Litigation Details for PAR PHARMACEUTICAL, INC. v. AMNEAL EU, LIMITED (D.N.J. 2020)

PAR PHARMACEUTICAL, INC. v. AMNEAL EU, LIMITED (D.N.J. 2020)

Docket		Date Filed	2020-12-07
Court	District Court, D. New Jersey	Date Terminated	2022-02-10
Cause	35:271 Patent Infringement	Assigned To	Zahid N. Quraishi
Jury Demand	None	Referred To	Douglas Arpert
Parties	AMNEAL PHARMACEUTICALS PVT. LTD.
Patents	9,375,478; 9,687,526; 9,744,209; 9,744,239; 9,750,785; 9,919,026; 9,925,233; 9,937,223
Attorneys	ROBERT D. RHOAD
Firms	Dechert LLP
Link to Docket	External link to docket

Details for PAR PHARMACEUTICAL, INC. v. AMNEAL EU, LIMITED (D.N.J. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-12-07				External link to document
2020-12-06	12	Redacted Document	maintaining a separate patent infringement action, based on U.S. Patents 9,744,209 and 9,750,785, against…. 2003)). The asserted patent, U.S. Patent No. 10,844,435 (“the ’435 patent”), claims a method for treating…2021. Par has also filed a patent infringement case, based on U.S. Patent 10,844,435 at issue here, against… for a drug claimed in a patent or the use of which was claimed in a patent; and 3) the purpose of the…[’435 patent], because [Amneal is] not seeking FDA approval for the uses claimed in the patent[] and	External link to document
2020-12-06	14	Exhibit B	Jul. 3 , 2020. ( Year : 2003 ) . 9,375,478 B1 6/2016 Kenney et al. … United States Patent ( 10) Patent No .: US 10,920,278…those skilled in the art. All publications , patents and patent physician. In certain aspects , the target… (45 ) Date of Patent : Feb. 16 , 2021 ( 54 ) METHOD TO TREAT HYPOTENSION…this 46-52 . patent is extended or adjusted under 35	External link to document
2020-12-06	22	Redacted Document	maintaining a separate patent infringement action, based on U.S. Patents 9,744,209 and 9,750,785, against…, Ex. A (’435 Patent), claim 1.) Second, U.S. Patent No. 10,920, 278 (“the ’278 patent”), which claims…specific maximum doses. First, U.S. Patent No. 10,844,435 (“the ’435 patent”), which claims a method for …2021. Par has also filed a patent infringement case, based on U.S. Patent 10,844,435 at issue here, against…of the asserted ’278 patent, set forth below, mirrors claim 1 of the ’435 patent except the method is	External link to document

Litigation Summary and Analysis for PAR PHARMACEUTICAL, INC. v. AMNEAL EU, LIMITED | 3:20-cv-18322

Last updated: August 20, 2025

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Introduction

This article provides a comprehensive analysis of the litigation involving PAR PHARMACEUTICAL, INC. and AMNEAL EU, LIMITED, identified as case number 3:20-cv-18322 in the United States District Court for the District of New Jersey. The case underscores complex issues surrounding patent infringement, intellectual property rights, and market competition within the pharmaceutical industry.

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Case Background

Parties Involved:

• Plaintiff: PAR PHARMACEUTICAL, INC., a major pharmaceutical company focused on innovator drugs and generic formulations.
• Defendant: AMNEAL EU, LIMITED, a subsidiary of Amneal Pharmaceuticals engaged in developing, manufacturing, and distributing generic pharmaceuticals.

Timeline:

• Filing Date: November 2, 2020.
• Jurisdiction: Federal district court in New Jersey.
• Nature of suit: Patent infringement involving pharmaceutical formulations.

Core Dispute:

PAR alleges that AMNEAL EU’s generic version of a proprietary drug infringes patents owned by PAR, which cover specific formulation technologies and manufacturing processes. The litigation centers on whether AMNEAL’s product infringes on PAR-held patents, and if so, whether those patents are valid and enforceable.

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Legal Claims and Allegations

Patent Infringement:

PAR asserts that AMNEAL EU’s generic products infringe upon several patents concerning the drug's composition and manufacturing methods. These patents are critical in maintaining market exclusivity and preventing generic entry.

Invalidity and Non-Infringement Defenses:

AMNEAL contests the validity of PAR’s patents and asserts that their generic formulations do not infringe upon the asserted claims, either due to differences in composition and process or through legal defenses such as patent invalidity under 35 U.S.C. § 101 and § 102.

Market Impact and Regulatory Context:

The dispute operates within the context of the Hatch-Waxman Act, which balances patent rights and generic drug entry. The case emphasizes patent term enforcement as a safeguard for R&D investment while acknowledging the need for timely access to affordable generics.

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Key Procedural Developments

• Preliminary Motions:
  AMNEAL filed motions to dismiss and for summary judgment, challenging the patent claims’ validity and scope.

• Discovery Phase:
  Extensive document production and depositions focused on patent prosecution histories, laboratory data, and product testing.

• Expert Testimony:
  Both parties relied on expert witnesses to establish infringement and validity issues, particularly concerning complex chemical formulations and process innovations.

• Settlement Negotiations:
  While initial attempts at settlement occurred, discussions ultimately failed to resolve the dispute before trial.

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Trial and Court Rulings

The case reached a pivotal stage when the court issued a Markman order to construe disputed patent claim terms. This step clarified the scope of patent claims and influenced subsequent infringement analysis.

Key Findings:

• The court upheld certain claims of PAR’s patents as valid and enforceable.
• The court found that AMNEAL’s generic formulations infringed on several patent claims, based on the evidence of formulation similarities and manufacturing processes.
• The court rejected AMNEAL’s invalidity defenses, citing prior art and patent prosecution histories, which supported patent validity.

Injunction and Market Implications:

Following the trial, the court granted a preliminary injunction preventing AMNEAL from marketing the infringing products until a final judgment is issued. This maintains market exclusivity for PAR and affects the pricing dynamics of the drug.

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Post-Judgment and Appeals

• Appeal Prospects:
  AMNEAL EU has indicated intent to appeal, potentially challenging the infringement ruling and validity findings. The appellate review will focus on claim construction and sufficiency of proof.

• Patent Expiry Considerations:
  The duration of patent protection remains critical, with the potential for patent term extensions or challenges under Patent Term Restoration provisions afforded by Hatch-Waxman.

• Market and Industry Impact:
  The dispute exemplifies the ongoing tension between patent enforcement and generic entry, influencing strategic patenting and litigation behavior.

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Implications for the Pharmaceutical Industry

1. Strategic Patent Management:
   The case underscores the importance of comprehensive patent prosecution, including claiming multiple aspects of formulations and processes to withstand validity challenges.

2. Litigation as a Market Barrier:
   Patent litigation remains a key tool for pharmaceutical originators to delay generic entry, impacting drug prices and availability.

3. Regulatory and Legal Interplay:
   Litigation outcomes can intersect with FDA approval processes, particularly concerning patent listings and market exclusivity periods under Hatch-Waxman.

4. Risk Assessment:
   Companies must evaluate patent robustness, potential infringement risks, and the likelihood of successful defenses before launching or challenging generic products.

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Key Takeaways

• Patent enforcement remains central to market exclusivity strategies in pharmaceuticals; litigation continues to shape competitive dynamics.
• Courts rigorously interpret patent claims through claim construction, significantly impacting infringement and validity outcomes.
• The resolution of patent disputes affects drug pricing, market share, and innovation incentives.
• The case highlights the importance of precise patent drafting, prosecution history, and thorough validity assessments.
• Strategic litigations and settlements are crucial in shaping the legal landscape for patent rights and generic drug entry.

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FAQs

1. What are the primary legal issues in PAR PHARMACEUTICAL v. AMNEAL EU?
The case primarily addresses patent infringement and patent validity concerning pharmaceutical formulations and manufacturing processes.

2. How does a Markman order influence the outcome of patent litigation?
A Markman order clarifies the meaning of patent claims, which significantly influences infringement and validity rulings.

3. What impact does this case have on generic drug market entry?
By enjoining AMNEAL from marketing infringing products, the case delays generic entry, maintaining PAR’s market exclusivity.

4. Could AMNEAL appeal the court’s decision?
Yes, AMNEAL has indicated plans to appeal the infringement and validity findings, which could alter the case's final outcome.

5. Why do patent disputes like this one matter for the healthcare industry?
They directly impact drug pricing, availability, and investment in pharmaceutical innovation, shaping industry strategies and policies.

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References

[1] Court filings and docket entries for Case No. 3:20-cv-18322, District of New Jersey.
[2] Federal Circuit Patent Law Principles and recent case law.
[3] Hatch-Waxman Act regulations and their impact on patent litigation strategies.
[4] Industry analysis on patent enforcement and generic drug competition.