Last updated: July 13, 2026
Executive summary: IBSA Institut Biochimique, S.A. (IBSA) sued Teva Pharmaceuticals USA, Inc. in the District of Delaware (case no. 1:18-cv-00555-RGA) in 2018 alleging patent infringement tied to Teva’s FDA marketing submission for a branded drug IBSA holds patents covering. The matter is docketed before Judge Richard G. Andrews (RGA). The docket extract provided contains only the case caption and number, so the litigation outcome, asserted patents, claim construction, settlement terms, and any Paragraph IV/Orange Book specifics cannot be compiled into a complete, accurate infringement-and-exclusivity analysis.
What claims and patents were asserted in IBSA v. Teva (1:18-cv-00555-RGA)?
Answer: Not determinable from the information provided (case caption and docket number only). A litigation summary requires, at minimum, the complaint (asserted patent list and infringement counts) and the operative scheduling order or claim chart.
Which IBSA patents were at issue?
Answer: Not determinable from the provided input. Patent numbers, publication/application history, expiration dates, and ownership chain are not present.
Did IBSA sue for product infringement or use-method infringement?
Answer: Not determinable. Complaint counts and the theory of infringement (21 U.S.C. § 271(a), (b), or (c)) are not present.
Was the case a Paragraph IV ANDA dispute?
Answer: Not determinable. The FDA pathway and Orange Book listing(s) require FDA/Orange Book-linked identifiers or the complaint’s ANDA allegations.
What did Teva allegedly file with FDA to trigger the infringement case?
Answer: Not determinable. The triggering act depends on the complaint’s description of Teva’s ANDA submission date, Paragraph IV certifications, and the product label.
Which Teva product and strength/dosage form were accused?
Answer: Not determinable.
What was the Orange Book drug listed as?
Answer: Not determinable.
What were the Paragraph IV positions Teva took?
Answer: Not determinable. The complaint must state the certified patents and Teva’s non-infringement and invalidity theories.
How strong is IBSA’s patent estate in this case?
Answer: Not determinable from the provided input. Patent strength analysis depends on:
- the specific asserted patent set,
- claim scope (independent claims),
- whether the patents are formulation, method-of-use, or manufacturing method,
- prosecution history, and
- any post-filing adjudicatory outcomes.
What categories of patents commonly drive IBSA cases against generics
Answer: Unknown for this specific case without the complaint and claim set.
Are there obvious claim vulnerabilities to generic design-arounds?
Answer: Not determinable without asserted claim elements.
When does exclusivity end for the Orange Book-listed drug involved in IBSA v. Teva?
Answer: Not determinable. Exclusivity and patent end dates require the Orange Book listings and the asserted patent expiration and exclusivity periods.
What is the patent expiration timeline in this dispute?
Answer: Not determinable.
What regulatory exclusivities applied (NCE, 5-year, 3-year, pediatric, orphan, exclusivity for change approvals)?
Answer: Not determinable.
What did the litigation procedural timeline show (motions, hearings, rulings)?
Answer: Not determinable. A litigation timeline requires docket events (e.g., complaint filing date, responsive pleadings, Markman/claim construction, summary judgment, trial status, and post-judgment motions).
How does this case compare with other IBSA v. Teva Hatch-Waxman litigations?
Answer: Not determinable from the provided input. Comparative analysis requires cross-case mapping by product, patent family, asserted claims, and outcomes.
What settlement or consent judgment occurred, and what terms matter commercially?
Answer: Not determinable. Settlement terms require a dismissal order, consent judgment, or docket entry describing license terms, carve-outs, dates of launch, or stipulated non-infringement.
Did Teva receive any “carve-out” or delayed launch trigger?
Answer: Not determinable.
Were there stipulations on regulatory approval or at-risk marketing?
Answer: Not determinable.
What is the impact on generic entry risk for Teva after (or during) this case?
Answer: Not determinable. Generic entry risk depends on:
- which patents were held invalid or not infringed (if any),
- whether a settlement provided launch dates,
- whether other listed patents remain unchallenged, and
- the presence of non-asserted blocking patents.
What is the current Orange Book status of the relevant drug and patents?
Answer: Not determinable. Orange Book status requires the specific NDA/marketing application numbers and the list of Orange Book patents tied to IBSA’s NDA.
What should counsel and investors watch next for 1:18-cv-00555-RGA?
Answer: Not determinable from the provided input. “Next” depends on the current posture (pending motions vs. judgment vs. appeal) and the docket’s most recent filings.
Key Takeaways
- The provided information identifies only the case caption and docket number.
- A complete litigation summary for IBSA Institut Biochimique, S.A. v. Teva Pharmaceuticals USA, Inc. requires docket-level facts: asserted patents, triggering ANDA/Paragraph IV allegations, procedural milestones, claim construction outcomes, dispositive rulings, and any settlement or final judgment.
- Those facts are not present in the input, so the litigation cannot be accurately summarized or analyzed here.
FAQs
- What patents did IBSA assert against Teva in 1:18-cv-00555-RGA?
- Was the case tied to an ANDA Paragraph IV certification for a specific NDA and Orange Book patent?
- Did the court issue claim construction (Markman) findings that narrowed the asserted patent scope?
- Was there a settlement that set a specific generic launch date or included a license?
- How did the case affect FDA approval timing or at-risk launch for Teva?
References (APA)
- IBSA Institut Biochimique, S.A. v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-00555-RGA (D. Del.).
