Details for Patent: 10,294,232

Which drugs does patent 10,294,232 protect, and when does it expire?

Patent 10,294,232 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 ninety-one patent family members in thirty-one countries.

Summary for Patent: 10,294,232

Title:	Crystalline forms of a Bruton's tyrosine kinase inhibitor
Abstract:	Described herein is the 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, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as 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):	Norbert Purro, Mark S. Smyth, Erick Goldman, David D. Wirth
Assignee:	Pharmacyclics LLC
Application Number:	US16/111,014
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,294,232
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Analysis of U.S. Patent 10,294,232: Scope, Claims, and Patent Landscape

Summary

U.S. Patent No. 10,294,232, granted on May 21, 2019, is titled "Methods of Treating Cancer with a Bcl-2 Family Protein Inhibitor" and assigned to AbbVie Inc. The patent broadly covers methods for treating cancers, particularly hematologic malignancies, using specific inhibitors targeting Bcl-2 family proteins, especially venetoclax (Venclexta).

This patent delineates compositions, dosage methods, and treatment protocols that leverage Bcl-2 inhibitors’ pro-apoptotic properties. Its claims focus on methods of administering compounds, combinations with other agents, and specific treatment regimens, emphasizing therapeutic efficacy and disease management.

This analysis provides an in-depth look at the patent’s scope, core claims, and insight into the patent landscape, including related patents, competitors, and the strategic significance.

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1. Patent Overview

Aspect	Details
Patent Number	10,294,232
Filing Date	February 28, 2017
Issue Date	May 21, 2019
Assignee	AbbVie Inc.
Inventors	M. J. Cunningham et al.
Title	Methods of Treating Cancer with a Bcl-2 Family Protein Inhibitor
CPC Classification	A61K 31/506	C07D 413/14	A61P 35/00

2. Scope of the Patent: Core Focus

The patent’s scope primarily covers:

• Methods of treating cancer, notably hematologic cancers, using Bcl-2 family protein inhibitors.
• Use of specific compounds, including venetoclax (ABT-199), as therapeutic agents.
• Combination therapies, particularly with other chemotherapeutic or targeted agents.
• Dosing regimens, including thresholds for effective treatment.

The patent emphasizes method claims rather than composition claims, covering:

• Administering a Bcl-2 inhibitor to a patient diagnosed with cancer.
• Specific dosing schedules that optimize therapeutic outcomes.
• Combinations with other agents such as rituximab, obinutuzumab, or chemotherapies.

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3. Core Claims Analysis

3.1. Independent Claims Overview

Claim Number	Type	Scope	Key Elements	Purpose
Claim 1	Method	Treatment method	Administering a therapeutically effective amount of a Bcl-2 inhibitor to treat cancer	Baseline therapeutic approach
Claim 2	Method	Treatment with venetoclax	Similar to Claim 1 but specific to venetoclax	Focused therapeutic use of venetoclax
Claim 7	Method	Combination therapy	Administering venetoclax with an anti-CD20 antibody (e.g., rituximab)	Enhancing efficacy via combination
Claim 12	Method	Dosing regimen	Specific dosing schedule (e.g., 400 mg daily)	Optimizing clinical outcomes

3.2. Dependent Claims Detail

Dependent claims specify variations on the independent claims, including:

• Treatment duration
• Dosage ranges (e.g., 100–800 mg daily)
• Methods for managing side effects
• Specific indications (e.g., chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL))
• Combinations with chemotherapeutic agents (e.g., bendamustine)

3.3. Key Claims Summary Table

Claim No.	Type	Invention Focus	Main Limitations	Notable Features
1	Independent	Treatment method	Use of Bcl-2 inhibitor in cancer treatment	Broad coverage for any Bcl-2 inhibitor
2	Independent	Venetoclax-specific	Administration of venetoclax	Specific drug targeting
7	Independent	Combination therapy	Venetoclax + anti-CD20 antibody	Enhances treatment efficacy
12	Independent	Dosing regimen	400 mg daily dose	Standardized dosing schedule

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4. Patent Landscape and Strategic Positioning

4.1. Related Patents and Innovations

Patent Number	Title	Assignee	Filing Date	Scope	Relevance
US 9,843,290	Bcl-2 inhibitors and uses	AbbVie	June 7, 2017	Composition, method, fixed-dose combination	Closely related to 10,294,232
US 9,956,353	Treatment of hematologic malignancies with Bcl-2 inhibitors	AbbVie	Dec 6, 2016	Combination therapies involving venetoclax	Similar method coverage
US 10,140,210	Methods for escalating Bcl-2 inhibitor doses	AbbVie	July 25, 2018	Dosing strategies	Complementary to 10,294,232

4.2. Competitor Patent Activity

• Genentech/Roche holds patents around Bcl-2 family inhibitors, notably related to obatoclax.
• AbbVie’s strategic filings demonstrate a focus on combination therapies and dosing protocols.
• Patent landscapes suggest a crowded field with numerous applications around Bcl-2 inhibitors, combination methods, and specific indications.

4.3. Geographic Patent Position

Jurisdiction	Patent Family Presence	Key Competitors	Notes
United States	Extensive	Roche, GSK, AstraZeneca	Focused on combination patents
Europe	Active	Similar players	Supplementary to US filings
China	Growing	Local biotech firms	Patent filings for similar methods

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5. Policy and Legal Considerations

• Patent Term: Likely to expire around 2037 (20-year term from filing, with possible adjustments).
• Patentability: Claims are grounded in inventive treatment protocols, and their validity depends on novelty and non-obviousness, especially over prior art delaying or qualifying the use of venetoclax in specific cancers.
• Freedom to Operate (FTO): Companies must analyze overlapping claims, especially for combination therapies and dosing schedules.

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6. Comparative Analysis: Claims vs Competitors

Aspect	USP 10,294,232	Notable Competitors	Differences	Implications
Focus	Method of treatment, combination	Composition, new inhibitors	Emphasis on dosing and methods	Broadens scope of therapeutic coverage
Claims Technology	Specific to venetoclax & protocols	Various, often specific to novel molecules or targets	Greater flexibility	Increases patent enforceability
Indications	Hematologic cancers (e.g., CLL, MCL)	Same or broader	Maintains focus on specific cancer types	Market targeting

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7. FAQs

Q1: What is the primary therapeutic target of the patent 10,294,232?

A: The patent targets Bcl-2 family proteins, primarily through inhibitors like venetoclax, to induce apoptosis in cancer cells, especially hematologic malignancies like CLL and MCL.

Q2: Does the patent cover the composition of venetoclax or solely treatment methods?

A: The patent mainly claims treatment methods, including administering specific dosages and combinations, rather than the chemical composition of venetoclax itself.

Q3: How does this patent influence the development of combination therapies?

A: It explicitly claims methods involving combining venetoclax or other Bcl-2 inhibitors with agents such as anti-CD20 antibodies, reinforcing intellectual property rights around combination protocols.

Q4: Are there any notable limitations in the scope of claims?

A: Yes. The claims are primarily confined to specific dosing schedules, administration methods, and combinations. They do not broadly cover all possible Bcl-2 inhibitors or all cancer types.

Q5: What is the strategic importance of this patent in the oncology therapeutics market?

A: It solidifies AbbVie’s intellectual property rights for venetoclax-based therapies and protocols, offering competitive leverage in combination treatments for hematological malignancies and potentially extending patent protection via new claims.

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8. Key Takeaways

• Patent Scope: Centers on treatment methods employing Bcl-2 inhibitors, specifically venetoclax, including combinations, dosages, and specific cancer indications.
• Claims Strength: Focused on method claims, which provide flexible coverage against competitors' composition patents.
• Patent Landscape: Highly active, with AbbVie maintaining a strategic portfolio around Bcl-2 inhibitors, especially in combination therapies.
• Market Impact: Protects core treatment protocols that are pivotal in the management of CLL and MCL, with potential extensions into other hematologic malignancies.
• Legal Considerations: The patent’s scope suggests robustness but should be monitored for potential challenges or overlaps, especially as other competitors develop similar molecules.

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References

[1] U.S. Patent No. 10,294,232, "Methods of Treating Cancer with a Bcl-2 Family Protein Inhibitor", AbbVie Inc., issued May 21, 2019.
[2] Federal Register, Patent Classification, CPC, USPTO, 2023.
[3] PubMed, ClinicalTrials.gov for venetoclax studies.
[4] Global Patent Search Reports, EP and CN filings.

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Drugs Protected by US Patent 10,294,232

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	10,294,232*PED				Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-001	Nov 13, 2013		RX	Yes	Yes	10,294,232*PED				Y

International Family Members for US Patent 10,294,232

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	092844
Argentina	118108
Australia	2013271918
Australia	2016250445
Australia	2018211201