United States Patent 7,838,657: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,838,657, titled "Spinal Muscular Atrophy (SMA) Treatment Via Targeting of SMN2 Splice Site Inhibitory Sequences," is a significant patent in the field of genetic therapies, particularly for the treatment of spinal muscular atrophy (SMA). This patent, assigned to the University of Massachusetts, plays a crucial role in the development and commercialization of therapies like Spinraza (nusinersen).
Background and Inventors
The patent was filed on December 5, 2005, and granted on November 23, 2010. The inventors include Ravindra N. Singh, Natalia N. Singh, Nirmal K. Singh, and Elliot J. Androphy, all of whom are associated with the University of Massachusetts and other research institutions in Massachusetts and Texas[4].
Patent Scope and Claims
Claims Overview
The patent includes claims that cover compositions and methods for modulating the splicing of the SMN2 gene. Specifically, it targets inhibitory sequences within the SMN2 gene to enhance the production of functional survival motor neuron (SMN) protein, which is deficient in SMA patients. The claims are broad enough to encompass various antisense oligonucleotides designed to bind to these inhibitory sequences, thereby promoting the inclusion of exon 7 in the SMN2 mRNA transcript[4].
Independent Claims
The patent has several independent claims that define the scope of the invention. These claims include:
- Composition Claims: These claims cover the antisense oligonucleotides themselves, including their chemical structure and the specific sequences they target.
- Method Claims: These claims cover the methods of using these oligonucleotides to treat SMA by modulating SMN2 splicing.
- Use Claims: These claims specify the therapeutic uses of the compositions, including the treatment of SMA in pediatric and adult patients[4].
Patent Claims and Scope Metrics
Independent Claim Length and Count
Research on patent scope metrics suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. For U.S. Patent 7,838,657, the independent claims are detailed and specific, indicating a well-defined scope that is narrow enough to be enforceable but broad enough to cover the essential aspects of the invention[3].
Regulatory Review and Patent Term Extension
FDA Approval and Regulatory Review
The approval of Spinraza, which is based on the technology described in this patent, involved a significant regulatory review period. The FDA approved Spinraza on December 23, 2016, after a regulatory review period of 1,891 days, which included both the testing and approval phases[2].
Patent Term Extension
Under the Drug Price Competition and Patent Term Restoration Act of 1984, patents can be extended for up to five years if the patented product was subject to regulatory review before marketing. For U.S. Patent 7,838,657, the FDA determined that the regulatory review period justified a patent term extension. However, the actual extension granted was subject to statutory limitations, resulting in an extended patent term until July 11, 2027[2][4].
Patent Landscape and Related Patents
Related Patents
The treatment of SMA involves several related patents, including U.S. Patent Nos. 8,110,560, 8,361,977, and 8,980,853. These patents, held by the University of Massachusetts and Biogen MA Inc., cover various aspects of SMN2 splicing modulation and the use of antisense oligonucleotides in SMA treatment[2][5].
Generic Availability and Exclusivity
As of the current date, there is no generic version of Spinraza available in the United States. The patent landscape, including the extended patent terms, contributes to the exclusivity period for Spinraza, ensuring that Biogen maintains market exclusivity until the patents expire[5].
Impact on Innovation and Litigation
Innovation Incentives
The patent scope and claims of U.S. Patent 7,838,657 are designed to balance innovation incentives with the need for clear and enforceable intellectual property rights. Narrower claims, as seen in this patent, can reduce licensing and litigation costs, thereby promoting further innovation in the field[3].
Litigation and Licensing
The specific and well-defined claims of this patent help in reducing the likelihood of overly broad or vague claims that could lead to increased litigation. This clarity is crucial for licensing agreements and collaborations among researchers and pharmaceutical companies[3].
Key Statistics and Dates
- Filing Date: December 5, 2005
- Grant Date: November 23, 2010
- Regulatory Review Period: 1,891 days
- FDA Approval Date: December 23, 2016
- Patent Expiration Date: July 11, 2027 (with extension)[2][4].
Conclusion
U.S. Patent 7,838,657 is a pivotal patent in the treatment of spinal muscular atrophy, providing a detailed and specific scope that covers the use of antisense oligonucleotides to modulate SMN2 splicing. The patent's claims, regulatory review, and extension contribute to the complex patent landscape surrounding SMA therapies, ensuring that Biogen and other stakeholders maintain exclusivity while promoting innovation in genetic therapies.
Key Takeaways
- Specific Claims: The patent includes specific claims covering compositions and methods for SMN2 splicing modulation.
- Regulatory Review: The FDA-approved Spinraza underwent a significant regulatory review period.
- Patent Term Extension: The patent term was extended due to the regulatory review period.
- Related Patents: Several related patents cover various aspects of SMA treatment.
- Exclusivity: No generic version of Spinraza is currently available, ensuring market exclusivity.
Frequently Asked Questions (FAQs)
What is the main subject of U.S. Patent 7,838,657?
U.S. Patent 7,838,657 covers compositions and methods for treating spinal muscular atrophy (SMA) by modulating the splicing of the SMN2 gene.
Who are the inventors of this patent?
The inventors include Ravindra N. Singh, Natalia N. Singh, Nirmal K. Singh, and Elliot J. Androphy.
What is the significance of the regulatory review period for this patent?
The regulatory review period of 1,891 days justified a patent term extension, ensuring the patent remains in effect until July 11, 2027.
Is there a generic version of Spinraza available?
No, there is currently no generic version of Spinraza available in the United States.
How does this patent impact innovation in genetic therapies?
The patent's specific and well-defined claims help reduce licensing and litigation costs, promoting further innovation in the field of genetic therapies.
Cited Sources:
- Regulations.gov: FEB l 7 2017 - Regulations.gov
- Federal Register: Federal Register, Volume 86 Issue 208 (Monday, November 1, 2021)
- SSRN: Patent Claims and Patent Scope - Search eLibrary :: SSRN
- Google Patents: United States Patent - googleapis.com
- Drugs.com: Generic Spinraza Availability - Drugs.com
