Understanding the Scope and Claims of United States Patent 10,995,337
Introduction
United States Patent 10,995,337, titled "Antisense oligonucleotides for inducing exon skipping and methods of use thereof," is a significant patent in the field of genetic therapy, particularly for the treatment of genetic disorders such as Duchenne muscular dystrophy (DMD). Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape.
Background
The patent, assigned to the University of Western Australia, was issued on May 4, 2021. It is part of a series of patents focused on antisense oligonucleotides designed to induce exon skipping in the dystrophin gene, a crucial approach for treating DMD[4].
Scope of the Patent
The patent describes antisense molecules that are capable of binding to specific target sites within the dystrophin gene to induce exon skipping. This process is aimed at bypassing mutations in the gene that lead to DMD, allowing for the production of a functional dystrophin protein.
- Antisense Molecules: The patent outlines a range of antisense oligonucleotides, listed in Table 1A, which are designed to bind to specific sequences within the dystrophin gene. These molecules are selected or adapted to aid in the prophylactic or therapeutic treatment of genetic disorders[4].
- Exon Skipping: The method involves selecting an antisense molecule that targets specific exons in the dystrophin gene. By inducing exon skipping, the mutation that causes DMD can be bypassed, leading to the production of a shorter but functional dystrophin protein[4].
Claims of the Patent
The patent includes several key claims that define its scope:
- Claim 1: This claim describes an antisense molecule capable of binding to a selected target site to induce exon skipping in the dystrophin gene. The molecule is selected from a group listed in the patent specification[4].
- Claim 2: This claim pertains to the method of treating a patient suffering from a genetic disease by administering an antisense molecule that induces exon skipping. The method involves selecting the appropriate antisense molecule and administering it to the patient[4].
- Claim 3: This claim covers the use of purified and isolated antisense oligonucleotides for the manufacture of a medicament for treating genetic diseases[4].
Patent Landscape
The patent landscape surrounding Vyondys 53, the drug that utilizes these antisense oligonucleotides, is complex and involves multiple patents.
- Patent Expiration Dates: Several patents related to Vyondys 53, including US10,995,337, are set to expire on June 28, 2025. This includes patents such as US9994851, US9024007, and US10421966, all of which protect the active ingredient and methods of use[2][5].
- Global Protection: While the patents mentioned provide exclusivity within the United States, Vyondys 53 is also protected by patents in multiple other countries. Understanding this global patent landscape is crucial for strategizing market entry and identifying potential generic launch points[2].
Patent Analytics and Claim Coverage
To fully understand the protection and potential gaps in the patent coverage, patent analytics tools are essential.
- Claim Coverage Matrix: This tool helps in categorizing patents by claims and scope concepts, making it easier to identify which patents and claims are actively protecting the intellectual property. It also highlights areas where there may be gaps in coverage[3].
- Claim Charts: These charts, generated by tools like ClaimScape®, facilitate the review of patent coverage with technical experts. They help in determining whether a particular scope concept is applicable to a target product or method and in identifying future design opportunities[3].
Legal and Regulatory Aspects
The patent has undergone various legal and regulatory processes:
- Continuation of Applications: The patent is a continuation of several previous applications, dating back to 2011, which reflects the ongoing development and refinement of the technology[1].
- Patent Interferences: There have been patent interference proceedings, such as those filed in Patent Interference No. 106007, which indicate the complexity and competition in this field of research[1].
Generic Launch Implications
As the patent expiration dates approach, the possibility of generic versions of Vyondys 53 becomes more relevant.
- Current Status: As of now, there is no therapeutically equivalent generic version of Vyondys 53 available in the United States. The expiration of the patents in June 2025 will likely pave the way for generic entries[5].
Key Takeaways
- Antisense Oligonucleotides: The patent focuses on antisense oligonucleotides designed to induce exon skipping in the dystrophin gene, a critical approach for treating DMD.
- Patent Expiration: The patents protecting Vyondys 53 are set to expire in June 2025, which will impact the exclusivity of the drug.
- Global Patent Landscape: Understanding the global patent landscape is crucial for market strategy and generic launch planning.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for analyzing and managing patent claims effectively.
FAQs
Q: What is the primary focus of United States Patent 10,995,337?
A: The primary focus is on antisense oligonucleotides designed to induce exon skipping in the dystrophin gene for treating genetic disorders like DMD.
Q: When are the patents related to Vyondys 53 set to expire?
A: The patents are set to expire on June 28, 2025.
Q: What is the significance of patent analytics in this context?
A: Patent analytics helps in understanding which patents and claims are actively protecting the intellectual property and identifying gaps or opportunities in the patent landscape.
Q: Are there any generic versions of Vyondys 53 available currently?
A: No, there are currently no therapeutically equivalent generic versions of Vyondys 53 available in the United States.
Q: How does the global patent landscape affect market strategy for Vyondys 53?
A: Understanding the global patent landscape helps in identifying markets with weaker patent protection, which could be ideal for generic entry points.
Cited Sources
- United States Patent and Trademark Office, "Antisense oligonucleotides for inducing exon skipping and methods of use thereof," US10995337B2.
- Pharsight, "Vyondys 53 patent expiration."
- Schwegman Lundberg & Woessner, "Patent Analytics."
- Google Patents, "US10995337B2 - Antisense oligonucleotides for inducing exon skipping and methods of use thereof."
- Drugs.com, "Generic Vyondys 53 Availability."
