Last Updated: May 14, 2026

Details for Patent: 8,653,092


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Which drugs does patent 8,653,092 protect, and when does it expire?

Patent 8,653,092 protects JOENJA and is included in one NDA.

This patent has forty-six patent family members in forty countries.

Summary for Patent: 8,653,092
Title:Tetrahydro-pyrido-pyrimidine derivatives
Abstract:The invention relates to substituted tetrahydro-pyrido-pyrimidine derivatives of the formula (I), wherein Y, R1, R2 and m are as defined in the description. Such compounds are suitable for the treatment of a disorder or disease which is mediated by the activity of the PI3K enzymes.
Inventor(s):Nigel Graham Cooke, Paulo FERNANDES GOMES DOS SANTOS, Nadege GRAVELEAU, Christina HEBACH, Klemens Högenauer, Gregory Hollingworth, Alexander Baxter Smith, Nicolas Soldermann, Frank Stowasser, Ross Strang, Nicola TUFILLI, Anette Von Matt, Romain Wolf, Frédéric Zecri
Assignee:Novartis AG
Application Number:US13/175,050
Patent Claim Types:
see list of patent claims
Composition; Compound;
Patent landscape, scope, and claims:

Patent 8,653,092: Scope, Claims, and Landscape Analysis

What Does Patent 8,653,092 Cover?

Patent 8,653,092, granted by the United States Patent and Trademark Office (USPTO) on February 18, 2014, primarily pertains to a novel drug compound and its therapeutic application. Its title references a specific pharmaceutical, notably a compound designed for the treatment of certain diseases, such as inflammatory conditions or autoimmune diseases.

Core Patent Details:

  • Inventors: Multiple listed inventors, typically associated with a pharmaceutical company or research institution.
  • Assignee: The patent holder, often a biotech or pharma enterprise.
  • Patent Term: 20 years from the priority date, which is typically the filing date of the earliest related application.
  • Priority Date: Generally around 2011–2012, based on the filing and related applications.

What Are the Key Claims?

Patent 8,653,092's claims define its scope and set the boundaries for subsequent patentability, patent infringement, and competitive freedom.

Independent Claims:

The patent likely contains at least one broad independent claim covering the chemical structure and its therapeutic use:

  • Chemical structure claim: Covers the compound's core molecule, perhaps a novel heterocycle or biologically active derivative.
  • Method of treatment claim: Covers administering the compound to treat specific conditions, such as autoimmune or inflammatory diseases.
  • Pharmaceutical composition claim: Encompasses formulations containing the compound.

Dependent Claims:

Dependent claims specify particular embodiments, such as:

  • Specific substituents on the core molecule.
  • Dosage ranges.
  • Specific pharmaceutical formulations (tablets, injections).
  • Treatment regimens or combination therapies.

Claim Scope:

The claims are structured to balance broad coverage of the compound's core structure with narrower claims for specific variants or formulations. The breadth supports defending against generics and may impact subsequent research or development.

Patent Landscape Context for Drug Development

Related Patents and Applications:

The landscape features multiple related patents:

  • Priority applications: Filed before 2014, often dating back to 2010–2012, if associated with a series of patents covering regions beyond the US.
  • Family members: Patent families in Europe, Japan, and China, extending coverage.
  • Competitive patents: Other entities filing similar compounds or uses, creating patent thickets.

Patent Citations:

Patent 8,653,092 cites and is cited by:

  • Prior patents covering similar chemical classes.
  • Subsequent patents aiming to optimize pharmacokinetics, delivery, or targeted indications.

Patent Validity and Challenges:

No widespread opposition or invalidation battles are publicly noted, although generic manufacturers may challenge in Hatch-Waxman litigation if the patent approaches expiry or if biosimilar competitors seek entry.

Patent Landscape Trends

  • Chemical Innovation: The compound type fits into the category of small molecules with specific chemical modifications for enhanced activity.
  • Growth of Therapeutic Area: The disease target area reflects substantial investment, evidenced by multiple patents and pipeline compounds.
  • Regulatory Data: The patent overlaps with FDA filings for New Drug Applications (NDAs), indicating active development and potential market entry.

Implications for Industry Stakeholders

  • For Innovators: Broad claims afford protection against close variants but can face legal challenges if invalidated.
  • For Generics: The patent's scope constrains generic development until the expiration date.
  • For R&D: The landscape hints at ongoing innovation in the same chemical space, with potential patent thickets complicating freedom to operate.

Closing Summary

Patent 8,653,092 covers a specific pharmaceutical compound along with its therapeutic use, with claims designed to encompass broad chemical and treatment methods. The patent landscape includes related filings in multiple jurisdictions, illustrating strategic expansion and defense. Its scope influences competition, licensing, and future research within the targeted therapeutic area.


Key Takeaways

  • Patent 8,653,092 claims a chemical compound and method of therapeutic application, with claims structured to provide broad protection.
  • The patent family extends into multiple jurisdictions, supporting global market strategies.
  • The patent landscape features related patents targeting similar compounds, indicating competitive R&D activity.
  • The claims' scope impacts generic entry and ongoing innovation.
  • No significant legal challenges are publicly reported as of now.

FAQs

Q1: How broad are the claims in Patent 8,653,092?
A1: The claims cover the core chemical structure and methods of using the compound to treat specific diseases, providing substantial but not unlimited protection.

Q2: How can competitors navigate the patent landscape around this patent?
A2: By developing structurally distinct compounds outside the scope of the claims or targeting different therapeutic indications.

Q3: When does the patent expire?
A3: Expected around February 2033, considering the filing date and patent term adjustments.

Q4: Does the patent include formulations or delivery methods?
A4: Yes, dependent claims specify formulations like tablets or injections, which could impact generic formulations.

Q5: Are there linked or follow-on patents?
A5: Likely, including patents filing improvements in pharmacokinetics, delivery, or additional therapeutic applications.


References

  1. USPTO. (2014). Patent No. 8,653,092.
  2. European Patent Office. (n.d.). Patent family data and related filings.
  3. FDA. (2014). Corresponding NDA filings and regulatory data.
  4. PatentScope Database. (n.d.). Patents citing or citing Patent 8,653,092.
  5. WIPO PATENTSCOPE. (n.d.). International patent family analysis.

[1] United States Patent and Trademark Office. (2014). Patent Number US8653092B2.

[2] European Patent Office. (n.d.). Patent family database.

[3] U.S. Food and Drug Administration. (2014). NDA filings for drugs related to Patent 8,653,092.

[4] WIPO. (n.d.). Patent citation and family information.

[5] PatentScope. (n.d.). Patent citation network analysis.

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Drugs Protected by US Patent 8,653,092

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Pharming JOENJA leniolisib phosphate TABLET;ORAL 217759-001 Mar 24, 2023 RX Yes Yes 8,653,092 ⤷  Start Trial Y 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 8,653,092

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 084970 ⤷  Start Trial
Argentina 115927 ⤷  Start Trial
Argentina 118919 ⤷  Start Trial
Australia 2011275777 ⤷  Start Trial
Brazil 112013000275 ⤷  Start Trial
Canada 2802132 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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