United States Patent 8,946,292: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,946,292, titled "Formulations of low dose diclofenac and beta-cyclodextrin," is a significant patent in the pharmaceutical industry, particularly in the field of pain management and drug formulation. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Invention Description
The patent describes pharmaceutical compositions containing a unit dose of a diclofenac compound, effective for inducing analgesia, in combination with beta-cyclodextrin. The formulations are designed to provide low doses of diclofenac, which is a nonsteroidal anti-inflammatory drug (NSAID) commonly used for pain relief[4].
Key Components
- Diclofenac Compound: The patent specifies that the diclofenac compound can be in the form of diclofenac sodium or other salts.
- Beta-Cyclodextrin: The beta-cyclodextrin can be 2-hydroxypropyl-beta-cyclodextrin, which enhances the solubility and stability of the diclofenac.
- Dosage Forms: The compositions include solid dosage forms (e.g., perioral, transnasal, or rectal) and liquid dosage forms (e.g., for parenteral administration)[4].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention:
- Claim 1: A pharmaceutical composition comprising a unit dose of a diclofenac compound and beta-cyclodextrin, where the dose of diclofenac is less than any effective dose previously reported.
- Claim 2: The composition may further include a stabilizer, such as monothioglycerol, to increase storage life.
- Claim 3: Methods for treating a mammal in need of analgesia by administering the pharmaceutical composition[4].
Claim Dependencies
The claims are interdependent, with subsequent claims building upon the earlier ones. For example, Claim 2 depends on Claim 1, specifying additional components like stabilizers.
Patent Claims and Scope Measurements
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides insights into the scope and complexity of patent claims. This dataset, which includes claims from U.S. patents granted between 1976 and 2014, can help in understanding the breadth and depth of claims in similar pharmaceutical patents[3].
Scope Measurements
Research by the USPTO's Office of Chief Economist has developed measures of patent scope, which can be applied to understand the breadth of protection offered by this patent. These measures include claim-level statistics and document-level statistics, providing a detailed view of the patent's scope[3].
Patent Landscape
Prior Art and Citations
The patent cites prior art related to diclofenac and beta-cyclodextrin formulations. The Common Citation Document (CCD) application, which consolidates prior art cited by participating IP offices, can be useful in understanding the global citation landscape for this invention[1].
International Patent Offices
To assess the global patent landscape, one must refer to searchable databases from other international intellectual property offices, such as the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO)[1].
Competing Patents
Other patents in the same field, such as those related to NSAID formulations or cyclodextrin-based pharmaceuticals, need to be considered to understand the competitive landscape. For instance, patents related to different formulations of diclofenac or other analgesics could be relevant[4].
Classification and Categories
International Classification
The patent is classified under various international categories, including A61K (Preparations for medical, dental, or toilet purposes) and A61P (Specific therapeutic activity of chemical compounds or medicinal preparations)[4].
Subcategories
Subcategories such as A61K9/00 (Medicinal preparations characterized by special physical form) and A61P25/00 (Drugs for disorders of the nervous system) further refine the classification, indicating the specific areas of application[4].
Expiration and Legal Status
Patent Expiration
The patent's expiration date is crucial for understanding its current legal status. According to PharmaCompass, the patent's expiration dates and any listed in the FDA Orange Book need to be considered to determine its current validity[5].
Legal Status
The legal status of the patent, whether it is active or has lapsed, affects its enforceability and the freedom to operate for other entities in the same field. As of the last update, the patent was listed as active, but this status can change over time[4].
Practical Applications and Impact
Clinical Use
The pharmaceutical compositions described in the patent are designed for clinical use, particularly for treating pain. The low-dose formulations of diclofenac in combination with beta-cyclodextrin offer a novel approach to pain management, potentially reducing side effects associated with higher doses of NSAIDs[4].
Market Impact
The patent's impact on the market includes the potential to influence the development of new pain management drugs and formulations. It also sets a precedent for the use of cyclodextrins in enhancing drug solubility and stability.
Conclusion
United States Patent 8,946,292 is a significant contribution to the field of pharmaceuticals, particularly in pain management. Understanding its scope, claims, and the broader patent landscape is essential for researchers, manufacturers, and legal professionals.
Key Takeaways
- The patent describes low-dose diclofenac formulations with beta-cyclodextrin.
- Claims include specific compositions and methods for treating pain.
- The patent is classified under international categories related to medicinal preparations.
- The legal status and expiration dates are critical for determining its current validity.
- The patent has practical applications in clinical pain management and influences the development of new pharmaceutical formulations.
FAQs
1. What is the main invention described in US Patent 8,946,292?
The main invention is a pharmaceutical composition containing a low dose of diclofenac and beta-cyclodextrin for pain relief.
2. What are the key components of the pharmaceutical composition?
The key components include diclofenac (or its salts), beta-cyclodextrin (such as 2-hydroxypropyl-beta-cyclodextrin), and optional stabilizers like monothioglycerol.
3. How does the patent classify the pharmaceutical compositions?
The compositions are classified under international categories such as A61K and A61P, specifically A61K9/00 and A61P25/00.
4. What is the significance of beta-cyclodextrin in the formulation?
Beta-cyclodextrin enhances the solubility and stability of the diclofenac, allowing for effective low-dose formulations.
5. Is the patent still active?
As of the last update, the patent was listed as active, but its status can change over time and should be verified through current legal records.
Sources
- USPTO - Search for patents https://www.uspto.gov/patents/search
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... https://insight.rpxcorp.com/litigation_documents/11928454
- USPTO - Patent Claims Research Dataset https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - Formulations of low dose diclofenac and beta-cyclodextrin https://patents.google.com/patent/US8946292B2/en
- PharmaCompass - US Patent 8946292 https://www.pharmacompass.com/us-patent-8946292
