United States Patent 4,863,742: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,863,742, titled "Controlled Absorption Pharmaceutical Composition," is a significant patent in the field of pharmaceuticals, particularly for the development of controlled-release drug formulations. This patent, issued to Schwarz Pharma, Inc., has played a crucial role in the advancement of drug delivery systems.
Patent Overview
The patent, filed in 1987 and granted in 1989, focuses on a controlled absorption form of the drug verapamil, a calcium channel blocker used to treat cardiovascular conditions such as hypertension and angina. The invention aims to provide a once-daily administration formulation, enhancing patient compliance and therapeutic efficacy[1][4].
Scope of the Patent
The patent describes a method for preparing a controlled-release pharmaceutical composition. Here are the key aspects:
Formulation
The composition involves a core containing the active ingredient (verapamil) coated with multiple layers of a polymer membrane. This design ensures a controlled and sustained release of the drug over an extended period[1][4].
Preparation Method
The preparation involves several steps, including:
- Coating seeds (e.g., sugar spheres or other inert cores) with a polymer suspension.
- Applying multiple coats of the polymer membrane to the core.
- Drying the coated seeds to remove solvents.
- Ensuring the final product has a consistent and controlled release profile[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Composition Claims
These claims describe the specific components of the controlled-release formulation, including the active ingredient, the core material, and the polymer coating[1][2].
Method Claims
These claims outline the steps involved in preparing the controlled-release formulation, including the application and drying of the polymer membrane[1].
Use Claims
The patent also includes claims related to the therapeutic use of the controlled-release verapamil formulation, particularly for treating cardiovascular disorders[1].
Patent Landscape Analysis
A comprehensive patent landscape analysis is crucial for understanding the strategic implications of this patent.
Geographical Spread
The geographical spread of this technology is primarily focused in the United States, given the patent's jurisdiction. However, the impact of this technology can be global, as similar formulations may be developed and patented in other countries[3].
Saturation of Patent Space
The patent space for controlled-release pharmaceutical formulations is relatively saturated, with numerous patents existing for various drugs and delivery systems. This saturation indicates a high level of competition and innovation in this area[3].
Competitors and New Entrants
Key competitors in this space include other pharmaceutical companies that have developed similar controlled-release formulations. New entrants may include biotech firms or generic drug manufacturers looking to capitalize on the expiration of patents like the '742 patent[3].
Time-Slicing and Trends
Analyzing the patent landscape over time reveals trends in innovation and patent filings. For instance, the '742 patent has expired, but its teachings continue to influence newer formulations, such as the Verelan® PM capsule formulation described in U.S. Patent 6,500,459[4].
Impact on the Pharmaceutical Industry
The '742 patent has had a significant impact on the pharmaceutical industry:
Innovation in Drug Delivery
The controlled-release formulation described in the patent has set a standard for once-daily administration of drugs, enhancing patient compliance and therapeutic outcomes. This innovation has inspired further research and development in drug delivery systems[1][4].
Litigation and Enforcement
The patent has been involved in litigation, such as the case of Schwarz Pharma, Inc. v. Mylan Pharmaceuticals, Inc., where Schwarz alleged infringement of the '742 patent by Mylan's generic version of the controlled-release verapamil formulation[5].
Strategic Insights
A patent landscape analysis of the '742 patent provides several strategic insights:
Market Analysis
Understanding the principal patent holders and their activities in adjacent technology spaces can help companies determine potential competitors and market disruptions[3].
Geographical Filing Strategies
Knowing the geographical spread of similar patents can advise companies on where to file patents to maximize protection and minimize costs[3].
Niche Technologies
Identifying underappreciated niche patent areas can guide companies to focus on less saturated spaces, potentially leading to more innovative and protected technologies[3].
Key Takeaways
- Controlled Release Formulation: The '742 patent introduced a significant advancement in controlled-release drug formulations, particularly for verapamil.
- Patent Scope: The patent covers the composition, preparation method, and therapeutic use of the controlled-release formulation.
- Patent Landscape: The patent space for controlled-release formulations is saturated, with ongoing innovation and competition.
- Impact: The patent has influenced drug delivery systems and been involved in significant litigation.
- Strategic Insights: A comprehensive patent landscape analysis can guide companies in making strategic decisions about patent filings, market positioning, and innovation.
FAQs
What is the main focus of United States Patent 4,863,742?
The main focus is on a controlled absorption form of the drug verapamil, designed for once-daily administration.
How is the controlled-release formulation prepared?
The formulation involves coating a core with multiple layers of a polymer membrane, ensuring a sustained release of the drug.
What are the key claims of the patent?
The claims include the composition, preparation method, and therapeutic use of the controlled-release verapamil formulation.
Why is patent landscape analysis important for this patent?
It helps in understanding the competitive landscape, identifying new entrants, and making strategic decisions about patent filings and innovation.
What is the current status of the '742 patent?
The patent has expired, but its teachings continue to influence newer drug delivery systems.
Cited Sources
- US4863742A - Controlled absorption pharmaceutical composition - Google Patents
- Patent 4,863,742 pharmaceutical drug patent claims, expiration, and ... - Drug Patent Watch
- Patent Landscape Analysis - Uncovering Strategic Insights - AcclaimIP
- US6500459B1 - Controlled onset and sustained release dosage ... - Google Patents
- Schwarz Pharma, Inc. v. Mylan Pharmaceuticals, Inc. - Casetext
