DCT

1:17-cv-00394

iCeutica Pty Ltd v. Lupin Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00394, D. Md., 02/10/2017
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Maryland because Defendant Lupin Pharmaceuticals, Inc. has a principal place of business in Baltimore, and both defendants conduct regular business in the state, have previously submitted to the court's jurisdiction in other matters, and purposefully directed infringing activities at the district by seeking to market a generic drug there.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for generic meloxicam capsules constitutes an act of infringement of a patent covering specific low-dose, fast-dissolving formulations of the drug.
  • Technical Context: The technology relates to pharmaceutical formulations of nonsteroidal anti-inflammatory drugs (NSAIDs), specifically using nanoparticle technology to improve the dissolution rate and pharmacokinetic profile of meloxicam for pain management.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiffs' receipt of a Paragraph IV Notice Letter from Lupin. The letter advised that Lupin had filed an ANDA seeking to market a generic version of Plaintiffs' VIVLODEX® product prior to the expiration of the asserted patent. The ’734 patent is listed in the FDA's "Orange Book" as covering VIVLODEX®.

Case Timeline

Date Event
2014-06-09 '734 Patent Priority Date
2016-12-27 '734 Patent Issue Date
2016-12-27 Lupin's Paragraph IV Letter Dated
2017-01-04 Plaintiffs Receive Lupin's Paragraph IV Letter
2017-02-10 Complaint Filing Date

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

  • Patent Identification: U.S. Patent No. 9,526,734, "Formulation of Meloxicam," issued December 27, 2016 (Compl. ¶27; ’734 Patent, p. 1).

  • The Invention Explained:

    • Problem Addressed: The patent’s background section notes that the NSAID meloxicam is "practically insoluble in water," which can lead to slow dissolution and oral absorption from the gastrointestinal tract (’734 Patent, col. 1:51-63). It further notes the general desirability of using the "lowest effective dose for the shortest possible duration" for NSAIDs to mitigate serious side effects (’734 Patent, col. 1:44-49).
    • The Patented Solution: The invention is a pharmaceutical formulation of meloxicam with a reduced particle size, described as having a median particle size on a volume basis between 100 nm and 5000 nm (’734 Patent, col. 4:30-40). This nanoparticulate form increases the drug's surface area, which is intended to increase its rate of dissolution. This faster dissolution is claimed to result in desirable pharmacokinetic properties (e.g., rapid absorption and specific blood plasma concentrations) that allow for effective pain relief at lower doses (5 mg or 10 mg) than conventional products (’734 Patent, Abstract; col. 4:54-65).
    • Technical Importance: This formulation technology aims to provide a faster-acting, lower-dose version of a known pain relief drug, which could potentially offer a better safety profile compared to higher-dose alternatives (’734 Patent, col. 1:44-49).

  • Key Claims at a Glance:
    The complaint alleges infringement of "one or more of the claims in the '734 patent" without specifying which claims will be asserted (Compl. ¶68). The two independent claims, Claims 1 and 5, cover the 5 mg and 10 mg dosages, respectively.

    • Independent Claim 1:

      • A capsule form of a pharmaceutical composition comprising 5 mg of meloxicam;
      • Having a median particle size between 100 nm and 500 nm and a D(0.9) between 1200 nm and 3000 nm;
      • Providing a specific mean plasma AUC (7500-20000 h*ng/ml) and Cmax (350-950 ng/ml) in healthy, fasted adults;
      • Having a dissolution rate where at least 80% dissolves in 10 minutes or less under specified test conditions;
      • Wherein a single capsule is effective for treating osteoarthritis pain.

    • Independent Claim 5:

      • A capsule comprising 10 mg of meloxicam;
      • Having a median particle size between 100 nm and 500 nm and a D(0.9) between 1200 nm and 3000 nm;
      • Providing a specific mean plasma AUC (16000-44000 h*ng/ml) and Cmax (700-1900 ng/ml) in healthy, fasted adults;
      • Having a dissolution rate where at least 80% dissolves in 15 minutes or less under specified test conditions;
      • Wherein a single capsule is effective for treating osteoarthritis pain.

III. The Accused Instrumentality

  • Product Identification: The accused instrumentalities are "Lupin's proposed generic Meloxicam capsules 5 mg and 10 mg," for which Lupin has filed Abbreviated New Drug Application (ANDA) No. 209-487 with the FDA (Compl. ¶35).
  • Functionality and Market Context: The accused products are generic versions of Plaintiffs' VIVLODEX® brand meloxicam capsules, which are approved for managing osteoarthritis pain (Compl. ¶1, ¶35). The complaint alleges that Lupin seeks to manufacture, use, and sell these generic products in the United States before the '734 patent expires (Compl. ¶35, ¶40). The infringement allegation is based on the act of filing the ANDA itself, as Plaintiffs state they have been unable to obtain and test samples of the proposed generic product (Compl. ¶44-45). The central premise of the infringement allegation is that to gain FDA approval, Lupin's generic product must be bioequivalent to VIVLODEX®, which Plaintiffs allege is covered by the '734 patent (Compl. ¶33, ¶45).
    No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or provide a detailed, element-by-element comparison of the accused product to the patent claims. The infringement allegations are made on information and belief, based on Lupin’s submission of an ANDA for a generic version of Plaintiffs' patented VIVLODEX® product (Compl. ¶44). The theory of infringement under 35 U.S.C. § 271(e)(2) is that the act of filing the ANDA for a drug claimed in a patent is an act of infringement (Compl. ¶47). The complaint presupposes that because Lupin's product must be bioequivalent to VIVLODEX® to be approved as a generic, it will necessarily meet the limitations of the '734 patent claims that cover VIVLODEX® (Compl. ¶33, ¶45).

  • Identified Points of Contention:
    • Technical Question: The primary factual question is whether Lupin's proposed generic product, as described in its confidential ANDA, actually has the specific particle size distributions, pharmacokinetic profiles (AUC and Cmax), and dissolution rates recited in the asserted claims. The complaint acknowledges that this information is not yet available to Plaintiffs and must be obtained through discovery (Compl. ¶43).
    • Scope Questions: The dispute will likely focus on whether Lupin's formulation falls within the precise numerical boundaries of the claims. For example, a key question will be whether testing of Lupin's 5 mg product shows that "at least 80% of the meloxicam dissolves in 10 minutes or less" as required by Claim 1, or if it falls outside this specific performance window.

V. Key Claim Terms for Construction

  • The Term: "median particle size, on a volume basis" (’734 Patent, col. 25:34-35)

  • Context and Importance: This term is fundamental to the invention, as the claimed therapeutic benefits derive from the reduction of meloxicam's particle size to the nano-scale. Infringement will directly depend on whether the accused product's particle size, when measured, falls within the claimed range of "between 100 nm and 500 nm." Practitioners may focus on this term because the specific methodology used to measure particle size can yield different results, making the definition of the measurement protocol a potentially dispositive issue.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claims do not specify a particular measurement technique, which may support an interpretation that any scientifically accepted method for determining volume-based median particle size is acceptable. The specification describes laser diffraction as a possible technique but does not explicitly limit the invention to it (’734 Patent, col. 13:9-10).
    • Evidence for a Narrower Interpretation: A party could argue that the term should be interpreted in light of the specific examples in the patent, which utilize a "Malvern Mastersizer 2000" instrument (’734 Patent, col. 19:46-48). This could support an argument that the term’s scope is limited to results obtained using that specific methodology.

  • The Term: "effective for treating osteoarthritis pain" (’734 Patent, col. 25:48-49)

  • Context and Importance: This functional language links the physical characteristics of the capsule to a required therapeutic outcome. Its construction is important as it sets the standard of proof for the claimed utility. Practitioners may focus on this term to raise questions of indefiniteness under 35 U.S.C. § 112, arguing that "effective" is a subjective term lacking objective boundaries.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: A party may argue that "effective" should be given its plain and ordinary meaning: that the drug provides a discernible, statistically significant relief from osteoarthritis pain. This is supported by the extensive clinical trial data presented in the patent's Example 4, which demonstrates such an effect using standard industry metrics like the WOMAC pain subscale (’734 Patent, col. 21-24).
    • Evidence for a Narrower Interpretation: A party could argue that "effective" is tied to the specific clinical results disclosed in the specification. For example, one could argue it requires achieving the specific "statistically significant treatment benefit" shown in the Phase 3 trial described, potentially limiting the claim to a specific magnitude of pain reduction (’734 Patent, col. 21:54-58).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges future inducement of infringement under 35 U.S.C. § 271(b). The factual basis alleged is that upon FDA approval, Lupin will package its generic product with "a label and/or instructions for use that instruct patients to use the capsule claimed in the '734 patent," and that a patient's use according to those instructions would constitute direct infringement (Compl. ¶67-68).
  • Willful Infringement: Willfulness is alleged based on Lupin's awareness of the '734 patent "no later than when it was issued...and/or listed in the Orange Book" (Compl. ¶69). The complaint alleges that by proceeding with its ANDA in the face of this knowledge, Lupin "either actually knew of the potential for infringement...or was willfully blind" to it (Compl. ¶70).

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

  • A central evidentiary question will be one of characterization: will discovery of Lupin's confidential ANDA and subsequent testing of its proposed generic product reveal a formulation that in fact possesses the specific particle size, dissolution, and pharmacokinetic properties recited in the '734 patent's claims?
  • A key legal issue will be one of boundary definition: how will the court construe the claim limitations that are defined by precise numerical ranges (e.g., a median particle size "between 100 nm and 500 nm" or a dissolution rate of "10 minutes or less"), and will the measured characteristics of Lupin's product fall definitively inside or outside those construed boundaries?