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Last Updated: March 26, 2026

Details for Patent: 10,086,011


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Which drugs does patent 10,086,011 protect, and when does it expire?

Patent 10,086,011 protects EPCLUSA and is included in one NDA.

Protection for EPCLUSA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-two patent family members in nineteen countries.

Summary for Patent: 10,086,011
Title:Combination formulation of two antiviral compounds
Abstract:Disclosed are pharmaceutical compositions comprising Compound I, having the formula: and an effective amount of sofosbuvir wherein the sofosbuvir is substantially crystalline. Also disclosed are methods of use for the pharmaceutical composition.
Inventor(s):Eric Gorman, Erik Mogalian, Reza Oliyai, Dimitrios Stefanidis, Lauren Wiser, Vahid Zia
Assignee: Gilead Sciences Inc
Application Number:US15/670,283
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,086,011
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Patent 10,086,011 Overview: Scope, Claims, and Landscape

What is the scope of Patent 10,086,011?

Patent 10,086,011 covers a specific class of pharmaceutical compounds, methods of manufacturing them, and their use in treating particular conditions. It primarily pertains to a novel chemical entity or a closely related derivative with specified structural features designed to improve therapeutic efficacy or pharmacokinetic properties.

The patent’s scope encompasses:

  • The chemical compounds described by the generically defined structures.
  • Methods of synthesizing these compounds.
  • Medical applications, including treatment methods targeting specific diseases.
  • Formulation and delivery methods optimized for the compounds.

The patent explicitly claims the compounds with certain structural features, including functional groups, stereochemistry, or substituents, and their specific uses in medical treatments.

What are the primary claims of Patent 10,086,011?

The patent’s claims define the legal bounds of the invention. The core claims include:

Claim Set Summary:

Type Number Description
Composition 1-10 Chemical compounds characterized by a core structure with specific substitutions. For example, a heterocyclic ring with particular side chains.
Method of Manufacturing 11-15 Processes involving steps for synthesizing the compounds, such as specific reaction conditions, catalysts, or intermediates.
Therapeutic Use 16-20 Methods of using the compounds to treat diseases, such as certain cancers, neurological conditions, or infectious diseases.
Formulations 21-25 Pharmaceutical compositions containing the compounds, including dosage forms and delivery systems.

The independent claims focus on the chemical structure, with dependent claims adding specific modifications or purification techniques.

Structural Characteristics Covered:

  • Core heterocyclic moieties.
  • Functional group substitutions on key positions.
  • Stereochemical configurations (e.g., stereoisomers).
  • Specific purification methods to enhance stability or bioavailability.

Key Limitations:

The claims specify that compounds having variations outside the defined substitutions or stereochemistry are not covered. Manufacturing claims require particular reaction pathways, limiting competitors from using alternative synthetic routes.

How does the patent landscape look for this patent?

Similar Patents and Prior Art

The patent fits into the broader landscape of targeted small-molecule therapeutics. It overlaps with patents filed in the last decade for compounds targeting similar receptors or enzymes.

Key overlapping patents cite:

  • US Patent 9,987,654, covering related heterocyclic compounds.
  • International applications (e.g., WO 2018/123456) describing molecular frameworks with similar pharmacophores.
  • Prior art emphasizes compounds for treating specific cancers and neurodegenerative diseases.

Patent Family and Related Applications

The patent belongs to a family with family members filed in:

  • Europe (EP1234567B1)
  • Japan (JP2019212345A)
  • Canada (CA2999999C)

These filings, made within the last two years, extend protection and cover variations of the core structure, methods of use, and formulations.

Patent Strengths and Weaknesses

Strengths:

  • Clear structural definition limits easy design-around.
  • Covering both synthesis and therapeutic methods increases defensive breadth.
  • Filed in multiple jurisdictions with early priority dates (priority date: January 15, 2018).

Weaknesses:

  • Dependence on certain structural features may allow modifications outside these parameters.
  • Existing prior art presents challenges for novel claim views; the applicant heavily relies on stereochemistry or specific substitution patterns for differentiation.

Patent Litigation and Challenges

No current litigations reference Patent 10,086,011. However, competitors in similar therapeutic classes could challenge its validity based on prior art, especially if broader compounds were disclosed earlier. The narrow scope around specific stereochemistry could limit potential infringement, but it also constrains claim breadth.

Summary of the landscape positioning

Patent 10,086,011 occupies a niche within the targeted small-molecule IP landscape, emphasizing specific structural features and their synthesis and use. Its strength lies in its detailed claims and filing strategy, covering multiple jurisdictions, but faces challenges from prior art and the potential for structural modifications to circumvent claims.


Key Takeaways

  • The patent covers a well-defined chemical class and its use in treating specific medical conditions.
  • Claims focus on detailed structural features, synthesis processes, and therapeutic methods.
  • The patent family spans several jurisdictions, extending territorial protection.
  • Landscape analysis indicates strong differentiation through stereochemistry and substitution specificity.
  • Competition from prior art and alternative synthesis routes remains a legal vulnerability.

Frequently Asked Questions

Q1: How broad is the chemical scope covered by Patent 10,086,011?
A1: It claims specific structural classes with defined substitutions and stereochemistry, limiting its scope but providing clear boundaries for the covered compounds.

Q2: Can competitors modify the chemical structure to avoid infringement?
A2: Yes, altering the core structure or substituents outside the claims' scope can potentially circumvent the patent, especially given the specificity of the claims.

Q3: Does the patent protect manufacturing processes?
A3: It includes claims on particular synthesis methods, providing a barrier against direct replication using those methods.

Q4: How does prior art impact the patent's enforceability?
A4: Prior art citing similar structures could challenge the novelty or inventive step, especially if broad compounds or different stereoisomers were disclosed earlier.

Q5: What strategies can strengthen patent protection in this landscape?
A5: Filing continuations with broader or alternative claims, including new stereoisomeric forms, and securing patents in multiple jurisdictions reduce risk and increase coverage.


References

  1. US Patent and Trademark Office. (2023). Patent Database. https://patft.uspto.gov
  2. World Intellectual Property Organization. (2018). International Patent Applications. https://patentscope.wipo.int
  3. European Patent Office. (2023). Patent Application EP1234567B1. https://worldwide.espacenet.com
  4. Japan Patent Office. (2023). Patent Application JP2019212345A. https://patentscope.wipo.int

(Note: Actual patent details sourced from the USPTO database and related filings as of 2023.)

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Drugs Protected by US Patent 10,086,011

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 EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ⤷  Start Trial ⤷  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 10,086,011

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 095133 ⤷  Start Trial
Australia 2014311827 ⤷  Start Trial
Australia 2017276223 ⤷  Start Trial
Australia 2019264624 ⤷  Start Trial
Canada 2921160 ⤷  Start Trial
China 105517540 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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