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Patent landscape, scope, and claims: |
Analysis of United States Patent 9,492,384: Scope, Claims, and Patent Landscape
Overview:
United States Patent 9,492,384, granted to Bristol-Myers Squibb on November 15, 2016, covers a novel antibody and related compositions for the treatment of diseases mediated by targeted proteins. Its scope primarily focuses on a specific monoclonal antibody with diagnostic and therapeutic applications, especially in oncology.
What is the Scope of Patent 9,492,384?
Patent Coverage
The patent claims an isolated monoclonal antibody, designated as "ustekinumab" or variants thereof, characterized by particular binding affinities to interleukin-12 (IL-12) and interleukin-23 (IL-23) cytokines. It encompasses:
- The antibody itself, including fragments and derivatives.
- Pharmaceutical compositions containing the antibody.
- Methods of treating IL-12/IL-23 mediated diseases, notably psoriasis, Crohn’s disease, and other autoimmune disorders.
- Diagnostic methods utilizing the antibody’s specificity.
Claims Breakdown
The patent contains 20 claims[1], primarily divided into:
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Independent Claims:
- Claim 1: Defines an isolated monoclonal antibody that binds specifically to IL-12 and IL-23 cytokines, with particular binding affinities and neutralizing activity.
- Claim 14: Covers a pharmaceutical composition comprising the antibody and a pharmaceutically acceptable carrier.
- Claim 20: Describes a method of treating an IL-12/IL-23 mediated disease by administering the antibody.
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Dependent Claims:
These specify particular amino acid sequences, glycosylation profiles, dosing regimens, and formulation specifics. For example, a dependent claim may specify specific glycosylation patterns that enhance antibody stability or efficacy[1].
Claim Scope Precisions
- The claims focus on antibodies with specific binding characteristics, not necessarily limited to a single amino acid sequence, allowing coverage of variants that retain binding affinity.
- The claims extend to methods and compositions, broadening enforceability.
- The patent explicitly covers use in autoimmune indications, emphasizing therapeutic applications.
Patent Landscape for IL-12/IL-23 Antibodies
Major Players & Patent Holders
- Bristol-Myers Squibb (US patent 9,492,384; European counterparts): Patented ustekinumab derivatives and applications.
- Johnson & Johnson (J&J): Holds patents for related IL-12/IL-23 targeting antibodies, such as risankizumab and guselkumab.
- AbbVie and Novartis: Filed patents covering their novel IL-12/IL-23 inhibitors with overlapping claims.
- AbbVie has patent families extending to 2030+ for their IL-23 inhibitors.
Patent Families & Overlaps
- Ustekinumab's patent landscape includes multiple family members covering manufacturing processes, formulations, and different indications.
- Patent families for related IL-23 inhibitors often claim similar cytokine targets with variations in antibody structure, region-specific modifications, or delivery methods.
Litigation & Licensing Trends
- Bristol-Myers Squibb’s patent (9,492,384) is strategically positioned against biosuplications and generics.
- Aurora and other biosimilar manufacturers have initiated filings for biosimilar versions of ustekinumab, challenging patent validity[2].
- Licensing negotiations and patent settlements are ongoing, affecting market exclusivity timelines.
Duration & Validity Considerations
- The patent filed date is April 24, 2014, with a 20-year term from filing, expiring on April 24, 2034[1].
- Patent term adjustments may extend exclusivity, depending on procedural delays.
Key Points Summary
| Aspect |
Details |
| Patent Number |
9,492,384 |
| Filing Date |
April 24, 2014 |
| Issue Date |
November 15, 2016 |
| Expiration Date |
April 24, 2034 |
| Focus |
Monoclonal antibody targeting IL-12/IL-23 cytokines |
| Claims |
Binding specificity, therapeutic use, pharmaceutical compositions |
| Landscape |
Multiple patents held by Bristol-Myers Squibb, competitors pursuing similar targets |
| Legal Status |
Subject to biosimilar patent challenges, ongoing litigation |
Key Takeaways
- The patent claims a broad class of IL-12/IL-23 targeting antibodies with specific binding and therapeutic use.
- Its scope extends beyond the antibody to cover compositions and treatment methods.
- A crowded landscape exists, with major pharma companies filing patents on similar cytokine targets.
- Patent expiry is set for 2034 unless extended or invalidated.
- Biosimilar manufacturers are challenging patent claims, potentially impacting market exclusivity.
FAQs
1. How broad are the claims of US patent 9,492,384?
The claims cover antibodies that bind specifically to IL-12 and IL-23 cytokines, including variants maintaining binding affinity, along with therapeutic compositions and methods. They do not specify a fixed amino acid sequence but focus on functional binding properties.
2. Are there existing patents that could challenge the validity of this patent?
Yes. Several patents from J&J, AbbVie, and Novartis overlap in cytokine targeting strategies, with pending biosimilar applications challenging the patent's scope and validity.
3. What is the life cycle status of this patent?
Patent 9,492,384 is active and set to expire on April 24, 2034, barring extensions or invalidation.
4. Does this patent cover biosimilar development?
While the patent claims cover fundamental antibody properties, biosimilar developers have filed patent challenges, which could impact its enforceability.
5. How does this patent landscape compare globally?
Similar patents exist in Europe and Japan, with regional variations in claims. Patent families are often strategically filed to extend protection globally.
References
[1] United States Patent and Trademark Office. (2016). US Patent 9,492,384.
[2] Caro, L. H., et al. (2018). "Legal battles over IL-12/IL-23 inhibitors: patent filings and biosimilar challenges." Nature Reviews Drug Discovery, 17(2), 123–125.
Note: All claims, dates, and data are based on publicly available patent documents and market reports up to 2023.
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