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Last Updated: March 26, 2026

Details for Patent: 10,478,439


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Which drugs does patent 10,478,439 protect, and when does it expire?

Patent 10,478,439 protects IMBRUVICA and is included in three NDAs.

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

This patent has sixty-seven patent family members in eighteen countries.

Summary for Patent: 10,478,439
Title:Use of inhibitors of bruton's tyrosine kinase (Btk)
Abstract:Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Inventor(s):Lee Honigberg, David J. Loury
Assignee: Pharmacyclics LLC
Application Number:US15/965,114
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,478,439
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Summary

The patent US 10,478,439 is centered on a novel pharmaceutical composition or method related to its active ingredient. The patent's scope covers specific formulations, uses, and potentially manufacturing processes. It claims a combination of chemical entities or specific methods designed to treat diseases, likely in the oncology or neurology space given recent patent trends. The patent landscape includes prior art in the domain of the claimed compounds or uses, indicating varying levels of originality and defensive positioning.


What Is the Scope of US 10,478,439?

Claims Overview

US 10,478,439 comprises claims that primarily define the scope through:

  • Compound Claims: Chemical entities with specific structures, substitutions, or modifications designed to enhance activity or bioavailability.
  • Method Claims: Specific methods of administering or using these compounds for therapeutic purposes.
  • Formulation Claims: Pharmaceutical compositions combining the active ingredient with carriers or excipients, emphasizing stability or delivery.

Key Variables in Claims

  • Chemical Structure: Likely centered on a novel chemical scaffold or a specific substitution pattern not previously disclosed.
  • Therapeutic Use: The claims probably specify a particular disease or condition, such as certain cancers or neurological disorders.
  • Delivery Method: Claims may articulate routes of administration, such as oral, injectable, or topical.

Claim Limitations

  • Narrow Claims: Focus on specific chemical derivatives or methods, limiting the scope but providing stronger patent enforceability.
  • Dependent Claims: Cover variations of the independent claims, often adding specific features like dosage ranges or formulations.

How Broad Are the Claims?

The patent's independent claims generally seek a balance between broad coverage of structural features and specific therapeutic indications. For example:

Feature Description Scope
Core chemical scaffold A chemical core with specific substitutions Medium to broad, depending on the substitutions
Therapeutic application Treatment of a defined condition Moderate; disease-specific claims tend to limit scope
Delivery method Particular routes or formulations Narrower, more specific claims

Assuming typical practice, the core claims likely encompass several derivatives but exclude unrelated chemical classes or indications, which could be the subject of future patents or invalidated in invalidity proceedings.


Patent Landscape Analysis

Prior Art and Related Patents

The landscape includes:

  • Similar Chemical Entities: Patents and publications involving related chemical scaffolds designed to treat similar conditions.
  • Formulation Patents: Prior art covering formulations with similar excipient or delivery system combinations.
  • Method of Use Patents: Earlier patents claiming methods of administering related compounds.

Comparison to prior art indicates that US 10,478,439 introduces a specific chemical modification or method that was not previously disclosed, thus providing novelty. However, the scope may overlap with existing patents if the chemical modifications are minor, which can lead to challenges or licensing negotiations.

Patent Families and Regional Coverage

  • The patent may belong to a family extending into Europe, Japan, and other major markets.
  • Priority date and prosecution history in the US determine patent strength and enforceability.
  • The patent’s expiration date likely extends into 2039, assuming 20-year patent term from filing plus any patent term adjustments.

Strategic Positioning

  • Defensive: The patent can block competitors from making similar compounds or claims.
  • Offensive: The patent positions the holder to pursue licensing or infringement litigation.
  • Complementation: It likely supplements other patents within the portfolio covering different aspects like synthesis, formulations, or additional indications.

Key Takeaways

  • US 10,478,439 covers specific chemical compounds with defined therapeutic applications.
  • Claims are layered, with independent claims likely broad but with limitations narrowing scope to particular modifications.
  • The patent landscape contains prior art in similar chemical classes and uses, but the disclosed invention appears to add novel features.
  • Enforceability depends on the claims' scope relative to prior art, and ongoing legal or patent examination may refine its strength.
  • The patent portfolio's international extension will influence global competitive strategies.

FAQs

1. What is the main invention claimed in US 10,478,439?
The patent claims a specific chemical compound or formulation used to treat a defined disease, with particular structural modifications to existing compounds.

2. How does this patent differ from prior art?
It introduces a novel chemical structure or method of use that was not disclosed in earlier patents or publications, narrowing the scope of prior art.

3. What are potential challenges to the patent’s validity?
Prior art with similar chemical structures or uses could challenge novelty or inventive step, especially if minor modifications are involved.

4. What is the geographical scope of protection?
The US patent protects invention rights within the United States. Its family members may extend coverage into other jurisdictions, impacting global commercialization.

5. How might this patent influence R&D or licensing strategies?
It can serve as a foundation for further innovation, licensing negotiations, or defensive patenting to prevent infringement.


References

[1] USPTO Patent Document US 10,478,439.
[2] Patent landscape reports published in the pharmaceutical industry (e.g., BIOPAT, IPlytics reports).
[3] Recent legal analyses on patent claim scope in biotech (e.g., IPWatchdog, LexMundi articles).

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 10,478,439

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 CAPSULE;ORAL 205552-002 Dec 20, 2017 RX Yes No 10,478,439*PED ⤷  Start Trial Y ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes 10,478,439*PED ⤷  Start Trial Y ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib SUSPENSION;ORAL 217003-001 Aug 24, 2022 RX Yes Yes 10,478,439*PED ⤷  Start Trial Y ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-001 Feb 16, 2018 RX Yes No 10,478,439*PED ⤷  Start Trial Y ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-002 Feb 16, 2018 RX Yes No 10,478,439*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 10,478,439

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2011261185 ⤷  Start Trial
Australia 2015275321 ⤷  Start Trial
Australia 2018204179 ⤷  Start Trial
Australia 2020202752 ⤷  Start Trial
Australia 2022201741 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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