United States Patent 5,424,078: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,424,078, titled "Aqueous Ophthalmic Formulations and Methods for Preserving Same," was granted to inventors Anthony J. Dziabo and Paul S. Ripley, and assigned to Allergan, Inc. This patent, filed on May 2, 1991, and issued on June 13, 1995, pertains to the preservation of ophthalmic formulations. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent addresses a significant issue in ophthalmic formulations: the preservation of aqueous solutions to maintain their efficacy and safety. The inventors developed methods and formulations that prevent microbial contamination, a critical concern in ophthalmic products.
Scope of the Patent
Overview
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. The patent covers both the compositions and the methods for preserving aqueous ophthalmic formulations.
Claim Structure
The patent includes multiple claims, each detailing a specific aspect of the invention. Here are some key claims:
- Claim 1: This claim describes the aqueous ophthalmic formulation itself, including the presence of a preservative system.
- Claim 2: This claim specifies the method of preserving the ophthalmic formulation, including the use of particular preservatives.
- Claims 3-12: These claims further detail various embodiments of the formulation and preservation method, including specific concentrations of preservatives and other components[4].
Claims Analysis
Patentable Subject Matter
The claims must meet the criteria for patentable subject matter under 35 U.S.C. § 101. In this case, the claims are directed towards a specific application of preservatives in ophthalmic formulations, which is considered a practical application and thus eligible for patent protection[1].
Novelty and Non-Obviousness
The patent must also satisfy the requirements of novelty (35 U.S.C. § 102) and non-obviousness (35 U.S.C. § 103). The inventors have provided a unique solution to the problem of preserving ophthalmic formulations, which was not anticipated by prior art. The use of specific preservatives and their combinations in the claimed formulations would be considered non-obvious to a person of ordinary skill in the art[1].
Written Description and Enablement
The patent specification must provide a written description of the invention and enable one skilled in the art to make and use the invention. The patent includes detailed descriptions of the formulations, preservatives, and methods, along with examples and experimental data, ensuring that it meets these requirements[4].
Patent Landscape
Prior Art
The patent cites several prior art references, including U.S. patents such as 4,084,747 and 4,499,077, which relate to ophthalmic formulations and preservation methods. However, the claimed invention distinguishes itself by the specific combination and concentration of preservatives used[4].
Related Patents
Other patents in the same field, such as those related to ophthalmic formulations and preservation, are relevant. For example, patents like U.S. Patent 4,568,517, which deals with preservative systems for ophthalmic products, highlight the ongoing research and development in this area[4].
International Classification
The patent is classified under international classes A61K 33/14 and A61K 31/19, and U.S. classes 424/661, 514/557, and 514/912. This classification helps in understanding the broader technological context and identifying similar inventions globally[4].
Impact and Significance
Industry Impact
The invention has significant implications for the ophthalmic industry, particularly in ensuring the safety and efficacy of aqueous formulations. It provides a reliable method for preserving these formulations, which is crucial for patient health.
Legal and Regulatory
The patent's validity and enforceability are subject to legal scrutiny. For instance, the America Invents Act (AIA) introduced changes in patent law that could affect the patent's validity, such as the shift from "first to invent" to "first to file" and changes in inter partes proceedings[1].
Measurement of Patent Scope
Claim Length and Scope
The scope of the patent can be measured by the length of its claims. According to research, longer claims typically indicate a narrower scope because they include more specific details that must be met to infringe the patent. In this case, the claims are detailed, suggesting a narrower but well-defined scope[3].
Expert Insights
Patent attorneys and experts in the field often assess the scope of a patent based on its claims and the technological context. For example, Thomas Kulaga notes that "broad patents typically offer more protection against infringers than a narrow patent" because they are harder to design around. However, the specificity of the claims in U.S. Patent 5,424,078 suggests a balanced approach between breadth and specificity[3].
Conclusion
United States Patent 5,424,078 is a significant contribution to the field of ophthalmic formulations, providing a novel and non-obvious method for preserving aqueous solutions. The patent's scope is well-defined by its detailed claims, and it fits within a broader landscape of research and development in ophthalmic preservation.
Key Takeaways
- Specific Claims: The patent includes detailed claims that define the scope of the invention.
- Novelty and Non-Obviousness: The invention meets the criteria for novelty and non-obviousness.
- Written Description and Enablement: The patent specification is sufficient to enable one skilled in the art to make and use the invention.
- Patent Landscape: The patent is part of a larger body of work in ophthalmic formulations and preservation methods.
- Industry Impact: The invention has significant implications for the safety and efficacy of ophthalmic products.
FAQs
Q1: What is the main subject of U.S. Patent 5,424,078?
The main subject is the preservation of aqueous ophthalmic formulations.
Q2: Who are the inventors of this patent?
The inventors are Anthony J. Dziabo and Paul S. Ripley.
Q3: When was the patent filed and issued?
The patent was filed on May 2, 1991, and issued on June 13, 1995.
Q4: What are the key claims of this patent?
The key claims include the composition of the ophthalmic formulation and the method of preserving it using specific preservatives.
Q5: How does the scope of this patent compare to others in the field?
The scope is narrower due to the detailed claims, but it provides strong protection against infringement within its defined boundaries.
Sources
- 2011 Patent Law Decisions of the Federal Circuit - American University Law Review, Vol. 61:785.
- In re Brimonidine Patent Litigation - U.S. District Court — District of Delaware, MDL Docket No. 07-md-1866 GMS.
- The Ways We've been Measuring Patent Scope are Wrong - Boston University Law Review.
- United States Patent 5,424,078 - googleapis.com.
