Last updated: July 28, 2026
ecutive summary: The 2010-era Hatch-Waxman patent dispute in Eli Lilly and Co. v. Teva Parenteral Medicines, Inc. (D.N.J., case no. 1:10-cv-01376) centers on Teva’s attempt to market a Lilly-branded drug product covered by a Lilly patent estate listed in the Orange Book. The litigation record for this docket supports a standard Paragraph IV framework: Lilly asserts patent infringement, Teva challenges validity and/or non-infringement, and the case outcome typically drives FDA launch timing for the generic or authorized follow-on product. However, no docket-specific claim, asserted patent numbers, rulings, or settlement terms are provided in the input, so a complete, citation-grade litigation summary and analysis cannot be produced.
Eli Lilly v. Teva Parenteral Medicines Inc. 1:10-cv-01376: Litigation Summary and Patent Analysis
What patents were asserted in Eli Lilly and Company v. Teva Parenteral Medicines, Inc. (1:10-cv-01376)?
No asserted-patent identifiers (publication numbers or U.S. patent numbers), claim numbers, or the Orange Book listing(s) tied to the dispute are included in the provided information. Without the specific asserted patent numbers and the asserted claims, the infringement/validity analysis cannot be constructed at the level required for patent and litigation decision-making.
Which Lilly patent estate entries were challenged under Paragraph IV?
No Orange Book listings, Orange Book drug reference product, listed patents, or Teva certification dates are provided for this docket.
What legal theories did Lilly plead (infringement, inducement, willfulness, contributory infringement)?
No complaint-level detail is available in the input.
What was Teva’s Paragraph IV position in 1:10-cv-01376?
No Paragraph IV certification text or Teva non-infringement/invalidity theories (anticipation, obviousness, lack of enablement, indefiniteness, prosecution history estoppel, inequitable conduct) are provided.
Did Teva argue invalidity under 35 U.S.C. §§ 102/103/112, or non-infringement by design-around?
No claim construction results, claim charts, or Markman order outcomes are included in the input.
What happened procedurally in Eli Lilly v. Teva Parenteral Medicines, Inc. (1:10-cv-01376)?
No procedural milestones (complaint filing date within the docket, answer, counterclaims, Markman, summary judgment, trial, PTO reexamination/inter partes review, stay/withdrawal) are provided.
Were any claim construction rulings issued that shaped infringement analysis?
No Markman or claim construction order details are included.
Were there summary judgment motions, JMOL, or dispositive rulings?
No docket disposition entries are included.
Was the case stayed due to related PTAB proceedings or settlement negotiations?
No related administrative or settlement event data is included.
What is the litigation outcome for 1:10-cv-01376 (judgment, dismissal, settlement, consent judgment)?
No final judgment, consent decree, dismissal-with-prejudice terms, or settlement agreement dates/terms are provided.
Did Lilly win on infringement, or did Teva prevail on invalidity/non-infringement?
Outcome is not available from the provided input.
Was there a licensing or coexistence arrangement affecting FDA launch timing?
No license or settlement detail is provided.
When did exclusivity or patent expiration move the generic launch timeline in 1:10-cv-01376?
No exclusivity basis (statutory exclusivity, pediatric exclusivity, 180-day exclusivity, restoration) or patent expiration dates for the asserted patents are included.
Which exclusivity framework applied (180-day exclusivity, 30-month stay, pediatric exclusivity)?
No certification or exclusivity facts are provided.
What was the earliest permissible FDA launch date after the litigation?
Not provided.
How does the 1:10-cv-01376 litigation compare with other Lilly-Teva patent disputes?
No comparative set of other dockets, asserted patents, or outcomes is included in the input.
Are there consistent themes in Lilly’s enforcement against Teva across different products?
No cross-docket pattern data is provided.
Which FDA product was implicated and what is its Orange Book status?
The provided input does not name the underlying drug, the FDA application number, dosage form, strength, reference listed drug (RLD), or the Orange Book listing(s) relevant to this dispute. Without that, an Orange Book status section cannot be reliably completed.
What was the FDA pathway (ANDA, 505(b)(2)) and what did Teva seek to market?
No FDA pathway or application detail is included.
What is the commercial and competitive impact of 1:10-cv-01376 for Lilly and Teva?
No revenue at risk, expected launch date, market share, or post-litigation entry timing is included.
What generics or biosimilars would have entered next if Lilly’s patents were invalidated?
No entry cascade details are provided.
What were the litigation-driven barriers (design constraints, formulation changes, manufacturing process requirements)?
No technical barriers or design-arounds are included.
Key Takeaways
- A docket number alone is insufficient to produce a litigation-grade summary and analysis. The input provides no asserted patent numbers, no claim scope, no procedural history, and no disposition or settlement terms for Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., D.N.J. 1:10-cv-01376.
- A complete analysis for business use requires complaint and court order facts, including asserted patents, claim construction results, and final judgment/settlement terms. Those facts are not present in the provided information.
FAQs
- What is a Paragraph IV certification and how does it shape Hatch-Waxman litigation like 1:10-cv-01376?
- How do courts conduct claim construction (Markman) in pharmaceutical patent cases and what issues usually drive outcomes?
- What are the most common Lilly patent categories (composition, method-of-use, formulation) seen in Orange Book disputes?
- How does 180-day exclusivity interact with patent litigation outcomes in generic entry timing?
- What settlement terms are typical in ANDA patent cases (license scope, launch dates, payment structures, covenant terms)?
References
- No citable sources were provided in the input.
