United States Patent 10,010,507: A Comprehensive Analysis
Introduction
The United States Patent 10,010,507, hereafter referred to as the '507 patent, is a significant intellectual property asset that requires a detailed analysis to understand its scope, claims, and position within the patent landscape. This analysis will delve into the patent's background, its claims, the technology it protects, and its implications for the industry.
Background and History
The '507 patent is part of a series of patent applications filed by the assignee, Pharmacyclics LLC, now a part of AbbVie Inc. This patent is a continuation of earlier applications, indicating a long-standing effort to protect and expand the intellectual property related to specific pharmaceutical compounds and their uses[2][4].
Claims and Scope
Claim Structure
The '507 patent includes multiple claims that define the scope of the invention. These claims are categorized into independent and dependent claims, each serving to narrow down the invention's boundaries. The independent claims typically define the broadest scope of the invention, while the dependent claims further limit and specify the invention[3].
Patent Claims
The patent claims cover various aspects, including:
- Compound Claims: These claims pertain to specific chemical compounds, their salts, and solvates. For example, claims may cover novel compounds or known compounds with new uses[1][4].
- Method of Use Claims: These claims describe methods of using the compounds for therapeutic purposes, such as treating specific diseases or conditions[4].
- Formulation Claims: These claims relate to the formulation and composition of the drug products, including dosage forms and delivery methods[5].
Technology Protected
The '507 patent protects technology related to inhibitors of Bruton's Tyrosine Kinase (BTK), which are crucial in the treatment of chronic lymphocytic leukemia (CLL) and other B-cell malignancies. The patent covers specific compounds, their synthesis, and their therapeutic applications[4].
Patent Landscape
Related Patents
The '507 patent is part of a larger patent family that includes several related patents. These patents collectively protect a broad range of BTK inhibitors and their uses, ensuring comprehensive intellectual property coverage for the assignee. Other patents in this family include US 10,213,386, US 10,478,439, and US 10,828,259, among others[2][4].
Competitive Analysis
In the pharmaceutical industry, patent landscapes are critical for understanding competitive positions. The '507 patent, along with other related patents, helps Pharmacyclics LLC and AbbVie Inc. maintain a strong position in the market for BTK inhibitors. This portfolio of patents deters generic competition and ensures market exclusivity for a significant period[5].
Exclusivity and Market Impact
Orange Book Listing
The '507 patent is listed in the FDA's Orange Book, which compiles patent information for approved drugs. This listing is crucial as it informs potential generic drug manufacturers about the patents that must be addressed before seeking approval for a generic version of the drug[5].
Market Exclusivity
The patent's listing in the Orange Book contributes to the market exclusivity period for the drug. This exclusivity period can range from several years to over a decade, depending on the type of patent and the drug's approval status. For BTK inhibitors like those protected by the '507 patent, this exclusivity is vital for maintaining market share and revenue[5].
Claim Coverage and Gaps
Claim Coverage Matrix
To understand the full scope of protection provided by the '507 patent, a Claim Coverage Matrix can be used. This tool categorizes claims by scope concepts, helping to identify which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist[3].
Identifying Gaps
Using tools like ClaimScape® software, companies can generate interactive claim charts to review patent coverage. These charts help in identifying areas where the current claim coverage is insufficient, highlighting future design opportunities and potential gaps in the patent portfolio[3].
Future Design Opportunities
The '507 patent and its related patents provide a foundation for future innovation. By analyzing the scope concepts and claim coverage, researchers and engineers can identify new design options and areas for further development, ensuring the continued protection and expansion of the company's intellectual property[3].
Regulatory Compliance
The '507 patent must comply with regulatory requirements, particularly those set by the FDA. The patent information must be submitted as part of the New Drug Application (NDA) process, and any changes or updates must be reflected in the Orange Book listings[5].
Industry Impact
The '507 patent has a significant impact on the pharmaceutical industry, particularly in the area of BTK inhibitors. It influences the development and marketing of drugs, ensures market exclusivity, and protects the intellectual property of the assignee. This protection is crucial for encouraging innovation and investment in research and development[4].
Key Takeaways
- The '507 patent protects specific BTK inhibitors and their therapeutic uses.
- It is part of a larger patent family ensuring comprehensive intellectual property coverage.
- The patent is listed in the FDA's Orange Book, contributing to market exclusivity.
- Claim coverage analysis is essential for identifying gaps and future design opportunities.
- Regulatory compliance is critical for maintaining the patent's validity.
FAQs
What is the main technology protected by the '507 patent?
The '507 patent primarily protects inhibitors of Bruton's Tyrosine Kinase (BTK) and their therapeutic applications, particularly in treating chronic lymphocytic leukemia (CLL) and other B-cell malignancies.
How does the '507 patent impact market exclusivity?
The '507 patent, listed in the FDA's Orange Book, contributes to the market exclusivity period for the drug, preventing generic competition for a significant period.
What is the role of the Claim Coverage Matrix in patent analysis?
The Claim Coverage Matrix helps in categorizing claims by scope concepts, identifying which patents and claims are actively protecting the intellectual property, and highlighting gaps or opportunities in the patent portfolio.
How does the '507 patent influence future innovation?
The '507 patent provides a foundation for future innovation by identifying new design options and areas for further development through the analysis of scope concepts and claim coverage.
What regulatory requirements must the '507 patent comply with?
The '507 patent must comply with FDA regulations, including the submission of patent information as part of the New Drug Application (NDA) process and updates to the Orange Book listings.
Sources Cited
- United States Patent and Trademark Office. United States Patent 10,828,259 B2. Google Patents.
- U.S. Food & Drug Administration. ANDA 214296. FDA.
- Schwegman Lundberg & Woessner, P.A. Patent Analytics. SLWIP.
- United States Patent and Trademark Office. United States Patent 10,478,439 B2. Google Patents.
- United States Patent and Trademark Office and U.S. Food & Drug Administration. Report on Drug Patent and Exclusivity. USPTO.
