United States Patent 6,133,310: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,133,310, titled "Method of treatment of rosacea," is a significant patent in the field of dermatology, particularly for the treatment of rosacea using ivermectin. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
The patent, granted on October 17, 2000, is assigned to Galderma S.A. and pertains to the topical application of ivermectin for treating rosacea. Rosacea is a chronic skin condition characterized by inflammation, redness, and the appearance of small, pus-filled bumps on the face. The invention addresses the need for effective and well-tolerated treatments for this condition[4].
Technical Field of the Invention
The patent falls under the classification of A61K, which pertains to preparations for medical, dental, or toiletry purposes. Specifically, it is categorized under A61K31/70, which includes medicinal preparations containing organic active ingredients, particularly those with saccharide radicals and heterocyclic rings[4].
Summary of the Invention
The patent describes a method of treating rosacea using topical applications of ivermectin. Unlike earlier experimental preparations, this invention focuses on creating industrially acceptable pharmaceutical compositions with good cosmetic properties and a sufficient shelf-life. The compositions include ivermectin in various forms such as lotions, creams, and gels, which are well-tolerated and effective in treating rosacea symptoms[2][4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
- Claim 1: This claim specifies the method of treating rosacea by topically applying a composition containing ivermectin.
- Subsequent Claims: These claims detail various aspects of the composition, including the concentration of ivermectin, the type of excipients used, and the form of the pharmaceutical preparation (e.g., lotion, cream, gel)[4].
Scope of the Patent
The scope of the patent is defined by its claims and the detailed description provided. It covers the use of ivermectin in topical formulations specifically designed for treating rosacea. The patent emphasizes the importance of creating compositions that are not only effective but also well-tolerated and cosmetically acceptable. This scope is narrow enough to protect the specific invention while broad enough to encompass various formulations that achieve the same therapeutic effect[2][4].
Patent Landscape
The patent landscape surrounding U.S. Patent 6,133,310 is rich with related inventions and patents:
- Prior Art: Earlier patents, such as U.S. Pat. No. 4,133,983 and U.S. Pat. No. 5,569,651, also address treatments for rosacea but do not involve the use of ivermectin in the same way[4].
- Related Patents: Patents like U.S. Pat. No. 8,093,219 and U.S. Pat. No. 8,080,530, filed by the same assignee, further develop the use of ivermectin in topical formulations for dermatological conditions[2].
- European Counterparts: The European Patent Specification EP 1 729 811 B1 also covers similar compositions and methods, highlighting the global nature of this invention[5].
Impact on Innovation and Patent Quality
The granting of this patent and others like it has sparked debates about patent quality and scope. Critics argue that broad patents can stifle innovation by increasing licensing and litigation costs. However, metrics such as independent claim length and count can help measure patent scope and quality. Studies have shown that narrower claims, like those in U.S. Patent 6,133,310, are associated with a higher probability of grant and shorter examination processes, indicating a more focused and valid patent[3].
Clinical and Commercial Significance
The clinical significance of this patent lies in its provision of an effective treatment for rosacea, a condition that affects millions. The commercial significance is evident in the market presence of products based on this patent, such as Soolantra, which has become a leading treatment for rosacea.
Study of Irritation and Acceptability
The patent includes detailed studies on the irritation and acceptability of the ivermectin compositions. These studies show that the formulations are well-tolerated and have high acceptability rates among users, which is crucial for a topical treatment[2].
Legal and Regulatory Aspects
The patent's validity and enforceability are subject to legal scrutiny. For instance, any generic or similar product seeking FDA approval must navigate the patent landscape to avoid infringement. This is exemplified by cases where generic manufacturers have been sued for submitting ANDAs (Abbreviated New Drug Applications) that allegedly infringe on existing patents[1].
Key Takeaways
- Effective Treatment: U.S. Patent 6,133,310 provides an effective method for treating rosacea using ivermectin.
- Well-Tolerated Formulations: The patent emphasizes the creation of well-tolerated and cosmetically acceptable compositions.
- Narrow but Protective Scope: The claims are narrow enough to protect the specific invention while allowing for various formulations.
- Global Patent Landscape: The invention is part of a broader global patent landscape addressing dermatological treatments.
- Clinical and Commercial Impact: The patent has significant clinical and commercial implications, leading to the development of successful products like Soolantra.
FAQs
Q: What is the main claim of U.S. Patent 6,133,310?
A: The main claim is the method of treating rosacea by topically applying a composition containing ivermectin.
Q: What forms of ivermectin compositions are described in the patent?
A: The patent describes lotions, creams, and gels containing ivermectin.
Q: How does this patent impact the treatment of rosacea?
A: It provides an effective and well-tolerated treatment option, improving the quality of life for patients with rosacea.
Q: Are there any related patents or European counterparts?
A: Yes, there are related patents and European counterparts that further develop the use of ivermectin in dermatological treatments.
Q: What are the implications of this patent on innovation and patent quality?
A: The patent's narrow scope and focused claims contribute to a higher probability of grant and shorter examination processes, indicating a more valid and quality patent.
Cited Sources
- IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN... - Insight.rpxcorp.com
- Topical application of ivermectin for the treatment of dermatological... - Patents.justia.com
- Patent Claims and Patent Scope - Hoover Institution
- US6133310A - Method of treatment of rosacea - Google Patents
- CREAM-GEL CONTAINING IVERMECTIN - European Patent Specification
