Understanding the Scope and Claims of United States Patent 10,245,276
Introduction
United States Patent 10,245,276, titled "Co-crystals of Tramadol and Coxibs," is a significant patent in the pharmaceutical field, particularly in the area of pain management. This patent, assigned to ESTEVE PHARMACEUTICALS, S.A., involves the development of co-crystals of tramadol and coxibs, which are crucial for improving the therapeutic efficacy and stability of these drugs.
Background
The patent is part of a series of continuations and amendments, starting from the initial application filed on August 9, 2016. It builds upon earlier research and patents, such as application No. 14/665,055 and No. 14/066,127, which were filed on March 23, 2015, and October 29, 2013, respectively[4].
Inventors and Assignees
The patent was invented by Carlos-Ramón Plata-Salaman and Nicolas Tesson, both affiliated with ESTEVE PHARMACEUTICALS, S.A., based in Barcelona, Spain. The assignee is also ESTEVE PHARMACEUTICALS, S.A.[4].
Patent Scope
The scope of the patent revolves around the creation and characterization of co-crystals formed between tramadol and coxibs, such as celecoxib. Co-crystals are solid forms of active pharmaceutical ingredients (APIs) that can enhance the solubility, stability, and bioavailability of the drugs.
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically describe the composition of the co-crystals, the methods of preparing them, and their therapeutic applications. For example:
- Claim 1 might describe the co-crystal composition of tramadol and celecoxib in a specific molar ratio.
- Claim 2 could outline the method of preparing these co-crystals using specific solvents and conditions[4].
Dependent Claims
Dependent claims further specify the details of the independent claims. These could include:
- The specific crystalline form of the co-crystal.
- The process conditions for achieving the desired crystal structure.
- The pharmaceutical formulations that incorporate these co-crystals[4].
Claim Language and Patent Scope Metrics
The scope of the patent can be analyzed using metrics such as independent claim length and independent claim count. Research has shown that these metrics can provide insights into the breadth and clarity of the patent claims. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Technical Details
The patent provides detailed technical information on the preparation and characterization of the co-crystals. This includes:
- DSC Analysis: Differential Scanning Calorimetry (DSC) is used to analyze the thermal properties of the co-crystals, which helps in understanding their stability and phase transitions[4].
- X-Ray Diffraction: This technique is used to determine the crystal structure of the co-crystals, ensuring their uniformity and purity.
- Pharmacological Effects: The patent also discusses the pharmacological effects of these co-crystals, including their enhanced solubility and bioavailability, which are critical for their therapeutic efficacy.
Prior Art and References
The patent cites several prior art documents, including earlier patents and publications related to co-crystal formation and pharmaceutical applications. These references help in establishing the novelty and non-obviousness of the invention[4].
Economic and Legal Implications
Compliance with patent office disclosure requirements is crucial. Failure to list the true and only inventors or disclose federal funding can lead to the invalidation of the patent. This highlights the importance of accurate and complete disclosure in patent applications[5].
Industry Impact
The development of co-crystals of tramadol and coxibs has significant implications for the pharmaceutical industry. These formulations can improve patient outcomes by enhancing the efficacy and stability of pain management drugs. This innovation can also influence the broader landscape of pharmaceutical research and development.
Future Directions
The patent opens up avenues for further research into co-crystal technology. Future studies could focus on exploring other API combinations, optimizing preparation methods, and investigating the clinical efficacy of these co-crystals in various therapeutic areas.
Key Takeaways
- Co-crystal Technology: The patent highlights the importance of co-crystal technology in enhancing the therapeutic properties of drugs.
- Patent Scope Metrics: Independent claim length and count are key metrics for assessing patent scope and clarity.
- Technical Details: Detailed technical analysis, such as DSC and X-ray diffraction, is essential for characterizing co-crystals.
- Compliance: Accurate disclosure of inventors and funding is critical for maintaining patent validity.
- Industry Impact: The innovation has significant implications for pain management and pharmaceutical research.
FAQs
Q: What is the main subject of United States Patent 10,245,276?
A: The main subject is the development of co-crystals of tramadol and coxibs, such as celecoxib, for improved therapeutic efficacy.
Q: Who are the inventors of this patent?
A: The inventors are Carlos-Ramón Plata-Salaman and Nicolas Tesson.
Q: What is the significance of co-crystal technology in this patent?
A: Co-crystal technology enhances the solubility, stability, and bioavailability of the drugs, improving their therapeutic efficacy.
Q: What metrics are used to analyze the scope of the patent?
A: Metrics such as independent claim length and independent claim count are used to analyze the scope and clarity of the patent claims.
Q: Why is accurate disclosure important in patent applications?
A: Accurate disclosure of inventors and funding is crucial to avoid patent invalidation and ensure compliance with patent office requirements.
Sources
- United States Patent and Trademark Office, "United States Patent: CO-CRYSTALS OF TRAMADOL AND COXIBS," US 10,548,909 B2.
- USPTO, "Patent Claims Research Dataset."
- SSRN, "Patent Claims and Patent Scope."
- Google Patents, "United States Patent: CO-CRYSTALS OF TRAMADOL AND COXIBS," US 10,245,276.
- IPWatchdog, "Claims That Scientists are Underreporting Federal Support on Patents Don’t Pass the Smell Test."
