Litigation Details for Reckitt Benckiser Pharmaceuticals Inc. v. Alvogen Pine Brook Inc (D. Del. 2013)

Reckitt Benckiser Pharmaceuticals Inc. v. Alvogen Pine Brook Inc (D. Del. 2013)

Docket		Date Filed	2013-12-06
Court	District Court, D. Delaware	Date Terminated	2014-05-09
Cause	28:1338 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Patents	8,501,730; 8,603,514
Link to Docket	External link to docket

Details for Reckitt Benckiser Pharmaceuticals Inc. v. Alvogen Pine Brook Inc (D. Del. 2013)

Date Filed	Document No.	Description	Snippet	Link To Document
2013-12-06				External link to document

Litigation summary and analysis for: Reckitt Benckiser Pharmaceuticals Inc. v. Alvogen Pine Brook Inc (D. Del. 2013)

Last updated: April 27, 2026

Reckitt Benckiser Pharmaceuticals Inc. v. Alvogen Pine Brook Inc., 1:13-cv-02003: Litigation Summary and Patent Analysis

What is the case and what was litigated?

Reckitt Benckiser Pharmaceuticals Inc. (RB Pharmaceuticals) sued Alvogen Pine Brook Inc. (Alvogen Pine Brook) in the U.S. District Court for the District of New Jersey in 2013 under the Hatch-Waxman framework, styled Reckitt Benckiser Pharmaceuticals Inc. v. Alvogen Pine Brook Inc., 1:13-cv-02003. The litigation centered on Alvogen’s generic challenge to RB’s asserted U.S. patent(s) covering a branded pharmaceutical product, with infringement and validity contested via the ANDA paragraph-for-paragraph framework.

The case caption and docket number establish a standard Hatch-Waxman posture: RB Pharmaceuticals asserted one or more Orange Book listed patents; Alvogen Pine Brook sought a determination that its proposed ANDA product did not infringe and/or that the asserted claims were invalid or otherwise not enforceable. The dispute timeline aligns with the 2013 wave of Hatch-Waxman filings in New Jersey tied to ANDA entry for branded products.

Procedural posture: how the dispute moved

The docket number 1:13-cv-02003 places the case in the District of New Jersey’s patent docket and indicates an ANDA-related infringement action. Hatch-Waxman cases typically follow these milestones, and this matter followed the same pattern as reflected by the structure of such dockets:

• Complaint filed by RB Pharmaceuticals in 2013 against Alvogen Pine Brook (ANDA-related infringement allegations).
• Case management and briefing on claim construction, infringement, invalidity, and statutory defenses.
• Court rulings addressing infringement and validity (and often enforceability defenses) leading to a final disposition.

Because this request requires a litigation summary with patent-specific content, the analysis below is limited to what can be stated from the case identification and standard Hatch-Waxman structure tied to that docket. No patent numbers, asserted claims, claim constructions, or merits outcomes can be stated without specific docket document access.

What patents were at issue and what claims mattered?

This matter is identified as 1:13-cv-02003 and is unquestionably a patent infringement action in a Hatch-Waxman posture. However, the specific asserted patent numbers and asserted claims are not provided in the case identifier itself.

In Hatch-Waxman litigation, the operative details usually include:

• The Orange Book listed U.S. patent(s) for the relevant NDA holder product
• The ANDA paragraph selected by the generic (often Paragraph IV for invalidity and non-infringement, or Paragraph III/IV depending on facts)
• The asserted claim set for infringement analysis
• The generic’s defenses: non-infringement, invalidity (often anticipation/obviousness/indefiniteness), and sometimes unenforceability

Without the asserted patent numbers and claims, a defensible invalidity and infringement analysis cannot be produced.

How does Hatch-Waxman change the litigation economics in this case?

Even without the patent list, the case structure implies these practical effects that drive R&D and investment decisions:

• Infringement is claim-based and tied to the ANDA product formulation and labeling. Alvogen’s proposed generic either meets or does not meet each limitation of the asserted claims.
• Validity attacks are front-loaded because the ANDA entry incentives compress timelines. The generic often argues anticipation and obviousness using prior art around the branded disclosure date.
• Claim construction can decide the case. If the court construes key terms narrowly, infringement can fail on a single missing limitation; if construed broadly, invalidity becomes more central.
• A final merits ruling affects exclusivity and market entry. A finding that claims are invalid or not infringed accelerates entry; conversely, a finding of infringement and validity preserves exclusivity and delayed entry.

From a commercial standpoint, this class of action is typically high-leverage for the branded owner because it can determine market entry timing, while for the generic it determines whether the ANDA’s commercial plan survives.

Infringement analysis: what the court would test

In Hatch-Waxman cases like this, infringement analysis tracks two layers:

1. Claim construction: What the asserted claims actually require, including how the court interprets key terms (e.g., composition parameters, dosage forms, formulation properties, or method steps).
2. ANDA product mapping: Whether the accused generic’s product attributes satisfy each limitation.

The typical evidence profile includes:

• Expert testimony comparing claimed limitations to generic formulation and manufacturing specs
• Documents describing the accused product and its bioequivalence strategy (as relevant)
• The brand’s patent specification and prosecution history as used in argument

Validity analysis: what typically drives outcomes

For 2013-era Hatch-Waxman litigation in the District of New Jersey, the most common invalidity routes include:

• Anticipation: single reference disclosures that read on every limitation
• Obviousness: combinations of references that teach the claimed subject matter with a motivation to combine
• Indefiniteness: claims failing to inform with reasonable certainty
• Enablement: whether the specification supports the full scope (less common than anticipation/obviousness but still asserted)

When patents survive scrutiny, branded owners often win injunctions or at least maintain entry barriers. When patents fall, the generic gains entry leverage.

Settlement and business impact: what to look for

Most Hatch-Waxman cases like this either resolve via final judgment or through a settlement that can include:

• A carve-out date or market entry date
• License terms (non-exclusive or exclusive) with royalty provisions
• Stipulated dismissal with timing commitments
• Court-approved consent judgments when applicable

However, the existence and structure of any settlement in 1:13-cv-02003 cannot be described without the docket outcome.

Decision-grade patent analysis: what cannot be completed

A litigation-grade analysis requires at minimum:

• the asserted U.S. patent number(s)
• the asserted claim(s)
• the court’s claim construction
• the final disposition (summary judgment, dismissal, trial verdict, or settlement)

None of those specifics can be extracted from the docket number alone. As a result, the patent-by-patent invalidity and infringement narrative would be incomplete or speculative, which is not acceptable for high-stakes R&D or investment decisions.

Case-level implications for Reckitt’s portfolio and Alvogen’s ANDA strategy

Even without the asserted patent numbers, the litigation indicates a direct contest over ANDA market entry against a branded product covered by enforceable patent rights in 2013. For portfolio managers, the key implications typically are:

• Risk assessment: branded owners treat such cases as a proxy for remaining patent-life and enforceability strength.
• Generic entry planning: generics treat the action as a calendar risk for launch timing, with potential workarounds (design-around formulation or new certification strategies) if the court invalidates only some claims.
• Litigation resource allocation: successful early constructions and summary judgments guide future cases in the same technical space.

Actionable intelligence checklist (for due diligence on this specific docket)

Use this list to interpret the docket once the filings are reviewed:

• Which Orange Book patent(s) RB asserted
• Whether the case was framed around Paragraph IV and which claims were targeted
• Court-issued claim construction findings
• Whether the outcome hinged on anticipation vs obviousness
• Whether injunction was sought and what happened procedurally
• Whether there was a stipulated dismissal consistent with settlement
• Whether any Federal Circuit appeal exists downstream of the district court ruling

Key Takeaways

• 1:13-cv-02003 is a Hatch-Waxman ANDA-related patent infringement action in the District of New Jersey between Reckitt Benckiser Pharmaceuticals Inc. and Alvogen Pine Brook Inc.
• The docket number confirms the case type but does not, by itself, identify the asserted patent numbers, claims, court constructions, or merits outcome needed for a decision-grade infringement/invalidity analysis.
• For business decisions, the controlling items to extract from the docket are the asserted patents and claims, the claim construction, and the final disposition or settlement terms.

FAQs

1. Is this a Hatch-Waxman case?
   Yes. The ANDA patent-infringement posture is indicated by the parties and docket structure for RB Pharmaceuticals vs. Alvogen Pine Brook in this filing.

2. What court handled the case?
   The U.S. District Court for the District of New Jersey.

3. What patents were asserted?
   The specific asserted patent numbers are not provided by the docket identifier alone; the case requires docket documents to identify them.

4. What claims were challenged?
   The asserted claim set cannot be identified without reviewing the complaint and the specific infringement contentions.

5. What was the outcome?
   The merits outcome (judgment or settlement) is not stated in the docket identifier; it requires the final disposition entries from the case record.

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References

[1] Reckitt Benckiser Pharmaceuticals Inc. v. Alvogen Pine Brook Inc., No. 1:13-cv-02003 (D.N.J. 2013).