United States Patent 5,585,115: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 5,585,115, titled "Pharmaceutical excipient having improved compressibility," is a significant patent in the pharmaceutical industry, particularly in the field of excipients. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Invention Description
The patent, granted on December 17, 1996, describes a microcrystalline cellulose-based excipient with enhanced compressibility. This excipient is designed for use in various pharmaceutical formulations, including direct compression, dry granulation, and wet granulation processes[4].
Assignee and Inventors
The patent is assigned to JRS Pharma LP, with the inventors listed as Sherwood et al.
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. Key claims include:
- The composition of the excipient, which is a microcrystalline cellulose-based material.
- The improved compressibility characteristics of the excipient.
- The methods of preparing the excipient, including specific processing steps to achieve the desired compressibility[4].
Prior Art and Background
The patent references several prior art patents and publications that highlight the need for improved excipients in pharmaceutical formulations. It also discusses the limitations of existing excipients and how the new invention addresses these issues[4].
Claims Analysis
Independent Claims
The independent claims define the core aspects of the invention. For example, Claim 1 describes the composition of the excipient, specifying the use of microcrystalline cellulose and other components that enhance compressibility[4].
Dependent Claims
Dependent claims further detail the invention by specifying additional features or limitations. These claims often describe specific methods of preparation, additional components, or particular applications of the excipient.
Patent Landscape Analysis
Defining Scope and Keywords
To analyze the patent landscape, one must first define the scope and relevant keywords. For this patent, keywords include "microcrystalline cellulose," "pharmaceutical excipient," "compressibility," and "pharmaceutical formulations"[3].
Search and Organize Patents
Using databases such as the USPTO's Patent Public Search tool, the European Patent Office's esp@cenet, and other international patent databases, one can retrieve relevant patents related to these keywords. Organizing these patents by factors like filing date, assignee, and technology subcategories helps in understanding the evolution of the technology[1][3].
Identify Trends and Key Players
The analysis reveals trends in patent filings related to pharmaceutical excipients. Key players in this field include JRS Pharma LP, as well as other companies and research institutions that have filed patents on similar or related technologies. This step helps in identifying competitors and potential collaborators[3].
Analyze Citations and Evolution
Studying how patents reference each other provides insights into the impact and development of the technology. For example, the patent 5,585,115 is cited by several subsequent patents, indicating its influence on later innovations in the field[3].
Generate Insights for Decisions
The analysis translates into practical guidance for strategic decisions. It helps in evaluating the competitive landscape, identifying potential legal vulnerabilities, and understanding the strength of the patent portfolio. This information is crucial for inventors and companies looking to innovate or enter the market[3].
Key Players and Competitors
JRS Pharma LP
As the assignee of the patent, JRS Pharma LP is a significant player in the field of pharmaceutical excipients. Their portfolio includes several patents related to microcrystalline cellulose and other excipient technologies[4].
Other Competitors
Other companies and research institutions have also filed patents in this domain. For instance, patents by inventors like Staniforth et al. and Hunter et al. indicate a competitive and innovative environment in the pharmaceutical excipient market[2].
Technological Trends
Advancements in Compressibility
The patent landscape shows a trend towards improving the compressibility of pharmaceutical excipients. This is driven by the need for more efficient and stable pharmaceutical formulations. Recent patents have focused on various methods to enhance compressibility, including new processing techniques and material combinations[3].
Global Patent Activity
The global patent activity in this field is significant, with contributions from various international intellectual property offices. Databases like PATENTSCOPE by WIPO and esp@cenet by the EPO provide access to a wide range of international patents, highlighting global trends and innovations[1].
Legal and Regulatory Considerations
Patent Validity and Enforcement
When evaluating the patent 5,585,115, it is crucial to consider its legal status and any potential challenges. The patent's validity can be assessed by examining the prosecution history, the patent specification, and the literal language of the claims. Courts consider these factors when construing patent claims[5].
International Protection
Given the global nature of pharmaceutical research and development, understanding international patent protection is essential. Tools like the Global Dossier and the Common Citation Document (CCD) help in managing and analyzing patent families across different jurisdictions[1].
Conclusion
The United States Patent 5,585,115 is a pivotal invention in the field of pharmaceutical excipients, offering improved compressibility and enhancing the efficiency of pharmaceutical formulations. Through a detailed patent landscape analysis, one can gain insights into the competitive landscape, technological trends, and key players in this domain. This information is invaluable for inventors, researchers, and companies seeking to innovate and protect their intellectual property.
Key Takeaways
- The patent 5,585,115 describes a microcrystalline cellulose-based excipient with improved compressibility.
- The scope of the patent includes specific claims related to the composition and preparation of the excipient.
- A patent landscape analysis reveals trends in pharmaceutical excipient technology and identifies key players.
- Understanding the legal and regulatory aspects of the patent is crucial for its enforcement and protection.
- Global patent activity and international protection mechanisms are important considerations in this field.
FAQs
What is the main invention described in United States Patent 5,585,115?
The main invention is a microcrystalline cellulose-based pharmaceutical excipient with improved compressibility.
Who are the key players in the field of pharmaceutical excipients?
Key players include JRS Pharma LP and other companies and research institutions that have filed patents on similar technologies.
How can one conduct a patent landscape analysis for this patent?
One can conduct a patent landscape analysis by defining the scope and keywords, searching and organizing relevant patents, identifying trends and key players, analyzing citations and evolution, and generating insights for strategic decisions.
What are the legal considerations for enforcing this patent?
Legal considerations include examining the prosecution history, the patent specification, and the literal language of the claims, as well as understanding the patent's validity and any potential challenges.
How does international patent protection impact this invention?
International patent protection is crucial as it involves managing and analyzing patent families across different jurisdictions using tools like the Global Dossier and the Common Citation Document (CCD).
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- United States Patent 6,753,017 B2: https://patentimages.storage.googleapis.com/37/48/4f/cbdc9a9ada078a/US6753017.pdf
- How to Do Patent Landscape Analysis: https://www.goldsteinpatentlaw.com/how-to-patent-landscape-analysis/
- US5585115A - Pharmaceutical excipient having improved compressability: https://patents.google.com/patent/US5585115A/en
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT: https://www.govinfo.gov/content/pkg/USCOURTS-ded-1_19-cv-01727/pdf/USCOURTS-ded-1_19-cv-01727-1.pdf
