United States Patent 4,310,515: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 4,310,515, titled "Pharmaceutical compositions of cisplatin," is a significant patent in the field of oncology, particularly in the development of chemotherapeutic agents. This patent, granted in 1982, revolves around the formulation and use of cisplatin, a potent antitumor agent. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Cisplatin
Cisplatin, or cis-platinum(II) diamminedichloride, is an inorganic compound first noted for its ability to prevent the replication of E. coli and later found to possess antitumor activity. It was discovered by Barnett Rosenberg and his colleagues in 1965 and has since become a cornerstone in cancer treatment, especially for various types of tumors such as testicular, ovarian, lung, bladder, and stomach cancers[4].
Scope of the Patent
The patent 4,310,515 focuses on providing a stable, therapeutically acceptable, intravenously injectable dosage form of cisplatin. Here are the key aspects of its scope:
Field of the Invention
The patent pertains to the field of pharmaceutical compositions, specifically those involving platinum compounds with antineoplastic properties. It aims to improve the stability and efficacy of cisplatin solutions for clinical use[4].
Description of the Prior Art
Prior to this patent, platinum compounds were known for their antibiotic and antitumor effects. However, the stability and formulation of these compounds for intravenous administration were significant challenges. The patent addresses these issues by providing a stabilized aqueous solution of cisplatin[4].
Object of the Invention
The primary objective of this patent is to develop a pharmaceutical composition of cisplatin that is stable, therapeutically acceptable, and suitable for intravenous injection. This involves formulating cisplatin in a way that maintains its potency and reduces potential side effects associated with its administration[4].
Claims of the Patent
The claims of the patent are crucial as they define the scope of protection granted to the inventor. Here are some key claims:
Claim 1
The first claim describes a pharmaceutical composition comprising cisplatin dissolved in an aqueous solution, where the solution is stabilized to prevent degradation of the cisplatin. This claim sets the foundation for the invention by specifying the core components and their relationship[4].
Claim 2
This claim elaborates on the concentration range of cisplatin in the aqueous solution, ensuring that the formulation is within a therapeutically effective range while maintaining stability[4].
Claim 3
This claim addresses the method of preparing the stabilized aqueous solution of cisplatin, including the steps involved in ensuring the solution's stability and efficacy[4].
Patent Landscape
Understanding the patent landscape surrounding US 4,310,515 involves analyzing related patents, the evolution of cisplatin formulations, and the broader intellectual property context.
Related Patents
Other patents related to cisplatin and platinum compounds have been filed and granted over the years. For example, patents focusing on different formulations, delivery methods, and combinations with other chemotherapeutic agents have expanded the therapeutic applications of cisplatin[4].
Evolution of Cisplatin Formulations
Since the granting of US 4,310,515, there have been significant advancements in the formulation and delivery of cisplatin. These include liposomal formulations, nanoparticle-based delivery systems, and combination therapies that enhance the efficacy and reduce the toxicity of cisplatin[4].
Intellectual Property Context
The patent landscape for cisplatin is complex, with multiple patents covering various aspects of its use, formulation, and administration. Patent analytics tools, such as those described by Schwegman, can help in categorizing and analyzing these patents to identify gaps in coverage and future development opportunities[3].
Impact on Cancer Treatment
The invention described in US 4,310,515 has had a profound impact on cancer treatment. Cisplatin is now a widely used chemotherapeutic agent, and its stable formulation has improved patient outcomes by ensuring consistent and effective treatment.
Clinical Applications
Cisplatin is used in the treatment of various types of cancers, including testicular, ovarian, lung, bladder, and stomach cancers. Its synergistic effects with other chemotherapeutic agents have made it a cornerstone in combination therapies[4].
Future Directions
Continued research and development in cisplatin formulations and delivery systems are expected to further enhance its therapeutic efficacy and reduce side effects. Emerging technologies such as targeted delivery systems and personalized medicine approaches are likely to play a significant role in the future of cisplatin-based treatments.
Claim Coverage and Patent Analytics
To fully understand the protection and opportunities provided by US 4,310,515, it is essential to conduct thorough patent analytics. This involves creating a Claim Coverage Matrix and using tools like ClaimScape® to categorize patents by claims and scope concepts. This approach helps in identifying gaps in current coverage and highlighting future design opportunities[3].
Legal and Regulatory Aspects
The legal and regulatory environment surrounding patents, including those related to false patent marking, is evolving. Recent decisions, such as the Federal Circuit's ruling in Crocs, Inc. v. Effervescent, Inc., have implications for how patent marking and false advertising claims are handled under the Lanham Act[5].
Key Takeaways
- Stable Formulation: The patent provides a stable, therapeutically acceptable, intravenously injectable dosage form of cisplatin.
- Clinical Impact: Cisplatin has become a cornerstone in cancer treatment, used in various types of cancers.
- Patent Landscape: The patent landscape for cisplatin is complex, with multiple patents covering different aspects of its use and formulation.
- Future Directions: Continued research in cisplatin formulations and delivery systems is expected to enhance its therapeutic efficacy.
- Patent Analytics: Tools like Claim Coverage Matrix and ClaimScape® are essential for analyzing and managing patent claims effectively.
FAQs
Q1: What is the primary focus of US Patent 4,310,515?
The primary focus of US Patent 4,310,515 is to provide a stable, therapeutically acceptable, intravenously injectable dosage form of cisplatin.
Q2: What are the key claims of the patent?
The key claims include the description of the pharmaceutical composition, the concentration range of cisplatin, and the method of preparing the stabilized aqueous solution.
Q3: How has the patent impacted cancer treatment?
The patent has significantly improved cancer treatment by providing a stable formulation of cisplatin, which is now widely used in treating various types of cancers.
Q4: What are the future directions in cisplatin research?
Future research is expected to focus on improving delivery systems, such as targeted delivery and personalized medicine approaches, to enhance the therapeutic efficacy and reduce side effects of cisplatin.
Q5: How can patent analytics help in managing patent claims related to cisplatin?
Patent analytics tools, such as Claim Coverage Matrix and ClaimScape®, help in categorizing and analyzing patents to identify gaps in coverage, highlight future design opportunities, and ensure comprehensive protection of intellectual property.
Sources
- US Patent for Doxorubicin adjuvants to reduce toxicity and methods ... - Justia Patents.
- Patent Claims Research Dataset - USPTO.
- Patent Analytics | Intellectual Property Law - SLWIP.
- US4310515A - Pharmaceutical compositions of cisplatin - Google Patents.
- The Federal Circuit Breathes New Life into False Patent Marking ... - Spencer Fane.
