United States Patent 10,633,397: A Detailed Analysis
Introduction
United States Patent 10,633,397, titled "Substituted polycyclic pyridone derivatives and prodrugs thereof," is a significant patent in the pharmaceutical sector, particularly in the area of antiviral treatments. This patent is held by Shionogi & Co., Ltd., and it plays a crucial role in the development and protection of certain antiviral compounds.
Background and Context
The patent in question is part of a broader portfolio of patents related to baloxavir marboxil, an antiviral drug used to treat influenza. This drug is marketed under the brand name Xofluza and is protected by multiple patents listed in the FDA's Orange Book[2][5].
Scope of the Patent
Compounds and Derivatives
The patent 10,633,397 covers specific substituted polycyclic pyridone derivatives and their prodrugs. These compounds are designed to exhibit antiviral activity, particularly against influenza viruses. The patent describes the chemical structure and synthesis of these compounds, highlighting their potential therapeutic uses[1].
Claims
The patent includes multiple claims that define the scope of protection. These claims cover:
- The specific chemical structures of the substituted polycyclic pyridone derivatives.
- The prodrugs of these derivatives.
- Methods for preparing these compounds.
- Uses of these compounds for treating viral infections, particularly influenza.
Patent Landscape
Related Patents
The patent 10,633,397 is part of a larger family of patents related to baloxavir marboxil. Other relevant patents include U.S. Patent Nos. 8,927,710, 9,815,835, 10,392,406, 10,759,814, 11,261,198, and 11,306,106. These patents collectively protect various aspects of baloxavir marboxil, including its formulation, method of manufacture, and use[2][5].
Litigation and Enforcement
The patent has been involved in several legal disputes, particularly with generic drug manufacturers seeking to produce and market generic versions of Xofluza before the patent's expiration. For instance, the submission of ANDA No. 217449 by defendants has led to infringement claims by the patent holders, alleging that the proposed generic products infringe one or more claims of the '397 Patent[2][5].
Patent Citations and Value
Citation Analysis
Patent citations are often used as a proxy for the value and impact of an invention. The '397 Patent, along with other related patents, has been cited in subsequent patent applications, indicating its significance in the field of antiviral research. Studies have shown that highly cited patents tend to have higher private and social value, although the direct relationship between citations and value is complex and subject to various factors[4].
Economic and Social Value
The economic value of the '397 Patent is substantial, given the commercial success of Xofluza. The social value is also significant, as these antiviral compounds contribute to public health by providing effective treatments for influenza. The patent's protection ensures that the innovator company can recoup its investment in research and development, while also incentivizing further innovation in the field[4].
Regulatory Aspects
FDA Approval and Orange Book Listing
The '397 Patent is listed in the FDA's Orange Book, which is a publication that lists approved drugs and their corresponding patents. This listing is crucial for regulatory purposes, as it helps to prevent generic versions of the drug from entering the market before the patent expires[2][5].
Patent Term Extensions
The patent may be eligible for term extensions under the Hatch-Waxman Act, which can extend the patent term to compensate for delays in the regulatory approval process. This is particularly relevant for pharmaceutical patents, where the regulatory review period can be lengthy[4].
Technical and Legal Scope
Chemical Structure and Synthesis
The patent provides detailed descriptions of the chemical structures and synthesis methods for the substituted polycyclic pyridone derivatives. This technical information is essential for understanding the invention and for any potential infringement analysis[1].
Legal Scope and Infringement
The legal scope of the patent is defined by its claims, which are subject to interpretation in legal proceedings. Infringement claims against generic manufacturers often involve detailed analyses of whether the proposed generic products fall within the scope of the patent claims[2][5].
Industry Impact
Innovation and Competition
The '397 Patent, along with other related patents, influences the competitive landscape in the antiviral drug market. By protecting the intellectual property of the innovator company, these patents ensure that there is a financial incentive for continued research and development in this critical area of public health[4].
Public Health Implications
The antiviral compounds protected by this patent have significant public health implications. Effective treatments for influenza are crucial, especially during outbreaks and pandemics. The protection afforded by this patent ensures that these treatments remain available and that further research is conducted to improve them[4].
Key Takeaways
- Patent Scope: The patent covers specific substituted polycyclic pyridone derivatives and their prodrugs with antiviral activity.
- Related Patents: Part of a larger family of patents protecting baloxavir marboxil.
- Litigation: Involved in disputes with generic manufacturers over infringement claims.
- Citation and Value: Highly cited, indicating significant economic and social value.
- Regulatory Aspects: Listed in the FDA's Orange Book and potentially eligible for patent term extensions.
- Technical and Legal Scope: Detailed chemical structures and synthesis methods, with claims subject to legal interpretation.
- Industry Impact: Influences competition and innovation in the antiviral drug market, with significant public health implications.
FAQs
What is the main subject of United States Patent 10,633,397?
The main subject of this patent is substituted polycyclic pyridone derivatives and their prodrugs, which exhibit antiviral activity.
Which drug is protected by this patent?
This patent protects baloxavir marboxil, an antiviral drug marketed under the brand name Xofluza.
Why is this patent listed in the FDA's Orange Book?
The patent is listed in the FDA's Orange Book to prevent generic versions of the drug from entering the market before the patent expires.
What is the significance of patent citations for the '397 Patent?
Patent citations indicate the significance and impact of the invention, suggesting higher private and social value for highly cited patents.
How does this patent affect the antiviral drug market?
The patent influences competition and innovation in the antiviral drug market by protecting the intellectual property of the innovator company, ensuring financial incentives for continued research and development.
Cited Sources
- US10633397B2 - Substituted polycyclic pyridone derivatives and prodrugs thereof - Google Patents
- Case 1:23-cv-00161-UNA Document 1 Filed 02/13/23 - RPX Insight
- Supplementary Material - Inventing AI - USPTO
- Pharmaceutical Patent Citations and Real Value - NYU Law
- in the united states district court - RPX Insight
