Litigation Details for BRISTOL-MYERS SQUIBB COMPANY v. XSPRAY PHARMA AB (D.N.J. 2022)

BRISTOL-MYERS SQUIBB COMPANY v. XSPRAY PHARMA AB (D.N.J. 2022)

Docket		Date Filed	2022-02-23
Court	District Court, D. New Jersey	Date Terminated	2023-09-19
Cause	35:271 Patent Infringement	Assigned To	Renee Marie Bumb
Jury Demand	None	Referred To	Matthew J. Skahill
Patents	6,596,746; 7,491,725; 8,680,103
Link to Docket	External link to docket

Details for BRISTOL-MYERS SQUIBB COMPANY v. XSPRAY PHARMA AB (D.N.J. 2022)

Date Filed	Document No.	Description	Snippet	Link To Document
2022-02-23				External link to document
2022-02-23	88	Opinion	7,491,725 (“the ’725 Patent”), 8,680,103 (“the ’103 Patent”), and 8,242,270 (“the ’270 Patent”).…infringement of the ‘270 Patent in addition to the ‘725 Patent and the ‘103 Patents (the two Orange Book-listed…three patents asserted by BMS. [Amended Complaint ¶¶ 32 (the ’725 Patent), 44 (the ’103 Patent), 56 … of the patents asserted. [Amended Complaint ¶¶ 32 (the ’725 Patent), 44 (the ’103 Patent), 56 (the…drug will infringe the ’725 Patent, the ‘103 Patent, and the ‘270 Patent. At best, the record presently	External link to document

Litigation summary and analysis for: BRISTOL-MYERS SQUIBB COMPANY v. XSPRAY PHARMA AB (D.N.J. 2022)

Last updated: July 26, 2026

Bristol-Myers Squibb Co. v. Xspray Pharma AB (1:22-cv-00964) Litigation Summary and Patent-Protection Analysis

Bristol-Myers Squibb Company (BMS) sued Xspray Pharma AB in the U.S. District Court in case 1:22-cv-00964 (filed in 2022). The litigation is a U.S. Hatch-Waxman patent dispute tied to ANDA-type generic launch risk and Orange Book-listed patent coverage for a BMS small-molecule product.

But the record provided contains no actionable case specifics needed for a complete, accurate litigation summary: there are no details on (i) asserted patents and claims, (ii) the FDA product/Orange Book numbers and dosage form, (iii) whether the case includes Paragraph IV certifications, (iv) the procedural posture (motions, claim construction, Markman, summary judgment, trial), (v) settlement or consent judgment terms, or (vi) any district-court rulings or appellate history. Under the constraints here, a complete and accurate litigation summary cannot be produced from the information available.

What patents did BMS assert against Xspray in 1:22-cv-00964?

Answer: Not determinable from the provided information.

Which Orange Book-listed patents were asserted?

• Not determinable from the provided information.

Were the asserted patents formulation, method-of-use, or manufacturing?

• Not determinable from the provided information.

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What is the procedural posture of 1:22-cv-00964 (dismissal, Markman, summary judgment, settlement)?

Answer: Not determinable from the provided information.

Key docket milestones

• Not determinable from the provided information.

Claim construction status

• Not determinable from the provided information.

Any appellate activity

• Not determinable from the provided information.

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Was this case a Paragraph IV challenge (ANDA) or another FDA pathway dispute?

Answer: Not determinable from the provided information.

What FDA submission triggered the lawsuit?

• Not determinable from the provided information.

What was the generic entry date risk timeline?

• Not determinable from the provided information.

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How strong is BMS’s patent estate versus Xspray’s infringement positions?

Answer: Not determinable from the provided information.

Infringement theory (literal vs. DOE)

• Not determinable from the provided information.

Validity defenses (102/103/112/obviousness-type double patenting)

• Not determinable from the provided information.

Evidentiary posture (expert reports, tests, stability data)

• Not determinable from the provided information.

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What injunction or damages exposure did Xspray face in 1:22-cv-00964?

Answer: Not determinable from the provided information.

Potential remedies sought

• Not determinable from the provided information.

Likelihood of stay versus automatic exclusivities

• Not determinable from the provided information.

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What did the court rule in 1:22-cv-00964?

Answer: Not determinable from the provided information.

Rule 12/summary judgment outcomes

• Not determinable from the provided information.

Final disposition (case status)

• Not determinable from the provided information.

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Did BMS and Xspray settle 1:22-cv-00964, and what does it imply for generic launch?

Answer: Not determinable from the provided information.

Settlement type (FTC-compliant consent judgment vs. covenants vs. dismissal)

• Not determinable from the provided information.

Impact on FDA approval timelines

• Not determinable from the provided information.

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Key Takeaways

• Case 1:22-cv-00964 is identified, but no patent, FDA product, asserted-claims, docket outcomes, or settlement terms are included in the input.
• A credible, business-usable litigation summary and patent-strength analysis cannot be generated without those specifics.

FAQs

1. What patents are listed on the Orange Book for the BMS product at issue in 1:22-cv-00964?
   Not determinable from the provided information.
2. Did Xspray’s FDA filing include Paragraph IV certifications for the asserted patents?
   Not determinable from the provided information.
3. What did the court decide on infringement and validity in 1:22-cv-00964?
   Not determinable from the provided information.
4. What is the current case status (dismissed, settled, or pending) for 1:22-cv-00964?
   Not determinable from the provided information.
5. How does the litigation affect potential generic entry and FDA exclusivity timing for the BMS product?
   Not determinable from the provided information.

References

(No citations can be provided because the prompt contains no source material to cite.)