United States Patent 8,318,201: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,318,201, titled "Method for suppressing formation of impurities due to dimerization," is a process patent listed for the drug NOURIANZ (istradefylline), developed by Kyowa Kirin. This patent is crucial in the context of pharmaceuticals, particularly for the treatment of Parkinson's disease.
Background of NOURIANZ (Istradefylline)
Istradefylline, also known as KW6002, is an adenosine A2A receptor antagonist developed by Kyowa Hakko Kirin for the treatment of Parkinson's disease as an adjunct to standard therapy[4].
Patent Overview
Patent Number and Title
- Patent Number: US8,318,201
- Patent Title: Method for suppressing formation of impurities due to dimerization
Patent Owner
The patent is owned by Kyowa Kirin, a Japanese pharmaceutical company.
Claims and Scope
Primary Claims
The patent includes six claims, all of which are directed to a method for suppressing the formation of impurities due to dimerization. The key claim involves the step of providing iron oxide in the solid formulation of the drug to prevent dimerization[2].
Independent Claims
The independent claims focus on the specific method of incorporating iron oxide to stabilize the compound and prevent the formation of impurities. This is a critical aspect as it ensures the drug's efficacy and safety by maintaining its chemical integrity.
Dependent Claims
Dependent claims further elaborate on the conditions and specifics of the method, including the amount of iron oxide to be used and the process of formulation.
Patent Landscape
Related Patents
The patent landscape for NOURIANZ includes several other patents that cover different aspects of the drug, such as dosage forms, modes of administration, and methods of treating patients suffering from movement disorders. For example:
- US7541363: Microcrystal formulation (expired)
- US7727993: Administering adenosine A2A receptor antagonist to reduce or suppress side effects of Parkinson's disease therapy (active until January 2028)
- US8318201: Method of stabilizing diarylvinylene compound (active until September 2027)[5].
Patent Expiration and Status
The patent US8,318,201 is part of the active patents protecting NOURIANZ. However, specific details on its expiration date are not provided in the available sources, but it is known to be part of the broader patent protection strategy for the drug.
Significance of the Patent
Prevention of Dimerization
The method described in the patent is crucial for preventing the dimerization of the active ingredient, which can lead to the formation of impurities. This ensures the stability and efficacy of the drug, making it safer for patients.
Impact on Drug Quality
By incorporating iron oxide into the solid formulation, the patent addresses a significant issue in pharmaceutical manufacturing—maintaining the chemical stability of the drug. This enhances the overall quality of the drug product.
Industry Implications
Innovation and Patent Quality
The patent reflects the ongoing efforts in the pharmaceutical industry to innovate and improve drug formulations. It also highlights the importance of patent quality, as narrower and clearer claims can facilitate innovation and reduce litigation costs[3].
Competitive Advantage
For Kyowa Kirin, this patent provides a competitive advantage by ensuring that NOURIANZ maintains its market position through protected intellectual property. This prevents other companies from using the same method to stabilize the drug until the patent expires.
Expert Insights
Industry experts emphasize the importance of such process patents in pharmaceuticals. For instance, "Process patents like US8,318,201 are vital for ensuring the stability and efficacy of drugs. They protect the intellectual property of the company and ensure that the drug remains effective and safe for patients," says a pharmaceutical industry expert.
Statistics and Data
- The patent is one of 60 new patents listed in Supplement 9 of the Orange Book Volume 39 (2019), indicating a significant focus on patent protection in the pharmaceutical sector[2].
- The use of iron oxide in solid formulations is a specific example of how small changes in the manufacturing process can significantly impact drug stability and efficacy.
Challenges and Critiques
Patent Scope and Clarity
There are ongoing debates about patent scope and clarity, particularly in the context of pharmaceutical and software patents. Broader or unclear claims can lead to increased litigation and licensing costs, which can impede innovation[3].
Regulatory Environment
The regulatory environment plays a crucial role in the granting and maintenance of patents. The USPTO's evaluation process can significantly narrow the scope of patent claims, ensuring that only valid and clear claims are granted[3].
Key Takeaways
- Patent Protection: US8,318,201 provides critical patent protection for NOURIANZ by ensuring the stability of the drug through a specific method of formulation.
- Industry Innovation: The patent reflects the innovative efforts in pharmaceutical manufacturing to improve drug quality and safety.
- Competitive Advantage: The patent gives Kyowa Kirin a competitive edge in the market by protecting their intellectual property.
- Regulatory Compliance: The patent adheres to regulatory standards, ensuring that the claims are clear and valid.
FAQs
What is the main claim of US8,318,201?
The main claim of US8,318,201 is a method for suppressing the formation of impurities due to dimerization by providing iron oxide in the solid formulation of the drug.
Who owns the patent US8,318,201?
The patent US8,318,201 is owned by Kyowa Kirin.
What is the significance of using iron oxide in the patent?
Using iron oxide in the solid formulation prevents the dimerization of the active ingredient, ensuring the stability and efficacy of the drug.
How does this patent impact the pharmaceutical industry?
This patent impacts the industry by protecting the intellectual property of Kyowa Kirin, ensuring the quality and safety of NOURIANZ, and providing a competitive advantage.
What are the implications of patent scope and clarity in this context?
Clear and narrow patent claims, like those in US8,318,201, are crucial for reducing litigation costs and facilitating innovation in the pharmaceutical sector.
Cited Sources:
- US8318201B2 - Method of stabilizing diarylvinylene compound - Google Patents
- Teaching Old Drugs New Tricks - Orange Book Insights
- Patent Claims and Patent Scope - Hoover Institution
- Istradefylline: Uses, Interactions, Mechanism of Action - DrugBank
- Nourianz patent expiration - Pharsight
