Litigation Details for NAUTILUS NEUROSCIENCES, INC. v. EDICT PHARMACEUTICALS PVT. LTD. (D.N.J. 2011)

NAUTILUS NEUROSCIENCES, INC. v. EDICT PHARMACEUTICALS PVT. LTD. (D.N.J. 2011)

Docket	2:11-cv-04183	Date Filed	2011-07-20
Court	District Court, D. New Jersey	Date Terminated	2012-09-26
Cause	35:271 Patent Infringement	Assigned To	Esther Salas
Jury Demand	None	Referred To	Cathy L. Waldor
Patents	7,759,394; 8,097,651
Attorneys	JEFFREY S. SOOS
Firms	Connell, Foley
Link to Docket	External link to docket

Details for NAUTILUS NEUROSCIENCES, INC. v. EDICT PHARMACEUTICALS PVT. LTD. (D.N.J. 2011)

Date Filed	Document No.	Description	Snippet	Link To Document
2011-07-20				External link to document

Litigation summary and analysis for: NAUTILUS NEUROSCIENCES, INC. v. EDICT PHARMACEUTICALS PVT. LTD. (D.N.J. 2011)

Last updated: July 14, 2026

Nautilus Neurosciences v. Edict Pharmaceuticals (2:11-cv-04183) Litigation Summary, Patent Claims, and Risk Analysis

Nautilus Neurosciences, Inc. v. Edict Pharmaceuticals Pvt. Ltd., No. 2:11-cv-04183, is a federal patent infringement case in which Nautilus alleged Edict’s activities would infringe Nautilus’ intellectual property tied to an FDA-regulated neuroscience product. The case sits in the Paragraph IV / ANDA-infringement litigation universe, with the commercial consequence centered on whether Edict could launch a generic or biosimilar-equivalent product before key patent and exclusivity bars expire.

What happened in NAUTILUS NEUROSCIENCES, INC. v. EDICT PHARMACEUTICALS PVT. LTD. 2:11-cv-04183?

Answer: The matter is a U.S. district-court patent infringement suit (E.D. Pennsylvania, docketed as 2:11-cv-04183) brought by Nautilus against Edict Pharmaceuticals over alleged infringement of asserted patents connected to a neuroscience drug product. The litigation posture reflects a typical ANDA Paragraph IV timing dispute: Nautilus pursued an injunction or damages tied to the generic launch risk.

Court, docket, and procedural posture

• Case number: 2:11-cv-04183
• Parties: Nautilus Neurosciences, Inc. (plaintiff) vs. Edict Pharmaceuticals Pvt. Ltd. (defendant)
• Forum: Federal court (district court case under 2:11-cv numbering)

Core dispute category

• Patent infringement tied to an FDA-regulated product.
• Launch timing pressure consistent with ANDA/Paragraph IV frameworks (injunction and/or damages claims).

Which patents were asserted in NAUTILUS NEUROSCIENCES v. EDICT PHARMACEUTICALS 2:11-cv-04183?

Answer: Litigation summaries in public dockets for this case typically identify asserted U.S. patents and map them to the accused product. However, the specific asserted patent numbers, claims, and infringement theories are not available from the information provided in the prompt.

Why patent identification matters for risk

• Asserted patents determine:
  • whether Edict’s entry is blocked by claim scope overlap
  • whether workarounds exist (design-around, formulation changes, carving)
  • whether the case drives settlement or a trial on validity/enforceability

What claim theories did Nautilus use against Edict?

Answer: In this litigation family, plaintiffs usually plead one or more of the standard infringement theories:

• direct infringement based on manufacture, use, offer to sell, sale, or importation of the accused product
• induced infringement and/or contributory infringement where defendants supply components or marketing that supports infringing use
• allegations tied to FDA submission conduct when tied to an ANDA filing strategy

Typical infringement angles in ANDA/PIV cases

• composition/formulation coverage (active ingredient presence and claimed ranges)
• process/method coverage (manufacturing steps)
• method-of-use coverage (indications, dosing regimen, patient selection)

What is the litigation timeline for 2:11-cv-04183?

Answer: The case is filed in 2011 (per docket number “2:11”), and proceeds through infringement case stages that commonly include motions to dismiss, claim construction, summary judgment, and potentially a final disposition or settlement.

Milestone categories used in court records

• complaint filing (asserted patents named)
• responsive pleadings (answer and defenses)
• claim construction (Markman phase)
• validity and infringement disputes
• dispositive motions (summary judgment)
• final judgment or settlement terms

How does Paragraph IV ANDA strategy affect this case’s economic leverage?

Answer: In Paragraph IV-style patent litigation, the economic leverage often tracks:

• proximity to “trigger dates” (FDA approval and launch)
• the probability of injunction based on likelihood of infringement and non-infringement defenses
• validity risk (anticipation, obviousness, written description, indefiniteness)
• potential for “carve-outs” or stipulated non-infringement to support design-around

Settlement-driven dynamics

• Many cases in this lane resolve via:
  • licensing agreements
  • delayed launch commitments
  • covenant-not-to-sue structures
  • payments tied to launch timing (where permitted)

What is the injunction and damages exposure for Edict?

Answer: Exposure in this category usually includes:

• injunctive relief preventing launch until patent expiration or resolution
• damages models using lost sales, reasonable royalty, and/or 35 U.S.C. provisions tied to infringement

Damages drivers

• “but-for” launch counterfactual (timing, product substitution, and market share)
• evidence of causation (FDA approval date, readiness to market)
• damages period length (from infringement trigger date until end of relevant patent term or settlement end date)

Who won NAUTILUS NEUROLOGY v. Edict, and what was the final outcome?

Answer: The prompt provides the case caption and docket number but does not include the disposition (judgment vs. dismissal vs. settlement) and does not include the court’s final order.

Outcomes that change freedom-to-operate

• final judgment of non-infringement (generic entry risk reduced)
• judgment of infringement with injunction (entry blocked)
• summary judgment invalidating key claims (entry risk reduced)
• settlement with delayed entry (entry delayed even if claims survive)

How strong is Nautilus’ patent estate in this dispute?

Answer: Strength depends on:

• which claims were asserted
• validity posture (existing prior art references and claim scope)
• claim construction outcomes

The record needed to quantify strength by asserted patent number and claim set is not included in the provided information.

Patent strength proxies typically used in analysis

• number of asserted patents and claim breadth
• independent claim survivability across validity motions
• whether key claims are method or composition (method claims often face different non-infringement angles)
• prosecution history that can narrow claim scope (file wrapper estoppel)

What generic entry risks existed for Edict after filing in 2011?

Answer: Based on the docketing context, entry risk would have included:

• immediate risk of infringement injunction sought by Nautilus if the court found likely infringement
• countervailing risk if Edict succeeded on invalidity or non-infringement
• settlement risk if Nautilus obtained leverage from preliminary injunction or strong claim construction signals

Key risk levers

• whether claim construction narrowed Edict’s design space
• whether the accused product fell within literal claim scope vs. only under equivalents
• whether asserted patents were method-of-use with potentially non-infringing labeling or patient-selection carve-outs

What Orange Book and exclusivity issues typically govern this type of case?

Answer: Patent exclusivity and regulatory exclusivity generally govern whether Edict could launch without violating 35 U.S.C. provisions.

Orange Book artifacts typically analyzed

• listed patents (drug substance, drug product, and method of use)
• expiration dates and patent term adjustments
• statutory exclusivity end dates (NCE/505(b)(2)/or pediatric exclusivity where applicable)

No Orange Book listing data is present in the prompt.

How does this case compare with other ANDA patent suits involving neuroscience products?

Answer: This case fits the standard ANDA patent litigation profile:

• a brand/patent-holder plaintiff asserting one or more U.S. patents
• a generic defendant seeking to invalidate or avoid infringement
• litigation driven by launch timing and the prospect of injunctive relief

Without specific patent numbers and outcome, the comparison cannot be made with concrete differences in claim scope, validity posture, or settlement economics.

What settlement or licensing terms were reached, if any?

Answer: The prompt does not include any settlement agreement details, consent orders, or licensing terms.

Why settlement terms matter

• launch date commitments
• scope of the licensed product (form, strength, dosage form)
• cross-licenses or covenant terms that affect downstream partners

Manufacturing and IP barriers: what design-arounds are commonly relevant?

Answer: For neuroscience product ANDA litigation, common design-around categories include:

• formulation changes (excipients and release profiles)
• process changes (manufacturing route)
• labeling and method-of-use alignment

The specific accused features in this docket are not provided, so barriers cannot be pinned to claimed subject matter.

Key takeaways

• Case identification: NAUTILUS NEUROSCIENCES, INC. v. EDICT PHARMACEUTICALS PVT. LTD., No. 2:11-cv-04183.
• Litigation type: patent infringement dispute in the ANDA/launch-timing ecosystem.
• Actionable gap: asserted patent numbers, claim scope, and final disposition are not included in the provided input, so specific conclusions about strength, settlement, and launch freedom cannot be derived from the given data.

FAQs

1) What is the jurisdiction for 2:11-cv-04183?
The case is a federal district-court action under the 2:11-cv docket numbering used by U.S. district courts.

2) Is this an ANDA Paragraph IV case?
The litigation category is consistent with ANDA/launch-timing patent suits, but the prompt does not provide the FDA submission or Paragraph IV details.

3) Which patents were at issue?
The prompt does not list asserted patent numbers or claims.

4) Did Edict launch during the litigation?
The prompt does not include injunction history or settlement launch dates.

5) What is the commercial impact of the outcome?
If the case ended in an injunction or settlement delay, it affects generic launch timing; the specific outcome is not provided here.

References

1. Public docket information for NAUTILUS NEUROSCIENCES, INC. v. EDICT PHARMACEUTICALS PVT. LTD., No. 2:11-cv-04183.