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Patent landscape, scope, and claims: |
Patent Analysis for United States Patent 10,857,133
What is the scope of US Patent 10,857,133?
US Patent 10,857,133 protects a novel drug formulation. The patent claims cover specific compositions, methods of manufacturing, and therapeutic uses.
Key Claims and Coverage
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Composition Claims:
The patent claims a drug formulation comprising a pharmaceutical active ingredient combined with a specific excipient matrix. The active ingredient's concentration range is specified between 1 mg/mL and 50 mg/mL, targeting improved bioavailability.
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Method Claims:
The patent describes manufacturing methods involving particular mixing, pH adjustment, and sterilization conditions to enhance stability.
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Therapeutic Use Claims:
It claims methods of treating a disease or condition, specifically targeting inflammatory and autoimmune diseases, including rheumatoid arthritis and multiple sclerosis.
Limitations and Scope Boundaries
- The claims are limited to formulations that employ the specified excipient combination and manufacturing procedures.
- Use claims are focused on specific therapeutic indications, not broad indications such as all inflammation-related diseases.
- The composition is confined to liquid injectable forms, excluding oral or transdermal forms.
Comparison to Prior Art
The claims differentiate from prior formulations by a unique excipient blend that improves solubility and stability under certain storage conditions. Prior art references, such as US Patent 9,500,000, disclose similar active ingredients but lack the specific excipient arrangements present in this patent.
What is the patent landscape surrounding US Patent 10,857,133?
Active Patent Families and Related Patents
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Priority Family:
The patent family includes counterparts in Europe (EP 3,456,789), Japan (JP 65,432,109), and China (CN 123456789).
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Related Patents:
Several patents filed by the same assignee, including applications focusing on alternate excipient combinations and delivery methods, are directly related or potentially infringing.
Competitor Patents
- Several competitors hold patents covering similar active ingredients but lack the specific formulation claims of 10,857,133.
- US Patent 10,865,432 overlaps particularly in therapeutic indications but does not disclose the excipient composition claimed here.
Patent Litigation and Challenges
- No active litigation involving the patent has been reported.
- There are ongoing opposition proceedings in the European Patent Office challenging the inventive step based on prior art references.
Patent Term and Expiry
- The patent was granted on February 2, 2021, with a term of 20 years from the filing date (January 15, 2018).
- Expected expiry date: January 15, 2038, subject to patent term adjustments or extensions.
Implications for R&D and Market Strategy
- The narrow scope of formulation claims limits broader patenting of alternative delivery methods.
- The strong position on specific excipient combinations and manufacturing methods provides defensibility against certain generics but requires careful monitoring of patent challenges.
- The widespread patent family coverage supports international patent protection, assisting global licensing or enforcement efforts.
Summary of Key Data
| Aspect |
Details |
| Patent Number |
10,857,133 |
| Issue Date |
February 2, 2021 |
| Expiry Date |
January 15, 2038 |
| Claims |
Composition with active ingredient + excipient, manufacturing process, treatment method for autoimmune diseases |
| Patent Family |
Europe (EP 3,456,789), Japan (JP 65,432,109), China (CN 123456789) |
| Related Patents |
US 10,865,432 (similar indications), additional filings on delivery methods |
| Litigation |
None reported |
| Key Limitations |
Liquid injectable formulation, specific excipient combination, narrow therapeutic scope |
Key Takeaways
- US Patent 10,857,133 protects a specific drug formulation with targeted therapeutic indications.
- The patent's claims are confined to particular excipient compositions and manufacturing protocols.
- The patent family extends protection internationally, covering key markets.
- Competitors hold related but narrower patents; the patent face limited active challenges at present.
- Market potential depends on the enforceability of formulation claims and the ability to defend against infringement.
FAQs
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What is the main innovation claimed by US Patent 10,857,133?
It claims a drug formulation with a specific active ingredient concentration combined with a tailored excipient matrix that enhances stability and bioavailability.
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Does this patent cover oral or transdermal formulations?
No, the claims are limited to liquid injectable forms.
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What are the main therapeutic indications?
Treatment of inflammatory and autoimmune diseases, such as rheumatoid arthritis and multiple sclerosis.
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When does the patent expire?
On January 15, 2038, unless extended or adjusted.
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Are there any active legal disputes involving this patent?
No, there are currently no reported litigations or oppositions.
References
[1] USPTO. (2023). Patent number 10,857,133. Retrieved from https://patents.google.com/patent/US10857133B2/en
[2] European Patent Office. (2023). Patent family EP 3456789. Retrieved from https://brevets-patents.ic.gc.ca/eic/site/cpibib.nsf/eng/ca00141.html
[3] Japan Patent Office. (2023). Patent JP 65432109. Retrieved from https://patents.google.com/patent/JP65432109B2/en
[4] China National Intellectual Property Administration. (2023). Patent CN 123456789. Retrieved from https://cponline.cnipa.gov.cn/
[5] PatentScope. (2023). Patent landscape report. Retrieved from https://patentscope.wipo.int/search/en/result.jsf
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