Details for Patent: 8,623,883

Which drugs does patent 8,623,883 protect, and when does it expire?

Patent 8,623,883 protects VIZIMPRO and is included in one NDA.

This patent has fifty-seven patent family members in forty-six countries.

Summary for Patent: 8,623,883

Title:	4-phenylamino-quinazolin-6-yl-amides
Abstract:	This invention provides quinazoline compounds of the formula: ##STR00001## wherein: R.sub.1 is halo; R.sub.2 is H or halo; R.sub.3 is a) C.sub.1-C.sub.3 alkyl, optionally substituted by halo; or b) --(CH.sub.2).sub.n-morpholino, --(CH.sub.2).sub.n-piperidine, --(CH.sub.2).sub.n-piperazine, --(CH.sub.2).sub.n-piperazine-N(C.sub.1-C.sub.3 alkyl), --(CH.sub.2).sub.n-pyrrolidine, or --(CH.sub.2).sub.n-imidazole; n is 1 to 4; R.sub.4 is --(CH.sub.2).sub.m-Het; Het is morpholine, piperidine, piperazine, piperazine-N(C.sub.1-C.sub.3 alkyl), imidazole, pyrrolidine, azepane, 3,4-dihydro-2H-pyridine, or 3,6-dihydro-2H-pyridine, each optionally substituted by alkyl, halo, OH, NH.sub.2, NH(C.sub.1-C.sub.3 alkyl) or N(C.sub.1-C.sub.3 alkyl).sub.2; m is 1-3; and X is O, S or NH; or a pharmaceutically acceptable salt thereof, as well as processes and intermediate compounds for making them, useful pharmaceutical compositions and methods of using the compounds in the treatment of proliferative diseases.
Inventor(s):	Fakhoury; Stephen Alan (Fishers, IN), Lee; Helen Tsenwhei (Ann Arbor, MI), Reed; Jessica Elizabeth (Ann Arbor, MI), Schlosser; Kevin Matthew (North Wales, PA), Sexton; Karen Elaine (Kent, GB), Tecle; Haile (Ann Arbor, MI), Winters; Roy Thomas (Pinckney, MI)
Assignee:	Warner-Lambert Company LLC (Morris Plains, NJ)
Application Number:	13/914,410
Patent Claim Types: see list of patent claims	Use;

Understanding the Scope and Claims of United States Patent 8,623,883

Introduction

United States Patent 8,623,883, titled "4-phenylamino-quinazolin-6-yl-amides," is a patent that covers a specific class of quinazoline compounds. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

The patent, filed as US13/914,410, was granted on January 7, 2014, and is currently active[4][5].

Scope of the Patent

The patent describes a series of quinazoline compounds, specifically 4-phenylamino-quinazolin-6-yl-amides. These compounds are defined by a specific chemical structure, where various substituents (R1, R2, R3) can be modified to create different derivatives.

• Chemical Structure: The patent specifies that R1 can be a halo group, R2 can be hydrogen or a halo group, and R3 can be a C1-C3 alkyl group, optionally substituted by other functional groups[4].

Claims of the Patent

The claims section is crucial as it defines the legal boundaries of what is protected by the patent.

Independent Claims

• The patent includes several independent claims that describe the general structure of the quinazoline compounds.
• For example, Claim 1 might describe the basic structure of the compound, while subsequent claims might specify particular substituents or combinations thereof[4].

Dependent Claims

• Dependent claims further narrow down the scope by specifying additional features or limitations.
• These claims often build upon the independent claims, providing more detailed descriptions of the compounds and their potential uses[4].

Patent Claims Analysis

To understand the full scope of the patent, it is essential to analyze the claims in detail.

Claim Dependency

• The claims are often interdependent, with later claims referencing earlier ones. This structure helps in defining a clear hierarchy of what is protected[3].

Claim Scope

• The scope of each claim is critical in determining what is covered by the patent. Broader claims provide a wider protection, while narrower claims offer more specific protection but may be easier to invalidate[3].

Patent Landscape

The patent landscape surrounding US 8,623,883 involves several key aspects:

Related Patents

• Other patents in the same field, particularly those related to quinazoline compounds, can influence the scope and validity of this patent.
• Cross-referencing these patents can help in understanding potential overlaps or distinctions[4].

Prior Art

• The prior art section of the patent lists earlier patents and publications that are relevant to the invention. This section is crucial for understanding the novelty and non-obviousness of the claimed compounds[4].

Litigation and Enforcement

• Patents can be subject to litigation, especially if there are disputes over infringement or validity. Understanding the legal status and any ongoing or past litigation is essential for assessing the patent's strength[2].

Economic and Technological Impact

The economic and technological impact of this patent can be significant, particularly in the pharmaceutical industry.

Pharmaceutical Applications

• The quinazoline compounds covered by this patent may have therapeutic applications, such as in the treatment of various diseases. The patent's scope and claims will determine the extent to which these compounds can be used and developed by other entities[4].

Generic Entry

• The expiration of the patent will allow for generic entry, which can significantly impact the market for these compounds. Understanding the patent's expiration date and any potential extensions is crucial for both the patent holder and competitors[5].

Statistical Context

To put this patent into a broader statistical context, it is helpful to look at general trends in patent allowances and the patent system.

Patent Allowance Rates

• The overall allowance rate for U.S. patent applications is around 55.8%, though this rate has been decreasing over time, especially in fields like Drugs and Medical Instruments and Computers and Communications[1].

Continuation Procedures

• Many patent applications use continuation procedures to create related applications. This can affect the overall landscape by extending the life of the original application and potentially broadening its scope[1].

Key Takeaways

• Scope and Claims: The patent covers specific quinazoline compounds with detailed chemical structures and substituents.
• Patent Landscape: Understanding related patents, prior art, and potential litigation is crucial for assessing the patent's strength.
• Economic Impact: The patent has significant implications for the pharmaceutical industry, including potential therapeutic applications and generic entry upon expiration.
• Statistical Context: The patent fits into a broader trend of decreasing allowance rates and the use of continuation procedures.

FAQs

1. What is the main subject of United States Patent 8,623,883?

   • The main subject is 4-phenylamino-quinazolin-6-yl-amides, a class of quinazoline compounds.

2. When was the patent granted?

   • The patent was granted on January 7, 2014.

3. What is the current legal status of the patent?

   • The patent is currently active.

4. How do continuation procedures affect patent applications?

   • Continuation procedures can extend the life of the original application and potentially broaden its scope by creating related applications.

5. What is the significance of the patent's expiration date?

   • The expiration date marks when generic versions of the covered compounds can enter the market, significantly impacting the market dynamics.

Sources

1. Carley, M., Hegde, D., & Marco, A. (2015). What Is the Probability of Receiving a US Patent? Yale Journal of Law & Technology, 17, 203.
2. MOBILE ACUITY LTD. v. BLIPPAR LTD. (2024). United States Court of Appeals for the Federal Circuit.
3. USPTO. (2017). Patent Claims Research Dataset.
4. US Patent 8,623,883 B2. (2014). 4-phenylamino-quinazolin-6-yl-amides.
5. DrugPatentWatch. (n.d.). Pharmaceutical drugs covered by patent 8,623,883.

Drugs Protected by US Patent 8,623,883

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	Sep 27, 2018		RX	Yes	No						FIRST-LINE TREATMENT OF METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-002	Sep 27, 2018		RX	Yes	No						FIRST-LINE TREATMENT OF METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018		RX	Yes	Yes						FIRST-LINE TREATMENT OF METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST

International Family Members for US Patent 8,623,883

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1746999		301004	Netherlands
European Patent Office	1746999		PA2019016	Lithuania
European Patent Office	1746999		122019000080	Germany
European Patent Office	1746999		2019C/540	Belgium