United States Patent 8,987,441: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,987,441, titled "Substituted polycyclic carbamoyl pyridone derivative prodrug," is a significant patent in the pharmaceutical industry, particularly in the field of antiviral treatments. This patent is associated with the drug XOFLUZA (baloxavir marboxil), which is used for the treatment of acute uncomplicated influenza. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The patent was granted to Shionogi & Co., Ltd., a Japanese pharmaceutical company, and it covers a compound with antiviral effects, specifically targeting influenza viruses. The patent application was submitted on October 24, 2011, and the patent was issued on March 24, 2015[4].
Scope of the Patent
The scope of U.S. Patent 8,987,441 is defined by its claims, which describe a specific class of compounds known as substituted polycyclic carbamoyl pyridone derivatives. These compounds are prodrugs, meaning they are metabolized in the body to produce the active antiviral agent.
Claim Structure
The patent includes multiple claims that outline the chemical structure and properties of the compounds. Key aspects include:
- Chemical Structure: The claims specify the polycyclic carbamoyl pyridone derivative structure, including various substituents such as alkyl, alkoxy, and halogen groups[4].
- Prodrug Characteristics: The patent emphasizes the prodrug nature of these compounds, which are designed to be converted into the active form in the body.
- Antiviral Activity: The claims highlight the compounds' growth inhibitory activity against influenza viruses.
Claims Analysis
The patent contains several independent and dependent claims that define the scope of protection.
Independent Claims
Independent claims are broad and stand alone, defining the core invention. For example:
- Claim 1 describes the general structure of the substituted polycyclic carbamoyl pyridone derivative prodrug[4].
Dependent Claims
Dependent claims narrow down the scope by adding additional limitations to the independent claims. These claims often specify particular substituents or structural features.
Patent Landscape
The patent landscape surrounding U.S. Patent 8,987,441 is complex and involves several related patents and legal proceedings.
Related Patents
Several other patents are associated with XOFLUZA, including U.S. Patent Nos. 9,815,835, 10,392,406, 10,633,397, 10,759,814, 11,261,198, and 11,306,106. These patents cover various aspects of the drug, including its formulation, method of manufacture, and use[2][5].
Litigation and Infringement
The patent has been involved in several legal disputes. For instance, Shionogi & Co., Ltd., along with other plaintiffs, has filed lawsuits against generic drug manufacturers alleging infringement of the patents listed in the Orange Book for XOFLUZA. These lawsuits typically involve Paragraph IV certifications, where the generic manufacturers argue that the patents are invalid, unenforceable, or will not be infringed by their proposed generic products[2][5].
Regulatory Approval and Patent Term Extension
The FDA approved XOFLUZA on October 24, 2018, and subsequent to this approval, the USPTO received an application for patent term restoration. The regulatory review period, which includes both the testing and approval phases, was critical in determining the potential patent term extension. The USPTO applies statutory limitations to calculate the actual period for patent extension, and in this case, the applicant sought 399 days of patent term extension[1].
Impact on the Pharmaceutical Industry
U.S. Patent 8,987,441 has significant implications for the pharmaceutical industry, particularly in the development and marketing of antiviral drugs.
Innovation and Competition
The patent protects a novel class of antiviral compounds, which can limit competition from generic manufacturers until the patent expires. This protection period allows the patent holder to recoup investment in research and development and incentivizes further innovation in the field[3].
Litigation Costs and Licensing
The ongoing litigation related to this patent highlights the complexities and costs associated with patent disputes in the pharmaceutical industry. These costs can include licensing fees, litigation expenses, and the potential for delayed market entry for generic competitors[3].
Key Takeaways
- Scope and Claims: U.S. Patent 8,987,441 covers a specific class of substituted polycyclic carbamoyl pyridone derivative prodrugs with antiviral activity against influenza viruses.
- Patent Landscape: The patent is part of a broader landscape involving multiple related patents and ongoing litigation.
- Regulatory Approval: The FDA approval of XOFLUZA and subsequent patent term restoration application are critical aspects of the patent's lifecycle.
- Industry Impact: The patent influences innovation, competition, and the economic dynamics within the pharmaceutical industry.
FAQs
What is the primary use of the compound described in U.S. Patent 8,987,441?
The compound is primarily used for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
Which company holds U.S. Patent 8,987,441?
Shionogi & Co., Ltd., a Japanese pharmaceutical company, holds this patent.
What is the significance of the regulatory review period for this patent?
The regulatory review period is crucial for determining the potential patent term extension, which can extend the patent's protection period.
How does this patent impact the pharmaceutical industry?
It protects a novel class of antiviral compounds, limiting competition and allowing the patent holder to recoup investment in research and development, while also incentivizing further innovation.
What are some of the related patents associated with XOFLUZA?
Related patents include U.S. Patent Nos. 9,815,835, 10,392,406, 10,633,397, 10,759,814, 11,261,198, and 11,306,106.
Sources:
- Federal Register/Vol. 89, No. 153/Thursday, August 8, 2024/Notices
- Case 1:23-cv-00161-UNA Document 1 Filed 02/13/23 Page 1 of 22
- Patent Claims and Patent Scope - Hoover Institution
- Substituted polycyclic carbamoyl pyridone derivative prodrug - Google Patents
- in the united states district court - RPX Insight
