United States Patent 6,333,044: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,333,044, titled "Therapeutic compositions for intranasal administration which include KETOROLAC®," is a significant patent in the pharmaceutical industry, particularly in the field of pain management and nasal drug delivery. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication and Status
The patent, US6333044B1, was published on December 18, 2001, and has since expired due to the completion of its lifetime[4].
Inventors and Assignees
While the specific inventors and assignees are not detailed in the provided sources, it is common for such patents to be assigned to pharmaceutical companies or research institutions.
Scope of the Patent
Therapeutic Compositions
The patent describes therapeutic compositions designed for intranasal administration of KETOROLAC®, a nonsteroidal anti-inflammatory drug (NSAID). These compositions are formulated to provide effective pain relief through nasal delivery, which is a novel approach compared to traditional oral or injectable methods[4].
Dosage Forms
The patent outlines various dosage forms, including solutions, sprays, suspensions, ointments, and gels. The formulations can be tailored to ensure the optimal delivery of the active ingredient, with concentrations ranging from 5% to 20% weight/volume, preferably around 15%[4].
Excipients and Vehicles
The compositions include various excipients such as humectants, isotoning agents, antioxidants, buffers, and preservatives. The selection of these excipients depends on the desired formulation and the need to maintain osmotic balance similar to biological fluids. Suitable vehicles include aqueous solutions, oily or gel vehicles, and polymeric materials that confer bioadhesive characteristics[4].
Claims of the Patent
Independent and Dependent Claims
The patent includes several claims that define the scope of the invention. Independent claims typically describe the broadest aspects of the invention, while dependent claims narrow down the scope by adding specific details.
- Independent Claims: These claims cover the general composition of the therapeutic formulations, including the active ingredient KETOROLAC®, the dosage forms, and the excipients.
- Dependent Claims: These claims specify particular aspects such as the concentration of KETOROLAC®, the types of excipients used, and the methods of administration (e.g., drops or sprays)[4].
Claim Examples
- Claim 1 might broadly cover "a therapeutic composition for intranasal administration comprising KETOROLAC® and an isotoning agent."
- Dependent claims could include specifics like "the composition of claim 1, wherein the KETOROLAC® concentration is between 5% and 20% weight/volume."
Patent Landscape
Classification
The patent is classified under the International Patent Classification (IPC) system as A61K31/00, which pertains to medicinal preparations containing organic active ingredients. More specifically, it falls under A61K31/33 and A61K31/40, which involve heterocyclic compounds with nitrogen as a ring hetero atom[4].
Prior Art and Citations
The patent cites prior art related to dosage forms, active ingredients, and excipients. The Common Citation Document (CCD) application, which consolidates prior art cited by multiple patent offices, would be useful in understanding the broader citation landscape[1].
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, which provides access to related applications filed at participating IP Offices. This helps in identifying similar patents or applications in other jurisdictions[1].
Litigation and Enforcement
There have been legal actions related to this patent, such as the one documented in the litigation documents involving United States Patent Number 6,333,044. This indicates that the patent has been subject to infringement claims and legal disputes[5].
Search and Analysis Tools
USPTO Resources
For a comprehensive analysis, one can use the USPTO's Patent Public Search tool, which provides enhanced access to prior art and allows for detailed searches of patent documents. The Patent Examination Data System (PEDS) and the Patent Claims Research Dataset can also be utilized to analyze the claims and scope of the patent in detail[1][3].
International Databases
Searching international patent databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) can help in identifying similar patents or applications globally[1].
Key Takeaways
- Innovative Delivery Method: The patent introduces an innovative method for intranasal administration of KETOROLAC®, offering an alternative to traditional delivery methods.
- Detailed Formulations: The patent provides detailed formulations and excipients necessary for maintaining the stability and efficacy of the therapeutic compositions.
- Legal and Global Context: The patent has been subject to legal actions and is part of a broader global patent landscape, highlighting its significance in the pharmaceutical industry.
- Search and Analysis: Utilizing USPTO resources and international databases is crucial for a thorough analysis of the patent's scope and claims.
FAQs
What is the main subject of United States Patent 6,333,044?
The main subject is therapeutic compositions for the intranasal administration of KETOROLAC®, a nonsteroidal anti-inflammatory drug (NSAID).
What are the different dosage forms described in the patent?
The patent describes solutions, sprays, suspensions, ointments, and gels as potential dosage forms.
What is the significance of isotoning agents in the patent?
Isotoning agents are used to maintain an osmotic pressure similar to that of biological fluids, ensuring the stability and tolerability of the formulations.
Has this patent been involved in any legal actions?
Yes, there have been legal actions related to this patent, including infringement claims.
How can one analyze the global reach of this patent?
Using services like the Global Dossier and searching international patent databases can help in understanding the global patent family and similar applications.
Sources
- USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
- USPTO - Trademark Registration. Retrieved from https://api.huski.io/uspto/api/v2/doc/Y21zL2Nhc2UvOTAxMzk5MDYvcmVnaXN0cmF0aW9uLWNlcnRpZmljYXRlLzYzMzMwNDRfOTAxMzk5MDZfMDQyNzIxX09SQy5wZGY=?date=20210427&ext=pdf&sn=US-TM-90139906×tamp=1726950736&sign=01a80c76c4f4cf66efd97b007e0528d223aa53ba
- USPTO - Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US6333044B1. Retrieved from https://patents.google.com/patent/US6333044
- Insight.RPXcorp - Litigation Documents. Retrieved from https://insight.rpxcorp.com/litigation_documents/9560165
