United States Patent 5,919,479: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 5,919,479, titled "Solid-Forming Local Anesthetic Formulations for Pain Control," was granted on July 6, 1999, to inventors Jie Zhang and others, and assigned to Crescita Therapeutics Inc. This patent is significant in the field of pharmaceuticals, particularly in the development of local anesthetic formulations. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
Local anesthetics are crucial in medical procedures for pain management. The development of solid-forming local anesthetic formulations aimed to improve the efficacy, safety, and convenience of these medications. The patent in question addresses these needs by introducing a novel formulation.
Scope of the Patent
Invention Overview
The patent describes solid-forming local anesthetic formulations designed to provide controlled release of the anesthetic agent. These formulations are typically biodegradable and can be administered in various forms, such as injectables or implants, to manage pain effectively[1].
Key Components
The formulations include a local anesthetic agent, a biodegradable polymer, and optionally, other additives to enhance the properties of the formulation. The biodegradable polymer ensures the slow release of the anesthetic, providing prolonged pain relief.
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover various aspects of the formulation, including:
- Claim 1: A solid-forming local anesthetic formulation comprising a local anesthetic agent and a biodegradable polymer.
- Claim 5: A method of preparing the solid-forming local anesthetic formulation.
- Claim 9: A method of using the solid-forming local anesthetic formulation for pain control[1].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the types of biodegradable polymers, the concentration of the local anesthetic agent, and the methods of administration.
Patent Landscape
Prior Art and Related Patents
The patent landscape in this area is rich with prior art and related patents. For instance, patents like U.S. Patent 5,329,976 (Haber et al.) and U.S. Patent 5,330,452 (Zook) also deal with biodegradable polymers and drug delivery systems. These patents highlight the ongoing research and development in the field of controlled drug release[1].
Citations and References
The patent 5,919,479 cites several prior patents and publications, indicating the evolutionary nature of the invention. These citations include patents from the 1970s to the 1990s, reflecting the continuous advancements in pharmaceutical formulations[1].
Legal and Regulatory Aspects
Patent Validity and Challenges
Patents, like 5,919,479, can face legal challenges and validity disputes. For example, the case of Arbutus Biopharma Corporation v. Moderna Therapeutics, Inc. illustrates how patents can be challenged through inter partes review (IPR) proceedings. Such challenges can impact the patent's validity and the rights of the patent holder[2].
Patent Office Procedures
The U.S. Patent and Trademark Office (USPTO) plays a crucial role in granting and maintaining patents. The USPTO's procedures, including the examination process and the handling of patent applications, are critical in determining the validity and scope of patents like 5,919,479[5].
Economic and Market Value
Valuation Methods
The value of a patent like 5,919,479 can be determined using various methods: cost, income, and market approaches. The cost approach considers the development costs, the income approach looks at future benefits, and the market approach evaluates what a willing buyer would pay for similar assets[4].
Market Significance
The market value of pharmaceutical patents can be substantial. For instance, the Google-Motorola deal, where Google acquired Motorola Mobility for $12.5 billion, included a significant portion attributed to the value of patents. This highlights the strategic importance of patents in the pharmaceutical and technology sectors[4].
Impact on the Pharmaceutical Industry
Innovation and Competition
Patents like 5,919,479 drive innovation by protecting intellectual property and encouraging further research. They also influence competition within the pharmaceutical industry, as companies strive to develop new and improved formulations.
Patient Benefits
The solid-forming local anesthetic formulations described in the patent have the potential to significantly benefit patients by providing more effective and longer-lasting pain relief. This can improve patient outcomes and quality of life.
Key Takeaways
- Invention Scope: The patent covers solid-forming local anesthetic formulations with biodegradable polymers for controlled release.
- Claims: Independent and dependent claims define the formulation, preparation methods, and use for pain control.
- Patent Landscape: The patent is part of a broader landscape of related patents and prior art in drug delivery systems.
- Legal Aspects: Patents can face legal challenges, and their validity can be disputed through IPR proceedings.
- Economic Value: The patent's value can be determined using cost, income, and market approaches.
- Industry Impact: The patent drives innovation, influences competition, and benefits patients through improved pain management.
FAQs
Q: What is the main invention described in U.S. Patent 5,919,479?
A: The main invention is a solid-forming local anesthetic formulation designed for controlled release of the anesthetic agent.
Q: What are the key components of the formulation?
A: The key components include a local anesthetic agent and a biodegradable polymer.
Q: How are the claims structured in this patent?
A: The patent includes independent claims that define the scope of the invention, and dependent claims that provide further specifications.
Q: What is the significance of this patent in the pharmaceutical industry?
A: This patent drives innovation, influences competition, and provides improved pain management options for patients.
Q: How can the value of this patent be determined?
A: The value can be determined using cost, income, and market approaches, considering factors like development costs, future benefits, and market demand.
Sources
- United States Patent 5,919,479 - Solid-Forming Local Anesthetic Formulations for Pain Control[1].
- Arbutus Biopharma Corporation v. Moderna Therapeutics, Inc. - Court of Appeals for the Federal Circuit[2].
- Patent Claims Research Dataset - USPTO Economic Working Paper 2016-04[3].
- The Value of a Patent - Perpetual Motion Patents[4].
- U.S. Patent and Trademark Office (USPTO) - USAGov[5].
