Details for Patent: 6,417,191

Summary for Patent: 6,417,191

Title:	Synergistic combinations of zidovudine, 1592U89 and 3TC
Abstract:	The present invention relates to therapeutic combinations of (1S,4R)-cis-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl)-2-cyclopentene- 1-methanol (1592U89), 3'-azido-3'-deoxythymidine (zidovudine) and (2R,cis)-4-amino-]-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin- 2-one (3TC) (or, alternatively to 3TC, (2R,cis)-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyr imidin-2-one (FTC)) which have anti-HIV activity. The present invention is also concerned with pharmaceutical compositions containing said combinations and their use in the treatment of HIV infections including infections with HIV mutants bearing resistance to nucleoside and/or non-nucleoside inhibitors.
Inventor(s):	Barry; David Walter (Chapel Hill, NC), St. Clair; Martha Heider (Rougemont, NC)
Assignee:	GlaxoSmithKline (Research Triangle Park, NC)
Application Number:	08/930,225
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,417,191
Patent Claim Types: see list of patent claims	Use; Dosage form; Formulation; Composition;

Understanding the Scope and Claims of United States Patent 6,417,191

Introduction

United States Patent 6,417,191, titled "Synergistic combinations of zidovudine, 1592U89 and 3TC," is a significant patent in the field of antiviral therapy, particularly for the treatment of HIV infections. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background

The patent, issued on July 9, 2002, pertains to a method for treating or preventing the symptoms or effects of HIV infection using a combination of antiviral agents: zidovudine, 1592U89, and 3TC (lamivudine). These drugs are well-known for their efficacy in managing HIV/AIDS.

Claims Overview

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

Independent Claims

• The primary claim describes a method for treating an HIV-infected animal by administering a synergistic combination of zidovudine, 1592U89, and 3TC. This combination is designed to enhance the antiviral efficacy and reduce the toxicity associated with individual drugs[2][5].

Dependent Claims

• Dependent claims further specify the dosages, administration routes, and the types of HIV infections treated. For example, some claims detail the use of these combinations in treating specific strains of HIV or in patients with certain clinical conditions[2].

Scope of the Invention

The scope of the patent is narrowly focused on the synergistic effects of combining these three antiviral agents. Here are some key points:

Synergistic Combinations

• The patent highlights the benefits of combining zidovudine, 1592U89, and 3TC, which include enhanced antiviral activity and reduced side effects compared to monotherapy or dual therapy regimens[2].

Therapeutic Applications

• The method is specifically designed for treating HIV infections in animals, including humans. The claims cover various aspects of treatment, such as reducing viral load and improving clinical outcomes[2].

Patent Landscape

To understand the broader context, it is essential to analyze the patent landscape surrounding this invention.

Prior Art and Related Patents

• The patent builds upon earlier research and patents related to antiviral therapies. For instance, individual patents for zidovudine, 1592U89, and 3TC existed before this combination patent. The novelty here lies in the synergistic combination and its therapeutic benefits[2].

Global Patent Coverage

• The patent is part of a larger global patent landscape. Similar combinations may be patented in other jurisdictions, and international databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) can be consulted to understand the global scope[4].

Claim Analysis and Eligibility

To determine the patentability and scope of the claims, several factors are considered:

Subject Matter Eligibility

• The claims must meet the criteria for subject matter eligibility under U.S. patent law. This involves ensuring that the method is not merely an abstract idea or a natural phenomenon but rather a practical application with tangible benefits. In this case, the synergistic combination of antiviral agents provides a concrete therapeutic improvement, making it eligible for patent protection[1].

Novelty and Non-Obviousness

• The claims must be novel and non-obvious over the prior art. The combination of these specific antiviral agents in a synergistic manner was not obvious at the time of filing, thus meeting these criteria[2].

Patent Analytics and Claim Coverage

To manage and analyze the patent portfolio effectively, tools like patent analytics can be employed.

Claim Coverage Matrix

• A Claim Coverage Matrix can help identify which patents and claims are actively protecting the intellectual property related to this combination therapy. This tool categorizes patents by claims and scope concepts, making it easier to filter and analyze large numbers of patent claims[3].

Interactive Claim Charts

• Interactive claim charts generated by tools like ClaimScape® can be used to review patent coverage with technical experts. These charts help in determining whether a particular scope concept is applicable to a target product or method, highlighting gaps in current coverage and future design opportunities[3].

Expiry and Current Status

The patent has expired, as it was issued in 2002 and the typical patent term is 20 years from the filing date.

Impact on the Pharmaceutical Industry

The patent has had a significant impact on the treatment of HIV/AIDS by providing a synergistic combination therapy that enhances efficacy and reduces side effects. This approach has been influential in the development of subsequent antiviral therapies.

Key Takeaways

• Synergistic Combinations: The patent highlights the benefits of combining zidovudine, 1592U89, and 3TC for treating HIV infections.
• Therapeutic Applications: The method is specifically designed for treating HIV infections in animals, including humans.
• Patent Landscape: The patent is part of a larger global patent landscape related to antiviral therapies.
• Claim Analysis: The claims meet the criteria for subject matter eligibility, novelty, and non-obviousness.
• Patent Analytics: Tools like Claim Coverage Matrix and interactive claim charts are essential for managing and analyzing the patent portfolio.

FAQs

1. What is the primary claim of United States Patent 6,417,191?

   • The primary claim describes a method for treating an HIV-infected animal by administering a synergistic combination of zidovudine, 1592U89, and 3TC.

2. What are the benefits of the synergistic combination described in the patent?

   • The combination enhances antiviral efficacy and reduces the toxicity associated with individual drugs.

3. Is the patent still in force?

   • No, the patent has expired as it was issued in 2002 and the typical patent term is 20 years from the filing date.

4. How does the patent contribute to the broader patent landscape?

   • The patent builds upon earlier research and patents related to antiviral therapies and is part of a larger global patent landscape.

5. What tools can be used to manage and analyze the patent portfolio related to this invention?

   • Tools like Claim Coverage Matrix and interactive claim charts generated by ClaimScape® can be used to manage and analyze the patent portfolio effectively.

Cited Sources

1. Mintz, "Understanding the 2024 USPTO Guidance Update on AI Patent"
2. Google Patents, "Synergistic combinations of zidovudine, 1592U89 and 3TC"
3. Schwegman, "Patent Analytics"
4. USPTO, "Search for patents"
5. DrugPatentWatch, "Patent 6,417,191"

Drugs Protected by US Patent 6,417,191

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 6,417,191

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	9506489	Mar 30, 1995
United Kingdom	9506490	Mar 30, 1995

PCT Information
PCT Filed	March 28, 1996	PCT Application Number:	PCT/EP96/01352
PCT Publication Date:	October 03, 1996	PCT Publication Number:	WO96/30025

International Family Members for US Patent 6,417,191

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	0817637		91171	Luxembourg
European Patent Office	0817637		SPC/GB05/027	United Kingdom
European Patent Office	0817637		300195	Netherlands
European Patent Office	0817637		SPC016/2005	Ireland
European Patent Office	0817637		CA 2005 00028	Denmark
European Patent Office	0817637		288	Finland
European Patent Office	0817637		C300195	Netherlands