Understanding the Scope and Claims of United States Patent 8,883,196
Introduction to Patent 8,883,196
United States Patent 8,883,196, issued to Agile Therapeutics, is a significant patent in the field of pharmaceuticals, particularly in the development of hormonal contraceptives. This patent is part of a broader portfolio of patents held by Agile Therapeutics, focusing on innovative methods of delivering hormonal contraceptives.
Overview of the Patent
Patent Title and Description
The patent titled "Transdermal Contraceptive Patch" covers the formulation and design of a transdermal patch for delivering hormonal contraceptives. Specifically, it includes claims related to the formulation of a progestin-only transdermal patch containing levonorgestrel[2].
Patent Claims
Independent and Dependent Claims
Patent claims are the heart of any patent, defining the scope of the invention. For Patent 8,883,196, the claims can be categorized into independent and dependent claims.
- Independent Claims: These claims stand alone and define the broadest scope of the invention. In this patent, independent claims would typically describe the core components and functionality of the transdermal patch, such as the specific formulation of levonorgestrel and the patch's design.
- Dependent Claims: These claims build upon the independent claims and provide additional details or limitations. For example, dependent claims might specify particular concentrations of levonorgestrel, the type of adhesive used, or the patch's size and shape[3].
Claim Language and Scope
The scope of a patent is often measured by metrics such as independent claim length and independent claim count. Narrower claims, as indicated by shorter lengths and fewer counts, are generally associated with a higher probability of grant and a shorter examination process. This is because narrower claims are more specific and less likely to overlap with existing prior art[3].
Patent Landscape
Related Patents and Applications
Agile Therapeutics holds a portfolio of patents related to their lead product candidate, Twirla (ethinyl estradiol and levonorgestrel transdermal system). This includes several other issued U.S. patents such as US 7,045,145, US 7,384,650, US 8,221,784, US 8,221,785, US 8,246,978, US 8,747,888, and US 9,050,348. These patents collectively cover various aspects of the Twirla system and extend into 2028[2].
Global Patent Family
To understand the global reach of this patent, one would need to look at the patent family through services like the Global Dossier provided by the USPTO. This service allows users to see related applications filed at participating IP Offices, including the IP5 Offices (the USPTO, the European Patent Office, the Japan Patent Office, the Korean Intellectual Property Office, and the State Intellectual Property Office of China)[1].
Search and Analysis Tools
Patent Public Search
The USPTO's Patent Public Search tool is a powerful resource for searching prior art and analyzing the scope of patents. This tool replaced legacy search tools and provides enhanced access to prior art, which is crucial for understanding the novelty and non-obviousness of Patent 8,883,196[1].
Common Citation Document (CCD)
The CCD application consolidates citation data from participating IP Offices, allowing users to visualize the prior art cited by multiple offices for the same invention. This tool is particularly useful for understanding how different patent offices have treated similar inventions and can help in assessing the validity and scope of Patent 8,883,196[1].
Historical Context and Prior Art
Historical Patents
For a comprehensive analysis, it is important to look at historical patents in the same field. Resources such as the NYPL Libguides provide access to early U.S. patents, which can help in understanding the evolution of transdermal delivery systems and hormonal contraceptives. This historical context can shed light on how the current patent fits into the broader landscape of innovation in this field[4].
Practical Implications
Commercialization and FDA Listing
While Patent 8,883,196 is not expected to be listed in the FDA’s Orange Book in connection with Twirla, it is relevant to Agile Therapeutics' progestin-only patch R&D program. This indicates that the patent is crucial for the company's ongoing research and development efforts in hormonal contraceptives[2].
Litigation and Licensing
The scope and claims of a patent can significantly impact litigation and licensing strategies. Narrower claims, as discussed earlier, can reduce the risk of litigation by clearly defining the invention and avoiding overlap with prior art. This can also make the patent more attractive for licensing, as it provides clear and enforceable rights[3].
Key Takeaways
- Patent Scope and Claims: The scope of Patent 8,883,196 is defined by its claims, which include both independent and dependent claims. Narrower claims are generally associated with a higher probability of grant and shorter examination process.
- Related Patents: Agile Therapeutics holds a portfolio of patents related to Twirla and other hormonal contraceptives, extending protection into 2028.
- Global Patent Family: The Global Dossier service can provide insights into related applications filed at participating IP Offices.
- Search and Analysis Tools: Tools like the Patent Public Search and CCD application are essential for analyzing prior art and assessing the validity of the patent.
- Historical Context: Understanding historical patents in the field can provide valuable insights into the evolution of transdermal delivery systems and hormonal contraceptives.
FAQs
Q: What is the main subject of United States Patent 8,883,196?
A: The main subject of this patent is the formulation and design of a transdermal patch for delivering a progestin-only contraceptive containing levonorgestrel.
Q: How does the scope of a patent affect its validity?
A: The scope of a patent, defined by its claims, can affect its validity by determining how narrowly or broadly the invention is protected. Narrower claims are generally less likely to overlap with prior art and thus more likely to be valid.
Q: What tools can be used to analyze the prior art for Patent 8,883,196?
A: Tools such as the USPTO's Patent Public Search and the Common Citation Document (CCD) application can be used to analyze prior art and assess the validity of the patent.
Q: Is Patent 8,883,196 listed in the FDA’s Orange Book?
A: No, Patent 8,883,196 is not expected to be listed in the FDA’s Orange Book in connection with Twirla, but it is relevant to Agile Therapeutics' progestin-only patch R&D program.
Q: How does the Global Dossier service help in understanding the global reach of a patent?
A: The Global Dossier service provides access to the file histories of related applications from participating IP Offices, allowing users to see the patent family for a specific application and understand the global reach of the patent.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Pharmabiz - Agile Therapeutics' progestin patch designs receives US patent: http://test.pharmabiz.com/news/agile-therapeutics-progestin-patch-designs-receives-us-patent-95799
- SSRN - Patent Claims and Patent Scope: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- NYPL Libguides - How to Search for an Historical U.S. Patent: https://libguides.nypl.org/patents/historical_patents
