Last updated: July 28, 2026
Executive summary
OSI Pharmaceuticals, LLC v. Accord Healthcare Inc., USA (D. Del., No. 1:17-cv-01868) is a patent infringement case tied to an FDA Orange Book-listed product and a generic/ANDA entrant. The docket exists, but the litigation-specific substance needed for a complete infringement-and-stay analysis (asserted patents, claim scope, claim constructions, scheduling/settlement posture, and final disposition) is not present in the provided information. Without those case particulars, an accurate litigation summary cannot be produced.
What is OSI Pharmaceuticals, LLC v. Accord Healthcare Inc. (1:17-cv-01868) about?
A complete, citation-grade litigation summary requires at minimum: (1) the asserted patent numbers, (2) the asserted claims, (3) the ANDA/application number or FDA product, (4) the procedural posture at filing (TRO/preliminary injunction, expedited discovery, or stay), and (5) the case outcome (dismissal, summary judgment, consent judgment, trial verdict, or settlement with dismissal). None of these details are included in the request payload, so the case cannot be summarized precisely.
Which patents were asserted in the case?
No asserted-patent list is included.
Which drug product and ANDA/FDA submission triggered the suit?
No Orange Book product identification or ANDA number is included.
What relief did OSI seek (injunction vs damages, and whether it sought an injunction)?
No remedies/prayer for relief details are included.
What did the court decide in OSI v. Accord (1:17-cv-01868)?
A decision-level analysis depends on: motions ruled (Rule 12, summary judgment, claim construction rulings), Markman outcomes, infringement and invalidity holdings, and any final judgment. Those rulings and orders are not provided, so a decision summary cannot be generated.
Was there a claim construction (Markman) and what happened to it?
No claim construction orders are included.
Did Accord file invalidity defenses and what patents/grounds were used?
No invalidity defenses are included.
Did the case end in settlement or judgment?
No disposition outcome is included.
Was the case stayed under the Hatch-Waxman framework, and when did the stay end?
A Hatch-Waxman stay analysis requires: (1) which patents triggered the 30-month stay, (2) the statutory mechanism (e.g., suit within 45 days of notice), and (3) any carve-outs or lifting events tied to dismissal, non-infringement rulings, or expired/withdrawn patents. None of that is included.
What patents controlled the 30-month stay?
No controlling patents are included.
Did any patents expire during the litigation, affecting exclusivity or the injunction request?
No expiration timeline is included.
What Paragraph IV and Orange Book information ties to OSI v. Accord (1:17-cv-01868)?
A Paragraph IV analysis requires the Orange Book “listed drug” name, NDA/BLA, patent numbers listed for drug, and the specific Paragraph IV certifications (IV vs I vs II) tied to the generic. None of that is in the request.
What is the Orange Book status of the drug in dispute?
Not provided.
Which certifications did Accord make (Paragraph IV to which patents)?
Not provided.
How strong is OSI’s asserted patent estate in this litigation?
Strength analysis typically covers: claim breadth, remaining term, prosecution history bars, means-plus-function limitations, obviousness/anticipation landscape, and any Federal Circuit outcomes on related patents. Those inputs are not provided.
Remaining patent term at filing
Not provided.
Known validity outcomes in related cases
Not provided.
What generic entry risks existed for Accord after the litigation was filed?
Entry-risk assessment depends on: (1) whether the court issued an injunction, (2) whether any patents were held invalid, (3) settlement and dismissal with or without “carve-out” dates, and (4) subsequent FDA approvals/launch timing. None of those inputs are included.
Did the case result in an injunction preventing FDA approval/launch?
Not provided.
Did OSI obtain a consent judgment or stipulated dismissal?
Not provided.
How does this case compare with other OSI v. generic challenges?
A comparison requires at least another case docket identifier or the same product’s broader litigation map (other defendants, common patents, consistent claim constructions). None of that is included.
Key takeaways
- The docket identifier alone (OSI Pharmaceuticals, LLC v. Accord Healthcare Inc., 1:17-cv-01868) is insufficient to produce a litigation-grade summary without asserted-patent, Orange Book/FDA product, procedural disposition, and ruling details.
- A complete infringement, validity, and exclusivity analysis must be grounded in specific orders and filings, which are not contained in the provided prompt.
FAQs
- What documents in a Hatch-Waxman case determine whether a 30-month stay was granted or lifted?
- How do claim construction rulings typically drive outcomes in ANDA Paragraph IV litigation?
- What indicators in the docket suggest settlement versus dispositive summary judgment?
- How do consent judgments affect launch dates and “carve-out” patent coverage?
- What data points are required to map asserted patents to Orange Book listings and FDA certifications?
References
- None provided in the prompt.
