Analyzing the Scope and Claims of United States Patent 10,369,117
Introduction
United States Patent 10,369,117, assigned to Novaliq GmbH, is a significant patent in the field of ophthalmology, particularly for the treatment of dry eye disease. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent in question, U.S. Patent 10,369,117, is related to a method for treating keratoconjunctivitis sicca (dry eye disease) caused by meibomian gland dysfunction (MGD). This condition is a common cause of dry eye symptoms and affects a substantial portion of the population.
Scope of the Patent
The scope of the patent encompasses a specific method of treatment involving the use of perfluorohexyloctane, a perfluorocarbon compound. Here are the key aspects of the scope:
Treatment Method
The patent describes a method for treating dry eye disease by administering perfluorohexyloctane, which is indicated for the signs and symptoms of dry eye disease caused by MGD. This method involves the topical application of the compound to the eye, which helps in restoring the normal function of the meibomian glands and alleviating the symptoms of dry eye[4].
Active Ingredient
The active ingredient, perfluorohexyloctane, is a critical component of the invention. The patent details the composition and the formulation of the drug product, highlighting its efficacy and safety in treating dry eye disease.
Claims of the Patent
The claims of the patent are the legal definitions of what the inventor considers to be their invention. Here are some key claims:
Independent Claims
The independent claims define the broadest scope of the invention. For example, Claim 1 might describe the method of treating dry eye disease by administering a composition containing perfluorohexyloctane to the eye[4].
Dependent Claims
Dependent claims narrow down the scope of the independent claims by adding additional limitations. These could include specific concentrations of the active ingredient, methods of administration, or specific patient populations.
Patent Landscape
Understanding the patent landscape is crucial for assessing the competitive environment and potential infringement risks.
Related Patents
The patent 10,369,117 is part of a family of patents related to the treatment of dry eye disease. Other patents in this family include U.S. Patent Nos. 10,058,615, 10,449,164, 10,576,154, and 11,357,738, all assigned to Novaliq GmbH. These patents cover various aspects of the treatment method, formulations, and compositions[4].
Global Patent Family
The patent family extends beyond the United States, with corresponding patents filed in other countries. The Global Dossier service provided by the USPTO allows users to view the file histories of related applications from participating IP Offices, which is useful for understanding the global patent landscape[1].
Competitor Patents
Other companies and researchers may have filed patents related to dry eye treatments, which could potentially compete with or complement the invention described in U.S. Patent 10,369,117. Conducting a thorough search using resources like the Patent Public Search tool, European Patent Office (EPO), and World Intellectual Property Organization (WIPO) databases can help identify these patents[1].
Regulatory Aspects
The regulatory review process is a critical aspect of the patent landscape, especially for pharmaceuticals.
FDA Approval
The FDA has approved the human drug product MIEBO (perfluorohexyloctane) for the treatment of dry eye disease. This approval is a significant milestone and has implications for the patent term restoration. The FDA's determination of the regulatory review period is essential for calculating the potential patent term extension[4].
Patent Term Restoration
The USPTO has received applications for patent term restoration for the patents related to MIEBO. The FDA's assistance in determining the regulatory review period helps in establishing the maximum potential length of the patent extension. However, the actual period of extension is subject to statutory limitations[4].
Economic and Market Impact
The economic and market impact of U.S. Patent 10,369,117 is substantial.
Market Demand
Dry eye disease is a prevalent condition, and effective treatments are in high demand. The approval and patent protection of MIEBO position Novaliq GmbH as a key player in the ophthalmic pharmaceutical market.
Competitive Advantage
The patent provides Novaliq GmbH with a competitive advantage by preventing others from using the same method and composition for a specified period. This exclusivity can lead to significant market share and revenue.
Conclusion
U.S. Patent 10,369,117 is a pivotal patent in the treatment of dry eye disease, offering a specific method and composition that have been approved by regulatory bodies. Understanding the scope, claims, and broader patent landscape is essential for both the patent holder and competitors in the field.
Key Takeaways
- Treatment Method: The patent describes a method for treating dry eye disease using perfluorohexyloctane.
- Active Ingredient: Perfluorohexyloctane is the key component of the invention.
- Claims: The patent includes independent and dependent claims that define the scope of the invention.
- Patent Landscape: The patent is part of a family of patents with global filings and potential competitors.
- Regulatory Aspects: FDA approval and patent term restoration are critical for the patent's validity and extension.
- Economic Impact: The patent provides a competitive advantage and significant market potential.
FAQs
Q: What is the main subject of U.S. Patent 10,369,117?
A: The main subject is a method for treating keratoconjunctivitis sicca (dry eye disease) caused by meibomian gland dysfunction using perfluorohexyloctane.
Q: Who is the assignee of U.S. Patent 10,369,117?
A: The assignee is Novaliq GmbH.
Q: What is the regulatory status of the drug product described in the patent?
A: The FDA has approved the human drug product MIEBO (perfluorohexyloctane) for the treatment of dry eye disease.
Q: How does the patent term restoration process affect this patent?
A: The patent term restoration process involves determining the regulatory review period, which can extend the patent term. However, this is subject to statutory limitations.
Q: What resources can be used to search for related patents globally?
A: Resources such as the USPTO's Patent Public Search, Global Dossier, European Patent Office (EPO), and World Intellectual Property Organization (WIPO) databases can be used to search for related patents globally.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Regulations.gov - FDA Determination: https://downloads.regulations.gov/FDA-2024-E-0189-0002/attachment_1.pdf
- USPTO - Patent and patent application Claims data: https://developer.uspto.gov/product/patent-and-patent-application-claims-data-stata-dta-and-ms-excel-csv
- Federal Register - FDA Notice: https://www.govinfo.gov/content/pkg/FR-2024-08-15/html/2024-18265.htm
- Regulations.gov - FDA Verification: https://downloads.regulations.gov/FDA-2024-E-0189-0006/attachment_1.pdf
