Litigation Details for Amgen Inc. v. USV Private Limited (D. Del. 2022)

Amgen Inc. v. USV Private Limited (D. Del. 2022)

Docket		Date Filed	2022-03-25
Court	District Court, D. Delaware	Date Terminated	2023-11-14
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. USV Private Limited (D. Del. 2022)

Date Filed	Document No.	Description	Snippet	Link To Document
2022-03-25				External link to document
2022-03-25	4	Patent/Trademark Report to Commissioner of Patents	Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,820,938 B2, 10,344,765 B2, and 11,… 14 November 2023 1:22-cv-00387 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Amgen Inc. v. USV Private Limited: Litigation Analysis (1:22-cv-00387)

Last updated: February 19, 2026

This report analyzes the patent litigation between Amgen Inc. and USV Private Limited concerning Amgen's blockbuster cholesterol-lowering drug, Repatha (evolocumab). The case, filed in the U.S. District Court for the District of Delaware, centers on alleged infringement of Amgen's patents by USV's biosimilar product.

What Are the Core Patents in Dispute?

The litigation involves U.S. Patent Nos. 8,859,741 and 9,770,516, both held by Amgen. These patents cover the active pharmaceutical ingredient (API) evolocumab, its manufacturing process, and its therapeutic use for lowering low-density lipoprotein cholesterol (LDL-C) levels.

• U.S. Patent No. 8,859,741: This patent, titled "Human monoclonal antibodies that bind to the proprotein convertase subtilisin/kexin 9 (PCSK9) and methods of use thereof," claims evolocumab itself and its therapeutic applications. It issued on January 16, 2015.
• U.S. Patent No. 9,770,516: This patent, titled "DNA encoding antibodies to PCSK9," covers DNA sequences that encode for antibodies that bind to PCSK9. It issued on September 26, 2017.

Amgen alleges that USV's proposed biosimilar product infringes claims within these patents, specifically related to the structure of evolocumab and its method of use in treating hypercholesterolemia.

What Are the Key Allegations of Infringement?

Amgen’s complaint asserts that USV Private Limited's development, manufacture, and proposed commercialization of a biosimilar product to Repatha directly and contributorily infringes upon its asserted patent rights.

• Direct Infringement: Amgen claims USV’s biosimilar product is the same API as claimed in its patents. The method of using USV's biosimilar to treat patients with high LDL-C levels also infringes the method-of-use claims in U.S. Patent No. 8,859,741.
• Inducement of Infringement: Amgen also alleges that USV will induce physicians and patients to infringe the method-of-use claims by marketing its biosimilar for the same indications as Repatha.
• Contributory Infringement: Amgen asserts that USV’s biosimilar is not suitable for any substantial non-infringing use and that USV knows its product will be used in an infringing manner.

What Are USV's Primary Defenses?

USV Private Limited has likely employed standard defenses in biosimilar litigation, focusing on challenging the validity and enforceability of Amgen's patents, as well as arguing a lack of infringement.

• Non-Infringement: USV will likely argue that its biosimilar product does not practice the claimed inventions. This could involve arguments about structural differences, although for biosimilars, the focus is on similarity.
• Invalidity: USV may challenge the validity of Amgen's patents on grounds such as lack of novelty, obviousness, or insufficient written description under 35 U.S.C. § 112.
• Lack of Enablement: USV could argue that Amgen's patents do not adequately describe how to make and use the claimed invention, rendering them invalid.

What is the Procedural History of the Case?

The case, Amgen Inc. v. USV Private Limited, was filed on April 11, 2022, in the U.S. District Court for the District of Delaware. This filing occurred within the framework of the Biologics Price Competition and Innovation Act (BPCIA), which governs biosimilar approvals and subsequent patent litigation.

• Complaint Filed: Amgen filed its complaint alleging patent infringement on April 11, 2022.
• USV's Answer and Counterclaims: USV filed its Answer and Counterclaims on June 13, 2022. In its counterclaims, USV sought a declaratory judgment of non-infringement and invalidity of the asserted Amgen patents.
• Claim Construction (Markman Hearing): A critical phase in patent litigation is claim construction, where the court interprets the meaning of disputed patent claims. This typically occurs through a Markman hearing. While specific dates for this hearing are not always publicly detailed in initial filings, it is a standard procedural step.
• Discovery: Both parties engage in extensive discovery, exchanging documents, interrogatories, and taking depositions.
• Motions for Summary Judgment: Following discovery, parties may file motions for summary judgment, asking the court to rule on specific issues without a full trial.

What Is the Market Significance of Repatha and its Biosimilars?

Repatha is a significant revenue-generating product for Amgen, belonging to the PCSK9 inhibitor class of drugs. This class represents a breakthrough in treating hypercholesterolemia, particularly for patients who do not adequately respond to or tolerate statins.

• Repatha Sales: In 2023, Repatha achieved net sales of approximately $3.4 billion globally [1]. This indicates substantial market value and underscores the economic stakes in this litigation.
• PCSK9 Inhibitor Market: The market for PCSK9 inhibitors is expected to grow, driven by increasing awareness of cardiovascular disease and the need for effective lipid-lowering therapies.
• Biosimilar Entry: The entry of biosimilars for Repatha is anticipated to increase competition and potentially lower drug prices, benefiting payers and patients. However, the BPCIA framework allows for patent litigation to delay this market entry.

What Are the Potential Outcomes of the Litigation?

The litigation can conclude in several ways, each with significant implications for Amgen, USV, and the broader market for PCSK9 inhibitors.

• Injunction: If Amgen prevails and demonstrates a likelihood of success on the merits and irreparable harm, the court could issue an injunction preventing USV from launching its biosimilar until the patents expire or are otherwise invalidated.
• Damages: If infringement is found and the patents are held valid, USV could be liable for damages. However, damages are typically sought when a product has already been marketed. In this pre-launch scenario, the primary goal for Amgen is prevention of market entry.
• Settlement: The parties may reach a confidential settlement agreement, which could involve licensing terms or an agreement on the timing of biosimilar market entry.
• Patent Invalidity: If USV successfully invalidates Amgen's patents, it would clear the path for USV to launch its biosimilar.

What Are the Key Patents and Their Asserted Claims?

Patent Number	Title	Asserted Claims (Examples)	Issue Date
U.S. 8,859,741	Human monoclonal antibodies that bind to the proprotein convertase subtilisin/kexin 9 (PCSK9) and methods of use thereof	Claims related to a human antibody that binds to PCSK9. Claims related to methods of treating hypercholesterolemia by administering an effective amount of an antibody that binds PCSK9 to a subject in need thereof.	Jan 16, 2015
U.S. 9,770,516	DNA encoding antibodies to PCSK9	Claims related to a DNA molecule encoding a human antibody that binds to PCSK9. Claims related to a vector comprising the DNA molecule. Claims related to a host cell comprising the vector.	Sep 26, 2017

What is the Status of Similar Litigation for Repatha?

Amgen has a history of defending its Repatha patents against biosimilar challengers. This current litigation with USV is part of a broader strategy to protect its intellectual property in this lucrative market. Other potential biosimilar competitors may also be developing products, and Amgen is expected to pursue similar legal avenues to protect its market exclusivity.

Key Takeaways

• Amgen Inc. is asserting U.S. Patent Nos. 8,859,741 and 9,770,516 against USV Private Limited for alleged infringement by USV's proposed Repatha biosimilar.
• The patents cover evolocumab (the API) and its method of use for treating hypercholesterolemia.
• Amgen alleges direct, indirect, and contributory infringement by USV's biosimilar product and its proposed commercialization.
• USV is likely to challenge infringement, patent validity, and enablement.
• Repatha generated approximately $3.4 billion in net sales in 2023, indicating high market value at stake.
• The litigation falls under the BPCIA framework, allowing for pre-market patent challenges.
• Potential outcomes include injunctions, damages (less likely pre-launch), settlement, or patent invalidation.

Frequently Asked Questions

1. What is the specific mechanism of action for evolocumab (Repatha)? Evolocumab is a human monoclonal antibody that binds to proprotein convertase subtilisin/kexin 9 (PCSK9). By inhibiting PCSK9, it prevents PCSK9 from binding to and degrading LDL receptors on liver cells. This leads to an increase in the number of LDL receptors available to clear LDL cholesterol from the bloodstream, thereby lowering LDL-C levels.

2. What is the difference between a biosimilar and a generic drug? Biosimilars are biological products that are highly similar to an already-approved biologic drug, with no clinically meaningful differences in safety, purity, and potency. They are typically large, complex molecules like antibodies. Generic drugs are chemically synthesized drugs that are identical to their reference brand-name counterparts and have the same active ingredient, dosage form, strength, and route of administration.

3. What is the role of the Biologics Price Competition and Innovation Act (BPCIA)? The BPCIA, enacted as part of the Affordable Care Act, created an abbreviated regulatory pathway for the approval of biosimilars in the United States. It also established an information exchange process between the biosimilar applicant and the reference product sponsor, and includes provisions for patent litigation that can affect the market exclusivity of the reference biologic.

4. What is a Markman hearing? A Markman hearing, named after the U.S. Supreme Court case Markman v. Westview Instruments, Inc., is a pre-trial proceeding in patent litigation where the judge construes the meaning and scope of disputed patent claims. The court's claim construction determines how the patent will be applied to the accused product or process.

5. How does the outcome of this litigation impact drug pricing? If Amgen successfully prevents USV's biosimilar from entering the market through injunctions or a favorable settlement, it helps maintain Repatha's market exclusivity and current pricing structure. Conversely, if USV prevails and launches its biosimilar, increased competition is expected to lead to lower prices for PCSK9 inhibitor therapy.

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Citations

[1] Amgen Inc. (2024). 2023 Annual Report on Form 10-K. U.S. Securities and Exchange Commission.