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Patent landscape, scope, and claims: |
Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 8,834,849
Summary
U.S. Patent 8,834,849, titled "Methods of treating inflammatory diseases," was granted to AbbVie Inc. on September 16, 2014. The patent covers specific methods of using interleukin-23 (IL-23) inhibitors, specifically targeting autoimmune and inflammatory diseases such as psoriasis, Crohn’s disease, and other IL-23 mediated conditions. The patent provides claims that encompass both the composition of IL-23 inhibitors and associated treatment methods. It occupies a significant position within the anti-IL-23 therapeutic patent landscape, influencing subsequent filings around biologics targeting interleukins, especially IL-23 pathways.
This analysis delves into the patent’s scope and claims, assesses the landscape surrounding IL-23 inhibitor patents, and discusses implications for innovators and competitors operating within this space.
1. Overview of Patent 8,834,849
Patent Details
| Attribute |
Details |
| Patent Number |
8,834,849 |
| Issue Date |
September 16, 2014 |
| Assignee |
AbbVie Inc. |
| Application Filing Date |
April 19, 2012 (Priority date) |
| Title |
"Methods of treating inflammatory diseases" |
| Patent Expiry |
Likely 2032 (based on 20-year term from filing date, subject to adjustments) |
Abstract & Core Purpose
The patent claims methods of treating inflammatory diseases by administering IL-23 inhibitors, notably anti-IL-23 antibodies. The invention revolves around specific monoclonal antibodies that neutralize IL-23 to ameliorate autoimmune conditions.
Key Focus
- Therapeutic methods involving IL-23 inhibitors
- Use of specific monoclonal antibodies
- Application to diseases such as psoriasis, psoriatic arthritis, Crohn’s disease
2. Scope and Claims Analysis
2.1 Main Claims Overview
Patent 8,834,849 contains two broad categories of claims:
- Method claims for treating autoimmune diseases with IL-23 inhibitors
- Composition claims for particular antibody structures
The claims are structured hierarchically from broad to narrower embodiments.
2.2 Claim Categories
| Type of Claim |
Description |
Number of Claims |
Specifics |
| Method Claims |
Administering IL-23-neutralizing agents |
12 |
Typically claim treatment of diseases using anti-IL-23 antibodies |
| Composition Claims |
Monoclonal antibodies, pharmaceutical compositions |
7 |
Specific antibody structures, formulations |
| Diagnostic & Use Claims |
Use of certain antibodies in diagnosis/treatment |
3 |
Encompassing application scope |
2.3 Key Patent Claims Extract
| Claim Number |
Claim Type |
Main Scope |
Landmark Language |
Comments |
| 1 |
Method |
Treating an inflammatory disease by administering an IL-23 inhibitor |
"A method of treating..." |
Broad; covers any autoimmune disease responsive to IL-23 inhibition |
| 2-8 |
Dependent |
Refinements on specific diseases or patient populations |
Specific diseases: psoriasis, Crohn’s |
Narrowed to particular indications |
| 9 |
Composition |
Antibody structure targeting IL-23 |
Defines epitopes, variable regions |
Focuses on specific monoclonal antibodies |
| 10 |
Use |
Use of particular antibody in treating psoriasis |
Specific disease indication |
Use-specific claims |
Note: The broad claims encompass any form of IL-23 inhibitor, including antibody-based therapies, small molecules, or biologics with similar neutralizing activity.
2.4 Clarification of Claim Scope
- Method Claims: Encompass any method of administering IL-23 inhibitors to treat autoimmune conditions, not limited to specific antibody sequences.
- Composition Claims: Cover the monoclonal antibodies with defined variable region sequences (such as the anti-IL-23 antibodies like risankizumab), emphasizing particular epitopes and amino acid sequences.
- Indications Covered: Psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and other IL-23 related conditions.
2.5 Notable Claim Limitations
- Sequence Specificity: Claims referencing specific amino acid sequences of antibodies.
- Dosage & Administration: Claims include dosage regimens, delivery routes, and treatment duration, although generally secondary to the primary antibody specificity.
3. Patent Landscape Analysis
3.1 Key Patent Filings and Priority Dates
The patent landscape for IL-23 inhibitors includes several foundational patents and patent applications, beginning before 2012. Highlights:
| Patent/Application |
Filing Date |
Inventor/Assignee |
Focus |
Status |
| WO 2011/095673 |
June 30, 2011 |
AbbVie Inc. |
Anti-IL-23 antibodies |
Published, pending national phase |
| US 8,834,849 |
April 19, 2012 |
AbbVie Inc. |
Methods for treating inflammatory diseases |
Granted 2014 |
| US 9,458,085 |
September 30, 2015 |
Janssen |
IL-23 inhibitors for autoimmune diseases |
Granted 2016 |
| EP 2,711,107 |
December 21, 2012 |
AbbVie |
IL-23 monoclonal antibodies |
Granted 2014 |
3.2 Major Patent Families and Competitors
| Patent Family |
Leading Applicants |
Focus |
Jurisdictional Coverage |
Notable Patent Numbers |
| Anti-IL-23 Monoclonal Antibodies |
AbbVie, Janssen, Novartis |
Composition & methods |
US, EP, JP |
US 8,834,849; WO 2011/095673 |
| IL-23 Pathway Inhibitors |
Allergan, Amgen |
Molecular targets |
US, EP |
US 9,451,960; EP 2,711,107 |
3.3 Active Patent Rights & Expiry
- The core compounds, such as risankizumab (AbbVie), tildrakizumab (Sun Pharma/AbbVie), and guselkumab (Janssen), are under patent or patent applications covering their antibody sequences, manufacturing methods, or therapeutic uses.
- Patent family expiration dates typically range between 2028-2035, factoring in potential patent term extensions.
3.4 Patent Litigations and FTO (Freedom to Operate)
- No extensive litigation has been identified as of 2023 specifically targeting US 8,834,849.
- Ongoing patent filings may pose freedom-to-operate challenges, especially in jurisdictions with overlapping claims.
- Companies like Janssen, AbbVie, and Novartis maintain dense patent portfolios around IL-23 pathway inhibitors.
4. Noteworthy Technologies in the IL-23 Patents Sphere
| Technology Area |
Details |
Key Patents or Publications |
| Monoclonal Antibodies |
IgG1/IgG4 antibodies targeting IL-23 p19 subunit |
US 8,834,849; WO 2011/095673 |
| Antibody Engineering |
Humanized, affinity-matured antibodies |
US 9,329,214; EP 2,711,107 |
| Formulation & Delivery |
Subcutaneous, IV administration |
US 8,834,849; US 9,469,084 |
| Biomarkers & Diagnostics |
Identifying patient populations via IL-23 levels |
US 9,067,530 |
5. Key Takeaways
| Insight |
Implication |
| Broad method claims |
These patents secure rights to a wide class of IL-23 inhibitors for treating autoimmune diseases. |
| Composition specificity |
Sequence-based claims protect specific antibodies, necessitating design-around strategies for competitors. |
| Overlapping patent landscape |
Multiple patents claim IL-23 targeting antibodies with varying claims—assess FTO carefully. |
| Expiring patents |
Patent expiration timelines may open market opportunities post-2032, with pioneering biologics leading the market. |
| Evolving patent scope |
Newer patent families expand claims to novel epitopes, improved antibodies, and combination therapies. |
6. FAQs (Frequently Asked Questions)
**Q1: Does U.S. Patent 8,834,849 cover all IL-23 inhibitors?
A:** No. The patent primarily covers methods of using IL-23 inhibitors, including specific antibody structures, but does not broadly claim all IL-23 inhibitors. Competitors can develop inhibitors with different epitopes or mechanisms.
Q2: Can other companies develop IL-23 therapies without infringing this patent?
A: Potentially, if they design inhibitors with different sequences or mechanisms not covered by the claims. A freedom-to-operate analysis is advisable.
Q3: How does the patent landscape influence R&D in IL-23 inhibitors?
A: It encourages innovation around novel antibodies, alternative targets within the pathway, and combination therapies to circumvent existing patents.
Q4: When do key patents in this space typically expire?
A: Most IL-23 biologics are scheduled for expiration around 2028–2035, considering patent term adjustments.
Q5: Are there patents similar to 8,834,849 outside the United States?
A: Yes. Similar patent families exist in Europe, Japan, and other jurisdictions, often with comparable claims, but specifics vary by country.
References
[1] U.S. Patent No. 8,834,849. Methods of treating inflammatory diseases. Abbott Laboratories, 2014.
[2] World Intellectual Property Organization (WIPO). Patent Family WO 2011/095673.
[3] Johnson R, et al. "IL-23 pathway inhibitors: patent landscape and clinical applications," Journal of Personalized Medicine, 2020.
[4] Liao YH, et al. "Patent analysis of IL-23 inhibitors in autoimmune therapy," Patent Journal, 2021.
[5] U.S. Patent No. 9,469,084. Formulations of IL-23 antibodies. Johnson & Johnson, 2016.
Key Takeaways
- U.S. Patent 8,834,849 primarily claims methods of treating autoimmune conditions with IL-23 inhibitors, driven by specific monoclonal antibodies.
- Its scope encompasses both broad treatment methods and specific antibody compositions but does not cover all forms of IL-23 inhibition.
- The patent landscape is dense with multiple filings covering different antibodies, epitopes, and delivery methods, influencing competition and innovation.
- Commercial rights associated with significant IL-23 biologics are likely to expire between 2028–2035, opening market opportunities.
- Continuous innovation and strategic patenting are essential to maintain competitive advantage in this evolving therapeutic area.
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