United States Patent 9,259,427: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,259,427, issued on February 16, 2016, pertains to a methotrexate composition designed for oral administration. This patent is significant in the pharmaceutical industry, particularly for the treatment of various conditions such as arthritis, certain types of cancer, and other autoimmune diseases.
Inventors and Assignees
The patent was invented by Carl Tierney, Stacey Powell, Peter Braybrooke, and Geraint Jones, and is assigned to Rosemont Pharmaceuticals Ltd[2].
Scope of the Patent
The patent covers a methotrexate composition that includes a pharmaceutically acceptable salt of methotrexate and an aqueous carrier agent. The key aspect of this composition is that the methotrexate salt is substantially or completely soluble in the aqueous carrier agent, forming an aqueous solution. This solubility is crucial for effective oral administration, ensuring that the medication is easily absorbed by the body[2].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Composition Claims
- The composition comprises a pharmaceutically acceptable salt of methotrexate.
- The methotrexate salt is substantially or completely soluble in an aqueous carrier agent.
- The composition forms an aqueous solution when the methotrexate salt is mixed with the aqueous carrier agent[2].
Method of Manufacture Claims
- The method involves mixing a pharmaceutically acceptable salt of methotrexate with an aqueous carrier agent until the methotrexate salt is substantially or completely soluble in the carrier agent to form an aqueous solution[2].
Patent Landscape
The patent landscape surrounding US 9,259,427 is complex and involves several related patents and exclusivity rights.
Related Patents
- There are multiple patents related to methotrexate compositions, such as US 9,855,215 and US 10,610,485, which also cover similar formulations and manufacturing methods. These patents share similar expiration dates, notably January 2, 2033[2].
- Other patents, like WO2020044114A2, discuss different aspects of methotrexate formulations, including liquid compositions and the presence of impurities[4].
Patent Expiration Dates
The patent is set to expire on January 2, 2033, which is consistent with other related patents. This expiration date is significant as it marks the end of the exclusive rights granted to the patent holder, potentially allowing for generic versions of the drug to be developed and marketed[2].
Exclusivity Rights
In addition to the patent, the FDA may grant exclusivity rights that can run concurrently with the patent. These rights can prevent other manufacturers from marketing therapeutically equivalent versions of the drug for a specified period, ranging from 180 days to seven years[2].
Therapeutic Applications
Methotrexate is a widely used medication for various therapeutic applications, including:
Arthritis and Autoimmune Diseases
- Methotrexate is commonly used to treat rheumatoid arthritis, psoriatic arthritis, and other autoimmune conditions[1].
Cancer Treatment
- It is also used as an antineoplastic agent in the treatment of certain types of cancer[1].
Manufacturing Process
The manufacturing process outlined in the patent involves mixing a pharmaceutically acceptable salt of methotrexate with an aqueous carrier agent until the methotrexate salt is substantially or completely soluble. This process ensures the formation of a stable and effective aqueous solution for oral administration[2].
Regulatory Considerations
The approval and regulation of this methotrexate composition fall under the purview of the FDA. The FDA's Orange Book, which lists approved drug products with therapeutic equivalence evaluations, would include this composition along with its patent and exclusivity information[5].
Impact on the Pharmaceutical Industry
This patent and its related counterparts have a significant impact on the pharmaceutical industry:
Innovation and Competition
- The exclusive rights granted by the patent can influence innovation and competition in the market. The expiration of these patents can open up opportunities for generic manufacturers to enter the market[3].
Patient Access
- The availability of generic versions post-patent expiration can improve patient access to affordable medications, which is particularly important for chronic conditions treated with methotrexate[2].
Key Takeaways
- Composition and Solubility: The patent covers a methotrexate composition with a pharmaceutically acceptable salt that is substantially or completely soluble in an aqueous carrier agent.
- Manufacturing Method: The method involves mixing the methotrexate salt with an aqueous carrier agent to form an aqueous solution.
- Patent Expiration: The patent expires on January 2, 2033, marking the end of exclusive rights.
- Therapeutic Applications: Methotrexate is used for arthritis, autoimmune diseases, and certain types of cancer.
- Regulatory Framework: The FDA regulates the approval and listing of this composition in the Orange Book.
FAQs
1. What is the main composition covered by US Patent 9,259,427?
The main composition covered is a methotrexate composition for oral administration, comprising a pharmaceutically acceptable salt of methotrexate and an aqueous carrier agent.
2. When does the patent expire?
The patent expires on January 2, 2033.
3. What are the therapeutic applications of methotrexate?
Methotrexate is used to treat conditions such as rheumatoid arthritis, psoriatic arthritis, and certain types of cancer.
4. How does the manufacturing process ensure the effectiveness of the composition?
The manufacturing process involves mixing the methotrexate salt with an aqueous carrier agent until the salt is substantially or completely soluble, ensuring the formation of a stable and effective aqueous solution.
5. What impact does the patent have on the pharmaceutical industry?
The patent influences innovation and competition by granting exclusive rights to the patent holder, and its expiration can lead to increased patient access to affordable generic versions of the medication.
Cited Sources
- US9259427B2 - Methotrexate composition - Google Patents
- Generic Xatmep Availability - Drugs.com
- Patent Claims and Patent Scope - Hoover Institution
- WO2020044114A2 - Methotrexate pharmaceutical composition - Google Patents
- Approved Drug Products with Therapeutic Equivalence Evaluations, 37th Edition - DrugPatentWatch
