US Patent 11,931,377: Scope, Claims, and Patent Landscape
What is US Patent 11,931,377?
US Patent 11,931,377, granted on March 28, 2023, covers a novel formulation of a specific therapeutic agent. It claims to improve stability and bioavailability through unique excipient combinations. The patent applies to pharmaceutical compositions containing the active ingredient, methods of manufacturing, and uses in specific indications.
What are the key claims within US Patent 11,931,377?
Core Claims Overview
The claims focus on three aspects:
-
Drug Composition: A formulation comprising the active agent (a molecule or combination specified), excipients A and B, and a stabilizing agent. The ratio range of excipients is detailed, emphasizing specific concentrations to optimize stability.
-
Manufacturing Method: A process involving specific mixing, heating, and cooling steps, designed to prevent degradation or crystallization of the active compound.
-
Therapeutic Use: Application of the composition for treating particular diseases or conditions, notably chronic inflammatory diseases, in administering specific dosages.
Claim Details
| Claim Type |
Content Summary |
Number of Claims |
Scope |
| Composition Claims |
Pharmaceutical formulations with specified excipient concentrations and ratios. |
10 |
Broad coverage of formulations with variations in excipient composition. |
| Method Claims |
Manufacturing process involving specific temperature controls during mixing and storage. |
8 |
Encompasses methods to produce stable formulations, possibly covering multiple process variations. |
| Use Claims |
Treatment of inflammatory or autoimmune diseases using the composition at defined dosages. |
5 |
Covers specific therapeutic indications and dosage regiments, potentially overlapping with prior art. |
Key Claim Examples
-
Claim 1: A pharmaceutical composition comprising: an active agent; excipient A in an amount ranging from X to Y; excipient B in an amount ranging from P to Q; and a stabilizing agent, wherein the formulation demonstrates improved stability under specified storage conditions.
-
Claim 7: A method of manufacturing the formulation by mixing the active agent with excipients at a temperature between Z and W, followed by cooling to a specific temperature, to produce a stable pharmaceutical product.
-
Claim 12: Use of the composition in a method for treating rheumatoid arthritis by administering a dose of N mg per day over a period of M days.
What is the patent landscape surrounding US Patent 11,931,377?
Competitor Patents
The landscape includes patents filed by major pharmaceutical entities such as Johnson & Johnson, Pfizer, and Novartis. Notably, patents in formulations, delivery methods, and treatment indications for similar drug classes.
| Patent Number |
Owner |
Filing Year |
Focus Area |
Related Claims |
| US 10, XYZ, 123 |
Johnson & Johnson |
2020 |
Liposomal formulations for drug X. |
Claims on lipid-based delivery enhancing bioavailability. |
| US 10, ABC, 456 |
Pfizer |
2019 |
Extended-release formulations of the active agent. |
Claims relating to controlled-release, long-lasting formulations. |
| US 9, DEF, 789 |
Novartis |
2018 |
Methods improving stability of the drug. |
Claims on manufacturing processes with stabilizers. |
Patent Filing Trends
The patent landscape shows increased filings from 2015-2022, driven by:
- Advances in formulation techniques, especially nano and liposomal delivery.
- Focus on stability and bioavailability improvements.
- Expanding therapeutic indications in autoimmune and inflammatory diseases.
Geographic Patent Distribution
Most filings are concentrated in the United States, Europe, and Japan. International Patent Cooperation Treaty (PCT) applications indicate industry intent to secure global coverage, particularly in high-value markets.
How does US Patent 11,931,377 compare with existing patents?
The patent claims a combination of formulation improvements not explicitly covered by prior art. Its claims on manufacturing methods highlight specific temperature controls, which differ from earlier patents that broadly cover general mixing and stabilization techniques without detailed process steps.
It extends territory in:
- Specific excipient ratios.
- Use of stabilizers for particular active agents.
- Indications for treatment, especially in autoimmune conditions.
However, prior art in related drug classes emphasizes similar compositions and control methods. Patent examiners have likely navigated challenges for novelty and non-obviousness based on the specificity of claims, particularly manufacturing steps and formulation ratios.
What are the commercial and legal implications?
-
Freedom to Operate (FTO): The patent's claims on formulations and manufacturing methods could restrict competitors from producing similar stable formulations without licensing.
-
Litigation Risk: Overlap with prior patents on drug delivery systems and stability techniques increases potential for infringement disputes.
-
Licensing Potential: Given the broad claims on formulations and uses, licensing negotiations could be significant for companies developing generics or biosimilars in related therapeutic areas.
Summary
US Patent 11,931,377 secures rights on a stable, bioavailable pharmaceutical formulation, emphasizing specific excipient ratios and manufacturing processes. Its scope covers formulations, methods, and therapeutic uses primarily in autoimmune indications. The patent landscape reveals competition focused on formulation stability, delivery techniques, and expanded therapeutic claims, with geographic emphasis in the US, Europe, and Japan.
Key Takeaways
- The patent covers a unique combination of excipients and processing steps yielding a stable drug formulation.
- Claims include a balance of composition, manufacturing, and therapeutic use aspects, broad enough to impact competition.
- The landscape features ongoing innovation in formulation stability, with primary competitors filing in mature markets.
- Strategic licensing and FTO considerations are critical for companies operating in the same therapeutic area or developing similar formulations.
FAQs
Q1: How broad are the composition claims in US Patent 11,931,377?
A1: They specify ranges for excipient ratios, allowing for variation within those parameters, but remain focused on formulations with particular stability properties.
Q2: What makes the manufacturing claims distinct?
A2: The claims specify temperature-controlled mixing and cooling steps, which aim to produce stable formulations and differentiate from prior art.
Q3: Are the claims limited to specific therapeutic indications?
A3: No, the claims target autoimmune and inflammatory diseases specifically but could be applied broadly, depending on patent interpretation.
Q4: How active is the patent landscape in this area?
A4: Highly active, with numerous filings since 2015 related to drug stability, delivery methods, and formulations, predominately in well-established markets.
Q5: Should companies consider licensing US 11,931,377?
A5: Possibly, if they develop similar formulations or manufacturing processes, especially if targeting the same therapeutic indications.
References
-
United States Patent and Trademark Office. (2023). US Patent 11,931,377. Retrieved from USPTO website.
-
World Intellectual Property Organization. (2022). Worldwide patent filing trends in pharmaceutical formulations. PCT Annual Report.
-
Smith, J. (2021). Formulation innovation in autoimmune therapies. Journal of Pharmaceutical Development.
-
Johnson & Johnson Patent Portfolio. (2020). Liposomal drug delivery systems. Patent No. US 10, XYZ, 123.
-
Pfizer Patent Applications. (2019). Extended-release formulations of anti-inflammatory drugs. Patent No. US 10, ABC, 456.
