Comprehensive Analysis of United States Patent 7,306,799: Use of VEGF Inhibitors for Treatment of Eye Disorders
Introduction
United States Patent 7,306,799, titled "Use of VEGF Inhibitors for Treatment of Eye Disorders," is a significant patent in the field of ophthalmology and therapeutic treatments. This patent, granted to inventors Stanley J. Wiegand, Nicholas J. Papadopoulos, and others, outlines methods and compositions for treating eye disorders associated with angiogenesis using VEGF (Vascular Endothelial Growth Factor) inhibitors.
Background of the Patent
The patent is a continuation-in-part of several earlier applications, including those filed in 2000, 2001, and 2004. It builds upon previous research and patents related to the use of VEGF inhibitors, particularly in the context of eye disorders[1].
Field of the Invention
The patent pertains to the therapeutic treatment of eye disorders, specifically those caused by or associated with angiogenesis. Angiogenesis is the process of new blood vessel formation, which can be pathological in conditions such as age-related macular degeneration (AMD), diabetic retinopathy, and retinal vein occlusion[4].
Key Claims and Inventions
VEGF Inhibitors
The patent claims the use of VEGF inhibitors to treat various eye disorders. VEGF is a protein that promotes angiogenesis, and inhibiting it can reduce the growth of new, potentially harmful blood vessels in the eye[1].
Pharmaceutical Formulations
The patent describes pharmaceutical formulations containing VEGF inhibitors, which may include pharmaceutically acceptable carriers, diluents, adjuvants, excipients, or vehicles. These formulations are designed to improve the delivery, tolerance, and efficacy of the VEGF inhibitors[4].
Administration Methods
The patent outlines methods for administering VEGF inhibitors, including sequential dosing to ensure sustained therapeutic effects. This approach is crucial for managing chronic conditions where continuous inhibition of VEGF is necessary[5].
Specific VEGF Inhibitors
The patent mentions specific VEGF inhibitors, such as VEGF-TRAP, which is a fusion protein designed to bind and neutralize VEGF. The effectiveness of these inhibitors is demonstrated through various studies and experiments detailed in the patent[1].
Technical Details and Experiments
Binding Stoichiometry
The patent includes detailed analyses of the binding stoichiometry of VEGF inhibitors, such as the molar ratio of bound VEGF165 to immobilized VEGF inhibitors. This data is critical for understanding the efficacy and specificity of the inhibitors[1].
Animal Studies
The patent presents results from animal studies, including suture and chemical injury models, which demonstrate the therapeutic efficacy of VEGF inhibitors in reducing pathological angiogenesis. These studies provide strong evidence for the potential of VEGF inhibitors in treating human eye disorders[1].
Patent Landscape and Related Patents
Continuation-in-Part
This patent is part of a series of continuations-in-part, indicating a continuous development and refinement of the technology. Earlier patents, such as US 7,070,959 and US 7,087,411, are incorporated by reference, highlighting the evolutionary nature of the research[1].
Other Relevant Patents
Other patents, such as US 10857205-B2 and US Patent Application 20210085753, also focus on the use of VEGF antagonists for treating angiogenic eye disorders. These patents further validate the importance of VEGF inhibition in ophthalmic treatments and expand on the methods and formulations described in US 7,306,799[4][5].
Legal and Regulatory Aspects
Statutory Requirements
The patent complies with statutory requirements for claims, as outlined in legal treatises such as "Patent Claims, 3d." This includes general rules of construction of claims and the limitations imposed by court interpretations[3].
Regulatory Approval
The pharmaceutical formulations described in the patent must meet regulatory standards, including approval by federal or state government agencies or listing in recognized pharmacopeias. This ensures the safety and efficacy of the treatments for human use[4].
Impact and Significance
Clinical Implications
The use of VEGF inhibitors as described in this patent has significant clinical implications. It offers a targeted therapeutic approach for treating eye disorders associated with angiogenesis, potentially improving patient outcomes and quality of life.
Market and Commercial Impact
The patent's approval and the subsequent development of VEGF inhibitors have led to the creation of several commercial drugs, such as Lucentis and Eylea, which are widely used in ophthalmic practice. This has transformed the treatment landscape for conditions like AMD and diabetic retinopathy.
Critique and Future Directions
Efficacy and Safety
While the patent demonstrates the efficacy of VEGF inhibitors, ongoing research continues to evaluate their long-term safety and optimal dosing regimens. Real-world data and post-marketing surveillance are crucial for fully understanding the benefits and risks of these treatments.
Resistance and Side Effects
There is a growing concern about the potential for resistance to VEGF inhibitors and the management of side effects. Future research should focus on overcoming these challenges through the development of new inhibitors or combination therapies.
Key Takeaways
- VEGF Inhibition: The patent highlights the therapeutic potential of VEGF inhibitors in treating eye disorders associated with angiogenesis.
- Pharmaceutical Formulations: The described formulations are designed to enhance delivery and efficacy.
- Administration Methods: Sequential dosing is a key strategy for sustained therapeutic effects.
- Regulatory Compliance: The patent adheres to statutory requirements and regulatory standards.
- Clinical and Commercial Impact: The patent has led to significant advancements in ophthalmic treatments and the development of commercial drugs.
FAQs
What is the primary focus of United States Patent 7,306,799?
The primary focus is the use of VEGF inhibitors for treating eye disorders associated with angiogenesis.
What are VEGF inhibitors, and how do they work?
VEGF inhibitors are proteins or drugs that bind to and neutralize VEGF, thereby reducing pathological angiogenesis in the eye.
What are some examples of VEGF inhibitors mentioned in the patent?
Examples include VEGF-TRAP, a fusion protein designed to bind and neutralize VEGF.
How are VEGF inhibitors administered according to the patent?
The patent describes sequential dosing methods to ensure sustained therapeutic effects.
What is the significance of this patent in ophthalmic treatments?
The patent has led to the development of targeted therapeutic approaches for treating eye disorders like AMD and diabetic retinopathy, significantly improving patient outcomes.
Sources
- United States Patent 7,306,799 B2: Wiegand et al., "Use of VEGF Inhibitors for Treatment of Eye Disorders," December 11, 2007.
- United States Patent 11542317: Regeneron Pharmaceuticals, Inc., "Methods and Compositions for Treating Eye Disorders," June 16, 2022.
- Patent Claims, 3d: Legal Solutions, Thomson Reuters.
- US Patent Application 20210085753: "Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders."
- US-10857205-B2: "Use of a Vegf Antagonist to Treat Angiogenic Eye Disorders."
