United States Patent 8,420,656: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,420,656, titled "Substituted 5-fluoro-1H-pyrazolopyridines and their use," is a significant patent in the pharmaceutical sector, particularly in the development of cardiovascular and other related disorders treatments. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Inventors
The patent was filed by inventors associated with Bayer Pharma Aktiengesellschaft and later assigned to Adverio Pharma GmbH. The inventors, including Peter Fey, Alfons Grunenberg, and Donald Bierer, developed novel substituted 5-fluoro-1H-pyrazolopyridines, which are crucial for various therapeutic applications[4].
Scope of the Patent
Therapeutic Applications
The patent covers the use of substituted 5-fluoro-1H-pyrazolopyridines for treating various cardiovascular disorders. These compounds are designed to address conditions such as heart failure, hypertension, and other cardiovascular diseases. The scope extends to the preparation processes of these compounds and their pharmaceutical compositions[5].
Chemical Structure
The patent details the chemical structure of the substituted 5-fluoro-1H-pyrazolopyridines, including specific substituents and their positions on the pyrazolopyridine ring. This specificity is crucial for the patent's claims and distinguishes these compounds from others in the same class[5].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of protection. These claims cover the novel compounds themselves, methods for their preparation, and their use in treating specific medical conditions. For example, Claim 1 typically defines the general structure of the substituted 5-fluoro-1H-pyrazolopyridines, while subsequent claims narrow down to specific substituents and therapeutic uses[1].
Dependent Claims
Dependent claims further specify the independent claims by adding additional limitations or features. These claims help to ensure that the patent covers a range of variations within the scope of the invention, providing broader protection against infringement[1].
Patent Landscape
Related Patents
The patent 8,420,656 is part of a larger family of patents related to substituted 5-fluoro-1H-pyrazolopyridines. It is a continuation of earlier applications, such as US Patent 9,266,885 and US Patent 8,921,377, indicating a long-standing research and development effort in this area[1].
Assignments and Ownership
The patent has undergone several assignments, initially from the inventors to Bayer Intellectual Property GmbH and later to Adverio Pharma GmbH. These assignments are recorded with the U.S. Patent and Trademark Office (USPTO), ensuring clear ownership and rights to the intellectual property[4].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To understand the full extent of the patent's protection, a Claim Coverage Matrix can be used. This tool categorizes patents and claims by scope concepts, helping to identify which claims are actively protecting the intellectual property and where gaps or opportunities exist. For patent 8,420,656, this matrix would highlight the specific claims related to the chemical structures, preparation methods, and therapeutic applications[3].
Claim Charts
Interactive claim charts generated by tools like ClaimScape® software can facilitate a detailed review of the patent coverage. These charts help technical experts, engineers, and management to determine whether specific scope concepts are applicable to target products or methods, ensuring that there are no gaps in the current coverage and highlighting future design opportunities[3].
Regulatory and Extension Aspects
Regulatory Review
The regulatory review period for the drug associated with this patent, VERQUVO (vericiguat), began on July 17, 2013, and ended on January 19, 2021. This period is crucial for calculating the patent term extension under 35 U.S.C. §156, which can extend the patent term to compensate for the time spent in regulatory review[4].
Patent Term Extension
The application for patent term extension for U.S. Patent 9,604,948, which is related to the same family of patents, seeks to extend the term by 784 days. This extension is based on the regulatory review period and ensures that the patent remains in force until January 19, 2035, providing additional protection for the intellectual property[4].
Industry Impact and Market Domination
Competitive Advantage
The patent 8,420,656 provides a significant competitive advantage to Adverio Pharma GmbH in the development and marketing of cardiovascular treatments. The unique compounds and their therapeutic applications allow the company to differentiate its products in a crowded market.
Market Potential
The market potential for these compounds is substantial, given the prevalence of cardiovascular diseases. The patent's protection ensures that Adverio Pharma GmbH can capitalize on this market without immediate competition from generic or similar products.
Key Takeaways
- Therapeutic Focus: The patent is centered on treating cardiovascular disorders using novel substituted 5-fluoro-1H-pyrazolopyridines.
- Chemical Specificity: The patent details specific chemical structures and their therapeutic applications.
- Claims Structure: Independent and dependent claims provide comprehensive protection for the invention.
- Patent Landscape: Part of a larger family of related patents with clear ownership and assignment history.
- Regulatory Aspects: The patent term can be extended based on regulatory review periods.
- Market Impact: Provides a competitive advantage and significant market potential.
FAQs
Q: What is the primary therapeutic application of the compounds covered by U.S. Patent 8,420,656?
A: The primary therapeutic application is the treatment of cardiovascular disorders, including heart failure and hypertension.
Q: Who are the inventors of U.S. Patent 8,420,656?
A: The inventors include Peter Fey, Alfons Grunenberg, and Donald Bierer, associated with Bayer Pharma Aktiengesellschaft.
Q: What is the significance of the chemical structure specified in the patent?
A: The chemical structure defines the novel substituted 5-fluoro-1H-pyrazolopyridines, distinguishing them from other compounds and ensuring specific therapeutic efficacy.
Q: How does the patent term extension work for related patents?
A: The patent term extension is based on the regulatory review period under 35 U.S.C. §156, compensating for the time spent in regulatory review.
Q: What tool can be used to analyze the claim coverage of this patent?
A: A Claim Coverage Matrix and interactive claim charts generated by tools like ClaimScape® software can be used to analyze the claim coverage.
Sources
- United States Patent and Trademark Office. US Patent No. 11,439,642 B2. September 13, 2022.
- Regulations.gov. Patent Extension Application from VERQUVO US Patent No 8420656.
- Schwegman Lundberg & Woessner. Patent Analytics.
- Regulations.gov. Patent Number - Regulations.gov. December 2, 2020.
- World Intellectual Property Organization. WO-2011147809-A1 - Substituted 5-fluoro-1H-pyrazolopyridines.
