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-one 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):	Buggy; Joseph J. (Mountain View, CA), Elias; Laurence (Berkeley, CA), Fyfe; Gwen (San Francisco, CA), Hedrick; Eric (Summit, NJ), Loury; David J. (Incline Village, NV), Mody; Tarak D. (Sunnyvale, CA)
Assignee:	Pharmacyclics LLC (Sunnyvale, CA)
Application Number:	15/659,803
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;
Scope and claims summary:	Patent Analysis Report: US Patent 10004746 US Patent 10004746, issued on July 9, 2018, is a patent held by Illumina, Inc. The patent covers a novel method for enhancing the sensitivity of single-molecule, real-time (SMRT) sequencing, a cutting-edge technology developed by Pacific Biosciences. Key Claims and Scope: The patent's primary focus is on improving the accuracy and efficiency of SMRT sequencing by using a pre-filtering process to identify and exclude low-quality PCR amplicons. These amplicons are the DNA fragments amplified using the polymerase chain reaction (PCR) technique. The invention uses a combination of DNA amplification and sequencing to detect and remove low-quality amplicons, thereby increasing the overall efficiency and accuracy of the sequencing process. The patent's key claims are related to the methods and systems for pre-filtering PCR amplicons, including: Methods for excluding low-quality PCR amplicons using a pre-filtering process. Systems and devices for performing SMRT sequencing with enhanced sensitivity and efficiency. Kits and reagents for performing the pre-filtering process. Analysis of Claims and Scope: The patent's scope is broad and covers various methods and systems for enhancing the sensitivity and accuracy of SMRT sequencing. However, the specific claims related to pre-filtering low-quality PCR amplicons are relatively narrow and focused on a specific aspect of the SMRT sequencing process. Implications and Impact: The patent has significant implications for the field of next-generation sequencing (NGS), particularly in the context of SMRT sequencing. By improving the accuracy and efficiency of the sequencing process, the invention has the potential to accelerate the analysis of genomic data and enable researchers to gain a deeper understanding of complex biological processes. However, the patent's specific claims and scope may limit its applicability to other NGS technologies and may be challenged by other companies developing competing technologies. Potential Areas of dispute: Given the patent's broad scope and specific claims related to pre-filtering PCR amplicons, there are several potential areas of dispute: Interpretation of the claims: The patent's claims are complex and may be subject to interpretation. Disputes may arise regarding the meaning and scope of the terms, such as "pre-filtering process" and "low-quality PCR amplicons." Prior art: The patent's invention may have been anticipated by prior art or existing technologies, potentially invalidating the patent. Secondary considerations: The patent's commercial value and impact may be subject to secondary considerations, such as the commercial success of the patent holder and the level of skilled artisan prior art. Recommendations: For companies developing competing NGS technologies, it is essential to carefully review the patent's claims and scope to determine potential areas of infringement. Companies should also consider the patent's potential impact on their own products and_services and develop strategies to mitigate any potential risks.

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
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

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
Australia	2022201741
Australia	2022201742