United States Patent 9,211,259: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,211,259, hereafter referred to as the '259 patent, is a significant intellectual property asset in the pharmaceutical sector. This patent is associated with a method of treating or preventing certain skin conditions, and it has been the subject of several legal disputes. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Inventors
The '259 patent was granted to LEO Pharma A/S, a Danish pharmaceutical company. The inventors listed on the patent are experts in dermatology and pharmaceutical formulation, reflecting the patent's focus on dermatological treatments.
Scope of the Patent
The '259 patent pertains to a method of treating or preventing skin conditions, specifically acne and rosacea, using a foamable composition containing azelaic acid. Azelaic acid is a well-known ingredient in dermatological treatments due to its antibacterial and anti-inflammatory properties.
Claims Overview
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
- Claim 1: This claim describes a method of treating or preventing acne or rosacea by applying a foamable composition containing azelaic acid to the affected skin area.
- Subsequent Claims: These claims further specify the composition, including the concentration of azelaic acid, the type of foamable base used, and the method of application.
Patent Claims and Scope
The claims in the '259 patent are designed to protect the specific method and composition described. Here’s a breakdown of the claim structure:
- Independent Claims: These claims stand alone and define the core invention. For example, Claim 1 is an independent claim that outlines the method of treatment.
- Dependent Claims: These claims build upon the independent claims and provide additional details or limitations. For instance, dependent claims might specify the concentration range of azelaic acid or the type of foamable base[2].
Patent Landscape
The '259 patent is part of a larger patent family related to azelaic acid formulations and their use in treating skin conditions.
Related Patents
Other patents in this family include U.S. Patent No. 7,700,076, U.S. Patent No. 8,435,498, U.S. Patent No. 8,722,021, U.S. Patent No. 8,900,554, and U.S. Patent No. 10,117,812. These patents collectively cover various aspects of azelaic acid formulations, including different concentrations, formulations, and methods of application[2][5].
Global Dossier
The '259 patent is also part of the Global Dossier system, which allows users to access the file histories of related applications from participating IP Offices. This includes the IP5 Offices (the United States, Europe, Japan, Korea, and China). This system provides a comprehensive view of the patent family and related applications across different jurisdictions[1].
Litigation and Enforcement
The '259 patent has been involved in several patent infringement cases, particularly against generic drug manufacturers seeking to market similar products before the patent's expiration.
Example Litigation
In one notable case, LEO Pharma A/S sued Taro Pharmaceuticals over Taro's Abbreviated New Drug Application (ANDA) for a generic version of FINACEA® Foam, which contains 15% azelaic acid. The lawsuit alleged that Taro's product infringed multiple claims of the '259 patent, among others[2].
Economic and Strategic Impact
The '259 patent, along with other related patents, plays a crucial role in protecting LEO Pharma's intellectual property and market position.
Market Protection
By enforcing these patents, LEO Pharma can prevent generic competitors from entering the market until the patents expire, thereby maintaining market exclusivity and revenue.
Research and Development
The protection afforded by these patents also incentivizes continued research and development in dermatological treatments, as companies can recoup their investment through exclusive market rights.
Statistical Insights
Studies on patent allowance rates and continuation procedures provide context on the broader patent landscape. For instance, the family allowance rate, which includes the outcomes of continuation applications, highlights the complexity and persistence required in patent prosecution. According to USPTO data, about 15.8% of progenitor applications result in at least one serialized continuation, indicating a significant effort in securing comprehensive patent protection[4].
Expert Opinions
Industry experts emphasize the importance of robust patent protection in the pharmaceutical sector. As noted by Deepak Hegde and others, "Pioneering inventors or thicket-builders" use continuation procedures to build a dense network of patents around their core inventions, enhancing their defensive and offensive capabilities in the market[4].
Conclusion
The '259 patent is a critical component of LEO Pharma's intellectual property portfolio, protecting a specific method of treating skin conditions using azelaic acid. Understanding the scope, claims, and the broader patent landscape is essential for navigating the complex world of pharmaceutical patents.
Key Takeaways
- Scope and Claims: The '259 patent covers a method of treating acne and rosacea using a foamable composition containing azelaic acid.
- Patent Landscape: The patent is part of a larger family of patents related to azelaic acid formulations.
- Litigation: The patent has been involved in several infringement cases against generic drug manufacturers.
- Economic Impact: The patent protects LEO Pharma's market position and incentivizes further research and development.
- Statistical Insights: The patent is part of a broader trend in patent prosecution, including the use of continuation procedures.
Frequently Asked Questions (FAQs)
1. What is the main subject of the '259 patent?
The '259 patent pertains to a method of treating or preventing skin conditions such as acne and rosacea using a foamable composition containing azelaic acid.
2. Who is the assignee of the '259 patent?
The assignee of the '259 patent is LEO Pharma A/S, a Danish pharmaceutical company.
3. What are some related patents to the '259 patent?
Related patents include U.S. Patent No. 7,700,076, U.S. Patent No. 8,435,498, U.S. Patent No. 8,722,021, U.S. Patent No. 8,900,554, and U.S. Patent No. 10,117,812.
4. Why is the '259 patent important in the pharmaceutical sector?
The '259 patent is important because it protects LEO Pharma's intellectual property and market position, allowing the company to maintain exclusivity and revenue in the market for dermatological treatments.
5. How does the '259 patent fit into the Global Dossier system?
The '259 patent is part of the Global Dossier system, which provides access to the file histories of related applications from participating IP Offices, including the IP5 Offices.
Cited Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF DELAWARE: https://insight.rpxcorp.com/litigation_documents/13222244
- Patent Claims Research Dataset - USPTO: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- What Is the Probability of Receiving a US Patent?: https://yjolt.org/sites/default/files/carley_hegde_marco-what_is_the_probability_of_receiving_a_us_patent_0.pdf
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE: https://insight.rpxcorp.com/litigation_documents/13178586
