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Last Updated: December 23, 2024

Details for Patent: 11,401,517


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Summary for Patent: 11,401,517
Title:Modified double-stranded RNA agents
Abstract: One aspect of the present invention relates to double-stranded RNA (dsRNA) agent capable of inhibiting the expression of a target gene. The sense strand of the dsRNA agent comprises at least one thermally destabilizing nucleotide, and at least one said thermally destabilizing nucleotide occurring at a site opposite to the seed region (positions 2-8) of the antisense strand; and the antisense strand of the dsRNA agent comprises at least two modified nucleotides that provide the nucleotide a steric bulk that is less than or equal to the steric bulk of a 2'-OMe modification, wherein said modified nucleotides are separated by 11 nucleotides in length. Other aspects of the invention relates to pharmaceutical compositions comprising these dsRNA agents suitable for therapeutic use, and methods of inhibiting the expression of a target gene by administering these dsRNA agents, e.g., for the treatment of various disease conditions.
Inventor(s): Maier; Martin (Cambridge, MA), Foster; Don (Cambridge, MA), Milstein; Stuart (Cambridge, MA), Kuchimanchi; Satya (Cambridge, MA), Jadhav; Vasant (Cambridge, MA), Rajeev; Kallanthottathil (Cambridge, MA), Manoharan; Muthiah (Cambridge, MA), Parmar; Rubina (Cambridge, MA)
Assignee: ALNYLAM PHARMACEUTICALS, INC. (Cambridge, MA)
Application Number:16/693,683
Patent Claim Types:
see list of patent claims
Use; Composition; Compound; Delivery;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 11,401,517

Introduction

United States Patent 11,401,517, titled "Modified double-stranded RNA agents," is a significant patent in the field of molecular biology and genetic engineering. This patent deals with the development and application of double-stranded RNA (dsRNA) agents designed to inhibit the expression of target genes. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.

Background and Context

The patent in question is part of a larger body of research and innovation in RNA interference (RNAi) technology. RNAi is a natural process by which cells regulate gene expression, and it has been harnessed for therapeutic and research purposes. The development of modified dsRNA agents is crucial for enhancing the efficacy and stability of RNAi-based treatments.

Patent Scope

The scope of US Patent 11,401,517 is defined by its claims, which outline the specific inventions and innovations covered by the patent.

Independent Claims

The patent includes independent claims that define the core inventions. These claims typically describe the composition and structure of the modified dsRNA agents, including the nucleotide sequences and any chemical modifications that enhance their stability and effectiveness[1].

Dependent Claims

Dependent claims build upon the independent claims, providing additional details and variations of the invention. These claims may include specific applications, methods of use, or additional modifications to the dsRNA agents.

Claim Analysis

To understand the patent's scope, it is essential to analyze the claim language.

Claim Length and Count

Research has shown that the length and count of independent claims can be indicative of the patent's scope and quality. Narrower claims with fewer dependencies often result in a higher probability of grant and a shorter examination process[3].

Strategic Claim Management

Effective claim management is crucial for maximizing the value of the patent. This involves ensuring that the patent utilizes its full entitlement of claims, typically up to 20 claims in the United States, including both independent and dependent claims. This strategy enhances the patent's breadth and flexibility without incurring additional costs[5].

Patent Claims and Infringement Risks

The claims of US Patent 11,401,517 must be carefully analyzed to assess infringement risks. This involves mapping the patent portfolio and understanding how the claims interact with other patents in the field.

Freedom to Operate (FTO) Analysis

Tools like ClearstoneIP's FTO analysis can streamline the process of assessing infringement risks and ensuring freedom to operate. These tools use AI to analyze patent claims, design-around strategies, and specification extraction, helping to reduce time-to-market and infringement risks[4].

Patent Landscape

The patent landscape surrounding US Patent 11,401,517 is complex and dynamic.

Related Patents and Litigation

Other patents in the field, such as those related to RNAi technology, may intersect with the claims of this patent. For instance, disputes over patent validity and infringement, as seen in cases like Allergan USA, Inc. v. MSN Laboratories Private Ltd., highlight the importance of careful claim drafting and management to avoid legal challenges[2].

Industry Trends and Innovations

The field of RNAi technology is rapidly evolving, with continuous innovations in dsRNA agents and their applications. Staying abreast of these trends is crucial for maintaining the relevance and value of the patent.

Commercial and Licensing Implications

The strategic management of claims in US Patent 11,401,517 can significantly impact its commercial value.

Licensing and Collaboration

A robust and nuanced set of claims can enhance the patent's value in licensing discussions and potential collaborations. This is because each claim can be viewed as a unique tool for protecting different facets of the invention[5].

Defensive Capabilities

The breadth and flexibility of the patent's claims also enhance its defensive capabilities against potential infringers. This is particularly important in a competitive field like RNAi technology.

Key Takeaways

  • Claim Management: Effective claim management is crucial for maximizing the value and scope of the patent.
  • Infringement Risks: Careful analysis of claims is necessary to assess and mitigate infringement risks.
  • Patent Landscape: Understanding the broader patent landscape, including related patents and industry trends, is essential for maintaining the patent's relevance and value.
  • Commercial Implications: A well-managed set of claims can significantly enhance the patent's commercial value and defensive capabilities.

Frequently Asked Questions (FAQs)

Q: What is the primary focus of US Patent 11,401,517? A: The primary focus is on modified double-stranded RNA (dsRNA) agents designed to inhibit the expression of target genes.

Q: How important is claim management in patent filings? A: Claim management is crucial as it can streamline the patent prosecution process, enhance the patent's effectiveness, and maximize its value.

Q: What tools can be used to assess infringement risks related to patent claims? A: Tools like ClearstoneIP's FTO analysis, which utilize AI, can streamline the process of assessing infringement risks and ensuring freedom to operate.

Q: How does the patent landscape impact the value of US Patent 11,401,517? A: The patent landscape, including related patents and industry trends, can significantly impact the patent's value and relevance. Careful management and continuous monitoring are essential.

Q: What are the commercial implications of a well-managed set of claims in a patent? A: A well-managed set of claims can enhance the patent's value in licensing discussions, collaborations, and defensive capabilities against potential infringers.

Cited Sources:

  1. US11401517B2 - Modified double-stranded RNA agents - Google Patents
  2. ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD. - CAFC
  3. Patent Claims and Patent Scope - SSRN
  4. ClearstoneIP: Patent Risk Management & Analysis Solutions - ClearstoneIP
  5. Maximizing Patent Value: A Strategic Approach to Claim Management - Harrity LLP

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Drugs Protected by US Patent 11,401,517

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Alnylam Pharms Inc AMVUTTRA vutrisiran sodium SOLUTION;SUBCUTANEOUS 215515-001 Jun 13, 2022 RX Yes Yes 11,401,517 ⤷  Subscribe Y Y AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS ⤷  Subscribe
Alnylam Pharms Inc OXLUMO lumasiran sodium SOLUTION;SUBCUTANEOUS 214103-001 Nov 23, 2020 RX Yes Yes 11,401,517 ⤷  Subscribe Y Y TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1) ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,401,517

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2958758 ⤷  Subscribe
China 107075516 ⤷  Subscribe
China 114181942 ⤷  Subscribe
Eurasian Patent Organization 201790420 ⤷  Subscribe
European Patent Office 3186377 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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