United States Patent 10,392,406: A Detailed Analysis of Scope and Claims
Overview of the Patent
The United States Patent 10,392,406, 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., a Japanese pharmaceutical company, and is part of a broader portfolio of patents related to the drug baloxavir marboxil, marketed as Xofluza.
Patent Scope and Claims
General Description
The patent covers a class of compounds known as substituted polycyclic pyridone derivatives, which exhibit anti-viral activity. These compounds are designed to target and inhibit the influenza virus polymerase acidic (PA) endonuclease, a crucial enzyme for the replication of the influenza virus[4].
Specific Claims
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
- Chemical Structure: The patent describes compounds with specific chemical structures, including polycyclic pyridone derivatives with various substituents such as alkyl, aryl, halogen, and hydroxy groups[1].
- Prodrugs: The patent also covers prodrugs of these compounds, which are metabolized in the body to release the active drug. This is important for improving bioavailability and efficacy[1].
- Salts and Solvates: The claims extend to salts and solvates of these compounds, which can affect the physical and chemical properties of the drug, such as solubility and stability[1].
Patent Landscape
Related Patents
The patent 10,392,406 is part of a larger family of patents related to baloxavir marboxil. Other relevant patents include:
- U.S. Patent 8,927,710: Covers the method of manufacture and use of baloxavir marboxil.
- U.S. Patent 9,815,835: Another patent covering the composition and use of baloxavir marboxil.
- U.S. Patent 10,633,397, 10,759,814, 11,261,198, and 11,306,106: These patents also relate to various aspects of baloxavir marboxil, including its formulation and use[5].
Litigation and Enforcement
The patents, including 10,392,406, have been involved in several litigation cases. For example, Shionogi & Co., Ltd. and other plaintiffs have filed lawsuits against generic drug manufacturers alleging infringement of these patents. These lawsuits aim to prevent the early commercialization of generic versions of baloxavir marboxil before the patents expire[2][5].
Expiration Dates
The patent 10,392,406 is estimated to expire on April 27, 2036. This expiration date is crucial for the pharmaceutical industry as it determines when generic versions of the drug can be legally manufactured and sold[4].
Impact on Innovation and Competition
Patent Quality and Scope
The debate around patent quality and scope is relevant here. The patent 10,392,406, like many others, has undergone a rigorous examination process to ensure its claims are clear and not overly broad. Research suggests that narrower claims, such as those in this patent, are associated with a higher probability of grant and a shorter examination process[3].
Licensing and Litigation
The patents related to baloxavir marboxil have significant implications for licensing and litigation costs. The ongoing litigation indicates the importance of these patents to the innovator companies and the potential barriers they pose to generic competition[2][5].
Conclusion
The United States Patent 10,392,406 is a critical component of the intellectual property portfolio surrounding baloxavir marboxil. Its scope and claims are carefully defined to protect the innovative work in developing this antiviral drug. The patent landscape around this drug is complex, involving multiple related patents and ongoing litigation to enforce these intellectual property rights.
Key Takeaways
- Specific Chemical Structures: The patent covers specific polycyclic pyridone derivatives with anti-viral activity.
- Prodrugs and Salts: The claims include prodrugs and salts of these compounds to enhance bioavailability and stability.
- Related Patents: Part of a larger family of patents related to baloxavir marboxil.
- Litigation: Involved in several lawsuits to prevent early generic competition.
- Expiration Date: Estimated to expire on April 27, 2036.
- Impact on Innovation: Narrower claims contribute to higher grant probabilities and shorter examination processes.
FAQs
What is the main subject of United States Patent 10,392,406?
The main subject of this patent is substituted polycyclic pyridone derivatives and their prodrugs, which exhibit anti-viral activity against the influenza virus.
What is the significance of prodrugs in this patent?
Prodrugs are metabolized in the body to release the active drug, improving bioavailability and efficacy of the treatment.
Which company holds this patent?
This patent is held by Shionogi & Co., Ltd., a Japanese pharmaceutical company.
What is the estimated expiration date of this patent?
The patent is estimated to expire on April 27, 2036.
Why is this patent involved in litigation?
The patent is involved in litigation to prevent generic drug manufacturers from commercially manufacturing, using, offering for sale, selling, and/or importing generic versions of baloxavir marboxil before the patent expires.
How does this patent fit into the broader patent landscape for baloxavir marboxil?
It is part of a larger family of patents covering various aspects of baloxavir marboxil, including its composition, method of manufacture, and use.
