DCT

2:18-cv-09347

Impax Laboratories Inc v. Actavis Laboratories FL Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-09347, D.N.J., 05/17/2018
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because both defendant entities maintain a principal place of business in the state and intend to market and sell the accused products within New Jersey.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) for generic versions of Plaintiff's RYTARY® capsules constitutes an act of infringement of a patent covering controlled-release formulations of levodopa/carbidopa.
  • Technical Context: The technology concerns oral drug delivery formulations for Parkinson's disease, a market where maintaining stable plasma concentrations of active ingredients is critical for managing motor symptoms and reducing patient "off-time."
  • Key Procedural History: This action was filed under the Hatch-Waxman Act, triggered by Defendants' Paragraph IV certification asserting that the patent-in-suit is invalid or will not be infringed. The complaint also references prior, consolidated litigation between the same parties in the same district, indicating an existing history of patent disputes.

Case Timeline

Date Event
2007-12-28 U.S. Patent No. 9,901,640 Priority Date
2018-02-27 U.S. Patent No. 9,901,640 Issues
2018-04-16 Plaintiff receives Defendants' Paragraph IV Certification Letter (approx.)
2018-05-17 Complaint Filed

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

U.S. Patent No. 9,901,640 - "Controlled Release Formulations of Levodopa and Uses Thereof"

(Compl. ¶20)

The Invention Explained

Problem Addressed: The patent’s background section describes the clinical challenges with existing oral levodopa (LD) treatments for Parkinson's disease, specifically the fluctuating plasma concentrations that lead to debilitating motor skill variations known as the "on-off" phenomenon and "wearing off" between doses. (’640 Patent, col. 2:6-18).

The Patented Solution: The invention is an oral, controlled-release pharmaceutical formulation that combines levodopa, a decarboxylase inhibitor (like carbidopa), and a carboxylic acid. This three-part composition is designed to achieve steadier, more consistent plasma levels of levodopa over a prolonged period, aiming to mimic the therapeutic stability of continuous infusion therapy but in a more convenient oral dosage form. (’640 Patent, col. 2:55-68).

Technical Importance: The formulation represents an attempt to solve the central problem of oral levodopa therapy by creating a pharmacokinetic profile with a faster onset and a flatter, more sustained therapeutic window, thereby reducing debilitating motor fluctuations for patients. (’640 Patent, col. 2:45-55).

Key Claims at a Glance

The complaint asserts infringement of "at least one claim" without specifying which ones. (Compl. ¶27). The first independent claim, Claim 1, is representative of the core invention.

The essential elements of independent Claim 1 are:

  • An oral modified release dosage form comprising carbidopa, levodopa, a carboxylic acid, and a modified release excipient that provides for the modified release of all three components.
  • The carboxylic acid and levodopa are present in a molar ratio of greater than 1:4 and less than 4:1.
  • Administration of the dosage form every six hours produces a peak-to-trough levodopa plasma level of about 1 to about 3.

The complaint does not specify any dependent claims but implicitly reserves the right to assert them.

III. The Accused Instrumentality

Product Identification

Defendants' proposed generic carbidopa/levodopa extended-release capsules, which are the subject of Abbreviated New Drug Application (ANDA) No. 208522 (the "Actavis ANDA Product"). (Compl. ¶24).

Functionality and Market Context

The accused product is a generic version of Plaintiff’s RYTARY® drug, intended for oral administration in several dosage strengths (e.g., 23.75 mg/95 mg, 61.25 mg/245 mg). (Compl. ¶24).

The complaint alleges that the Actavis ANDA relies on the safety and efficacy data of the brand-name RYTARY® New Drug Application (NDA) and contains data purporting to demonstrate the bioequivalence of the accused product to RYTARY®. (Compl. ¶25). This allegation of bioequivalence is central to the infringement claim, as it suggests the accused generic product will exhibit the same patented pharmacokinetic behavior as the brand-name drug.

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not contain a claim chart. The infringement theory, typical in ANDA litigation, is based on the allegation that the proposed generic product is bioequivalent to the patented RYTARY® product and therefore will necessarily meet the limitations of the claims covering RYTARY®.

'640 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An oral modified release dosage form comprising carbidopa, levodopa, a carboxylic acid, and a modified release excipient... The Actavis ANDA Product is an extended-release capsule containing carbidopa and levodopa. Infringement of the "carboxylic acid" and "modified release excipient" elements is implicitly alleged by seeking to market a bioequivalent version of RYTARY®, which is based on the patented formulation. ¶24, ¶25, ¶27 col. 42:1-4
...the carboxylic acid and levodopa are present in the dosage form in a carboxylic acid to levodopa molar ratio of greater than 1:4 and less than 4:1... The complaint does not allege a specific molar ratio but relies on the ANDA submission itself as the act of infringement, which presumes the formulation must be sufficiently similar to RYTARY® to achieve bioequivalence. ¶25, ¶27 col. 42:5-8
...following administration of the dosage form every six hours produces a peak-to-trough levodopa plasma level of about 1 to about 3. The complaint alleges that the Actavis ANDA contains data demonstrating the bioequivalence of its product to RYTARY®, which is asserted to produce this specific pharmacokinetic profile. ¶25 col. 42:8-11

Identified Points of Contention

Scope Questions: The infringement analysis will likely turn on the construction of the pharmacokinetic (PK) limitation "peak-to-trough levodopa plasma level of about 1 to about 3." A key question for the court will be how to interpret the word "about" and whether the PK data for the Actavis product, as presented in its confidential ANDA, falls within the claimed range.

Technical Questions: A central evidentiary question will be whether the Actavis product’s formulation—specifically its excipients and the molar ratio of its components—meets the compositional limitations of the claims. The allegation of bioequivalence creates a strong inference of infringement, but the ultimate proof will require a technical comparison of the generic product’s composition and in vivo performance against the claim language.

V. Key Claim Terms for Construction

The Term: "peak-to-trough levodopa plasma level of about 1 to about 3"

Context and Importance: This functional, results-based limitation is at the heart of the invention and the dispute. Practitioners may focus on this term because infringement will be determined by whether the confidential bioequivalence data from the Actavis ANDA demonstrates a PK profile that meets this definition. The scope of "about" will be critical.

Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent specification contrasts the invention with prior art formulations having more significant plasma fluctuations, suggesting the term is meant to capture any formulation providing a meaningfully "flatter" profile than what was previously available. (See '640 Patent, col. 2:32-44).
  • Evidence for a Narrower Interpretation: The patent provides specific examples and simulation data, such as a calculated peak-to-trough ratio of 1.7 for the invention compared to 3.4 for Sinemet® CR. (’640 Patent, Table 16). A defendant may argue this data suggests the inventors had a more precise numerical range in mind, limiting the scope of "about."

The Term: "carboxylic acid"

Context and Importance: The inclusion of a carboxylic acid is a required compositional element and is described as key to the invention's performance. The identity and function of any acidic components in the Actavis product will be a point of factual dispute.

Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The specification provides a non-exhaustive list of suitable acids, including tartaric, adipic, succinic, and citric acids, implying the term is not limited to a single chemical entity but rather to a functional class of compounds. (’640 Patent, col. 6:18-22).
  • Evidence for a Narrower Interpretation: The patent’s examples heavily feature tartaric acid. (’640 Patent, Example 1). A defendant might argue that the term should be limited to acids that function in the specific manner described to enhance bioavailability, not merely any compound that is chemically a carboxylic acid.

VI. Other Allegations

Indirect Infringement: The complaint alleges that Actavis will induce infringement by marketing its product with package inserts that will inevitably instruct physicians and patients to use the drug in an infringing manner. (Compl. ¶33, ¶34). It also alleges contributory infringement on the basis that the accused product is not a staple article of commerce and is especially adapted for infringing uses. (Compl. ¶31, ¶32).

Willful Infringement: The complaint does not use the term "willful" but does allege that this is an "exceptional case" under 35 U.S.C. § 285, warranting an award of attorney fees. (Compl. ¶36). The basis for this allegation appears to be that Actavis knew of the '640 patent, as evidenced by its filing of a Paragraph IV certification against it. (Compl. ¶26, ¶33).

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

  • A core issue will be one of bioequivalence and claim scope: Does the confidential pharmacokinetic data in the Actavis ANDA demonstrate a "peak-to-trough levodopa plasma level of about 1 to about 3"? The outcome will depend on the court's construction of "about" and its application of that construction to the scientific data.
  • A key evidentiary question will be one of compositional identity: Does the precise formulation of the Actavis ANDA Product, once revealed in discovery, contain a "carboxylic acid" and "modified release excipient" that fall within the scope of the asserted claims, or can Actavis establish a meaningful difference in its formulation to support a non-infringement defense?