United States Patent 10,874,655: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,874,655, titled "Methods of treating Fabry patients having renal impairment," is a significant patent in the field of medical treatments, particularly for Fabry disease. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Overview of the Patent
Title and Description
The patent, assigned to Amicus Therapeutics US, LLC, describes methods for treating Fabry disease in patients with renal impairment. Fabry disease is a genetic disorder caused by mutations in the alpha-Gal A gene, leading to the deficiency of the enzyme alpha-Galactosidase A[4].
Publication and Legal Status
The patent was published on January 5, 2021, and is currently active. However, the legal status provided by Google Patents is an assumption and not a legal conclusion[4].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. These claims are categorized into independent and dependent claims.
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Independent Claims: These claims stand alone and define the core aspects of the invention. For example, Claim 1 describes a method for treating Fabry disease in a patient having a specific mutation in the alpha-Gal A gene and renal impairment, using a particular dosage of migalastat[4].
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Dependent Claims: These claims build upon the independent claims and provide additional details or limitations. For instance, dependent claims might specify the dosage regimen, the type of renal impairment, or other conditions under which the treatment is effective[4].
Key Components
- Migalastat: The patent centers around the use of migalastat, a chaperone therapy that stabilizes the alpha-Galactosidase A enzyme, allowing it to reach the lysosomes where it is needed to break down globotriaosylceramide (GL-3)[4].
- Renal Impairment: The methods described are specifically tailored for patients with renal impairment, a common complication in Fabry disease[4].
Claims Analysis
Claim Structure
The claims are structured to ensure broad protection for the invention while also providing specificity to distinguish it from prior art.
- Claim 1: This claim sets the foundation by describing the method of treatment using migalastat for patients with specific mutations and renal impairment[4].
- Subsequent Claims: These claims narrow down the scope by adding additional conditions, such as the dosage, administration schedule, and specific mutations[4].
Claim Examples
- Claim 1: "A method for treating Fabry disease in a patient having a mutation in the alpha-Gal A gene selected from the group consisting of c.1066C>G, c.887T>C, and rs104894837, and having renal impairment, comprising administering to the patient a therapeutically effective amount of migalastat."
- Dependent Claim: "The method of claim 1, wherein the migalastat is administered orally once daily."
Patent Landscape
Prior Art and Related Patents
The patent landscape for Fabry disease treatments is complex, with several patents and applications related to enzyme replacement therapies and chaperone therapies.
- International Patent Offices: Similar patents and applications can be found in other countries, such as those listed in the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO)[1].
- Competing Technologies: Other companies and research institutions may have patents or pending applications for different approaches to treating Fabry disease, such as enzyme replacement therapies or gene therapies[1].
Global Dossier and Common Citation Document (CCD)
The Global Dossier and CCD tools provided by the USPTO can help in understanding the global patent family and prior art citations related to this patent. These tools consolidate information from multiple patent offices, making it easier to visualize the patent landscape[1].
Litigation and Enforcement
Current Litigation
The patent has been involved in litigation, such as the case "Amicus Therapeutics US, LLC et al v. Teva Pharmaceutical Industries Ltd. et al," which highlights the importance of this patent in the pharmaceutical industry[5].
Enforcement Strategies
Amicus Therapeutics may employ various strategies to enforce this patent, including monitoring for infringement, negotiating licenses, and litigating against infringers. The patent's scope and claims are crucial in these enforcement efforts.
Economic and Market Impact
Market Significance
The treatment of Fabry disease is a significant market, and this patent holds substantial value due to its specificity in addressing renal impairment, a critical aspect of the disease.
Research and Development
The data from the Patent Claims Research Dataset by the USPTO can provide insights into the trends and scope of patent claims in the medical field, including those related to Fabry disease treatments[3].
Conclusion
United States Patent 10,874,655 is a critical patent in the treatment of Fabry disease, particularly for patients with renal impairment. The scope and claims of this patent are carefully crafted to protect the innovative method of using migalastat. Understanding the patent landscape, including prior art and related patents, is essential for navigating the complex world of intellectual property in medical treatments.
Key Takeaways
- Specific Treatment Method: The patent describes a specific method for treating Fabry disease in patients with renal impairment using migalastat.
- Claims Structure: The claims are structured to provide broad protection while ensuring specificity.
- Global Patent Landscape: The patent is part of a broader global landscape of Fabry disease treatments, with tools like Global Dossier and CCD aiding in understanding prior art.
- Litigation and Enforcement: The patent has been involved in litigation and is crucial for enforcement strategies.
- Market Impact: The patent holds significant market value due to its focus on treating renal impairment in Fabry disease patients.
FAQs
What is the main focus of United States Patent 10,874,655?
The main focus of this patent is on methods for treating Fabry disease in patients with renal impairment using the drug migalastat.
How does migalastat work in treating Fabry disease?
Migalastat is a chaperone therapy that stabilizes the alpha-Galactosidase A enzyme, allowing it to reach the lysosomes where it is needed to break down globotriaosylceramide (GL-3).
What are the key claims of this patent?
The key claims include the method of treatment using migalastat for patients with specific mutations in the alpha-Gal A gene and renal impairment, along with dependent claims that specify dosage regimens and other conditions.
Is this patent involved in any litigation?
Yes, this patent has been involved in litigation, such as the case "Amicus Therapeutics US, LLC et al v. Teva Pharmaceutical Industries Ltd. et al."
How can one search for similar patents globally?
One can use tools like the Global Dossier, Common Citation Document (CCD), and databases from international patent offices such as the EPO, JPO, and WIPO to search for similar patents globally[1].
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- USA.gov - U.S. Patent and Trademark Office (USPTO): https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - Methods of treating fabry patients having renal impairment: https://patents.google.com/patent/US10874655B2/en
- NPE Litigation Database - 10874655: https://npe.law.stanford.edu/patent/10874655
