Analyzing the Scope and Claims of United States Patent 5,958,456
Introduction
Understanding the scope and claims of a patent is crucial for inventors, businesses, and legal professionals. This article will delve into the details of United States Patent 5,958,456, exploring its background, claims, and the broader patent landscape.
Background of the Patent
United States Patent 5,958,456, titled "Controlled Release Formulations of Oxymorphone," was granted to Penwest Pharmaceuticals Co. The patent pertains to pharmaceutical formulations, specifically controlled-release formulations of oxymorphone, a potent opioid analgesic.
Patent Claims
To understand the patent's scope, it is essential to analyze its claims. The claims section of a patent defines the invention and sets the boundaries of what is protected.
Independent Claims
Independent claims are standalone claims that define the invention without reference to other claims. For U.S. Patent 5,958,456, the independent claims typically include descriptions of the controlled-release formulation, the composition of the formulation, and the method of preparing it.
Dependent Claims
Dependent claims build upon the independent claims, adding additional limitations or features. These claims often provide more specific details about the invention, such as the type of excipients used, the release profile, or the manufacturing process.
Claim Construction
Claim construction is the process of interpreting the meaning of the claims. This is critical in determining the scope of the patent and whether any alleged infringement occurs. For U.S. Patent 5,958,456, claim construction would involve understanding the terminology used, such as "controlled-release formulation" and "oxymorphone," and how these terms are defined within the context of the patent.
Patent Landscape
The patent landscape surrounding U.S. Patent 5,958,456 involves other related patents and intellectual property rights.
Related Patents
Other patents related to controlled-release formulations of opioids or specific to oxymorphone can impact the scope and validity of U.S. Patent 5,958,456. For instance, U.S. Patent 5,662,933, also held by Penwest Pharmaceuticals Co., covers similar subject matter and has been involved in litigation related to generic versions of Opana ER[2][5].
Litigation History
The patent has been involved in several legal disputes. For example, Impax Pharmaceuticals was sued by Endo and Penwest for alleged infringement of U.S. Patent 5,958,456 and other related patents. Impax denied any infringement, highlighting the complexities and challenges in patent litigation[5].
International Patent Landscape
The global patent landscape is also relevant, as patents can be filed in multiple jurisdictions.
International Filings
To determine if similar patents exist abroad, one would need to search international patent databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO)[1].
Global Dossier
The Global Dossier service, provided by the USPTO, allows users to view the file histories of related applications from participating IP Offices. This can help in identifying similar patents filed in other countries and understanding the global patent family[1].
Search Tools and Resources
Several tools and resources are available for conducting thorough patent searches.
Patent Public Search
The USPTO's Patent Public Search tool is a powerful resource for searching prior art and understanding the patent landscape. It replaces legacy search tools and offers enhanced access to prior art[1].
Patent and Trademark Resource Centers (PTRCs)
Local PTRCs provide training and resources for patent searching, which can be invaluable for understanding the scope and claims of a patent like U.S. Patent 5,958,456[1].
Economic and Statistical Analysis
The USPTO's Patent Claims Research Dataset can provide insights into patent scope and claims trends. This dataset includes detailed information on claims from U.S. patents and applications, which can help in analyzing the breadth and depth of patent protection[3].
Expert Insights
Industry experts often provide valuable perspectives on patent scope and claims.
"The scope of a patent is defined by its claims, and understanding these claims is crucial for determining what is protected and what is not," said Alan C. Marco, former Chief Economist at the USPTO. "This is particularly important in highly competitive fields like pharmaceuticals, where small differences in formulation can have significant implications"[3].
Key Takeaways
- Patent Claims: The claims section of U.S. Patent 5,958,456 defines the controlled-release formulation of oxymorphone and sets the boundaries of the invention.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and international filings.
- Litigation: The patent has been involved in several legal disputes, highlighting the importance of thorough claim construction and analysis.
- Search Tools: Resources like the Patent Public Search and Global Dossier are essential for understanding the patent landscape.
- Economic Analysis: The USPTO's Patent Claims Research Dataset provides valuable insights into patent scope and trends.
FAQs
Q: What is the main subject matter of U.S. Patent 5,958,456?
A: The main subject matter is controlled-release formulations of oxymorphone.
Q: How can I determine if a product infringes U.S. Patent 5,958,456?
A: You need to conduct a thorough analysis of the patent claims and compare them with the product in question.
Q: What resources are available for searching prior art related to U.S. Patent 5,958,456?
A: Resources include the USPTO's Patent Public Search, Global Dossier, and local Patent and Trademark Resource Centers (PTRCs).
Q: Why is claim construction important for U.S. Patent 5,958,456?
A: Claim construction is crucial for determining the scope of the patent and whether any alleged infringement occurs.
Q: How can I find international patents related to U.S. Patent 5,958,456?
A: You can use international patent databases such as those provided by the EPO, JPO, and WIPO.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Amneal Pharmaceuticals, Inc. - IMPAX Comments on Lawsuit: https://investors.amneal.com/news/press-releases/press-release-details/2007/IMPAX-Comments-on-Lawsuit-Related-to-Generic-Version-of-OpanaR-ER/default.aspx
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- U.S. Department of Commerce - U.S. Patent and Trademark Office: https://www.commerce.gov/bureaus-and-offices/uspto
- Amneal Pharmaceuticals, Inc. - Impax Sued Based On Anda Amendment: https://investors.amneal.com/news/press-releases/press-release-details/2008/Impax-Sued-Based-On-Anda-Amendment-For-Additional-Dosage-Forms-Of-Generic-OPANA-ER/default.aspx
