DCT

2:25-cv-13193

Novartis Pharma Corp v. Taro Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-13193, D.N.J., 07/11/2025
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant Taro Pharmaceutical Industries Ltd. is a foreign entity sueable in any district, and Defendant Taro Pharmaceuticals USA, Inc. has an established place of business in New Jersey and has agreed not to challenge venue for actions concerning its Abbreviated New Drug Application (ANDA).
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an ANDA to the FDA seeking approval to market generic versions of Plaintiff's Promacta® product constitutes an act of infringement of five patents related to specific pharmaceutical formulations of the active ingredient eltrombopag olamine.
  • Technical Context: The technology concerns pharmaceutical formulations for eltrombopag olamine, a compound used to treat thrombocytopenia (a condition characterized by a low blood platelet count), requiring specific compositions to ensure stability and bioavailability.
  • Key Procedural History: This lawsuit was initiated under the Hatch-Waxman Act following Defendant’s notification to Plaintiff of its ANDA filing, which included a Paragraph IV certification asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed. U.S. Patent No. 8,828,430 was previously the subject of a closed proceeding in the District of Delaware against an unrelated party.

Case Timeline

Date Event
2007-05-03 Earliest Priority Date for ’993, ’994, ’665, ’129 Patents
2007-08-01 Earliest Priority Date for ’430 Patent
2011-11-08 U.S. Patent No. 8,052,993 Issued
2011-11-08 U.S. Patent No. 8,052,994 Issued
2011-11-22 U.S. Patent No. 8,062,665 Issued
2011-12-06 U.S. Patent No. 8,071,129 Issued
2014-09-09 U.S. Patent No. 8,828,430 Issued
2025-05-27 Taro Notice Letter Sent to Novartis
2025-07-11 Complaint Filed

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

U.S. Patent No. 8,052,993 - "3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihyrdo-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)"

The Invention Explained

  • Problem Addressed: The patent’s background section describes technical challenges in formulating the active ingredient, eltrombopag olamine, into a stable and effective solid oral dosage form. These challenges include the compound's tendency to form insoluble metal complexes with common excipients (inactive ingredients), its slow dissolution from tablets, and its propensity to undergo a degradation reaction (a Maillard reaction) when mixed with excipients containing reducing sugars (’993 Patent, col. 2:40-52).
  • The Patented Solution: The invention addresses these problems by claiming a specific pharmaceutical tablet composition. The solution involves formulating eltrombopag olamine with a defined particle size range and combining it with particular classes of excipients that are "substantially free of coordinating metals" and "substantially free of reducing sugars" (’993 Patent, col. 3:1-14). This specific combination of particle size and excipient selection is described as providing a desirable pharmacokinetic profile and improved chemical stability, particularly when manufactured on a commercial scale (’993 Patent, col. 2:53-60).
  • Technical Importance: This formulation approach was designed to overcome stability and bioavailability issues that could otherwise hinder the development of a commercially viable oral tablet for a poorly soluble active pharmaceutical ingredient.

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶¶40, 43-45).
  • Claim 1 of the ’993 Patent requires:
    • A pharmaceutical tablet consisting essentially of:
    • (a) about 31.9 mg of the compound eltrombopag olamine;
    • wherein, (b) about 90% of the compound particles have a particle size of greater than 10 micron but less than 90 micron;
    • (c) the tablet is produced on a scale suitable to prepare at least about 50,000 tablets;
    • (d) the tablet contains from about 25% to about 89% by weight of one or more excipients from a specific group (microcrystalline cellulose, powdered cellulose, etc.);
    • (e) the tablet is film coated;
    • (f) the tablet contains a disintegrant in an amount from 4% to about 12% by weight;
    • and optionally contains a binder (g) and a lubricant (h) within specified amounts.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 8,052,994 - "3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)"

The Invention Explained

  • Problem Addressed: The ’994 Patent shares a common specification with the ’993 Patent and addresses the same formulation challenges of chemical stability, metal complex formation, and dissolution for eltrombopag olamine (’994 Patent, col. 2:40-52).
  • The Patented Solution: The patented solution is a pharmaceutical tablet with specific compositional and physical characteristics, including defined particle size ranges and the use of excipients that avoid chemical interactions with the active ingredient, to ensure consistent performance and bioavailability (’994 Patent, col. 3:1-14). The primary distinction from the ’993 Patent is the claimed dosage amount.
  • Technical Importance: As with the ’993 patent, this formulation technology enables the creation of a stable, commercially manufacturable oral tablet for eltrombopag olamine at a different dosage strength.

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶¶53, 56-58).
  • Claim 1 of the ’994 Patent requires:
    • A pharmaceutical tablet consisting essentially of:
    • (a) about 63.8 mg of the compound eltrombopag olamine;
    • The remaining limitations (b) through (h) are identical to those in claim 1 of the ’993 Patent, including requirements for particle size, production scale, specific excipients, film coating, disintegrant amount, and optional binder and lubricant amounts.
  • The complaint does not explicitly reserve the right to assert dependent claims.

Multi-Patent Capsule: U.S. Patent No. 8,062,665

  • Patent Identification: U.S. Patent No. 8,062,665, issued November 22, 2011, with a title identical to the ’993 and ’994 patents.
  • Technology Synopsis: This patent, part of the same family, addresses the same formulation challenges for eltrombopag olamine. It claims a specific tablet composition designed to ensure stability and proper dissolution by controlling particle size and the selection of excipients to avoid undesirable chemical reactions.
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶66).
  • Accused Features: The patent is alleged to be infringed by Defendant's proposed generic eltrombopag olamine tablets, which are alleged to contain the claimed active ingredient, excipients, and particle characteristics (Compl. ¶69). Claim 1 specifically recites "about 95.7 mg" of the compound (Compl. ¶66).

Multi-Patent Capsule: U.S. Patent No. 8,071,129

  • Patent Identification: U.S. Patent No. 8,071,129, issued December 6, 2011, with a title identical to the ’993 and ’994 patents.
  • Technology Synopsis: This patent also addresses the formulation challenges for eltrombopag olamine. It claims a tablet composition with specific attributes, including particle size and excipient limitations, intended to create a stable and bioavailable oral dosage form.
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶79).
  • Accused Features: The complaint alleges that Defendant's proposed generic tablets, by containing eltrombopag olamine and certain excipients and having specific physical properties, infringe the claims (Compl. ¶82). Claim 1 specifically recites "about 15.95 mg" of the compound (Compl. ¶79).

Multi-Patent Capsule: U.S. Patent No. 8,828,430

  • Patent Identification: U.S. Patent No. 8,828,430, issued September 9, 2014, with a title identical to the ’993 and ’994 patents.
  • Technology Synopsis: This patent likewise addresses the known formulation challenges for eltrombopag olamine. It claims a tablet composition defined by specific excipients, particle size parameters, and a minimum disintegrant amount to ensure product stability and performance.
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶92).
  • Accused Features: The complaint alleges infringement by Defendant's proposed generic tablets based on their alleged composition of eltrombopag olamine, excipients, coating, and particle properties (Compl. ¶95). Unlike the other asserted patents, claim 1 of the ’430 patent does not recite a specific milligram amount of the active ingredient, but does require a disintegrant amount "equal to or greater than 4% by weight" (Compl. ¶92).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are the proposed generic eltrombopag olamine tablets for which Defendants seek FDA approval in ANDA No. 220280 (Compl. ¶1). The ANDA covers multiple dosage strengths, including equivalents of 12.5 mg, 25 mg, 50 mg, and 75 mg (Compl. ¶1).

Functionality and Market Context

The accused products are generic versions of Novartis's PROMACTA®, which is indicated for the treatment of thrombocytopenia in certain patient populations (Compl. ¶¶1, 34). The complaint alleges that upon approval, these generic tablets will be commercially manufactured, marketed, and sold in the United States as therapeutic equivalents to PROMACTA® (Compl. ¶¶1, 22). The infringement action is based on the filing of the ANDA itself, which constitutes a statutory act of infringement enabling the patent holder to resolve infringement issues prior to the generic product's market launch (Compl. ¶10).

IV. Analysis of Infringement Allegations

8,052,993 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical tablet consisting essentially of: (a) about 31.9 mg of the compound... The complaint alleges on information and belief that the accused tablets contain eltrombopag olamine. ¶43 col. 16:21-26
wherein, (b) about 90% of the compound particles have a particle size of greater than 10 micron but less than 90 micron; The accused tablets are alleged to contain compound particles according to the size limitation of claim 1. ¶43 col. 8:7-12
(c) the tablet is produced on a scale suitable to prepare at least about 50,000 tablets; The complaint does not specifically allege this element but asserts infringement of claim 1 as a whole, which contains this limitation. ¶43 col. 6:31-35
(d) the tablet contains from about 25% to about 89% by weight of one or more excipients selected from the group consisting of microcrystalline cellulose... The accused tablets are alleged to contain excipients according to claim 1. ¶43 col. 8:28-30
(e) the tablet is film coated; The accused tablets are alleged to contain coating materials as recited in claim 1. ¶43 col. 8:61-66
(f) the tablet contains a disintegrant in an amount from 4% to about 12% by weight; The accused tablets are alleged to contain a disintegrant in the claimed amount. ¶43 col. 8:36-39

8,052,994 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical tablet consisting essentially of: (a) about 63.8 mg of the compound... The complaint alleges on information and belief that the accused tablets contain eltrombopag olamine. ¶56 col. 16:1-6
wherein, (b) about 90% of the compound particles have a particle size of greater than 10 micron but less than 90 micron; The accused tablets are alleged to contain compound particles according to the size limitation of claim 1. ¶56 col. 8:7-12
(c) the tablet is produced on a scale suitable to prepare at least about 50,000 tablets; The complaint asserts infringement of claim 1, which includes this element, without providing specific facts for this limitation. ¶56 col. 6:31-35
(d) the tablet contains from about 25% to about 89% by weight of one or more excipients selected from the group consisting of microcrystalline cellulose... The accused tablets are alleged to contain excipients according to claim 1. ¶56 col. 8:28-30
(e) the tablet is film coated; The accused tablets are alleged to contain coating materials as recited in claim 1. ¶56 col. 8:61-66
(f) the tablet contains a disintegrant in an amount from 4% to about 12% by weight; The accused tablets are alleged to contain a disintegrant in the claimed amount. ¶56 col. 8:36-39

Identified Points of Contention

  • Scope Questions: The preamble phrase "consisting essentially of" suggests a central question will be whether any unlisted excipients in the accused product materially alter the basic and novel properties of the claimed formulation, which the patents identify as stability and consistent dissolution (’993 Patent, col. 6:15-26). Furthermore, the interpretation of "about" will be critical for determining literal infringement of the numerical limitations for dosage, particle size, and excipient percentages.
  • Technical Questions: The infringement allegations are made "upon information and belief," which is typical for an ANDA complaint filed before discovery. A key technical question will be what evidence discovery reveals about the actual composition of Defendant's tablets. Specifically, what is the actual particle size distribution of the eltrombopag olamine in the accused product, and do its excipients, core, and coating materials fall within the claimed limitations?
  • Process Limitation in a Product Claim: The limitation "the tablet is produced on a scale suitable to prepare at least about 50,000 tablets" (element c) may be a point of contention. Defendant may argue this is an improper process limitation that does not define the final product and is therefore irrelevant to an infringement analysis of the tablet itself. Plaintiff may counter that this limitation is integral to the claimed product's properties, such as uniformity, which are only achieved at a commercial scale as described in the specification (’993 Patent, col. 6:31-35).

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

"consisting essentially of"

  • Context and Importance: This transitional phrase is critical for defining the scope of the claims. Its construction determines whether the presence of unlisted ingredients or excipients in Defendant's product would avoid infringement. Practitioners may focus on this term because the patents' primary contribution is the selective use of excipients to avoid specific negative reactions.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A broader interpretation would permit additional, unrecited ingredients so long as they do not materially affect the "basic and novel properties" of the invention. The specification's repeated emphasis on avoiding "coordinating metals" and "reducing sugars" may suggest that the "basic and novel properties" are primarily related to avoiding the formation of insoluble complexes and Maillard reactions (’993 Patent, col. 2:40-52).
    • Evidence for a Narrower Interpretation: A narrower view might argue that any additional excipient that affects the tablet's dissolution profile or stability, even if not a coordinating metal or reducing sugar, would fall outside the claim scope. The detailed list of suitable excipients in the claims and specification could be argued to implicitly exclude others (’993 Patent, col. 16:34-42).

"about"

  • Context and Importance: The term "about" modifies all key quantitative limitations in the asserted claims, including the active ingredient amount (e.g., "about 31.9 mg"), particle size ("about 90%"), and excipient/disintegrant percentages. The scope of "about" will be dispositive for literal infringement if the accused product's specifications are close to, but not exactly matching, the recited values.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Parties seeking a broader range may argue that "about" should account for standard manufacturing tolerances and measurement variability in the pharmaceutical industry.
    • Evidence for a Narrower Interpretation: The specification includes tables with precise formulations for different dosage strengths (e.g., Table 1, listing 31.9 mg, 63.8 mg, etc.) (’993 Patent, col. 13-14). A party arguing for a narrow interpretation may point to these exact values in the examples as evidence that the inventors intended "about" to cover only very minor deviations.

VI. Other Allegations

  • Indirect Infringement: The prayer for relief seeks a declaratory judgment that the commercial manufacture and sale of the ANDA Product will induce and/or contributorily infringe the Asserted Patents (Compl. ¶105). However, the individual counts for infringement in the complaint body focus on the statutory act of infringement under 35 U.S.C. § 271(e)(2)(A), which is the submission of the ANDA itself (e.g., Compl. ¶45).
  • Willful Infringement: The complaint alleges that Defendants had "actual knowledge" of each of the asserted patents prior to submitting their ANDA to the FDA (Compl. ¶¶46, 59, 72, 85, 98). This allegation of pre-suit knowledge forms the basis for a potential claim of willful infringement, and the prayer for relief requests a declaration that the case is "exceptional" under 35 U.S.C. § 285 (Compl. ¶107).

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

  • A core issue will be one of evidentiary proof: once discovery on the ANDA is complete, will the precise technical specifications of the accused generic product—specifically its active ingredient particle size distribution and the exact nature and quantity of its excipients—fall within the numerical and compositional boundaries defined by the asserted claims?
  • A central legal question will be one of claim scope: how broadly will the court construe the term "about" in the context of pharmaceutical formulations, and what unrecited ingredients, if any, are permissible under the "consisting essentially of" preamble without materially altering the invention's properties of stability and dissolution?
  • A further legal question concerns a potential defense strategy: will the limitation requiring production "on a scale suitable to prepare at least about 50,000 tablets" be construed as an enforceable structural limitation of the claimed tablet, or will it be deemed an improper and unenforceable process limitation?