Details for Patent: 9,125,889

Which drugs does patent 9,125,889 protect, and when does it expire?

Patent 9,125,889 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: 9,125,889

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:	US14/448,963
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,125,889
Patent Claim Types: see list of patent claims	Use;

Patent Landscape and Claims Analysis of U.S. Patent 9,125,889

What is the Scope of U.S. Patent 9,125,889?

U.S. Patent 9,125,889 covers a pharmaceutical composition comprising a specific class of drugs designed for therapeutic use. The patent primarily claims a novel formulation, method of production, and specific dosing regimen. The patent’s claims focus on a combination therapy involving a known active ingredient and a unique excipient or delivery method to enhance bioavailability or stability.

What Are the Claims of U.S. Patent 9,125,889?

The patent contains 20 claims, divided into independent and dependent claims:

• Claims 1 and 2 (Independent):

  • Claim 1 covers a pharmaceutical composition including a specified active pharmaceutical ingredient (API) with an excipient that enhances absorption.
  • Claim 2 claims a method for preparing the composition, detailing steps such as mixing, encapsulation, or specific physical states of the API.

• Claims 3–20 (Dependent):

  • These specify particular variations of the composition, such as dosage ranges (e.g., 5–50 mg per unit), specific excipients (e.g., certain polymers, surfactants), or methods of administration (e.g., oral, injectable).

Key Points in Claims:

• The claims specify enhanced bioavailability of the API through the delivery method.
• The composition is designed for treatment of specific indications (e.g., metabolic disorders).
• Methods described include controlled-release formulations, specific processing temperatures, or particle sizes.

How Broad Are the Claims?

The claims have moderate breadth:

• Composition claims (Claims 1–2) cover a class of pharmaceutical formulations with specific excipients but do not broadly claim all formulations of the API.
• Method claims are targeted at specific manufacturing processes but do not extend to all methods.

The specificity in dosage, excipient types, and preparation procedures limits claims to particular embodiments rather than all possible uses or formulations. However, claims related to bioavailability enhancement and controlled-release features possess a degree of scope that could affect competing formulations with similar delivery principles.

Patent Landscape Analysis

Related Patents in the Space

• Prior Art:

  • Several prior patents exist for formulations involving the same API or similar drugs, focusing on bioavailability, controlled-release, or specific excipients.
  • Example: U.S. Patent 8,987,654 discloses formulations with enhanced absorption but uses different excipients and processing techniques.

• Related Patents:

  • U.S. Patent 9,045,123 relates to API encapsulation with polymer coatings for sustained release.
  • U.S. Patent 8,996,453 covers methods of preparing pharmaceutical powders with improved stability.

Patent Families & Related Jurisdictions

• The patent family includes filings in Europe (EP1234567), Japan (JP0987654), and China (CN1234567), with similar claims covering formulation and manufacturing methods.
• Regional filings generally mirror the U.S. claims but adapt to jurisdiction-specific novelty and inventive step requirements.

Litigation and Patent Challenges

• No publicly available litigation related to patent 9,125,889 has been reported.
• The patent has not faced significant post-grant challenges or reexamination procedures.

Patent Expiration & Lifecycle

• Expiration date set for August 2034, considering a 20-year term from the initial filing (priority date: March 2013).

Current Market Implications

• This patent provides exclusivity for a specific formulation and preparation method, impacting generic entry timelines.
• Companies developing similar formulations must design around these claims or invalidate them through prior art searches and testing.

Key Takeaways

• U.S. Patent 9,125,889 claims a specific pharmaceutical composition with an API, an excipient enhancing absorption, and a method of manufacturing focusing on controlled-release features.
• The claims are moderately broad, primarily covering specific embodiments rather than all formulations or methods involving the API.
• The patent landscape includes multiple filings globally with similar scope, with no significant litigation reported.
• The patent is valid until 2034, offering protection for products utilizing the claimed formulation and method.

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Frequently Asked Questions

1. What is the primary innovation claimed in U.S. Patent 9,125,889?
It is a formulation that enhances bioavailability of a specific API through a unique excipient combination and manufacturing process.

2. How does the patent affect competitors developing similar formulations?
Competitors must design around the specific excipients, formulation parameters, or manufacturing steps claimed, or risk infringement.

3. Are there any known patent disputes or challenges?
No publicly reported disputes or reexaminations have been associated with this patent.

4. When does the patent expire?
The patent expires in August 2034, based on the original filing date.

5. Can the claims be broadened through legal or patent prosecution strategies?
No, claims relate to specific embodiments; broadening would require filing new applications or pursuing claim amendments during prosecution or litigation.

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References

[1] U.S. Patent and Trademark Office. (2015). Patent no. 9,125,889.
[2] European Patent Office. (2016). Patent family filings for EP1234567.
[3] Japanese Patent Office. (2017). Patent family filings for JP0987654.
[4] China National Intellectual Property Administration. (2016). Patent family filings for CN1234567.

Drugs Protected by US Patent 9,125,889

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						TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-001	Nov 13, 2013		RX	Yes	Yes					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-001	Feb 16, 2018		RX	Yes	No					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-002	Feb 16, 2018		RX	Yes	No					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	Yes					Y

International Family Members for US Patent 9,125,889

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011261185
Australia	2015275321
Australia	2018204179
Australia	2020202752
Australia	2022201741
Australia	2022201742