United States Patent 9,399,775: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,399,775, titled "RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases," is a significant patent in the field of RNA interference (RNAi) therapy. This patent, held by Alnylam Pharmaceuticals, Inc., is crucial for understanding the protection and application of RNAi agents in treating TTR-associated diseases. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent was applied for in 2012 and granted on August 16, 2016. It pertains to RNAi agents, specifically double-stranded RNAi agents, designed to target the transthyretin (TTR) gene. TTR is associated with various diseases, including transthyretin amyloidosis, a condition characterized by the accumulation of abnormal TTR protein in various tissues[2][4].
Scope of the Patent
The scope of the patent encompasses several key aspects:
RNAi Agents
The patent describes RNAi agents that are designed to silence the TTR gene. These agents are typically double-stranded RNA molecules that interfere with the expression of the TTR gene, thereby reducing the production of the TTR protein[2][5].
Compositions
The patent includes compositions that contain these RNAi agents, which can be formulated for various routes of administration, such as intravenous, subcutaneous, or oral delivery. These compositions may also include additional components to enhance stability, delivery, and efficacy[2].
Methods of Use
The methods of use outlined in the patent involve administering the RNAi agents to patients suffering from TTR-associated diseases. The patent details the therapeutic applications, including the treatment of transthyretin amyloidosis and other conditions related to TTR protein accumulation[2][5].
Claims of the Patent
The claims of the patent are critical in defining the scope of protection. Here are some key claims:
Independent Claims
- Claim 1 typically describes the RNAi agents themselves, specifying the sequences and structures that are protected.
- Claim 2 might describe the compositions containing these RNAi agents.
- Claim 3 could outline the methods of using these RNAi agents for treating TTR-associated diseases[4].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as specific sequences, delivery methods, and dosages. These claims help to narrow down the scope and ensure comprehensive protection for the invention[4].
Patent Landscape
Understanding the patent landscape is essential for assessing the competitive environment and potential infringement risks.
Family Patents
The patent US 9,399,775 is part of a larger family of patents related to RNAi agents and their use in treating TTR-associated diseases. Other patents in this family include US 8,106,022 B2, US 8,828,956 B2, and US 10,603,907 B2, which provide additional protection for delivery agents, compositions, and methods of use[4].
International Patents
Alnylam has also filed and been granted patents in other countries, including China. For example, CN 104080794 B and CN 108138182 B provide similar protection in China, although the patent landscape in China is slightly less comprehensive compared to the United States[4].
Competitor Patents
Other companies and research institutions may also hold patents related to RNAi therapy for TTR-associated diseases. Conducting a thorough search using databases like the USPTO's Patent Public Search, European Patent Office's esp@cenet, and the World Intellectual Property Organization's PATENTSCOPE can help identify these patents and assess potential competition[1].
Practical Operation and Analysis
To analyze the patent landscape effectively, one can follow a multi-stage process:
Retrieval of Patents
Use online intelligence platforms such as Patsnap Analytics or Synapse to retrieve relevant patents. This involves drawing or importing the ligand structure of the RNAi agents and conducting substructure searches to identify related patents[4].
Analysis of Core Patents
Analyze the core patents, including their claims, specifications, and legal status. This helps in understanding the main protection themes and the application dates of the patents[4].
Supplementary Retrieval
Conduct supplementary retrieval based on the drug profiles to ensure no key patents are missed. This involves filtering patents, creating folders based on application dates, and reviewing each patent’s claims and specifications[4].
Tools and Resources
Several tools and resources are available to facilitate patent research:
USPTO Resources
The USPTO provides the Patent Public Search tool, the Global Dossier, and the Patent and Trademark Resource Centers (PTRCs) to assist in patent searching and analysis[1].
International Databases
Databases such as the European Patent Office's esp@cenet, the Japan Patent Office's database, and the World Intellectual Property Organization's PATENTSCOPE offer access to international patent collections[1].
Analytical Platforms
Platforms like Patsnap Analytics and Synapse provide advanced tools for patent retrieval, analysis, and visualization, making it easier to navigate the complex patent landscape[4].
Key Takeaways
- RNAi Agents: The patent protects specific RNAi agents targeting the TTR gene.
- Compositions and Methods: It includes compositions and methods for treating TTR-associated diseases.
- Patent Family: The patent is part of a larger family of patents providing comprehensive protection.
- International Protection: Alnylam has secured patents in multiple countries, including the United States and China.
- Competitive Landscape: Conduct thorough searches to identify competitor patents and assess competition.
- Tools and Resources: Utilize USPTO resources, international databases, and analytical platforms for effective patent research.
FAQs
Q: What is the primary focus of United States Patent 9,399,775?
A: The primary focus is on RNAi agents that target the transthyretin (TTR) gene for treating TTR-associated diseases.
Q: How can one conduct a comprehensive patent search related to this patent?
A: Use tools like the USPTO's Patent Public Search, international databases, and analytical platforms to retrieve and analyze relevant patents.
Q: What are some key claims in this patent?
A: Key claims include descriptions of the RNAi agents, compositions containing these agents, and methods of using them for therapeutic purposes.
Q: How does Alnylam protect its RNAi agents internationally?
A: Alnylam has filed and been granted patents in various countries, including the United States and China, to ensure comprehensive international protection.
Q: What tools are available for analyzing the patent landscape?
A: Tools include the USPTO's resources, international patent databases, and analytical platforms like Patsnap Analytics and Synapse.
Sources
- USPTO: Search for patents - USPTO. Retrieved from https://www.uspto.gov/patents/search
- Golden: US Patent 9399775 RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases. Retrieved from https://golden.com/wiki/US_Patent_9399775_RNAi_agents,_compositions_and_methods_of_use_thereof_for_treating_transthyretin_(TTR)_associated_diseases-ANBJZVJ
- USPTO: Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Synapse: siRNA Drug Amvuttra Patent Research and Practical Operation Guide. Retrieved from https://synapse.patsnap.com/blog/sirna-drug-amvuttra-patent-research-and-practical-operation-guide3
- Unified Patents: US-20200318111-A1. Retrieved from https://portal.unifiedpatents.com/patents/patent/US-20200318111-A1
