DCT

2:15-cv-06797

Assertio Therap Inc v. Actavis Elizabeth LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:15-cv-06797, D.N.J., 09/11/2015
  • Venue Allegations: Venue is alleged to be proper based on Defendants maintaining places of business within the District of New Jersey.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to market a generic version of the pain medication NUCYNTA® ER constitutes infringement of a patent covering a method of treating a specific type of neuropathic pain.
  • Technical Context: The technology concerns the use of a specific chemical compound, tapentadol, for the treatment of neuropathic pain, a type of chronic pain caused by nerve damage that is often difficult to manage with conventional analgesics.
  • Key Procedural History: This is a Hatch-Waxman action triggered by Defendants' filing of ANDA No. 204972. The patent-in-suit is listed in the FDA's "Orange Book" for Plaintiffs' branded drug, NUCYNTA® ER (NDA No. 200533). The complaint notes that Defendants received tentative FDA approval for their generic product on or about May 18, 2015.

Case Timeline

Date Event
2007-03-12 U.S. Patent No. 8,536,130 Priority Date
< 2013-06-12 Actavis Inc Submits ANDA No. 204972 to FDA
2013-09-17 U.S. Patent No. 8,536,130 Issue Date
2015-05-18 Actavis Obtains Tentative Approval for ANDA No. 204972
2015-09-11 Complaint Filing Date

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

U.S. Patent No. 8,536,130 - USE OF 1 PHENYL-3-DIMETHYLAMINO-PROPANE COMPOUNDS FOR TREATING NEUROPATHIC PAIN

  • Patent Identification: U.S. Patent No. 8,536,130, issued September 17, 2013.

The Invention Explained

  • Problem Addressed: The patent's background section describes the challenge of treating neuropathic pain, which differs from normal (nociceptive) pain. It notes that existing treatments may be ineffective or cause problematic side effects, creating a need for new compounds with a "favorable ratio of effectiveness to side effects" (ʼ130 Patent, col. 2:26-34).
  • The Patented Solution: The invention is the use of a specific compound, (1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol, also known as tapentadol, for treating neuropathic pain. The patent asserts this compound is "highly effective in treating neuropathic pain, and surprisingly particularly effective in treating polyneuropathic and diabetic neuropathic pain" (ʼ130 Patent, col. 2:48-52). This efficacy is attributed to a dual mode of action (μ-opioid receptor agonist and noradrenaline uptake inhibitor) that provides analgesic effects with "low opioid-typical side effects" (ʼ130 Patent, col. 3:4-12).
  • Technical Importance: The invention claims to provide a targeted treatment for difficult-to-manage pain conditions, such as diabetic peripheral neuropathy, that affect a significant patient population (ʼ130 Patent, col. 3:51-54).

Key Claims at a Glance

  • The complaint asserts infringement of independent claim 1.
  • The essential elements of Claim 1 are:
    • A method of treating polyneuropathic pain in a subject suffering therefrom,
    • said method comprising administering to said subject
    • an effective polyneuropathic pain inhibiting amount of (1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol
    • or a pharmaceutically acceptable salt thereof.
  • The complaint alleges infringement of dependent claims 2-6 and reserves the right to assert other claims of the ʼ130 Patent (Compl. ¶¶ 24-25, 40-42).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Defendants' generic tapentadol hydrochloride extended-release tablets in 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg dosages, for which Defendants seek marketing approval under ANDA No. 204972 (the "ANDA Products") (Compl. ¶30).

Functionality and Market Context

The ANDA Products are generic versions of Plaintiffs' NUCYNTA® ER, an extended-release opioid pain medication (Compl. ¶¶ 1, 4). As a generic equivalent, the ANDA Product contains the same active ingredient, tapentadol hydrochloride, as the branded drug (Compl. ¶4, ¶30). The complaint alleges that upon approval, the ANDA Products will be marketed with a label that instructs for the same indications as NUCYNTA® ER, including "the management of neuropathic pain associated with diabetic peripheral neuropathy" (Compl. ¶6, ¶38).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

Claim Chart Summary

The complaint does not contain an explicit claim chart, but its allegations support the following infringement theory for Claim 1.

’130 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating polyneuropathic pain in a subject suffering therefrom... The filing of the ANDA seeks approval to market a drug for treating "neuropathic pain associated with diabetic peripheral neuropathy," which the complaint alleges is a form of polyneuropathic pain. ¶6, ¶40, ¶43 col. 2:21-22
...said method comprising administering to said subject... The proposed product label for the ANDA Products will instruct medical professionals and patients to administer the drug to a subject. ¶38, ¶44 col. 18:2-3
...an effective polyneuropathic pain inhibiting amount of (1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol... The ANDA Products contain the specified compound (tapentadol) and will be sold in dosage strengths that are alleged to be effective for treating the indicated pain. ¶30, ¶38 col. 5:63-65
...or a pharmaceutically acceptable salt thereof. The ANDA Products contain tapentadol hydrochloride, the hydrochloride salt of the claimed compound. ¶4, ¶30 col. 5:52

Identified Points of Contention

  • Scope Questions: A primary issue for the court will be construing the scope of the term "polyneuropathic pain". The infringement analysis will depend on whether the indication for "neuropathic pain associated with diabetic peripheral neuropathy," which will allegedly appear on the Defendants' product label, falls within the scope of the claim term "polyneuropathic pain".
  • Technical Questions: In this ANDA litigation, the infringement question is highly stylized. The central evidentiary question will be whether the instructions for use in Defendants' proposed product label direct users to perform all the steps of the claimed method. The complaint alleges this is the case (Compl. ¶38, ¶55).

V. Key Claim Terms for Construction

  • The Term: "polyneuropathic pain"
  • Context and Importance: The definition of this term is dispositive. Infringement hinges on whether the condition targeted by the accused product ("diabetic peripheral neuropathy") is properly classified as "polyneuropathic pain" as that term is used in the patent. Practitioners may focus on this term because the patent's specification makes a technical distinction between the compound's efficacy in polyneuropathic versus mononeuropathic pain models (ʼ130 Patent, col. 10:1-12).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent abstract and dependent claim 3 both explicitly link "polyneuropathic pain" with "diabetic neuropathic pain," which may support an interpretation where the latter is a species of the former (ʼ130 Patent, Abstract; col. 18:11-13).
    • Evidence for a Narrower Interpretation: The patent specification details specific animal models and provides comparative efficacy data between mononeuropathic and polyneuropathic pain (ʼ130 Patent, Example 6). A party could argue this detailed technical disclosure limits the claim term to the specific pain pathologies and characteristics demonstrated in the patent, potentially distinguishing it from a more general dictionary definition.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will induce infringement by distributing the ANDA Products with a label that "specifically instructs and directs doctors to prescribe, pharmacists to dispense, and patients to use the ANDA products for the treatments and methods claimed by the '130 Patent" (Compl. ¶38, ¶44).
  • Willful Infringement: Willfulness is alleged based on Defendants' knowledge of the ʼ130 Patent since its issuance date of September 17, 2013, and their subsequent pursuit of the ANDA (Compl. ¶46, ¶60). The complaint alleges Defendants acted without a reasonable basis for a good faith belief that they would not be liable for infringement (Compl. ¶60).

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

  • A core issue will be one of definitional scope: Is the term "polyneuropathic pain" in Claim 1 broad enough to read on the indication of "neuropathic pain associated with diabetic peripheral neuropathy" as it will be described in the Defendants' proposed product label? The resolution will likely depend on whether the patent's own detailed examples and distinctions between pain types are found to limit the term's scope.
  • A key evidentiary question will be one of instructed use: As an ANDA case, the infringement determination is based on the use for which approval is sought. The case will turn on the precise language of Defendants' proposed product label and whether it instructs medical providers and patients to perform each step of the patented method.