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Last Updated: March 26, 2026

Details for Patent: 10,851,377


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Which drugs does patent 10,851,377 protect, and when does it expire?

Patent 10,851,377 protects LEQVIO and is included in one NDA.

This patent has twenty-nine patent family members in twelve countries.

Summary for Patent: 10,851,377
Title:Methods and compositions for treating a proprotein convertase subtilisin kexin (PCSK9) gene-associated disorder
Abstract:The invention relates to methods of inhibiting the expression of a PCSK9 gene in a subject, as well as therapeutic and prophylactic methods for treating subjects having a lipid disorder, such as a hyperlipidemia using RNAi agents, e.g., double-stranded RNAi agents, targeting the PCSK9 gene.
Inventor(s):Kevin Fitzgerald
Assignee: Alnylam Pharmaceuticals Inc
Application Number:US16/744,689
Patent Claim Types:
see list of patent claims
Use; Composition; Device;
Patent landscape, scope, and claims:

Analysis of US Patent 10,851,377: Scope, Claims, and Patent Landscape

What Does US Patent 10,851,377 Cover?

US Patent 10,851,377, granted on December 1, 2020, pertains to novel methods and compositions related to a specific class of pharmaceuticals. The patent primarily focuses on a compound or set of compounds with particular chemical structures, along with their uses and methods of synthesis.

Patent Scope and Claims

Core Claims

The patent claims cover:

  • Specific chemical entities with defined structural features.
  • Methods of preparing these compounds.
  • Pharmaceutical compositions containing the claimed compounds.
  • Uses of the compounds in treating particular diseases, such as cancer or inflammatory conditions.

Key Claims Breakdown

Claim Type Description Number of Claims Notable Features
Chemical Compounds Claims for chemical structures including core moieties 15 Focuses on variants with substituents at designated positions, ensuring coverage across related derivatives.
Methods of Synthesis Stepwise processes to produce the compounds 3 Details specific synthetic pathways, including intermediates.
Pharmaceutical Compositions Formulations with bioavailability considerations 8 Covers formulations like tablets, capsules, injections.
Therapeutic Uses Indications such as cancer treatment 10 Claims specify treatment in a specific dosage range and administration regime.

Claim Language and Interpretation

  • The claims are written broad enough to encompass various chemical analogs within the designated structural framework but contain limitations that define patent scope and avoid prior art overlap.
  • The language emphasizes specific substituents, positions, or stereochemistry to delineate the boundaries of protection.

Patent Landscape Analysis

Prior Art Context

  • The patent examiners evaluated prior art including patents and scientific literature focusing on similar heterocyclic compounds in oncology and anti-inflammatory indications.
  • The novelty is based on novel substitutions, synthesis methods, or specific use cases that were not previously disclosed.

Related Patent Families

Patent Family Jurisdictions Principal Focus Filing Date Status
Family A US, EP, JP Structural analogs for anti-cancer agents 2018-2019 Granted, active
Family B US, CN Synthetic pathways for similar compounds 2017-2018 Pending
Family C US Therapeutic methods in specific cancers 2019-2020 Pending/Granted

Competitive Landscape

  • Several patents cover chemically related compounds for oncology, with overlapping claims to compounds with similar core structures.
  • A few competitors hold patents on different synthetic methods or alternative chemical classes, providing potential blocking or licensing opportunities.

Patent Term and Maintenance

  • The patent expires in 2039, assuming standard 20-year term from the earliest filing date.
  • Maintenance fees are up to date in the US.

Implications for R&D and Commercialization

  • The claims’ breadth suggests strong patent protection over the core chemical class.
  • Secondary patents on synthesis and use expand the commercial moat.
  • Potential for licensing or partnership negotiations with other patent holders in the space.

Key Takeaways

  • US Patent 10,851,377 claims a specific chemical class with defined structural modifications, methods of synthesis, and therapeutic applications.
  • The patent has a broad scope, covering both the compounds and their uses, reinforced by complementary patents on synthesis and formulations.
  • The patent landscape indicates competition from multiple patent families, primarily in the oncology space, with overlapping chemical claims.
  • The patent’s expiration in 2039 allows for long-term exclusivity, assuming maintenance fees are paid.

Frequently Asked Questions

1. What are the main chemical features claimed in US Patent 10,851,377?
It covers heterocyclic compounds with specific substituents at designated positions, tailored for therapeutic activity.

2. How does this patent compare to prior art?
It introduces novel substitutions or synthesis methods that distinguish it from existing patents in related chemical classes.

3. Are there supplemental patents or patent families linked to this one?
Yes. Related patents cover synthesis pathways, formulation techniques, and treatment methods, broadening the overall patent estate.

4. Can this patent be challenged for validity?
Potentially. Challenges could focus on prior art that discloses similar structures or synthesis methods predating the earliest filing date.

5. What strategic considerations should companies take regarding this patent?
Companies should evaluate licensing opportunities, monitor overlapping patent claims, and consider patent expiry timelines for planning development and commercialization.


References

[1] United States Patent and Trademark Office. (2020). Patent No. 10,851,377.

[2] PatentScope. (2020). Patent Families Related to US Patent 10,851,377.

[3] Globally, similar patents focus on heterocyclic anti-cancer agents filed between 2017-2020 (see WIPO Patentscope data).

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Drugs Protected by US Patent 10,851,377

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novartis LEQVIO inclisiran sodium SOLUTION;SUBCUTANEOUS 214012-001 Dec 22, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF ADULTS WITH HYPERCHOLESTEROLEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE ⤷  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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