United States Patent 4,695,578: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 4,695,578, hereafter referred to as the '578 patent, is a significant patent in the pharmaceutical industry, particularly in the production of ondansetron hydrochloride, a medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Ondansetron Hydrochloride
Ondansetron hydrochloride is a serotonin 5-HT3 receptor antagonist, widely used in clinical settings to manage emesis. The development and manufacturing processes of this drug are critical for its efficacy and stability.
Patent Overview
Inventors and Assignees
The '578 patent was granted to inventors associated with Glaxo Group Limited, a prominent pharmaceutical company. This patent is part of a larger portfolio of intellectual property held by Glaxo, now part of GlaxoSmithKline (GSK).
Patent Claims
The '578 patent primarily claims a process for preparing ondansetron hydrochloride dihydrate with specific particle size characteristics. Here are the key claims:
- Claim 1: A process for preparing ondansetron hydrochloride dihydrate, which involves cooling a solution of ondansetron hydrochloride, isopropanol, and water.
- Claim 2: An optional step of recrystallizing the product from a mixture of water and isopropanol to achieve a desired particle size distribution[1].
Scope of the Patent
Process Description
The patented process involves several steps:
- Cooling Step: Cooling a solution containing ondansetron hydrochloride, isopropanol, and water. This step is crucial for forming the dihydrate crystalline form of the drug.
- Recrystallization Step: Optionally, the product can be recrystallized from a mixture of water and isopropanol to refine the particle size distribution. This ensures that less than about 60% of the particles are smaller than 250 μm, which is important for the drug's bioavailability and stability[1].
Particle Size Importance
The particle size of ondansetron hydrochloride dihydrate is critical for its pharmaceutical properties. The specified particle size range ensures optimal dissolution rates and bioavailability, making the drug more effective in clinical use.
Patent Landscape
Related Patents
The '578 patent is part of a series of patents related to ondansetron hydrochloride. For example, U.S. Patent No. 5,344,658 also deals with the preparation and crystallization of ondansetron hydrochloride, highlighting the ongoing research and development in this area[1].
Patent Term Extensions
Patents like the '578 patent can be subject to term extensions under certain conditions. For instance, if a patent claims a product or a method that has undergone regulatory reviews by the FDA, the patent term can be extended up to five years under 35 U.S.C. 156(e)(1)[2].
Impact on the Pharmaceutical Industry
Manufacturing and Quality Control
The process described in the '578 patent has significant implications for the manufacturing of ondansetron hydrochloride. It ensures that the final product meets specific quality standards, which is crucial for patient safety and efficacy.
Competitive Advantage
Holding a patent like the '578 patent provides a competitive advantage to the patent holder. It prevents other companies from using the same process, thereby protecting the intellectual property and market share of the patent holder.
Litigation and Enforcement
Patents in the pharmaceutical industry are often subject to litigation, particularly when generic manufacturers attempt to enter the market. The '578 patent, like many others, would have been defended against potential infringers to maintain its exclusivity.
Economic Value
The economic value of a patent like the '578 patent can be substantial. Patents in the pharmaceutical sector are often highly valued due to their potential to generate significant revenue. For example, the sale of patent portfolios in the industry can involve billions of dollars, as seen in deals like the Google-Motorola acquisition, where patents were a key asset[4].
Conclusion
The '578 patent is a critical piece of intellectual property in the pharmaceutical industry, particularly in the production of ondansetron hydrochloride. Its claims and process descriptions are designed to ensure the quality and efficacy of the drug, providing a competitive advantage to the patent holder. Understanding the scope and claims of this patent is essential for both manufacturers and researchers in the field.
Key Takeaways
- The '578 patent describes a process for preparing ondansetron hydrochloride dihydrate with specific particle size characteristics.
- The process involves cooling a solution of ondansetron hydrochloride, isopropanol, and water, with an optional recrystallization step.
- Particle size is crucial for the drug's bioavailability and stability.
- The patent can be subject to term extensions under certain regulatory conditions.
- Holding this patent provides a competitive advantage in the pharmaceutical market.
- The economic value of such patents can be substantial.
FAQs
What is the primary claim of the '578 patent?
The primary claim is a process for preparing ondansetron hydrochloride dihydrate with specific particle size characteristics.
Why is particle size important in ondansetron hydrochloride production?
Particle size is crucial for ensuring optimal dissolution rates and bioavailability of the drug.
Can the '578 patent be extended?
Yes, the patent term can be extended up to five years if it undergoes regulatory reviews by the FDA under 35 U.S.C. 156(e)(1).
What is the economic significance of the '578 patent?
The patent holds significant economic value due to its potential to generate revenue and protect market share in the pharmaceutical industry.
How does the '578 patent impact the manufacturing process?
The patent ensures that the final product meets specific quality standards, which is critical for patient safety and efficacy.
