Understanding the Scope and Claims of United States Patent 10,231,927
Introduction
United States Patent 10,231,927, titled "Methotrexate composition," is a significant patent in the pharmaceutical industry, particularly for the treatment of certain medical conditions using methotrexate. Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape.
Patent Overview
Patent 10,231,927 was granted to Rosemont Pharmaceuticals Ltd. and inventors Carl Tierney, Stacey Powell, Peter Braybrooke, and Geraint Jones. The patent is associated with the New Drug Application (NDA) for XATMEP, a methotrexate sodium solution for oral administration[1].
Abstract and Summary
The patent describes a methotrexate composition for oral administration, comprising a pharmaceutically acceptable salt of methotrexate and an aqueous carrier agent. The methotrexate salt is substantially or completely soluble in the aqueous carrier agent, forming an aqueous solution. The method of manufacturing this composition involves mixing the methotrexate salt with the aqueous carrier agent until the salt is fully soluble[1].
Claims
The patent includes several claims that define the scope of the invention:
- Composition Claims: These claims specify the composition of the methotrexate solution, including the type of methotrexate salt and the aqueous carrier agent.
- Method Claims: These claims outline the method of manufacturing the methotrexate composition, emphasizing the process of mixing the methotrexate salt with the aqueous carrier agent.
- Dosage Form Claims: These claims describe the final form of the product, which is a solution for oral administration[1].
Patent Scope
The scope of the patent is crucial in understanding its protective boundaries. Here are some key aspects:
- Independent Claim Length and Count: Research suggests that the scope of a patent can be measured by the length and count of independent claims. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[2].
- Patent Maintenance Payments: The patent's scope can also be inferred from maintenance payments, which are typically higher for patents with broader claims. However, this patent's claims are specific to the methotrexate composition and its manufacturing process[4].
Patent Family and International Protection
The patent has three patent family members in three countries: the United Kingdom, the European Patent Office, and Spain. This international protection ensures that the invention is safeguarded across multiple jurisdictions[1].
Expiration and Generic Entry
The patent expiration date is critical for understanding when generic versions of the drug can enter the market. While the exact expiration date is not publicly available without subscription, it is generally known that patents like this one typically expire 20 years from the filing date of the earliest non-provisional application to which the patent is entitled[1].
Use and Indications
The patented methotrexate composition is approved for several indications, including the treatment of acute lymphoblastic leukemia and juvenile rheumatoid arthritis. These specific uses are protected under the patent, preventing other manufacturers from producing identical compositions for these purposes until the patent expires[1].
Economic and Innovation Impact
The patent's impact on innovation and economic activities is significant. Patents like this one incentivize pharmaceutical companies to invest in research and development by providing exclusive rights to market the drug. However, overly broad patents can lead to increased licensing and litigation costs, potentially stifling innovation[2].
Search and Analysis Tools
For professionals interested in analyzing this patent further, tools like the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) are invaluable. These resources provide detailed information on patent claims, family members, and prior art citations, helping to assess the patent's scope and validity[3].
Conclusion
United States Patent 10,231,927 is a well-defined patent that protects a specific methotrexate composition and its manufacturing process. Understanding its scope, claims, and international protection is essential for pharmaceutical companies, researchers, and legal professionals. The patent's impact on the market and innovation highlights the importance of balanced patent protection.
Key Takeaways
- Specific Composition: The patent protects a methotrexate composition with a pharmaceutically acceptable salt and an aqueous carrier agent.
- Manufacturing Process: The method of manufacturing involves mixing the methotrexate salt with the aqueous carrier agent until fully soluble.
- International Protection: The patent has family members in the UK, EPO, and Spain.
- Use and Indications: Approved for treating acute lymphoblastic leukemia and juvenile rheumatoid arthritis.
- Economic Impact: Provides exclusive rights, incentivizing R&D but potentially increasing licensing and litigation costs.
FAQs
Q: What is the main subject of United States Patent 10,231,927?
A: The main subject is a methotrexate composition for oral administration.
Q: Who are the inventors of this patent?
A: The inventors are Carl Tierney, Stacey Powell, Peter Braybrooke, and Geraint Jones.
Q: What are the approved indications for the patented drug?
A: The drug is approved for treating acute lymphoblastic leukemia and juvenile rheumatoid arthritis.
Q: How can one determine the scope of this patent?
A: The scope can be determined by analyzing the independent claim length and count, as well as other metrics such as patent maintenance payments and forward citations.
Q: Where can one find more detailed information about this patent?
A: Detailed information can be found using the USPTO's Patent Public Search, Global Dossier, and other international patent databases.
Sources
- DrugPatentWatch - Patent 10,231,927
- SSRN - Patent Claims and Patent Scope
- USPTO - Search for patents
- USPTO - Patent Claims Research Dataset
