Analyzing the Scope and Claims of United States Patent 5,998,402
Introduction
United States Patent 5,998,402, titled "Conjugated Estrogens/Bazedoxifene Acetate," is a patent that has significant implications in the pharmaceutical industry, particularly in the realm of women's health. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
The patent in question, U.S. Patent 5,998,402, pertains to a combination of conjugated estrogens and bazedoxifene acetate, which is marketed under the brand name DUAVEE. This combination is used for the treatment of moderate-to-severe vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis[5].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically outline the composition, method of use, and specific ratios of the active ingredients. For instance, Claim 1 might specify the combination of conjugated estrogens and bazedoxifene acetate in a particular dosage form, such as a tablet or capsule.
Dependent Claims
Dependent claims build upon the independent claims, providing more specific details or variations of the invention. These could include different dosages, formulations, or methods of administration. For example, a dependent claim might specify a particular ratio of conjugated estrogens to bazedoxifene acetate or a specific method of manufacturing the combination.
Scope of the Invention
Composition
The patent covers a specific combination of conjugated estrogens and bazedoxifene acetate. Conjugated estrogens are a mixture of estrogens used to treat menopausal symptoms, while bazedoxifene acetate is a selective estrogen receptor modulator (SERM) that helps in preventing osteoporosis without some of the risks associated with traditional hormone therapy[5].
Method of Use
The scope also includes the method of using this combination for treating menopausal symptoms and preventing osteoporosis. This involves administering the specified dosage to patients, typically postmenopausal women.
Patent Landscape
Related Patents
To understand the broader patent landscape, it is crucial to identify related patents and patent families. This can be done using tools like the USPTO's Patent Public Search or the Global Dossier service, which provides access to file histories and related applications from participating IP offices[4].
Technology Field
The patent falls under the "Drugs and Medical" technology field, one of the broad categories used by the USPTO to classify patents. This field is highly competitive, with numerous patents covering various aspects of pharmaceuticals and medical treatments[1].
Continuation Procedures
The patent may have undergone continuation procedures, such as Requests for Continued Examination (RCEs) or continuation-in-part (CIP) applications, which can extend the prosecution process and potentially lead to additional patents. Understanding these procedures is essential for determining the full scope of protection and any potential gaps or opportunities[1].
Claim Coverage Matrix
A Claim Coverage Matrix, as described by patent analytics services, can help in categorizing the patents and claims by scope concepts. This matrix can identify which patents and claims are actively protecting the intellectual property related to DUAVEE and where gaps or opportunities exist. This tool is particularly useful for managing large numbers of patent claims and ensuring comprehensive coverage[3].
Competitive Analysis
Market Position
Analyzing the market position of DUAVEE involves looking at competitors in the menopausal treatment and osteoporosis prevention markets. This includes other hormone therapies and SERMs that may offer similar benefits.
Patent Expiration and Term Extension
The patent term for U.S. Patent 5,998,402 may have been extended under certain conditions, such as delays in FDA approval. For instance, the application for patent term extension was filed under 35 U.S.C. § 156, which allows for the extension of a patent term due to regulatory review[5].
Future Design Opportunities
Using tools like Claim Charts and scope concepts, companies can identify future design opportunities and potential areas for innovation. This involves reviewing the claims and associated scope concepts to determine if there are gaps in current coverage or potential future directions for the technology[3].
Key Takeaways
- Patent Scope: U.S. Patent 5,998,402 covers a specific combination of conjugated estrogens and bazedoxifene acetate for treating menopausal symptoms and preventing osteoporosis.
- Claims Analysis: Independent and dependent claims define the composition, method of use, and specific ratios of the active ingredients.
- Patent Landscape: The patent falls under the "Drugs and Medical" technology field and may have undergone continuation procedures.
- Competitive Analysis: Understanding market competitors and patent expiration dates is crucial for strategic planning.
- Future Opportunities: Using patent analytics tools can help identify gaps and future design opportunities.
FAQs
Q1: What is the primary use of the combination covered by U.S. Patent 5,998,402?
The primary use is for treating moderate-to-severe vasomotor symptoms associated with menopause and preventing postmenopausal osteoporosis.
Q2: How can one determine the full scope of protection for this patent?
Using tools like the USPTO's Patent Public Search and Global Dossier service can help identify related patents and continuation procedures.
Q3: What is the significance of a Claim Coverage Matrix in patent analytics?
A Claim Coverage Matrix helps in categorizing patents and claims by scope concepts, identifying gaps or opportunities in intellectual property protection.
Q4: Can the patent term for U.S. Patent 5,998,402 be extended?
Yes, the patent term can be extended under certain conditions, such as delays in FDA approval, as allowed by 35 U.S.C. § 156.
Q5: How can companies identify future design opportunities related to this patent?
By reviewing the claims and associated scope concepts using tools like Claim Charts, companies can identify gaps in current coverage and potential future directions for the technology.
Sources
- Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent?. Yale Journal of Law and Technology.
- Regulations.gov. (n.d.). Patent Term Extension Application for DUAVEE® (conjugated estrogens/bezadoxifene acetate), Patent No. 5,998,402.
- SLWIP. (n.d.). Patent Analytics | Intellectual Property Law.
- USPTO. (n.d.). Search for patents - USPTO.
- FDA. (2013). Office of Regulatory Policy Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002.
