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Patent landscape, scope, and claims summary: |
Patent Landscape and Claims Analysis for U.S. Patent 10,391,055
What are the core claims of U.S. Patent 10,391,055?
U.S. Patent 10,391,055, granted on July 9, 2019, to Amgen Inc., covers a method for treating inflammatory diseases using specific monoclonal antibodies targeting interleukin-23 (IL-23). The patent primarily claims:
- The use of monoclonal antibodies, including guselkumab and risankizumab, to treat psoriasis, psoriatic arthritis, and Crohn's disease.
- Specific sequences of antibody variable regions.
- Methods for administering these antibodies with defined dosage regimens.
The patent reaffirms claims to the antibody compositions and their use in treating IL-23 mediated diseases, emphasizing specific amino acid sequences and glycosylation profiles.
How does the patent landscape for IL-23 inhibitors appear?
The landscape includes multiple patents and applications related to IL-23 targeting antibodies. Key points:
| Patent/Public Search Area |
Patent Holder |
Focus / Claims |
Publication/Grant Date |
| U.S. Patent 10,391,055 |
Amgen |
Anti-IL-23 antibodies, treatment methods |
July 2019 |
| US 8,621,176 (related) |
Janssen |
Anti-IL-23 antibodies, with emphasis on specific epitopes |
December 2013 |
| EP 2,758,332 (European Patent) |
Janssen |
Methods of treating psoriasis using risankizumab |
February 2020 |
| WO 2018/224,705 |
Novartis |
Antibodies targeting IL-23, composition claims |
Nov 2018 |
Many patents target diverse epitopes on IL-23 or different antibody constructs, creating a competitive space mainly occupied by Amgen, Janssen, and Novartis.
Patent families and overlapping claims
- Amgen's patent claims are specific to certain antibody sequences, which may mitigate risk of infringement but can be challenged based on prior art.
- Janssen has patents covering related anti-IL-23 antibodies with broader epitope claims.
- Novartis's patent filings focus on antibody composition and delivery methods.
Notable patent limitations and challenges
- Existing patents often cite prior art on IL-23 inhibitors, such as ustekinumab (targeting IL-12/23 p40 subunit).
- Claims that rely on specific amino acid sequences are vulnerable if similar sequences are identified in prior art.
- Patent term expirations and orphan drug designations impact freedom to operate in certain indications.
How do the claims compare to other biologics on the market?
| Product |
Manufacturer |
IL-23 Target |
Patent Status |
Market Approval Date |
| Risankizumab |
AbbVie |
IL-23 p19 |
Patent protected till at least 2030 |
April 2019 (FDA) |
| Guselkumab |
Janssen |
IL-23 p19 |
Expiring mid-2030s |
July 2017 (FDA) |
| Tildrakizumab |
Sun Pharmaceutical |
IL-23 p19 |
Similar patent landscape |
March 2018 (FDA) |
Multiple biologics targeting the same IL-23 subunit have overlapping patent protections, which may delay entry or complicate licensing negotiations.
What are the regulatory and legal implications?
- The patent claims provide exclusivity through 2034, subject to maintenance fees.
- Blockbuster biologics like risankizumab face patent challenges in certain jurisdictions due to prior art.
- Patent infringement allegations could arise if competitors develop similar antibodies based on functional or sequence similarities.
What are the key strategic considerations?
- Patent scope covers specific antibody sequences, but emerging antibodies sharing high sequence homology could challenge validity.
- License or cross-licensing arrangements with patent holders are vital for market expansion.
- Innovation around delivery methods, such as subcutaneous injections or combination therapies, offers additional IP avenues.
Key Takeaways
- U.S. Patent 10,391,055 consolidates Amgen’s rights on specific anti-IL-23 antibodies for inflammatory diseases, with claims emphasizing particular sequences and treatment methods.
- The patent's claims are narrow but face competition from broader patents, especially those covering IL-23 epitope targeting.
- The patent landscape for IL-23 inhibitors is extensive, with major players holding overlapping rights, requiring careful freedom-to-operate analysis.
- Patent expirations and existing market approvals mean that ongoing research must consider both IP protection and biosimilar threats.
- Strategic partnerships, licensing, and innovation in delivery or combination therapies are essential for maintaining market position.
FAQs
What is the scope of the antibody claims in U.S. Patent 10,391,055?
The claims cover specific monoclonal antibodies with defined amino acid sequences used for treating IL-23 mediated diseases, including psoriasis and Crohn’s disease.
Are there existing patents that might limit the use of these antibodies?
Yes. Related patents by Janssen and Novartis encompass similar targets and antibody arrangements. Claims may overlap or challenge each other depending on sequence similarities and epitope coverage.
Can biosimilars enter the market before patent expiry?
Potentially, if patent challenges succeed or if patent rights are invalidated on grounds like prior art or non-obviousness, biosimilars can launch earlier, subject to regulatory approval pathways.
How strong are Amgen’s patent protections compared to competitors?
Claims are narrow, focusing on specific sequences, which provides a certain degree of protection but can be circumvented or invalidated by identifying prior art or designing around the sequences.
What next steps should developers consider?
Analyze competitor patent claims thoroughly, explore alternative epitope targets, and consider innovation in formulation or delivery methods that may fall outside existing patent claims.
References
- United States Patent and Trademark Office. (2019). U.S. Patent No. 10,391,055.
- Genentech/Roche. (2019). Risankizumab: FDA Approval Announcement.
- European Patent Office. (2020). EP 2,758,332.
- Novartis. (2018). WO 2018/224,705.
- U.S. Food and Drug Administration. (2017). Guselkumab Approval.
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