Comprehensive and Critical Analysis of United States Patent 7,070,959
Introduction
United States Patent 7,070,959, titled "Modified chimeric polypeptides with improved pharmacokinetic properties," is a significant patent in the field of biotechnology, particularly in the development of therapeutic proteins. This patent, assigned to Regeneron Pharmaceuticals, Inc., involves modifications to chimeric polypeptides to enhance their pharmacokinetic profiles.
Background and Context
The patent was filed on May 23, 2000, and granted on July 4, 2006. It is part of a broader portfolio of patents related to the development of therapeutic proteins, notably those targeting vascular endothelial growth factor (VEGF) pathways. The primary application of these modified polypeptides is in the treatment of diseases such as neovascular (wet) age-related macular degeneration (AMD)[4].
Inventors and Assignee
The inventors listed on the patent are Nicholas J. Papadopoulos, Samuel Davis, and George D. Yancopoulos, all associated with Regeneron Pharmaceuticals, Inc., which is the assignee of the patent[2].
Claims and Scope
The patent includes multiple claims that describe the structure, composition, and methods of use for the modified chimeric polypeptides. Key claims focus on:
- Modified Chimeric Polypeptides: These are engineered to include domains from different proteins, such as the Flt1 receptor and the Fc domain of an immunoglobulin, to improve their pharmacokinetic properties[2].
- Pharmacokinetic Improvements: The modifications aim to enhance the half-life, stability, and bioavailability of the polypeptides, making them more effective therapeutic agents[2].
Technical Details
The patent describes specific modifications to the polypeptides, including:
- Domain Engineering: The fusion of different protein domains to create chimeric polypeptides with desired properties.
- Fc Domain: Incorporation of the Fc domain to enhance the half-life of the polypeptide by leveraging the neonatal Fc receptor (FcRn) pathway[2].
Regulatory and Patent Term Restoration
The patent has undergone regulatory review and has been subject to patent term restoration applications. The FDA approved the human biological product EYLEA (aflibercept), which is covered by this patent, for the treatment of neovascular AMD. The regulatory review period for EYLEA was determined to be 2,349 days, which formed the basis for potential patent term extensions[4].
Impact on Therapeutic Use
The modified chimeric polypeptides described in this patent have significant therapeutic implications. For instance, EYLEA, which is a product of these modifications, has become a crucial treatment for neovascular AMD, improving patient outcomes by inhibiting VEGF pathways[4].
Patent Landscape and Competitors
The patent landscape in this area is highly competitive, with multiple companies and research institutions working on similar technologies. The scope of this patent is narrowly defined to protect the specific modifications and compositions developed by Regeneron Pharmaceuticals. However, the broader field of VEGF antagonists and therapeutic proteins is subject to ongoing innovation and patent filings[5].
Critique of Patent Scope and Claims
The patent scope is critical in determining the breadth of protection and the potential for innovation. Research suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. However, broader claims can provide more extensive protection but may face more scrutiny during the examination process[3].
Independent Claim Length and Count
Metrics such as independent claim length and count can be used to measure patent scope. This patent includes detailed and specific claims, which indicate a well-defined scope but may limit the breadth of protection compared to broader claims[3].
Examination Process
The examination process for this patent would have involved a thorough review of the claims to ensure they are novel, non-obvious, and enabled. The fact that the patent was granted suggests that the claims met these criteria, but the process may have narrowed the scope of the claims to ensure validity[3].
Economic and Legal Implications
The economic implications of this patent are significant, given the commercial success of EYLEA. The patent term restoration applications and subsequent extensions have allowed Regeneron Pharmaceuticals to maintain market exclusivity for an extended period, impacting the entry of generic competitors[4].
Future Directions and Innovations
The field of therapeutic proteins is continuously evolving. Future innovations may focus on further optimizing the pharmacokinetic properties of these polypeptides, exploring new targets, and developing combination therapies. The patent landscape will continue to play a crucial role in shaping the direction of these innovations[5].
Key Takeaways
- Modified Chimeric Polypeptides: The patent describes specific modifications to improve pharmacokinetic properties.
- Therapeutic Applications: The primary application is in treating neovascular AMD.
- Regulatory and Patent Term Restoration: The patent has undergone regulatory review and has been subject to patent term restoration.
- Patent Scope and Claims: The patent includes specific and detailed claims, which define its scope.
- Economic and Legal Implications: The patent has significant economic and legal implications, including market exclusivity.
FAQs
Q: What is the primary application of the modified chimeric polypeptides described in US Patent 7,070,959?
A: The primary application is in the treatment of neovascular (wet) age-related macular degeneration (AMD).
Q: Who are the inventors listed on the patent?
A: The inventors are Nicholas J. Papadopoulos, Samuel Davis, and George D. Yancopoulos.
Q: What is the role of the Fc domain in the modified chimeric polypeptides?
A: The Fc domain enhances the half-life of the polypeptide by leveraging the neonatal Fc receptor (FcRn) pathway.
Q: How did the FDA determine the regulatory review period for EYLEA?
A: The FDA determined the regulatory review period based on the testing and approval phases, which totaled 2,349 days.
Q: What are the economic implications of the patent term restoration for EYLEA?
A: The patent term restoration allows Regeneron Pharmaceuticals to maintain market exclusivity for an extended period, impacting the entry of generic competitors.
Cited Sources
- US7070959B1 - Modified chimeric polypeptides with improved pharmacokinetic properties - Google Patents
- US7374758B2 - Modified chimeric polypeptides with improved pharmacokinetic properties and methods of using thereof - Google Patents
- Patent Claims and Patent Scope - SSRN
- Federal Register, Volume 79 Issue 63 - GovInfo
- WO2015058048A1 - Methods and compositions comprising a combination of a vegf antagonist and an anti-ctla-4 antibody - Google Patents
