Last updated: July 23, 2026
- Court / Case number: U.S. District Court for the District of Delaware; 1:13-cv-01114.
- Parties: Par Pharmaceutical Inc. (plaintiff) v. Breckenridge Pharmaceutical Inc. (defendant).
- Core IP issue: Whether Breckenridge’s proposed generic product infringes Par’s Orange-Book-listed patents for the relevant reference listed drug (RLD).
- Statutory framework: Hatch-Waxman (likely under 35 U.S.C. § 271(e)(2)) consistent with ANDA patent litigation captioning and timing.
H2: What patents did Par assert in Par v. Breckenridge 1:13-cv-01114
A complete infringement-summary requires (i) the asserted patent numbers in the complaint and (ii) the claims asserted and the accused dosage form/strength. Those specifics are not present in the user-provided information, so the asserted-patent set cannot be enumerated accurately here.
H3: How were claims typically framed in Par ANDA litigations in this period?
In Par’s ANDA-focused cases filed in the Delaware forum, complaints generally:
- Identify Orange-Book patents by number and list the specific claims allegedly infringed.
- Identify the ANDA product and the “patent infringement by filing” theory under § 271(e)(2).
- Seek a permanent injunction against commercial manufacture, use, offer for sale, sale, and importation if infringement is found.
H2: What did Breckenridge argue to avoid infringement in 1:13-cv-01114
A claim-by-claim validity/infringement analysis requires the responsive invalidity defenses (e.g., § 102/103 anticipation and obviousness grounds, § 112 definiteness/enablement arguments) and the accused product comparison. Those filings are not provided, so infringement-avoidance arguments cannot be summarized with citation-accurate specificity.
H3: Typical defenses in Par vs. generic ANDA cases
Common defense patterns include:
- Non-infringement by design-around (different formulation parameters, manufacturing conditions, or compositional ranges).
- Invalidity due to prior art or lack of written description/enablement.
- Statutory defenses tied to non-covered indications or expiry of particular patents.
H2: Did Par seek an injunction or damages, and what was the relief requested
Hatch-Waxman complaints usually seek:
- Injunctive relief to bar generic entry during the patent term.
- Damages under § 271(e)(4) if the statutory prerequisites are met and if infringement is established.
- Costs and attorneys’ fees if supported by statute and procedural posture.
A precise recitation of the requested relief in 1:13-cv-01114 requires the complaint’s prayer for relief, which is not included in the prompt.
H2: When did the case start and what was the timeline for motions and rulings
A timeline depends on the docket dates:
- Complaint filing date
- Defendant’s answer date
- Markman schedule (if any)
- Motion to dismiss, summary judgment, and claim construction milestones
- Trial date or dispositive ruling date
- Entry of final judgment and any appeal
Those docket events are not provided, so no authoritative chronology can be produced.
H2: How strong was Par’s patent estate in 1:13-cv-01114
“Strength” requires at least:
- The specific patents asserted
- Prosecution/claim scope characteristics
- Claim construction outcomes
- Validity findings (anticipation/obviousness determinations)
- Whether any asserted patents were held valid or infringed
Because patent numbers and rulings are missing, no strength analysis can be completed without fabricating facts.
H2: What generic entry risks did Breckenridge face based on this litigation
Generic entry risk is determined by:
- Whether Par obtained an injunction
- Whether any asserted patent claims survived dispositive challenges
- Settlement timing and any agreed launch dates
- Whether the case entered a phase that blocks launch until final adjudication
Without a docket outcome, launch risk cannot be mapped to an actionable entry date.
H2: Did the case settle, and what does the resolution imply for exclusivity
Settlement terms drive downstream market entry and carve-out timelines. A reliable settlement-and-effect summary requires:
- Settlement agreement date
- Scope (dismissal with prejudice vs. entry into a covenant)
- Remaining patents (if dismissed as to some but not all)
- Launch permission conditions (date, product scope, volume caps)
No settlement data is provided, so the resolution cannot be analyzed.
H2: What is the Orange Book status of the patents at issue in 1:13-cv-01114
Orange-Book mapping requires:
- The RLD name
- The listed patent numbers
- Expiration dates and whether any patents are tied to pediatric exclusivity or exclusivity extensions
- Current listing status (listed/expired/removed)
The prompt does not include the RLD or patent listing details, so Orange-Book status cannot be stated.
H2: How does this case compare with other Par v. ANDA filers in Delaware
A comparison can only be done if we know:
- Whether the same RLD class and formulation pattern repeats
- Whether the same patent family is repeatedly asserted
- Whether courts construed claims similarly
No patent family or RLD linkage is provided.
Key Takeaways
- The case caption indicates a Hatch-Waxman patent infringement dispute between Par and Breckenridge in the District of Delaware under No. 1:13-cv-01114, consistent with Paragraph IV ANDA litigation dynamics.
- The information required to produce a litigation-grade summary (asserted patent numbers, claim construction outcomes, dispositive rulings, injunction/settlement terms, Orange-Book mapping, and final judgment status) is not included in the prompt, so a data-accurate infringement/validity and outcome analysis cannot be completed here.
FAQs
- What is the typical litigation path in Delaware Paragraph IV cases involving Par and ANDA filers?
- What information in the complaint is needed to identify the asserted Orange-Book patents and claims?
- How do settlements in Par’s ANDA litigation typically affect launch timing and design-around strategy?
- What role does claim construction play in determining infringement risk for generic formulation disputes?
- How does the final judgment or dismissal posture affect whether a generic can commercialize at-risk?
References
- D. Del. Civil Action No. 1:13-cv-01114 (Par Pharmaceutical Inc. v. Breckenridge Pharmaceutical Inc.).
