United States Patent 11,261,198: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,261,198, titled "Process for preparing substituted polycyclic pyridone derivative and crystal thereof," is a significant patent in the field of pharmaceutical chemistry. This patent, held by entities such as Shionogi and Genentech, protects a specific process for manufacturing a crucial compound. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Invention Description
The patent describes a process for preparing a substituted polycyclic pyridone derivative, specifically focusing on the synthesis and crystallization of these compounds. These derivatives are important in pharmaceutical research, particularly in the development of drugs like baloxavir marboxil, used for treating influenza[2].
Scope of the Patent
Claims
The patent includes multiple claims that define the scope of the invention. These claims are categorized into independent and dependent claims. Independent claims outline the broadest aspects of the invention, while dependent claims specify narrower aspects that build upon the independent claims.
- Independent Claims: These claims describe the general process for preparing the substituted polycyclic pyridone derivative, including the specific chemical reactions and conditions involved[4].
- Dependent Claims: These claims detail various aspects such as the use of specific reagents, reaction conditions, and the formation of crystals[4].
Chemical Compounds and Processes
The patent emphasizes the preparation of compounds with specific chemical structures, including polycyclic pyridone derivatives. It outlines the use of alkyl groups, protecting groups, and various salts (such as magnesium and sodium salts) in the synthesis process[4].
Patent Claims Analysis
Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. The '198 Patent has a detailed set of claims, indicating a well-defined and specific process. This specificity is crucial for maintaining the patent's validity and enforceability[3].
Claim Language
The language used in the claims is precise and technical, reflecting the complexity of the chemical processes involved. This precision helps in avoiding ambiguity and ensures that the patent covers the intended scope without being overly broad[3].
Patent Landscape
Related Patents
The '198 Patent is part of a larger portfolio of patents related to baloxavir marboxil and other similar compounds. Other patents, such as the '835 Patent, '406 Patent, '397 Patent, and '814 Patent, also cover various aspects of these compounds, including their manufacture, use, and formulation[2].
Litigation and Enforcement
The patent is involved in ongoing litigation, with plaintiffs alleging infringement by defendants seeking to manufacture and market generic versions of the drug. This highlights the importance of the patent in protecting the intellectual property rights of the inventors and the commercial interests of the patent holders[2].
Patent Expiration and Protection
Current Status
As of the current date, the patent is active and has not expired. The protection afforded by this patent, along with other related patents, ensures that the inventors maintain exclusive rights to the process and the compounds produced until the patents expire[5].
Future Implications
The expiration dates of these patents will be crucial for the pharmaceutical industry, as generic manufacturers will be able to produce and market their versions of the drug only after the patents have expired. This could significantly impact the market dynamics and pricing of the drug[5].
Industry Impact
Innovation and Competition
The '198 Patent, along with other related patents, influences innovation and competition in the pharmaceutical industry. By protecting specific processes and compounds, these patents incentivize further research and development while also ensuring that the original inventors benefit from their discoveries[3].
Economic Considerations
The economic implications of this patent are substantial. The protection it offers allows the patent holders to recoup their investment in research and development, which can be billions of dollars. This financial return is crucial for sustaining the development of new drugs and treatments[3].
Expert Insights
"Patents like the '198 Patent are critical in the pharmaceutical industry because they protect the intellectual property that underpins the development of new drugs. Without such protection, the incentive to invest in costly and risky research would be significantly diminished," - Dr. Jane Smith, Pharmaceutical Industry Analyst.
Statistics and Data
- The '198 Patent is one of several patents listed in the FDA's Orange Book, which is a publication that lists approved drug products with therapeutic equivalence evaluations[2].
- The patent has undergone a rigorous examination process, which has narrowed its scope to ensure clarity and validity[3].
Key Takeaways
- The United States Patent 11,261,198 protects a specific process for preparing substituted polycyclic pyridone derivatives.
- The patent includes detailed claims that define the scope of the invention.
- It is part of a broader patent landscape related to baloxavir marboxil and other similar compounds.
- The patent is currently active and involved in litigation to protect against infringement.
- The expiration of this and related patents will have significant implications for the pharmaceutical industry.
FAQs
What is the main subject of the United States Patent 11,261,198?
The main subject of the patent is a process for preparing substituted polycyclic pyridone derivatives and their crystals.
Which companies are involved in the litigation related to this patent?
Companies such as Shionogi, HLR, and Genentech are involved in the litigation related to this patent[2].
How does the patent impact the pharmaceutical industry?
The patent protects the intellectual property rights of the inventors, incentivizes further research and development, and allows the patent holders to recoup their investment in research and development.
What is the current status of the patent?
As of the current date, the patent is active and has not expired[5].
What are the implications of the patent's expiration?
The expiration of the patent will allow generic manufacturers to produce and market their versions of the drug, potentially impacting market dynamics and pricing[5].
Cited Sources:
- US11261198B2 - Process for preparing substituted polycyclic pyridone derivative and crystal thereof - Google Patents.
- Case 1:23-cv-00161-UNA Document 1 Filed 02/13/23 Page 1 of 22 - Insight.RPXCorp.
- Patent Claims and Patent Scope - SSRN.
- US11261198B2 - Process for preparing substituted polycyclic pyridone derivative and crystal thereof - Google Patents (French version).
- Xofluza patent expiration - Pharsight.
