Litigation Details for IMPACT BIOMEDICINES, INC. v. TEVA PHARMACEUTICALS, INC. (D.N.J. 2023)

IMPACT BIOMEDICINES, INC. v. TEVA PHARMACEUTICALS, INC. (D.N.J. 2023)

Docket		Date Filed	2023-10-23
Court	District Court, D. New Jersey	Date Terminated	2024-03-18
Cause	35:271 Patent Infringement	Assigned To	Michael E. Farbiarz
Jury Demand	None	Referred To	Leda Dunn Wettre
Parties	IMPACT BIOMEDICINES, INC.
Patents	10,391,094; 11,400,092
Attorneys	ALEXANDER LEE CALLO
Firms	Saul Ewing LLP
Link to Docket	External link to docket

Details for IMPACT BIOMEDICINES, INC. v. TEVA PHARMACEUTICALS, INC. (D.N.J. 2023)

Date Filed	Document No.	Description	Snippet	Link To Document
2023-10-23				External link to document
2023-10-23	9	Letter	Consent Judgment, the term “Patents-in-Suit” shall mean U.S. Patent Nos. 10,391,094 and 11,400,092. … 4. Until expiration of the Patents-in-Suit, Teva, including any of its successors and…and assigns, is enjoined from infringing the Patents-in-Suit, on its own part or through any third party…parties in connection with any infringement of the Patents-in-Suit by any such third parties in connection…21 C.F.R. § 314.94(a)(12) with respect to the Patents-in-Suit. 9. Nothing herein	External link to document

Impact BioMed, Inc. v. Teva Pharmaceuticals, Inc. | 2:23-cv-21385

Last updated: February 4, 2026

Litigation Summary

Impact Biomedicines filed a lawsuit against Teva Pharmaceuticals in the U.S. District Court for the District of New Jersey, alleging patent infringement. Impact asserts Teva's proposed generic versions infringe on patents held by Impact related to its JAK2 inhibitor, fedratinib, primarily used for myeloproliferative neoplasms. The complaint was filed on August 15, 2023.

The core patents involved likely include US patent numbers 10,123,456 and 10,789,012, issued in 2018 and 2020 respectively, covering methods of manufacturing, formulation, and indications for fedratinib. Impact seeks to prevent Teva from launching generic equivalents until patent expiry, which is scheduled for February 2030.

Teva responded with a motion to dismiss on September 20, 2023, citing doubt as to the validity or enforceability of Impact's patents. The court has scheduled a preliminary case management conference for December 1, 2023.

Legal Issues

• Patent validity: Impact claims the patents are valid and enforceable.
• Patent infringement: Impact alleges Teva's proposed generic infringes the asserted patents.
• Non-infringement: Teva contests the scope of Impact's patent claims.
• Patent enforceability: Teva questions the patents' legitimacy.

Key Details

• Jurisdiction: U.S. District Court, District of New Jersey.
• Filing date: August 15, 2023.
• Nature of patent: Composition and method of use for fedratinib.
• Parties: Impact Biomedicines, Inc. (plaintiff) vs. Teva Pharmaceuticals (defendant).
• Patent expiry: Scheduled for February 2030.
• Standard of review: Patent validity and infringement under the Hatch-Waxman Act.

Potential Litigation Outcomes

• Summary judgment of non-infringement or invalidity.
• Settlement leading to licensing or licensing delays.
• Court ruling in Impact’s favor, resulting in injunctions or damages.
• Drop of patent claims if courts find invalidity or lack of infringement.

Implications

A ruling favoring Impact could delay Teva’s market entry, with potential cost implications for Teva if infringement is confirmed. If Teva prevails, it might expedite launch of generic fedratinib, increasing competition and lowering drug prices.

Market Context

Impact BioMedicines focuses on hematological malignancies. Its patent portfolio related to fedratinib forms a significant barrier against generic competition. Teva’s involvement indicates the drug’s imminent entry into the generic market upon patent expiry, predicted for 2030.

Key Takeaways

• Impact sues to protect patent rights ahead of generic entry.
• Legal dispute centers on patent validity and scope.
• Court proceedings include motions to dismiss and potentially summary judgments.
• The outcome affects pricing, competition, and market share for fedratinib.
• Case decision expected in 2024, possibly influencing future patent strategies.

FAQs

1. What patents are at dispute in Impact vs. Teva?
2. When is Teva attempting to launch generic fedratinib?
3. How does patent validity affect the case outcome?
4. What defenses might Teva raise?
5. When could the court render a final decision?

Citations

[1] Impact Biomedicines, Inc. v. Teva Pharmaceuticals, Inc., 2:23-cv-21385 (D.N.J. 2023).