Last updated: June 27, 2026
Novartis Pharmaceuticals Corporation v. Breckenridge Pharmaceutical Inc., No. 1:16-cv-00431, is a U.S. patent and Hatch-Waxman related dispute filed in 2016 that targets Breckenridge’s FDA-related generic entry. The case package is centered on asserted Novartis patent rights tied to a branded Novartis product, with the litigation posture consistent with a Paragraph IV (or related) challenge.
What patents are at issue, which claims/therapeutic product are asserted, and the operative settlement terms cannot be stated from the case caption alone. Without the complaint, court docket filings, or the FDA/Orange Book link that identifies the specific listed drug and patent numbers, an accurate litigation summary cannot be produced.
Litigation Summary: What happened in Novartis v. Breckenridge (1:16-cv-00431)?
Answer (for business use): No specific patent numbers, claims, dismissal/claim construction outcomes, or settlement terms can be derived from the identifier “1:16-cv-00431” plus the party names.
Procedural posture typically relevant in this docket type
Cases with this caption format in the Hatch-Waxman context usually involve:
- Novartis asserting one or more Orange Book-listed patents tied to the reference listed drug.
- Breckenridge filing an Abbreviated New Drug Application with a Paragraph IV certification, triggering filing of a patent infringement suit within statutory deadlines.
- Motions practice that can include dismissals, transfer, claim construction, summary judgment, and trial setting, followed by a negotiated settlement (often before merits resolution).
Key litigation facts that must be matched to this specific docket
A complete litigation summary requires:
- The patent list asserted (numbers, expiration dates, assignees).
- The listed drug (NDA reference) tied to the Orange Book entries.
- The counts asserted (induced infringement, contributory infringement, direct infringement).
- The district court outcomes (claim construction rulings, summary judgment, permanent injunctions).
- The final resolution (stipulation of dismissal, consent judgment, or settlement agreement).
None of these can be stated accurately from the docket number alone.
What patents protect Novartis’s drug in this case?
Answer: Not determinable from the case caption.
What “at-issue patents” usually include in Novartis generics disputes
For Novartis-branded products commonly litigated in this posture, asserted patents may cover:
- Composition-of-matter (active ingredient / salt / polymorph)
- Formulation patents (tablet/capsule composition, film coating, release profile)
- Method-of-use patents (dose regimen, indication, biomarker-defined use)
- Manufacturing/processing patents (granulation, crystallization, particle size, stability)
But the specific patent family in 1:16-cv-00431 cannot be identified without the actual complaint and Orange Book patent list for the involved NDA.
When does exclusivity or patent protection expire for the product in 1:16-cv-00431?
Answer: Not determinable without the specific reference listed drug, NDA, and asserted patent numbers.
Inputs needed for expiration timelines
A proper exclusivity-and-expiration timeline depends on:
- NDA approval date (for statutory exclusivities)
- Orange Book “drug substance” and “drug product” patent expiration
- Any patent term adjustments (PTA) and patent term extensions (PTE)
- Any pediatric exclusivity extensions
Those inputs cannot be mapped to the docket number without the underlying product identity.
What generic entry risks existed for Breckenridge if the court ruled for Novartis?
Answer: The generic entry risk exists in this litigation type, but the magnitude and timing depend on the specific patents asserted and the resolution date.
Scenario mapping (decision-grade, not speculative)
A real risk matrix would quantify:
- Earliest possible generic launch date under the FDA approval pathway
- Carve-outs for noninfringed patents
- Design-around workability (formulation or method changes)
- Injunction coverage if the court grants one
This requires docket outcomes and the patent list.
How does FDA Orange Book status affect Paragraph IV litigation in this case?
Answer: Not determinable from the docket identifier alone.
Orange Book elements used in litigation analysis
A business-grade analysis links:
- Listed drug (reference product)
- Patent numbers and listed expiration dates
- Certification type (Paragraph IV vs. others)
- Triggering event for suit timing
Without the Orange Book record for the involved NDA, no factual mapping is possible.
What litigation outcomes matter for investors and licensing strategy?
Answer: Material outcomes include claim construction findings, any injunction, settlement payment/side letter terms, and final dismissal date, but these cannot be specified without court records.
What an outcome summary must include
For each materially dispositive event, the analysis needs:
- Date of filing of motions and hearing
- Court holdings (allowed/denied)
- Scope of injunction (if any) and carve-outs
- Final settlement date and any permitted launch date
Settlement and regulatory timeline: when could Breckenridge launch?
Answer: Not determinable without the final disposition docket entry or settlement agreement summary.
Why the launch date cannot be inferred
Launch permissions in these disputes are contract- and patent-specific:
- Some settlements permit launch at a defined date regardless of patent expiry
- Some allow launch only after specific patents expire
- Some allow a “design-around” product before expiration
- Some delay launch contingent on ongoing appeals
Without the operative agreement terms or final order, any launch date would be guesswork.
Key Takeaways
- The docket identifier “1:16-cv-00431” and the party names are insufficient to produce an accurate, litigation-grade summary.
- A complete analysis requires the asserted patent numbers, the reference listed drug/NDA, and the docket disposition (claim construction, dispositive motions, and final judgment/settlement).
- No patent expiration, injunction scope, or generic launch timing can be stated reliably without the underlying complaint and final resolution filings.
FAQs
- What is the “1:16-cv-00431” case about in Hatch-Waxman terms?
- Which Orange Book patents were asserted by Novartis against Breckenridge in this docket?
- Did the court resolve infringement or only procedural issues in Novartis v. Breckenridge?
- Does the final disposition indicate a settlement, dismissal, or consent judgment?
- What is the earliest generic launch date permitted under the settlement for this case?
References
(Unable to compile a numbered APA reference list because specific court filings, patent numbers, and Orange Book records for No. 1:16-cv-00431 are not provided in the prompt.)
