DCT
1:25-cv-00644
Novartis Pharma Corp v. Zenara Pharma Pvt Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Novartis Pharmaceuticals Corporation (Delaware) and Novartis AG (Switzerland)
- Defendant: Zenara Pharma Private Limited (India) and Biophore India Pharmaceuticals Private Limited (India)
- Plaintiff’s Counsel: McCarter & English, LLP
- Case Identification: 1:25-cv-00644, D. Del., 05/23/2025
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendants are foreign entities, which may be sued in any judicial district.
- Core Dispute: This is a Hatch-Waxman action in which Plaintiff alleges that Defendants’ Abbreviated New Drug Application (ANDA) for a generic version of the drug PROMACTA® infringes a patent covering a specific pharmaceutical formulation of the active ingredient eltrombopag olamine.
- Technical Context: The technology concerns stable, oral pharmaceutical tablet formulations for eltrombopag olamine, a drug used to treat low platelet counts that is otherwise prone to chemical instability and poor dissolution when mixed with common manufacturing excipients.
- Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Plaintiff’s receipt of a notice letter, dated April 10, 2025, informing it that Defendants had filed an ANDA with a Paragraph IV certification challenging the patent-in-suit. The complaint does not mention any prior litigation or administrative proceedings involving the asserted patent.
Case Timeline
| Date | Event |
|---|---|
| 2007-05-03 | '430 Patent Priority Date |
| 2014-09-09 | '430 Patent Issue Date |
| 2025-04-10 | Zenara Notice Letter Sent to Novartis |
| 2025-05-23 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,828,430 - "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)"
- Patent Identification: U.S. Patent No. 8,828,430, “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),” issued September 9, 2014.
The Invention Explained
- Problem Addressed: The patent’s background section states that the active pharmaceutical ingredient (API), eltrombopag olamine, presents "unique concerns" for formulation on a commercial scale ('430 Patent, col. 2:41-48). Specifically, the API has a tendency to form "insoluble metal complexes" when it contacts excipients containing a "coordinating metal" and to undergo a "Maillard reaction" with excipients containing "reducing sugars," both of which can lead to slow dissolution and chemical instability ('430 Patent, col. 2:48-52).
- The Patented Solution: The invention claims a solid oral tablet formulation that overcomes these challenges. The solution involves a combination of features: controlling the API particle size, using specific excipients (such as mannitol and microcrystalline cellulose) that are substantially free of coordinating metals and reducing sugars, and including a minimum percentage of a disintegrant to promote dissolution ('430 Patent, col. 2:56-62; col. 6:1-12). This combination is described as providing a "desirable pharmacokinetic profile" for a stable, commercially-produced tablet ('430 Patent, col. 2:56-59).
- Technical Importance: The claimed formulation provided a method for creating a stable, effective, and commercially scalable oral tablet for an API that otherwise faced significant bioavailability and manufacturing hurdles ('430 Patent, col. 2:41-48).
Key Claims at a Glance
- The complaint asserts infringement of at least Claim 1 ('430 Patent, Compl. ¶34).
- The essential elements of independent Claim 1 are:
- A pharmaceutical tablet "consisting essentially of" the API eltrombopag olamine.
- Wherein "about 90%" of the API particles have a size between 10 and 90 microns.
- The tablet contains "from about 25% to about 89% by weight" of specific, listed excipients (e.g., microcrystalline cellulose, mannitol).
- The tablet is "film coated."
- The tablet contains a disintegrant in an amount "equal to or greater than 4% by weight."
- The tablet optionally contains a binder and a lubricant up to specified amounts.
- The complaint does not explicitly reserve the right to assert dependent claims, though this is common practice in patent litigation.
III. The Accused Instrumentality
Product Identification
- Defendants' proposed generic eltrombopag olamine tablets in 12.5 mg, 25 mg, 50 mg, and 75 mg dosages, as described in ANDA No. 220033 (the "ANDA Product") (Compl. ¶1, ¶9).
Functionality and Market Context
- The ANDA Product is a generic version of Plaintiff's PROMACTA® tablets and is intended for the same therapeutic uses, including the treatment of thrombocytopenia (Compl. ¶1, ¶28). The complaint alleges that the '430 Patent is listed in the FDA's "Orange Book" in connection with PROMACTA®, signifying that Plaintiff considers the patent to cover the branded drug (Compl. ¶30). The filing of the ANDA is an attempt to enter the market with a generic competitor prior to the expiration of the '430 patent (Compl. ¶1).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
The complaint alleges that the ANDA Product will infringe at least Claim 1 of the '430 patent because it contains "eltrombopag olamine, the core and coating materials, the excipients, and compound particles according to claim 1" (Compl. ¶37).
'430 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical tablet consisting essentially of: (a) 3'-... acid bis-(monoethanolamine); | The ANDA Product is alleged to contain the active ingredient eltrombopag olamine. | ¶37 | col. 1:12-24 |
| wherein, (b) about 90% of the compound particles have a particle size of greater than 10 micron but less than 90 micron; | The ANDA Product is alleged to have compound particles with a particle size distribution as required by the claim. | ¶37 | col. 3:23-26 |
| (c) the tablet contains from about 25% to about 89% by weight of one or more excipients selected from the group consisting of microcrystalline cellulose...and maltodextrin; | The ANDA Product is alleged to contain the same class and amounts of excipients as required by the claim. | ¶37 | col. 6:1-12 |
| (d) the tablet is film coated; | The ANDA Product is alleged to be a film-coated tablet. | ¶37 | col. 7:65-67 |
| (e) the tablet contains a disintegrant in an amount equal to or greater than 4% by weight; | The ANDA Product is alleged to contain a disintegrant in an amount meeting the claim's requirement. | ¶37 | col. 7:24-31 |
| (f) the tablet optionally contains a binder in an amount up to about 8% by weight; and (g) the tablet optionally contains a lubricant in an amount up to about 2% by weight. | The ANDA Product is alleged to contain excipients, which may include optional binders and lubricants, according to the claim. | ¶37 | col. 6:35-50; col. 6:56-7:2 |
Identified Points of Contention
- Scope Questions: The transitional phrase "consisting essentially of" will likely be a key point of dispute. The central question is whether Defendants' ANDA product contains any unrecited ingredients that materially affect the "basic and novel properties" of the claimed invention, which the patent identifies as chemical stability and a specific dissolution profile ('430 Patent, col. 2:41-59).
- Technical Questions: As the complaint provides no specific data from the ANDA, the infringement analysis will depend entirely on evidence produced during discovery. Key factual questions will include: (1) What is the actual particle size distribution of the API in the ANDA Product and does it meet the "about 90%" limitation? (2) What are the precise weight percentages of the excipients and do they fall within the claimed ranges?
V. Key Claim Terms for Construction
The Term: "consisting essentially of"
Context and Importance
This transitional phrase is more limiting than "comprising" but less limiting than "consisting of." Its construction is critical because it determines whether the presence of any unrecited components in Defendants' formulation would allow it to avoid infringement. Practitioners may focus on this term because the patent's core purpose is to avoid specific negative interactions with certain types of excipients.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: A party could argue the phrase only excludes components that would entirely vitiate the tablet's identity or purpose.
- Evidence for a Narrower Interpretation: The specification repeatedly emphasizes that the formulation's success depends on avoiding "coordinating metals" and "reducing sugars" ('430 Patent, col. 2:48-52). This suggests that the "basic and novel characteristics" are improved stability and dissolution, and therefore the presence of any unrecited ingredient that materially degrades these properties (e.g., an excipient with trace metal impurities) would place the product outside the scope of the claim.
The Term: "about"
Context and Importance
This term modifies several quantitative limitations in Claim 1, including particle size ("about 90%") and excipient weight percent ("about 25% to about 89%"). The scope of "about" will determine how much deviation from these numerical values is permissible.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: A party may argue "about" should be read broadly to account for standard manufacturing tolerances and measurement variability inherent in pharmaceutical production.
- Evidence for a Narrower Interpretation: The patent links specific particle size ranges to functional outcomes in dissolution tests ('430 Patent, Fig. 2; col. 16:18-27). This could support an argument that the numerical ranges are not arbitrary and that "about" should be construed more narrowly to preserve the claimed functional advantages.
VI. Other Allegations
Indirect Infringement
- The complaint's prayer for relief seeks a declaratory judgment of future induced and contributory infringement (Compl. ¶47). However, the factual allegations in the body of the complaint focus on infringement under 35 U.S.C. § 271(e)(2) via the ANDA submission and do not plead specific facts to support a separate claim for indirect infringement post-launch.
Willful Infringement
- The complaint alleges that Defendants had "actual knowledge of the '430 patent prior to the submission of ANDA No. 220033" (Compl. ¶40). This allegation of pre-suit knowledge forms the basis for the willfulness claim and the request for enhanced damages and attorney's fees (Compl. ¶48, ¶49).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: how will the court construe "consisting essentially of"? The outcome will depend on whether Defendants' formulation contains unrecited substances and, if so, whether those substances are found to materially alter the stability and dissolution properties that the patent identifies as the invention's "basic and novel characteristics."
- The case will also turn on a question of evidentiary proof: does the ANDA Product, as disclosed to Plaintiff in discovery, actually meet the specific quantitative limitations of Claim 1? The resolution of the dispute may depend less on legal argument and more on a factual comparison of the accused product's specifications against the patent's claimed ranges for particle size and excipient content.