United States Patent 9,024,007: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,024,007, assigned to Sarepta Therapeutics, Inc., is a significant patent in the field of pharmaceuticals, particularly related to the treatment of Duchenne muscular dystrophy (DMD). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background
The patent in question, U.S. Patent 9,024,007, is titled "Methods for treating Duchenne muscular dystrophy" and was granted on May 5, 2015. It is part of a series of patents related to exon skipping therapies, which are innovative approaches to treating genetic disorders like DMD.
Patent Scope
Claim Structure
The patent includes a series of claims that define the scope of the invention. These claims are categorized into independent and dependent claims. Independent claims stand alone and define the invention broadly, while dependent claims further limit the scope of the independent claims[3].
- Independent Claims: These claims outline the core invention, which in this case involves methods for treating DMD by skipping specific exons in the dystrophin gene.
- Dependent Claims: These claims provide additional details and limitations, such as specific sequences, dosages, and administration methods.
Claim Language and Scope
The scope of the patent is determined by the language used in the claims. For U.S. Patent 9,024,007, the claims are narrowly focused on the method of treating DMD by skipping exon 51, which is a common mutation site in the dystrophin gene. The narrow scope is intended to ensure clarity and validity, avoiding the pitfalls of overly broad claims that can lead to licensing and litigation issues[3].
Patent Claims Analysis
Independent Claim Length and Count
Research has shown that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims, as seen in U.S. Patent 9,024,007, are associated with a higher probability of grant and a shorter examination process. This suggests that the patent office found the claims to be clear and well-defined, which is crucial for maintaining the integrity of the patent system[3].
Forward Citations and Patent Maintenance
The number of forward citations and patent maintenance payments can also indicate the significance and scope of a patent. U.S. Patent 9,024,007 has been cited in various subsequent patents and has undergone regular maintenance payments, indicating its importance in the field of DMD treatment.
Patent Landscape
Interference Cases
The patent has been involved in several interference cases, particularly with BioMarin Pharmaceutical. The Patent Trial and Appeal Board (PTAB) decisions in these cases have been crucial in defining the patent landscape. For instance, the PTAB decision in the exon 53 composition of matter patent interference case did not negatively impact Sarepta’s key composition of matter patent protection for EXONDYS 51 and SRP-4053[5].
Regulatory Approvals
The patent is closely tied to the regulatory approval of EXONDYS 51 (eteplirsen), a drug developed by Sarepta Therapeutics for treating DMD. The FDA approved EXONDYS 51 on December 12, 2019, after verifying the regulatory review period, which is a critical step in ensuring the drug's safety and efficacy[2][4].
International Patent Landscape
Global Dossier and International Search
The patent is part of a global patent family, with related applications filed in various international intellectual property offices. Tools like the Global Dossier and international patent databases (such as those provided by the EPO, JPO, and WIPO) allow for the tracking of related applications and citations across different jurisdictions[1].
Challenges and Controversies
Patent Quality and Scope
There has been ongoing debate about patent quality and the scope of patents, particularly in the pharmaceutical sector. Some argue that broader patents can stifle innovation due to increased licensing and litigation costs. However, the narrow and well-defined claims in U.S. Patent 9,024,007 mitigate these concerns, ensuring that the patent provides clear protection without overly broad claims[3].
Key Takeaways
- Narrow Claims: U.S. Patent 9,024,007 has narrowly defined claims that focus on the method of treating DMD by skipping exon 51.
- Regulatory Approval: The patent is closely tied to the FDA approval of EXONDYS 51.
- Interference Cases: The patent has been involved in interference cases with BioMarin Pharmaceutical, with favorable outcomes for Sarepta Therapeutics.
- Global Patent Family: The patent is part of a global patent family with related applications in various jurisdictions.
- Patent Scope Metrics: The patent's scope is well-defined, aligning with metrics that indicate higher grant probabilities and shorter examination processes.
FAQs
Q: What is the main subject of U.S. Patent 9,024,007?
A: The main subject is methods for treating Duchenne muscular dystrophy (DMD) by skipping specific exons in the dystrophin gene.
Q: What is the significance of the PTAB decisions in relation to this patent?
A: The PTAB decisions, particularly in the exon 53 composition of matter patent interference case, have ensured that Sarepta’s key composition of matter patent protection for EXONDYS 51 and SRP-4053 remains valid.
Q: How does the FDA approval relate to this patent?
A: The FDA approved EXONDYS 51, a drug developed based on the methods described in U.S. Patent 9,024,007, on December 12, 2019.
Q: What tools can be used to track related international patent applications?
A: Tools like the Global Dossier and international patent databases provided by the EPO, JPO, and WIPO can be used to track related international patent applications.
Q: Why are narrow claims important in patent scope?
A: Narrow claims are important because they ensure clarity and validity, reducing the risk of licensing and litigation issues associated with overly broad claims.
Sources
- USPTO: Search for patents - USPTO.
- FDA: FDA U.S. FOOD & DRUG OCT 2 2 2021 - Regulations.gov.
- SSRN: Patent Claims and Patent Scope - Search eLibrary :: SSRN.
- Federal Register: Determination of Regulatory Review Period for Purposes of Patent ...
- Sarepta Therapeutics: Sarepta Therapeutics Announces Favorable USPTO Decisions in Exon 51 and Exon 53 Composition of Matter Patent Interference Cases against BioMarin Pharmaceutical.
