DCT

2:19-cv-17170

Assertio Therap Inc v. Alkem Laboratories Ltd

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:19-cv-17170, D.N.J., 08/23/2019
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Ascend Laboratories is organized and resides in the state, and Defendant Alkem Laboratories, an Indian corporation, may be sued in any judicial district where it is subject to the court's personal jurisdiction.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the opioid analgesic NUCYNTA® ER constitutes an act of infringement of a patent covering an abuse-resistant pharmaceutical formulation.
  • Technical Context: The patent-in-suit relates to technology for creating abuse-proofed oral dosage forms of drugs, particularly opioids, by making them physically resistant to crushing and extraction, a field of significant public health importance.
  • Key Procedural History: This is a Hatch-Waxman action initiated after Plaintiffs received a "Notice Letter" dated July 10, 2019, in which Defendant Alkem Labs provided a Paragraph IV certification against the patent-in-suit for its ANDA No. 205016. The complaint notes that Alkem has previously been sued in the District of New Jersey and has not challenged personal jurisdiction, suggesting a history of availing itself of the jurisdiction of the court.

Case Timeline

Date Event
2003-08-06 U.S. Patent No. 8,309,060 Priority Date
2012-11-13 U.S. Patent No. 8,309,060 Issue Date
2019-07-10 Date of Defendants' Notice Letter to Plaintiffs
2019-08-23 Complaint Filing Date

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

U.S. Patent No. 8,309,060 - "ABUSE-PROOFED DOSAGE FORM", issued November 13, 2012

The Invention Explained

  • Problem Addressed: The patent’s background section describes the problem of pharmaceutical abuse, where individuals pulverize dosage forms like tablets to extract the active ingredient for nasal or parenteral administration, which can produce a euphoric "kick" or "rush" not experienced with proper oral administration (’060 Patent, col. 1:26-44).
  • The Patented Solution: The invention is a "thermoformed" solid dosage form containing an active ingredient with abuse potential. The solution involves using at least one polymer with a high molecular weight to impart a high mechanical breaking strength (at least 500 Newtons), making the dosage form extremely difficult to pulverize using conventional means like a mortar and pestle or a hammer, thereby complicating or preventing extraction of the drug for abuse (’060 Patent, Abstract; col. 2:5-14).
  • Technical Importance: The invention provides a method for formulating potent analgesics that delivers the intended therapeutic effect when taken as prescribed but incorporates physical barriers to mitigate the risks of common forms of tampering and abuse (’060 Patent, col. 1:5-14).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims, including independent claim 1 and dependent claim 28 (Compl. ¶41, ¶49).
  • Independent Claim 1 requires:
    • An abuse-proofed, thermoformed dosage form
    • comprising one or more active ingredients with abuse potential
    • at least one synthetic or natural polymer (C), wherein the polymer (C) has a molecular weight of at least 0.5 million
    • wherein the dosage form exhibits a breaking strength of at least 500 N
  • The complaint reserves the right to assert additional claims, including those dependent from the asserted independent claims (Compl. ¶41).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the proposed generic tapentadol hydrochloride extended-release tablets described in Defendants' ANDA No. 205016 (Compl. ¶28).

Functionality and Market Context

The complaint alleges that the ANDA product is a generic version of Plaintiffs' NUCYNTA® ER tablets, which are indicated for the management of severe pain, including neuropathic pain associated with diabetic peripheral neuropathy (Compl. ¶2, ¶4-5, ¶43). Defendants have allegedly represented to the FDA that their proposed generic products are "pharmaceutically and therapeutically equivalent to NUCYNTA® ER tablets" (Compl. ¶38). Upon approval, Defendants would market these products for the same pain management indications (Compl. ¶43).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

’060 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An abuse-proofed, thermoformed dosage form The proposed generic product is alleged to be an abuse-proofed, thermoformed dosage form. ¶41 col. 1:15-16
comprising an active ingredient with abuse potential The proposed generic product contains tapentadol hydrochloride, an opioid analgesic with abuse potential. ¶28, ¶41 col. 2:55-64
and at least one polymer having a molecular weight of at least 0.5 million The proposed generic product is alleged to comprise at least one polymer with a molecular weight of at least 0.5 million. ¶41 col. 5:65-6:3
wherein the dosage form has a breaking strength of at least 500 N The proposed generic product is alleged to have a breaking strength of at least 500 N. ¶41 col. 2:23-24
  • Identified Points of Contention:
    • Factual Questions: As an ANDA case filed on "information and belief," the central dispute will be factual. The key question is whether Defendants' proposed generic product, once its composition and manufacturing process are revealed in discovery, will actually meet the quantitative limitations of Claim 1, specifically the polymer molecular weight of at least 0.5 million and a final dosage form breaking strength of at least 500 N, when measured by the methods described in the patent.
    • Scope Questions: The term "thermoformed" is recited in the claim preamble. A significant legal and technical question will be whether the manufacturing process used for the accused generic product falls within the scope of "thermoformed" as used and described in the patent (’060 Patent, col. 11:16-41). The definition of this process-related term could be critical to the infringement analysis.

V. Key Claim Terms for Construction

  • The Term: "thermoformed"

  • Context and Importance: This term, found in the preamble of Claim 1, relates to the manufacturing process of the dosage form. Its construction is critical because if the accused product is made by a process that does not involve "thermoforming," Defendants may argue for non-infringement. Practitioners may focus on this term because it links the claimed product to a method of its creation, raising questions about whether the claim scope is limited by the process.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes producing the dosage form with "preceding, simultaneous, or subsequent exposure to heat" relative to the press-forming step, which may support an interpretation that covers a range of processes involving heat and pressure (’060 Patent, col. 11:20-23).
    • Evidence for a Narrower Interpretation: The detailed examples in the patent describe a specific process where the "tabletting tool...was heated to 80° C.," which may support an argument that "thermoformed" requires a specific type of heated-tool pressing rather than any process that involves heat (’060 Patent, col. 17:60-65).

  • The Term: "breaking strength of at least 500 N"

  • Context and Importance: This quantitative limitation is the core of the patent's "abuse-proofed" feature. The entire infringement case may depend on whether the accused product meets this threshold. The dispute will likely focus on the precise methodology required to measure this property.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: A party could argue that any scientifically valid method for measuring tablet breaking strength should be acceptable, as long as it demonstrates the claimed hardness.
    • Evidence for a Narrower Interpretation: The patent provides a highly specific test method, stating that the breaking strength is determined "in accordance with the method...published in the European Pharmacopoeia 1997, page 143-144, method no. 2.9.8" and specifies the use of a particular testing apparatus (’060 Patent, col. 17:1-18). This provides strong intrinsic evidence that the claim term should be construed as being limited to the result obtained using this specific protocol.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement, asserting that the proposed product label for the generic tablets "will explicitly instruct Healthcare Providers and patients" to administer the dosage form to treat pain, thereby infringing method claims such as claim 28 (Compl. ¶49). It also pleads contributory infringement, alleging the products are "especially made or especially adapted for use in the infringement" and lack a "substantial non-infringing use" (Compl. ¶46-47).
  • Willful Infringement: The complaint alleges that Defendants have had actual knowledge of the ’060 patent since at least the date of their July 10, 2019 Notice Letter (Compl. ¶39). It further alleges that if Defendants proceed with commercialization after approval, they will be acting with knowledge or willful blindness that their acts constitute infringement (Compl. ¶50).

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

  • A central issue will be one of evidentiary proof: Do the specific formulation and manufacturing process of the Defendants' proposed generic product, as will be detailed in the confidential ANDA submission, actually meet the quantitative physical and chemical limitations of Claim 1, specifically the polymer molecular weight of at least 0.5 million and the tablet breaking strength of at least 500 N? The case may turn on a battle of experts and test results related to these objective metrics.
  • A second core issue will be one of definitional scope: How will the court construe the term "thermoformed"? The resolution of whether this term is limited to the specific heated-tool methods exemplified in the patent or covers a broader range of manufacturing processes involving heat could be dispositive for the infringement analysis, independent of the product's final physical properties.