United States Patent 9,085,553: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 9,085,553, titled "LFA-1 inhibitor and methods of preparation and polymorph thereof," is a significant patent in the field of pharmaceuticals, particularly in the area of immunomodulatory drugs. This patent, issued on July 21, 2015, covers a compound and its methods of preparation, purification, and polymorphs, which are crucial for treating various diseases.
Background
LFA-1 (Lymphocyte Function-Associated Antigen 1) is an integrin involved in the immune response, and inhibitors of LFA-1 are used to modulate immune reactions. The patent in question focuses on a specific compound and its derivatives that inhibit LFA-1, which is relevant for treating conditions such as dry eye disease, among others[4].
Scope of the Patent
Broad Claims vs. Narrow Claims
The scope of a patent is often determined by the breadth of its claims. According to patent experts, broader patents offer more protection against infringers because they are harder to design around. The patent in question includes multiple claims, but the broadest claims define the legal right to exclude others from making, using, or selling the invention[3].
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims are the broadest and define the invention, while dependent claims are narrower and build upon the independent claims. In this patent, the independent claims cover the compound, its polymorphs, and methods of preparation and purification. Dependent claims specify various embodiments, such as different solvents and reaction conditions used in the preparation methods[1].
Claims Analysis
Compound and Polymorphs
The patent claims cover a compound of Formula I, its polymorphs, and related compounds. These claims are detailed and specify the chemical structure and properties of the compound, ensuring that any variations or polymorphs are also protected[1].
Methods of Preparation and Purification
The patent includes claims for various methods of preparing and purifying the compound. These methods involve different chemical reactions, solvents, and conditions, such as hydrolysis, recrystallization, and the use of phase transfer catalysts. This comprehensive coverage ensures that the patent holder has protection over a wide range of manufacturing processes[1].
Intermediates and Related Compounds
The patent also covers intermediates and related compounds used in the synthesis of the LFA-1 inhibitor. This is crucial because it prevents others from developing similar compounds by slightly modifying the intermediates or related compounds[1].
Patent Landscape
Competitor Analysis
The patent landscape for LFA-1 inhibitors is competitive, with several other patents and drugs targeting similar mechanisms. For example, lifitegrast (Xiidra) is another drug that inhibits LFA-1 and is used to treat dry eye disease. However, the specific compound and methods covered in US 9,085,553 are unique and provide a distinct competitive advantage[4].
Patent Expiration and Extensions
The patent has several related patents with different expiration dates, ranging from 2024 to 2033. This staggered expiration timeline ensures continued protection for the invention over an extended period. Additionally, pediatric extensions and other regulatory extensions can further prolong the patent's life[4].
Measurement of Patent Scope
Traditional Measures
Traditional measures of patent scope include the number of patent classes, the number of citations, and the number of claims. However, research has shown that these measures are often misleading or lack explanatory power. For instance, the number of patent classes is negatively correlated with patent scope, and the number of citations is only weakly related to patent scope[3].
Modern Measures
A more predictive measure of patent scope involves counting the number of words in the first claim. This method is highly predictive and explains nearly half of the variation in patent scope as judged by experts. In the case of US 9,085,553, the length and specificity of the claims suggest a well-defined scope that is difficult to circumvent[3].
Practical Implications
Protection Against Infringement
The broad and detailed claims in this patent provide strong protection against infringement. Competitors would need to significantly alter the compound or methods to avoid infringing on the patent, which is challenging given the comprehensive coverage of the claims[3].
Licensing and Collaboration
The patent's strong scope also makes it an attractive candidate for licensing and collaboration agreements. Companies may seek to license the technology to develop new drugs or improve existing manufacturing processes, which can be lucrative for the patent holder[3].
Regulatory and Legal Considerations
Patent Litigation
In the event of patent infringement, the detailed claims and broad scope of US 9,085,553 would be crucial in litigation. The patent's specificity makes it easier to argue against infringers and protect the intellectual property rights of the patent holder[5].
Compliance with Regulatory Requirements
The patent must comply with various regulatory requirements, including those related to drug safety and efficacy. The detailed methods of preparation and purification ensure that the compound meets these standards, which is essential for FDA approval and other regulatory clearances[4].
Key Takeaways
- Broad and Specific Claims: The patent includes broad and specific claims that cover the compound, its polymorphs, and methods of preparation and purification.
- Competitive Advantage: The unique compound and methods provide a distinct competitive advantage in the market for LFA-1 inhibitors.
- Patent Expiration: The patent has a staggered expiration timeline, ensuring continued protection over an extended period.
- Measurement of Scope: The patent's scope is best measured by the length and specificity of its claims, which are highly predictive of its protective power.
- Practical Implications: The patent offers strong protection against infringement and is attractive for licensing and collaboration agreements.
FAQs
What is the main subject of United States Patent 9,085,553?
The main subject of this patent is an LFA-1 inhibitor, including its compound, polymorphs, and methods of preparation and purification.
How does the patent protect against infringement?
The patent protects against infringement through broad and specific claims that cover various aspects of the compound and its manufacturing processes.
What is the significance of the patent's expiration dates?
The patent has multiple related patents with different expiration dates, ranging from 2024 to 2033, ensuring continued protection over an extended period.
How is the scope of the patent measured?
The scope of the patent is best measured by the length and specificity of its claims, which are highly predictive of its protective power.
What are the practical implications of this patent?
The patent offers strong protection against infringement, makes it an attractive candidate for licensing and collaboration agreements, and ensures compliance with regulatory requirements.
Sources
- US9085553B2 - LFA-1 inhibitor and methods of preparation and polymorph thereof - Google Patents
- lfa-1 inhibitor and polymorph thereof - Patent BR-112015001608-A2 - PubChem
- The Ways We've been Measuring Patent Scope are Wrong - Boston University Law
- Lifitegrast: Uses, Interactions, Mechanism of Action | DrugBank Online - DrugBank
- Case 1:20-cv-01426-MN Document 126 Filed 07/07/22 Page 1 of 69 - Insight.RPXCorp
