United States Patent 10,612,027: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,612,027, issued on April 7, 2020, is a significant patent in the field of RNA interference (RNAi) technology. This patent, assigned to Alnylam Pharmaceuticals, Inc., pertains to modified double-stranded RNA (dsRNA) agents designed to inhibit the expression of a target gene. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of RNA Interference (RNAi)
RNA interference is a natural process by which cells regulate gene expression. It involves the use of small RNA molecules to silence specific genes by degrading their mRNA transcripts. This technology has been harnessed to develop therapeutic agents that can target and reduce the expression of disease-causing genes[2].
Scope of the Patent
The patent 10,612,027 focuses on the development of modified dsRNA agents. These agents are engineered to enhance stability, efficacy, and specificity in targeting and silencing specific genes. The scope includes:
Modified dsRNA Agents
The patent describes dsRNA agents with modifications at specific nucleotide positions to improve their pharmacokinetic and pharmacodynamic properties. These modifications can include chemical alterations such as methylation, phosphorothioation, and the use of nucleotide analogs[1][4].
Target Gene Expression
The primary goal of these dsRNA agents is to inhibit the expression of a target gene. In the context of this patent, the target gene is often associated with diseases, such as Primary Hyperoxaluria Type 1 (PH1), which is caused by the overexpression of the Hydroxyacid Oxidase 1 (HAO1) gene[2].
Claims of the Patent
The claims of the patent are crucial as they define the legal boundaries of the invention. Here are some key claims:
Composition Claims
The patent claims compositions comprising dsRNA agents with specific modifications. These claims include the structure and sequence of the dsRNA molecules, as well as the types of modifications used to enhance their stability and efficacy[1].
Method Claims
The patent also claims methods for using these dsRNA agents to inhibit the expression of a target gene. This includes methods for administering the dsRNA agents, dosing regimens, and treatment protocols for various diseases[1].
Therapeutic Claims
Specific claims are made for the use of these dsRNA agents in treating diseases such as PH1 by inhibiting the expression of the HAO1 gene. These claims are supported by experimental data demonstrating the efficacy and safety of the dsRNA agents in preclinical and clinical settings[2].
Patent Landscape
Understanding the patent landscape is essential for navigating the intellectual property rights associated with RNAi technology.
Related Patents
Several other patents are related to this technology, including patents issued to Alnylam Pharmaceuticals, Inc., and Dicerna Pharmaceuticals, Inc. These patents cover various aspects of RNAi agents, including different types of modifications, delivery methods, and therapeutic applications[2].
Patent Expiration Dates
The patent 10,612,027 is set to expire on December 26, 2034, which is 20 years from the date of filing. This expiration date is crucial for understanding the timeline for generic versions of the therapeutic agents developed under this patent[2].
Competitive Landscape
The competitive landscape in RNAi technology is highly active, with multiple companies developing similar therapeutic agents. Alnylam Pharmaceuticals, Inc., and Dicerna Pharmaceuticals, Inc., are among the key players in this field, each with their own portfolio of patents and products[2].
Delivery and Formulation
The patent also addresses the delivery and formulation of these dsRNA agents. This includes the use of carbohydrate conjugates as delivery agents, which enhance the stability and cellular uptake of the dsRNA molecules[2].
Clinical Applications
The clinical applications of these dsRNA agents are a significant focus of the patent. For example, the inhibition of the HAO1 gene is critical for treating PH1, a rare genetic disorder characterized by excessive oxalate production[2].
Regulatory Considerations
The regulatory environment for RNAi therapeutics is stringent. The FDA grants exclusivity periods that can run concurrently with patent protection, ensuring that the innovator company has exclusive marketing rights for a specified period[2].
Intellectual Property Strategy
To manage their intellectual property effectively, companies like Alnylam Pharmaceuticals, Inc., use advanced patent analytics tools. These tools help in tracking patents by claims and scope concepts, identifying gaps in coverage, and highlighting future design opportunities[3].
Future Directions
The future of RNAi technology looks promising, with ongoing research aimed at improving the efficacy, specificity, and delivery of dsRNA agents. New patents and innovations in this field are expected to expand the therapeutic applications of RNAi technology.
Key Takeaways
- Modified dsRNA Agents: The patent focuses on dsRNA agents with specific modifications to enhance stability and efficacy.
- Target Gene Expression: The primary goal is to inhibit the expression of target genes associated with diseases like PH1.
- Claims: The patent includes composition, method, and therapeutic claims.
- Patent Landscape: The patent is part of a broader landscape of RNAi technology patents with various expiration dates.
- Clinical Applications: The dsRNA agents have significant clinical applications, particularly in treating genetic disorders.
- Regulatory Considerations: The patent is subject to regulatory exclusivity periods and stringent FDA approval processes.
FAQs
What is the primary focus of United States Patent 10,612,027?
The primary focus is on modified double-stranded RNA (dsRNA) agents designed to inhibit the expression of a target gene.
Which company is assigned this patent?
The patent is assigned to Alnylam Pharmaceuticals, Inc.
What is the target gene in the context of this patent?
The target gene is often the Hydroxyacid Oxidase 1 (HAO1) gene, associated with Primary Hyperoxaluria Type 1 (PH1).
When is the patent set to expire?
The patent is set to expire on December 26, 2034.
How are the dsRNA agents delivered?
The dsRNA agents can be delivered using carbohydrate conjugates, which enhance their stability and cellular uptake.
Cited Sources:
- US10612027B2 - Modified double-stranded RNA agents - Google Patents
- Generic Oxlumo Availability - Drugs.com
- Patent Analytics | Intellectual Property Law - SLWIP
- US10612024B2 - Modified double-stranded RNA agents - Google Patents
