DCT
1:22-cv-01549
Janssen Biotech Inc v. Amgen Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Janssen Biotech, Inc. (Pennsylvania)
- Defendant: Amgen Inc. (Delaware)
- Plaintiff’s Counsel: McCarter & English, LLP; Latham & Watkins LLP
- Case Identification: 1:22-cv-01549, D. Del., 11/29/2022
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Amgen Inc. is a Delaware corporation and therefore resides in the judicial district.
- Core Dispute: Plaintiff alleges that Defendant’s proposed biosimilar drug, ABP 654, will infringe two patents that claim the biologic drug STELARA® (ustekinumab) and its use in treating ulcerative colitis.
- Technical Context: The technology concerns a fully human monoclonal antibody that targets the IL-12/IL-23 pathway, a key mediator of inflammation in various autoimmune diseases.
- Key Procedural History: This action arises under the Biosimilar Price Competition and Innovation Act (BPCIA). Plaintiff states that Defendant provided a 180-day notice of commercial marketing for its biosimilar product but declined to provide its regulatory application (aBLA) to Plaintiff, a step contemplated by the BPCIA's "patent dance" information exchange procedures.
Case Timeline
| Date | Event |
|---|---|
| 2000-08-07 | U.S. Patent No. 6,902,734 Priority Date |
| 2005-06-07 | U.S. Patent No. 6902734 Issues |
| 2009-09-01 | STELARA® first approved by FDA for plaque psoriasis |
| 2018-09-24 | U.S. Patent No. 10,961,307 Priority Date |
| 2019-10-01 | FDA approves STELARA® for treating ulcerative colitis |
| 2021-03-30 | U.S. Patent No. 10961307 Issues |
| 2022-11-03 | Alleged latest date of Amgen's aBLA submission to FDA |
| 2022-11-07 | Amgen provides 180-day notice of commercial marketing |
| 2022-11-29 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,902,734 - "Anti-IL-12 Antibodies and Compositions Thereof"
The Invention Explained
- Problem Addressed: The patent's background describes the need for therapeutic agents that can modulate the activity of Interleukin-12 (IL-12), a cytokine central to mediating cellular immune responses, to address diseases where such responses are pathological. (’734 Patent, col. 1:21-49). A further problem addressed is the immunogenicity of non-human antibodies, creating a need for human antibodies that can avoid adverse immune reactions in patients. (’734 Patent, col. 2:1-18).
- The Patented Solution: The invention provides an isolated, fully human monoclonal antibody that specifically binds to the human IL-12 protein. The patent claims the antibody by defining the precise amino acid sequences of its heavy and light chain variable regions—the portions of the antibody responsible for antigen binding. (’734 Patent, Abstract; col. 6:21-49).
- Technical Importance: The invention provides a composition of matter for a fully human antibody against a key inflammatory target, which was designed to offer therapeutic benefits with potentially lower immunogenicity than prior-art chimeric or murine antibodies. (’734 Patent, col. 5:46-59).
Key Claims at a Glance
- The complaint asserts infringement of at least Claim 1 (Compl. ¶42).
- The essential elements of independent Claim 1 are:
- An isolated anti-IL-12 antibody,
- comprising a heavy chain variable region (VH) of the amino acid sequence set forth in SEQ ID NO:7
- and a light chain variable region (VL) of the amino acid sequence set forth in SEQ ID NO:8.
U.S. Patent No. 10,961,307 - "Methods of Treating Moderately to Severely Active Ulcerative Colitis by Administering an Anti-IL12/IL23 Antibody"
The Invention Explained
- Problem Addressed: The patent addresses an unmet need for effective therapies for patients with moderately to severely active ulcerative colitis (UC), particularly those who have had an inadequate response to or are intolerant of conventional treatments such as anti-TNF biologics. (’307 Patent, col. 2:21-38).
- The Patented Solution: The invention is a method of treating UC by administering a specific anti-IL-12/IL-23p40 antibody (ustekinumab). The patent claims this method by defining the antibody through its complementarity-determining regions (CDRs) and full amino acid sequences, and by further requiring that the treatment result in a specified positive clinical outcome for the patient, such as clinical remission or endoscopic healing. (’307 Patent, Abstract; FIG. 1).
- Technical Importance: This patent provides method-of-use protection for a known biologic drug (ustekinumab) for a new therapeutic indication (UC), extending patent coverage to a specific application of the drug.
Key Claims at a Glance
- The complaint asserts infringement of at least Claim 3, which depends from independent Claim 1 (Compl. ¶77).
- The essential elements of independent Claim 1 are:
- A method of treating moderately to severely active ulcerative colitis (UC) in a subject in need thereof,
- comprising administering to the subject a pharmaceutical composition comprising a clinically proven safe and effective amount of an anti-IL-12/IL-23p40 antibody,
- wherein the antibody comprises a heavy chain variable region with specific CDRH1, CDRH2, and CDRH3 amino acid sequences (SEQ ID NO:1-3),
- and a light chain variable region with specific CDRL1, CDRL2, and CDRL3 amino acid sequences (SEQ ID NO:4-6),
- wherein after treatment, the subject is a "responder to treatment" by at least one of seven specified clinical measures of response.
III. The Accused Instrumentality
Product Identification
- Defendant Amgen's proposed biosimilar product, ABP 654 (Compl. ¶2).
Functionality and Market Context
- ABP 654 is described as a "biosimilar" copy of Plaintiff's STELARA® product, meaning it is designed to have the same amino acid sequence as STELARA®'s active ingredient, ustekinumab, and to be highly similar in its physical and biological properties (Compl. ¶2, ¶41).
- The complaint alleges that ABP 654 will have the same pharmaceutical form, dosage strength, route of administration, and dosing regimen as STELARA® (Compl. ¶19). It further alleges Defendant intends to market ABP 654 for all FDA-approved indications for STELARA®, which includes plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis (Compl. ¶4, ¶17).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
U.S. Patent No. 6,902,734
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An isolated anti-IL-12 antibody, | The complaint alleges on information and belief that the active ingredient in ABP 654 is an isolated anti-IL-12 antibody, as it must be highly similar to STELARA®'s active ingredient, ustekinumab (Compl. ¶43). | ¶43 | col. 6:21-23 |
| comprising a heavy chain variable region (VH) of the amino acid sequence set forth in SEQ ID NO:7 | The complaint alleges that as a biosimilar to STELARA®, the active ingredient in ABP 654 has the same heavy chain variable region sequence as ustekinumab, which is recited as SEQ ID NO:7 (Compl. ¶44). | ¶44 | col. 55:20-56:1 |
| and a light chain variable region (VL) of the amino acid sequence set forth in SEQ ID NO:8. | The complaint alleges that as a biosimilar to STELARA®, the active ingredient in ABP 654 has the same light chain variable region sequence as ustekinumab, which is recited as SEQ ID NO:8 (Compl. ¶44). | ¶44 | col. 56:1-19 |
Identified Points of Contention
- Scope Questions: The central issue may be one of factual identity. The regulatory standard for a "biosimilar" requires the product to be "highly similar" to the reference product, but not necessarily identical. The question for the court will be whether the amino acid sequence of Amgen's ABP 654 is, in fact, identical to the sequences recited in Claim 1 of the ’734 Patent.
- Technical Questions: A potential point of contention could be whether any minor differences in post-translational modifications, such as glycosylation, between ABP 654 and ustekinumab are sufficient to place ABP 654 outside the literal scope of the claims, even if the primary amino acid sequence is identical.
U.S. Patent No. 10,961,307
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating moderately to severely active ulcerative colitis (UC) in a subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising a clinically proven safe and clinically proven effective amount of an anti-IL-12/IL-23p40 antibody... [with specified CDRs]... | The complaint alleges that Amgen intends to market ABP 654 with a label directing its use for treating UC, thereby inducing medical professionals to administer the product, which is alleged to be the claimed antibody, ustekinumab (Compl. ¶76, ¶78). | ¶76, ¶78 | col. 3:21-46 |
| wherein after treating with the antibody, the subject is a responder to treatment by at least one measure of response to treatment selected from the group consisting of: (i) clinical remission... (ii) endoscopic healing... [etc.] | The complaint alleges that Amgen's label for ABP 654 will indicate that patients will achieve the same or highly similar clinical responses as those for STELARA®, and that these described responses meet the definitions of a "responder" as recited in the claim (Compl. ¶80-81). | ¶80-81 | col. 3:50-col. 4:1 |
Identified Points of Contention
- Scope Questions: The infringement theory for the ’307 Patent is inducement. A key question will be whether the language on Amgen's FDA-approved label for ABP 654 will actively encourage, recommend, or promote the specific method of treatment claimed, thereby inducing direct infringement by physicians and patients.
- Technical Questions: A potential dispute may arise over whether the clinical outcomes described on the ABP 654 label will map precisely onto the detailed definitions of a "responder" as laid out in the seven sub-parts of Claim 1. Any variance between the label's description of efficacy and the patent's claimed outcomes could be a point of contention.
V. Key Claim Terms for Construction
"isolated" (’734 Patent, Claim 1)
- Context and Importance: This term modifies "anti-IL-12 antibody." Its construction is important because the nature of a biologic's manufacturing process could be used to argue that the resulting product is not "isolated" in the sense required by the patent, potentially avoiding infringement. Practitioners may focus on this term to determine if it imparts a specific purity level or requires separation from particular contaminants that could be a basis for a non-infringement argument.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification does not appear to provide a special definition for "isolated," which may suggest it should be given its plain and ordinary meaning to one of skill in the art—generally, being separated from its natural environment.
- Evidence for a Narrower Interpretation: The specification describes the production of antibodies using recombinant host cells (e.g., CHO cells) (’734 Patent, col. 45:1-46:54). A defendant might argue that "isolated" should be construed in light of these examples to mean separated from all or substantially all components of the host cell culture medium, a standard that could be contested.
"responder to treatment" (’307 Patent, Claim 1)
- Context and Importance: This term is explicitly defined by a list of seven alternative clinical outcomes. Infringement requires that the induced method results in a patient being a "responder." The dispute will center on whether the actions encouraged by the accused product's label inevitably lead to outcomes that meet at least one of these seven specific definitions.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language states the subject must be a responder "by at least one measure of response," indicating that meeting any single one of the seven listed criteria is sufficient to satisfy this limitation.
- Evidence for a Narrower Interpretation: Each of the seven criteria includes precise clinical language (e.g., "clinical remission based on... Mayo score ≤2 points with no individual subscore >1"). A defendant may argue that these definitions must be strictly construed and that its product label might describe clinical outcomes using different metrics that do not literally read on these definitions.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for the ’734 patent (Compl. ¶48). For the ’307 method patent, the core allegation is induced infringement, based on the assertion that Amgen's product label will instruct medical professionals and patients to use ABP 654 in the patented manner (Compl. ¶84).
- Willful Infringement: The complaint alleges that Amgen is aware of the patents-in-suit, citing a November 11, 2022 email from Janssen's counsel as providing notice, in addition to the filing of the complaint itself (Compl. ¶49, ¶85). It asserts that Amgen is acting with knowledge or willful blindness to the alleged infringement.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue for the composition patent will be one of molecular identity: will discovery reveal that Amgen's ABP 654 possesses the exact heavy and light chain variable region sequences defined in Claim 1 of the ’734 patent, or are there differences in the primary amino acid sequence or post-translational modifications sufficient to place it outside the claim's literal scope?
- A key evidentiary question for the method-of-use patent will be one of induced conduct: does the language of Amgen’s future FDA-approved label for ABP 654 actively instruct or encourage physicians to administer the drug for ulcerative colitis in a way that satisfies all the specific administration and clinical outcome limitations of the asserted claims in the ’307 patent?