Last updated: July 28, 2026
Actelion Pharmaceuticals Ltd. v. Sun Pharma Industries Inc. (3:17-cv-05015-PGS-DEA): Litigation Summary, Patent Targets, and Case Posture
The case Actelion Pharmaceuticals Ltd. v. Sun Pharmaceutical Industries, Inc. (D.N.J.) No. 3:17-cv-05015-PGS-DEA centers on alleged Hatch-Waxman patent infringement tied to Sun’s generic/biosimilar-related FDA submission (as framed by the complaint). The litigation record available for this matter does not include sufficient docket and claims-level details in the prompt to produce a complete, accurate infringement map (asserted patents, listed Orange Book reference products, infringement theories, claim construction outcomes, or settlement status) without risking errors.
What patents were asserted in Actelion v. Sun (3:17-cv-05015-PGS-DEA)?
A litigation summary requires three hard inputs that are not present in the request: (1) asserted patent numbers, (2) asserted Orange Book listed patents and claims, and (3) the specific Sun product and FDA filing type referenced in the complaint. Without those items, any listing of patent numbers or claim targets would be speculative.
Which patent categories were at issue (composition, method-of-use, formulation)?
No complaint or order excerpts are provided. The asserted patent categories cannot be determined reliably from the case caption alone.
Which Actelion patents protect the relevant product?
No asserted patent identities, application families, or assignee data are included in the request, so “what protects” cannot be answered without guessing.
What did Sun file with FDA, and what Orange Book status triggered the suit?
The case caption identifies the parties and the district, but not the FDA pathway (ANDA vs. 505(b)(2)), whether the submission cited patents with Paragraph IV, or which reference listed drug was implicated. Those details come from the complaint and the FDA submission record, not from the case number alone.
Was the challenge a Paragraph IV notice, and what patents were certified?
No Paragraph IV certification details are included. Patent-by-patent certification is required to summarize infringement scope.
What was the FDA product described in the litigation?
The request provides no product name, dosage form, strength, or NDC.
What is the litigation timeline for 3:17-cv-05015-PGS-DEA?
A full timeline needs docket event dates (complaint filing, service, answers, claim construction orders, motions practice, summary judgment, trial dates, and any stipulations or dismissal orders). Those are not provided here.
Key procedural steps typically analyzed
- Initial complaint and patent list
- Case management and scheduling orders
- Markman/claim construction timeline
- Summary judgment and dispositive motions
- Final disposition (verdict, settlement, consent judgment, or dismissal)
No event dates are present in the prompt, so the timeline cannot be stated accurately.
How did the court rule on claim construction and dispositive motions?
A litigation analysis must reference:
- claim construction rulings
- indefiniteness or non-infringement findings
- validity challenges
- means-plus-function interpretation
- infringement mapping outcomes
No orders or holdings are provided in the prompt. Without those, describing “how the court ruled” would not meet the requirement for accuracy.
What is the status of the case today (pending, settled, dismissed, judgment entered)?
Status cannot be derived from the case caption or number alone. The prompt contains no disposition order, docket termination code, or settlement documentation.
Was there a settlement agreement or consent judgment?
Settlement details require docket termination entries or court orders. None are included.
How does this litigation affect the competitive landscape for Actelion products and Sun’s generic entry risk?
A credible competitive analysis depends on:
- which Actelion drug is the reference product
- which patents remain listed
- whether Sun obtained approval or entered at risk
- whether exclusivity blocks approval beyond patent expiry
- whether there are follow-on formulation or method patents
Those facts are not included in the request.
What generic entry risks exist for Sun based on this case?
Unidentifiable without the asserted patents, their expirations, and any court rulings.
Do other Paragraph IV cases show similar outcomes?
No comparative cases are referenced.
What patent estate strength issues arise from Actelion’s enforcement against Sun?
A patent estate strength analysis requires:
- number of asserted patents and their breadth (independent vs dependent claims)
- remaining life at time of filing
- prosecution history estoppel implications
- whether courts sustained validity/infringement theories
None of those inputs are available in the prompt.
Key Takeaways
- The requested docket (3:17-cv-05015-PGS-DEA) identifies the parties and court, but the prompt does not include the asserted patent list, FDA product details, or docket orders needed for an accurate litigation summary and legal analysis.
- A complete summary requires complaint-to-Orange-Book mapping, claim construction outcomes, and disposition status. Those are not present, so a factually grounded analysis cannot be produced.
FAQs
- How can I determine which patents were asserted in Actelion v. Sun (3:17-cv-05015-PGS-DEA)?
- Did this case involve Paragraph IV certifications, and which Orange Book patents were triggered?
- What claim construction issues typically determine infringement in Hatch-Waxman cases like this?
- How do court outcomes in patent infringement cases affect generic launch at risk?
- What docket entries establish whether a Hatch-Waxman case settled or ended in a judgment?
References
- United States District Court for the District of New Jersey. Case docket: Actelion Pharmaceuticals Ltd. v. Sun Pharmaceutical Industries, Inc., 3:17-cv-05015-PGS-DEA. (Source: court docket).
