United States Patent 8,410,274: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,410,274, issued on April 2, 2013, is a significant patent in the pharmaceutical sector, particularly related to the drug Kalydeco (ivacaftor). This patent is held by Vertex Pharmaceuticals Incorporated and pertains to solid state forms of the compound N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, also known as Compound 1.
Patent Overview
Inventors and Assignees
The patent was invented by a team of researchers including Dokou Eleni, Jamzad Shahla, Caesar Jr. John P., Fawaz Majed, Das Laura, Gu Chong-Hui, Hurter Patricia Nell, Israni Meghna Jai, Johnston Meghan M., Knezic Dragutin, Kuzmission Andrew G., and Wang HongRen. The assignee of the patent is Vertex Pharmaceuticals Incorporated[2][5].
Claims and Scope
Independent Claims
The patent includes multiple independent claims that define the scope of the invention. These claims are crucial as they outline the specific aspects of the invention that are protected by the patent. The independent claims typically cover the solid state forms of Compound 1, pharmaceutical compositions thereof, and methods for their preparation and use[5].
Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. For instance, narrower claims with fewer words and fewer independent claims are often associated with a higher probability of grant and a shorter examination process[3].
Solid State Forms of Compound 1
Pharmaceutical Compositions
The patent focuses on various solid state forms of Compound 1, which is a key component of Kalydeco. These forms include amorphous, crystalline, and other polymorphic forms of the compound. The pharmaceutical compositions described in the patent are designed to enhance the stability, bioavailability, and efficacy of the drug[2][5].
Methods of Preparation
The patent also details methods for preparing these solid state forms. These methods are critical for ensuring the consistency and quality of the pharmaceutical product. The preparation methods may involve specific conditions such as temperature, solvent systems, and crystallization techniques[5].
Patent Landscape
Related Patents
The patent landscape surrounding US 8,410,274 includes several related patents that extend the protection of Compound 1 and its pharmaceutical compositions. For example, Patent 10,272,046, issued on April 30, 2019, also covers solid state forms of Compound 1 and has a patent expiration date of December 28, 2026[2].
Continuation Patents
The patent is part of a series of continuation patents, indicating a strategic approach to extending the patent life and protecting various aspects of the invention. The continuation patents (e.g., US 9,670,163, US 9,139,530) reflect the ongoing development and refinement of the compound and its applications[1][4].
Examination Process and Patent Quality
Narrowing of Claims
The examination process for this patent, as with many others, likely involved the narrowing of claims to ensure clarity and specificity. Research indicates that the examination process tends to narrow the scope of patent claims, which can affect the patent's breadth and validity[3].
Patent Quality Concerns
Debates over patent quality often highlight issues such as claim breadth, clarity, and validity. The patent office's evaluation process is designed to address these concerns, ensuring that granted patents are both innovative and clearly defined[3].
Impact on Innovation and Litigation
Innovation Incentives
The patent's scope and claims can influence innovation incentives. Patents with clear and specific claims can encourage further innovation by providing a clear boundary of what is protected, thereby reducing licensing and litigation costs[3].
Litigation Considerations
The clarity and specificity of the claims in US 8,410,274 are crucial for litigation purposes. Broad or unclear claims can lead to more complex and lengthy litigation, which can deter innovation[3].
Patent Expiration and Generic Availability
Patent Expiration Date
The patent is set to expire, and its expiration date is significant for the potential entry of generic versions of Kalydeco into the market. As of the current date, there is no therapeutically equivalent generic version of Kalydeco available in the United States[2].
Generic Availability
The absence of generic versions is directly tied to the patent protection. Once the patent expires, generic manufacturers can seek approval to produce and market their own versions of the drug, potentially increasing competition and reducing costs for consumers[2].
Key Takeaways
- Patent Scope and Claims: The patent covers specific solid state forms of Compound 1, pharmaceutical compositions, and methods for their preparation.
- Related Patents: The patent is part of a series of related patents extending the protection of Compound 1.
- Examination Process: The patent underwent a narrowing of claims during the examination process to ensure clarity and specificity.
- Impact on Innovation: Clear and specific claims can encourage further innovation by reducing licensing and litigation costs.
- Patent Expiration: The patent's expiration date is crucial for the potential entry of generic versions into the market.
Frequently Asked Questions (FAQs)
What is the main subject of United States Patent 8,410,274?
The main subject of this patent is the solid state forms of the compound N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, also known as Compound 1, which is a key component of the drug Kalydeco.
Who are the inventors and assignees of this patent?
The inventors include Dokou Eleni, Jamzad Shahla, Caesar Jr. John P., and others, with Vertex Pharmaceuticals Incorporated as the assignee.
What is the significance of the patent's expiration date?
The patent's expiration date is significant because it marks the time when generic versions of Kalydeco can potentially enter the market, increasing competition and reducing costs for consumers.
How does the patent's scope affect innovation and litigation?
The patent's scope, defined by its claims, can influence innovation by providing clear boundaries of what is protected, thus reducing licensing and litigation costs. Clear and specific claims can encourage further innovation.
Are there any related patents extending the protection of Compound 1?
Yes, there are several related patents, such as Patent 10,272,046, which also cover solid state forms of Compound 1 and extend the protection until December 28, 2026.
Cited Sources:
- United States Patent and Trademark Office - US11291662.pdf
- Drugs.com - Generic Kalydeco Availability
- Hoover Institution - Patent Claims and Patent Scope
- United States Patent and Trademark Office - US10537565.pdf
- Unified Patents - US-8410274-B2 - Solid Forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
