DCT

1:26-cv-01134

Bristol Myers Squibb Co v. Amgen Inc

Log In
Key Events
Complaint
complaint Intelligence

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:26-cv-01134, D. Del., 09/14/2026
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Amgen is a Delaware corporation and is therefore subject to personal jurisdiction and resides in the district.
  • Core Dispute: Plaintiffs allege that Defendant’s abbreviated Biologics License Application (“aBLA”) for a proposed biosimilar of OPDIVO® (nivolumab) constitutes an act of infringement and that the future commercial manufacture and sale of the product would infringe seven U.S. patents related to the antibody composition and methods of its use in cancer immunotherapy.
  • Technical Context: The technology relates to checkpoint inhibitor immunotherapy, where monoclonal antibodies are used to block the PD-1 receptor on T-cells, thereby preventing cancer cells from deactivating the immune system and enabling it to attack tumors.
  • Key Procedural History: The complaint describes pre-suit interactions under the Biologics Price Competition and Innovation Act (“BPCIA”), also known as the “patent dance,” alleging that Amgen failed to provide complete information regarding its manufacturing process. The complaint also notes that Amgen had previously challenged the ’449 and ’320 patents in inter partes review (IPR) proceedings, which were denied.

Case Timeline

Date Event
2005-05-09 Priority Date for U.S. Patent No. 8,008,449
2006-01-01 Plaintiffs began clinical trials on nivolumab (approx. date)
2011-08-30 Issue Date for U.S. Patent No. 8,008,449
2012-05-15 Priority Date for U.S. Patent Nos. 9,856,320; 10,072,082; 12,590,154; 12,624,107
2014-07-01 Japan approves OPDIVO® for advanced melanoma (approx. date)
2014-12-01 FDA approves OPDIVO® for advanced melanoma (approx. date)
2015-04-28 Priority Date for U.S. Patent No. 12,590,153
2018-01-02 Issue Date for U.S. Patent No. 9,856,320
2018-09-11 Issue Date for U.S. Patent No. 10,072,082
2018-10-23 Priority Date for U.S. Patent No. 12,479,917
2025-02-28 Amgen filed request for IPR of the '320 Patent (approx. date)
2025-07-10 Amgen had knowledge of the '449 Patent (approx. date)
2025-11-25 Issue Date for U.S. Patent No. 12,479,917
2026-03-31 Issue Date for U.S. Patent Nos. 12,590,154; 12,590,153
2026-05-12 Issue Date for U.S. Patent No. 12,624,107
2026-09-14 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,008,449 - “Human Monoclonal Antibodies to Programmed Death 1 (PD-1) and Methods for Treating Cancer Using Anti-PD-1 Antibodies Alone or in Combination with Other Immunotherapeutics”

  • Patent Identification: U.S. Patent No. 8,008,449 (“the ’449 Patent”), “Human Monoclonal Antibodies to Programmed Death 1 (PD-1) and Methods for Treating Cancer Using Anti-PD-1 Antibodies Alone or in Combination with Other Immunotherapeutics,” issued August 30, 2011 Compl. ¶31

The Invention Explained

  • Problem Addressed: The human immune system relies on T-cells to attack abnormal cells like cancer cells, but it has a safeguard receptor on T-cells called PD-1 that acts as a "brake" to prevent attacks on healthy tissue Compl. ¶3 Cancer cells exploit this safeguard to engage the PD-1 pathway, effectively applying the brakes on the immune response and shielding themselves from attack Compl. ¶3
  • The Patented Solution: The invention is a recombinant human antibody, nivolumab, which is an anti-PD-1 therapy designed to solve this problem Compl. ¶3 Compl. ¶34 By binding directly to the PD-1 receptor on T-cells, the antibody "releases the brake," permitting the T-cells to remain active and attack cancer cells Compl. ¶3 The patent discloses and claims the specific amino acid sequence of this antibody Compl. ¶34
  • Technical Importance: The claimed antibody, commercialized as OPDIVO®, was the first anti-PD-1 therapy approved anywhere in the world, pioneering a new class of cancer care that harnesses the patient's own immune system to fight cancer Compl. ¶1

Key Claims at a Glance

  • The complaint asserts independent claim 3 and dependent claim 20 (Compl. ¶¶35, 76, 84).
  • Independent Claim 3 recites:
    • An isolated monoclonal antibody, or antigen-binding portion thereof, comprising a heavy chain variable region and a light chain variable region;
    • Wherein the heavy and light chain variable regions are selected from a group of seven specific amino acid sequence pairs (SEQ ID NOs: 1 and 8; 2 and 9; 3 and 10; 4 and 11; 5 and 12; 6 and 13; or 7 and 14);
    • Wherein the antibody or portion thereof specifically binds to PD-1 Compl. ¶35
  • Claim 20 is dependent on claim 3 and further narrows the invention to the antibody comprising the heavy chain variable region of SEQ ID NO: 4 and the light chain variable region of SEQ ID NO: 11, which corresponds to nivolumab Compl. ¶35 Compl. ¶34

U.S. Patent No. 9,856,320 - “Cancer Immunotherapy by Disrupting PD-1/PD-L1 Signaling”

  • Patent Identification: U.S. Patent No. 9,856,320 (“the ’320 Patent”), “Cancer Immunotherapy by Disrupting PD-1/PD-L1 Signaling,” issued January 2, 2018 Compl. ¶38

The Invention Explained

  • Problem Addressed: While anti-PD-1 monotherapy was a breakthrough, Plaintiffs sought to discover ways to administer it in combination therapies to treat cancers that were difficult or impossible to treat with a single product Compl. ¶5
  • The Patented Solution: The patent claims a specific method of treating cancer using a combination immunotherapy regimen Compl. ¶41 It recites a protocol involving an initial phase of administering both an anti-PD-1 antibody and an anti-CTLA-4 antibody for a set number of doses, followed by a subsequent phase of administering the anti-PD-1 antibody alone Compl. ¶41
  • Technical Importance: This combination therapy approach expanded the use of immunotherapy to a range of cancers, including advanced and metastatic cancers, for which few effective treatments had previously existed Compl. ¶5

Key Claims at a Glance

  • The complaint asserts independent claim 5 Compl. ¶41
  • Independent Claim 5 recites:
    • A method of treating a human subject afflicted with a cancer;
    • Comprising administering to the subject 1 mg/kg of an anti-PD-1 antibody and 3 mg/kg of an anti-CTLA-4 antibody every 3 weeks for 4 doses;
    • Followed by subsequently administering the anti-PD-1 antibody alone at a dosing frequency of once every 2 weeks Compl. ¶41
  • The complaint alleges infringement of "one or more claims" of the patent, including claim 5 Compl. ¶100

U.S. Patent No. 10,072,082 - “Cancer Immunotherapy by Disrupting PD-1/PD-L1 Signaling”

  • Patent Identification: U.S. Patent No. 10,072,082 (“the ’082 Patent”), “Cancer Immunotherapy by Disrupting PD-1/PD-L1 Signaling,” issued September 11, 2018 Compl. ¶44

Technology Synopsis

The patent describes a method for treating cancer that involves a patient selection step Compl. ¶47 The method comprises assessing a tumor tissue sample to determine if the proportion of cells expressing the PD-L1 biomarker is at or above a certain threshold (≥1%), and if so, administering an anti-PD-1 antibody Compl. ¶47 ’082 Patent, abstract

Asserted Claims

Independent claim 1 is asserted Compl. ¶47

Accused Features

Plaintiffs allege that Amgen's proposed labeling for its biosimilar will encourage healthcare providers to administer the product in a manner that directly infringes one or more claims of the ’082 Patent Compl. ¶¶125, 127

U.S. Patent No. 12,590,154 - “Cancer Immunotherapy by Disrupting PD-1/PD-L1 Signaling”

  • Patent Identification: U.S. Patent No. 12,590,154 (“the ’154 Patent”), “Cancer Immunotherapy by Disrupting PD-1/PD-L1 Signaling,” issued March 31, 2026 Compl. ¶49

Technology Synopsis

The patent claims a method of treating hepatocellular carcinoma (HCC) specifically Compl. ¶52 The method involves administering a combination of 1 mg/kg of nivolumab and 3 mg/kg of ipilimumab every 3 weeks for 4 cycles, followed by administering nivolumab alone Compl. ¶52

Asserted Claims

Independent claim 1 is asserted Compl. ¶52

Accused Features

The complaint alleges that Amgen’s aBLA submission and its proposed labeling, which contains instructions for use, will induce infringement of the claimed treatment method for HCC (Compl. ¶¶149-150, 152).

U.S. Patent No. 12,624,107 - “Cancer Immunotherapy by Disrupting PD-1/PD-L1 Signaling”

  • Patent Identification: U.S. Patent No. 12,624,107 (“the ’107 Patent”), “Cancer Immunotherapy by Disrupting PD-1/PD-L1 Signaling,” issued May 12, 2026 Compl. ¶54

Technology Synopsis

The patent claims a method for treating renal cell carcinoma Compl. ¶57 The claimed method comprises administering 3 mg/kg of nivolumab and 1 mg/kg of ipilimumab every 3 weeks for 4 cycles, followed by administering nivolumab alone Compl. ¶57

Asserted Claims

Independent claim 1 is asserted Compl. ¶57

Accused Features

Plaintiffs allege Amgen’s proposed labeling will instruct healthcare providers to administer the biosimilar in a manner that infringes the claimed treatment method for renal cell carcinoma (Compl. ¶¶175, 177).

U.S. Patent No. 12,590,153 - “Treatment of PD-L1-negative Melanoma Using an Anti-PD-1 Antibody and an Anti-CTLA-4 Antibody”

  • Patent Identification: U.S. Patent No. 12,590,153 (“the ’153 Patent”), “Treatment of PD-L1-negative Melanoma Using an Anti-PD-1 Antibody and an Anti-CTLA-4 Antibody,” issued March 31, 2026 Compl. ¶59

Technology Synopsis

This patent covers a method for treating a melanoma tumor by administering a weight-based dose of nivolumab and ipilimumab for about 4 doses, followed by administration of a flat dose of nivolumab (about 240 mg or 480 mg) Compl. ¶62

Asserted Claims

Independent claim 1 is asserted Compl. ¶62

Accused Features

The complaint alleges that Amgen’s proposed labeling will instruct the use of the biosimilar in a manner that infringes the claimed treatment method for melanoma (Compl. ¶¶200, 202).

U.S. Patent No. 12,479,917 - “Methods of Treating NSCLC Comprising Administering Platinum Doublet Chemotherapy Followed by an Anti-PD-1 Antibody and an Anti-CTLA-4 Antibody”

  • Patent Identification: U.S. Patent No. 12,479,917 (“the ’917 Patent”), “Methods of Treating NSCLC Comprising Administering Platinum Doublet Chemotherapy Followed by an Anti-PD-1 Antibody and an Anti-CTLA-4 Antibody,” issued November 25, 2025 Compl. ¶64

Technology Synopsis

The patent claims a method of treating non-small cell lung carcinoma (NSCLC) using a combination of platinum doublet chemotherapy, a flat dose of an anti-PD-1 antibody, and a weight-based dose of an anti-CTLA-4 antibody, administered in specific cycles and schedules Compl. ¶67

Asserted Claims

Independent claim 1 is asserted Compl. ¶67

Accused Features

Plaintiffs allege that Amgen's proposed labeling will instruct healthcare providers to administer the biosimilar in a way that directly infringes the claimed multi-part treatment regimen for NSCLC (Compl. ¶¶225, 227).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is Amgen's "Proposed Amgen Nivolumab Biosimilar," also identified as ABP 206 Compl. ¶8 The infringement action is based on Amgen’s filing of an abbreviated Biologics License Application (“aBLA”) with the FDA seeking approval to commercialize this product Compl. ¶8
  • Functionality and Market Context:
    • The proposed product is a biosimilar version of Plaintiffs' OPDIVO® (nivolumab), a recombinant human antibody designed to bind to the PD-1 receptor on T-cells (Compl. ¶¶3, 8). By blocking the PD-1 pathway, the antibody prevents cancer cells from deactivating the immune system, thereby permitting T-cells to remain active and attack the cancer Compl. ¶3
    • The complaint alleges that Amgen seeks to commercialize its biosimilar before the expiration of Plaintiffs' patents, threatening the exclusivity that protects Plaintiffs' investment in developing the breakthrough therapy Compl. ¶2 OPDIVO® is described as one of Plaintiffs' largest-selling products and a cornerstone of modern oncology (Compl. ¶¶1, 7). The infringement allegations concerning methods of use are based on the confidential information Amgen provided to BMS pursuant to the BPCIA, including proposed labeling that will allegedly instruct and encourage infringing uses (Compl. ¶¶73, 85, 97).

IV. Analysis of Infringement Allegations

The complaint’s specific factual allegations describing how the Proposed Amgen Nivolumab Biosimilar infringes the asserted claims are almost entirely redacted (Compl. ¶¶75, 99, 124, 149, 174, 199, 224). As such, a detailed claim chart summary cannot be constructed.

The general infringement theory for the composition of matter patent (’449 Patent) is that Amgen's proposed biosimilar, ABP 206, has the same composition as the claimed nivolumab antibody, thereby directly infringing Compl. ¶¶73, 76 For the method of treatment patents (’320, ’082, ’154, ’107, ’153, and ’917 patents), the primary infringement theory is indirect infringement. Plaintiffs allege that the proposed labeling for Amgen's product will instruct and encourage healthcare providers to administer the biosimilar using the specific, patented dosing regimens, patient selection criteria, and cancer indications, which will constitute induced infringement Compl. ¶¶100-102, 125-127

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Scope Questions: For the ’449 Patent, a central question will be one of identity: does Amgen's proposed biosimilar have an amino acid sequence that falls within the literal scope of the asserted claims, or will the analysis turn on the doctrine of equivalents? For the method-of-use patents, a key question will be whether the instructions in Amgen's proposed label recommend the exact dosing amounts, frequencies, combinations, and patient populations recited in the claims, or if there are material differences.
    • Technical Questions: A primary evidentiary question for the method patents will be one of inducement: what specific language in Amgen's proposed product label, user manuals, and marketing materials will Plaintiffs point to as evidence of Amgen's specific intent to encourage infringement of the claimed methods? As the infringement allegations are based on an aBLA filing, the dispute will center on the contents of that application and what it reveals about the final product and its intended uses Compl. ¶8

V. Key Claim Terms for Construction

’449 Patent

  • The Term: "An isolated monoclonal antibody"
  • Context and Importance: This term appears in the preamble of independent claim 3 and defines the fundamental nature of the claimed invention. The construction of "isolated" is often a point of contention in biologics litigation. Practitioners may focus on this term because its interpretation could impact whether a commercially produced antibody, which exists in a formulation with other excipients, meets the claim limitation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification of the related ’082 Patent defines an “isolated antibody” as one that is “substantially free of other Abs having different antigenic specificities,” suggesting the key distinction is from other antibody types, not necessarily from all other materials ’082 Patent, col. 7:23-28
    • Evidence for a Narrower Interpretation: The same section of the ’082 Patent specification also states an isolated antibody may be "substantially free of other cellular material and/or chemicals," which could be argued to imply a high degree of purity that a defendant might claim its product does not possess ’082 Patent, col. 7:29-31

’320 Patent

  • The Term: "administering... 1 mg/kg of an anti-PD-1 antibody and 3 mg/kg of an anti-CTLA-4 antibody"
  • Context and Importance: This phrase from claim 5 recites precise, weight-based dosages for a combination therapy. The infringement analysis will hinge on whether Amgen’s proposed label instructs or encourages physicians to use this exact dosing regimen. Practitioners may focus on whether any deviation in the accused product's labeled dosage, or the allowance of physician discretion, is sufficient to avoid infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The related ’082 Patent specification provides a broad definition of "administering" as the "physical introduction of a composition," covering numerous routes of administration ’082 Patent, col. 6:57-7:12 This suggests the act of administration itself is not limited.
    • Evidence for a Narrower Interpretation: The claim language recites highly specific numerical values ("1 mg/kg" and "3 mg/kg"). This precision suggests that the scope is limited to methods that utilize these exact weight-based doses, potentially allowing a defense if the accused label recommends a different dose, a flat dose, or a dosage range.

VI. Other Allegations

  • Indirect Infringement: Plaintiffs allege both induced and contributory infringement for all asserted patents. The inducement allegations are based on the assertion that Amgen’s proposed product labeling will instruct and encourage healthcare providers to administer the biosimilar in an infringing manner Compl. ¶¶77, 102 The contributory infringement allegations are based on the assertion that the Proposed Amgen Nivolumab Biosimilar is a material part of the inventions, is especially made for infringing use, and is not a staple article of commerce suitable for substantial noninfringing use Compl. ¶¶78, 103
  • Willful Infringement: Plaintiffs allege willful infringement for all patents. The basis for this allegation is Amgen's alleged pre-suit knowledge of the patents, citing specific dates derived from prior IPR proceedings and communications during the BPCIA patent dance Compl. ¶¶36, 42, 77, 79 The complaint asserts that Amgen’s infringement is willful because it intends to market a product that it knows was approved by the FDA only by exploiting Plaintiffs' patented inventions Compl. ¶¶79, 104

VII. Analyst’s Conclusion: Key Questions for the Case

  • A central issue will be one of compositional identity: For the ’449 composition of matter patent, what evidence, obtained from Amgen's confidential aBLA submission, will demonstrate that the Proposed Amgen Nivolumab Biosimilar is structurally identical to the claimed nivolumab antibody? The case will likely turn on whether Amgen’s product is a literal copy or if any structural differences are insubstantial under the doctrine of equivalents.
  • A second core question will be one of induced infringement via product labeling: For the six asserted method-of-use patents, will the language in Amgen’s proposed label be found to specifically instruct or encourage physicians to follow the exact dosing regimens, patient selection criteria, and indications for use as recited in the claims, thereby satisfying the legal standard for specific intent to induce infringement?
  • A key procedural question will be the impact of the BPCIA patent dance: The complaint alleges Amgen failed to fully comply with its disclosure obligations during the pre-suit "patent dance" Compl. ¶¶23-24 A background issue for the court will be to what extent these alleged procedural shortcomings affect the broader infringement case or any remedies sought by the Plaintiffs.