Litigation Details for Promius Pharma LLC v. Taro Pharmaceuticals, Inc. (S.D.N.Y. 2018)

Promius Pharma LLC v. Taro Pharmaceuticals, Inc. (S.D.N.Y. 2018)

Docket		Date Filed	2018-05-23
Court	District Court, S.D. New York	Date Terminated	2019-02-15
Cause	35:271 Patent Infringement	Assigned To	Alvin K. Hellerstein
Jury Demand	Plaintiff	Referred To
Patents	9,364,485; 9,433,630; 9,439,911; 9,655,907; 9,775,851; 9,877,974
Link to Docket	External link to docket

Details for Promius Pharma LLC v. Taro Pharmaceuticals, Inc. (S.D.N.Y. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-05-23				External link to document

Litigation summary and analysis for: Promius Pharma LLC v. Taro Pharmaceuticals, Inc. (S.D.N.Y. 2018)

Last updated: July 18, 2026

Promius Pharma LLC v. Taro Pharmaceuticals, Inc. (1:18-cv-04576): litigation summary, patent issues, and generic entry risk analysis

Executive summary: The case Promius Pharma LLC v. Taro Pharmaceuticals, Inc. | 1:18-cv-04576 is a US Hatch-Waxman patent infringement action filed in 2018 targeting Taro’s proposed generic of a Promius-marketed product. The core litigation focus in the record is patent infringement tied to FDA approval of a generic version, with disputes centered on Orange Book-listed patents and whether the generic would infringe and/or avoid infringement through claim construction, non-infringement positions, and potential invalidity arguments. For business planning, the principal decision points are: (1) which specific Orange Book patents were asserted; (2) whether Promius asserted formulation, method-of-use, or manufacturing claims; (3) whether the litigation reached claim construction, a final merits judgment, or an early settlement; and (4) the resulting impact on launch timing for Taro and other ANDA filers.

Note: A complete, citation-grade litigation summary requires access to the complaint, infringement chart, claim list, court orders, and docket/settlement entries for docket 1:18-cv-04576. Those record elements are not present in the prompt, so a full “hard data” case brief cannot be produced without fabricating specifics.

What patents were asserted in Promius Pharma LLC v. Taro Pharmaceuticals, Inc. (1:18-cv-04576)?

Answer (data-dependent): The asserted patent set is determined by the Orange Book listings referenced in Promius’s infringement complaint and the ANDA notice(s) served under 35 U.S.C. § 271(e)(2).

Which Orange Book patents typically drive these Promius v. Taro disputes

In this dispute class, Promius commonly pleads one or more patent categories:

• Formulation patents (composition of matter for drug product)
• Method-of-use patents (therapeutic dosing/indication regimens)
• Manufacturing/process patents (process steps, controlled release formation, particle properties)
• Device or delivery system patents (if the product uses a specific delivery or dose form)

How to map the litigation to the asserted claims

A complete analysis requires:

• The asserted claim numbers
• The specific patent numbers
• The infringement theories (literal vs. doctrine of equivalents)
• The generic product label/ANDA data used in infringement allegations

What was Taro’s ANDA / Paragraph IV position in 1:18-cv-04576?

Answer (data-dependent): Taro’s position is set by its ANDA certification (Paragraph IV vs. Paragraph III/II), plus its non-infringement and invalidity arguments in its answer and claim construction briefs.

Common defenses in Hatch-Waxman suits

• Non-infringement (claim elements not met in Taro’s proposed product)
• Indefiniteness or lack of enablement (pleading-based)
• Invalidity on anticipation/obviousness grounds
• Prosecution history estoppel limiting doctrine of equivalents
• Lack of statutory basis if challenged on proper listing/standing/patent scope

Did the case reach claim construction or a final merits judgment?

Answer (data-dependent): Procedural endpoints control exclusivity and downstream generic risk. In Hatch-Waxman litigation, business-relevant milestones include:

• Markman/claim construction orders
• Summary judgment rulings on non-infringement/invalidity
• Final judgment after trial
• Dismissal tied to settlement or covenant not to sue
• Stays pending reexamination or post-grant review outcomes

Why procedural posture changes the commercial picture

• If claim construction narrows key terms, infringement risk can drop quickly for the ANDA filer.
• If patents survive summary judgment, launch risk becomes higher for Taro and other generics using similar formulations.

What settlement terms affected launch timing for Taro and competitors?

Answer (data-dependent): Settlement terms in Hatch-Waxman cases frequently include:

• Agreed launch dates or delayed launch commitments
• Carve-outs tied to patent scope, dosing strengths, or dosage forms
• Payment terms or “reverse payment” structures under antitrust scrutiny
• Covenants not to sue for specific claims or for future regulatory submissions

How to translate settlement into actionable generic entry risk

Business decisions depend on:

• Whether the settlement is global (all asserted patents) or partial
• Whether future FDA filings are covered (e.g., additional strengths or reformulations)
• Whether the settlement includes stipulations affecting exclusivity expiration

When does the asserted patent estate expire, and when could generics launch?

Answer (data-dependent): Expiration timing depends on:

• The filing date, patent term adjustment (PTA), and terminal disclaimer
• Whether patents are subject to extensions (for method-of-use, depend on statutory basis)
• Whether the litigation resulted in earlier launch permission

Exclusivity timing framework

A robust timeline analysis must align:

• Primary regulatory exclusivity (if applicable to the reference product)
• Patent expiration of each asserted Orange Book patent
• Any 180-day exclusivity claims by ANDA filers
• Any court-ordered delays via settlement or injunctions

What Orange Book status applied to the reference product in this case?

Answer (data-dependent): The Orange Book status is the list of patents that made Taro’s ANDA certification actionable. It determines:

• Which patents could support a Paragraph IV suit
• Which patents are subject to “safe harbor” defenses or non-infringement routes

What to pull from the Orange Book for litigation-grade mapping

• Patent numbers
• Patent expiration dates
• Patent exclusivity descriptions (if listed as such)
• Dosage form and strength coverage

How strong was Promius’s patent estate in this litigation?

Answer (data-dependent): Strength is measured by:

• Claim scope as construed by the court
• Whether Promius survived dispositive motions
• Whether defendants proved invalidity by clear and convincing evidence
• Whether reexamination or inter partes review outcomes weakened claims (if pursued)

Litigation signals that increase patent enforceability

• Narrow claim construction favoring Promius’s element mapping
• Dismissal of invalidity theories
• Injunctive relief or damages exposure sustaining liability
• Settlement terms that imply ongoing risk recognition by Taro

How does this case affect other ANDA filers and biosimilar risk?

Answer (data-dependent): In branded generic competition, the key spillover channels are:

• Whether the court construed key claim terms in a way that later filers can copy
• Whether settlement creates a shared launch structure or global clearance
• Whether other ANDA applicants coordinate around the same formulation/method

Biosimilar angle (only if the underlying product is biological)

If the product is biological, the framework shifts to BPCIA rather than Hatch-Waxman. This is case- and product-dependent, so it cannot be asserted without the underlying reference product identity.

What is the competitive impact for Taro and Promius post-2018?

Answer (data-dependent): Competitive impact is driven by:

• Whether Taro launched on time or delayed by injunction/settlement
• Whether Promius preserved market share via exclusivity and enforceable patents
• Whether Taro pivoted to additional strengths, authorized generics, or alternative formulations

Revenue exposure logic

• If Taro delayed launch, Promius’s revenue line would continue under patent protection.
• If Taro prevailed (non-infringement or invalidity), generic pricing pressure could appear sooner.

Key takeaways

• 1:18-cv-04576 is a Hatch-Waxman infringement action that turns on the Orange Book patent list and Taro’s ANDA certification.
• A litigation-grade summary requires the specific asserted patent numbers, asserted claims, claim construction rulings, dispositive motions, final outcomes, and docket/settlement entries.
• Business risk (generic launch timing and design-around strategy) is controlled by: (1) the final enforcement disposition for each asserted patent; and (2) the settlement’s scope for future filings.

FAQs

1. What does a Paragraph IV certification change in Promius v. Taro-style litigation?
2. How do claim construction rulings shift infringement risk for later generic challengers?
3. What settlement provisions matter most for next-strength launches and label changes?
4. How do PTA and terminal disclaimers affect the practical “launch window” more than the calendar year of filing?
5. What court outcomes typically lead to immediate design-around viability for an ANDA filer?

References

1. (No citable sources were provided in the prompt for docket-level facts, filings, or orders in 1:18-cv-04576.)