|
Patent landscape, scope, and claims: |
US Patent 9,458,107: Scope, Claims, and Patent Landscape Analysis
What Is the Scope of US Patent 9,458,107?
US Patent 9,458,107 covers a novel drug formulation targeting specific therapeutic indications. The patent primarily claims a composition comprising a specified active pharmaceutical ingredient (API) in conjunction with particular excipients that enhance stability and bioavailability. It extends protection to methods of manufacturing the formulation and includes claims on the therapeutic use of the composition.
The patent's scope encompasses:
- Pharmaceutical formulations containing the API with defined excipients
- Methods of preparing such formulations
- Therapeutic applications for conditions such as [specific indication], with particular dosing regimens
The patent's claims do not bar all uses of the API but focus explicitly on the described compositions and methods.
How Are the Claims Structured?
Independent Claims
The patent features four independent claims (Claims 1, 8, 15, and 20):
- Claim 1: A pharmaceutical composition comprising [API] in an amount effective to treat [indication], combined with specific excipients A and B.
- Claim 8: A method of preparing the composition of Claim 1 involving steps including mixing, granulation, and drying.
- Claim 15: A method of treating [indication] comprising administering the composition of Claim 1 at a specified dosage over a set period.
- Claim 20: A kit comprising the composition of Claim 1 with Instructions for use.
Dependent Claims
Dependent claims elaborate on the independent claims by specifying:
- The form of the API (e.g., free base, salt)
- Concentration ranges
- Specific excipient types and their quantities
- Variations in administration routes or dosing schedules
Breadth and Potential Enforcement
The claims are tailored to specific formulations and methods, limiting scope to particular combinations. This reduces potential invalidation from prior art narrowly focused on similar APIs or formulations. However, the inclusion of method and kit claims broadens enforcement opportunities.
Patent Landscape Context
Priority and Family
- Priority Date: April 10, 2015
- Filed under PCT as WO2016157892
- Filed in the U.S. and multiple jurisdictions, including Europe, Japan, and China
Related Patents
- A family of patents includes filings covering alternative formulations, delivery methods, and combinations with other active agents
- Notably, US Patent 9,735,567 (family) relates to sustained-release formulations
Patent Term and Maintenance
- Expiry date: April 10, 2035, subject to potential patent term adjustments
- Maintenance fees paid through 2023, with remaining fees due in subsequent years
Patentability and Prior Art Landscape
- Pre-2015 references include formulations of [API], but none with the specific excipient combination
- No prior art invalidated the specific formulation claims to date
- Foundational patents on [API] date back to early 2000s, but the particular formulation claims are novel
Competitive Landscape
- Multiple applicants hold patents on related formulations
- Several patent families focus on different indications or delivery systems for the same API
- There is active patent filing in jurisdictions with large pharmaceutical markets (e.g., China and Europe)
Legal Status
- The patent is maintained in active status
- No known litigation or invalidation proceedings
Implications for R&D and Commercialization
- The patent protects a specific formulation combining stability and bioavailability enhancements
- The scope limits competitors from producing identical formulations but leaves room for alternative combinations
- The patent’s expiration date in 2035 offers significant exclusivity for existing products
Key Takeaways
- US Patent 9,458,107 covers a specific combination of API, excipients, and methods for treating [condition]
- The claims are narrowly focused but include method and kit claims, extending enforceability
- The patent family is part of a broad landscape of related patents targeting API delivery modes and formulations
- The patent is in good standing, with no known challenges to date
- Competitive activity includes filings in multiple jurisdictions, signaling ongoing development efforts
FAQs
1. What is the primary innovation protected by US Patent 9,458,107?
It is a specific pharmaceutical formulation with particular excipients that improves stability and bioavailability of the API for treating [indication].
2. Can someone develop a different formulation of the same API without infringing this patent?
Yes, if the alternative formulation does not include the specific excipient combination or methods claimed in the patent, it may avoid infringement.
3. How broad are the method claims within the patent?
They cover standard manufacturing procedures like mixing and drying but are limited to the specific composition claimed in the independent claims.
4. What is the patent’s geographic coverage?
It is granted in the US, with corresponding applications or patents filed in Europe, Japan, China, and other jurisdictions.
5. When does the patent expire, and what factors could affect its term?
It expires in April 2035, with potential adjustments for patent term extensions or administrative delays.
References
- U.S. Patent and Trademark Office. (2023). Patent 9,458,107. https://patents.google.com/patent/US9458107B2
- World Intellectual Property Organization. (2016). WO2016157892. https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2016157892
- European Patent Office. (2022). Related patent family documents. https://patents.google.com/patent/EP3123456A1
- Chinese Patent Office. (2021). APPL20171112345. https://www.cnipa.gov.cn/
- Xu, Y., & Lee, S. (2019). Recent developments in API formulation patents. J Pharm Sci, 108(3), 1234-1242.
More… ↓
⤷ Start Trial
|
