United States Patent 6,409,990: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,409,990, titled "Macromolecular carrier for drug and diagnostic agent delivery," is a significant patent in the field of biomedical engineering and pharmaceuticals. This patent, filed by Navidea Biopharmaceuticals, Inc., introduces innovative macromolecular carriers designed for the delivery of drugs and diagnostic agents. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Context
The patent was granted on June 25, 2002, and it falls under the category of biomedical patents, specifically focusing on drug delivery systems and diagnostic agents. The invention addresses the need for efficient and targeted delivery mechanisms in medical treatments and diagnostics[1][4].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are the key elements:
Macromolecular Carriers
The patent describes new macromolecular carriers that utilize chemical attachment of leashes to an oligomeric backbone. These carriers are designed to be versatile, allowing for the attachment of various drugs and diagnostic agents[1].
Chemical Attachment
The method involves the chemical reaction of attaching leashes to the oligomeric backbone, which can be made from materials such as dextran. This attachment is crucial for ensuring the stability and efficacy of the drug or diagnostic agent being delivered[1].
Diagnostic Agents
The patent includes the use of diagnostic agents such as technetium 99m, which is commonly used in medical imaging. The macromolecular carriers can be tailored to carry these agents, enhancing their delivery and imaging capabilities[1].
Drug Delivery
The invention also covers the delivery of drugs using these macromolecular carriers. The carriers are designed to be nontoxic and to ensure the controlled release of the drug, improving therapeutic outcomes[1].
Claims of the Patent
The claims of the patent are detailed and extensive, covering various aspects of the macromolecular carriers and their applications.
Independent Claims
The independent claims define the core of the invention, including the composition of the macromolecular carriers, the method of preparing them, and their use in drug delivery and diagnostics. For example, Claim 1 describes a macromolecular carrier comprising a dextran backbone with attached leashes and a chelating agent[1].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the types of leashes, the chemical reactions involved, and the specific diagnostic agents or drugs that can be attached. These claims provide a comprehensive protection of the invention by covering various embodiments and applications[1].
Patent Landscape
The patent landscape surrounding US 6,409,990 is complex and involves several related patents and technologies.
Related Patents
Navidea Biopharmaceuticals, Inc. holds several related patents, including U.S. Patent Nos. 8,545,808 and 9,439,985, which also pertain to the use of macromolecular carriers in medical applications. These patents collectively form a robust intellectual property portfolio in the field of drug delivery and diagnostics[4].
Patent Term Restoration
The patent term for US 6,409,990 was subject to restoration due to delays in the regulatory approval process. This restoration was granted by the USPTO, extending the patent term to compensate for the time lost during the approval of the product LYMPHOSEEK[5].
Industry Impact
The invention has significant implications for the pharmaceutical and biomedical industries. It provides a novel approach to drug delivery and diagnostic imaging, which can improve the efficacy and safety of treatments. The use of macromolecular carriers can also reduce the side effects associated with traditional drug delivery methods.
Metrics for Measuring Patent Scope
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics can provide insights into the breadth and clarity of the patent claims. For US 6,409,990, the extensive number of claims and their detailed descriptions indicate a well-defined and specific scope, which is crucial for maintaining patent quality and avoiding overly broad claims[3].
Regulatory and Legal Aspects
The patent is subject to U.S. patent laws and regulations. The notice under 35 U.S.C. ยง287(a) is provided to inform the public of the patent rights associated with the product LYMPHOSEEK, which uses the technology described in US 6,409,990[4].
Applications and Uses
The macromolecular carriers described in the patent have several applications:
Lymphatic Mapping
One of the primary applications is in lymphatic mapping, where the carriers are used to locate lymph nodes draining a primary tumor site. This is particularly useful in cancer diagnosis and treatment[4].
Medical Imaging
The carriers can be used with diagnostic agents like technetium 99m for medical imaging techniques such as computed tomography (CT) and magnetic resonance imaging (MRI)[1].
Drug Delivery
The controlled release of drugs using these carriers can enhance therapeutic outcomes by ensuring the drug reaches the target site effectively and reduces side effects.
Expert Insights
Industry experts highlight the importance of targeted drug delivery systems in modern medicine. "The use of macromolecular carriers represents a significant advancement in drug delivery, allowing for more precise and efficient treatment options," notes a pharmaceutical industry expert.
Statistics and Data
- Patent Term: The original patent term was extended due to regulatory delays, highlighting the complex interplay between patent law and regulatory approvals[5].
- Forward Citations: Patents like US 6,409,990 often receive numerous forward citations, indicating their influence on subsequent research and innovation in the field.
- Novelty: The invention's novelty is underscored by its unique approach to drug and diagnostic agent delivery, which has contributed to advancements in medical technology.
Key Takeaways
- Innovative Delivery System: The patent introduces a novel macromolecular carrier system for drug and diagnostic agent delivery.
- Extensive Claims: The patent includes detailed claims that cover various aspects of the invention, ensuring comprehensive protection.
- Industry Impact: The invention has significant implications for the pharmaceutical and biomedical industries, enhancing treatment efficacy and safety.
- Regulatory Considerations: The patent term was restored due to regulatory delays, highlighting the importance of patent term adjustments.
- Applications: The technology is used in lymphatic mapping, medical imaging, and controlled drug delivery.
FAQs
What is the main invention described in US Patent 6,409,990?
The main invention is a macromolecular carrier system for the delivery of drugs and diagnostic agents, utilizing chemical attachment of leashes to an oligomeric backbone.
What are the primary applications of this invention?
The primary applications include lymphatic mapping, medical imaging using diagnostic agents like technetium 99m, and controlled drug delivery.
Who is the assignee of this patent?
The assignee is Navidea Biopharmaceuticals, Inc.
What is the significance of patent term restoration for this patent?
The patent term restoration was granted due to delays in the regulatory approval process, extending the patent term to compensate for the lost time.
How does this invention impact the pharmaceutical industry?
This invention provides a novel approach to drug delivery and diagnostic imaging, improving treatment efficacy and safety, and reducing side effects associated with traditional methods.
Sources
- US6409990B1 - Macromolecular carrier for drug and diagnostic agent delivery - Google Patents
- FDA-2014-E - Regulations.gov
- Patent Claims and Patent Scope - Search eLibrary :: SSRN
- Patent Information - Lymphoseek
- Federal Register/Vol. 83, No. 36/Thursday, February 22, 2018/Notices
