United States Patent 8,476,268: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 8,476,268, titled "Pyrrolidine-1,2-dicarboxamide derivatives," was granted to Novartis AG on July 2, 2013. This patent is significant in the field of pharmaceuticals, particularly for its application in anticancer therapies. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignee
The patent was invented by Robin Alec Fairhurst, Vito Guagnano, Patricia Imbach-Weese, Giorgio Caravatti, and Pascal Furet, and is assigned to Novartis AG, a leading pharmaceutical company based in Basel, Switzerland[1][4].
Background and Purpose
The patent describes a series of pyrrolidine-1,2-dicarboxamide derivatives, which are designed to act as kinase inhibitors. These compounds are particularly useful in the treatment of various diseases, including tumor diseases and leukemias. The invention aims to provide compounds with improved metabolic stability and pharmacokinetic profiles, enhancing their therapeutic efficacy[1].
Scope of the Patent
Claim Structure
The patent's scope is defined by its claims, which outline the specific characteristics of the pyrrolidine-1,2-dicarboxamide derivatives. The claims are structured around the general formula (I) of the compounds, detailing the various substituents and their possible variations. For instance, the claims specify that R" can represent optionally substituted alkyl, cycloalkyl, aryl, amine, sulfonyl, or halo groups, among others[1].
Breadth of Protection
The breadth of the patent's scope is a critical factor in determining its protective power. According to patent law principles, broader patents offer more protection against infringers because they are harder to design around. The claims in this patent are detailed but not overly restrictive, providing a balanced level of protection. For example, the patent covers a wide range of substituents, making it challenging for competitors to create readily substitutable variations without infringing the patent[3].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the core aspects of the invention. These claims specify the chemical structure of the pyrrolidine-1,2-dicarboxamide derivatives, including the types of substituents and their positions. For instance, Claim 1 describes the general formula of the compounds, while subsequent claims provide more specific examples and variations[1].
Dependent Claims
Dependent claims further narrow down the scope by adding additional limitations to the independent claims. These claims help to ensure that the patent covers specific embodiments of the invention while maintaining a broad enough scope to prevent easy circumvention by competitors.
Patent Landscape
Related Patents
The patent landscape surrounding US 8,476,268 includes several related patents and applications. For example, the patent is a continuation of application No. 12/556,964, now Pat. No. 8,227,462, and also references various other U.S. and foreign patent documents. These include patents related to similar chemical compounds and therapeutic applications, such as kinase inhibitors and anticancer agents[1].
Competitive Environment
The pharmaceutical industry is highly competitive, and patents like US 8,476,268 play a crucial role in protecting intellectual property. Novartis AG, as the assignee, benefits from the exclusive rights granted by this patent, allowing the company to develop and market these compounds without immediate competition. However, the patent landscape is dynamic, with other companies and research institutions continually developing new compounds and therapies that may intersect with or challenge existing patents.
Measurement of Patent Scope
Claim Length and Scope
Research has shown that the length of a patent's claims can be a reliable indicator of its scope. Generally, longer claims imply more conditions that must be met for a patent to be violated, making the patent narrower. In contrast, shorter claims suggest broader protection. The claims in US 8,476,268 are detailed, indicating a balanced scope that is neither too broad nor too narrow[3].
Traditional Measures
Traditional measures of patent scope, such as the number of patent classes, citations, and claims, have been found to be less reliable. For instance, the number of patent classes assigned to a patent is often negatively correlated with patent scope, and the number of citations is only weakly related to scope. In contrast, the length of the first claim is a more predictive measure of patent scope[3].
Therapeutic Applications
Kinase Inhibitors
The pyrrolidine-1,2-dicarboxamide derivatives described in the patent are designed to act as kinase inhibitors, which are crucial in the treatment of various cancers. Kinase inhibitors block specific enzymes (kinases) involved in the signaling pathways that control cell growth and division. By inhibiting these kinases, the compounds can help in controlling tumor growth and proliferation[1][4].
Combination Therapies
The patent also mentions the use of these compounds in combination with other anticancer agents, such as Epidermal Growth Factor Receptor (EGFR) inhibitors. This combination therapy approach can enhance the therapeutic efficacy and provide better treatment outcomes for patients[1].
Conclusion
The United States Patent 8,476,268 is a significant contribution to the field of pharmaceuticals, particularly in the development of anticancer therapies. The patent's scope, defined by its detailed claims, provides a balanced level of protection against infringement while allowing for the development of various embodiments of the pyrrolidine-1,2-dicarboxamide derivatives. Understanding the patent landscape and the traditional measures of patent scope helps in appreciating the strategic importance of this patent in the competitive pharmaceutical industry.
Key Takeaways
- Patent Scope: The patent's scope is defined by detailed claims that specify the chemical structure and substituents of the pyrrolidine-1,2-dicarboxamide derivatives.
- Therapeutic Applications: The compounds are designed as kinase inhibitors for the treatment of tumor diseases and leukemias.
- Combination Therapies: The patent suggests the use of these compounds in combination with other anticancer agents to enhance therapeutic efficacy.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and applications in the pharmaceutical industry.
- Measurement of Scope: The length of the claims is a more reliable indicator of patent scope compared to traditional measures.
FAQs
Q1: What is the main subject of United States Patent 8,476,268?
The main subject of the patent is pyrrolidine-1,2-dicarboxamide derivatives, which are designed as kinase inhibitors for anticancer therapies.
Q2: Who are the inventors and assignee of the patent?
The inventors are Robin Alec Fairhurst, Vito Guagnano, Patricia Imbach-Weese, Giorgio Caravatti, and Pascal Furet, and the assignee is Novartis AG.
Q3: How is the scope of the patent measured?
The scope of the patent is measured by the length of its claims, with longer claims indicating a narrower scope and shorter claims suggesting broader protection.
Q4: What are the therapeutic applications of the compounds described in the patent?
The compounds are used as kinase inhibitors in the treatment of tumor diseases and leukemias, and can be used in combination with other anticancer agents.
Q5: Why is the patent significant in the pharmaceutical industry?
The patent is significant because it provides Novartis AG with exclusive rights to develop and market these compounds, protecting their intellectual property in a highly competitive industry.
Sources
- Fairhurst et al., United States Patent 8,476,268 B2, July 2, 2013.
- Garner et al., United States Patent 10,548,876 B2, February 4, 2020.
- *The Ways We've been Measuring Patent Scope are Wrong: How to Measure and Draw Causal Inferences with Patent Scope, Boston University Law Review.
- *US8476268B2 - Pyrrolidine-1,2-dicarboxamide derivatives, Google Patents.
