Last updated: July 29, 2026
Orexo AB v. Actavis Elizabeth LLC (D. N.J.) | 1:15-cv-00996: Litigation Summary, Patent Issues, and Infringement Posture
Orexo AB sued Actavis Elizabeth LLC under Hatch-Waxman litigation framework in U.S. District Court for the District of New Jersey (case 1:15-cv-00996) in 2015, placing at issue one or more Orange Book-listed patents tied to Orexo’s branded product(s) and evaluating whether Actavis’s proposed generic product would infringe and/or be covered by statutory exclusivity and patent validity defenses.
However, no docket-level record, asserted patent list, claim charts, or decision documents are provided in the input. Under the operating constraint, producing a complete and accurate litigation summary without the underlying case filings would risk material errors.
What patents were asserted by Orexo AB against Actavis in 1:15-cv-00996?
No asserted-patent numbers, Orange Book listings, or claim-level allegations are included in the provided information. Without the complaint or docket entries identifying each asserted patent, the asserted estate cannot be stated.
Which Orexo patents were listed in the Orange Book for the Orange Book drug at issue
No Orange Book identifier (NDA/BLA), drug name, dosage form, or patent list is included.
Were method-of-use, formulation, or formulation-manufacturing patents asserted
No independent claim type (composition, method, formulation manufacturing, or use) is provided.
What is the procedural history of Orexo AB v. Actavis Elizabeth LLC (1:15-cv-00996)?
No docket timeline is provided (e.g., complaint filing date, answer, motions to dismiss, Markman scheduling, preliminary injunction, summary judgment, trial, or final judgment).
Was there an automatic stay under 35 U.S.C. § 271(e)(2) / § 355(j)
No FDA filing date, paragraph IV notice date, or court stay order is provided.
Were there Markman hearings or claim construction outcomes
No claim construction orders are included.
Was there a preliminary injunction or TRO
No injunctive order is included.
How did Actavis respond: validity and non-infringement positions in the pleadings
No answer or amended pleadings are provided, so the defenses (invalidity grounds, non-infringement theory, carve-outs, design-around, prosecution-history estoppel) cannot be enumerated.
Did Actavis challenge written description, enablement, indefiniteness, or anticipation/obviousness
No invalidity contentions are provided.
Did Actavis argue non-infringement via formulation, release profile, or manufacturing changes
No product design details or infringement comparisons are provided.
What did the court rule: motions, claim construction, summary judgment, and final outcome
No court decisions are included, so the litigation posture (dismissal, settlement, consent judgment, or merits ruling) cannot be stated.
Were any patents found invalid or not infringed
No merits findings are provided.
Was the case dismissed with prejudice or without prejudice
No dismissal terms are provided.
Were there any appellate outcomes
No appellate docket information is included.
Did the parties settle, and what was the settlement structure
No settlement agreement terms, entry-forcing dates, confidentiality or non-reliance clauses, or stipulated injunction terms are provided.
Was there a paid licensing or “reverse payment” style settlement
No settlement payment or license terms are included.
Were there agreed design-around constraints
No constraints on formulation or dosing are provided.
What is the FDA regulatory posture tied to the case (ANDA pathway, Orange Book status)
No NDA/ANDA identifiers or regulatory milestones are provided.
What ANDA applicant(s) were involved
No ANDA number or applicant entity list is included.
When did the FDA accept the ANDA and when did it qualify for approval
No FDA review timelines are included.
What is the Orange Book status for the asserted patents
No Orange Book patent list or status (expired, listed, expired-by-terms) is included.
What generic entry risks existed for Actavis (launch timing vs. patent exclusivity)
No patent expiration dates, pediatric exclusivity, patent-term adjustment, or exclusivity end dates are provided.
When does Orexo exclusivity end under the relevant patent estate
No exclusivity and patent expiration schedule is included.
Which patents blocked generic launch at the time
No block list is provided.
How strong is Orexo’s patent estate in this dispute compared with typical Orexo litigation
No patent numbers or claim scopes are provided, so relative strength cannot be quantified.
Are Orexo’s asserted patents generally formulation and controlled-release IP
No asserted claims are provided to categorize.
How do these claims compare to prior Orexo vs. generic challenges
No prior-case mapping is provided.
Who else was litigating Orexo patents around 2015, and how does this case fit
No co-litigant or consolidated litigation information is included.
Were there parallel Hatch-Waxman cases against other generics
No parallel-case identifiers are provided.
Were there related PTAB or ITC proceedings
No cross-forum filings are provided.
Key Takeaways
- This case is identified as Orexo AB v. Actavis Elizabeth LLC, D.N.J. No. 1:15-cv-00996.
- A litigation summary cannot be completed to a business-usable standard from the provided input because no docket record, asserted patent list, FDA/Orange Book context, procedural milestones, or court orders are present.
- Actionable infringement, validity, and timing analysis require asserted patent numbers and decision documents, which are not provided in the prompt.
FAQs
- What patents were asserted in Orexo AB v. Actavis Elizabeth LLC (1:15-cv-00996)?
- What was the case timeline for 1:15-cv-00996 from complaint to disposition?
- Did the court grant or deny any preliminary injunction in this matter?
- Did Actavis file a paragraph IV certification and trigger an automatic stay?
- What settlement terms or licensing commitments were agreed, and did they delay generic launch?
References
- No citations available from the provided input.
