United States Patent 8,778,922: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,778,922, granted on July 15, 2014, is a significant patent in the pharmaceutical sector, particularly protecting the drug TLANDO. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Title and Inventors
The patent titled "Steroidal Compositions" was invented by Shattalia AEG, Nachiappan Chidambaram, Mahesh V. Patel, and Srinivasan Venkateshwaran. It is assigned to the respective assignees listed in the patent document[1][4].
Scope of the Patent
Protected Drug: TLANDO
This patent specifically protects TLANDO, a pharmaceutical product. TLANDO is included in one New Drug Application (NDA) and has a global presence with thirty-one patent family members in fifteen countries[4].
Steroidal Compositions
The patent describes pharmaceutical compositions and methods of using these compositions. It focuses on steroidal compounds, which are crucial in various therapeutic applications. The detailed description outlines the formulation, preparation, and use of these steroidal compositions[1].
Claims Analysis
Number and Type of Claims
The patent includes multiple claims that define the scope of protection. Understanding these claims is essential for determining what is protected and what is not.
- Independent Claims: These are the core claims that define the invention without reference to other claims.
- Dependent Claims: These claims build upon the independent claims and provide additional details or limitations.
- Multiple Dependent Claims: These claims depend on more than one preceding claim[5].
Claim Fees and Strategy
In the context of patent fees, the number and type of claims are critical. For instance, in the US, claim fees are payable for each claim in excess of 20, each independent claim in excess of 3, and for the presence of multiple dependent claims. This highlights the importance of strategically managing the number and type of claims to minimize costs[5].
Patent Claims and Scope Concepts
Claim Coverage Matrix
To effectively manage and analyze the claims of this patent, a Claim Coverage Matrix can be used. This matrix helps in identifying which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist. By categorizing patents not only by claims but also by overarching scope concepts, companies can better understand their patent landscape[3].
Interactive Claim Charts
Tools like ClaimScape® software generate interactive claim charts that facilitate the review of patent coverage with technical experts. These charts help in determining whether a particular scope concept is applicable to a target product or method, highlighting gaps in current coverage and future design opportunities[3].
Patent Landscape
Global Presence
The patent has a significant global presence with thirty-one patent family members in fifteen countries. This extensive coverage ensures broad protection for TLANDO across various jurisdictions[4].
Related Patents and Prior Art
The patent is part of a larger family of steroidal composition patents. Understanding the prior art and related patents is crucial for navigating the patent landscape and avoiding potential infringement issues. The USPTO Patent Claims Research Dataset can provide valuable insights into the scope and dependency relationships between claims in related patents[2].
Economic and Strategic Implications
Value Assessment
The scope concepts of the patent claims directly relate to their value. Claims can be categorized as high-value (currently valuable to the company), medium-value (indicating potential future directions), or low-value (perhaps not worth maintaining). This categorization helps in strategic decision-making regarding patent maintenance and enforcement[3].
Future Design Opportunities
The analysis of patent claims and scope concepts also highlights future design opportunities. By identifying gaps in current coverage, companies can direct their research and development efforts towards areas that are not yet protected, thereby expanding their intellectual property portfolio[3].
Regulatory Considerations
Claim Fees in Different Jurisdictions
The rules for claim fees vary significantly between jurisdictions. For example, in the US, claim fees are payable for claims exceeding certain thresholds, whereas in Europe, fees are due for claims exceeding 15. Understanding these regulations is essential for managing patent costs and ensuring compliance[5].
Amendment Rules
The rules for amending claims also differ. In Europe, amendments can be made under specific conditions, such as during the regional phase of a PCT application or after the issuance of the search report for direct filings. These rules must be carefully navigated to avoid additional fees and ensure that the claims remain supported by the description[5].
Key Takeaways
- Patent Protection: United States Patent 8,778,922 provides broad protection for TLANDO, a pharmaceutical product, with extensive global coverage.
- Claims Analysis: Understanding the number and type of claims is crucial for managing patent costs and ensuring compliance with regulatory requirements.
- Patent Landscape: The patent is part of a larger family of steroidal composition patents, and analyzing related patents and prior art is essential for navigating the patent landscape.
- Strategic Implications: The value assessment of patent claims and the identification of gaps in coverage can guide strategic decisions on patent maintenance and future research and development.
- Regulatory Compliance: Different jurisdictions have varying rules for claim fees and amendments, which must be carefully managed to ensure compliance and minimize costs.
FAQs
Q: What is the primary drug protected by United States Patent 8,778,922?
A: The primary drug protected by this patent is TLANDO.
Q: How many patent family members does this patent have globally?
A: This patent has thirty-one patent family members in fifteen countries.
Q: What is the significance of claim fees in patent applications?
A: Claim fees are payable for claims exceeding certain thresholds and can significantly impact the cost of maintaining a patent. Managing the number and type of claims is crucial for minimizing these costs.
Q: How can a Claim Coverage Matrix help in patent management?
A: A Claim Coverage Matrix helps in identifying which patents and claims are actively protecting intellectual property and where gaps or opportunities exist, facilitating better management of the patent landscape.
Q: What are the differences in claim amendment rules between the US and Europe?
A: In the US, claims can be amended at any time before the issuance of the first office action. In Europe, amendments can be made under specific conditions, such as during the regional phase of a PCT application or after the issuance of the search report for direct filings.
