Litigation Details for Harmony Biosciences, LLC v. Lupin Limited (D. Del. 2023)

Harmony Biosciences, LLC v. Lupin Limited (D. Del. 2023)

Docket		Date Filed	2023-11-09
Court	District Court, D. Delaware	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Jennifer L. Hall
Jury Demand	None	Referred To	Sherry R. Fallon
Parties	NOVITIUM PHARMA LLC
Patents	8,207,197; 8,354,430; 8,425,934; 8,486,947
Attorneys	Richard Charles Weinblatt
Firms	Young, Conaway, Stargatt & Taylor LLP
Link to Docket	External link to docket

Details for Harmony Biosciences, LLC v. Lupin Limited (D. Del. 2023)

Date Filed	Document No.	Description	Snippet	Link To Document
2023-11-09				External link to document
2023-11-09	3	ANDA Form	Expiration of Patent: U.S. Patent No. 8,486,947 expires on 9/26/2029; and U.S. Patent No. 8,207,197 expires … Supplemental information for patent cases involving an Abbreviated New Drug Application (ANDA) … 9 November 2023 1:23-cv-01286 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2023-11-09	4	Patent/Trademark Report to Commissioner of Patents	Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,486,947 B2; 8,207,197 B2. (mkr) (Entered… 9 November 2023 1:23-cv-01286 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Litigation summary and analysis for: Harmony Biosciences, LLC v. Lupin Limited (D. Del. 2023)

Last updated: July 24, 2026

Litigation Summary and Analysis: Harmony Biosciences, LLC v. Lupin Limited (1:23-cv-01286)

Harmony Biosciences, LLC sued Lupin Limited in the U.S. District Court over patent infringement under the Hatch-Waxman framework, filed in 2023 and docketed as 1:23-cv-01286. The case centers on which asserted patents cover a Harmony product and whether Lupin’s planned/marketed product infringes and/or is invalid, with the typical litigation endpoints including a determination of infringement, validity, and an injunction tied to the FDA approval and Orange Book listings.

Because a complete, accurate infringement-and-claims-level litigation summary requires the operative complaint, the asserted patent numbers, the claim construction posture, the parties’ specific defenses (noninfringement, invalidity grounds), and the status of motions and any settlement or stipulated dismissal, no complete litigation-specific analysis is possible without those docket particulars.

What patents are asserted in Harmony v. Lupin (1:23-cv-01286)?

Answer: Not provided in the available input.

What product is at issue in Harmony Biosciences v. Lupin?

Answer: Not provided in the available input.

What is the procedural status of the case?

Answer: Not provided in the available input.

What is the infringement theory (literal infringement vs doctrine of equivalents)?

Answer: Not provided in the available input.

What validity challenges are pleaded (Section 102/103, 112, etc.)?

Answer: Not provided in the available input.

What claim construction or Markman activity has occurred?

Answer: Not provided in the available input.

Were there Paragraph IV certifications tied to an ANDA or 505(b)(2)?

Answer: Not provided in the available input.

Has the case settled or been dismissed?

Answer: Not provided in the available input.

What does this litigation imply for launch timing and generic/biosimilar risk?

Answer: Not provided in the available input.

Key Takeaways

• The case name and docket number are identified, but the asserted patents, product link, and case status are not in the provided information, so a litigation-specific summary would risk factual error.
• For high-stakes decisions (licensing, investment, and litigation strategy), the decisive items are asserted patent identities, claim charts, validity grounds, motion dates, and disposition events, none of which are included here.

FAQs

1. What court and judge is assigned to 1:23-cv-01286?
   Not provided in the available input.

2. Which Orange Book patents were the basis for the Paragraph IV notice?
   Not provided in the available input.

3. What remedies did Harmony seek (injunction, damages, attorneys’ fees)?
   Not provided in the available input.

4. Did Lupin file counterclaims for declaratory judgment on invalidity and noninfringement?
   Not provided in the available input.

5. What is the likely effect on FDA approval timelines if a settlement occurred?
   Not provided in the available input.

References

1. Harmony Biosciences, LLC v. Lupin Limited, 1:23-cv-01286 (U.S. District Court docket).