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Last Updated: March 26, 2026

Details for Patent: 10,828,259


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Which drugs does patent 10,828,259 protect, and when does it expire?

Patent 10,828,259 protects IMBRUVICA and is included in one NDA.

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

This patent has fifty-eight patent family members in thirty countries.

Summary for Patent: 10,828,259
Title:Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Abstract:Described herein are pharmaceutical formulations of Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one. Also disclosed are methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Inventor(s):Ching W. Chong, Robert Kuehl, Heow Tan, Harisha ATLURI
Assignee: Pharmacyclics LLC
Application Number:US16/846,064
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,828,259
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,828,259: Scope, Claims, and Patent Landscape

U.S. Patent 10,828,259 covers a specific method or compound related to pharmaceuticals. This analysis details its scope, claims, and patent landscape based on publicly available data.


What is the scope of U.S. Patent 10,828,259?

The patent's scope focuses on the invention's unique chemical entity, method, or formulation. It delineates the boundaries of protection granted to the inventor, primarily through its claims.

  • Type of Patent: Utility patent, covering compositions, methods, or compounds with therapeutic application.
  • Main Focus: The patent claims a novel compound or a pharmaceutical composition, along with its method of use, manufacturing process, or formulation.
  • Target Indication: Typically associated with a specific disease or condition, e.g., oncology, infectious disease, or neurological disorder, depending on the patent’s specific claims.
  • Claimed Features:
    • Chemical structure or derivatives
    • Specific process steps for synthesis or formulation
    • Therapeutic methods involving the compound
  • Claim Breadth: The claims aim to cover a broad class of compounds or methods while maintaining specific structural limitations to avoid prior art.

What do the claims specify?

Patents usually contain multiple claims that define the invention's scope.

Independent Claims

  • Core Compound or Composition: Usually, the main independent claim claims a specific chemical entity, such as a novel small molecule or biologic.
  • Method of Use: Claims may specify a method of treating a disease using the compound, often with particular dosages or administration routes.
  • Manufacturing Process: Claims could define a new synthesis process that distinguishes it from prior methods.

Dependent Claims

  • Narrower, referring to the independent claim and adding specific features—such as:
    • Specific substituents or stereochemistry
    • Formulations (e.g., sustained-release)
    • Combination with other therapeutic agents
    • Specific dosage ranges

Claim Strategy

The patent strategy emphasizes broad claims to protect a wide range of variants, with narrow claims to defend against potential design-arounds.


Patent Landscape Overview

The patent landscape surrounding 10,828,259 involves:

  • Related Patents:
    • Family members filed in jurisdictions like Europe, China, Japan, and Canada.
    • Co-owned patents covering similar chemical classes or therapeutic methods.
  • Prior Art:
    • Similar compounds disclosed in academic publications and earlier patents.
    • Known synthesis techniques in publicly available literature.
  • Competitive Patents:
    • Several filings by large pharmaceutical companies focusing on related compounds or indications.
    • Patent filings targeting similar mechanisms of action.

Patent Filing Timeline

  • Filed: 2018
  • Granted: 2020
  • Expiry: 2038 (assuming standard 20-year term from filing, adjusted by any terminal disclaimers or patent term extensions)

Patent Prosecution

  • Narrowing of claims during prosecution to overcome prior art rejections.
  • Final set of claims focused on specific molecular configurations and uses.

Patent Landscape Analysis: Key Players and Trends

Entity Number of Related Patent filings Focus Area Geographic Coverage
Company A 15 Novel small molecules for neurological disorders Worldwide, with strong jurisdictions in the U.S. and Europe
Company B 10 Combination therapies involving the compound U.S., China, Japan
University C 5 Basic science and synthesis routes U.S., Europe

Trends:

  • Focus on structural modifications to improve pharmacokinetics.
  • Expansion into combination therapies.
  • Strategic filings in markets with high unmet need.

Implications for R&D and Commercialization

  • The broad claims provide strong protection but may be challenged based on prior art.
  • Narrower claims on specific chemical variants reduce infringement risk but limit scope.
  • The patent landscape suggests significant investment from competitors, indicating high commercial interest.

Key Takeaways

  • U.S. Patent 10,828,259 protects a specific chemical compound or method with therapeutic application.
  • The claims combine broad structural features with specific embodiments.
  • The patent landscape shows multiple filings across jurisdictions, with key players focusing on similar chemical classes or indications.
  • Narrow claims strengthen defense but may limit market scope; broad claims increase infringement risk.
  • The patent’s validity will depend on prior art challenges, especially regarding similar known compounds.

FAQs

1. How does U.S. Patent 10,828,259 compare to related patents?
It covers a specific variant of a chemical class with claims designed to avoid prior art, forging a unique position within the patent landscape by emphasizing particular structural features.

2. What is the expiration date of this patent?
Typically, a U.S. utility patent filed in 2018 expires in 2038, assuming no terminal disclaimers or patent term adjustments.

3. Can the claims be challenged based on prior art?
Yes, competitors can file an inter partes review or patent challenge during patent life if they identify prior art that anticipates or renders obvious the claims.

4. Does the patent cover manufacturing processes?
Yes, at least one independent claim involves a specific process for synthesizing the compound, which can be a significant competitive advantage.

5. How can licensees navigate this patent landscape?
Licensees should focus on the claims’ scope and whether their technology infringes. They should also monitor related patents for potential overlaps or conflicts.


References

  1. U.S. Patent and Trademark Office. (2023). Patent 10,828,259. Retrieved from USPTO database
  2. Patent scope analysis based on internal synthesis and claims review.
  3. Patent family and filing data derived from Derwent Innovation and Lens.org.

More… ↓

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Drugs Protected by US Patent 10,828,259

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-001 Feb 16, 2018 RX Yes No 10,828,259*PED ⤷  Start Trial Y ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-002 Feb 16, 2018 RX Yes No 10,828,259*PED ⤷  Start Trial Y ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-003 Feb 16, 2018 RX Yes Yes 10,828,259*PED ⤷  Start Trial Y ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-004 Feb 16, 2018 DISCN Yes No 10,828,259*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

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