DCT
1:20-cv-10543
Biogen Inc v. Creative Biolabs Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Biogen Inc. (Massachusetts) and University of Zürich (Switzerland)
- Defendant: Creative Biolabs Inc. (New York)
- Plaintiff’s Counsel: Foley Hoag LLP
- Case Identification: 1:20-cv-10543, D. Mass., 03/18/2020
- Venue Allegations: Venue is based on allegations that Defendant regularly conducts business and sells the accused products into the District of Massachusetts through its website.
- Core Dispute: Plaintiffs allege that Defendant’s antibody products, marketed as aducanumab, infringe a patent covering a specific human monoclonal antibody developed for the treatment of Alzheimer's disease.
- Technical Context: The technology concerns therapeutic human antibodies engineered to selectively target pathological protein aggregates associated with neurodegenerative diseases, such as amyloid-beta plaques in Alzheimer's, while avoiding reactions with normal physiological proteins.
- Key Procedural History: The complaint states that Plaintiff Biogen sent a demand letter to Defendant on October 18, 2019, alleging infringement and demanding that Defendant cease its accused activities, to which Defendant allegedly never responded.
Case Timeline
| Date | Event |
|---|---|
| 2007-01-05 | U.S. Patent No. 8,906,367 Priority Date |
| 2014-12-09 | U.S. Patent No. 8,906,367 Issues |
| 2019-10-01 | Defendant press release touting its aducanumab antibody (approximate date) |
| 2019-10-18 | Biogen sends pre-suit demand letter to Defendant |
| 2020-03-18 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 8,906,367, Method of providing disease-specific binding molecules and targets, issued December 9, 2014.
The Invention Explained
- Problem Addressed: The patent describes the challenge of developing antibody-based therapies for diseases like Alzheimer's. A key problem is creating antibodies that specifically target the pathological forms of proteins (e.g., aggregated amyloid-beta) without cross-reacting with the proteins' normal, physiologically functional forms, which could trigger a dangerous autoimmune response ('367 Patent, col. 2:1-15). Additionally, antibodies derived from non-human sources (like mice) can be rejected by the human immune system ('367 Patent, col. 2:45-51).
- The Patented Solution: The invention discloses a method of isolating fully human antibodies from clinically stable or symptom-free human subjects who are at risk for a disease. The patent is based on the finding that such individuals can naturally produce antibodies directed against 'neoepitopes'—unique structures that appear only on the disease-associated, pathological variants of proteins ('367 Patent, col. 2:45-51). By targeting these neoepitopes, the resulting antibodies can neutralize the harmful protein aggregates without attacking healthy tissue ('367 Patent, Abstract).
- Technical Importance: This approach allows for the development of highly specific, fully human antibodies that could offer a safer and more effective therapeutic option for neurodegenerative diseases by precisely targeting the disease pathology.
Key Claims at a Glance
- The complaint asserts independent claim 1 and method claim 16, as well as dependent claims 2-6 (Compl. ¶¶64, 71).
- Independent claim 1 recites the essential structural elements of the antibody:
- An isolated antibody or antigen-binding fragment that binds to beta amyloid.
- It comprises specific heavy chain (VH) and light chain (VL) variable regions.
- The VH region is defined by three specific Complementarity Determining Regions (CDRs): VHCDR1 (SEQ ID NO:20), VHCDR2 (SEQ ID NO:21), and VHCDR3 (SEQ ID NO:22).
- The VL region is defined by three specific CDRs: VLCDR1 (SEQ ID NO:23), VLCDR2 (SEQ ID NO:24), and VLCDR3 (SEQ ID NO:25).
- The antibody further comprises a human IgG1 constant region or a fragment thereof.
- The complaint reserves the right to assert additional claims (Compl. ¶71).
III. The Accused Instrumentality
Product Identification
The accused products are a series of antibody products advertised and sold by Defendant, including "Afuco™ Anti-APP ADCC Therapeutic Antibody (Aducanumab)" (AFC-TAB-717), "Anti-APP Therapeutic Antibody (Aducanumab)" (TAB-717), and numerous aducanumab antibodies labeled with fluorescent dyes, such as "Aducanumab-Alexa 350" (ADC-FL-127) (Compl. ¶¶37, 40).
Functionality and Market Context
The complaint alleges these are "copycat products" of Biogen's patented aducanumab antibody (Compl. ¶35). The functionality is that of a monoclonal antibody intended for research related to Alzheimer's disease (Compl. ¶60). The complaint alleges that Defendant's website and marketing materials expressly identify the products as "aducanumab" and use Biogen's internal development code for the antibody, "BIIB037" (Compl. ¶¶59, 69). The complaint references an "Aducanumab Overview" page on Defendant's website, which allegedly cites Biogen's own clinical trials as evidence of the product's applicability (Compl. ¶59).
IV. Analysis of Infringement Allegations
The complaint's theory of infringement rests on the allegation that Defendant markets and sells products under the name "aducanumab" and that these products are copies of Biogen's patented aducanumab antibody, which is embodied by the asserted claims (Compl. ¶¶69-71). The complaint does not contain a traditional claim chart mapping specific product features to claim elements but alleges that the accused products are, by their nature as aducanumab, covered by the claims. No probative visual evidence provided in complaint.
8,906,367 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An isolated antibody or antigen-binding fragment thereof which binds to beta amyloid... | The accused products are marketed as "aducanumab" and for research into Alzheimer's disease, a condition characterized by beta amyloid plaques. The complaint alleges these products are copies of Biogen's antibody, which binds to beta amyloid (Compl. ¶¶1, 16, 59). | ¶¶59, 69 | col. 26:25-34 |
| and comprises a heavy chain variable region (VH)...wherein the VH comprises a...VHCDR1 with...SEQ ID NO:20...VHCDR2 with...SEQ ID NO:21, and a VHCDR3 with...SEQ ID NO:22... | The complaint alleges that the accused products are "aducanumab," which Plaintiffs contend is the antibody defined by the specific CDR sequences recited in the claim (Compl. ¶70). The infringement allegation is based on compositional identity. | ¶¶69, 70, 71 | col. 27:56-61 |
| and a light chain variable region (VL)...wherein the VL comprises a VLCDR1 with...SEQ ID NO:23, a VLCDR2 with...SEQ ID NO:24, and a VLCDR3 with...SEQ ID NO:25... | The complaint alleges that the accused products are "aducanumab," which Plaintiffs contend is the antibody defined by the specific CDR sequences recited in the claim (Compl. ¶70). The infringement allegation is based on compositional identity. | ¶¶69, 70, 71 | col. 27:56-61 |
| wherein the antibody or fragment thereof further comprises a human IgG1 constant region or fragment thereof. | The accused products are alleged to be copies of Biogen's aducanumab, which is an antibody of the human IgG1 isotype (Compl. ¶¶1, 16, 69). | ¶¶69, 70, 71 | col. 119:25-27 |
Identified Points of Contention
- Factual Question: The central issue appears to be one of factual identity. The complaint relies on Defendant's marketing to allege that the accused products are aducanumab. The key question for the court will be whether discovery and analysis (e.g., amino acid sequencing) confirm that Defendant’s products possess the exact molecular structure, specifically the six CDR sequences, recited in Claim 1.
- Pleading Sufficiency Question: A potential threshold issue is whether the complaint's reliance on Defendant's marketing claims, without direct factual allegations about the antibody's composition, is sufficient to state a plausible claim for relief under the Twombly/Iqbal pleading standard.
V. Key Claim Terms for Construction
Because the asserted independent claim is a composition claim defined by specific amino acid sequences, the dispute may focus more on factual evidence of identity than on claim construction. However, the construction of certain functional terms could become relevant.
- The Term: "binds to beta amyloid"
- Context and Importance: This functional limitation defines the target of the claimed antibody. While the core of the case may be structural identity, if Defendant's product is shown to have minor structural differences, the parties might dispute whether it still "binds to beta amyloid" in the way contemplated by the patent. Practitioners may focus on this term to determine if the scope of binding is limited to specific forms of beta amyloid.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain language of the claim does not specify any particular conformation of beta amyloid (e.g., monomer, fibril, or plaque). This may support a construction that covers binding to any form of the protein.
- Evidence for a Narrower Interpretation: The patent specification repeatedly distinguishes the invention from prior art by emphasizing its specificity for pathological, aggregated forms of proteins over their normal, physiological counterparts ('367 Patent, col. 2:45-51). Figures and examples in the patent demonstrate preferential binding to amyloid plaques and fibrils, not monomers ('367 Patent, Figs. 6, 8). This evidence may support a narrower construction limited to pathological aggregates, which could be relevant for arguments regarding infringement or validity.
VI. Other Allegations
- Willful Infringement: The complaint alleges that Defendant's infringement is and has been willful (Compl. ¶74). This allegation is based on Defendant's alleged pre-suit knowledge of the ’367 patent, citing a demand letter sent by Biogen on October 18, 2019, and Defendant's subsequent failure to respond or cease its accused activities (Compl. ¶¶66-67).
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this dispute will likely depend on the answers to two primary questions:
- A core issue will be one of compositional identity: Does the Defendant's product, sold as "aducanumab," possess the exact heavy and light chain CDR amino acid sequences specified in Claim 1 of the ’367 patent? This is a central evidentiary question that will likely be resolved through scientific analysis of the accused products during discovery.
- A key procedural question will be one of pleading sufficiency: Does the complaint's assertion that Defendant markets its product using Plaintiffs' proprietary names ("aducanumab," "BIIB037") provide a sufficiently plausible factual basis for infringement to proceed, or is it merely a conclusory allegation that requires more direct structural evidence at the pleading stage?