Understanding the Scope and Claims of United States Patent 7,981,439
Introduction
United States Patent 7,981,439, issued in July 2011, is a significant patent in the field of pharmaceuticals, particularly focusing on abuse deterrent compositions for opioid analgesic products. This article delves into the details of the patent's scope, claims, and the broader patent landscape it operates within.
Overview of the Patent
The patent, titled "Abuse Deterrent Compositions," was issued to Acura Pharmaceuticals, Inc. and encompasses specific compositions designed to deter the misuse and abuse of prescription opioid analgesic products. Here are the key aspects:
Issuance and Expiration
- The patent was issued on July 19, 2011, and is set to expire on August 19, 2024[4].
Claims
- The patent includes 7 allowed claims, which are specific statements that define the scope of the invention. These claims outline the various compositions and methods for deterring opioid abuse[4].
Scope of the Patent
The scope of Patent 7,981,439 is defined by its claims, which are critical in determining what is protected under the patent.
Claim Language
The claims in this patent are structured to cover a range of abuse deterrent compositions, including:
- Specific combinations of active pharmaceutical ingredients and inactive ingredients.
- Methods for formulating these compositions to prevent common methods of abuse, such as crushing or dissolving the drug[4].
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims. For example, an independent claim might describe a broad composition, while a dependent claim might specify a particular ingredient or method of preparation[3].
Determining Inventorship
Inventorship is a crucial aspect of any patent, including Patent 7,981,439.
Conception and Reduction to Practice
To be listed as an inventor, an individual must have contributed to the conception of the idea or the reduction of the idea to practice. Conception is defined as the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention[2].
Correct Identification of Inventors
The correct identification of inventors is essential to ensure the patent's validity. Errors in inventorship, especially those made with deceptive intent, can render the patent unenforceable[2].
Patent Examination Process
The examination process for Patent 7,981,439 would have involved several key steps:
Claim Analysis
During the examination, the claims of the patent would have been analyzed for their breadth and clarity. Narrower claims are often associated with a higher probability of grant and a shorter examination process[3].
Scope Narrowing
The examination process may have resulted in the narrowing of the patent claims to ensure they are not overly broad and to clarify their scope. This is a common outcome, as the examination process tends to narrow the scope of patent claims in terms of both claim length and claim count[3].
Patent Landscape and Litigation
Patent 7,981,439 operates within a complex patent landscape, particularly in the pharmaceutical industry.
Patent Challenges
The patent has been challenged by generic sponsors through Paragraph IV Certification Notices, which are part of the process for approving generic drugs. Acura Pharmaceuticals, Inc. has filed lawsuits against several generic sponsors alleging infringement of this patent[4].
Settlements and Litigation
The company has engaged in litigation and settlements with various generic sponsors, such as Par Pharmaceutical, Inc. and Impax Laboratories, Inc. These actions are part of the ongoing effort to protect the patent and the associated intellectual property rights[4].
Small Claims Patent Court Considerations
While not directly related to Patent 7,981,439, the concept of a small claims patent court is relevant to the broader patent landscape.
Need for a Small Claims Court
There has been a study conducted by the Administrative Conference of the United States (ACUS) on the feasibility of a small claims patent court. This court would aim to provide a more efficient and cost-effective way to resolve patent disputes, which could impact how future patents, including those related to pharmaceuticals, are enforced[5].
Key Takeaways
- Patent Scope and Claims: The patent's scope is defined by its 7 allowed claims, which cover specific abuse deterrent compositions and methods.
- Inventorship: Correct identification of inventors is crucial for the patent's validity.
- Examination Process: The patent examination process likely involved narrowing the claims to ensure clarity and specificity.
- Litigation and Challenges: The patent has faced challenges from generic sponsors and has been the subject of litigation and settlements.
- Broader Patent Landscape: The patent operates within a complex landscape where small claims patent courts could potentially play a role in future dispute resolutions.
FAQs
Q: What is the primary focus of United States Patent 7,981,439?
A: The primary focus is on abuse deterrent compositions for opioid analgesic products.
Q: How many claims are included in Patent 7,981,439?
A: The patent includes 7 allowed claims.
Q: What is the significance of correct inventorship in patent law?
A: Correct inventorship is essential to ensure the patent's validity and enforceability.
Q: How does the patent examination process affect the scope of patent claims?
A: The examination process often results in the narrowing of patent claims to ensure clarity and specificity.
Q: What is the current status of Patent 7,981,439 in terms of litigation?
A: The patent has been the subject of litigation and settlements with generic sponsors.
Sources
- U.S. Patent and Trademark Office (USPTO) | USAGov
- Determining Inventorship for US Patent Applications
- Patent Claims and Patent Scope - Search eLibrary :: SSRN
- September 29, 2014 Jeffrey P. Riedler Assistant Director Securities ...
- U.S. Patent Small Claims Court