United States Patent 8,399,520: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,399,520, titled "Selective estrogen receptor modulator," is a significant patent in the field of pharmaceuticals, particularly in the treatment of cancers influenced by estrogen receptors. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Invention
Overview of the Patent
The patent 8,399,520, issued on March 19, 2013, describes selective estrogen receptor modulators (SERMs) and their applications in treating breast cancers and other conditions influenced by estrogen receptors. SERMs are compounds that act on the estrogen receptor to selectively modulate its activity, either by mimicking or blocking the effects of estrogen in various tissues[4].
Inventors and Assignees
The patent is assigned to Eisai R&D Management Co., Ltd., and was filed by inventors associated with this company. The assignment indicates that the intellectual property rights are held by Eisai, a global pharmaceutical company known for its research and development in various therapeutic areas.
Scope of the Patent
Claims
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 includes independent claims that describe the specific compounds and their structures. For example, Claim 1 might describe a particular SERM compound, its chemical structure, and its use in treating breast cancer[4].
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Dependent Claims: Dependent claims further specify the invention by detailing various aspects such as the method of preparation, specific uses, and formulations of the SERM compounds.
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Claim Language and Scope: The claim language is crucial in defining the patent's scope. The use of specific chemical structures and functional descriptions helps in delineating what is covered under the patent and what is not. For instance, the patent might claim a specific SERM compound and its use in treating ER-positive breast cancer, but not other types of cancers or different compounds[4].
Metrics for Patent Scope
Research on patent scope often uses metrics such as independent claim length (ICL) and independent claim count (ICC) to measure the breadth and clarity of patent claims. Narrower claims, as indicated by shorter ICL and lower ICC, are generally associated with higher patent quality and a shorter examination process[3].
Patent Landscape
Related Patents and Applications
The patent landscape around 8,399,520 includes other patents related to SERMs and cancer treatments. For example:
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ORSERDU: This is a drug approved by the FDA for the treatment of postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. The regulatory review period for ORSERDU involved significant testing and approval phases, which are relevant for patent term restoration applications[1][2].
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Other SERM Patents: Patents like US8399520B2 are part of a broader portfolio of SERM-related patents. These patents cover various aspects of SERM compounds, including their synthesis, formulations, and therapeutic uses.
Patent Expiration Dates
Understanding the expiration dates of related patents is crucial for navigating the patent landscape:
- Patent 8,399,520: This patent, issued in 2013, would typically expire 20 years from its filing date, assuming no extensions or adjustments.
- Other Relevant Patents: For instance, patents related to ORSERDU have expiration dates ranging from 2026 to 2038, depending on the specific patent and any extensions granted[5].
Generic Availability
As of the current date, there is no generic version of ORSERDU or other drugs covered by these patents available in the United States. This indicates that the patents remain in force and protect the exclusive rights of the patent holders until their expiration dates[5].
Regulatory and Legal Aspects
FDA Approval and Regulatory Review
The FDA approval process for drugs like ORSERDU involves a rigorous regulatory review period, which includes both a testing phase and an approval phase. The determination of this period is critical for patent term restoration applications, as seen in the case of ORSERDU where the FDA verified the regulatory review period to be 2,965 days[1][2].
Patent Term Restoration
The patent term restoration process is governed by specific regulations that allow for the extension of patent terms to compensate for the time spent in regulatory review. For the patents related to ORSERDU, the applicants have sought various extensions based on the regulatory review period determined by the FDA[1][2].
Industry Impact and Innovation
Innovation Incentives
The quality and scope of patents like 8,399,520 can significantly impact innovation in the pharmaceutical industry. Narrow and clear claims can encourage innovation by providing clear boundaries and reducing litigation costs. Conversely, overly broad or unclear claims can hinder innovation by increasing licensing and litigation complexities[3].
Litigation and Patent Quality
The quality of patent claims is often debated in the context of litigation. High-quality patents with clear and narrow claims tend to have shorter examination processes and are less likely to be involved in lengthy and complex litigation. This is crucial for maintaining an environment that fosters innovation rather than litigation[3].
Key Takeaways
- Scope and Claims: The patent 8,399,520 defines specific SERM compounds and their therapeutic uses, with claims that delineate the invention's scope.
- Patent Landscape: The patent is part of a broader landscape that includes other SERM-related patents and drugs like ORSERDU.
- Regulatory Aspects: FDA approval and regulatory review periods are critical for patent term restoration applications.
- Industry Impact: The quality and scope of patents influence innovation and litigation in the pharmaceutical industry.
FAQs
What is the main subject of United States Patent 8,399,520?
The main subject of this patent is selective estrogen receptor modulators (SERMs) and their use in treating breast cancers and other conditions influenced by estrogen receptors.
Who is the assignee of this patent?
The assignee of this patent is Eisai R&D Management Co., Ltd.
What are the key metrics for measuring patent scope?
Key metrics include independent claim length (ICL) and independent claim count (ICC), which help in assessing the breadth and clarity of patent claims.
Is there a generic version of ORSERDU available?
No, there is currently no therapeutically equivalent generic version of ORSERDU available in the United States.
How does the FDA's regulatory review period impact patent term restoration?
The FDA's determination of the regulatory review period is crucial for calculating the potential extension of a patent term, as it forms the basis for determining the amount of extension an applicant may receive.
Sources
- Federal Register/Vol. 89, No. 179/Monday, September 16, 2024
- Federal Register/Vol. 89, No. 179/Monday, September 16, 2024
- Patent Claims and Patent Scope - Hoover Institution
- US8399520B2 - Selective estrogen receptor modulator - Google Patents
- Generic Orserdu Availability - Drugs.com
