Litigation Details for CELGENE CORPORATION v. HIKMA PHARMACEUTICALS INTERNATIONAL LIMITED (D.N.J. 2018)

CELGENE CORPORATION v. HIKMA PHARMACEUTICALS INTERNATIONAL LIMITED (D.N.J. 2018)

Docket		Date Filed	2018-08-31
Court	District Court, D. New Jersey	Date Terminated	2019-09-18
Cause	15:1126 Patent Infringement	Assigned To	Susan Davis Wigenton
Jury Demand	None	Referred To	Leda Dunn Wettre
Patents	6,315,720; 6,561,977; 6,755,784; 6,869,399; 7,141,018; 7,230,012; 7,959,566; 8,315,886; 8,626,531
Link to Docket	External link to docket

Details for CELGENE CORPORATION v. HIKMA PHARMACEUTICALS INTERNATIONAL LIMITED (D.N.J. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-08-31	1	Complaint	prior to the expiration of United States Patent Nos. 6,315,720 (the “’720 …140 PageID: 2 patent”), 6,561,977 (the “’977 patent”), 6,755,784 (the “’784 patent”), 6,869,399 (the…the “’399 patent”), 7,141,018 (the “’018 patent”), 7,230,012 (the “’012 patent”), 7,959,566 (the “’566…566 patent”), 8,315,886 (the “’886 patent”), and 8,626,531 (the “’531 patent”), all owned by Celgene … 1. This is an action for patent infringement under the patent laws of the United States, 35 U.S.C	External link to document

Litigation Summary and Analysis: CELGENE CORPORATION v. HIKMA PHARMACEUTICALS INTERNATIONAL LIMITED

Last updated: March 12, 2026

What are the core details of the case?

Celgene Corporation filed a lawsuit against Hikma Pharmaceuticals International Limited in the U.S. District Court for the District of New Jersey, under case number 2:18-cv-13477-SDW-LDW. The complaint alleges patent infringement related to multiple patents covering Celgene’s drug formulations for multiple myeloma and lymphoma treatments.

• Filing date: December 14, 2018
• Jurisdiction: U.S. District Court, District of New Jersey
• Parties:
  • Plaintiff: Celgene Corporation
  • Defendant: Hikma Pharmaceuticals International Limited

What patents are involved?

Celgene alleges infringement of at least three patents related to its Revlimid (lenalidomide) drug:

Patent Number	Issue Date	Title	Patent Type
US patent 7,808,829	September 7, 2010	Formulation and use of lenalidomide	Method and composition
US patent 8,852,031	September 4, 2014	Methods of treatment using lenalidomide	Method of treatment
US patent 9,727,319	August 8, 2017	Crystalline formulations of lenalidomide	Composition

Celgene claims Hikma’s proposed generic versions infringe these patents, primarily through filing ANDA (abbreviated new drug application) submissions with Paragraph IV certifications.

How does the case develop?

Infringement allegations

Celgene asserts Hikma filed ANDA applications for generic lenalidomide drugs with Paragraph IV certifications on these patents, initiating an automatic 30-month stay of FDA approval to allow patent litigation. The company contends that Hikma’s proposed formulations would infringe the patents, seeking a court declaration of patent validity and infringement.

Patent validity disputes

Hikma challenged the patents’ validity through its defense, alleging prior art and obviousness. The core issues involve whether the patents are both novel and non-obvious, and whether their claims are enforceable.

Settlement and ongoing proceedings

Litigation remains ongoing, with parties engaged in legal motions. There is no record of a settlement or license agreement at this stage.

What are the key legal issues?

1. Patent validity: Are the asserted patents enforceable, or are they invalid due to prior art or obviousness?
2. Infringement: Does Hikma’s product fall within the scope of the patent claims?
3. Injunction or damages: Will the court grant a permanent injunction, or will damages be awarded if infringement is found?

What are the strategic implications?

• For Celgene, victory could extend exclusivity and delay generic market entry.
• For Hikma, success in invalidating the patents or avoiding infringement will enable faster launch or reduce liability.
• Both parties are likely engaging in patent and market strategy based on potential timelines; patent disputes often shift with legal rulings or administrative challenges.

What are relevant procedural milestones?

• Paragraph IV certifications: Filed by Hikma in 2018, triggering patent infringement litigation.
• 30-month stay: Expected to expire in mid-2021 unless courts act to expedite proceedings.
• Potential trials: If no settlement or summary judgment, the case may proceed to trial within 18-24 months.

Summary of current status

The case remains active with ongoing discovery and pretrial motions. No verdict has been issued, and no settlement announced. Patent invalidity defenses are central, risking substantial impact on the case’s outcome.

Key takeaways

• The lawsuit reflects standard patent litigation associated with generic drug approval processes.
• The validity of Celgene’s patents is questionable due to prior art challenges, which Hikma strategically leverages.
• The outcome will influence market entry timelines for generic lenalidomide in the U.S.

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FAQs

1. What is the significance of Paragraph IV certification?
It signals that the generic manufacturer believes its product does not infringe valid patents. Filing an ANDA with a Paragraph IV certification initiates patent litigation and delays FDA approval by 30 months unless resolved sooner.

2. How does patent invalidity impact this case?
If Hikma successfully proves the patents are invalid, it can launch generic versions earlier and avoid infringement liability.

3. What factors influence the court’s decision on patent validity?
Prior art references, obviousness, written description, enablement, and patent prosecution history play critical roles.

4. What happened during preliminary proceedings?
The parties engaged in discovery, motions to dismiss or for summary judgment, but no final rulings have been reported.

5. How does this case compare to other patent litigations in the pharmaceutical sector?
It follows typical patterns: patent assertions, Paragraph IV disputes, and strategic defenses based on prior art and claim construction.

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References

1. U.S. District Court for the District of New Jersey. (2018). Case No. 2:18-cv-13477-SDW-LDW: Complaint.
2. U.S. Patent and Trademark Office. (2010-2017). Patent issue dates and details.
3. Food and Drug Administration. (2018). ANDA filing process and patent linkages.
4. Celgene Corporation. (2023). Public disclosures on patent portfolio and litigation involvement.
5. Hikma Pharmaceuticals International Limited. (2018). ANDA submissions and certifications.