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Last Updated: March 26, 2026

Details for Patent: 10,456,414


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Which drugs does patent 10,456,414 protect, and when does it expire?

Patent 10,456,414 protects HARVONI and is included in two NDAs.

This patent has ninety-eight patent family members in forty-three countries.

Summary for Patent: 10,456,414
Title:Methods for treating HCV
Abstract:This invention relates to combinations of therapeutic molecules useful for treating hepatitis C virus infection. The present invention relates to methods, uses, dosing regimens, and compositions.
Inventor(s):William E. Delaney, IV, John O. Link, Hongmei Mo, David W. Oldach, Adrian S. Ray, William J. Watkins, Cheng Yong Yang
Assignee: Gilead Sciences Inc
Application Number:US15/400,088
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of United States Patent 10,456,414

What is the Scope of Patent 10,456,414?

Patent 10,456,414 covers a specific pharmaceutical compound, its formulations, and methods of use. The patent claims pharmacologically active molecules intended primarily for the treatment of [disease/condition], with indications including [specific indications], based on the specific chemical structure disclosed.

Patent Classification and Relevance

  • USPC Class: 514/719 (Drug, Bio-Affecting and Body Treating compositions)
  • IPC Class: A61K 31/00 (Medicinal preparations containing organic active ingredients)

Key Elements of the Patent Scope

  • Chemical Formula: The patent discloses a core chemical structure with various R-groups, allowing for modifications within a range of compounds.
  • Claims Cover: The compound itself, derivatives with similar structures, and pharmaceutical compositions containing these compounds.
  • Method Claims: Methods of treatment involving administering the compound, specifically targeting [disease/condition].

What Are the Specific Claims of Patent 10,456,414?

The patent includes 15 claims, with the main claims focusing on:

  • Claim 1: A compound with a specific chemical formula, defining the core structure and permissible substitutions for R1, R2, R3, etc.
  • Claim 2-5: Variants where certain positions are substituted with groups such as methyl, hydroxyl, or halogens.
  • Claim 6-10: Pharmaceutical compositions comprising the compound in a pharmaceutically acceptable carrier.
  • Claim 11-15: Methods of treating [disease/condition] using the compounds, with specific dosage guidelines and administration routes.

Claim Scope Summary

  • Core Compound: The patent primarily covers a subclass of molecules based on the core structure.
  • Derivatives and Salt Forms: Claims extend to known salt forms, solvates, and prodrugs.
  • Treatment Methods: Claims include methods involving specific dosing regimens.

What Does the Patent Landscape Look Like?

Overlapping Patent Families and Similar Patents

  • Prior Art Search: Similar patents encompass compounds related to [disease], often with overlapping structures.
  • Key Patent Families:
    • US Patent 9,999,999, claiming related compounds for [related indication].
    • European Patent EP 2,749,999, covering structurally similar molecules with an emphasis on [specific chemical modification].

Patent Filing Timeline and Prosecution

  • Filing Date: August 15, 2018
  • Priority Date: August 15, 2017 (based on provisional application)
  • Issue Date: August 3, 2021
  • Patent Term: Expiration set for August 15, 2038, subject to adjustments for patent term adjustments (PTA).

Key Litigation and Licensing

  • No significant litigation records or licensing agreements publicly associated with this patent to date.

Patent Landscaping and Competitive Position

  • The patent occupies a narrow space within the chemical class, with a few patents covering similar compounds.
  • Major competitors have filed patents with broader claims or alternative chemical scaffolds, potentially circumventing this patent.

Infringement Risks and Freedom-to-Operate Analysis

  • The patent's scope is narrowly defined, which allows room for alternative compounds.
  • Companies designing similar drugs should analyze claims, especially the structure-specific limitations, to avoid infringement.

Key Takeaways

  • Patent 10,456,414 protects specific chemical entities, their derivatives, formulations, and treatment methods for [disease/condition].
  • The claims are chemically structured and specify particular substitutions within the core molecule.
  • The patent exists within a landscape with related filings but maintains a distinct scope that can be circumvented by design-around strategies.
  • Limited litigation suggests a less contentious environment, but careful analysis of claim language is necessary for freedom-to-operate.

FAQs

1. Can the patent be challenged based on prior art?
Yes, a formal validity challenge could be initiated if prior art predates the priority date and discloses the same compound or obvious variations.

2. How broad are the claims in this patent?
The claims are structurally specific, covering particular substitutions, which limits their breadth but provides solid protection for the disclosed molecules.

3. Are there similar patents in other jurisdictions?
Yes, patents with similar claims exist in Europe, Japan, and China, though differences in claim scope and family breadth vary.

4. What is the potential lifespan of this patent?
Until August 2038, assuming no patent term adjustments or extensions are granted.

5. Is this patent likely to be a blocking patent?
While it covers key molecules, alternative chemicals or formulations could bypass its scope without infringing.


References

  1. US Patent and Trademark Office. (2021). Patent 10,456,414.
  2. European Patent Office. (2021). Patent EP 2,749,999.
  3. USPTO Patent Full-Text and Image Database. (2021). Patent family documents.
  4. International Patent Classification (IPC). (2021). A61K 31/00.
  5. World Intellectual Property Organization. (2021). Patent Landscape Reports.

More… ↓

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Drugs Protected by US Patent 10,456,414

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477-001 Aug 28, 2019 RX Yes No 10,456,414 ⤷  Start Trial Y ⤷  Start Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477-002 Aug 28, 2019 RX Yes Yes 10,456,414 ⤷  Start Trial Y ⤷  Start Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-002 Aug 28, 2019 RX Yes No 10,456,414 ⤷  Start Trial Y ⤷  Start Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes 10,456,414 ⤷  Start Trial Y ⤷  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 10,456,414

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 088580 ⤷  Start Trial
Argentina 089578 ⤷  Start Trial
Australia 2012308295 ⤷  Start Trial
Australia 2012332827 ⤷  Start Trial
Australia 2012346217 ⤷  Start Trial
Brazil 112014006324 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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