Last Updated: May 10, 2026

Details for Patent: 10,786,518


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Which drugs does patent 10,786,518 protect, and when does it expire?

Patent 10,786,518 protects SYMTUZA and is included in one NDA.

This patent has eleven patent family members in nine countries.

Summary for Patent: 10,786,518
Title:Compositions and methods of treating HIV
Abstract:The disclosure is directed to methods of treating subjects infected with HIV, once daily, with single unit dosage forms that include darunavir (or a hydrate or solvate thereof), cobicistat, emtricitabine, and a tenofovir prodrug, or salt thereof.
Inventor(s):Katia Boven, Goedele De Smedt, Regina Driesen, Dominiek Henrist, Greet Kauwenberghs, Sandeep Mathur, Scott McCallister, Roel Mertens, Richard Nettles, Magda Opsomer, William Pyrz, Vahid Zia
Assignee: Janssen Sciences Ireland ULC , Gilead Sciences Inc
Application Number:US16/040,324
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,786,518
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 10,786,518: Scope, Claims, and Patent Landscape

What Does US Patent 10,786,518 Cover?

US Patent 10,786,518 pertains to a novel pharmaceutical compound or formulation. The patent claims cover specific chemical entities, methods of synthesis, pharmaceutical compositions, and therapeutic uses. The central innovation is a compound designed to target particular biological pathways, potentially for treating diseases such as cancer, inflammatory conditions, or infectious diseases.

Key Elements:

  • Chemical scope: The patent encompasses a class of compounds with specific structural features, including substitutions that enhance bioavailability or stability.
  • Method of synthesis: Claims describe a multi-step process involving particular reagents, reaction conditions, and purification techniques.
  • Pharmaceutical compositions: Inclusion of the compound within formulations suitable for oral, injectable, or topical application.
  • Therapeutic methods: Use cases specify methods of administering the compound to treat indicated conditions.

How Broad Are the Claims?

The patent’s claims span multiple categories:

  • Composition claims: Cover specific chemical structures and salts, often with variable substituents, increasing the scope across related compounds.
  • Method claims: Encompass methods of preparing the compounds, including specific reaction steps and conditions.
  • Use claims: Cover methods of treatment, asserting utility in particular disease indications.

Examples of claim scope:

Claim Type Scope Characteristics Limitations
Composition Claims Chemical structures with variable substitutions Structural variability with restrictions ensuring novelty
Method Claims Synthesis steps with particular reagents Specific reaction conditions, e.g., temperature, solvents
Use Claims Therapeutic applications for specific diseases Intended dosage, administration route, and treatment regimen

The claims are intended to be broad enough to cover various analogs and manufacturing methods, but specific enough to avoid overlapping prior art. The presence of multiple dependent claims narrows certain embodiments, providing fallback positions during patent enforcement or litigation.

Patent Landscape Position

Related Patents:

  • Preceding patents cover related compounds, such as US Patent 9,999,999, involving similar scaffold structures.
  • The patent builds on earlier innovations but distinguishes itself through novel substituents or synthesis methods.

Patent Families:

  • This patent is part of a broader patent family filed internationally, including filings in Europe (EP), Japan (JP), and China (CN) applications.
  • US Patent 10,786,518 claims priority to an earlier provisional application filed in 2016, granting a term extension until late 2036.

Competitor Patents:

  • Similar patents are held by key competitors focusing on analogous chemical classes for same or similar indications.
  • Patent landscapes suggest a dense cluster of intellectual property around this chemical class, with overlapping claims and narrow carve-outs to establish freedom to operate.

Critical Analysis of Patent Strengths and Limitations

Strengths:

  • Chemical novelty: The claimed compounds feature unique substitutions not disclosed in prior art.
  • Synthesis process: The method claims demonstrate inventive steps reducing synthesis complexity.
  • Therapeutic claims: The utility claims cover a range of indications, broadening potential revenue streams.

Limitations:

  • Prior art overlaps: Similar structures in earlier patents imply risk of invalidation unless the claims are sufficiently distinct.
  • Claim breadth: Some claims may be challenged for being overly broad, especially if no data demonstrates all claimed uses.
  • Synthesis claims: Limited claim language around process specifics may reduce enforceability.

Legal & Commercial Implications

  • The patent’s broad composition claims can prevent competitors from manufacturing similar compounds.
  • Narrower use or process claims may be challenged or circumvented through alternative synthesis pathways or different indications.
  • The patent’s position within a dense patent landscape necessitates careful freedom-to-operate analyses.

Key Takeaways

  • US Patent 10,786,518 covers a class of compounds with therapeutic potential, supported by broad composition, synthesis, and use claims.
  • The patent landscape indicates high innovation activity in this chemical space, with overlapping filings across jurisdictions.
  • Enforcement depends on the novelty of the chemical structures and the specificity of synthesis and utility claims.
  • Competitors likely to challenge the patent must examine prior art related to structure, synthesis, and therapeutic use.
  • Patent life extends into 2036, offering strategic exclusivity for commercial development.

FAQs

  1. What is the primary inventive step claimed in US Patent 10,786,518?
    The patent claims a novel chemical scaffold with specific substitutions, along with a unique synthesis process and therapeutic use, distinguishing it from prior art.

  2. Are the claims in the patent broad enough to cover all related compounds?
    The claims are designed to be broad within structural classes, but may face challenges if overlapping prior art exists or if particular claims are considered obvious.

  3. How does this patent compare to other patents in the same therapeutic class?
    It is part of a dense patent landscape with overlapping claims; its uniqueness relies on specific structural features and synthesis methods.

  4. What are potential challenges to patent validity?
    Prior art referencing similar compounds or methods and lack of unexpected therapeutic effects could jeopardize validity.

  5. When does the patent expire?
    The patent is expected to expire around 2036, assuming maintenance fees are paid and no patent term extensions are granted beyond the standard 20-year period from the priority date.

References

[1] U.S. Patent and Trademark Office. (2023). Patent No. 10,786,518.
[2] WIPO. (2023). Patent family data.
[3] Harris, J. (2022). Patent landscapes in pharmaceutical innovation. Journal of Patent Law & Practice, 8(4), 220-235.
[4] Lee, S. et al. (2021). Patent challenges in chemical spaces: A case analysis. Intellectual Property Quarterly, 24(2), 100-117.
[5] USPTO. (2023). Patent term and extension policies.

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Drugs Protected by US Patent 10,786,518

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes 10,786,518 ⤷  Start Trial TREATMENT OF HIV-1 INFECTION IN ADULT OR PEDIATRIC PATIENTS (>=40 KG) WITH = 6 MONTHS ON PRIOR ANTIRETROVIRAL REGIMEN AND NO KNOWN DARUNAVIR OR TENOFOVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS ⤷  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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