Olink Proteomics Ab v. Alamar Biosciences Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Olink Proteomics AB (Sweden) and Olink Proteomics Inc. (Delaware)
  • Defendant: Alamar Biosciences, Inc. (Delaware)
  • Plaintiff's Counsel: Richards, Layton & Finger, P.A.
• Case Identification: 1:23-cv-01303, D. Del., 04/02/2026
• Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant, Alamar Biosciences, Inc., is a Delaware corporation and therefore resides in the judicial district.
• Core Dispute: Plaintiffs allege that Defendant's NULISA biomarker detection platform infringes a patent related to methods for detecting functional interactions between molecules using nucleic acid tags.
• Technical Context: The technology at issue involves high-sensitivity proteomic immunoassays, a critical field for biomarker discovery and diagnostics, where molecules like proteins are identified by attaching DNA strands to antibodies that bind to them.
• Key Procedural History: Prior to this amended complaint, Defendant Alamar challenged the validity of the patent-in-suit in an inter partes review (IPR) proceeding before the Patent Trial and Appeal Board (PTAB). The complaint alleges that the PTAB issued a Final Written Decision concluding that Alamar had not demonstrated that the patent's claims were unpatentable, a finding that may influence the current litigation.

Case Timeline

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

U.S. Patent No. 7,883,848 - "Regulation Analysis by Cis Reactivity, RACR"

The Invention Explained

• Problem Addressed: The patent's background describes the limitations of then-current high-throughput methods for identifying molecular interactions (e.g., protein-protein interactions) ʼ848 Patent, col. 1:22-31 Existing techniques, such as protein microarrays, were often limited by the number of detectable interactions, were costly, and could be unreliable because immobilizing one interaction partner on a solid surface might interfere with its function ʼ848 Patent, col. 2:15-24
• The Patented Solution: The invention proposes a method to detect molecular interactions in a solution without requiring pre-existing knowledge of the interacting pairs ʼ848 Patent, abstract Each molecule of interest is coupled with a unique nucleic acid moiety (NAM) that acts as an identifiable tag ʼ848 Patent, col. 6:6-10 When two molecules of interest interact functionally, their attached NAMs are brought into close proximity. This proximity enables the NAMs to associate with each other (e.g., through ligation), forming a new, combined "associated oligonucleotide" ʼ848 Patent, col. 6:11-19 This newly formed oligonucleotide, which contains the identification tags from both original molecules, serves as a detectable signal confirming the interaction ʼ848 Patent, col. 6:19-24
• Technical Importance: This approach allows for the combinatorial screening of all possible interactions within a complex library of molecules simultaneously, converting protein interaction information into a nucleic acid format that is easily amplified and analyzed ʼ848 Patent, col. 3:53-59

Key Claims at a Glance

• The complaint asserts infringement of at least claims 1-8, 11, 12, 14, and 15, with independent claim 1 being foundational Compl. ¶22
• Independent Claim 1 consists of the following essential elements:
  • a. Forming a plurality of "interactors" by coupling each molecule of interest with a nucleic acid moiety containing an "identification sequence element" and an "association element."
  • b. Forming a plurality of "cis-reactive cells," where each cell comprises at least two interactors bound in proximity by an "associated oligonucleotide" formed from the association of their nucleic acid moieties.
  • c. Subjecting the "cis-reactive cells" to conditions that stimulate a functional interaction having a "detectable trace."
  • d. Selecting the "cis-reactive cells" that exhibit the "detectable trace."
  • e. Subjecting the "associated oligonucleotides" from the selected cells to an analysis that permits detection of the identification elements.
• The complaint does not explicitly reserve the right to assert other dependent claims, but the list of asserted claims is presented non-exclusively Compl. ¶22 Compl. ¶34

III. The Accused Instrumentality

Product Identification

• The accused instrumentalities are Defendant Alamar's Nucleic Acid Linked Immuno-Sandwich Assay ("NULISA") platform, which includes the NULISAseq platform, and the associated ARGO system for automated processing Compl. ¶1

Functionality and Market Context

• The complaint describes the NULISA platform as a biomarker detection and quantification assay Compl. ¶19 The method allegedly uses matched pairs of antibodies, each conjugated to a specific oligonucleotide Compl. ¶25 When both antibodies in a pair bind to a target protein in a sample, they form an immunocomplex, bringing the oligonucleotides into close proximity Compl. ¶28
• A "specific DNA ligator sequence" is then added, which hybridizes to the proximal ends of the two oligonucleotides, allowing an enzyme (T4 DNA ligase) to join them into a single, new DNA reporter molecule Compl. ¶27 Compl. ¶29 This reporter molecule, containing barcodes from the original oligonucleotides, is then quantified using methods like quantitative PCR (qPCR) or Next Generation Sequencing (NGS) to measure the amount of the target protein Compl. ¶31 Compl. ¶32
• The complaint alleges that Alamar markets the NULISA platform for its high sensitivity in detecting low-abundance biomarkers and acknowledges that the technology is based on the Proximity Ligation Assay (PLA) technology originally commercialized by Olink's forerunner Compl. ¶21 The complaint also references a figure from an academic paper co-authored by Alamar's Director of R&D to illustrate the NULISA workflow Compl. ¶32

IV. Analysis of Infringement Allegations

The complaint provides a narrative walkthrough of how the accused NULISA platform allegedly practices each step of claim 1 of the '848 Patent.

'848 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: A primary question may be whether the NULISA process, which uses a third nucleic acid strand (the "DNA ligator sequence") to bridge the two antibody-bound oligonucleotides, meets the claim limitation of "an associated oligonucleotide formed from the association between at least two nucleic acid moieties" Compl. ¶28 Compl. ¶29 A defendant could argue this language requires a direct association between the moieties themselves, not a mediated one.
  • Technical Questions: The patent's term "cis-reactive cell" appears to be a neologism. The infringement analysis may turn on whether the transient immunocomplex formed in the accused NULISA process, which exists to facilitate an enzymatic ligation, constitutes a "cis-reactive cell" as understood and defined within the patent's specification.

V. Key Claim Terms for Construction

• The Term: "cis-reactive cell"

• Context and Importance: This term defines the central structure from which the detectable signal originates. Its construction is critical because the infringement allegation hinges on equating Alamar's immunocomplex with the patent's "cis-reactive cell" Compl. ¶29 Practitioners may focus on this term because it is not a standard term of art, suggesting its meaning is heavily dependent on the patent's own definitions.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: Claim 1 defines the term functionally as comprising "at least two interactors bound in proximity to one another by an associated oligonucleotide" ʼ848 Patent, col. 42:43-46 This broad, structural definition could be argued to encompass any complex meeting these criteria.
  • Evidence for a Narrower Interpretation: The detailed description discusses creating a "secondary library of 'cis reactive cells' (CRCs)" and suggests diluting this library to "lessen the probability of trans activation" ʼ848 Patent, col. 6:28-39 This could imply that a "cis-reactive cell" is a relatively stable, isolatable entity, a characteristic that may not apply to the transient complex in the accused NULISA process.

• The Term: "an associated oligonucleotide formed from the association between at least two nucleic acid moieties"

• Context and Importance: This term describes the core mechanism that generates the detectable signal. The dispute may focus on whether "association between" the moieties requires direct interaction (e.g., hybridization) or if it can include being joined by a third, bridging molecule, as Alamar's NULISA process allegedly does Compl. ¶27 Compl. ¶29

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The specification describes non-limiting examples of association, including "ligation approaches" and "polymerization" ʼ848 Patent, col. 15:42-47 This flexibility may support an interpretation that includes various methods of joining the moieties, including via a template or ligator.
  • Evidence for a Narrower Interpretation: Many of the patent's figures, such as Figure 5, illustrate direct interactions like end-to-end ligation or hybridization between the NAMs themselves ʼ848 Patent, Fig. 5 A defendant might argue that these specific embodiments limit the scope of "association between" to such direct mechanisms, excluding the use of a separate ligator sequence.

VI. Other Allegations

• Indirect Infringement: The complaint alleges active inducement by asserting that Alamar encourages its customers to use the NULISA platform in an infringing manner through advertising, promotional materials, and publications Compl. ¶43 It also alleges contributory infringement, claiming the NULISA platform and ARGO system are especially made for the infringing use and are not staple articles of commerce with substantial non-infringing uses Compl. ¶44 Compl. ¶48
• Willful Infringement: The complaint alleges willfulness based on both pre- and post-suit knowledge. It claims Alamar had pre-suit knowledge of the '848 patent as of an August 11, 2023, letter from Olink's President to Alamar's CEO Compl. ¶42 Post-suit knowledge is based on the filing of the lawsuit and Alamar's subsequent loss in the PTAB proceeding it initiated Compl. ¶42

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

• A core issue will be one of mechanistic interpretation: Does the accused NULISA method, which uses a separate "DNA ligator sequence" to bridge two oligonucleotides, fall within the scope of Claim 1's requirement for an "associated oligonucleotide formed from the association between at least two nucleic acid moieties"? The case may turn on whether this language requires a direct interaction or permits a mediated one.
• A second central issue will be one of definitional scope: Can the patent-specific term "cis-reactive cell," which the specification discusses in the context of a "secondary library," be construed to cover the transient immunocomplex allegedly formed in the accused NULISA process for the purpose of a single enzymatic reaction?
• A final key evidentiary question will concern intent: Given the complaint's allegation that Alamar's technology is based on Olink's foundational PLA work and that Alamar received express notice of the '848 patent pre-suit, what evidence will be presented to establish the knowledge and intent required for the claims of indirect and willful infringement?