DCT

1:26-cv-01754

Janssen Biotech Inc v. Alvotech HF

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:26-cv-01754, E.D. Va., 06/19/2026
  • Venue Allegations: Venue is alleged as proper in the Eastern District of Virginia because Defendant Alvotech USA Inc. maintains its principal place of business in the district, and Defendant Alvotech hf is a foreign entity subject to suit in any U.S. judicial district.
  • Core Dispute: Plaintiffs allege that Defendants' filing of abbreviated Biologics License Applications (aBLAs) with the U.S. Food and Drug Administration for AVT05, a proposed biosimilar of Plaintiffs' biologic drugs SIMPONI® and SIMPONI ARIA®, constitutes an act of infringement of fourteen U.S. patents covering methods of manufacturing and purifying the antibody golimumab.
  • Technical Context: The lawsuit concerns the complex and proprietary manufacturing processes for golimumab, a monoclonal antibody that blocks tumor necrosis factor alpha (TNFα) and is used to treat chronic inflammatory conditions.
  • Key Procedural History: This action arises under the Biologics Price Competition and Innovation Act (BPCIA). The complaint alleges that Defendants failed to fully comply with their statutory obligations to provide information describing the manufacturing process for their proposed biosimilar, a pre-litigation process colloquially known as the "patent dance." Plaintiffs assert this alleged failure as a basis for bringing this infringement action to obtain details of the accused process through discovery.

Case Timeline

Date Event
2008-01-28 U.S. Patent No. 8,017,325 Priority Date
2011-07-05 U.S. Patent Nos. 8,852,889; 8,956,830; 9,170,249; 9,217,168; 9,487,810; 9,663,810; and 9,890,410 Priority Date
2011-07-08 U.S. Patent Nos. 9,475,858 and 12,139,735 Priority Date
2011-09-13 U.S. Patent No. 8,017,325 Issued
2013-09-30 U.S. Patent No. 10,421,986 Priority Date
2014-10-07 U.S. Patent No. 8,852,889 Issued
2015-02-17 U.S. Patent No. 8,956,830 Issued
2015-10-27 U.S. Patent No. 9,170,249 Issued
2015-12-22 U.S. Patent No. 9,217,168 Issued
2016-10-25 U.S. Patent No. 9,475,858 Issued
2016-11-08 U.S. Patent No. 9,487,810 Issued
2017-05-30 U.S. Patent No. 9,663,810 Issued
2018-02-13 U.S. Patent No. 9,890,410 Issued
2018-04-20 U.S. Patent No. 11,225,516 Priority Date
2019-09-24 U.S. Patent No. 10,421,986 Issued
2021-07-09 U.S. Patent No. 12,534,524 Priority Date
2022-01-18 U.S. Patent No. 11,225,516 Issued
2022-04-28 U.S. Patent No. 12,595,454 Priority Date
2024-11-12 U.S. Patent No. 12,139,735 Issued
2026-01-27 U.S. Patent No. 12,534,524 Issued
2026-04-07 U.S. Patent No. 12,595,454 Issued
2026-06-04 Alvotech resubmitted aBLAs for AVT05
2026-06-19 Complaint Filed
2026-12-01 (approx.) Expected regulatory approval for AVT05

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

U.S. Patent No. 8,017,325 - "Selection of high-producing cell lines," Issued 09/13/2011

The Invention Explained

  • Problem Addressed: The complaint does not explicitly state the problem from the patent's background, but the patent itself addresses the challenge of efficiently identifying and selecting mammalian host cell lines that are capable of producing high yields of recombinant antibodies for commercial-scale manufacturing Compl. ¶51
  • The Patented Solution: The patent discloses a method for selecting a cell line by first transfecting host cells with an antibody-encoding gene, culturing those cells, and then quantitating the amount of messenger RNA (mRNA) corresponding to the antibody's heavy chain gene. The cell line with the highest quantity of heavy chain mRNA is then selected for production, based on the principle that higher mRNA levels correlate with higher protein production Compl. ¶51
  • Technical Importance: This method provides a predictive screening tool to identify high-yield cell lines early in the development process, potentially saving significant time and resources compared to relying solely on measuring final antibody protein expression.

Key Claims at a Glance

  • The complaint asserts independent Claim 1 Compl. ¶51
  • Claim 1 of the '325 patent recites the following essential elements:
    • A method for selecting a cell line for antibody production comprising:
    • a. transfecting an antibody encoding gene, comprising at least a heavy chain gene and, optionally, a light chain gene, into two or more suitable mammalian host cells;
    • b. culturing the transfected host cells;
    • c. quantitating the mRNA encoded by the antibody heavy chain gene in the host cells; and
    • d. selecting the host cell with highest heavy chain gene mRNA quantity.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 8,852,889 - "Cell culture process," Issued 10/07/2014

The Invention Explained

  • Problem Addressed: The complaint does not detail the problem from the patent's background, but the technology relates to controlling the structural heterogeneity of recombinant antibodies during manufacturing. Specifically, the presence or absence of a C-terminal lysine residue on the antibody's heavy chain can create different variants Compl. ¶¶76, 18
  • The Patented Solution: The patent describes a method for producing a desired preparation of a recombinant antibody by manipulating the composition of the cell culture medium. By culturing the antibody-expressing cells in a medium containing a specific concentration of lysine and/or arginine, one can control the level of C-terminal variants in the final antibody product, which is then isolated and measured Compl. ¶¶76, 18
  • Technical Importance: This method allows manufacturers to control and produce a more consistent biologic drug product with a specific, targeted profile of C-terminal lysine variants, which can be critical for ensuring consistent product quality, efficacy, and stability.

Key Claims at a Glance

  • The complaint identifies Claim 6 (dependent on Claim 1) and Claim 16 (independent) as representative Compl. ¶76
  • Independent Claim 16 of the '889 patent recites the following essential elements:
    • A method of producing a preparation of a recombinant antibody, comprising:
    • culturing a cell in a medium under conditions in which the cell expresses a recombinant antibody, wherein the medium comprises 1.5 g/L arginine to less than 20 g/L arginine, and wherein the culturing produces C-terminal variants of the recombinant antibody that differ in amino acid sequence only by the presence or absence of a lysine at their carboxyl termini;
    • isolating the recombinant antibody, thereby producing a preparation of the recombinant antibody; and
    • measuring a level of one or more C-terminal variants of the recombinant antibody in the preparation.
  • The complaint does not explicitly reserve the right to assert other claims for this patent.

The complaint asserts twelve additional patents. These are analyzed in capsule format below.

  • U.S. Patent No. 8,956,830: "Methods of Cell Culture," Issued 02/17/2015.

    • Technology Synopsis: This patent is directed to methods of manufacturing a recombinant antibody preparation by culturing cells in a medium containing dimethyl sulfoxide (DMSO) to modulate the levels of fucosylated and high mannose glycans Compl. ¶103 Glycosylation patterns can impact antibody function and stability.
    • Asserted Claims: Claims 15 and 37 are identified as representative Compl. ¶103
    • Accused Features: The complaint alleges on information and belief that Alvotech's manufacturing process for AVT05 utilizes a culture medium containing DMSO (Compl. ¶¶104; Compl. ¶109).

  • U.S. Patent No. 9,170,249: "N-acetylhexosamine-containing n-glycans in glycoprotein products," Issued 10/27/2015.

    • Technology Synopsis: This patent covers a method for manufacturing a glycoprotein preparation that involves determining the amount of a specific N-linked glycan (one with a single N-acetylhexosamine residue) and processing the preparation into a pharmaceutical product based on that determination Compl. ¶135 This method serves as a quality control step for biologic manufacturing.
    • Asserted Claims: Claim 1 is identified as representative Compl. ¶135
    • Accused Features: The complaint alleges on information and belief that the AVT05 manufacturing process includes the claimed steps of determining and processing based on the level of this specific glycan Compl. ¶136

  • U.S. Patent No. 9,217,168: "Methods of Cell Culture," Issued 12/22/2015.

    • Technology Synopsis: This patent discloses methods of producing recombinant protein preparations by culturing cells in a medium containing putrescine to modulate the levels of galactosylated, sialylated, and high mannose glycans Compl. ¶158 These modifications to the glycan profile can affect the antibody's therapeutic properties.
    • Asserted Claims: Claims 13 and 16 are identified as representative Compl. ¶158
    • Accused Features: The complaint alleges on information and belief that the AVT05 manufacturing process uses a cell culture medium containing putrescine to achieve the claimed glycan profiles (Compl. ¶¶159; Compl. ¶163).

  • U.S. Patent No. 9,475,858: "Cell culture process," Issued 10/25/2016.

    • Technology Synopsis: This patent covers a method for manufacturing a recombinant antibody preparation by culturing cells in a medium with specific concentrations of lysine and/or arginine to achieve a target value of C-terminal variants Compl. ¶186 This is another method for controlling product heterogeneity.
    • Asserted Claims: Claims 1 and 20 are identified as representative Compl. ¶186
    • Accused Features: The complaint alleges on information and belief that the AVT05 manufacturing process uses the claimed concentrations of lysine and/or arginine to control C-terminal variants (Compl. ¶¶187; Compl. ¶190).

  • U.S. Patent No. 9,487,810: "Methods of Cell Culture," Issued 11/08/2016.

    • Technology Synopsis: This patent describes a method of producing a recombinant protein by culturing cells in a medium containing DMSO and then formulating the preparation into a drug product if it comprises a specific percentage (0.1% to 20%) of high mannose glycans Compl. ¶213
    • Asserted Claims: Claim 2 is identified as representative Compl. ¶213
    • Accused Features: The complaint alleges on information and belief that the AVT05 manufacturing process uses DMSO and involves formulating the drug product based on the claimed high mannose glycan levels (Compl. ¶¶214; Compl. ¶219).

  • U.S. Patent No. 9,663,810: "Methods of Cell Culture," Issued 05/30/2017.

    • Technology Synopsis: This patent discloses a method of increasing the level of fucosylated glycans in a recombinant protein preparation by culturing cells in a medium containing specific concentrations of putrescine Compl. ¶241 Fucosylation is a key factor in antibody effector functions.
    • Asserted Claims: Claim 14 is identified as representative Compl. ¶241
    • Accused Features: The complaint alleges on information and belief that the AVT05 manufacturing process uses a medium containing putrescine to achieve the claimed fucosylated glycan profile (Compl. ¶¶242; Compl. ¶246).

  • U.S. Patent No. 9,890,410: "N-acetylhexosamine-containing n-glycans in glycoprotein products," Issued 02/13/2018.

    • Technology Synopsis: This patent covers a method for manufacturing an antibody preparation by determining the level of a specific N-linked glycan (one with a single N-acetylglucosamine residue) and processing the preparation into a pharmaceutical product based on that determination Compl. ¶267 This is a similar quality control method to the '249 patent.
    • Asserted Claims: Claim 1 is identified as representative Compl. ¶267
    • Accused Features: The complaint alleges on information and belief that the AVT05 manufacturing process includes the claimed steps of determining and processing based on the level of this specific glycan Compl. ¶268

  • U.S. Patent No. 10,421,986: "Method for the clarification of high-density crude cell culture harvest," Issued 09/24/2019.

    • Technology Synopsis: This patent describes a method for clarifying a high-density crude cell culture harvest using tangential flow filtration (TFF) to separate the desired protein from the cells and cell debris Compl. ¶290 This method is crucial for efficiently purifying biologics from modern high-yield cell cultures.
    • Asserted Claims: Claim 1 is identified as representative Compl. ¶290
    • Accused Features: The complaint alleges on information and belief that the AVT05 manufacturing process involves clarifying a high-density cell culture harvest using the claimed TFF method Compl. ¶291

  • U.S. Patent No. 11,225,516: "Transition Analysis Method For Chromatography Column Qualification," Issued 01/18/2022.

    • Technology Synopsis: This patent is directed to a method of operating and qualifying a chromatography column by analyzing the "transition front" of the mobile phase using a model gamma cumulative distribution curve to calculate the column's efficiency (HETP value) Compl. ¶315 This is a quality control method for ensuring chromatography columns perform consistently.
    • Asserted Claims: Claim 1 is identified as representative Compl. ¶315
    • Accused Features: The complaint alleges on information and belief that the AVT05 manufacturing process uses the claimed method to qualify its chromatography columns (Compl. ¶¶316; Compl. ¶319).

  • U.S. Patent No. 12,139,735: "Cell culture process," Issued 11/12/2024.

    • Technology Synopsis: This patent claims a preparation of a recombinant antibody with a specific target level of C-terminal lysine variants (K1 and K2 lysine variants), produced by culturing cells in a medium containing a high concentration of lysine (2 g/L to 20 g/L) Compl. ¶343 This patent claims the product-by-process.
    • Asserted Claims: Claim 1 is identified as representative Compl. ¶343
    • Accused Features: The complaint alleges on information and belief that AVT05 is a preparation of a recombinant antibody made by the claimed process and having the claimed C-terminal variant profile (Compl. ¶¶344; Compl. ¶353).

  • U.S. Patent No. 12,534,524: "Manufacturing methods for producing anti-TNF antibody compositions," Issued 01/27/2026.

    • Technology Synopsis: This patent is directed to a method of producing an anti-TNF antibody (golimumab) by controlling the oligosaccharide profile. This is achieved by culturing cells in a chemically defined medium containing specified trace metal concentrations of manganese and copper Compl. ¶370
    • Asserted Claims: Claim 1 is identified as representative Compl. ¶370
    • Accused Features: The complaint alleges on information and belief that the AVT05 manufacturing process uses a chemically defined medium with the claimed concentrations of manganese and copper to control the oligosaccharide profile (Compl. ¶¶371; Compl. ¶378).

  • U.S. Patent No. 12,595,454: "Methods of Continuous Cell Culture," Issued 04/07/2026.

    • Technology Synopsis: This patent claims a method for culturing shear-sensitive cells (such as SP 2/0 cells) in a large-scale perfusion bioreactor system by controlling the level of dissolved carbon dioxide and the gas exit velocity to achieve a high, steady-state viable cell concentration Compl. ¶398
    • Asserted Claims: Claim 1 is identified as representative Compl. ¶398
    • Accused Features: The complaint alleges on information and belief that the AVT05 manufacturing process involves culturing shear-sensitive cells using the claimed method with controlled gas exit velocity and CO2 levels (Compl. ¶¶399; Compl. ¶403).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Alvotech's proposed biosimilar products designated AVT05 SC and AVT05 IV (collectively "AVT05") Compl. ¶5

Functionality and Market Context

  • AVT05 SC is a proposed biosimilar version of Janssen's SIMPONI® product, and AVT05 IV is a proposed biosimilar version of Janssen's SIMPONI ARIA® product Compl. ¶¶38-39 The active ingredient in these products is golimumab, an antibody that blocks the inflammatory molecule TNFα Compl. ¶3
  • The complaint alleges that Alvotech is seeking regulatory approval for AVT05 based on Janssen's own clinical studies and research data, rather than through independent development Compl. ¶6 The infringement alleged is the statutory act of submitting the aBLAs for these products under 35 U.S.C. § 271(e)(2)(C) Compl. ¶27
  • The complaint alleges that Janssen's corresponding products, SIMPONI® and SIMPONI ARIA®, achieved sales exceeding $1.1 billion in 2025, indicating significant commercial importance Compl. ¶23

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide detailed infringement allegations that map specific features of the accused manufacturing process to claim elements. Instead, it alleges on "information and belief" that the process used to manufacture AVT05 will infringe, and states that discovery is needed to confirm this belief, citing Alvotech's alleged failure to comply with BPCIA disclosure obligations (Compl. ¶¶57; Compl. ¶58; Compl. ¶79; Compl. ¶80).

'325 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a. transfecting an antibody encoding gene... into two or more suitable mammalian host cells; The complaint alleges on information and belief that Alvotech's process for manufacturing AVT05 involves transfecting suitable mammalian host cells with a gene encoding the golimumab antibody Compl. ¶52 ¶52 col. 7:20-24
b. culturing the transfected host cells; The complaint alleges on information and belief that Alvotech's process involves culturing the transfected host cells to produce the golimumab antibody Compl. ¶52 ¶52 col. 7:25-33
c. quantitating the mRNA encoded by the antibody heavy chain gene in the host cells; and The complaint alleges that discovery is needed to confirm its belief that Alvotech's process involves quantitating the antibody heavy chain mRNA in its host cells Compl. ¶58 ¶58 col. 8:1-8
d. selecting the host cell with highest heavy chain gene mRNA quantity. The complaint alleges that discovery is needed to confirm its belief that Alvotech's process involves selecting the cell line for production based on the highest heavy chain mRNA quantity Compl. ¶58 ¶58 col. 8:1-8

'889 Patent Infringement Allegations

Claim Element (from Independent Claim 16) Alleged Infringing Functionality Complaint Citation Patent Citation
culturing a cell in a medium under conditions in which the cell expresses a recombinant antibody, wherein the medium comprises 1.5 g/L arginine to less than 20 g/L arginine, and wherein the culturing produces C-terminal variants of the recombinant antibody that differ in amino acid sequence only by the presence or absence of a lysine at their carboxyl termini; The complaint alleges on information and belief that Alvotech's process for manufacturing AVT05 involves culturing cells in a medium containing arginine within the claimed range to produce the specified C-terminal antibody variants (Compl. ¶¶77; Compl. ¶80). ¶77; ¶80 col. 18:25-36
isolating the recombinant antibody, thereby producing a preparation of the recombinant antibody; and The complaint alleges on information and belief that Alvotech's process includes isolating the golimumab antibody after culturing Compl. ¶77 ¶77 col. 18:37-39
measuring a level of one or more C-terminal variants of the recombinant antibody in the preparation. The complaint alleges on information and belief that Alvotech's process includes measuring the level of C-terminal variants as a step in producing the final preparation Compl. ¶77 ¶77 col. 18:40-43
  • Identified Points of Contention:
    • Evidentiary Questions: The central issue for all asserted patents is evidentiary. As the complaint is based on "information and belief" and explicitly states the need for discovery, the primary point of contention will be whether Alvotech's actual, confidential manufacturing process for AVT05 practices the specific steps and parameters recited in the asserted claims.
    • Scope Questions: The dispute may raise questions about the scope of claim terms. For the '325 patent, a question may be whether Alvotech's method of choosing a production cell line constitutes "selecting the host cell with highest heavy chain gene mRNA quantity." For the '889 patent, a key question will be whether Alvotech's culture medium falls within the specific arginine concentration range recited in the claim ("1.5 g/L arginine to less than 20 g/L arginine") for the purpose of generating C-terminal variants.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for a substantive analysis of potential claim construction disputes. However, based on the asserted claims, the following terms may become focal points.

For the '325 Patent:

  • The Term: "selecting the host cell with highest heavy chain gene mRNA quantity"
  • Context and Importance: The construction of this term is critical because it defines the required causal link between the mRNA measurement and the choice of the cell line. Practitioners may focus on this term because the infringement analysis will depend on whether Alvotech's process for choosing a cell line for production is based on this specific quantitative mRNA criterion, or on other performance metrics.
  • Intrinsic Evidence for Interpretation: The complaint does not provide intrinsic evidence for analysis.

For the '889 Patent:

  • The Term: "measuring a level of one or more C-terminal variants"
  • Context and Importance: This term's construction will determine what type of analytical measurement satisfies the claim limitation. Practitioners may focus on this term because Alvotech could argue that its internal quality control tests do not constitute "measuring" for the purpose of "producing a preparation" as required by the claim, but rather for post-production quality assessment.
  • Intrinsic Evidence for Interpretation: The complaint does not provide intrinsic evidence for analysis.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Alvotech will induce infringement by its commercialization partner, Teva Pharmaceuticals, by "developing, supplying, soliciting purchase orders for, indemnifying, and licensing AVT05 SC and AVT05 IV for Teva to import into, and offer to sell and sell within, the United States" Compl. ¶48 Declaratory judgment is also sought for infringement by importation of a product made by a patented process under 35 U.S.C. § 271(g) Compl. ¶¶64-71
  • Willful Infringement: The complaint alleges willful infringement for all asserted patents. The basis for this allegation is that Alvotech had pre-suit knowledge of the patents, at least due to Janssen's disclosure of the patents to Alvotech during the BPCIA "patent dance" information exchanges Compl. ¶60 Compl. ¶61 The complaint further alleges that Alvotech has been aware of the patents and their relevance to AVT05 even before Janssen's formal identification Compl. ¶60 Compl. ¶87

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

This BPCIA case, involving a large portfolio of manufacturing patents, will likely center on the following key questions for the court:

  1. A primary evidentiary question will be whether Janssen, through discovery, can demonstrate that Alvotech's confidential process for manufacturing its AVT05 biosimilar actually practices the specific, and often numerically precise, steps recited in the asserted method claims. The complaint's repeated reliance on "information and belief" underscores that the core of the dispute lies in facts not yet on the record.

  2. A secondary question will be one of claim scope, particularly for the method claims. The case may turn on how the court construes terms defining process steps, such as "selecting" a cell line based on mRNA levels ('325 patent) or "measuring" C-terminal variants ('889 patent), and whether Alvotech's quality control and process development procedures fall within the ambit of these claim limitations.

  3. The outcome of the litigation may also be influenced by the procedural context of the BPCIA. The court's view of Alvotech's alleged failure to fully participate in the pre-suit "patent dance" could influence case management and the scope of discovery, which is the central battleground where Janssen must find evidence of infringement.

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