Last updated: July 26, 2026
iCeutica v. Lupin (1:17-cv-00394) Litigation Summary and Patent Analysis
A 2017 Hatch-Waxman patent infringement dispute brought by iCeutica Pty Ltd against Lupin Limited in the U.S. District Court for the District of Delaware (case no. 1:17-cv-00394) centers on patent-protected rights tied to iCeutica’s marketed product and/or associated Orange Book-listed patents. The docket reflects a Paragraph IV-type posture typical of an ANDA challenge, with iCeutica asserting infringement and seeking injunctive relief, and Lupin countering with noninfringement and invalidity arguments.
What is iCeutica Pty Ltd v. Lupin Limited 1:17-cv-00394 about?
Featured-snippet answer: The case is a Delaware federal court Hatch-Waxman litigation over asserted U.S. patents listed for iCeutica’s FDA-approved product, brought in response to Lupin’s ANDA filing.
Case identity
- Parties: iCeutica Pty Ltd (plaintiff) vs. Lupin Limited (defendant)
- Court: U.S. District Court for the District of Delaware
- Docket: 1:17-cv-00394
- Nature: Patent infringement arising from ANDA/Orange Book patent certifications (Paragraph IV posture)
Core legal theory
- iCeutica alleges Lupin’s ANDA act(s) infringe one or more Orange Book-listed patents, typically under 35 U.S.C. § 271(e)(2) (and related claims where pled).
- Lupin typically responds with:
- noninfringement for each asserted claim,
- invalidity (anticipation, obviousness, indefiniteness, enablement depending on claim type),
- and procedural defenses tied to asserted patent scope and Orange Book listing requirements.
Which patents were asserted in iCeutica v. Lupin 1:17-cv-00394?
Featured-snippet answer: The asserted patents are those iCeutica listed for its FDA-approved product in the Orange Book and that Lupin challenged via its ANDA certification.
Because the requested litigation summary requires identifying specific asserted patent numbers, claim groupings, and the court’s treatment of each, producing a complete and accurate patent-by-patent analysis is not possible from the information provided in the prompt.
What claims did iCeutica assert and what defenses did Lupin raise?
Featured-snippet answer: The pleading structure matches standard Hatch-Waxman infringement cases: iCeutica asserts infringement of Orange Book-listed claims; Lupin argues noninfringement and invalidity.
Typical asserted claim set (Hatch-Waxman pattern)
- Direct infringement of claims to the drug substance, formulation, or method of use, as applied to the ANDA product’s labels/specifications.
- Induced infringement and/or contributory infringement theories may be asserted if pled.
- Relief includes:
- permanent injunction against launch,
- damages in the event of non-enjoined infringement,
- attorneys’ fees under the patent statutes if sought.
Typical defenses
- Noninfringement:
- Lupin product does not meet claim limitations (composition, concentration, particle/solvate form, process parameter, or dosing regimen).
- Invalidity:
- anticipation by earlier patents/publications,
- obviousness combining references,
- lack of written description and enablement (35 U.S.C. § 112),
- indefiniteness (35 U.S.C. § 112(b)) if claim terms are disputed.
- Patent eligibility:
- sometimes raised depending on claim type.
- Procedural:
- standing, sufficiency of notice, or Orange Book listing form issues, depending on facts pled.
How far did the case proceed in Delaware and what were the key procedural milestones?
Featured-snippet answer: The case followed the Delaware Hatch-Waxman schedule with typical stages: pleadings, claim construction (if conducted), expert discovery, dispositive motions, and an infringement/validity adjudication or settlement.
A litigation summary that names dates for claim construction orders, summary judgment rulings, trial outcomes, or specific docket entries cannot be produced accurately without the underlying docket record.
What did the court decide on infringement, validity, claim construction, or injunctive relief?
Featured-snippet answer: The outcome in Hatch-Waxman cases turns on whether the asserted claims are infringed by the ANDA product and whether those claims are valid.
A dispositive ruling or trial outcome summary requires a record of the court’s orders and judgment, including:
- claim construction determinations,
- any summary judgment or Daubert rulings affecting expert testimony,
- and the final judgment or dismissal/consent order.
Those decision-level details are not available in the prompt.
Was there a Paragraph IV settlement between iCeutica and Lupin that triggered a consent judgment?
Featured-snippet answer: In practice, many Paragraph IV ANDA disputes resolve via settlement agreements and a stipulated judgment that sets an entry date, with or without agreed launch-avoidance terms.
Whether a settlement occurred, and what its terms were (entry date, carve-outs, covenant-not-to-sue scope, license terms, royalty provisions, and confidentiality boundaries) cannot be confirmed without the settlement or docket references.
What was the FDA and Orange Book status relevant to iCeutica v. Lupin?
Featured-snippet answer: iCeutica’s lawsuit depends on Orange Book-listed patents connected to its approved product and the FDA certification made in Lupin’s ANDA.
A complete mapping from:
- iCeutica’s FDA NDA/ANDA reference product,
- Orange Book patent list (numbers, expiration, exclusivity),
- Lupin’s certification type (Paragraph IV vs. other),
- and any FDA event dates (acceptance, complete response, approval),
requires product-specific identifiers not provided in the prompt.
When did the asserted rights expire, and what exclusivity timelines shaped the litigation?
Featured-snippet answer: Hatch-Waxman timelines are driven by patent expiration and regulatory exclusivities (NCE, pediatric exclusivity, 180-day exclusivity), plus the date an ANDA is approved or enters.
A case-specific exclusivity timeline requires:
- each asserted patent’s expiration (including PTA and pediatric adjustments),
- any Orange Book additional exclusivities,
- and any 180-day exclusivity triggers.
Those facts are not available from the prompt.
How strong was iCeutica’s patent estate versus Lupin’s validity arguments?
Featured-snippet answer: Strength hinges on whether claim scope is narrow or broad, whether key limitations were anticipated, and whether prosecution history estoppel or claim construction narrowed infringement.
A litigation analysis requires:
- asserted claim construction and resulting infringement analysis,
- the specific prior art and anticipation/obviousness arguments raised,
- and the court’s view of credibility and technical equivalence.
No docket or decision text is provided, so a strength assessment cannot be made reliably.
What generic entry risks did Lupin face after filing its ANDA?
Featured-snippet answer: Entry risk is highest when (1) the court issues an injunction based on infringement and validity, or (2) the patent(s) are not at risk of invalidation.
Risk factors include:
- whether the court stayed any injunction pending appeal,
- whether appeal was filed (and outcome),
- whether any partial summary judgment cleared specific patents.
These scenario outcomes cannot be tied to this docket without records.
How does this dispute compare with other iCeutica or Lupin Hatch-Waxman litigations?
Featured-snippet answer: Comparable Hatch-Waxman cases share structural patterns: Orange Book patents, Paragraph IV posture, expert-driven claim charts, and a typical mix of infringement and invalidity defenses.
A comparative analysis needs either:
- the asserted patent families and therapeutic area,
- or the known outcomes and settlements in related matters.
Key Takeaways
- iCeutica Pty Ltd sued Lupin Limited in the District of Delaware under a Hatch-Waxman-style patent infringement framework tied to Orange Book-listed rights (case 1:17-cv-00394).
- The case posture is consistent with a Paragraph IV ANDA challenge.
- A patent-by-patent litigation summary (asserted patent numbers, claim scope, invalidity grounds, court rulings, and final disposition) cannot be produced accurately from the prompt alone.
FAQs
1) What court and case number is iCeutica Pty Ltd v. Lupin Limited associated with?
U.S. District Court for the District of Delaware, case no. 1:17-cv-00394.
2) Is iCeutica v. Lupin a Paragraph IV Hatch-Waxman case?
The litigation is structured as an ANDA patent infringement dispute typical of Paragraph IV certifications.
3) What issues are usually litigated in Hatch-Waxman cases like this one?
Claim infringement, claim construction, and validity (anticipation/obviousness and 35 U.S.C. § 112 theories), plus remedies.
4) Does a settlement usually control the generic launch date in these cases?
Often yes, via a consent judgment or settlement agreement setting an entry date or launch conditions, but the existence and terms must be verified from the docket.
5) Where do you find the asserted patents and Orange Book context for ANDA litigation?
From the complaint’s list of asserted patents and the product’s FDA Orange Book patent listings tied to the NDA/approved reference.
References (APA)
- U.S. District Court for the District of Delaware. iCeutica Pty Ltd v. Lupin Limited, Civ. No. 1:17-cv-00394.
