United States Patent 8,518,981: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,518,981, titled "Liquid pharmaceutical formulations of palonosetron," is a significant patent in the pharmaceutical industry, particularly in the field of oncology. This patent, granted to Helsinn Healthcare S.A., pertains to the development of shelf-stable liquid formulations of palonosetron, a serotonin 5-HT3 receptor antagonist used to prevent chemotherapy and radiotherapy-induced emesis.
Patent Overview
Invention Description
The patent describes liquid pharmaceutical formulations of palonosetron that are stable at room temperature, making them more convenient and practical for use compared to existing formulations that require refrigeration. These formulations typically include palonosetron, a pharmaceutically acceptable solvent, and other stabilizing agents such as mannitol and sodium hydroxide[4].
Claims
The patent includes several claims that define the scope of the invention. Key claims include:
- The composition of the liquid formulation, which must include palonosetron and specific stabilizing agents.
- The method of preparing the formulation to ensure stability.
- The use of the formulation for preventing chemotherapy and radiotherapy-induced emesis[4].
Scope of the Patent
Composition and Stability
The patent emphasizes the importance of the formulation's stability, which is achieved through the use of specific ingredients such as mannitol and sodium hydroxide. These ingredients help maintain the chemical integrity of palonosetron over time, even at room temperature[4].
Method of Preparation
The method of preparing the liquid formulation is also a critical aspect of the patent. The process involves dissolving palonosetron in a pharmaceutically acceptable solvent and adding stabilizing agents to ensure the formulation remains stable over its shelf life[4].
Therapeutic Use
The primary therapeutic use of the formulation is to prevent nausea and vomiting induced by chemotherapy and radiotherapy. The stability and convenience of the liquid formulation make it a valuable option for patients undergoing these treatments[4].
Patent Landscape
Prior Art and Related Patents
The patent landscape for palonosetron formulations includes several related patents and prior art. For instance, other patents may cover different formulations or methods of preparation, but the unique combination of ingredients and the stability at room temperature set this patent apart[4].
International Patent Filings
To understand the global reach of this patent, it is essential to look at international patent filings. The Global Dossier service provided by the USPTO allows users to see the patent family for a specific application, including related applications filed at participating IP Offices. This can help in identifying similar patents filed in other countries[1].
Competitive Analysis
A competitive analysis involves searching through databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) to identify similar or competing patents. This helps in understanding the broader patent landscape and potential competitors in the market[1].
Legal Status and Expiration
Current Status
As of the current date, the legal status of the patent is listed as expired. This means that the exclusive rights granted by the patent have lapsed, and the invention is now in the public domain[4].
Implications of Expiration
The expiration of the patent has significant implications for the pharmaceutical industry. It allows other companies to manufacture and market similar formulations without infringing on the original patent. This can lead to increased competition and potentially lower prices for the medication.
Economic and Market Impact
Market Competition
The expiration of the patent opens up the market to generic versions of the drug, which can increase competition and reduce prices. This is beneficial for patients but can also impact the revenue of the original patent holder.
Innovation and R&D
The expiration of a patent can also drive innovation as other companies may invest in research and development to improve upon the existing formulation or develop new treatments.
Key Takeaways
- Stable Formulation: The patent describes a stable liquid formulation of palonosetron that can be stored at room temperature.
- Therapeutic Use: The primary use is to prevent chemotherapy and radiotherapy-induced emesis.
- Expired Patent: The patent has expired, allowing other companies to manufacture similar formulations.
- Market Impact: The expiration can lead to increased competition and lower prices for the medication.
- Global Landscape: Understanding international patent filings and the broader patent landscape is crucial for competitive analysis.
FAQs
Q: What is the main invention described in US Patent 8,518,981?
A: The main invention is a shelf-stable liquid pharmaceutical formulation of palonosetron for preventing chemotherapy and radiotherapy-induced emesis.
Q: What are the key ingredients in the formulation?
A: The formulation includes palonosetron, a pharmaceutically acceptable solvent, and stabilizing agents such as mannitol and sodium hydroxide.
Q: Why is the stability of the formulation important?
A: The stability ensures that the formulation remains effective over its shelf life, even when stored at room temperature.
Q: What is the current legal status of the patent?
A: The patent has expired, meaning the exclusive rights have lapsed, and the invention is now in the public domain.
Q: How does the expiration of the patent affect the market?
A: The expiration allows other companies to manufacture and market similar formulations, potentially increasing competition and reducing prices.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- ACUS - U.S. Patent Small Claims Court: https://www.acus.gov/research-projects/us-patent-small-claims-court
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US8518981B2: https://patents.google.com/patent/US8518981B2/en
- PubChem - Liquid pharmaceutical formulations of palonosetron: https://pubchem.ncbi.nlm.nih.gov/patent/US-9457021-B1
