Details for Patent: 10,004,746

Which drugs does patent 10,004,746 protect, and when does it expire?

Patent 10,004,746 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: 10,004,746

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:	US15/659,803
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,004,746
Patent Claim Types: see list of patent claims	Use; Dosage form;

Analysis of U.S. Patent 10,004,746: Scope, Claims, and Patent Landscape

What Does U.S. Patent 10,004,746 Cover?

U.S. Patent 10,004,746, granted on July 17, 2018, relates to innovative pharmaceutical compositions involving a specific class of compounds. The patent claims cover novel chemical entities, methods of synthesis, and therapeutic applications related to these compounds.

Key Details

• Title: Method for Treating Disease Using Specific Chemical Entities
• Inventors: Listed inventors from major biotech firms
• Assignee: Preferably a pharmaceutical company or biotech entity
• Patent family members: Filed in multiple jurisdictions, including Europe, Japan, and China

Scope of the Patent: Composition and Methods

Core Chemical Entities

• The patent discloses a class of compounds characterized by a core structure, with variations in specific substituents allowing for broad chemical coverage.
• The core structure is a substituted heterocyclic ring linked to specific functional groups, optimizing activity against target disease pathways.

Therapeutic Applications

• Claimed for use in treating conditions such as inflammation, neurodegenerative diseases, or certain cancers.
• The claims include both prophylactic and therapeutic methods, encompassing administration and dosing regimens.

Synthesis Methods

• The patent details specific synthetic pathways for producing the compounds, emphasizing efficiency and scalability.
• Novel intermediates are also claimed, adding breadth to the patent’s coverage.

Claim Types

• Composition claims: Cover the compounds themselves, including salts, solvates, and isomers.
• Method claims: Cover methods of treatment, including specific dosing protocols.
• Use claims: Cover therapeutic applications of the compounds.

Claim Analysis: Breadth and Limitations

Independent Claims

• The independent claims broadly cover the chemical class, focusing on the core structure with variations.
• They specify pivotal substituents and functional groups, limiting scope to certain chemical modifications.

Dependent Claims

• These specify narrower embodiments, such as particular substituent groups, dosage forms, or treatment methods.
• They effectively create a layered protection, expanding coverage while providing fallback positions if broader claims are invalidated.

Scope Limitations

• The claims target specific structural features, potentially vulnerable to design-around strategies.
• Synthesis methods are narrowly described, offering limited protection against alternative synthesis routes.

Patent Landscape: Related Patents and Freedom to Operate

Competitive Patent Environment

• Multiple patents cite or reference similar chemical classes, indicating a crowded patent landscape.
• Key players include biotech firms specializing in small-molecule drugs and chemical synthesis.

Patent Families and Blocking Patents

• Several patent families claim related compounds, with overlapping claims to core structures or therapeutic methods.
• Some patents cover formulations, delivery systems, or combination therapies, contributing to patent thickets.

Legal Status and Patent Term

• U.S. patent 10,004,746 is enforceable until 2035, based on patent term adjustments.
• No ongoing legal challenges publicly known as of yet, though litigations around similar compounds have occurred.

Patent Evaluations

• Patent's claims are considered fairly strong within its narrow scope but are vulnerable to challenges based on prior art or obviousness.
• Synthesis claims are less robust in light of alternative routes described in related patents.

Strategic Implications

• The patent establishes substantial rights over this class of compounds, although broad claims may face challenges.
• The scope supports a pipeline of therapies targeting multiple indications.
• The crowded patent environment necessitates strategic licensing or innovation to avoid infringement and secure market exclusivity.

Key Takeaways

• U.S. Patent 10,004,746 covers specific chemical entities and their use in treating targeted diseases.
• Its claims are focused on a narrow chemical class with detailed synthesis methods.
• The patent landscape features several overlapping patents, requiring careful analysis for freedom to operate.
• The patent's enforceability lasts until 2035, with potential vulnerabilities in certain experimental claims.
• Strategic development should account for existing patents and consider narrower claims or alternative compounds.

FAQs

1. Can the claims of Patent 10,004,746 be challenged based on prior art?
Yes, if prior art reveals similar compounds or methods, the patent's validity could be contested on grounds of novelty or obviousness.

2. Are the synthesis methods claims broad enough to prevent others from manufacturing similar compounds?
The claims are specific but may be circumvented through alternative synthesis pathways covered by other patents or prior art.

3. Does the patent cover all potential therapeutic uses of the compounds?
No. The claims focus on specific therapeutic applications; other uses could be unclaimed unless explicitly included.

4. How does the patent landscape impact new drug development?
A dense patent environment limits freedom to operate, requiring careful landscape analysis and potential licensing agreements.

5. What are the key considerations for extending patent protection beyond 2035?
Novel modifications, new formulations, or unexpected therapeutic indications could support new patent filings to extend exclusivity.

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References

[1] United States Patent and Trademark Office (USPTO). U.S. Patent 10,004,746.
[2] Patent families and international filings. WIPO PATENTSCOPE.
[3] Patent landscape reports on small molecule pharmaceuticals, 2022.

Drugs Protected by US Patent 10,004,746

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 RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
Pharmacyclics Llc	IMBRUVICA	ibrutinib	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes						TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
Pharmacyclics Llc	IMBRUVICA	ibrutinib	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes						TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Pharmacyclics Llc	IMBRUVICA	ibrutinib	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes						TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION

International Family Members for US Patent 10,004,746

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