United States Patent 10,421,966: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,421,966, titled "Antisense oligonucleotides for inducing exon skipping and methods of use thereof," is a significant patent in the field of genetic therapy, particularly for treating muscular dystrophy. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Invention Description
The patent describes antisense oligonucleotides designed to induce exon skipping in the dystrophin gene, a crucial approach for treating Duchenne muscular dystrophy (DMD) and other related disorders. These oligonucleotides are engineered to bind to specific target sites on the dystrophin gene, facilitating the skipping of mutated exons and thereby restoring the reading frame of the gene, which can lead to the production of a functional dystrophin protein[4].
Claims
The patent includes multiple claims that define the scope of the invention:
- Independent Claims: These claims outline the core invention, including the specific sequences of the antisense oligonucleotides and their methods of use.
- Dependent Claims: These claims build upon the independent claims, specifying additional features such as the chemistry of the oligonucleotides, the target sites within the dystrophin gene, and the therapeutic compositions containing these oligonucleotides[4].
Scope of the Patent
Patent Scope Metrics
Research on patent scope often uses metrics such as independent claim length and independent claim count to measure the breadth of a patent. Narrower claims, as seen in this patent, are associated with a higher probability of grant and a shorter examination process, indicating a more focused and potentially stronger patent[3].
Specificity of Claims
The claims in this patent are highly specific, detailing the exact sequences of the antisense oligonucleotides and their target sites within the dystrophin gene. This specificity helps in defining a clear boundary around the invention, reducing the likelihood of overlap with other patents and enhancing the patent's validity[4].
Patent Landscape
Global Patent System
The patent is part of a global patent family, with related applications filed at various international intellectual property offices. Tools like the Global Dossier and the Common Citation Document (CCD) facilitate the management and analysis of these global patent families, providing a comprehensive view of the prior art and office actions across different jurisdictions[1].
Related Patents and Applications
Other patents and applications related to antisense oligonucleotides and exon skipping therapies are part of the broader landscape. For instance, patents like those held by other biotech companies or research institutions may cover similar but distinct aspects of genetic therapy, such as different chemistries or target genes[4].
Regulatory Environment
The regulatory environment plays a crucial role in the lifecycle of such patents. For example, the FDA's approval process and the subsequent patent term extension under 35 U.S.C. § 156 can significantly impact the patent's duration and commercial viability. The regulatory review period, which includes both the testing and approval phases, is a key factor in determining the extent of any patent term extension[5].
Search and Analysis Tools
Patent Public Search
Tools like the Patent Public Search provided by the USPTO offer enhanced access to prior art, allowing for a thorough search of existing patents and published patent applications. This is crucial for ensuring the novelty and non-obviousness of the invention claimed in the patent[1].
International Patent Databases
Databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) are essential for conducting a comprehensive global patent search. These resources help in identifying prior art and related patents worldwide[1].
Practical Applications and Impact
Therapeutic Use
The antisense oligonucleotides described in this patent have the potential to significantly impact the treatment of Duchenne muscular dystrophy and other genetic disorders. By inducing exon skipping, these oligonucleotides can restore the production of functional dystrophin protein, thereby alleviating the symptoms of these diseases[4].
Commercial and Licensing Implications
The patent's scope and claims have significant commercial implications. The specificity and breadth of the claims can influence licensing agreements and the potential for litigation. Narrower, well-defined claims can reduce licensing and litigation costs, making the patent more attractive for commercialization[3].
Key Takeaways
- Specificity and Breadth: The patent's claims are highly specific, focusing on particular sequences and methods, which enhances its validity and commercial viability.
- Global Patent Family: The patent is part of a global family, managed through tools like the Global Dossier and CCD.
- Regulatory Impact: The FDA's regulatory review process is crucial for determining patent term extensions.
- Therapeutic Potential: The invention has significant therapeutic potential for treating genetic disorders like Duchenne muscular dystrophy.
- Commercial Implications: The patent's scope influences licensing and litigation, making it an important asset for commercialization.
FAQs
Q: What is the primary invention described in United States Patent 10,421,966?
A: The primary invention is antisense oligonucleotides designed to induce exon skipping in the dystrophin gene, used for treating Duchenne muscular dystrophy and related disorders.
Q: How do the claims in this patent impact its validity and commercial viability?
A: The specific and narrow claims enhance the patent's validity by clearly defining the invention and reduce licensing and litigation costs, making it more commercially viable.
Q: What tools are available for searching and analyzing patents related to this invention?
A: Tools such as the Patent Public Search, Global Dossier, and international patent databases like those from the EPO, JPO, and WIPO are available.
Q: How does the FDA's regulatory review process affect this patent?
A: The FDA's regulatory review period is crucial for determining any potential patent term extension under 35 U.S.C. § 156.
Q: What is the therapeutic potential of the invention described in this patent?
A: The invention has significant therapeutic potential for treating genetic disorders by restoring the production of functional dystrophin protein through exon skipping.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- FDA U.S. FOOD & DRUG OCT 2 2 2021 - Regulations.gov: https://downloads.regulations.gov/FDA-2020-E-1320-0005/attachment_1.pdf
- Patent Claims and Patent Scope - Search eLibrary :: SSRN: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- US10421966B2 - Antisense oligonucleotides for inducing exon skipping and methods of use thereof - Google Patents: https://patents.google.com/patent/US10421966B2/en
- 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES ...: https://public-inspection.federalregister.gov/2021-23724.pdf
