DCT

2:20-cv-12470

Alkermes Inc v. Teva Pharmaceutical Industries USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:20-cv-12470, D.N.J., 09/09/2020
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Teva USA has a regular and established place of business in the district, is registered to do business in the state, and has committed and will commit acts of infringement there.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of VIVITROL® constitutes an act of patent infringement under the Hatch-Waxman Act.
  • Technical Context: The technology involves a long-acting, injectable formulation of naltrexone for the treatment of alcohol dependence, designed to improve patient outcomes by replacing a daily oral medication regimen with a monthly injection, thereby addressing patient compliance issues.
  • Key Procedural History: The lawsuit was initiated following Plaintiff's receipt of a notice letter from Teva, dated July 29, 2020, which included a Paragraph IV certification against U.S. Patent No. 7,919,499. The patent is listed in the FDA's "Orange Book" as covering Plaintiff's VIVITROL® product. This filing triggers a 30-month statutory stay on the FDA’s approval of Teva's generic product.

Case Timeline

Date Event
2004-04-22 '499 Patent Priority Date
2011-04-05 '499 Patent Issue Date
2020-07-29 Teva sends Paragraph IV Notice Letter to Plaintiffs
2020-09-09 Complaint Filing Date

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

U.S. Patent No. 7,919,499 - "Naltrexone Long Acting Formulations and Methods of Use"

  • Patent Identification: U.S. Patent No. 7,919,499, "Naltrexone Long Acting Formulations and Methods of Use," issued April 5, 2011.

The Invention Explained

  • Problem Addressed: The patent identifies patient compliance as a "serious problem" in the treatment of alcohol dependence, where traditional therapies often require daily oral medication, leading to inconsistent use and reduced efficacy (ʼ499 Patent, col. 1:25-26).
  • The Patented Solution: The invention is a method of treatment using a parenterally administered, long-acting formulation of naltrexone. This formulation, comprising naltrexone and a biocompatible polylactide-co-glycolide (PLGA) polymer, is designed to be injected monthly. It achieves a significantly higher total exposure to the drug (measured by serum Area Under the Curve, or AUC) compared to daily oral doses, a result described as an "unexpected discovery" from clinical trials that led to improved treatment outcomes (ʼ499 Patent, col. 1:31-40).
  • Technical Importance: The invention's shift from a daily oral pill to a monthly injection directly addresses the critical issue of patient non-compliance, a primary failure point in managing chronic conditions like alcohol dependence ('499 Patent, col. 1:23-26).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-13 ('499 Patent, Compl. ¶31). The independent claims are 1 and 14.
  • Independent Claim 1:
    • A method of treating an individual in need of naltrexone
    • comprising parenterally administering a long-acting formulation
    • which includes about 310 mg to about 480 mg of naltrexone
    • and a polylactide-co-glycolide biocompatible polymer,
    • wherein the resulting serum AUC of naltrexone is "about three times greater" than that from a 50 mg/day oral dose.
  • Independent Claim 14:
    • A method of treating an individual in need of naltrexone
    • comprising parenterally administering a long-acting formulation
    • which includes about 190 mg to about 240 mg of naltrexone
    • and a polylactide-co-glycolide biocompatible polymer,
    • wherein the resulting serum AUC of naltrexone is "about two times greater" than that from a 50 mg/day oral dose.
  • The complaint reserves the right to assert dependent claims, which add limitations regarding specific dosages, treatment indications, and administration schedules (Compl. ¶31).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is "Teva's ANDA Product," identified as a generic version of VIVITROL® (naltrexone) extended-release intramuscular injectable suspension, 380 mg/vial, for which Teva seeks FDA approval via ANDA No. 213195 (Compl. ¶14).

Functionality and Market Context

The complaint alleges that Teva's ANDA Product is a copy of the VIVITROL® branded product and is intended for the same use: the treatment of alcohol dependence (Compl. ¶¶14, 26). As a generic drug, it is intended to be therapeutically equivalent and thus have the same clinical effect and safety profile as the brand-name drug it copies, allowing it to be substituted for VIVITROL® (Compl. ¶14). The complaint notes the product would be commercially manufactured, used, and sold throughout the United States upon FDA approval (Compl. ¶17).

IV. Analysis of Infringement Allegations

The complaint alleges that Teva’s act of filing its ANDA constitutes infringement under 35 U.S.C. § 271(e)(2)(A), and that commercialization of the proposed product would constitute direct and indirect infringement (Compl. ¶¶ 34, 36). The infringement theory is based on the premise that Teva's ANDA product, being a 380 mg generic version of VIVITROL®, will necessarily meet the limitations of the asserted claims when administered as directed. For example, a bar chart in the patent illustrates the median number of heavy drinking days per month for patients receiving placebo, 190 mg, and 380 mg doses of naltrexone, compared to a baseline measurement ('499 Patent, Fig. 2). This data supports the efficacy that underlies the claimed method, which the generic product is intended to replicate.

'499 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating an individual in need of naltrexone comprising the step of parenterally administering a long acting formulation... Teva’s ANDA seeks approval for an intramuscular injectable suspension, which is a form of parenteral administration, for the treatment of alcohol dependence. ¶14 col. 1:34-37
...comprising about 310 mg to about 480 mg of naltrexone... Teva’s ANDA Product is a 380 mg/vial formulation of naltrexone, which falls within the claimed dosage range. ¶14 col. 1:45-46
...and a biocompatible polymer... wherein the biocompatible polymer is a polylactide-co-glycolide polymer. As a generic copy of VIVITROL®, the ANDA product is alleged to contain the same active and inactive ingredients, including the polylactide-co-glycolide polymer described in the patent as the release vehicle. ¶14 col. 3:5-9
...wherein the serum AUC of naltrexone is about three times greater than that achieved by 50 mg/day oral administration... Teva’s ANDA must demonstrate that its product is bioequivalent to VIVITROL®, which is alleged to exhibit the pharmacokinetic profile (AUC) recited in the claim. ¶14 col. 1:35-40
  • Identified Points of Contention:
    • Scope Questions: A central issue may be the proper construction of the phrase "about three times greater." The parties may dispute the numerical range encompassed by "about," and whether the bioequivalence data for Teva's ANDA product falls within that range.
    • Technical Questions: The complaint states that Teva's notice letter "does not identify any factual basis for, or any opinion of, noninfringement" (Compl. ¶31). A key question for discovery will be what pharmacokinetic data Teva's ANDA contains and how that data compares to the specific AUC ratio required by the claims. The dispute may turn on whether being "bioequivalent" for FDA purposes is legally identical to meeting the specific AUC limitation defined in the patent claim.

V. Key Claim Terms for Construction

  • The Term: "about three times greater" (Claim 1) and "about two times greater" (Claim 14).
  • Context and Importance: These terms of degree are at the heart of the invention's patentability and the infringement analysis. The definition of "about" will determine the scope of the pharmacokinetic limitation. Practitioners may focus on this term because the infringement case could succeed or fail based on whether the measured AUC for Teva's product, while bioequivalent, falls inside or outside the boundary of what "about" is construed to mean.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the results as a "substantially improved" serum level of naltrexone, suggesting the term should be interpreted functionally to cover any significant and unexpected improvement over the prior art, rather than being tied to a precise number (ʼ499 Patent, col. 2:30-31).
    • Evidence for a Narrower Interpretation: The specification links a specific dose (380 mg) to a specific outcome ("about 3.3 times greater") ('499 Patent, col. 28:18-22 (Claim 5)). A party could argue that "about three times" should be construed narrowly around the specific values disclosed in the patent's examples and preferred embodiments.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Teva will induce infringement by providing a product with labeling that instructs physicians and patients to administer it in a manner that practices the claimed method (e.g., monthly injection of the 380 mg dose for alcohol dependence) (Compl. ¶36).
  • Willful Infringement: The complaint alleges that Teva was aware of the '499 patent prior to the lawsuit, as evidenced by its Paragraph IV certification and the patent's listing in the Orange Book (Compl. ¶¶ 27, 38). This pre-suit knowledge forms the basis for an allegation that any future infringement would be willful. The prayer for relief also requests a finding that the case is "exceptional" under 35 U.S.C. § 285 (Compl. Prayer for Relief ¶ C).

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

  • A core issue will be one of definitional scope: how will the court construe the term "about," which modifies the numerical pharmacokinetic ratios in the independent claims? The case may turn on whether the range assigned to "about" is broad enough to read on the bioequivalence data presented in Teva's ANDA.
  • A key legal and evidentiary question will be one of infringement equivalence: does the evidence submitted to the FDA to establish "bioequivalence" for regulatory purposes also suffice to prove, as a matter of law, that Teva's product meets the specific quantitative "serum AUC" limitation as construed from the patent?