DCT

1:23-cv-22221

Purdue Pharma LP v. Elite Laboratories Inc

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-22221, D.N.J., 12/08/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because both Defendants maintain their principal place of business in Northvale, New Jersey. The complaint also notes a stipulation by the Defendants not to contest venue for this action.
  • Core Dispute: Plaintiff alleges that Defendants' Abbreviated New Drug Application (ANDA) to market generic versions of the opioid analgesic OxyContin® infringes ten patents covering tamper-resistant dosage forms and manufacturing processes.
  • Technical Context: The technology at issue relates to extended-release pharmaceutical formulations, specifically using polyethylene oxide and a thermal curing process to create tablets that are resistant to crushing and solvent extraction, key methods of opioid abuse.
  • Key Procedural History: The action was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 217939 and a "Paragraph IV" certification asserting that Plaintiff's patents are invalid, unenforceable, or will not be infringed. The complaint cites a Notice Letter dated September 28, 2023, and a Supplemental Notice Letter dated March 28, 2025, as establishing Defendants' knowledge of the patents-in-suit.

Case Timeline

Date Event
2006-08-25 Earliest Priority Date for all Patents-in-Suit
2016-11-15 '389, '391, '392, and '393 Patents Issue Date
2017-09-19 '933 and '886 Patents Issue Date
2017-09-26 '416 Patent Issue Date
2017-10-03 '808 and '811 Patents Issue Date
2023-08-17 Defendants' ANDA Filed with the FDA
2023-09-19 FDA Accepted Defendants' ANDA for Review
2023-09-28 Defendants Sent Notice of Paragraph IV Certification
2024-04-23 '056 Patent Issue Date
2025-03-28 Defendants Sent Supplemental Notice Letter
2025-12-08 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 9,763,933 - "TAMPER RESISTANT DOSAGE FORMS"

The Invention Explained

  • Problem Addressed: The patent addresses the abuse of pharmaceutical products, particularly opioid agonists, which can be tampered with by crushing or solvent extraction to achieve an immediate, high-dose release for illicit use (U.S. 11,964,908, col. 1:17-38).
  • The Patented Solution: The invention is a pharmaceutical composition, typically a tablet, made with a high molecular weight polyethylene oxide (PEO) polymer. The key inventive step is a thermal curing process where a compressed tablet is heated "without compression" to a temperature above the softening point of the PEO, then cooled and hardened ('933 Patent, claim 1, as quoted in Compl. ¶55). This process creates a hardened, extended-release matrix that is difficult to manipulate for abuse (U.S. 11,964,908, col. 2:44-55).
  • Technical Importance: This thermal curing method provided a technique to create opioid dosage forms with enhanced physical resistance to tampering, a significant development in abuse-deterrent formulation technology (U.S. 11,964,908, col. 2:44-47).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 11, along with various dependent claims (Compl. ¶54).
  • Independent Claim 1:
    • A pharmaceutical composition comprising at least one active agent and at least one high molecular weight PEO (1-15 million).
    • The composition is a solid oral dosage form that is (i) compression shaped, (ii) air cured by heated air without compression for at least 5 minutes at a temperature above the PEO's softening temperature, (iii) cooled, and (iv) hardened.
    • The high molecular weight PEO comprises at least 30% by weight of the dosage form.
    • The molecular weight of the PEO is based on rheological measurements.
  • Independent Claim 11:
    • A pharmaceutical composition comprising an opioid active agent, a high molecular weight PEO (1-8 million), and at least one additive.
    • The composition is a solid oral dosage form that is (i) compression shaped, (ii) air cured by heated air without compression for at least 10 minutes at a temperature of at least 60° C., (iii) cooled, and (iv) hardened.
    • The high molecular weight PEO comprises at least 30% by weight, and the active agent comprises at least 1.3% by weight.
  • The complaint reserves the right to assert additional claims (Compl. ¶54).

U.S. Patent No. 9,770,416 - "TAMPER RESISTANT DOSAGE FORMS"

The Invention Explained

  • Problem Addressed: The '416 Patent, part of the same family as the '933 Patent, addresses the same problem of opioid abuse via tampering with dosage forms ('416 Patent, col. 1:17-38).
  • The Patented Solution: This patent claims a pharmaceutical composition with more specific parameters and resulting physical properties from the thermal curing process. It specifies a curing time of "about 15 minutes to about 8 hours" at "about 60° C. to about 90° C." and explicitly requires that the PEO is "at least partially melted upon curing" ('416 Patent, claim 1, as quoted in Compl. ¶70). The invention results in a dosage form that is "expanded upon curing" and provides a specified minimum hardness, which contributes to its tamper-resistant properties ('416 Patent, col. 2:50-55).
  • Technical Importance: The invention defines a specific set of process parameters and resulting physical characteristics (partial melting, expansion, hardness) intended to optimize the tamper-resistance of the final opioid tablet ('416 Patent, col. 2:50-55).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 12, along with various dependent claims (Compl. ¶69).
  • Independent Claim 1:
    • A pharmaceutical composition with an opioid active agent and high molecular weight PEO (1-8 million).
    • The dosage form is air cured without compression for about 15 minutes to 8 hours at 60-90° C.
    • The PEO is "at least partially melted" and comprises at least 50% of the dosage form by weight.
    • The dosage form is "expanded upon curing," measured by a density decrease of at least 1.5%, and provides a hardness of at least 439 N.
  • Independent Claim 12:
    • A pharmaceutical tablet with an opioid active agent, high molecular weight PEO (1-8 million), additive, and film coating.
    • The tablet is shaped by direct compression and air cured without compression for at least 15 minutes at a temperature of at least 65° C., then cooled below 50° C.
    • Recites the same requirements as claim 1 for PEO weight percentage (≥50%), expansion upon curing (≥1.5% density decrease), and hardness (≥439 N).
  • The complaint reserves the right to assert additional claims (Compl. ¶69).

Multi-Patent Capsule Summaries

  • U.S. Patent No. 9,492,389: Titled "TAMPER RESISTANT DOSAGE FORMS", issued November 15, 2016. This patent claims a cured pharmaceutical tablet comprising a matrix that is "compression shaped and then air cured... without compression" using heated air. The claims specify particular molecular weights for the PEO (4,000,000 or 7,000,000) and require the high molecular weight PEO to be at least 54% by weight of the uncoated tablet. Asserted Claims: Claims 18-20 and 28-30 depending from independent claim 1 (Compl. ¶99). Accused Features: The complaint alleges that the Defendants' ANDA Products, or their use or manufacture, are covered by the asserted claims (Compl. ¶99).

  • U.S. Patent No. 9,492,391: Titled "TAMPER RESISTANT DOSAGE FORMS", issued November 15, 2016. This patent claims a method of treating pain by administering a pharmaceutical tablet. The claimed tablet has the same composition and manufacturing process limitations as the '389 Patent, including the "compression shaped and then air cured... without compression" matrix and specific PEO molecular weight and weight percentage requirements. Asserted Claims: Claims 18-20 and 28-30 depending from independent claim 1 (Compl. ¶112). Accused Features: The complaint alleges that the use of Defendants' ANDA Products will infringe the asserted method claims (Compl. ¶112).

  • U.S. Patent No. 9,492,392: Titled "TAMPER RESISTANT DOSAGE FORMS", issued November 15, 2016. This patent claims a cured pharmaceutical tablet containing oxycodone with specific compositional requirements based on the dosage strength. For lower doses (10-30 mg), the total PEO must be at least 79% by weight, while for higher doses (40-80 mg), it must be at least 65% by weight. It also recites the same "compression shaped and then air cured" manufacturing process. Asserted Claims: Claims 17-19 and 27-29 depending from independent claim 1 (Compl. ¶132). Accused Features: The complaint alleges that Defendants' ANDA Products, which cover a range of dosage strengths, are covered by the asserted claims (Compl. ¶132).

  • U.S. Patent No. 9,492,393: Titled "TAMPER RESISTANT DOSAGE FORMS", issued November 15, 2016. This patent claims a method of treating pain by administering a tablet with the same dosage-specific compositional requirements as the '392 Patent. The claims cover the administration of a tablet made by the "compression shaped and then air cured" process with PEO percentages tied to the dose of oxycodone. Asserted Claims: Claims 17-19 and 27-29 depending from independent claim 1 (Compl. ¶145). Accused Features: The complaint alleges that the use of Defendants' ANDA Products will infringe the asserted method claims (Compl. ¶145).

  • U.S. Patent No. 9,775,808: Titled "TAMPER RESISTANT DOSAGE FORMS", issued October 3, 2017. This patent claims a pharmaceutical composition containing oxycodone, a high molecular weight PEO, and an additive/film coating. It recites the "air cured by heated air, without compression" process similar to the '933 Patent, and further claims a resulting product that is "expanded upon curing" with a hardness of at least 439 N. Asserted Claims: Claims 8 and 10 depending from independent claim 1, and claims 16-17, 20, 22-23, and 25-30 depending from independent claim 11 (Compl. ¶165). Accused Features: The complaint alleges that Defendants' ANDA Products are covered by the asserted claims (Compl. ¶165).

  • U.S. Patent No. 11,964,056: Titled "TAMPER RESISTANT DOSAGE FORMS", issued April 23, 2024. This patent claims a solid oral extended-release dosage form comprising an extended-release matrix with specific dissolution rate profiles (e.g., between 12.5% and 55% release after 1 hour). The claims also require that the dosage form "is expanded upon curing, as measured by a decrease in density of at least about 1.0%". Asserted Claims: Independent claims 1, 19, and 20, and claims 2-15 dependent therefrom (Compl. ¶186). Accused Features: The complaint alleges that Defendants' ANDA Products are covered by the asserted claims (Compl. ¶186).

  • U.S. Patent No. 9,775,811: Titled "TAMPER RESISTANT DOSAGE FORMS", issued October 3, 2017. This patent claims a method of producing a plurality of solid oral extended-release pharmaceutical tablets. The claimed steps include mixing an active agent (oxycodone) with high molecular weight PEO, compressing the mixture into tablets, curing the tablets with heated air, and cooling them. Asserted Claims: Claims 28-30 depending from independent claim 11 (Compl. ¶209). Accused Features: The complaint alleges that the process for making Defendants' ANDA Products is covered by the asserted claims (Compl. ¶209).

  • U.S. Patent No. 9,763,886: Titled "TAMPER RESISTANT DOSAGE FORMS", issued September 19, 2017. This patent also claims a method of producing a plurality of solid oral extended-release pharmaceutical tablets. The method steps are substantially similar to those in the '811 Patent, including mixing an opioid with high molecular weight PEO, compressing, curing with heated air, and cooling. Asserted Claims: Claim 30 depending from independent claim 11 (Compl. ¶221). Accused Features: The complaint alleges that the method for making Defendants' ANDA Products is covered by the asserted claim (Compl. ¶221).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Defendants' proposed generic oxycodone hydrochloride extended-release tablets, which are the subject of Abbreviated New Drug Application (ANDA) No. 217939 ("Defendants' ANDA Products") (Compl. ¶¶2-3).

Functionality and Market Context

  • The complaint alleges that Defendants' ANDA Products are generic versions of Purdue's OxyContin® product, intended for the treatment of pain (Compl. ¶3). The ANDA seeks approval for 10, 15, 20, 30, 40, 60, and 80 mg dosage strengths (Compl. ¶3).
  • The complaint's sections detailing the specific formulation and manufacturing process of the Defendants' ANDA Products are heavily redacted (Compl. ¶¶49-51). Consequently, the complaint does not provide sufficient public detail for a technical analysis of the accused products' composition or method of manufacture. The infringement analysis is based on information and belief derived from documents that are not publicly available as part of the complaint.
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that the Defendants' ANDA Products, and/or the manufacture or use thereof, will infringe the asserted patents, with details provided in a confidential exhibit (Exhibit S) that was not included with the public filing (Compl. ¶54, ¶69). As such, a detailed claim chart summary cannot be constructed from the provided documents. The infringement theory is necessarily based on information and belief regarding the undisclosed characteristics of the accused products and manufacturing processes.

Identified Points of Contention

Based on the asserted claims, the central infringement disputes will likely revolve around the following technical and legal questions:

  • Process Questions (for '811 and '886 Patents): What are the specific steps of Defendants' manufacturing process? Does that process include a thermal treatment step that qualifies as "curing the shaped matrix compositions by exposure to heated air at a curing temperature that is at least about 60° C. for a curing time of at least about 10 minutes," as required by the method claims? The definition and evidentiary proof of each parameter (temperature, duration, use of "heated air") will be critical.
  • Composition and Product-by-Process Questions (for '933, '416, '389, etc.): Does Defendants' process result in a product made by the claimed method (e.g., "air cured by heated air, without compression")? Does the final tablet meet the claimed physical characteristics, such as being "expanded upon curing," having a "decrease in density of at least about 1.5%," and providing a "hardness of at least about 439 N"? The case may turn on expert testing of Defendants' ANDA products to determine if they possess these claimed properties.
  • Scope Questions: A potential area of dispute may be the interpretation of claim terms such as "softening temperature," "air cured," and "without compression." Defendants may argue that their manufacturing process, even if it involves heat, differs in a way that falls outside a proper construction of these terms.

V. Key Claim Terms for Construction

The Term: "air cured by heated air, without compression, for at least about [X] minutes at a temperature above the softening temperature of the high molecular weight PEO" (from '933 Patent, claim 1)

  • Context and Importance: This phrase constitutes the core of the patented manufacturing process and is central to nearly all asserted patents. The definition of "curing... without compression" and "softening temperature" will be critical for determining whether Defendants' manufacturing process infringes. Practitioners may focus on this term because it distinguishes the invention from simple drying or standard tablet compression techniques.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification of the patent family describes curing in various apparatuses, including a "coating pan or fluidized bed" (U.S. 9,763,933, col. 19:38-43). Plaintiff may argue this supports a broad construction that is not limited to a specific type of oven or device, so long as it uses heated air without applying mechanical compression.
    • Evidence for a Narrower Interpretation: Defendants may point to specific embodiments and figures that depict particular temperature profiles (e.g., a "plateau-like form") or curing devices to argue for a narrower construction limited to those examples (U.S. 9,763,933, col. 18:3-4). The term "softening temperature" itself, defined by a specific viscosity measurement, may be another point of contention regarding how it applies to Defendants' specific PEO polymer and process conditions.

The Term: "expanded upon curing, as measured by a decrease in density of at least about 1.5%" (from '416 Patent, claim 1)

  • Context and Importance: This is a key structural and result-oriented limitation that distinguishes several of the asserted patents. The infringement analysis will require determining whether Defendants' tablets exhibit this physical property and how it is measured.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself provides the objective metric ("decrease in density of at least about 1.5%"). Plaintiff may argue that if Defendants' product meets this metric as a result of a thermal treatment process, it infringes, regardless of the precise mechanism of expansion.
    • Evidence for a Narrower Interpretation: Defendants may argue that the "expanded upon curing" limitation must be read in the context of the specification, which links the expansion to the partial melting of PEO during the curing step ('416 Patent, claim 1(b)). They may argue that a decrease in density caused by a different mechanism would not meet this limitation. The patent's statement, "Without wanting to be bound by any theory, it is believed that the... matrix formulation... expands, resulting in a density decrease," suggests the mechanism may not be strictly limiting (U.S. 9,770,416, col. 24:45-51).

VI. Other Allegations

Indirect Infringement

The complaint alleges induced infringement for the method-of-use patents ('391 and '393 Patents). It alleges that Defendants, if their ANDA is approved, will "actively induce others including, e.g., Healthcare Providers and patients" by instructing them, through the proposed product label, to administer the tablets for pain in a manner that directly infringes the method claims (Compl. ¶¶126, 128). Knowledge is alleged based on the Notice Letter (Compl. ¶126).

Willful Infringement

While the word "willful" is not used in a standalone count, the complaint repeatedly alleges that "Since at least the date of the Notice Letter, Defendants have acted with knowledge, or at least with willful blindness of the fact, that the induced acts would constitute infringement" of the patents-in-suit (Compl. ¶64, ¶94). This pleading standard supports a claim for enhanced damages by alleging post-suit knowledge of the patents and infringement.

VII. Analyst’s Conclusion: Key Questions for the Case

  1. A central issue will be one of process equivalence: Will discovery reveal that Defendants' manufacturing method for their generic tablets includes a thermal treatment step that falls within the scope of the patents' "air cured by heated air, without compression" limitations, either literally or under the doctrine of equivalents?
  2. A key evidentiary question will be one of physical characterization: Does Defendants' final tablet product possess the specific, measurable physical properties recited in claims across multiple patents, such as a density decrease of at least 1.5% upon curing and a hardness of at least 439 N? The case will likely feature a "battle of the experts" over the testing and measurement of these characteristics.
  3. A significant procedural hurdle is the scope of discovery: Given the extensive redactions in the public complaint regarding the accused product's formulation, the outcome will depend entirely on evidence obtained in discovery concerning the precise composition and manufacturing steps of Defendants' ANDA products, which are currently confidential.