reckitt Benckiser LLC v. Amneal Pharmaceuticals LLC: A Comprehensive Litigation Summary and Analysis

Introduction

The case of Reckitt Benckiser LLC v. Amneal Pharmaceuticals LLC is a significant patent infringement dispute involving Reckitt Benckiser's (RB) popular expectorant drug, Mucinex®, and generic versions produced by Amneal Pharmaceuticals LLC (Amneal) and Dr. Reddy's Laboratories, Inc. (DRL). This litigation revolves around the infringement of several U.S. patents related to the formulation of Mucinex®.

The Drug Product and Patents-in-Suit

Mucinex® is an extended-release guaifenesin tablet designed to thin and loosen mucus, relieving chest congestion. The patents in question are U.S. Patent Nos. 6,372,252 (the '252 Patent), 6,955,821 (the '821 Patent), and 7,838,032 (the '032 Patent)[2][3].

Nature of the Case and Issues Presented

Reckitt Benckiser alleged that Amneal's and DRL's generic guaifenesin sustained-release tablets would infringe the patents-in-suit. The primary issue was whether the generic products had distinct formulations: an immediate-release (IR) formulation and a sustained-release (SR) formulation, as required by the patents[2][3].

Procedural History

• Initial Filings and Motions: Reckitt Benckiser filed complaints against Amneal and DRL, alleging infringement of the '252, '821, and '032 Patents. After the initial filings, RB dismissed its claims under the '252 Patent and its claims under the '821 Patent against DRL[2][3].
• Motions for Judgment on the Pleadings: Amneal and DRL filed motions for judgment on the pleadings, arguing that their products were single-formulation matrix tablets, which were disclaimed during the prosecution of the '252 Patent. The court denied these motions, allowing limited discovery on the structure of the defendants' products[1][2].
• Summary Judgment Motions: Defendants filed summary judgment motions arguing that their products were single-formulation release tablets, which should not infringe the patents due to the earlier disclaimer. The court denied these motions, leading to a trial on the merits[1][2].

Asserted Claims and Claim Construction

Reckitt Benckiser asserted specific claims from the '821 and '032 Patents against Amneal and DRL. The court construed the claims to require the presence of two distinct formulations: an immediate-release and a sustained-release formulation. This construction was crucial in determining infringement[2][3].

Expert Testimony and Evidence

• Reckitt's Expert Testimony: RB's expert attempted to demonstrate that the defendants' products had two formulations using Raman spectroscopy. However, the court found significant flaws in this methodology, including the inability to identify half of the ingredients and the potential to transform an SR formulation into an IR formulation by simply cutting the tablet[3].
• Defendants' Evidence: The defendants presented evidence showing their efforts to create tablets with only a single formulation. The court found that Reckitt failed to identify any step in the process that could result in the creation of two distinct formulations[3].

Court Findings and Rulings

The court ultimately found that neither Amneal's nor DRL's ANDA products infringed the patents-in-suit because they did not contain the required two distinct formulations. The court's decision was supported by previous cases, such as Reckitt v. Aurobindo Pharma Ltd., which had similar claim constructions[2][3].

Motion for Attorney Fees

Amneal and DRL moved for attorney fees under 35 U.S.C. § 285, arguing that the case was "exceptional" due to Reckitt Benckiser's conduct. The court denied this motion, although it warned Reckitt Benckiser that future litigation over the same patents could be viewed as unreasonable or abusive, potentially subjecting them to fees under Section 285[2].

Federal Circuit Appeal

The Federal Circuit affirmed the district court's decision, supporting the finding that the defendants' products did not infringe the patents due to the single-formulation nature of their tablets[2].

Key Takeaways

• Claim Construction: The court's construction of the patents requiring two distinct formulations (IR and SR) was pivotal in determining non-infringement.
• Expert Testimony: The reliability and methodology of expert testimony can significantly impact the outcome of patent infringement cases.
• Procedural History: The case highlights the importance of procedural steps, including motions and discovery, in shaping the litigation outcome.
• Previous Cases: Prior decisions, such as Reckitt v. Aurobindo Pharma Ltd., can influence subsequent litigation involving the same patents.

FAQs

1. What was the main issue in the Reckitt Benckiser LLC v. Amneal Pharmaceuticals LLC case? The main issue was whether the generic guaifenesin sustained-release tablets produced by Amneal and DRL infringed Reckitt Benckiser's patents by having distinct immediate-release and sustained-release formulations.

2. Which patents were involved in the litigation? The patents involved were U.S. Patent Nos. 6,372,252, 6,955,821, and 7,838,032.

3. What was the outcome of the court's claim construction? The court construed the claims to require the presence of two distinct formulations: an immediate-release and a sustained-release formulation.

4. Why did the court find that the defendants' products did not infringe the patents? The court found that the defendants' products were single-formulation matrix tablets, which did not meet the requirement of having two distinct formulations as specified in the patents.

5. Did the court grant attorney fees to the defendants? No, the court denied the defendants' motion for attorney fees under 35 U.S.C. § 285, although it warned Reckitt Benckiser about potential future fees for similar litigation.

Cited Sources

1. Reckitt Benckiser LLC v. Amneal Pharm. LLC - Casetext
2. Reckitt Benckiser LLC v. Amneal Pharms. LLC - Robins Kaplan LLP
3. Reckitt Benckiser LLC v. Amneal Pharms. LLC - Robins Kaplan LLP
4. Reckitt Benckiser LLC v. Amneal Pharms. LLC, 2017-2595 - Casetext
5. Reckitt Benckiser LLC v. Amneal Pharmaceuticals, LLC - Casetext