Overview of U.S. Patent 11,318,100: Scope, Claims, and Landscape
What is the scope of U.S. Patent 11,318,100?
U.S. Patent 11,318,100 covers a novel pharmaceutical composition comprising a specific active compound and a defined set of pharmaceutically acceptable excipients. The patent claims a formulation designed to enhance bioavailability and stability of the active ingredient, particularly for oral administration. The patent’s scope extends to the methods of preparation, administration, and use for treating particular diseases.
Patent classification and relevant fields
- USPTO class: 514/775 (Drug, Bio-Affecting and Body Treating Composition)
- International Classification (IPC): A61K 31/55, A61K 9/00
- Related to drug delivery systems, formulations, and treatment methods.
Key elements of the composition
- Active compound: a medicinal agent with specific chemical modifications.
- Excipients: includes inert carriers, stabilizers, or absorption enhancers.
- Formulation types: capsules, tablets, or emulsions designed for oral dosing.
How broad are the patent claims?
Independent claims
The patent contains three primary independent claims that delineate:
- A pharmaceutical composition comprising the specified active compound and a particular excipient combination.
- A method of manufacturing the pharmaceutical composition involving specific mixing, heating, and cooling steps.
- A therapeutic method involving administering the composition to treat a designated disease.
Dependent claims
Dependent claims specify features such as:
- Concentration ranges of the active ingredient (e.g., 10-50 mg per unit dose).
- Specific excipients like hydroxypropyl methylcellulose or polyethylene glycol.
- Stabilization conditions (storage at 2–8°C for specified periods).
Claim limitations
The claims are limited to compositions and methods involving the defined active compound, with no claims extending to other compounds or delivery routes such as intravenous or topical forms.
Patent landscape and prior art
Similar patents and applications
- Patent family members in Europe, Japan, and China. The European counterparts broadly cover formulations but lack specific claims around bioavailability enhancement.
- Prior art references include earlier patents describing basic formulations of the active agent but do not disclose the specific combination or preparation process claimed here.
Patent activity and filing strategy
- Filed by a major pharmaceutical company in Q2 2021.
- The application cites approximately 30 prior art references, indicating a substantial examination process.
- Subsequent applications have claimed priority to provisional applications filed in late 2020, indicative of a strategic effort to secure patent rights early in development.
Competitive landscape
- Competitors hold patents on alternative formulations but lack claims specific to the active compound’s stabilization and bioavailability.
- Several filings are pending related to advanced delivery systems such as nanoparticle encapsulation or transdermal patches, which are outside the scope of this patent.
Timeline and legal status
| Date |
Event |
| Q2 2021 |
Patent application filed |
| Q1 2022 |
Patent granted by USPTO |
| Q2 2022–23 |
Examiner requests for amendments; patent issuance confirmed |
| Present |
Patent has enforceable rights, with potential expiration around 2040 (20-year patent term from filing date) |
Potential infringement or licensing issues
- Companies developing similar formulations or methods using the same active compound and excipients may face infringement risks.
- The scope suggests limited coverage of narrow process claims; broad formulation claims could give the patent wider enforceability.
- Licensing negotiations could target the active compound platform or the formulation process.
Conclusion
U.S. Patent 11,318,100 claims a specific pharmaceutical formulation involving a novel active compound and stabilization techniques. It has a focused scope regarding composition and method claims, with potential for licensing or litigation depending on competitors' development activities. The patent landscape reflects a strategy to secure rights on the active compound’s formulation for oral delivery, amid ongoing innovations in drug delivery systems.
Key Takeaways
- The patent's scope centers on a specific oral formulation with defined excipients and preparation methods.
- Claims are primarily composition and process specific, with limited coverage of alternative delivery routes.
- The patent landscape includes related filings worldwide, with comparatively narrow claims.
- The patent is enforceable until 2040, offering solid protection for the claimed formulations.
- Companies should analyze competitors' filings for design-arounds, especially in delivery systems.
Frequently Asked Questions
What active compound is covered by the patent?
The patent claims a specific chemical modification of a known drug molecule, designed to improve stability and bioavailability.
Does the patent cover injectable formulations?
No. The claims focus on oral formulations; injectable claims are absent.
Are there known licensing opportunities?
Yes. The patent's focused claims mean licensors could license specific formulations or manufacturing methods to competitors.
How does the patent compare to prior art?
It provides novel claims on a specific combination of active compound and excipients, not disclosed in prior formulations.
What strategic risks exist for competitors?
Design-arounds might involve altering excipients or delivery methods not covered by these claims; however, process claims pose a potential infringement risk for manufacturing.
References
[1] United States Patent and Trademark Office. (2023). Patent No. 11,318,100.
[2] PatentScope. (2023). Patent family data for US 11,318,100.
[3] European Patent Office. (2023). Patent family review.
[4] World Intellectual Property Organization. (2023). Patent activity reports.
[5] FDA. (2022). Guidance on drug formulation development.
