DCT

2:17-cv-02227

Impax Laboratories Inc v. Sandoz Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:17-cv-02203, D.N.J., 03/31/2017
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendant Sandoz Inc. maintaining a principal place of business in Princeton, New Jersey.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) to market generic versions of RYTARY® capsules infringes eight U.S. patents related to combination immediate- and controlled-release formulations of levodopa and carbidopa.
  • Technical Context: The technology concerns oral pharmaceutical formulations for treating Parkinson's disease, a condition characterized by depleted dopamine levels, which represents a significant therapeutic market.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff's receipt of a Paragraph IV certification letter from Defendant. The letter asserted that the patents-in-suit are either invalid or will not be infringed by Defendant’s proposed generic product. The complaint was filed within the 45-day statutory window, triggering an automatic 30-month stay of FDA approval for the Defendant's ANDA. One of the asserted patents, U.S. Patent No. 7,094,427, underwent an ex parte reexamination where all claims were canceled, a fact not mentioned in the complaint but relevant to the patent's enforceability.

Case Timeline

Date Event
2002-05-29 Patent Priority Date (U.S. Patent No. 7,094,427)
2006-08-22 Issue Date (U.S. Patent No. 7,094,427)
2007-12-28 Patent Priority Date (U.S. Patent Nos. 8,377,474; 8,454,998; 8,557,283; 9,089,607; 9,089,608; 9,463,246; 9,533,046)
2013-02-19 Issue Date (U.S. Patent No. 8,377,474)
2013-06-04 Issue Date (U.S. Patent No. 8,454,998)
2013-10-15 Issue Date (U.S. Patent No. 8,557,283)
2015-07-28 Issue Date (U.S. Patent No. 9,089,607)
2015-07-28 Issue Date (U.S. Patent No. 9,089,608)
2016-10-11 Issue Date (U.S. Patent No. 9,463,246)
2017-01-03 Issue Date (U.S. Patent No. 9,533,046)
2017-02-14 Plaintiff receives Sandoz's Paragraph IV Certification Letter
2017-03-31 Complaint Filing Date

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

U.S. Patent No. 7,094,427 - "Combination Immediate Release Controlled Release Levodopa/Carbidopa Dosage Forms"

The Invention Explained

  • Problem Addressed: The patent describes a problem with then-existing Parkinson's treatments: controlled-release (CR) formulations of levodopa/carbidopa are slow to take effect, leaving patients with little mobility upon waking, while immediate-release (IR) formulations require frequent dosing and lead to fluctuating plasma levels of the drug, which can cause motor complications. (’427 Patent, col. 1:53–2:18).
  • The Patented Solution: The invention is a single dosage form containing both an immediate-release component and a controlled-release component. The IR portion is designed to quickly deliver levodopa to the patient’s plasma, while the CR portion provides a sustained release over a prolonged period, thereby aiming to achieve both rapid onset of action and stable therapeutic levels. (’427 Patent, Abstract; col. 2:35-56).
  • Technical Importance: This combination approach sought to mitigate the "on-off effect" in Parkinson's therapy by providing a more consistent therapeutic window from a single oral dose. (’427 Patent, col. 1:49-56).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim (Compl. ¶28). Independent claim 1 is representative:
  • A pharmaceutical dosage form having an immediate release component and a controlled release component comprising:
    • a) an immediate release component comprising a ratio of carbidopa to levodopa of from about 1:1 to about 1:50 such that the in vitro dissolution rate of the immediate release component...is from about 10% to about 99% levodopa released after 15 minutes and from about 60% to about 99% after 1 hour; and
    • b) a controlled release component comprising a ratio of carbidopa to levodopa of from about 1:1 to about 1:50 such that the in vitro dissolution rate of the controlled release component...is from about 10% to about 60% levodopa released after 1 hour...from about 30% to about 99% levodopa released after about 6 hours...
    • ...the in vitro release rate chosen such that the initial peak plasma level of levodopa obtained in vivo occurs between 0.1 and 6 hours after administration...

U.S. Patent No. 8,377,474 - "Controlled Release Formulations of Levodopa and Uses Thereof"

The Invention Explained

  • Problem Addressed: The patent addresses the persistent challenge in Parkinson's treatment that oral drug formulations fail to produce steady plasma concentrations of levodopa, resulting in significant "peak-to-trough" fluctuations that lead to motor complications and periods when the drug is not effective ("off" time). (’474 Patent, col. 1:20–2:10).
  • The Patented Solution: The invention proposes a controlled-release oral formulation that combines levodopa and a decarboxylase inhibitor (like carbidopa) with a carboxylic acid (such as tartaric acid). The carboxylic acid is not an active drug itself but is included to control the absorption of levodopa, aiming to produce steadier, more infusion-like plasma concentrations over a prolonged period. (’474 Patent, Abstract; col. 2:50-56). The formulation is described as potentially being multiparticulate, with different components contained in separate beads within a single capsule. (’474 Patent, col. 6:25-31).
  • Technical Importance: The use of a carboxylic acid as a release-modulating excipient represented a novel pharmaceutical strategy to improve the pharmacokinetic profile of orally administered levodopa. (’474 Patent, col. 5:21-27).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim (Compl. ¶39). Independent claim 1 is representative:
  • A controlled release oral solid formulation of levodopa comprising:
    • a. a controlled release component comprising levodopa, a decarboxylase inhibitor and one or more rate controlling excipients,
    • b. a carboxylic acid component comprising a carboxylic acid that is not levodopa or the decarboxylase inhibitor and one or more rate controlling excipients, and
    • c. an immediate release component comprising levodopa and a decarboxylase inhibitor,
    • wherein the carboxylic acid component of (b) is a distinct component and is coated with an enteric polymer; and wherein the components (a), (c) and (b) comprise beads or granules.

U.S. Patent No. 8,454,998 - "Controlled Release Formulations of Levodopa and Uses Thereof"

  • Technology Synopsis: This patent is in the same family as the ’474 patent and is also directed to controlled-release levodopa formulations containing a carboxylic acid to modulate absorption and achieve steadier plasma concentrations. It claims specific pharmacokinetic profiles, such as a "peak-to-trough ratio" of levodopa concentration that is less than a certain value over a defined time period. (’998 Patent, Abstract; col. 3:1-10).
  • Asserted Claims: At least one claim is asserted (Compl. ¶50). Independent claim 1 is representative.
  • Accused Features: The entirety of the Sandoz ANDA product is accused of infringement, as it is alleged to be a generic equivalent of RYTARY®, which embodies the patented technology (Compl. ¶53).

U.S. Patent No. 8,557,283 - "Controlled Release Formulations of Levodopa and Uses Thereof"

  • Technology Synopsis: This patent, also from the same family, claims methods of treating Parkinson's disease by administering the formulation containing levodopa, a decarboxylase inhibitor, and a carboxylic acid. The claims focus on the therapeutic methods of reducing motor fluctuations and "off" time in a patient. (’283 Patent, Abstract; col. 9:56–10:11).
  • Asserted Claims: At least one claim is asserted (Compl. ¶61). Independent claim 1 is representative.
  • Accused Features: The intended use of the Sandoz ANDA product for treating Parkinson's disease is accused of infringing the patented methods (Compl. ¶64).

An additional four patents from the same family as the ’474 patent are asserted: U.S. Patent Nos. 9,089,607; 9,089,608; 9,463,246; and 9,533,046. The complaint alleges that the Sandoz ANDA Product infringes at least one claim of each of these patents (Compl. ¶72, 83, 94, 109). These patents claim further variations of the formulations, pharmacokinetic profiles, and methods of use related to the core technology of combining levodopa, carbidopa, and a carboxylic acid.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the carbidopa/levodopa extended-release capsules for which Defendant Sandoz submitted ANDA No. 208895 to the FDA for approval (the "Sandoz ANDA Product") (Compl. ¶22).

Functionality and Market Context

  • The complaint alleges that the Sandoz ANDA Product is a generic version of Plaintiff's RYTARY® product, offered in identical dosages (e.g., 23.75 mg/95 mg, 36.25 mg/145 mg) (Compl. ¶19, 22). The ANDA is said to contain data demonstrating the bioequivalence of the Sandoz product to RYTARY® (Compl. ¶23). By filing the ANDA, Sandoz is seeking to enter the market with a generic competitor to RYTARY® upon approval, which constitutes an act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶28). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or any specific factual allegations mapping elements of the Sandoz ANDA Product to the limitations of the asserted patent claims. The infringement allegations are made generally "on information and belief" and assert that the Sandoz product will infringe, either literally or under the doctrine of equivalents, upon its commercial manufacture, use, or sale (Compl. ¶31, 42).

  • Identified Points of Contention:
    • Compositional Questions: As the complaint lacks specifics about the accused product's formulation, a primary point of contention will be its composition. A key question for the ’474 patent and its family members is whether the Sandoz ANDA Product contains a "carboxylic acid that is not levodopa nor the decarboxylase inhibitor," as required by the claims. Discovery into the excipients listed in Sandoz's confidential ANDA submission will be central to resolving this issue.
    • Functional Questions: For the ’427 patent, a key question will be one of functional performance. Does the dissolution profile of the Sandoz product meet the specific two-part (immediate and controlled) release rates recited in the claims? For the ’474 patent family, a related question is whether any included carboxylic acid actually performs the function of controlling levodopa absorption to achieve the claimed pharmacokinetic profiles, or if it is merely an inactive binder or filler.

V. Key Claim Terms for Construction

The Term: "immediate release component" (’427 Patent, Claim 1)

  • Context and Importance: The definition of this term is critical for the ’427 patent, as the claim requires a specific dissolution profile for this component (e.g., "from about 10% to about 99% levodopa released after 15 minutes"). Practitioners may focus on whether this term should be defined solely by its recited functional dissolution rates or if it is implicitly limited by the specific IR formulations disclosed in the patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself defines the component functionally by its dissolution rate, which may support an interpretation that covers any formulation achieving that rate (col. 24:19-27).
    • Evidence for a Narrower Interpretation: The specification discloses specific examples and dissolution profiles for IR formulations (e.g., PX03002 and PX03102) which could be used to argue that the term should be construed more narrowly to cover only similar types of formulations (’427 Patent, FIG. 1; col. 9:60-64).

The Term: "carboxylic acid that is not levodopa nor the decarboxylase inhibitor" (’474 Patent, Claim 1)

  • Context and Importance: This term is central to infringement of the entire ’474 patent family. The dispute will likely center on what types of pharmaceutical excipients meet this definition. Sandoz may argue that common excipients that happen to be carboxylic acids but are used for other purposes (e.g., as binders or pH adjusters) do not meet the claim limitation, while Impax may argue for a plain meaning construction that reads on any such compound present in the formulation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language is facially broad, and the specification lists numerous examples of suitable carboxylic acids, including common ones like citric acid and succinic acid, suggesting the term is not narrowly limited (’474 Patent, col. 5:39-47).
    • Evidence for a Narrower Interpretation: The patent’s background and summary repeatedly frame the carboxylic acid’s purpose as controlling levodopa absorption to yield steadier plasma concentrations, which may support a narrower construction requiring the acid to perform this specific function, not just be passively present (’474 Patent, col. 2:50-56).

VI. Other Allegations

Indirect Infringement

  • The complaint alleges that Sandoz will induce infringement by providing promotional materials and package inserts that instruct physicians and patients to use the ANDA product in a manner that directly infringes the asserted claims (Compl. ¶34, 45). It further alleges contributory infringement on the basis that the Sandoz product is not a staple article of commerce suitable for substantial noninfringing use (Compl. ¶33, 44).

Willful Infringement

  • The complaint does not use the word "willful" but alleges that Sandoz had knowledge of the patents-in-suit prior to the litigation, based on its Paragraph IV certification (Compl. ¶24, 34, 45). Plaintiff requests that the case be found "exceptional" under 35 U.S.C. § 285, which warrants an award of attorney fees, a remedy often associated with findings of willful infringement (Compl. ¶37, 48).

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

  • A core issue will be one of compositional infringement: does the confidential formulation disclosed in the Sandoz ANDA contain the specific components required by the asserted claims, most notably the separate, enterically-coated "carboxylic acid" component that is central to the ’474 patent family? The outcome of this largely factual question, to be determined through discovery, may be dispositive for a significant portion of the case.
  • A second key issue will be one of functional performance: assuming the requisite components are present, does the Sandoz product exhibit the specific dissolution rates and achieve the pharmacokinetic profiles defined in the claims? This will likely evolve into a battle of expert evidence analyzing data from the ANDA and subsequent testing, focusing on whether any differences in release profiles are sufficient to place the accused product outside the scope of the claims.