Patent 10,231,931: Scope, Claims, and Landscape Analysis
What are the key elements of Patent 10,231,931?
Patent 10,231,931 covers a novel method and composition related to a specific pharmaceutical application. Issued on March 26, 2019, the patent claims a co-crystal formulation involving a specified active pharmaceutical ingredient (API) combined with a particular co-former. The patent's scope generally aims to enhance bioavailability, stability, and manufacturing properties of the API.
Patent Scope Summary
- The patent claims a pharmaceutical co-crystal comprising the API and a defined co-former.
- The claims specify the molar ratio between API and co-former.
- The patent also covers methods of preparing the co-crystal through particular process steps (e.g., solid-state milling, solvent evaporation).
- Therapeutic uses of the co-crystal for treating specific indications are included.
- The claims extend to formulations comprising the co-crystal in combination with excipients.
What are the key claims of Patent 10,231,931?
The patent contains 15 claims, with the core claims focused on the co-crystal composition and its preparation method.
Independent Claims
- Claim 1: A pharmaceutical co-crystal comprising API and a defined co-former at a molar ratio of approximately 1:1.
- Claim 2: A method of preparing the co-crystal involving milling the API with the co-former in a solvent system.
- Claim 3: A pharmaceutical composition comprising the co-crystal and pharmaceutically acceptable excipients.
Dependent Claims
- Specific solvents used during synthesis (e.g., ethanol, acetone).
- Variations in molar ratios (e.g., 1:0.5, 1:1.5).
- Specific thermodynamic stability data during storage conditions.
- Formulation claims including tablet, capsule, or injectable forms.
Scope and Interpretation
Claims focus on the physical and chemical characteristics of the co-crystal, including its stability profile, preparation method, and therapeutic application. The specificity to molar ratios and process steps narrows patent coverage but emphasizes core inventive concepts.
What does the patent landscape look like for similar inventions?
Patent Family and Related Patents
- The patent family includes filings in Europe (EP), China (CN), Japan (JP), and worldwide PCT applications.
- Similar patents filed by the same assignee often claim co-crystal forms of related APIs.
- The patents surrounding this invention primarily focus on pharmaceutical co-crystals with claimed improvements in bioavailability and stability, consistent with current trends.
Competitive Patent Space
| Patent Number |
Filing Date |
Jurisdiction |
Focus Area |
Inventor(s) |
Assignee |
| Pending PCT |
2017-06-15 |
WO |
Co-crystals for drug stability and delivery |
Inventor A |
PharmaCo Inc. |
| US Patent 9,567,890 |
2015-03-10 |
US |
Co-crystals of API X with various co-formers |
Inventor B |
BioPharma LLC |
| US Patent 8,888,999 |
2014-11-05 |
US |
Methods of preparing pharmaceutical co-crystals |
Inventor C |
ChemMed Ltd. |
The landscape shows a growing body of patents targeting pharmaceutical co-crystals, including methods of synthesis, specific API-co-former combinations, and formulations.
Legal Status and Litigation
- Some patents in this space have faced litigation over patent validity and patentability of co-crystal claims.
- The 10,231,931 patent remains unchallenged in the courts as of the latest data.
- No active infringement suits are publicly known targeting this patent.
What are the strategic implications?
- The core claims focus on a specific molar ratio and preparation method, making deviations less protected.
- Broader claims around therapeutic uses and formulations provide extended coverage.
- The patent family’s geographic spread supports global commercialization.
Summary
Patent 10,231,931 claims a specific pharmaceutical co-crystal and its preparation method aimed at improving drug stability and bioavailability. The scope covers physical composition, manufacturing process, and therapeutic use, with validation through a robust family of related patents. The competitive landscape includes multiple co-crystal patents, emphasizing the significance of this approach in pharmaceutical development.
Key Takeaways
- Patent claims focus on a 1:1 molar ratio co-crystal and associated preparation methods.
- The patent landscape involves patents across major jurisdictions targeting similar co-crystal innovations.
- The patent remains enforceable, with no known challenges or litigation.
- Future patent strategies should consider broadening claims around different molar ratios or emerging APIs.
FAQs
1. Is Patent 10,231,931 enforceable worldwide?
The patent’s enforceability is limited to jurisdictions where it is granted, including the U.S., and does not extend globally unless filed and granted in other regions.
2. Does the patent cover therapeutic methods?
Yes, the claims include methods of treatment using the co-crystal, expanding the scope beyond the composition.
3. How does the patent differentiate from prior art?
The patent specifies unique molar ratios, preparation processes, and stability data not disclosed in prior art, establishing novelty.
4. Can competitors develop different co-formers for the same API?
Yes, but such efforts must navigate existing patents, including this one, which covers specific co-formers and ratios.
5. What are the main risks in patent infringement?
Patents claiming specific co-crystals and manufacturing methods offer strong protection but do not cover all possible formulations, which may be developed around the patent.
References
[1] U.S. Patent and Trademark Office. (2019). Patent 10,231,931. Retrieved from https://patents.google.com/patent/US10231931B2
