United States Patent 5,914,131: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,914,131, titled "Hydromorphone therapy," is a significant patent in the pharmaceutical industry, particularly in the management of pain. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Invention
The patent, granted to Mallinckrodt Inc., discloses a hydromorphone composition, a hydromorphone dosage form, and a method for administering hydromorphone. Hydromorphone is an opioid analgesic used for the management of pain, and this patent focuses on specific formulations and methods to enhance its efficacy and safety[2].
Scope of the Patent
The scope of the patent is defined by its claims, which are the legally binding descriptions of the invention. Here are some key aspects:
Claims Overview
- The patent includes multiple claims that cover various aspects of hydromorphone therapy, such as specific dosage forms, compositions, and methods of administration.
- Claims range from the formulation of hydromorphone with specific excipients to the method of treating pain using these formulations[2].
Dosage Forms and Compositions
- The patent describes dosage forms that include hydromorphone combined with other substances like poly(ethylene oxide), magnesium stearate, and lactose. These combinations are designed to improve the bioavailability and stability of hydromorphone[2].
Methods of Administration
- The claims also cover methods for administering hydromorphone, including oral and other routes, with specific dosing regimens to manage pain effectively[2].
Claims Analysis
Independent Claims
- Independent claims are the broadest claims in the patent and define the core invention. For example, Claim 1 might describe a hydromorphone composition with specific excipients, while Claim 2 might describe a method for treating pain using this composition[2].
Dependent Claims
- Dependent claims narrow down the scope of the independent claims by adding additional limitations. These claims provide further details on the composition, dosage form, or method of administration, offering a more specific protection[2].
Patent Landscape
Related Patents and Applications
- The patent landscape includes other patents and applications related to hydromorphone therapy. This can involve patents from the same family or those from different inventors that cover similar or overlapping subject matter.
- For instance, other patents might cover different formulations or methods of administering hydromorphone, which could be relevant for determining the scope of protection and potential infringement[4].
Global Patent Family
- The global patent family for this invention includes patents and applications filed in various jurisdictions. Tools like the Global Dossier and Common Citation Document (CCD) can help in identifying related applications and citations across different IP offices[4].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
- A Claim Coverage Matrix can be used to analyze which patents and claims are actively protecting the intellectual property related to hydromorphone therapy. This matrix helps in identifying gaps or opportunities in the patent coverage[3].
Scope Concepts and Claim Charts
- Categorizing patents by scope concepts and generating interactive claim charts can facilitate a quick and accurate review of patent coverage. This method is particularly useful for determining whether a particular scope concept is applicable to a target product or method[3].
Litigation and Enforcement
Infringement Actions
- The patent has been involved in infringement actions, such as the case of Mallinckrodt v. Watson, where the patent holder sought to enforce their rights against alleged infringers. These actions highlight the importance of the patent in protecting the intellectual property related to hydromorphone therapy[5].
Expiry and Patent Term Adjustments
- The patent's term is crucial for understanding its current status. As with many patents, the term can be extended due to delays in the prosecution process or regulatory reviews. However, the patent in question has expired, as indicated by its legal status[2].
Impact on the Pharmaceutical Industry
Pain Management
- The patent's impact on pain management is significant, as it provides specific formulations and methods that enhance the efficacy and safety of hydromorphone. This has contributed to better patient outcomes and expanded treatment options for pain management.
Competitive Landscape
- The expiration of the patent opens up opportunities for generic manufacturers to enter the market, potentially increasing competition and reducing costs for patients. However, it also means that the original patent holder no longer has exclusive rights to the invention[2].
Key Takeaways
- Scope and Claims: The patent covers specific hydromorphone compositions, dosage forms, and methods of administration.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and applications globally.
- Patent Analytics: Tools like Claim Coverage Matrix and claim charts are essential for analyzing and managing patent coverage.
- Litigation: The patent has been involved in infringement actions to protect its intellectual property.
- Expiry: The patent has expired, affecting its current legal status and market implications.
Frequently Asked Questions (FAQs)
What is the main subject matter of United States Patent 5,914,131?
The main subject matter is a hydromorphone composition, dosage form, and method for administering hydromorphone for pain management.
What are the key claims of the patent?
The key claims include specific formulations of hydromorphone with excipients, dosage forms, and methods of administration.
How does the patent fit into the broader patent landscape?
The patent is part of a global patent family and is related to other patents and applications covering similar subject matter.
What tools can be used to analyze the patent coverage?
Tools such as Claim Coverage Matrix and claim charts can be used to analyze and manage patent coverage.
What is the current legal status of the patent?
The patent has expired, which means it no longer provides exclusive rights to the invention.
Cited Sources:
- US5914131A - Hydromorphone therapy - Google Patents
- US5914131A - Hydromorphone therapy - Google Patents
- Patent Analytics | Intellectual Property Law - SLWIP
- Search for patents - USPTO
- Mallinckrodt v. Watson - Patent Docs
