United States Patent 8,759,372: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 8,759,372, titled "N-(5S,6S,9R)-AMINO-6-(2,3-DIFLUOROPHENYL)-6,7,8,9-TETRAHYDRO 5H-CYCLOHEPTABIPYRIDIN-9-YL 4-(2-OXO-2,3-DIHYDRO-1H-IMIDAZO[4,5-B]PYRIDIN-1-CARBOXYLATE SALT," is a significant patent in the pharmaceutical sector, particularly for the treatment of migraine and other headaches. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Inventors
This patent was granted to Bristol-Myers Squibb Company on June 24, 2014. The inventors listed are Daniel Richard Roberts, Robbinsville, NJ; Richard Raymond Schartman, Wallingford, CT; and Chenkou Wei, Princeton Junction, NJ[4].
Patent Scope
Claims Overview
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
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Independent Claims: The patent has several independent claims that outline the specific compounds, their salts, and their uses. For example, Claim 1 describes the hemisulfate salt of a specific compound useful in treating, preventing, or ameliorating disorders including migraine and other headaches[4].
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Dependent Claims: These claims further specify the invention by detailing various aspects such as the method of preparation, dosage forms, and specific therapeutic uses.
Claim Language and Scope
The claims are written to ensure broad protection while maintaining clarity. The independent claim length and count are metrics often used to measure patent scope. In this case, the claims are detailed enough to cover the specific chemical structure and its therapeutic applications but narrow enough to avoid overly broad interpretations that could lead to invalidation[3].
Chemical Structure and Composition
The patent describes a specific chemical compound, N-(5S,6S,9R)-AMINO-6-(2,3-DIFLUOROPHENYL)-6,7,8,9-TETRAHYDRO 5H-CYCLOHEPTABIPYRIDIN-9-YL 4-(2-OXO-2,3-DIHYDRO-1H-IMIDAZO[4,5-B]PYRIDIN-1-CARBOXYLATE SALT, and its hemisulfate salt. This compound is particularly useful for its efficacy in treating migraines and other headaches[4].
Therapeutic Uses
Migraine Treatment
The primary therapeutic use of the compound is in the acute treatment of migraine with or without aura in adults. The patent highlights the compound's ability to prevent or ameliorate migraine symptoms, making it a valuable addition to the treatment options available for this condition[4].
Other Headaches
In addition to migraines, the compound is also indicated for the treatment of other types of headaches. This broadens its therapeutic scope and makes it a versatile treatment option for various headache disorders.
Patent Landscape
Assignee and Licensees
The patent is assigned to Bristol-Myers Squibb Company, a major pharmaceutical company. This assignment indicates that the company has the rights to manufacture, use, and distribute the compound and its salts as described in the patent[4].
Related Patents and Publications
The patent references several prior publications and patents, including those related to similar compounds and their therapeutic uses. For example, it cites patents such as US 8,044,043 B2 and US 8,143,403 B2, which are related to other headache treatments[4].
Litigation and Enforcement
Patents in the pharmaceutical sector are often subject to litigation, especially when generic versions are developed. The enforcement of this patent would involve ensuring that any generic or similar compounds do not infringe on the claims outlined in the patent. This is crucial for maintaining the exclusivity and profitability of the patented compound[2].
Examination Process and Patent Quality
The examination process for this patent would have involved a thorough review of the claims to ensure they are clear, specific, and not overly broad. The metrics used to measure patent scope, such as independent claim length and count, would have been considered to ensure the patent's validity and enforceability[3].
Impact on Innovation
The granting of this patent can have a dual impact on innovation. On one hand, it provides exclusive rights to the inventors and assignees, which can incentivize further research and development. On the other hand, it can limit competition and innovation from other companies that might be working on similar compounds, potentially stifling broader innovation in the field[3].
Conclusion
The United States Patent 8,759,372 is a significant patent in the pharmaceutical sector, particularly for the treatment of migraines and other headaches. Its scope and claims are carefully defined to ensure broad protection while maintaining clarity. The patent landscape surrounding this invention is complex, involving various related patents and the potential for litigation. Understanding the scope and claims of this patent is crucial for both the assignees and competitors in the field.
Key Takeaways
- Specific Compound: The patent describes a specific chemical compound and its hemisulfate salt.
- Therapeutic Uses: Primarily used for treating migraines and other headaches.
- Assignee: Assigned to Bristol-Myers Squibb Company.
- Patent Scope: Claims are detailed and specific to avoid overly broad interpretations.
- Litigation: Potential for litigation to enforce exclusivity.
- Impact on Innovation: Can incentivize further research but may limit competition.
FAQs
What is the primary therapeutic use of the compound described in the patent?
The primary therapeutic use is in the acute treatment of migraine with or without aura in adults.
Who is the assignee of the patent?
The patent is assigned to Bristol-Myers Squibb Company.
What metrics are used to measure patent scope?
Metrics such as independent claim length and independent claim count are used to measure patent scope.
How does the patent impact innovation in the pharmaceutical sector?
It can incentivize further research and development but may also limit competition and innovation from other companies.
What are the potential legal implications of this patent?
The patent could be subject to litigation to enforce its exclusivity and prevent infringement by generic or similar compounds.
Cited Sources
- United States Patent and Trademark Office. US011083724B2: RIMEGEPANT FOR CGRP RELATED DISORDERS. August 10, 2021.
- United States District Court. In the United States District Court. May 23, 2024.
- Hoover Institution. Patent Claims and Patent Scope. August 18, 2024.
- United States Patent and Trademark Office. US8759372B2: N-(5S,6S,9R)-AMINO-6-(2,3-DIFLUOROPHENYL)-6,7,8,9-TETRAHYDRO 5H-CYCLOHEPTABIPYRIDIN-9-YL 4-(2-OXO-2,3-DIHYDRO-1H-IMIDAZO[4,5-B]PYRIDIN-1-CARBOXYLATE SALT. June 24, 2014.
