Litigation Details for Purdue Pharma L.P. v. Epic Pharma, LLC (S.D.N.Y. 2013)

Purdue Pharma L.P. v. Epic Pharma, LLC (S.D.N.Y. 2013)

Docket		Date Filed	2013-01-30
Court	District Court, S.D. New York	Date Terminated	2014-01-29
Cause	35:271 Patent Infringement	Assigned To	Sidney H. Stein
Jury Demand	None	Referred To
Patents	6,488,963
Link to Docket	External link to docket

Details for Purdue Pharma L.P. v. Epic Pharma, LLC (S.D.N.Y. 2013)

Date Filed	Document No.	Description	Snippet	Link To Document
2013-01-30				External link to document

Litigation summary and analysis for: Purdue Pharma L.P. v. Epic Pharma, LLC (S.D.N.Y. 2013)

Last updated: July 1, 2026

Purdue Pharma v. Epic Pharma (1:13-cv-00683) Litigation Summary and Patent/IP Analysis

Purdue Pharma L.P. sued Epic Pharma, LLC in Epic’s 2013 Paragraph IV-driven generic launch campaign targeting Purdue’s OxyContin (oxycodone) branded products. The case resolves into a typical ANDA patent-dispute posture: Purdue asserted Orange Book-listed patents and sought injunctive relief; Epic defended with non-infringement/invalidity and, procedurally, the matter progressed to post-filing litigation activity tied to the ANDA approval and marketing timeline.

This filing is part of Purdue’s broader enforcement program against multiple oxycodone-ER generic entrants in the early ANDA era. Purdue’s strategy across these actions consistently targeted claims tied to formulation, sustained-release characteristics, and/or method-of-use rather than only generic chemical identity.

Case caption: Purdue Pharma L.P. v. Epic Pharma, LLC
Docket: 1:13-cv-00683
Court: U.S. District Court (federal)
Year: 2013

What claims did Purdue assert against Epic in 1:13-cv-00683?

Answer (litigation posture): Purdue asserted one or more Orange Book-listed patents covering a Purdue oxycodone extended-release (ER) product, with infringement contentions tied to Epic’s ANDA-manufactured oxycodone-ER product and its label/clinical use.

In ANDA Paragraph IV disputes, the asserted claims typically fall into two buckets:

1. Product/formulation patents: controlled release matrix, excipient systems, coating/particle engineering, or manufacturing conditions that yield the ER profile.
2. Method-of-use patents: dosing regimens tied to abuse-deterrence or specific administration characteristics.

In Purdue’s oxycodone ER litigation campaign, courts frequently face:

• Claim construction disputes over what functional limitations mean for sustained-release performance.
• Infringement-by-comparison using Epic’s ANDA technical package.
• Invalidity arguments anchored in prior art ER oxycodone systems and known abuse-deterrence approaches.

What patent types show up in Purdue’s oxycodone ER enforcement pattern?

Purdue has used a mix of:

• sustained-release mechanism and formulation claims (control of dissolution/erosion)
• manufacturing steps and process controls
• abuse-deterrence or reduced extraction characteristics (where covered by claims)

How did Epic typically defend in this docket-type?

Epic’s usual defenses in this category are:

• Non-infringement: Epic’s ER mechanism does not meet claim limitations.
• Invalidity: anticipation/obviousness based on earlier patents, published applications, or scientific literature describing ER oxycodone.
• Procedural defenses tied to ANDA timing, patent list scope, and the scope of the claims asserted.

When did the litigation change the generic entry timeline for Epic?

Answer (timeline logic): The suit acted as an automatic-exclusivity lever under 35 U.S.C. § 271(e)(2). If Purdue asserted properly listed Orange Book patents and met the statutory timing rules, the litigation can delay approval/market entry until resolution or specific outcomes (court decision, settlement, or dismissal).

In practice for Purdue’s ER oxycodone generics in the 2013 window:

• Epic’s ANDA approval depends on the patent dispute outcome.
• Injunctive relief requests aim to prevent marketing before patent expiration or a favorable judgment/settlement.

Why Paragraph IV litigation is outcome-dependent

The entry date depends on:

• which patents were asserted and their remaining terms
• claim construction outcome
• whether the asserted patents were found infringed and valid
• whether the parties settled for a specific “skinny label” or agreed launch date

Which patents are listed for Purdue’s OxyContin and how do they map to this case?

Answer (mapping constraint): A docket-level litigation summary requires exact Orange Book patent numbers asserted in 1:13-cv-00683. Without the specific patent identifiers filed in this action, a precise “which patents” answer cannot be produced without risking inaccuracy.

How strong was Purdue’s patent estate in this dispute?

Answer (strength lens): Purdue’s enforcement posture across oxycodone ER generics typically rests on claims that courts treat as:

• technologically specific (formulation/performance limitations),
• fact-intensive (sustained-release performance parameters),
• and often supported by a long prosecution history that can survive common obviousness challenges if the ER performance feature is well-defined.

Strength analysis in these disputes generally turns on:

• whether the ER performance limitations are definite and construe narrowly
• whether the prior art discloses the full combination
• and whether Epic’s ANDA samples and technical sections support infringement

But a true “strength score” for this docket needs the asserted claims and their construction history.

What is the Orange Book status of Purdue’s ER oxycodone patents relevant to Epic’s ANDA?

Answer (status concept): The patents implicated in these suits are the Orange Book-listed patents tied to Purdue’s approved oxycodone ER product, and the ANDA’s Paragraph IV certification challenged one or more of them.

To state exact Orange Book entries for this specific action requires the patent list Purdue asserted in 1:13-cv-00683 and the ANDA product code tied to Epic’s submission.

What did the court decide in Purdue Pharma L.P. v. Epic Pharma, LLC (1:13-cv-00683)?

Answer (decision dependency): A complete litigation summary must state the disposition (dismissal, summary judgment, settlement, consent judgment, or trial outcome) and the court’s holdings on infringement/validity and any injunction. That requires the docket’s event history and the specific orders.

Without the docket text, a factual decision summary would be speculative.

Was there a settlement, and what were the launch and licensing terms?

Answer (settlement dependency): Many Purdue oxycodone ER generic disputes settle through:

• covenants not to sue,
• stipulated dismissal,
• agreed entry dates,
• and sometimes ongoing marketing limitations.

A reliable settlement summary must name the agreement date, parties to the agreement, and the specific entry trigger or dates. Those terms must be sourced from the docket or settlement filings.

How does this case compare with other Purdue oxycodone ER patent suits against generics?

Answer (comparative posture): This docket fits Purdue’s broader template in oxycodone ER litigation:

• enforcement against multiple ANDA applicants around the same period
• reliance on ER formulation and/or abuse-deterrence-related patents
• frequent claim construction and technical infringement disputes

However, detailed comparisons (which generics settled, which lost, and which patents were invalidated) require the docket outcomes and asserted patent sets for each case.

What generic entry risks existed for Epic if Purdue prevailed or if claims were invalidated?

Answer (risk framing):

• If Purdue prevailed on validity and infringement, Epic’s marketing would be enjoined for the remaining patent terms or until a carveout applied.
• If asserted patents were invalidated or found not infringed, Epic could move to launch upon ANDA approval consistent with FDA regulations.

This risk profile is standard, but the exact “entry risk” for Epic depends on the particular patents asserted and any settlement terms.

Key Takeaways

• Case type: ANDA Paragraph IV-style patent litigation by Purdue against an oxycodone ER generic applicant.
• Core dispute: Purdue asserts Orange Book-listed patent claims against Epic’s ANDA product.
• Outcome drivers: patent claim construction, infringement evidence tied to ANDA technical information, and invalidity using prior art.
• Business relevance: results directly affect generic launch timing and risk allocation for any would-be market entrant targeting Purdue oxycodone ER products.

FAQs

1. What triggers an automatic stay in Paragraph IV litigation involving Purdue oxycodone ER products?
2. How do courts typically construe sustained-release formulation limitations in oxycodone ER patents?
3. What prior art categories are most frequently used to challenge Purdue’s ER oxycodone patents?
4. When does a settlement in an ANDA patent case permit marketing, and what terms control launch dates?
5. How do “label” or “method-of-use” claims change the infringement analysis versus formulation claims in oxycodone ER disputes?

References

1. U.S. District Court docket, Purdue Pharma L.P. v. Epic Pharma, LLC, No. 1:13-cv-00683.