Understanding the Scope and Claims of United States Patent 10,040,855
Introduction
United States Patent 10,040,855, titled "Formulation for anti-α4β7 antibody," is a significant patent in the field of pharmaceutical formulations, particularly for antibodies targeting the α4β7 integrin. This patent, granted to its inventors, outlines specific formulations and methods for stabilizing and delivering anti-α4β7 antibodies, which are crucial for treating various autoimmune and inflammatory diseases.
Patent Overview
The patent, published under the number US10040855B2, was filed on March 21, 2012, and granted on August 7, 2018. It is categorized under the pharmaceutical formulations and specifically deals with the stabilization and delivery of anti-α4β7 antibodies[4].
Key Components of the Patent
Antibody and Target
The anti-α4β7 antibody is designed to target the α4β7 integrin, a protein involved in the adhesion and migration of leukocytes. This integrin plays a critical role in the pathogenesis of several autoimmune and inflammatory diseases, such as Crohn's disease and ulcerative colitis[4].
Formulation Composition
The patent describes a formulation that includes:
- Anti-α4β7 antibody: The primary active ingredient.
- Antioxidant or chelator: To prevent oxidation and degradation of the antibody.
- Free amino acid: Such as glycine or arginine, which helps in stabilizing the antibody.
- Buffering agent: To maintain the pH stability of the formulation.
- Surface-active agent: Such as polysorbate 80, to reduce surface tension and prevent aggregation of the antibody[4].
Claim Structure
The claims of the patent are structured to cover various aspects of the formulation and its preparation.
Independent Claims
Independent claims define the broadest scope of the invention. For example, Claim 1 might describe the formulation comprising an anti-α4β7 antibody, an antioxidant or chelator, and at least one free amino acid. These claims are crucial as they set the boundaries of what is considered novel and non-obvious[4].
Dependent Claims
Dependent claims narrow down the scope by adding specific details to the independent claims. For instance, a dependent claim might specify the type of antioxidant or the concentration of the free amino acid. These claims provide additional protection by covering specific embodiments of the invention.
Patent Scope Metrics
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics are important in assessing the breadth and clarity of the patent claims.
Independent Claim Length
Longer independent claims often indicate a narrower scope, as they include more specific details. In contrast, shorter independent claims may suggest a broader scope but could be less clear or more prone to litigation[3].
Independent Claim Count
A higher number of independent claims can indicate a broader scope, as it covers more aspects of the invention. However, it also increases the complexity and potential for overlap with other patents[3].
Economic and Legal Implications
Patent Maintenance Payments
The scope of the patent can influence the maintenance payments required to keep the patent in force. Narrower claims, which are often associated with higher maintenance payments, may indicate a more focused and valuable invention[3].
Forward Citations
The number of forward citations (citations by later patents) can be an indicator of the patent's impact and scope. Patents with broader claims may receive more forward citations, as they cover a wider range of innovations[3].
Industry Impact
Innovation Incentives
The clarity and breadth of patent claims can significantly affect innovation incentives. Clear and narrowly defined claims can reduce litigation costs and encourage further innovation, while overly broad claims might deter innovation due to increased licensing and litigation costs[3].
Market Competition
The patent landscape around anti-α4β7 antibodies is competitive, with several pharmaceutical companies developing similar formulations. The scope and claims of US10040855B2 will influence how these companies navigate the market, either by licensing the technology or developing workarounds[4].
Storage and Stability
The patent also addresses the storage and stability of the formulation, which is critical for its efficacy and shelf life. The inclusion of antioxidants, chelators, and free amino acids helps in maintaining the stability of the antibody during storage and use[4].
Regulatory Considerations
The formulation must comply with regulatory standards for pharmaceutical products. The patent's claims and scope will be scrutinized by regulatory bodies to ensure that the product meets safety, efficacy, and quality standards.
Conclusion
United States Patent 10,040,855 provides a comprehensive framework for the formulation and stabilization of anti-α4β7 antibodies. The patent's scope, as defined by its claims, is crucial for understanding its impact on the pharmaceutical industry and the treatment of autoimmune and inflammatory diseases.
Key Takeaways
- Formulation Composition: Includes anti-α4β7 antibody, antioxidant or chelator, and free amino acid.
- Claim Structure: Independent and dependent claims define the scope and specific embodiments of the invention.
- Patent Scope Metrics: Independent claim length and count are key metrics for assessing the breadth and clarity of the patent.
- Economic and Legal Implications: Affects maintenance payments, forward citations, innovation incentives, and market competition.
- Industry Impact: Influences the development and marketing of similar formulations by other companies.
- Storage and Stability: Formulation components ensure stability during storage and use.
FAQs
Q: What is the primary target of the anti-α4β7 antibody?
A: The primary target is the α4β7 integrin, involved in the adhesion and migration of leukocytes.
Q: What components are included in the formulation described in the patent?
A: The formulation includes an anti-α4β7 antibody, an antioxidant or chelator, and at least one free amino acid.
Q: How do the metrics of independent claim length and count affect the patent scope?
A: Longer independent claims and a higher number of independent claims can indicate a narrower or broader scope, respectively, and influence the clarity and complexity of the patent.
Q: What are the economic implications of the patent scope?
A: The patent scope affects maintenance payments, forward citations, innovation incentives, and market competition.
Q: Why is the storage and stability of the formulation important?
A: The storage and stability are critical for maintaining the efficacy and shelf life of the anti-α4β7 antibody formulation.
Sources
- US10040855B2 - Formulation for anti-α4β7 antibody - Google Patents.
- Patent Claims Research Dataset - USPTO.
- Patent Claims and Patent Scope - SSRN.
- US10040855B2 - Formulation for anti-α4β7 antibody - Google Patents.
- Patent and patent application Claims data - USPTO.
