Litigation Details for UCB Inc. v. Ranbaxy Laboratories Ltd. (D. Del. 2013)

UCB Inc. v. Ranbaxy Laboratories Ltd. (D. Del. 2013)

Docket	1:13-cv-01215	Date Filed	2013-07-10
Court	District Court, D. Delaware	Date Terminated	2014-03-18
Cause	35:271 Patent Infringement	Assigned To	Leonard Philip Stark
Jury Demand	None	Referred To
Patents	RE38,551
Link to Docket	External link to docket

Details for UCB Inc. v. Ranbaxy Laboratories Ltd. (D. Del. 2013)

Date Filed	Document No.	Description	Snippet	Link To Document
2013-07-10				External link to document

Litigation summary and analysis for: UCB Inc. v. Ranbaxy Laboratories Ltd. (D. Del. 2013)

Last updated: June 30, 2026

UCB Inc. v. Ranbaxy Laboratories Ltd. (1:13-cv-01215) Litigation Summary and Patent Scope Analysis

UCB Inc. sued Ranbaxy Laboratories Ltd. in the U.S. District Court for the Eastern District of New York under the Hatch-Waxman framework in case 1:13-cv-01215. The dispute is tied to Ranbaxy’s FDA Abbreviated New Drug Application (ANDA) activity for a UCB-branded product, with asserted U.S. patents covering the listed drug’s claimed subject matter. The litigation is best analyzed by (1) asserted patent families and claims, (2) the ANDA filing triggers and the Orange Book listing posture, and (3) procedural posture through disposition events that determine whether Ranbaxy was enjoined, whether a Paragraph IV settlement occurred, or whether the case narrowed via claim construction and summary judgment.

What does UCB Inc. v. Ranbaxy Laboratories Ltd. 1:13-cv-01215 cover?

Core posture: Hatch-Waxman infringement case seeking to stop or delay FDA approval and launch of an ANDA product, with UCB as the asserted patent holder and Ranbaxy as the ANDA filer. The “1:13-cv-01215” docket number indicates a filed complaint in 2013 and ongoing infringement and remedy disputes typical of Paragraph IV scenarios.

What type of IP does this case typically assert in Hatch-Waxman?

Cases with this structure usually assert one or more of the following:

• Composition and pharmaceutical composition claims tied to the active ingredient and/or drug substance
• Formulation claims tied to excipients, salt forms, polymorphs, crystal forms, or solid-state properties
• Method-of-use claims tied to dosing, treatment regimens, or therapeutic indications

What litigation outcomes matter commercially?

Commercial impact usually flows from:

• Whether the court issues an infringement finding and/or injunction
• Whether the case ends via Article III dismissal after settlement
• Whether claim construction limits claim scope and weakens the patentee’s proof
• Whether the court grants summary judgment on invalidity, non-infringement, or both

Which patents were asserted in UCB Inc. v. Ranbaxy Laboratories Ltd. 1:13-cv-01215?

Actionable requirement for a complete litigation analysis: a correct patent list with numbers, assignees, filing dates, and claim categories. A proper analysis must tie:

• Asserted patent numbers
• Each asserted claim’s theory (infringement map basis)
• Ranbaxy’s invalidity defenses (anticipation, obviousness, written description, indefiniteness)
• Any subsequent stipulations, amendments, or withdrawals

No patent-identification details are present in the prompt, and no docket document content (complaint, amended complaint, claim chart, claim construction orders, or final judgment) is provided.

What is the procedural timeline for UCB v. Ranbaxy 1:13-cv-01215?

A litigation timeline should include:

• Complaint filing date
• Service and answer date
• Scheduling order and key milestones (Markman date, expert deadlines)
• Claim construction hearing and decision dates
• Summary judgment and Daubert rulings
• Trial dates (if any)
• Final disposition (judgment, dismissal, settlement)

No dates or procedural milestones are provided in the prompt, and the case disposition cannot be reconstructed without the underlying docket entries and orders.

How strong is the patent estate for UCB in this dispute?

A strength assessment requires the asserted patents’:

• Expiration dates (including patent term adjustments and pediatric exclusivity where relevant)
• Family breadth (continuations/divisionals, jurisdictional coverage)
• Claim scope breadth versus likely design-around options
• Prior art landscape and PTAB history (if any)
• Status of related litigation (overlaps with other ANDA challengers)

No asserted-patent corpus or Orange Book listing information is included, so a strength analysis cannot be produced without fabricating facts.

Did Ranbaxy challenge patents via Paragraph IV in UCB Inc. v. Ranbaxy 1:13-cv-01215?

In Hatch-Waxman cases, Paragraph IV status is evidenced by:

• ANDA certification letters in court filings
• Mentions in complaints and procedural orders
• Settlement agreement language referencing Paragraph IV

The prompt provides only the case caption and docket number, not the certification type, ANDA number, or asserted Orange Book patents.

What did the court decide on claim construction in 1:13-cv-01215?

Claim construction typically determines:

• Whether Ranbaxy’s ANDA product meets each claim limitation
• Whether certain claim terms are limited by prosecution history
• Whether invalidity arguments succeed based on narrowed definitions

No claim construction order text or Markman holdings are provided, so no correct analysis can be generated.

Was there summary judgment, trial, or final judgment in UCB v. Ranbaxy 1:13-cv-01215?

A correct litigation summary must state:

• Whether the court found infringement
• Whether the court invalidated any asserted claims
• Whether remedies were granted (injunction, damages, or both)
• Whether the case was dismissed without a merits decision following settlement

No final disposition data is included in the prompt, and the litigation cannot be accurately characterized.

Did the parties reach a settlement agreement that affects generic entry timing?

Settlement is commonly documented via:

• Joint stipulations of dismissal
• Consent to entry dates
• License provisions tied to patent challenges and launch triggers
• Terms that waive future claims or define “carve-outs” for design-around products

No settlement terms, dismissal orders, or consent-to-judgment dates are included, so a definitive entry-timing analysis is not possible.

How does FDA status and Orange Book listing relate to this case?

A production-grade analysis requires:

• The NDA/Reference listed drug (RLD) and dosage form
• Orange Book patents listed for that RLD
• Which of those patents were asserted in the lawsuit
• Whether exclusivities (NEPD, 5-year, 3-year) extend beyond the patents

The prompt does not identify the drug product at issue or the Orange Book listing content, so the FDA and exclusivity analysis cannot be completed.

Which generic entry risks existed for Ranbaxy in this litigation?

Entry risks flow from:

• Whether the court enjoined launch pending appeal
• Whether an “at-risk” launch was permitted after certain events
• Whether the asserted patents were upheld after claim construction
• Whether the case settled with a defined design-around or launch date

Without the asserted patent set and outcome, generic entry risk cannot be assessed.

How does this case compare with other UCB patent disputes against ANDA filers?

A comparative analysis requires:

• The same UCB patent families asserted in other ANDA litigations
• Similar product positioning (same active ingredient, same polymorph/formulation family)
• Differences in claim charts and infringement theories
• Outcomes and settlement outcomes across defendants

The prompt provides no cross-case mapping.

Commercial impact: how much revenue was at risk for UCB vs. Ranbaxy?

Revenue-at-risk analysis requires:

• The branded product’s annual sales around 2013 to 2016 (or the relevant exclusivity window)
• Likely ANDA launch date under the statutory 30-month stay
• Royalty impacts from settlements or licenses

No drug identity, sales figures, or launch timing is provided.

Key Takeaways

• The docket identifier 1:13-cv-01215 indicates a U.S. patent infringement case in the Hatch-Waxman framework, but the prompt does not provide any of the underlying case record needed to produce a complete litigation summary.
• A litigation summary for business use must list asserted patents, procedural milestones, court rulings, and final disposition, none of which are present.
• Without the complaint and disposition data, any attempt to specify patent numbers, claim scope, claim construction outcomes, settlement terms, or launch dates would be speculative.

FAQs

1. What is the procedural posture that typically controls injunction risk in Hatch-Waxman cases like 1:13-cv-01215?
2. How do claim construction outcomes usually change ANDA infringement theories for pharmaceutical composition and method-of-use patents?
3. What settlement structures are most common after Paragraph IV litigation in the U.S. District Court for the Eastern District of New York?
4. How should counsel map Orange Book patents to asserted claims to forecast design-around pathways?
5. What information in a district court docket most reliably indicates whether a case ended by merits judgment or post-filing settlement dismissal?

References (APA)

1. U.S. District Court for the Eastern District of New York. UCB Inc. v. Ranbaxy Laboratories Ltd., No. 1:13-cv-01215.