United States Patent 10,806,791: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 10,806,791, titled "CARBOHYDRATE CONJUGATES AS DELIVERY AGENTS FOR OLIGONUCLEOTIDES," is a significant patent in the field of pharmaceuticals, particularly in the delivery of oligonucleotides. This patent, assigned to Alnylam Pharmaceuticals, Inc., involves innovative methods and compositions for delivering therapeutic oligonucleotides. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Context
The patent is part of a series of continuations and provisional applications dating back to 2007, indicating a long-standing research and development effort in this area[1].
Scope of the Patent
Overview
The patent focuses on carbohydrate conjugates designed to enhance the delivery of oligonucleotides, which are crucial for various therapeutic applications, including RNA interference (RNAi) therapies. These conjugates are engineered to improve the stability, targeting, and cellular uptake of oligonucleotides.
Key Components
- Phosphorothioate-Modified Oligonucleotides: The patent describes specific structures of phosphorothioate-modified oligonucleotides, which are chemically modified to enhance stability and efficacy[1].
- Carbohydrate Conjugates: The invention involves conjugating oligonucleotides with carbohydrates, such as galactosides, to target specific receptors like the asialoglycoprotein receptor (ASGPR) in the liver. This targeting mechanism is crucial for delivering therapeutic oligonucleotides to the liver cells[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover:
- Composition of Matter: Specific chemical structures of the phosphorothioate-modified oligonucleotides and their carbohydrate conjugates[1].
- Methods of Preparation: Processes for synthesizing these conjugates, including the steps involved in modifying the oligonucleotides and attaching the carbohydrate moieties[1].
- Methods of Use: Therapeutic applications of these conjugates, including their use in treating various diseases by delivering oligonucleotides to specific cells or tissues[1].
Dependent Claims
Dependent claims further specify the independent claims by detailing:
- Specific Carbohydrate Structures: Particular types of carbohydrates and their linkages to the oligonucleotides[1].
- Dosage Forms: Different formulations and delivery methods for the conjugates, such as injectable solutions or oral formulations[1].
Patent Landscape
Related Patents and Applications
The patent is part of a larger family of patents and applications filed by Alnylam Pharmaceuticals, Inc. These include earlier patents and provisional applications that have been continued and expanded upon over the years. For example, the patent is a continuation of application No. 15/817,473, which itself was a continuation of earlier applications[1].
Government Funding and Public-Sector Patents
The patent landscape also involves government funding and public-sector patents. While this specific patent does not have a government-interest statement, many pharmaceutical patents, especially those involving significant research and development, may have received government funding. This is evident from studies on the Bayh-Dole Act, which mandates the inclusion of government-interest statements in patents funded by federal grants[2].
Metrics for Patent Scope
Independent Claim Length and Count
Research on patent scope suggests that metrics such as independent claim length and count can be used to measure the breadth and clarity of patent claims. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Industry Impact and Applications
Therapeutic Applications
The invention has significant implications for the delivery of RNAi therapies, which are used to treat a variety of diseases by silencing specific genes. For instance, inclisiran, a long-acting siRNA, uses similar delivery mechanisms to lower LDL-cholesterol levels[4].
Market and Competitive Landscape
The patent landscape in this area is highly competitive, with multiple companies and research institutions working on similar technologies. The ability to deliver oligonucleotides effectively is a critical factor in the development of RNAi therapies, making this patent a valuable asset in the pharmaceutical industry.
Challenges and Controversies
Patent Quality and Scope
Debates over patent quality and scope are relevant here. The patent system faces criticism for granting overly broad patents, which can stifle innovation. However, the detailed and specific claims in this patent suggest a well-defined scope that avoids such issues[3].
Regulatory and Legal Aspects
The use of government march-in rights to lower drug prices is another aspect of the patent landscape. While this patent does not directly involve such rights, the broader context of pharmaceutical patents and their impact on drug pricing is a significant regulatory and legal issue[2].
Key Takeaways
- Innovative Delivery Mechanism: The patent introduces a novel method for delivering oligonucleotides using carbohydrate conjugates.
- Therapeutic Applications: The invention has significant potential for treating various diseases through RNAi therapies.
- Detailed Claims: The patent includes specific and detailed claims that define the scope of the invention.
- Competitive Landscape: The patent is part of a highly competitive field with multiple stakeholders involved in similar research.
- Regulatory Considerations: The broader patent landscape involves regulatory and legal issues related to government funding and drug pricing.
FAQs
What is the main focus of United States Patent 10,806,791?
The main focus of this patent is on carbohydrate conjugates designed to enhance the delivery of oligonucleotides for therapeutic applications.
How do the carbohydrate conjugates work?
These conjugates target specific receptors, such as the asialoglycoprotein receptor (ASGPR) in the liver, to deliver oligonucleotides to liver cells.
What are the therapeutic applications of this invention?
The invention is primarily used for RNA interference (RNAi) therapies to treat various diseases by silencing specific genes.
Is this patent part of a larger family of patents?
Yes, this patent is a continuation of several earlier applications and patents filed by Alnylam Pharmaceuticals, Inc.
How does the patent landscape relate to government funding?
While this specific patent does not have a government-interest statement, many pharmaceutical patents involve government funding, which is mandated to be disclosed under the Bayh-Dole Act.
What metrics are used to measure the scope of patent claims?
Metrics such as independent claim length and count are used to measure the breadth and clarity of patent claims.
Sources
- United States Patent and Trademark Office. (2020). CARBOHYDRATE CONJUGATES AS DELIVERY AGENTS FOR OLIGONUCLEOTIDES. US Patent 10,806,791 B2.
- National Bureau of Economic Research. (n.d.). The Feasibility of Using Bayh-Dole March-In Rights to Lower Drug Prices. Working Paper No. 32217.
- Social Science Research Network. (2016). Patent Claims and Patent Scope. SSRN Electronic Journal.
- DrugBank. (n.d.). Inclisiran: Uses, Interactions, Mechanism of Action. Retrieved from https://go.drugbank.com/drugs/DB14901.
