United States Patent 8,246,978: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,246,978, titled "Dermal delivery device with reduced loss of its volatile components," is a significant patent in the field of pharmaceutical and medical device technology. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Invention Description
The patent US 8,246,978 describes a dermal delivery device designed to minimize the loss of volatile components. This device is crucial for delivering active pharmaceutical ingredients through the skin, ensuring that the efficacy of the treatment is maintained by reducing the evaporation or degradation of these volatile components[2].
Scope of the Patent
Technical Details
The patent outlines a specific design and methodology for creating a dermal delivery device. It includes details on the materials, structure, and functionality of the device, which are engineered to prevent the loss of volatile components. This scope is narrow but highly specialized, addressing a specific problem in the field of transdermal drug delivery.
Claims
The patent claims are detailed and specific, covering various aspects of the invention:
- Independent Claims: These claims define the broadest scope of the invention, including the overall structure and function of the dermal delivery device.
- Dependent Claims: These claims build upon the independent claims, providing additional details and variations of the invention, such as specific materials or manufacturing processes[2].
Claims Analysis
Claim Structure
The claims are structured to provide a clear and comprehensive description of the invention. They include:
- Composition Claims: These claims specify the materials used in the device.
- Method Claims: These claims describe the process of manufacturing and using the device.
- Apparatus Claims: These claims detail the structural components of the device[2].
Claim Scope
The scope of the claims is critical in determining the patent's enforceability and the protection it offers. The claims must be broad enough to cover the invention's core aspects but not so broad that they become invalid due to prior art or obviousness.
Patent Landscape
Prior Art and Related Patents
To understand the significance of US 8,246,978, it is essential to examine the prior art and related patents in the field of transdermal drug delivery. Tools like the USPTO's Patent Public Search and international databases such as the European Patent Office's esp@cenet and the World Intellectual Property Organization's PATENTSCOPE can be used to identify similar inventions and assess the novelty of the patent[1].
Global Patent Family
The patent may be part of a global patent family, with corresponding patents filed in other countries. The Global Dossier service provided by the USPTO can help identify related applications and their status in participating IP offices[1].
Competitor Patents
Companies like Agile Therapeutics, which have developed similar transdermal technologies, may hold related patents. For example, Agile Therapeutics has a portfolio of patents extending protection through at least 2028, which could be relevant when assessing the competitive landscape[5].
Economic and Market Impact
Market Protection
The patent provides significant market protection by preventing competitors from manufacturing or selling similar devices without infringing on the patent. This protection is crucial for the commercial success of the invention, allowing the patent holder to recoup investment in research and development.
Regulatory Considerations
For pharmaceutical applications, patents listed in the Orange Book by the FDA can impact the approval process for generic or similar products. The patent holder must ensure that any regulatory approvals align with the patent's claims and scope[4].
Legal and Enforcement Aspects
Patent Litigation
The enforceability of the patent is a critical aspect. The patent holder must be prepared to defend the patent against potential infringers. Tools like the Patent Examination Data System (PEDS) and the Common Citation Document (CCD) can help in identifying potential infringement and managing legal actions[1].
Patent Assignment and Licensing
The patent can be assigned or licensed to other entities, which can expand its reach and impact. The Patent Assignment Search website provided by the USPTO can help track changes in ownership and licensing agreements[1].
Conclusion
United States Patent 8,246,978 is a specialized patent that addresses a critical issue in transdermal drug delivery. Understanding its scope, claims, and the broader patent landscape is essential for both the patent holder and competitors in the field. This analysis highlights the importance of thorough patent searching, claim analysis, and market protection in ensuring the commercial success of the invention.
Key Takeaways
- Specific Design: The patent describes a specific design for a dermal delivery device to reduce the loss of volatile components.
- Claims Structure: The claims are detailed and include composition, method, and apparatus claims.
- Patent Landscape: The patent is part of a broader landscape that includes prior art, related patents, and global patent families.
- Market Protection: The patent provides significant market protection, especially in regulatory environments.
- Legal and Enforcement: The patent's enforceability and potential for litigation are critical aspects.
FAQs
Q: What is the main purpose of United States Patent 8,246,978?
A: The main purpose of this patent is to describe a dermal delivery device designed to minimize the loss of volatile components during transdermal drug delivery.
Q: How can one search for similar patents in the USPTO database?
A: One can use the USPTO's Patent Public Search tool, which provides enhanced access to prior art and allows users to search for patents using various criteria[1].
Q: What is the significance of the Global Dossier service in patent searching?
A: The Global Dossier service allows users to access the file histories of related applications from participating IP Offices, providing a comprehensive view of the patent family and related data[1].
Q: How do patent claims impact the commercial success of an invention?
A: Patent claims define the scope of protection for an invention, preventing competitors from making, using, or selling similar products without infringing on the patent. This protection is crucial for commercial success and recouping R&D investments.
Q: What role does the Orange Book play in patent protection for pharmaceuticals?
A: The Orange Book lists drug products and their associated patents, which potential competitors must certify against when seeking FDA approval for generic or similar products[4].
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- PubChem - US-8246978-B2: https://pubchem.ncbi.nlm.nih.gov/patent/US8246978
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- SEC - Agile Therapeutics Form 10-K: https://ir.agiletherapeutics.com/static-files/ee232cfd-63e5-43b8-b185-4cfe4b127777
- Biospace - Agile Therapeutics Announces New Patents: https://www.biospace.com/agile-therapeutics-inc-announces-three-new-u-s-patents-on-its-technology-and-the-brand-name-twirla-tm-for-its-first-contraceptive-patch/
