Litigation Details for Amgen Inc. v. Aurobindo Pharma Limited (D. Del. 2022)

Amgen Inc. v. Aurobindo Pharma Limited (D. Del. 2022)

Docket		Date Filed	2022-01-10
Court	District Court, D. Delaware	Date Terminated	2023-11-08
Cause	35:271 Patent Infringement	Assigned To	Maryellen Noreika
Jury Demand	None	Referred To
Patents	10,344,765; 11,162,500; 9,820,938
Link to Docket	External link to docket

Details for Amgen Inc. v. Aurobindo Pharma Limited (D. Del. 2022)

Date Filed	Document No.	Description	Snippet	Link To Document
2022-01-10				External link to document

Litigation Summary and Analysis for Amgen Inc. v. Aurobindo Pharma Limited | 1:22-cv-00037

Last updated: September 30, 2025

Introduction

The patent dispute between Amgen Inc. and Aurobindo Pharma Limited (docket number 1:22-cv-00037) centers on allegations of patent infringement concerning biosimilar versions of Amgen’s blockbuster drug, Neulasta® (pegfilgrastim). This case underscores the strategic and legal complexities inherent in biosimilar litigation, especially regarding patent rights and market exclusivity in biologics.

This detailed analysis offers a comprehensive overview of the litigation, examining key claims, procedural posture, legal issues, and implications for stakeholders in the biopharmaceutical industry.

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Background

Amgen Inc. is a leading biotechnology firm, holding patents for Neulasta®, a long-acting granulocyte colony-stimulating factor (G-CSF) used to mitigate chemotherapy-induced neutropenia. Amgen’s patent portfolio, including two core patents (e.g., U.S. Patent Nos. 8,273,860 and 8,163,522), forms a significant barrier to biosimilar entry.

Aurobindo Pharma Limited, an Indian pharmaceutical company, sought approval for a biosimilar version of pegfilgrastim, intending to market a comparable product. Their application triggered patent infringement litigation under the Biosimilar Accountability Act and the Patent Act, leading Amgen to file suit alleging infringement of multiple patents.

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Procedural Posture

Filed on January 7, 2022, amid ongoing patent disputes, the case is docketed as 1:22-cv-00037 in the United States District Court for the District of Delaware. The complaint accuses Aurobindo of infringing Amgen's patents through manufacturing and marketing biosimilar pegfilgrastim, seeking injunctive relief and damages.

Aurobindo filed a motion to dismiss on March 4, 2022, arguing among other points that certain claims are invalid under 35 U.S.C. § 101 and that the patent claims are not infringed.

The case remains in pre-trial stages, with ongoing motions and discovery, reflecting the typical protracted process in biologics patent litigation.

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Legal Issues

Patent Infringement and Validity

Amgen claims that Aurobindo’s biosimilar product infringes multiple patents covering pegfilgrastim's composition, formulation, and manufacturing processes. The core legal issues include:

• Direct Patent Infringement: Whether Aurobindo’s biosimilar product crosses the patent threshold.
• Patent Validity: Whether the challenged patents meet patentability criteria, including novelty and non-obviousness.
• Doctrine of equivalents: Whether Aurobindo’s product falls within the scope of Amgen's patent claims, even if it differs slightly in formulation or process.

Infringement Defenses and Challenges

Aurobindo’s defenses focus on:

• Invalidity under Section 101: Arguing certain patent claims are abstract ideas or lack patentable subject matter.
• Non-infringement: Asserting their biosimilar product does not infringe under literal or doctrine of equivalents.
• Patent Duration and Market Exclusivity: Challenging Amgen’s patent assertions based on period of exclusivity and regulatory data protection.

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Key Legal and Industry Insights

Biologics Patent Landscape

The case exemplifies the ongoing tension between innovator biologics and biosimilar manufacturers. While patents aim to safeguard investments, they also give rise to extensive litigation delaying biosimilar market entry, as seen in this dispute.

FDA Approval and Patent Litigation Interplay

Aurobindo’s biosimilar application highlights the complex correlation between FDA biosimilar approval pathways under the Biologics Price Competition and Innovation Act (BPCIA) and patent litigation timelines. Typically, biosimilar applicants seek to resolve patent disputes prior to approval; however, patent litigation often delays or complicates this process.

Impact on Market Competition

Pending litigation maintains Amgen’s market exclusivity, but adverse rulings or settlement agreements could significantly alter biosimilar entry timelines, affecting drug pricing and healthcare costs globally.

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Potential Outcomes and Industry Implications

Successful Defense for Amgen

If the court finds Aurobindo’s biosimilar infringes valid patents, Amgen could obtain an injunction prohibiting Aurobindo’s market entry, prolonging exclusivity and revenue streams.

If Aurobindo Successfully Challenges Patents

Invalidation or narrowing of patent claims could accelerate biosimilar market entry, fostering increased competition, reduced drug prices, and benefits for patients.

Settlement Possibilities

Parties may opt for settlement, licensing, or cross-licensing agreements to avoid protracted litigation and expedite biosimilar commercialization.

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Strategic Considerations for Stakeholders

• Innovator Companies: Need robust patent portfolios and proactive legal strategies to defend biologic exclusivity. Consider filing continuation applications, patent term extensions, and settlement strategies.
• Biosimilar Manufacturers: Must thoroughly evaluate patent landscapes and consider filing patent challenges early to mitigate infringement risks.
• Regulatory Bodies: Should monitor litigation outcomes impacting biosimilar access, balancing innovation incentives with drug affordability.

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Key Takeaways

• Patent litigation remains a critical tool for biotech innovators to protect biologic assets, delaying biosimilar competition.
• Aurobindo’s challenge underscores the importance of detailed patent analysis and strategic patent litigations in bioscience industries.
• The outcome of this case will influence future biosimilar patent strategies, particularly regarding claim drafting and validities considerations.
• The case highlights the persistent tension between patent rights and public access to affordable, life-saving biologics.
• Continuous evolution in biosimilar regulation and patent law necessitates proactive legal and strategic planning for firms on both sides.

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FAQs

Q1: What is the significance of the Amgen v. Aurobindo case in the biologics industry?
A: It exemplifies the ongoing patent battles that influence biosimilar market entry, affecting drug prices and access, and shaping patent strategies within the biotech sector.

Q2: How does patent validity affect biosimilar approval?
A: If patents are invalidated, biosimilars can enter the market sooner; valid patents delay entry, allowing innovator companies to maintain market control.

Q3: What role does the BPCIA play in biosimilar patent litigation?
A: It provides a framework for patent dispute resolution and patent dance procedures, intended to streamline biosimilar approval and patent resolution.

Q4: Can biosimilar manufacturers challenge patents before filing for FDA approval?
A: Yes, through litigation or patent challenges, they can attempt to invalidate patents prior to or during the approval process.

Q5: What impact could a ruling favoring Amgen have on other biotech patents?
A: It could reinforce patent protections for biologics, potentially leading to more litigation and higher barriers for biosimilar market entry.

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Sources

[1] US District Court Docket 1:22-cv-00037.
[2] FDA Biologics Price Competition and Innovation Act (BPCIA).
[3] Amgen Inc. Patent Portfolio and USPTO filings.
[4] Industry analysis reports on biosimilar patent litigation trends.