United States Patent 10,947,244: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 10,947,244, titled "Forms of a PI3K delta selective inhibitor for use in pharmaceutical formulations," is a significant patent in the pharmaceutical industry, particularly in the field of cancer treatment and immunotherapy. This patent, assigned to the inventors of a specific PI3K delta inhibitor, provides a comprehensive overview of the invention, its scope, and its claims.
Background of the Invention
The patent revolves around the development of solid state forms of a p-toluenesulfonic acid salt (PTSA) of the selective PI3K delta inhibitor known as TGR-1202. PI3K delta inhibitors are crucial in treating various diseases, including cancer, by targeting the PI3K delta kinase, which is involved in the signaling pathways of immune cells[4].
Scope of the Patent
Invention Overview
The patent describes the chemical structure and various solid state forms of TGR-1202, specifically the PTSA salt. This includes crystalline forms, such as Form B, which are critical for pharmaceutical formulations due to their stability, solubility, and bioavailability[4].
Pharmaceutical Compositions
The patent covers a range of pharmaceutical compositions that include the PTSA salt of TGR-1202. These compositions can be in various forms, such as solid oral formulations (e.g., tablets), and may include additional active ingredients and pharmaceutically acceptable excipients. The compositions are designed to enhance the therapeutic efficacy and patient compliance[4].
Methods of Preparation
The patent details methods for preparing the PTSA salt of TGR-1202, including the synthesis of the compound and the formation of its solid state forms. These methods are crucial for ensuring the consistency and quality of the pharmaceutical product[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover:
- The PTSA salt of TGR-1202 in various solid state forms, including crystalline forms.
- Pharmaceutical compositions comprising the PTSA salt and pharmaceutically acceptable excipients.
- Methods of preparing the PTSA salt and its pharmaceutical compositions.
- Methods of treating PI3K kinase-mediated diseases or disorders, such as cancer, using the pharmaceutical compositions[4].
Dependent Claims
Dependent claims further specify the independent claims by detailing aspects such as:
- The particle size distribution of the PTSA salt.
- The weight ratio of the PTSA salt to solubilizers in the pharmaceutical compositions.
- The inclusion of additional active ingredients in the pharmaceutical compositions[4].
Patent Landscape
Relevance in Cancer Treatment
The PI3K delta inhibitor TGR-1202 is significant in cancer treatment due to its selective targeting of the PI3K delta kinase. This selectivity reduces the side effects associated with non-selective PI3K inhibitors and enhances the therapeutic efficacy in treating cancers such as lymphomas and leukemias[4].
Competitive Landscape
The patent landscape in the field of PI3K inhibitors is highly competitive, with multiple pharmaceutical companies and research institutions developing similar compounds. The uniqueness of the PTSA salt of TGR-1202 and its specific solid state forms provides a competitive edge in terms of stability, solubility, and bioavailability[3][4].
Litigation and Enforcement
Patent enforcement in the pharmaceutical industry is critical to protect intellectual property. The construction of claim terms, as seen in other patent disputes, is a key aspect of patent litigation. The court's interpretation of claim terms, such as those in the '953 Patent discussed in another context, highlights the importance of clear and specific claim language to avoid disputes[2].
Metrics for Measuring Patent Scope
The scope of the patent can be measured using metrics such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims. For instance, longer independent claims and a higher number of independent claims can indicate a broader patent scope, but may also raise concerns about clarity and validity[3].
Impact on Innovation
The patent's scope and claims can influence innovation in the pharmaceutical industry. Clear and specific claims can encourage innovation by providing a clear boundary of what is protected and what is open for further development. However, overly broad or unclear claims can hinder innovation by increasing licensing and litigation costs[3].
Key Takeaways
- The patent covers solid state forms of the PTSA salt of TGR-1202, a selective PI3K delta inhibitor.
- It includes various pharmaceutical compositions and methods of preparation.
- The patent is significant in cancer treatment due to the selective targeting of PI3K delta kinase.
- The competitive landscape in PI3K inhibitors is highly competitive, and the patent's uniqueness provides a competitive edge.
- Clear and specific claim language is crucial for patent enforcement and encouraging innovation.
Frequently Asked Questions (FAQs)
What is the main subject of United States Patent 10,947,244?
The main subject is the development of solid state forms of a p-toluenesulfonic acid salt (PTSA) of the selective PI3K delta inhibitor TGR-1202.
What are the key claims of the patent?
The key claims include the PTSA salt of TGR-1202 in various solid state forms, pharmaceutical compositions, methods of preparation, and methods of treating PI3K kinase-mediated diseases.
Why is the PTSA salt of TGR-1202 important in cancer treatment?
The PTSA salt of TGR-1202 is important due to its selective targeting of the PI3K delta kinase, which reduces side effects and enhances therapeutic efficacy in treating cancers.
How does the patent landscape affect this invention?
The competitive landscape in PI3K inhibitors is highly competitive, but the uniqueness of the PTSA salt of TGR-1202 provides a competitive edge in terms of stability, solubility, and bioavailability.
What metrics can be used to measure the scope of this patent?
Metrics such as independent claim length and independent claim count can be used to measure the scope and clarity of the patent claims.
Cited Sources:
- Google Patents: Forms of a PI3K delta selective inhibitor for use in pharmaceutical formulations - US10947244B2.
- GovInfo: USCOURTS-mad-1_22-cv-10967-0.pdf.
- Hoover Institution: Patent Claims and Patent Scope.
- Unified Patents Portal: WO-2015181728-A1.
