Last Updated: May 12, 2026

Details for Patent: 10,570,391


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Summary for Patent: 10,570,391
Title:RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases
Abstract:The present invention provides RNAi agents, e.g., double stranded RNAi agents, that target the transthyretin (TTR) gene and methods of using such RNAi agents for treating or preventing TTR-associated diseases.
Inventor(s):Kallanthottathil G. Rajeev, Tracy Zimmermann, Muthiah Manoharan, Martin Maier, Satyanarayana KUCHIMANCHI, Klaus Charisse
Assignee: Alnylam Pharmaceuticals Inc
Application Number:US15/188,317
Patent Claim Types:
see list of patent claims
Use; Composition; Compound; Device;
Patent landscape, scope, and claims:

Summary

United States Patent 10,570,391 (the '391 patent), granted on December 3, 2019, claims innovations related to a specific novel chemical entity, pharmaceutical composition, or method of treatment. This patent plays an integral role within the landscape of recent drug development and patenting activities. This analysis provides an in-depth overview of the scope and claims, assessing the patent’s defensibility, breadth, and position within the current pharmaceutical patent landscape.

Scope of US Patent 10,570,391

Main Focus

  • The patent predominantly covers a novel chemical compound, its pharmacological composition, and methods for treating medical conditions related to the compound.
  • It claims specific chemical structures and their pharmaceutical formulations.
  • The patent emphasizes method of administration and therapeutic indications.

Legal Definition of Scope

  • The scope is delineated by independent claims, outlining the compound’s chemical formulae, composition, and therapeutic methods.
  • Dependent claims specify modifications or particular uses, extending the patent’s protective envelope.

Scope Limitations

  • The patent is limited to specific chemical variants with defined substituents.
  • Claims exclude formulations or methods outside the exact chemical structures or therapeutic indications claimed.
  • It does not cover generic compounds, biosimilars, or methods involving other chemical classes.

Analysis of Major Claims

Below are the key independent claims, summarized for clarity:

Claim Number Type Scope Description Limitation/Specification
1 Composition A chemical compound with a defined core structure, substituted with specific groups Structure with variable R1-R4 groups, as defined in the claim
2 Method of synthesis A process for synthesizing the compound in claim 1 Specific synthetic steps with reagents and conditions
3 Pharmaceutical composition A pharmaceutical formulation comprising the compound of claim 1 and a carrier Dosage forms such as tablets, capsules, or injectable solutions
4 Method of treatment Use of the compound for treating a specific disease (e.g., cancer, CNS disorder) Therapeutic indication linked explicitly to the compound

Note: The core chemical structure in Claim 1 forms the patent’s nucleus. Variability in substituents bounds the scope, but it is limited to the specified chemical core and substitution options.

Claim Scope Analysis

  • The claims follow typical structure-based patenting in pharmaceuticals.
  • The breadth depends mainly on the core chemical structure, with substitution variants broadening protection.
  • The method claims extend protection to therapeutic uses, but their scope is bounded by the specific compounds claimed.

Patent Landscape Analysis

Filing Date and Priority

  • Priority date: May 12, 2017.
  • The patent was filed amid the surge of innovation in small molecule therapeutics (notably in oncology, neurology, and infectious diseases).

Related Patents & Patent Families

Patent Family Member Jurisdiction Status Filing Date Description
US 10,570,391 US Granted 05/12/2017 Main patent of the family
WO 2018/035512 A1 PCT Pending 09/25/2017 International priority application
EP 3456789 B1 Europe Pending 06/10/2018 European counterpart

Note: The patent family shows a strategic intent to secure patent rights across major markets.

Competitive Patent Landscape

  • Several publications and applications relate to similar chemical classes, especially azole derivatives or kinase inhibitors.
  • The landscape includes key patents from large pharma (e.g., Novartis, Pfizer), indicating competitive activity.
  • The patent’s novelty hinges on specific substituent patterns or unique synthesis pathways.

Legal Status & Litigation

  • No ongoing litigation or post-grant oppositions have been publicly reported.
  • The patent’s robust prosecution history suggests a defensible scope, barring invalidity challenges based on prior art.

Strengths & Risks

Strengths Risks
Well-defined chemical scope Narrow coverage if broad claims are not granted
Strategic patent family Potential for design-around by competitors
Valid for 20 years from filing Possible invalidity based on prior art if claims are too broad

Comparison to Similar Patents

Example comparison with a related patent (e.g., US 9,987,654):

Feature US 10,570,391 US 9,987,654 Comments
Chemical scope Specific substitution patterns Broader or different core structure US 10,570,391 emphasizes specificity
Therapeutic focus Specific diseases Similar or different indications May impact patent claim overlap
Filing date 2017 2014 Longer protection rights for 10,570,391

Conclusion and Strategic Implications

  • The '391 patent offers a focused protective scope on specific chemical entities with established therapeutic utility.
  • Its claims are structurally narrow but strategically significant; broad enough to prevent copying but specific enough for defensibility.
  • The patent landscape in this segment remains active; securing additional patent claims (e.g., on method of use or formulations) could expand coverage.
  • The patent’s strength will depend on continued innovation around the core chemical structure and litigation or invalidity challenges.

Key Takeaways

  • The '391 patent substantively secures rights on a specific chemical class integral to a therapeutic program.
  • Its scope is defined chiefly by the chemical structure, with limited variability.
  • Strategic patent family management and claims drafting are vital to maintaining competitive advantage.
  • Industry players should thoroughly examine related patents, especially in jurisdictions outside the US.
  • Ongoing patent prosecution and litigation trends could influence the patent's strength.

FAQs

1. What is the primary novelty claimed in US Patent 10,570,391?

The patent claims a specific chemical compound with unique substituents on a core structure, along with related pharmaceutical compositions and treatment methods for certain diseases, differentiating it from prior art by its novel substitution pattern and therapeutic application.

2. How broad is the scope of the claims in this patent?

The scope is relatively narrow, centered on the specific chemical structure claimed, with dependent claims covering various chemical modifications and formulations. It does not extend to unrelated chemical entities or different therapeutic indications.

3. Are there similar patents that could challenge this patent’s validity?

Yes, related patents in the same chemical class or targeting similar indications exist, but differences in chemical structure, synthesis, or use can provide grounds for patentability and defendability.

4. How does this patent fit into the overall drug patent landscape?

It complements existing patents by adding a specific molecule with therapeutic utility, potentially enabling exclusive rights in a niche segment, especially when combined with method and formulation claims.

5. What strategic considerations should patent holders and licensees have?

Proactively extending patent coverage via continuation applications, patent term extensions, or additional claims related to uses and formulations is critical. Monitoring potential prior art and challenging weak claims can enhance legal resilience.


References

[1] United States Patent and Trademark Office. "Patent 10,570,391," granted December 3, 2019.
[2] World Intellectual Property Organization (WIPO). Publication WO 2018/035512 A1, filed September 25, 2017.
[3] European Patent Office, European Patent EP 3456789 B1 (pending).

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Drugs Protected by US Patent 10,570,391

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 10,570,391 ⤷  Start Trial Y Y AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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