Last updated: July 17, 2026
Richard v. Shire US, Inc. (1:16-cv-24907): Litigation Summary, Patent/Exclusivity Exposure, and Commercial Impact
Executive summary: No complete, case-specific litigation facts can be produced from the information provided. A litigation summary requires identifiable claim scope (plaintiff, asserted patents, parties to each side, patents-in-suit, Orange Book references, FDA product(s), and court filings such as complaints, answers, Markman, claim construction, summary judgment, trial/settlement, or dismissal orders). The docket identifier “1:16-cv-24907” alone is insufficient to generate an accurate, decision-grade analysis without risking fabrication.
What does Richard v. Shire US, Inc. 1:16-cv-24907 allege?
- A compliant litigation summary must specify:
- the drug(s) and FDA application(s) at issue,
- the Orange Book listed patents asserted,
- whether the case is an Hatch-Waxman 505(b)(2)/505(j) litigation (Paragraph IV),
- the theory (invalidity, noninfringement, unenforceability, §271(e)(2) scope),
- and the requested relief (injunction, declaratory judgment).
Which patents are in dispute in Richard v. Shire US, Inc. 1:16-cv-24907?
- Litigation analysis requires the patents-in-suit list with:
- publication/application numbers and assignees,
- expiration dates and adjusted terms (if pled),
- territory (US only vs. any foreign parallel),
- and asserted claims (independent claim numbers and dependent claim dependencies).
What procedural milestones happened in 1:16-cv-24907 (motions, Markman, summary judgment, trial)?
- A proper timeline depends on docket entries such as:
- motion to dismiss,
- order on pleading sufficiency,
- Markman schedule and claim construction order,
- summary judgment orders,
- pretrial conference/trial dates,
- and any appellate activity.
Was there a settlement or dismissal in Richard v. Shire US, Inc. 1:16-cv-24907?
- Settlement and dismissal facts require:
- the settlement agreement date (if publicly reflected),
- dismissal with/without prejudice,
- any stipulation of dismissal terms,
- and whether there was a consent judgment or reverse payment structure (if pled in any related filings).
How strong is Shire’s patent estate based on 1:16-cv-24907 outcomes?
- Patent strength assessment needs:
- infringement/noninfringement outcomes by claim,
- invalidity ruling bases (anticipation, obviousness, written description/enablement, indefiniteness, inequitable conduct),
- and whether the court issued a final or interlocutory ruling.
What generic entry risks do Richard v. Shire US, Inc. 1:16-cv-24907 create?
- Entry-risk analysis requires:
- whether the defendant planned a generic/AB-rated launch,
- FDA labeling alignment,
- and the effective dates implied by exclusivity and any settlement-triggered launch carveouts.
What is the Orange Book status of the product linked to 1:16-cv-24907?
- Orange Book analysis depends on:
- listed drug product,
- listed drug reference number (RLD),
- and the exact patents listed for the mechanism and formulation relevant to the case.
How does Richard v. Shire US, Inc. compare with other Shire Hatch-Waxman litigations?
- Comparative analysis requires:
- a list of parallel cases involving Shire and the same RLD,
- outcomes and timing,
- and whether courts treated similar patent families similarly.
What commercial impact would an adverse decision in 1:16-cv-24907 have had on Shire?
- Commercial impact must connect:
- the protected product’s revenue and market position during the litigation window,
- whether the ruling affected a blocking position for exclusivity or only specific claims,
- and whether the ruling influenced subsequent paragraph IV certifications.
Key Takeaways
- A litigation summary and analysis cannot be completed from the docket number alone without the case’s substantive record (complaint, patents-in-suit, FDA context, and dispositive outcomes).
- Proceeding without those facts risks producing an inaccurate, non-actionable patent and exclusivity assessment.
FAQs
- What constitutes a complete “patents-in-suit” set for a Hatch-Waxman litigation docket?
- How are Orange Book patent listings used to map §271(e)(2) theories to specific claims?
- What docket events typically signal claim construction outcomes in pharmaceutical patent cases?
- When do settlements in generic patent cases typically show up in public court dockets?
- How do court rulings on claim scope differ from rulings on validity for market exclusivity?
References
No sources are cited because no verifiable, case-specific documents were provided.
