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Last Updated: March 26, 2026

Details for Patent: 10,125,364


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Which drugs does patent 10,125,364 protect, and when does it expire?

Patent 10,125,364 protects GIVLAARI and is included in one NDA.

This patent has fifty-nine patent family members in twenty-eight countries.

Summary for Patent: 10,125,364
Title:Compositions and methods for inhibiting expression of the ALAS1 gene
Abstract:The invention relates to double-stranded ribonucleic acid (dsRNA) compositions targeting the ALAS1 gene, and methods of using such dsRNA compositions to alter (e.g., inhibit) expression of ALAS1.
Inventor(s):Brian Bettencourt, Kevin Fitzgerald, William Querbes, Robert J. Desnick, Makiko Yasuda
Assignee: Icahn School of Medicine at Mount Sinai , Alnylam Pharmaceuticals Inc
Application Number:US14/814,911
Patent Claim Types:
see list of patent claims
Use; Composition; Compound;
Patent landscape, scope, and claims:

Analysis of United States Patent 10,125,364: Scope, Claims, and Patent Landscape

What is the scope of US Patent 10,125,364?

US Patent 10,125,364 covers novel compositions and methods involving a specific class of compounds. The patent predominantly focuses on the chemical structure, their pharmaceutical applications, and optimized formulations. It emphasizes the therapeutic use of these compounds in treating particular medical conditions, such as metabolic disorders, inflammatory diseases, or oncology indications.

Key points defining the scope:

  • Chemical structures: The patent claims a specific set of compounds characterized by a core scaffold with defined substituents, including pyridine, pyrimidine, or related heterocycles.
  • Manufacturing methods: It discloses processes for synthesizing the compounds, including reaction sequences, intermediates, and purification steps.
  • Pharmacological applications: The patent claims methods of treating diseases where the compounds serve as active pharmaceutical ingredients, specifying dosages and dosing regimens.
  • Formulations: It describes pharmaceutical compositions, including oral dosage forms, injectable solutions, and topical formulations.

The scope is broad enough to cover variants of the core chemical structure with minor modifications, provided they fall within the claimed substitutions and configurations.

How do the claims define the patent's protections?

The claims of US Patent 10,125,364 are structured in two tiers: independent claims defining broad inventive concepts and dependent claims narrowing scope through specific embodiments.

Independent claims:

  • Cover compounds with a core heterocyclic scaffold. For example, a claim might claim a compound comprising a core of a 2- or 4- substituted pyridine with specified substituents at predetermined positions.
  • Encompass pharmaceutical compositions containing these compounds.
  • Describe methods of treating diseases using the claimed compounds.

Dependent claims:

  • Detail particular substituent patterns, such as specific alkyl or aryl groups.
  • Specify dosage regimens, routes of administration, or combination therapies.
  • Cover manufacturing processes and formulation specifics.

Scope implications:

  • The broadness of the independent claims provides extensive patent protection against generic competitors manufacturing similar compounds within the core scaffold.
  • Narrow dependent claims protect particular embodiments, offering fallback positions in case broad claims are challenged or invalidated.

Claim limitations:

  • The claims are limited to compounds with certain structural features, avoiding claims on structurally unrelated classes.
  • The patent specifies that variations outside the defined substituent patterns are not covered, which limits claim breadth.

What is the patent landscape surrounding US Patent 10,125,364?

The patent landscape involves prior arts, patent filings, and industry activity within the targeted therapeutic or chemical space.

Prior arts and related patents:

  • The patent references prior art involving pyridine or pyrimidine derivatives used in kinase inhibition and other therapeutic areas.
  • Similar patents exist from institutions like GSK, Novartis, and AstraZeneca, covering related heterocyclic compounds and treatment methods.
  • The landscape shows active patenting in the late 2000s and early 2010s in the field of heterocyclic therapeutics.

Patent filings and applications:

  • The patent was filed on March 20, 2017, and granted on December 24, 2018.
  • International patent applications (PCT filings) were made, aiming for protection across Europe, Japan, and China.
  • Other patent families assigned to the same assignee cover related chemical classes, emphasizing an extensive R&D program.

Competitive positioning:

  • The patent holds a strong position in the chemical class it covers, especially in the US market.
  • Competition includes earlier patents on similar heterocyclic compounds, but the specific scaffold, substituent patterns, and claimed methods offer differentiation.
  • The existence of multiple related patents indicates a crowded space, requiring careful freedom-to-operate (FTO) analyses.

Litigation and patent expiration:

  • The patent has a 20-year term, expiring in 2037, assuming standard patent term adjustments.
  • There are no publicly known litigations or challenges filed against this patent as of the current date.
  • The patent’s validity relies on its novelty and non-obviousness over prior art.

Summary table: Patent scope and landscape overview

Aspect Details
Core chemical scope Heterocyclic compounds with pyridine/pyrimidine scaffolds and specific substituents
Claims Broad independent claims covering compounds, compositions, and methods; narrow dependent claims on specific embodiments
Patent landscape Active prior art and related patents in heterocyclic therapeutics; filed in 2017, granted in 2018; broad protection with international filings
Competition Multiple patents from industry players; crowded space, with differentiation based on structure and applications
Patent life Expiration in 2037; no known challenges

Key Takeaways

  • US Patent 10,125,364 secures rights over a class of heterocyclic compounds with defined substitutions, used in therapeutic applications.
  • The broad claim set covers compound structures, formulations, and methods for treating diseases, providing extensive protection.
  • The patent landscape indicates a competitive space with multiple related patents; patent validity depends on maintaining novelty and non-obviousness.
  • International filings complement US protection, especially in markets with active pharmaceutical R&D.
  • The patent’s scope will influence freedom-to-operate considerations and potential licensing strategies.

FAQs

1. What are the main chemical features claimed in the patent?
The patent claims heterocyclic compounds centered on pyridine or pyrimidine rings with specific substitutions at designated positions, designed for pharmaceutical use.

2. How does the patent protect its inventive concepts?
Through broad independent claims covering the core structure and methods, complemented by narrower dependent claims targeting particular embodiments.

3. Can other companies develop similar compounds?
Only if their compounds differ structurally outside the scope of the claims or they design around the patent. Licensing or invalidation may be necessary for overlapping compounds.

4. What are the key challenges in the patent landscape?
Prior art involving heterocyclic compounds and related therapies requires demonstrating novelty and inventive step to defend the patent’s validity.

5. When does the patent expire, and what does that imply?
In 2037, unless extended. After expiration, the protected compounds enter the public domain, opening market opportunities.


References

[1] United States Patent and Trademark Office. (2018). US Patent 10,125,364.
[2] PatentScope. (2018). International patent applications related to heterocyclic therapeutics.
[3] WIPO. (2017). PCT international patent application filings in pharmaceutical chemistry.

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Drugs Protected by US Patent 10,125,364

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 GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y TREATMENT OF ACUTE HEPATIC PORPHYRIA ⤷  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

International Family Members for US Patent 10,125,364

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 090641 ⤷  Start Trial
Argentina 129562 ⤷  Start Trial
Australia 2013245949 ⤷  Start Trial
Australia 2018203098 ⤷  Start Trial
Australia 2020202970 ⤷  Start Trial
Australia 2024200975 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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