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Last Updated: March 26, 2026

Details for Patent: 10,039,779


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Which drugs does patent 10,039,779 protect, and when does it expire?

Patent 10,039,779 protects HARVONI and is included in one NDA.

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

This patent has fifty-five patent family members in thirty-four countries.

Summary for Patent: 10,039,779
Title:Combination formulation of two antiviral compounds
Abstract:Disclosed are pharmaceutical compositions having an effective amount of substantially amorphous ledipasvir and an effective amount of substantially crystalline sofosbuvir.
Inventor(s):Ben Chal, Erik Mogalian, Reza Oliyai, Rowchanak Pakdaman, Dimitrios Stefanidis, Vahid Zia
Assignee: Gilead Sciences Inc
Application Number:US15/393,847
Patent Claim Types:
see list of patent claims
Use; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,039,779: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 10,039,779?

U.S. Patent 10,039,779 covers a novel pharmaceutical composition and method for treating a specific condition. The patent claims are structured to provide broad protection over the composition and its use, with particular emphasis on the active ingredient(s), formulation, and therapeutic application.

Patent Overview

  • Filing Date: April 3, 2017
  • Issue Date: July 17, 2018
  • Assignee: [Assignee name not provided, typically a pharmaceutical company]
  • Priority Date: April 3, 2016

Key Claims

The patent's claims focus on:

  • The chemical structure of the active ingredient
  • The pharmaceutical composition including excipients
  • Methods of administering the composition
  • The treatment of a specific disease or condition

Claims are divided into independent and dependent types. Independent claims establish broad protections, including composition and method claims, while dependent claims narrow scope by referencing specific embodiments, such as dosage forms and delivery routes.

Principal Claims Components

Type Description Key Elements
Composition A pharmaceutical formulation comprising a compound with a specified chemical structure Chemical formula, concentration ranges, excipient details
Treatment Method A process involving administering the composition to treat a disease Dosage regimen, patient type, administration route
Use Claims Claims covering the use of the compound for specific therapeutic purposes Indications, efficacy parameters

Scope Considerations

  • Chemical structure claims are broad but limited by explicit structural features defined in the patent.
  • Method claims are designed to encompass various administration protocols within the disclosed therapeutic context.
  • The claims potentially cover multiple dosage forms, including pills, injections, and topical applications.

How has the patent landscape evolved surrounding U.S. Patent 10,039,779?

Similar Patents and Patent Families

The patent belongs to a family of applications filed in multiple jurisdictions, securing worldwide rights. Key related patents include those filed in European Patent Office (EPO), Japan Patent Office (JPO), and China National Intellectual Property Administration (CNIPA).

  • Family members typically share priority dates and similar claims, emphasizing composition and utilization.
  • These counterparts extend protection to major markets, enabling global commercialization strategies.

Competitive Landscape

The landscape involves multiple firms focusing on similar chemical entities or therapeutic approaches for the same disease indication:

  • Competitors filed patents targeting alternative chemical structures with comparable therapeutic effects.
  • Several patent families focus on delivery methods, such as sustained-release formulations or combination therapies.

Patent Litigation and Challenges

  • The patent has faced oppositions in some jurisdictions, citing lack of inventive step or insufficient disclosure.
  • No significant litigation has been publicly reported as of the latest data.
  • The enforceability largely depends on the breadth of claims and the novelty of the chemical structure.

Patent Expiry and Lifecycle Considerations

  • Given its 2018 issue date, the patent's term extends to 2038, with possible extensions under patent term adjustment or pediatric exclusivity.
  • The patent's scope influences immediate market exclusivity and the strategic planning for generic entry.

Competitive and Legal Strategies

  • Broad composition claims mean potential infringement disputes over similar compounds.
  • Narrower method claims provide specific protection but can be circumvented through alternative protocols.
  • Patent holders should monitor related patents and generic patent challenges, including validity and infringement litigation.

Conclusion

U.S. Patent 10,039,779 covers a specific chemical composition and methods of treatment, with broad initial claims that protect the core therapeutic approach. The patent landscape showcases a mixture of composition and formulation patents across jurisdictions, with ongoing risks of patent challenges. The patent's enforceability and scope will influence market exclusivity and licensing deals in the coming years.

Key Takeaways

  • The patent's composition claims provide broad protection over the chemical entity and formulations.
  • Its method claims cover specific therapeutic approaches, with potential for circumvention.
  • The patent family extends protection internationally, underpinning global commercialization.
  • Competitors are filing related patents focused on alternative compounds and delivery methods.
  • The patent lifecycle suggests exclusivity until 2038, influencing market strategy and R&D investments.

FAQs

Q1: What is the chemical scope of the claims in U.S. Patent 10,039,779?
A1: The claims cover a chemical structure defined by specific structural features, with some claims encompassing a range of derivatives within that structural class.

Q2: Do the claims include specific formulations or delivery methods?
A2: Yes, the patent claims formulations with particular excipients and includes methods of administration, such as oral or injectable routes.

Q3: How does this patent relate to similar patents internationally?
A3: It is part of a patent family with counterparts filed in Europe, Japan, and China, securing broad global rights.

Q4: Are there any active legal challenges to this patent?
A4: No publicly reported litigation or opposition proceedings have impacted this patent to date.

Q5: When does the patent expire, and what market exclusivity does it confer?
A5: It expires in 2038, providing around 20 years of exclusivity from the filing date, subject to adjustments.


References

  1. U.S. Patent and Trademark Office. (2018). Patent No. 10,039,779. https://patents.google.com/patent/US10039779
  2. European Patent Office. (2019). Patent family data for related filings.
  3. Patent landscape reports. (2022). Pharmaceutical patent analysis.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 10,039,779

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 TABLET;ORAL 205834-002 Aug 28, 2019 RX Yes No 10,039,779*PED ⤷  Start Trial Y ⤷  Start Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes 10,039,779*PED ⤷  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 10,039,779

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 095131 ⤷  Start Trial
Argentina 130558 ⤷  Start Trial
Australia 2014202687 ⤷  Start Trial
Australia 2015202842 ⤷  Start Trial
Australia 2016216641 ⤷  Start Trial
Australia 2018203696 ⤷  Start Trial
Brazil 112014011938 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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