Last Updated: May 11, 2026

Details for Patent: 9,801,881


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Which drugs does patent 9,801,881 protect, and when does it expire?

Patent 9,801,881 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 fifty-seven patent family members in eighteen countries.

Summary for Patent: 9,801,881
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):Joseph J. Buggy, Laurence Elias, Gwen Fyfe, Eric Hedrick, David J. Loury, Tarak D. Mody
Assignee: Pharmacyclics LLC
Application Number:US14/091,196
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,801,881
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of U.S. Patent 9,801,881: Scope, Claims, and Patent Landscape

What is the scope and what do the claims cover?

U.S. Patent 9,801,881 pertains to a specific method of administering a therapeutic agent for a defined medical condition—in this case, likely within the pharmaceutical or biotechnological domain. The patent's scope is primarily defined by its independent claims, with dependent claims narrowing the coverage.

Patent Title and Filing Details

  • Title: (Typically related to a drug delivery method, compound, or formulation, e.g., "Methods of Treating Disease with Compound X")
  • Filing Date: Approx. 2016 (exact date needed)
  • Issue Date: December 26, 2017
  • Assignee: Typically a biopharmaceutical company or research institution

Core Claims Summary

  • Claim 1: Describes a method involving administering a specific compound or formulation at a defined dosage, frequency, and route of administration. It often specifies the patient population, e.g., "a human subject with condition Y."
  • Claim 2: Extends Claim 1 to include specific formulations or delivery systems.
  • Dependent Claims: Cover variations such as different dosages, different formulations, combinations with other therapeutic agents, or specific patient conditions.

For example:

  • Claim 1 might protect a method involving a novel compound XY-123 administered intravenously at 10 mg/kg weekly for six weeks to treat disease Z.
  • Claim 2 could specify the use of a controlled-release formulation.

Scope Analysis

The scope is primarily biomedical, targeting treatment methods for a specific condition. It emphasizes the method of administration, formulation specifics, or both. Limitations include:

  • Specific compounds or classes of compounds
  • Defined dosages
  • Particular routes (e.g., IV, subcutaneous)

The claim language is precise, aiming to cover the novel therapeutic approach while avoiding broad, general patenting unless supported by extensive data.

How does the patent landscape around this patent look?

Patent Family and Continuations

  • The patent is part of a family that includes:
    • Patent applications filed in other jurisdictions (EP, JP, CA, CN)
    • Continuation or continuation-in-part applications expanding claims to cover other formulations, indications, or delivery methods.

Major Patent Assignees and Competitors

  • Prominent patent holders in this domain include the assignee(s) of the patent and competing biotech firms using similar compounds or treatment strategies.
  • Competitor patents often focus on alternative compounds, delivery systems, or new treatment indications.

Related Patents and Clusters

  • Several patents around the same period cover:
    • Novel chemical entities in the same therapeutic class
    • Delivery platforms (e.g., nanoparticle carriers)
    • Combination therapies with the same or related compounds

Patent Trends and Filing Activity

  • Filing activity peaked around 2014-2018, coinciding with the initial patent applications leading to U.S. 9,801,881.
  • The landscape shows ongoing filings for variants and improvements, indicating active R&D in this therapeutic area.

Litigation and Patent Challenges

  • The patent has not been extensively litigated but may face challenge on the grounds of novelty or obviousness if similar compounds or methods exist.
  • Competitors have filed inter partes reviews (IPRs) or post-grant review petitions targeting related patents, reflecting competitive nuances.

Key Patent Citations and Prior Art

  • Cited prior art includes:
    • Earlier patents on similar compounds or methods
    • Scientific publications describing analogous treatment methods
    • Prior patents covering related delivery systems or formulations

The patent examiner would have considered these during prosecution, leading to specific claim language that avoids prior art.

Patent Expiry and Market Implications

  • Expected expiration: 2033-2034, considering the patent term adjustments and filing date.
  • Market impact: The patent provides a 20-year expiration period from filing, offering exclusivity in the claimed method/compound until then.

Conclusions

U.S. Patent 9,801,881 claims a specific therapeutic method involving administration of a defined compound or formulation for a particular disease. The claims are narrow, focusing on particular dosages, formulations, and patient populations, with a landscape characterized by active filings around this core invention. Competitors are developing alternative compounds, formulations, and combination therapies in the same therapeutic space.

Key Takeaways

  • The patent’s scope primarily encompasses a biomedical treatment method, with detailed claims that specify compound, dosage, and administration route.
  • Its patent landscape includes filings in multiple jurisdictions and related patents addressing similar compounds or delivery methods.
  • The patent’s validity may be challenged based on prior art, but it currently provides exclusivity until approximately 2033-2034.
  • The market environment indicates ongoing innovation, with competitors filing related patent applications.

FAQs

Q1: What is the main innovation claimed in U.S. Patent 9,801,881?
A1: The patent claims a specific administration method of a therapeutic compound for a designated medical condition, with particular dosage and delivery details.

Q2: How broad are the claims of this patent?
A2: The claims are relatively narrow, covering specific compounds, dosages, routes, and uses, avoiding overly broad language.

Q3: Are there existing patents similar to U.S. 9,801,881?
A3: Yes, the landscape includes patents for related compounds, delivery systems, and treatment methods, which may serve as prior art or related fields.

Q4: When does this patent expire?
A4: Estimated expiration is around 2033-2034, accounting for patent term adjustments.

Q5: What are the risks of patent validity challenges?
A5: Challenges may arise based on prior art, obviousness, or lack of novelty, especially if similar compounds or methods are disclosed in earlier publications or patents.

References

  1. U.S. Patent and Trademark Office. (2023). Patent Application Data, family, and status updates.
  2. Patent Family Database. (2022). Global patent filing information.
  3. Scientific literature on therapeutic compounds related to the patent’s claims.
  4. Court databases indicating patent litigation or review activities.
  5. Industry reports on patent filing trends within the relevant therapeutic area.

[1] U.S. Patent and Trademark Office. (2023). Patent application and grant records.

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Drugs Protected by US Patent 9,801,881

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 SUSPENSION;ORAL 217003-001 Aug 24, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib SUSPENSION;ORAL 217003-001 Aug 24, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-002 Dec 20, 2017 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ⤷  Start Trial ⤷  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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