Details for Patent: 7,838,531

Which drugs does patent 7,838,531 protect, and when does it expire?

Patent 7,838,531 protects ZOKINVY and is included in one NDA.

This patent has nine patent family members in six countries.

Summary for Patent: 7,838,531

Title:	Farnesyltransferase inhibitors for treatment of laminopathies, cellular aging and atherosclerosis
Abstract:	Although it can be farnesylated, the mutant lamin A protein expressed in Hutchison Gilford Progeria Syndrome (HGPS) cannot be defarnesylated because the characteristic mutation causes deletion of a cleavage site necessary for binding the protease ZMPSTE24 and effecting defarnesylation. The result is an aberrant farnesylated protein (called "progerin") that alters normal lamin A function as a dominant negative, as well as assuming its own aberrant function through its association with the nuclear membrane. The retention of farnesylation, and potentially other abnormal properties of progerin and other abnormal lamin gene protein products, produces disease. Farnesyltransferase inhibitors (FTIs) (both direct effectors and indirect inhibitors) will inhibit the formation of progerin, cause a decrease in lamin A protein, and/or an increase prelamin A protein. Decreasing the amount of aberrant protein improves cellular effects caused by and progerin expression. Similarly, treatment with FTIs should improve disease status in progeria and other laminopathies. In addition, elements of atherosclerosis and aging in non-laminopathy individuals will improve after treatment with farnesyltransferase inhibitors.
Inventor(s):	Gordon; Leslie B. (Foxboro, MA), Collins; Francis S. (Rockville, MD), Glover; Thomas (Ypsilanti, MI), Glynn; Michael W. (Darien, CT), Capell; Brian C. (Rumson, NJ), Cox; Adrienne D. (Chapel Hill, NC), Der; Channing J. (Chapel Hill, NC)
Assignee:	The United States of America as represented by the Department of Health and Human Services (Washington, DC) N/A (Anne Arbor, MI) The Regents of the University of Michiga (Peabody, MA) Progeria Research Foundation, Inc. (Chapel Hill, NC) The University of North Carolina at Chapel Hill (N/A)
Application Number:	11/828,117
Patent Claim Types: see list of patent claims	Use;

United States Patent 7,838,531: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 7,838,531, titled "Farnesyltransferase inhibitors for treatment of laminopathies, cellular aging and atherosclerosis," is a significant patent in the field of medical research and pharmaceuticals. This patent, granted to inventors including Brian C. Capell, addresses the use of farnesyltransferase inhibitors (FTIs) in treating various diseases associated with cellular aging and nuclear lamina disorders.

Background and Context

Farnesyltransferase inhibitors are compounds that inhibit the enzyme farnesyltransferase, which is crucial in the prenylation of proteins, including progerin, a mutant form of lamin A associated with Hutchinson-Gilford progeria syndrome (HGPS)[4].

Patent Scope and Claims

Independent Claims

The patent includes several independent claims that define the scope of the invention. Here are some key aspects:

• Claim 1: This claim describes the use of farnesyltransferase inhibitors to treat laminopathies, which include diseases such as HGPS, and other conditions related to cellular aging and atherosclerosis[4].
• Claim 2: This claim specifies the types of farnesyltransferase inhibitors, including both direct effectors and indirect inhibitors, that can be used to inhibit the formation of progerin and other prenylated proteins[4].

Claim Language and Metrics

The scope of the patent claims can be analyzed using metrics such as independent claim length (ICL) and independent claim count (ICC). These metrics help in understanding the breadth and clarity of the claims. Generally, narrower claims with shorter lengths and fewer independent claims are associated with a higher probability of grant and a shorter examination process[3].

Patent Claims Analysis

Claim Breadth and Clarity

The claims in this patent are specific to the use of FTIs in treating certain diseases, which suggests a relatively narrow scope. This specificity is crucial for avoiding overly broad claims that could lead to litigation and licensing issues[3].

Claim Construction

The construction of claims in this patent is detailed, ensuring clarity on what is covered under the invention. This clarity is essential for patent quality and helps in avoiding disputes during litigation or licensing negotiations[3].

Patent Landscape

Related Patents and Applications

The patent landscape surrounding US7838531B2 includes other patents related to farnesyltransferase inhibitors and their applications. For instance, the inventors have filed multiple patents and applications related to the treatment of laminopathies and cellular aging, indicating a robust research and development effort in this area[1][4].

Government-Interest Statements

Given that some of these patents may have received government funding, they would include government-interest statements as mandated by the Bayh-Dole Act. This is relevant for understanding the potential for march-in rights, which could be exercised to lower drug prices or ensure public access to the technology[2].

Patent Term and Maintenance

Patent Term Extension

The patent has undergone several administrative actions, including a patent term extension application under 35 USC 156, which can extend the patent term to account for regulatory review periods. This extension is crucial for maintaining the patent's validity and protecting the invention for a longer period[5].

Maintenance Fees

The patent holders have paid maintenance fees to keep the patent in force. The payment of the 12th-year maintenance fee in 2022 indicates that the patent is still active and being maintained by the inventors[5].

Challenges and Expiration

Patent Challenges

As of November 2024, the patents associated with Zokinvy, which may include US7838531B2, have been open to challenges. This period allows other parties to contest the patent's validity or scope[5].

Expiration Date

The patent's legal status indicates that it has expired, but the exact expiration date is not specified in the available sources. Typically, patents expire 20 years from the filing date, but extensions and other factors can affect this timeline[4].

Impact on Medical Research and Treatment

Treatment of Laminopathies

The invention described in this patent has significant implications for the treatment of laminopathies, including HGPS. By inhibiting the farnesylation of progerin, these inhibitors can prevent the characteristic nuclear blebbing associated with these diseases[1][4].

Cellular Aging and Atherosclerosis

The use of FTIs also extends to treating cellular aging and atherosclerosis, indicating a broader potential therapeutic application. This research contributes to the understanding and treatment of age-related diseases[4].

Key Takeaways

• Specific Claims: The patent includes specific claims related to the use of FTIs in treating laminopathies, cellular aging, and atherosclerosis.
• Patent Term and Maintenance: The patent has undergone term extension applications and maintenance fee payments to ensure its validity.
• Government-Interest Statements: The patent may include government-interest statements due to potential government funding.
• Impact on Medical Research: The invention has significant implications for treating laminopathies and other age-related diseases.

Frequently Asked Questions (FAQs)

What is the main invention described in US Patent 7,838,531?

The main invention is the use of farnesyltransferase inhibitors (FTIs) to treat laminopathies, cellular aging, and atherosclerosis.

How do farnesyltransferase inhibitors work in treating these diseases?

FTIs inhibit the enzyme farnesyltransferase, preventing the prenylation of proteins such as progerin, which is associated with Hutchinson-Gilford progeria syndrome and other laminopathies.

What is the significance of government-interest statements in this patent?

Government-interest statements are important because they indicate if the patent received government funding, which could affect march-in rights and public access to the technology.

Has the patent term been extended for US7838531B2?

Yes, the patent has undergone a patent term extension application under 35 USC 156 to account for regulatory review periods.

Is the patent still active?

As of the latest information, the patent has expired, but specific details on the expiration date are not provided in the sources.

Cited Sources:

1. Brian C. Capell, MD, Ph.D. - Michigan Medicine
2. The Feasibility of Using Bayh-Dole March-In Rights to Lower Drug Prices
3. Patent Claims and Patent Scope - Hoover Institution
4. US7838531B2 - Farnesyltransferase inhibitors for treatment of laminopathies, cellular aging and atherosclerosis - Google Patents
5. Zokinvy patent expiration - Pharsight

Drugs Protected by US Patent 7,838,531

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sentynl Theraps Inc	ZOKINVY	lonafarnib	CAPSULE;ORAL	213969-001	Nov 20, 2020		RX	Yes	No						REDUCING THE RISK OF MORTALITY IN HUTCHINSON-GILFORD PROGERIA SYNDROME (HGPS)
Sentynl Theraps Inc	ZOKINVY	lonafarnib	CAPSULE;ORAL	213969-002	Nov 20, 2020		RX	Yes	Yes						REDUCING THE RISK OF MORTALITY IN HUTCHINSON-GILFORD PROGERIA SYNDROME (HGPS)

International Family Members for US Patent 7,838,531

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	547536
Australia	2003301446
Canada	2501464
European Patent Office	1552020
European Patent Office	1853265
Japan	2006507845