United States Patent 10,227,590: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,227,590, 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 Duchenne Muscular Dystrophy (DMD). This patent, assigned to The University of Western Australia, is part of a broader portfolio of patents related to antisense oligonucleotides.
Background
Duchenne Muscular Dystrophy is a severe genetic disorder caused by mutations in the dystrophin gene. The patent in question focuses on antisense oligonucleotides designed to induce exon skipping, a therapeutic approach aimed at bypassing the mutated exon and restoring the production of a functional dystrophin protein.
Patent Overview
Issuance and Assignee
The patent was issued on March 12, 2019, to The University of Western Australia, with inventors Stephen Donald Wilton, Sue Fletcher, and Graham McClorey[2][4].
Claims
The patent claims cover antisense molecules capable of binding to selected target sites on the dystrophin gene to induce exon skipping. Specifically, the claims include:
- Antisense oligonucleotides with sequences as set forth in SEQ ID NO: 1 to 214.
- Methods of using these antisense oligonucleotides to treat DMD by inducing exon skipping[2][4].
Target Region
The patent defines the target region as a segment of the pre-mRNA, specifically the dystrophin gene. The claims are clear that the target region is not limited to particular motifs or regulatory regions but rather encompasses any segment necessary for inducing exon skipping[1].
Scope of the Patent
Claim Language and Interpretation
The scope of the patent is defined by the claim language, which must be clear and distinct to inform those skilled in the art about the invention's boundaries. The patent's claims are structured to ensure that the antisense oligonucleotides are 100% complementary to consecutive bases in the target region, but this does not limit the entire antisense oligonucleotide to this sequence. The distinction between "a base sequence" and "antisense oligonucleotide" is crucial, indicating that these terms have different meanings[1].
Indefiniteness
The patent avoids indefiniteness by ensuring that the claims, when read in light of the specification and prosecution history, inform those skilled in the art with reasonable certainty about the scope of the invention. The court has clarified that the disputed term "target region" means a segment of the pre-mRNA, rejecting interpretations that could lead to ambiguity[1].
Patent Landscape
Related Patents
The University of Western Australia holds a series of patents related to antisense oligonucleotides for inducing exon skipping, including:
- U.S. Patent 10,266,827
- U.S. Patent 10,421,966
- U.S. Patent 10,968,450
- U.S. Patent 10,995,337
All these patents have similar claims and expiration dates, specifically June 28, 2025[2].
Exclusivity and Generic Availability
Currently, there is no generic version of Vyondys 53, a drug that utilizes the technology described in these patents, available in the United States. The exclusivity period and patent protection ensure that the proprietary rights of the patent holders are maintained until the patent expiration dates[2].
Impact on Innovation and Litigation
Patent Quality and Scope
The debate over patent quality and scope is relevant here. The metrics used to measure patent scope, such as independent claim length and count, suggest that narrower claims are associated with a higher probability of grant and a shorter examination process. This patent, with its clear and distinct claims, aligns with these metrics, indicating a well-defined scope that does not diminish innovation incentives[3].
Litigation
The patent has been involved in litigation, particularly in disputes over claim interpretation and infringement. The court's analysis emphasizes the importance of clear claim language and the distinction between different claim terms to avoid ambiguity and indefiniteness[1].
Commercial and Therapeutic Implications
Treatment of DMD
The antisense oligonucleotides covered by this patent offer a promising therapeutic approach for DMD by inducing exon skipping. This method can restore the production of a functional dystrophin protein, significantly improving the quality of life for patients with DMD.
Market Dominance
The exclusive rights granted by this patent and related patents ensure that the University of Western Australia and its licensees maintain a strong market position in the treatment of DMD using antisense oligonucleotides until the patent expiration dates.
Key Takeaways
- Clear Claim Language: The patent's claims are distinct and clear, ensuring that the scope of the invention is well-defined.
- Target Region: The target region is defined as a segment of the pre-mRNA, specifically the dystrophin gene.
- Patent Expiration: The patent is set to expire on June 28, 2025, along with related patents.
- Therapeutic Impact: The antisense oligonucleotides covered by this patent offer a significant therapeutic approach for treating DMD.
- Market Exclusivity: The patent ensures exclusive rights for the treatment method until its expiration.
FAQs
What is the main focus of U.S. Patent 10,227,590?
The main focus of U.S. Patent 10,227,590 is on antisense oligonucleotides designed to induce exon skipping in the dystrophin gene for the treatment of Duchenne Muscular Dystrophy.
Who are the inventors of this patent?
The inventors of this patent are Stephen Donald Wilton, Sue Fletcher, and Graham McClorey.
What is the expiration date of this patent?
The patent is set to expire on June 28, 2025.
Is there a generic version of Vyondys 53 available?
No, there is currently no generic version of Vyondys 53 available in the United States.
How does this patent impact the treatment of DMD?
This patent covers a therapeutic approach using antisense oligonucleotides to induce exon skipping, which can restore the production of a functional dystrophin protein, significantly improving the treatment of DMD.
Sources
- NIPPON SHINY AKU CO., LTD., Plaintiff, SAREPTA ... - U.S. District Court for the District of Delaware[1].
- Generic Vyondys 53 Availability - Drugs.com[2].
- Patent Claims and Patent Scope - SSRN[3].
- US10227590B2 - Antisense oligonucleotides for inducing exon skipping and methods of use thereof - Google Patents[4].
