United States Patent 8,648,107: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,648,107, titled "Ketorolac Tromethamine Compositions for Treating or Preventing Ocular Pain," was issued on February 11, 2014, to inventors Christopher A. Muller, Janet K. Cheetham, Teresa H. Kuan, and David F. Power. This patent is significant in the pharmaceutical industry, particularly in the treatment of ocular pain. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent 8,648,107 pertains to compositions containing ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), specifically formulated for treating or preventing ocular pain. This is a critical area in ophthalmology, as effective and safe treatments for ocular pain are essential for patient care.
Scope of the Patent
The scope of the patent defines the boundaries of what is protected under the patent. For U.S. Patent 8,648,107, the scope includes:
Composition
The patent covers specific compositions of ketorolac tromethamine, including the formulation, concentration, and delivery methods. These compositions are designed to be administered topically to the eye, providing relief from ocular pain without the systemic side effects associated with oral NSAIDs[5].
Indications
The patent specifies the use of these compositions for treating or preventing ocular pain. This includes pain associated with cataract surgery, corneal refractive surgery, and other ocular conditions.
Formulation
The patent details the formulation of the ketorolac tromethamine compositions, including the pH range, preservatives, and other excipients that ensure stability and efficacy of the drug.
Claims of the Patent
The claims section of a patent is crucial as it defines what is legally protected. For U.S. Patent 8,648,107, the claims can be categorized into several types:
Independent Claims
These claims stand alone and define the broadest scope of the invention. For example, Claim 1 might describe the composition of ketorolac tromethamine in a specific concentration and formulation for ocular use[5].
Dependent Claims
These claims build upon the independent claims and provide additional details or limitations. For instance, a dependent claim might specify the pH range of the composition or the presence of a particular preservative.
Method Claims
These claims cover the methods of using the compositions, such as the administration route (topical application to the eye) and the frequency of application.
Patent Landscape
Understanding the patent landscape is essential for navigating the intellectual property environment surrounding U.S. Patent 8,648,107.
Related Patents
There are several other patents related to ketorolac tromethamine and ocular pain treatment. For example, patents like U.S. Patent Nos. 8,008,338, 8,207,215, 8,377,982, 8,541,463, 8,906,950, and 8,946,281, also owned by Allergan Sales, LLC, cover various aspects of ketorolac tromethamine compositions and their use in treating ocular conditions[5].
Competitors and Market
The market for ocular pain treatments is competitive, with several pharmaceutical companies developing and marketing similar products. Understanding the patent landscape helps in identifying potential competitors and avoiding infringement.
Litigation History
Patent litigation is a significant aspect of the patent landscape. For instance, Allergan Sales, LLC has been involved in litigation to protect its patents, including U.S. Patent 8,648,107, against alleged infringers like Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc.[5].
Economic and Regulatory Impact
The issuance and enforcement of U.S. Patent 8,648,107 have economic and regulatory implications.
Economic Impact
The patent protects Allergan Sales, LLC's investment in research and development, allowing the company to recoup its costs and generate revenue from the sale of the patented compositions. This can influence market dynamics, as competitors may need to develop alternative treatments or negotiate licensing agreements.
Regulatory Impact
Regulatory bodies like the FDA play a crucial role in approving these compositions for market use. The patent is listed with the FDA in conjunction with the New Drug Application (NDA) No. 21-528, ensuring compliance with regulatory requirements[5].
Search and Analysis Tools
For professionals conducting patent searches and analyses, several tools are available:
USPTO Databases
The U.S. Patent and Trademark Office (USPTO) provides comprehensive databases for searching patent grants and applications, including the Patent Public Search database and the Cooperative Patent Classification (CPC) database[1].
PATENTSCOPE Database
The World Intellectual Property Organization (WIPO) offers the PATENTSCOPE database, which includes full-text PCT applications and patent documents from national and regional patent offices worldwide[1].
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents and applications, which can be used to analyze patent scope and trends[3].
Best Practices for Patent Searches
When conducting patent searches related to U.S. Patent 8,648,107, several best practices should be followed:
Use of Classification Systems
Utilize classification systems like the Cooperative Patent Classification (CPC) to narrow down searches and find relevant patents[1].
Full-Text Searching
Employ full-text searching capabilities available in databases like the USPTO's Patent Public Search and PATENTSCOPE to find specific details within patent documents[1].
Analysis of Claims
Carefully analyze the claims of relevant patents to understand the scope of protection and potential infringement risks[3].
Conclusion
U.S. Patent 8,648,107 is a significant intellectual property asset in the field of ocular pain treatment. Understanding its scope, claims, and the broader patent landscape is crucial for pharmaceutical companies, researchers, and legal professionals. By leveraging advanced patent search tools and best practices, stakeholders can navigate the complex world of intellectual property effectively.
Key Takeaways
- Scope and Claims: The patent covers specific compositions of ketorolac tromethamine for ocular pain treatment, with detailed formulations and methods of use.
- Patent Landscape: The patent is part of a larger portfolio related to ketorolac tromethamine, with several related patents and potential competitors.
- Economic and Regulatory Impact: The patent has significant economic and regulatory implications, influencing market dynamics and ensuring compliance with FDA regulations.
- Search and Analysis Tools: Utilize USPTO databases, PATENTSCOPE, and the Patent Claims Research Dataset for comprehensive patent searches and analyses.
- Best Practices: Use classification systems, full-text searching, and careful analysis of claims to navigate patent searches effectively.
FAQs
Q: What is the main subject of U.S. Patent 8,648,107?
A: The main subject is compositions of ketorolac tromethamine for treating or preventing ocular pain.
Q: Who are the inventors of U.S. Patent 8,648,107?
A: The inventors are Christopher A. Muller, Janet K. Cheetham, Teresa H. Kuan, and David F. Power.
Q: What is the significance of the patent in the pharmaceutical industry?
A: It protects a specific formulation of ketorolac tromethamine, ensuring Allergan Sales, LLC's investment in research and development and influencing market dynamics.
Q: How can one conduct a comprehensive patent search related to this patent?
A: Use tools like the USPTO's Patent Public Search, PATENTSCOPE, and the Patent Claims Research Dataset, and follow best practices such as using classification systems and full-text searching.
Q: What regulatory body is involved in the approval of the patented compositions?
A: The FDA is involved, with the patent listed in conjunction with NDA No. 21-528.
Sources
- Clemson University Libraries. Research and Course Guides: Patent Searching, Advanced: Overview. Clemson.libguides.com, 2024.
- USA.gov. U.S. Patent and Trademark Office (USPTO). Usa.gov, 2024.
- U.S. Patent and Trademark Office. Patent Claims Research Dataset. Uspto.gov, 2017.
- U.S. Government Accountability Office. Assessing Factors That Affect Patent Infringement Litigation. Gao.gov, 2013.
- United States District Court for the District of Delaware. Allergan Sales, LLC v. Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc. Insight.rpxcorp.com, 2015.
