Last updated: July 29, 2026
Executive summary
ACTELION PHARMACEUTICALS LTD. v. SUN PHARMACEUTICAL INDUSTRIES, INC. (3:17-cv-05015) is a Hatch-Waxman patent infringement dispute in which Actelion alleged Sun’s ANDA would infringe Actelion’s patents tied to pulmonary arterial hypertension (PAH) therapy. The case is filed in the U.S. District Court for the District of New Jersey. The dispositive enforcement posture and outcome depend on the specific patent list asserted under the ANDA Orange Book theory and the case’s litigation history (dismissals, claim construction, summary judgment, trial, or settlement), which are not included in the prompt.
Key litigation metadata that can be stated from the docket identifier provided
- Case caption: Actelion Pharmaceuticals Ltd. v. Sun Pharmaceutical Industries, Inc.
- Court / case no.: 3:17-cv-05015
- Court: U.S. District Court for the District of New Jersey (by standard docketing for “3:17-cv-#####” in this caption set).
- Litigation type: Hatch-Waxman ANDA patent infringement (inferred from Actelion v. generic ANDA filing context and the parties’ typical litigation profile).
- Parties:
- Plaintiff: Actelion Pharmaceuticals Ltd.
- Defendant: Sun Pharmaceutical Industries, Inc. (ANDA filer or parent entity; manufacturer and/or subsidiary entities are often separately named in ANDA disputes, but not confirmable from the prompt alone).
Because the prompt provides only the docket number and caption, a complete litigation summary (asserted patents, procedural milestones, rulings, and final outcome) cannot be produced accurately.
What patents were asserted in Actelion v. Sun (3:17-cv-05015)?
Direct answer (short): Not determinable from the information provided.
How asserted patents usually map to Actelion’s PAH portfolio in ANDA cases
In Actelion-driven ANDA litigation, asserted assets typically fall into one or more of these buckets:
- Drug substance composition of matter patents covering the active pharmaceutical ingredient (API)
- Formulation patents (tablet, capsule, film-coated, dosing regimen)
- Method-of-use patents covering PAH dosing or patient subpopulations
- Manufacturing patents (process claims for API or drug product)
Without the Orange Book list tied to Sun’s ANDA and the complaint’s asserted patent list, the litigation analysis cannot be completed without introducing errors.
What happens procedurally in Hatch-Waxman cases like this?
Direct answer (short): The case typically proceeds through pleadings, claim construction, infringement/invalidity briefing, and possible settlement or court judgment.
Common procedural milestones analysts track
- Complaint filing and service (asserted patents and infringement theories)
- Answer and counterclaims (invalidity, non-infringement, unenforceability)
- Claim construction (Markman)
- Summary judgment on infringement and/or invalidity
- Trial if factual disputes remain
- Permanent injunction and/or damages if infringement is adjudicated
- Carve-outs for FDA approval and “design-around” scenarios if settlement includes non-entry covenants
No milestone dates or rulings are provided in the prompt.
When does exclusivity or patent expiration drive market entry risk for Sun?
Direct answer (short): Not determinable from the information provided.
What timelines matter in ANDA patent litigation
High-value entry dates usually depend on:
- Earliest patent expiration (composition of matter vs. later formulation/method-use)
- Period of pediatric exclusivity (if applicable)
- FDA 30-month stay (triggered by a timely patent infringement suit)
- Settlement effective dates that govern “launch at risk” boundaries
None of these dates are specified in the prompt, and Sun’s ANDA and the asserted patent list are not stated.
Was it a Paragraph IV challenge? What Orange Book listing is implicated?
Direct answer (short): Not determinable from the information provided.
What “Paragraph IV” analysis requires
A complete analysis needs:
- The ANDA submission date
- The Orange Book NDA reference product
- The Orange Book patent numbers asserted
- The Paragraph IV certification basis (to which claims, “invalid” vs “not infringed”)
- Whether the case is later narrowed to certain patents
Without those details, a litigation narrative would be speculative.
How strong was Actelion’s patent estate in this specific case?
Direct answer (short): Not determinable from the information provided.
What you can measure in a defensible patent-strength analysis
A proper estate-strength view ties each asserted patent to:
- Claim construction outcomes
- The court’s view of novelty and obviousness standards
- Intrinsic record support and prosecution history
- Co-pending matters and litigation in the same family
- Final disposition (entered judgment, dismissal, or settlement)
None of those judgments or claim construction holdings are available in the prompt.
What did Sun risk if the court entered infringement?
Direct answer (short): Not determinable from the information provided.
Typical Hatch-Waxman risk buckets
- Injunction barring FDA approval for 180-day exclusivity dynamics
- Design-around required to avoid infringement (if claims are construed broadly)
- Monetary damages if infringement is found and the ANDA is launched during litigation windows
But the magnitude and form depend on the outcome and remedy, which are not supplied.
Did the case settle? What settlement terms usually matter?
Direct answer (short): Not determinable from the information provided.
Terms analysts model in Actelion generics settlements
- Launch date (carve-out date)
- Non-infringement concession or “covenant not to sue” boundaries
- Patent list reduction (dropping certain numbers)
- Design-around commitments (formulation changes)
- Stipulated dismissals after payment and/or agreement
No settlement disposition is stated.
Comparable Actelion v. Sun litigation patterns to use for triangulation
Direct answer (short): Not usable as a substitute for the specific docket’s findings.
Even within the same firm ecosystem, outcomes can swing based on:
- which patent family is asserted
- how the court construes the claims
- whether the case is narrowed before summary judgment
- which stage the parties reached before settlement
Triangulation without docket-specific record data would produce a non-falsifiable narrative.
Detailed timeline and procedural posture (needed for a real litigation summary)
Direct answer (short): Not determinable from the information provided.
A complete timeline should list:
- filing date
- amended complaints
- answer and counterclaims
- Markman schedule and decisions
- summary judgment orders
- trial dates (if any)
- dismissal order date or final judgment date
- entry of final judgment in favor of plaintiff or defendant
- any FDA-related status updates tied to the litigation stay
No dates or orders are included in the prompt.
Litigation impact on FDA ANDA approvals and “launch at risk”
Direct answer (short): Not determinable from the information provided.
What must be known to answer this correctly
- whether the ANDA approval was stayed, delayed, or allowed after a judgment
- whether Sun obtained approval “at risk” after expiration of asserted patents
- whether the parties’ settlement triggered a consent judgment or covenant structure
These are docket- and settlement-specific.
Key takeaways
- The docket identifier (3:17-cv-05015) and caption (Actelion v. Sun) establish that this is a Hatch-Waxman-style patent dispute, but the asserted patent list, procedural history, rulings, and final disposition are not provided.
- Without those record elements, a litigation summary and analysis cannot be completed accurately.
FAQs
- What Orange Book patents were listed for the Actelion NDA referenced in 3:17-cv-05015?
- Did Actelion assert method-of-use, formulation, or composition-of-matter claims in 3:17-cv-05015?
- Did the court grant claim construction rulings that narrowed infringement or invalidity theories?
- Was there a 30-month FDA stay in Actelion v. Sun, and when did it lift?
- Did Sun launch “at risk,” and were there any court orders affecting FDA approval after judgment or settlement?
References
- No sources were provided in the prompt.
