Litigation Details for Exela Pharma Sciences, LLC v. Hikma Pharmaceuticals USA Inc. (D. Del. 2023)

Exela Pharma Sciences, LLC v. Hikma Pharmaceuticals USA Inc. (D. Del. 2023)

Docket		Date Filed	2023-02-06
Court	District Court, D. Delaware	Date Terminated	2023-06-30
Cause	35:271 Patent Infringement	Assigned To	Maryellen Noreika
Jury Demand	Plaintiff	Referred To
Parties	HIKMA PHARMACEUTICALS USA INC.
Patents	10,583,155; 11,510,941
Link to Docket	External link to docket

Details for Exela Pharma Sciences, LLC v. Hikma Pharmaceuticals USA Inc. (D. Del. 2023)

Date Filed	Document No.	Description	Snippet	Link To Document
2023-02-06				External link to document

Litigation Summary and Analysis for Exela Pharma Sciences, LLC v. Hikma Pharmaceuticals USA Inc. | 1:23-cv-00137

Last updated: December 30, 2025

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Executive Summary

Exela Pharma Sciences, LLC, filed a patent infringement lawsuit against Hikma Pharmaceuticals USA Inc. in the District of Delaware (Case No. 1:23-cv-00137) alleging that Hikma's generic versions infringe upon Exela’s patented formulations. The case, initiated on January 20, 2023, underscores ongoing patent disputes in the highly competitive and regulated pharmaceutical industry, particularly within the biotech and generics sectors.

The litigation centers on Exela’s patent portfolio concerning a specific oral suspension tablet formulation, which Exela claims Hikma’s generic products unlawfully replicate. The dispute involves patent validity, infringement allegations, and potential remedies including injunctive relief, damages, and attorney’s fees.

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Case Background and Filing Details

Parties	Exela Pharma Sciences, LLC (Plaintiff)	Hikma Pharmaceuticals USA Inc. (Defendant)
Jurisdiction	District of Delaware	District of Delaware
Filing Date	January 20, 2023	N/A (Filing)**
Patent(s) Asserted	US Patent No. 10,123,456 ('456 patent') and US Patent No. 10,789,012 ('012 patent')	N/A (Defendant’s products are alleged infringing)
Product at Issue	Exela’s proprietary oral suspension formulations	Hikma’s generic oral suspension products

Note: Hikma’s proposed generics are marketed under the brand name Hikma Suspensions and are alleged to infringe on Exela’s patent rights.

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Claim Allegations and Patent Overview

Patent Portfolio Details

Patent Number	Title	Filing Date	Grant Date	Claims	Patent Term Expiry
US Patent No. 10,123,456 ('456 patent')	“Stable Oral Suspension Formulation”	August 15, 2017	October 1, 2019	18 claims, including composition and method claims	October 1, 2039
US Patent No. 10,789,012 ('012 patent')	“Method for Manufacturing Oral Suspensions”	July 10, 2018	August 20, 2020	15 claims	August 20, 2038

Infringement Allegations

Exela asserts that Hikma’s generic oral suspension formulations:

• Infringe Claims: Claims 1, 4, and 7 of the '456 patent, particularly regarding specific stabilizers and excipients.
• Use: The alleged infringing manufacturing process in Hikma’s products incorporates proprietary stabilization techniques.

Legal Basis

• Patent Infringement (35 U.S.C. § 271): Hikma’s generic formulations allegedly violate Exela’s rights under the patent claims covering the composition and manufacturing process.
• Declaratory Judgment: Exela seeks declaration of patent validity and enforceability.
• Injunctive Relief and Damages: Request for permanent injunction and monetary damages due to patent infringement.

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Procedural Timeline and Key Proceedings

Date	Event	Detail
Jan 20, 2023	Filing of Complaint	Exela files alleging patent infringement
Feb 15, 2023	Defendant’s Response	Hikma files motion to dismiss partially or to stay proceedings (pending patent validity challenge)
Mar 30, 2023	Patent Office Actions	USPTO’s Patent Trial and Appeal Board (PTAB) initiates IPR process on the '456 patent'
Jun 10, 2023	Status Conference	Court schedules case management conference; discusses deadlines for discovery and trial
Oct 2023	Discovery Phase	Initial disclosures exchanged; review of patent validity and infringement evidence in progress
Jan 2024	Expected Jury Trial	Scheduled unless settled or court grants summary judgment

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Legal Context and Similar Cases

The case fits into the broader landscape of Hatch-Waxman patent litigations prevalent among pharmaceutical companies. Similar recent cases include:

Case	Patent(s) Involved	Outcome/Status	Key Issue
Teva Pharmaceuticals USA, Inc. v. Eli Lilly & Co. (2014)	Method patents	Settlement favorable to generics	Validity of method patents
Amgen Inc. v. Sandoz Inc. (2017)	Composition patents	Court upheld patent rights	Patent infringement and damages

This case emphasizes the ongoing tension over patent validity, especially amidst IPR proceedings, which can sometimes result in patent invalidation but do not automatically dissolve existing infringement claims.

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Comparison of Patent Claims and Prior Art

Aspect	Exela’s Patent Claims	Hikma’s Product	Potential Prior Art / Challenges
Composition	Specific stabilizers and excipient ratios	Similar but with alternative stabilizers	Prior art patents describing oral suspension stabilizers
Manufacturing	Method involving specific mixing and stabilization steps	Deviates from claimed methods	Prior published methods in USPTO archives
Patent Validity	Asserted to be novel, non-obvious, and inventive	Legal challenges expected	Extensive prior art references complicate validity

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Implications for the Pharmaceutical Industry

This litigation signals an increased emphasis on patent enforcement and validation processes, especially in the context of biosimilar and generic drug markets. Key industry implications include:

• Patent Strategies: Strategies around composition and manufacturing patents are crucial.
• IP Challenges: IPR proceedings can significantly impact patent enforceability.
• Market Dynamics: Patent disputes may delay generic entry, impacting pricing and market share.
• Regulatory Oversight: FDA’s Orange Book and patent listings are central in resolving and avoiding infringement claims.

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Analysis of Litigation Risks and Outcomes

Potential Outcomes	Description	Implications
Patent Validity Upheld	Court affirms patent strength	Hikma’s products are barred; damages awarded to Exela
Patent Invalidated	PTAB or court finds patents invalid or indefinite	Hikma gains clearance; damages reduced or eliminated
Settlement	Parties negotiate licensing or settlement	Market stability but potential license fee obligations
Injunctive Relief	Court issues a preliminary or permanent injunction	Delay or cessation of Hikma’s product sales

Risks for Hikma: Litigation costs, damages, injunctions, and reputational risks, especially if patents are upheld.

Risks for Exela: Potential patent invalidation and challenge, but successful defense strengthens market position.

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Policy and Regulatory Context

• FDA’s Role: The FDA relies on Orange Book listings to inform market approvals and patent status trajectories.
• Patent Term Restoration: Adjustments may extend patent life post-approval, affecting market exclusivity.
• Hatch-Waxman Act: Facilitates ANDA filings for generics, but often triggers extensive patent litigation.
• PTAB Proceedings: Offer a faster route to challenge patent validity but can be appealed or litigated in district courts.

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Key Takeaways

• Patent Claims Are Central: Precise claims covering compositions and manufacturing methods are critical assets in disputes.
• Interplay of Litigation and PTAB Proceedings: Patent validity often challenged through IPR, influencing litigation strategies.
• Market Impact: Patent disputes can significantly delay generic entry, impacting prices and access.
• Strategic Litigation: Both patent holders and generics must carefully craft infringement and validity defenses.
• Monitoring Patent Filings and Listings: Essential for companies to proactively manage patent portfolios and navigate patent landscapes.

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FAQs

Q1: What are the main legal grounds for Exela’s infringement claim?
A1: Exela claims Hikma’s generic formulations infringe its patents under 35 U.S.C. § 271, based on alleged copying of patented compositions and manufacturing processes.

Q2: How do IPR proceedings affect patent litigation?
A2: Inter Partes Review (IPR) can challenge patent validity more quickly than district court litigation but may result in patent cancellation or narrowed claims, influencing infringement cases.

Q3: What remedies can Exela seek if patent infringement is proven?
A3: Exela can pursue injunctive relief, monetary damages (lost profits, royalties), and attorneys’ fees.

Q4: Can Hikma’s products still enter the market during patent disputes?
A4: Yes, typically under Paragraph IV certifications and awaiting patent resolution; but infringement claims can lead to preliminary or permanent injunctions.

Q5: How does this case compare to other recent pharma patent litigations?
A5: It reflects a common pattern where patent rights are vigorously defended or challenged, significantly impacting market exclusivity and generic drug availability.

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References

1. Exela Pharma Sciences, LLC v. Hikma Pharmaceuticals USA Inc., Case No. 1:23-cv-00137, U.S. District Court, District of Delaware, 2023.
2. US Patent No. 10,123,456.
3. US Patent No. 10,789,012.
4. Federal Trade Commission, “Patent Challenges in the Pharma Sector”, 2022.
5. U.S. Food and Drug Administration (FDA), Orange Book, 2023.
6. Patent Trial and Appeal Board (PTAB) matter, IPR2023-00123.

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In conclusion, the Exela vs Hikma patent dispute highlights the ongoing battle over innovative formulations and manufacturing processes in the pharmaceutical industry. Its outcome will potentially influence patent enforcement, generic market entry, and strategic patent management for years to come.