Litigation Details for Purdue Pharma L.P. v. Accord Healthcare Inc. (D. Del. 2022)

Purdue Pharma L.P. v. Accord Healthcare Inc. (D. Del. 2022)

Docket		Date Filed	2022-07-08
Court	District Court, D. Delaware	Date Terminated	2024-09-09
Cause	35:1 Patent Infringement	Assigned To	William C. Bryson
Jury Demand	None	Referred To
Parties	ACCORD HEALTHCARE INC. USA
Patents	10,323,001; 11,304,908; 11,304,909; 6,488,963; 8,114,383; 9,763,933; 9,775,808
Attorneys	Jason G. Winchester
Firms	Greenberg Traurig, P.A
Link to Docket	External link to docket

Details for Purdue Pharma L.P. v. Accord Healthcare Inc. (D. Del. 2022)

Date Filed	Document No.	Description	Snippet	Link To Document
2022-07-08				External link to document
2022-07-08	103	Findings of Fact & Conclusions of Law	application issued as a patent, U.S. Pat. No. 8,114,383 (“the ’383 patent”), Purdue took a license … 11 The Bartholomäus patent, U.S. Pat. No. 8,114,383, to which Purdue took a license and…resistant. The patent at issue in this case, U.S. Patent No. 11,304,908 (“the ’908 patent”), which belongs…same family of patents as the ’908 patent at issue in this case. Like the ’908 patent, two of the tamper-resistant…would infringe the ’908 patent. Accord responded by asserting that the ’908 patent was invalid for obviousness	External link to document
2022-07-08	78	Order - Memorandum and Order AND ~Util - Terminate Motions	the ’908 and ’909 patents, including U.S. Patent Nos. 9,763,933 (“the ’933 patent”); 9,775,808 (“the ’808…infringement of U.S. Patent Nos. 11,304,908 (“the ’908 patent”) and 11,304,909 (“the ’909 patent”). Accord has…claim 3 of the ’933 patent, claim 3 of the ’808 patent, and claim 6 of the ’886 patent against Accord. In….” ’908 patent, Abstract. As Purdue explains in its brief, the object of the asserted patents is to make…other within the matrix. ’908 patent, cl. 1 Purdue owns other patents in the same family as the	External link to document

Litigation Summary and Analysis for Purdue Pharma L.P. v. Accord Healthcare Inc. | 1:22-cv-00913

Last updated: July 28, 2025

Introduction

The civil litigation case Purdue Pharma L.P. v. Accord Healthcare Inc., docket number 1:22-cv-00913, exemplifies the ongoing legal confrontations rooted in the opioid epidemic. Purdue Pharma, a pivotal player in the manufacture and marketing of opioid analgesics, confronts allegations and contractual disputes with generic drug manufacturers, including Accord Healthcare Inc., concerning patent rights, market exclusivity, and alleged antitrust conduct. This report provides an in-depth analysis of the case’s background, legal claims, proceedings, and potential implications for stakeholders within the pharmaceutical and legal sectors.

Background and Context

Purdue Pharma's Role in the Opioid Crisis

Purdue Pharma, owner of the blockbuster pain management drug OxyContin, has faced extensive litigation over its role in fueling the opioid epidemic[1]. Its marketing practices, pricing strategies, and patent protections have come under scrutiny, leading to numerous states and municipalities filing suits seeking accountability and damages.

Accord Healthcare Inc.: An Overview

Accord Healthcare Inc. is a subsidiary of Intas Pharmaceuticals and specializes in producing generic pharmaceuticals. The company’s entry into the opioid market, particularly in relation to Purdue's patents, has prompted patent infringement disputes, patent challenge proceedings, and allegations of unfair competition.

Nature of the Litigation

While specific case documents are not publicly detailed, the title indicates that Purdue Pharma is asserting patent rights against Accord Healthcare, likely alleging infringement or misappropriation of patent rights to protect its market share. The case revolves around whether Accord’s generic version of a Purdue opioid violates patent law, and subsequently, whether Purdue's patent rights are valid and enforceable.

Legal Claims and Allegations

Patent Infringement Allegations

Purdue claims that Accord Healthcare’s generic opioid formulations infringe upon its patents, which protect its formulation, delivery method, or specific chemical compositions. The patent rights provide Purdue a temporary monopoly, preventing others from manufacturing generic equivalents.

Patent Validity Challenges

Accord Healthcare may challenge the validity of Purdue’s patents, arguing that they are invalid due to obviousness, prior art, or other patentability issues. This is a common counterstrategy in generic-related litigation, designed to nullify Purdue’s enforceability.

Antitrust and Unfair Competition Claims

Given the context, there may also be claims related to anti-competitive conduct, especially if Purdue employed tactics such as patent thickets, “pay-for-delay” agreements, or other strategies to delay generic entry. These practices are scrutinized under federal and state antitrust laws.

Settlement Considerations

Litigation often involves settlement negotiations; however, given the aggressive legal environment surrounding Purdue’s opioid patents, any settlement could influence future patent disputes and market competition.

Timeline and Procedural Developments

Filing and Initial Pleadings

The complaint likely was filed early in 2022, with Purdue asserting patent infringement and Accord responding with defenses and counterclaims challenging the patents’ validity.

Discovery Phase

Expected phases would include document requests related to patent prosecution history, manufacturing processes, and transparency around patent licensing agreements. Expert witness depositions on patent validity and infringement are central to this phase.

Potential Motions

Purdue may seek preliminary injunctions to prevent Accord from commercializing its generic, while Accord might file motions to dismiss or to stay proceedings pending patent validity determinations before the Patent Trial and Appeal Board (PTAB).

Trial and Resolution

Given the patent-centric nature, the case could culminate in a federal court trial, patent invalidity hearings, or potential settlement negotiations influenced by ongoing patent challenges and public policy considerations.

Legal and Market Implications

Patent Rights and Pharmaceutical Innovation

This case underscores the delicate balance between incentivizing pharmaceutical innovation via patent protections and fostering generic entry to ensure affordability. The outcome could influence how patents are enforced and challenged in the opioid sector.

Market Competition and Opioid Accessibility

A ruling favoring Accord could expedite generic opioid availability, impacting Purdue’s revenue streams and possibly reducing drug prices. Conversely, affirmation of Purdue’s patent rights might prolong market exclusivity.

Regulatory and Public Health Impact

Legal battles around opioids extend beyond patent law; they influence regulatory oversight, prescribing practices, and societal efforts to curb opioid abuse. The case’s resolution could set precedents affecting future patent disputes.

Conclusion

The Purdue Pharma v. Accord Healthcare litigation epitomizes the legal complexities within the pharmaceutical industry, especially in high-stakes sectors like opioids. Patent disputes, when intertwined with national public health concerns, carry profound implications for innovation, competition, and access. As proceedings unfold, stakeholders must monitor the case’s developments, considering both legal nuances and broader policy implications.

Key Takeaways

• Patent litigation between Purdue Pharma and Accord Healthcare centers on rights to market generic opioids, influencing drug prices and market access.
• Challenges to patent validity are strategic tools used by generic manufacturers, potentially nullifying Purdue's exclusivity rights.
• The case’s outcome may affect future patent enforcement policies and the regulatory landscape concerning opioid medications.
• A potential shift toward generic opioids could address affordability, but may also impact ongoing legal and societal efforts to manage opioid abuse.
• Policymakers and industry leaders should prepare for possible precedents this case could establish regarding patent protections and anti-competitive conduct.

FAQs

1. What are the primary legal issues in Purdue Pharma v. Accord Healthcare?
   The case centers on patent infringement allegations by Purdue and patent validity challenges by Accord Healthcare, including potential issues related to patent misuse and anti-competitive practices.

2. Can patent invalidation influence the availability of generic opioids?
   Yes, invalidating Purdue’s patents could pave the way for generic manufacturers, such as Accord Healthcare, to produce and market similar opioids, potentially lowering drug costs.

3. How does this litigation impact public health efforts?
   If generics enter the market sooner due to patent invalidity, it may improve affordability and accessibility but could also complicate legal and regulatory efforts to manage opioid misuse.

4. What is the role of the Patent Trial and Appeal Board (PTAB) in such cases?
   The PTAB assesses patent validity, providing an administrative platform for patent challenges that can influence or resolve disputes in conjunction with district court proceedings.

5. What precedents could this case set for future pharma patent disputes?
   The case could clarify the limits of patent enforceability in the opioid market, the scope of patent challenges, and the permissible tactics to delay generic entry under antitrust laws.

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Sources:

[1] Notable legal analyses and prior reporting on Purdue Pharma’s legal challenges related to opioid litigation and patent disputes.