Details for Patent: 10,888,558

Which drugs does patent 10,888,558 protect, and when does it expire?

Patent 10,888,558 protects ARAKODA and is included in one NDA.

This patent has eight patent family members in seven countries.

Summary for Patent: 10,888,558

Title:	Regimens of tafenoquine for prevention of malaria in malaria-naive subjects
Abstract:	Methods of prevention of symptomatic malaria in a malaria-naive, G6PD-normal human subject comprising administering to the human subject a compound of Formula (I), a pharmaceutically acceptable salt thereof, or pharmaceutical composition comprising a compound of Formula (I). A compound of Formula (I) can be administered prior to potential exposure of a species of Plasmodium, during potential exposure of a species of Plasmodium, and after potential exposure of a species of Plasmodium. The methods of the invention also pertains to kits comprising specific doses of Formula (I), a pharmaceutically acceptable salt thereof, or pharmaceutical composition comprising a compound of Formula (I), and instructions for administration of dosing quantity and frequency. The methods of the invention also pertain to determining doses of Formula (I) that meet the general regulatory requirement for a drug to be efficacious in the prevention of malaria in malaria-naive subjects. The methods of the invention further pertain to using the described algorithm to derive dosing regimens which can provide protection against symptomatic malaria in malaria-naive, G6PD-normal subjects. ##STR00001##
Inventor(s):	Dow; Geoffrey S. (Washington, DC), Smith; Bryan L. (Chevy Chase, MD), Jones; John P. (Richmond, VA), Shmuklarsky; Moshe (Bethesda, MD), Balasubrahmanyam; Budda (Richmond, VA)
Assignee:	60 Degrees Pharmaceuticals LLC (Washington, DC) The Government Of The United States As Represented By The Secretary Of The Army (Fort Detrick, MD)
Application Number:	16/504,533
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Delivery; Device;

Analyzing the Scope and Claims of United States Patent 10,888,558: A Comprehensive Guide

Understanding the US Patent System

The United States Patent and Trademark Office (USPTO) is the agency responsible for granting U.S. patents and registering trademarks. To analyze a patent, it is crucial to understand the broader patent landscape and the tools available for patent searching and analysis[2].

Finding the Patent

To begin analyzing United States Patent 10,888,558, you need to locate the patent document. The USPTO provides several tools for this purpose:

Patent Public Search

The Patent Public Search tool is a modern web-based application that replaces older tools like PubEast and PubWest. This tool offers enhanced access to prior art and allows users to search for patents using various criteria[1].

Global Dossier

The Global Dossier service provides access to the file histories of related applications from participating IP Offices, including the IP5 Offices. This can help in understanding the patent family and related applications[1].

Analyzing Patent Claims

Patent claims are the heart of any patent, defining the scope of protection.

Patent Claims Research Dataset

The USPTO's Patent Claims Research Dataset contains detailed information on claims from U.S. patents granted between 1976 and 2014 and U.S. patent applications published between 2001 and 2014. This dataset can help in understanding claim-level statistics and the dependency relationship between claims[3].

Claim Structure

To analyze the claims of Patent 10,888,558, you need to identify the independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims.

Understanding Patent Scope

The scope of a patent is determined by its claims, and several metrics can be used to measure this scope.

Patent Scope Measurements

The USPTO's Economic Working Paper 2016-04, "Patent Claims and Patent Scope," discusses newly-developed measures of patent scope. These measurements help in understanding the breadth and complexity of the patent claims[3].

Reviewing Prior Art

Prior art is crucial in determining the novelty and non-obviousness of the invention.

Common Citation Document (CCD)

The CCD application consolidates prior art cited by all participating IP5 Offices for the family members of a patent application. This helps in visualizing the search results for the same invention produced by several offices on a single page[1].

Legal and Policy Considerations

The legal and policy landscape surrounding patents can significantly impact the validity and enforceability of a patent.

Leahy-Smith America Invents Act (AIA)

The AIA introduced significant changes to the U.S. patent system, including changes to the number of defendants in a lawsuit and new proceedings that may affect patent litigation. Understanding these changes is essential for analyzing the patent's legal standing[4].

Patent Litigation and Infringement

Patent litigation can be a critical factor in the life of a patent.

Trends in Patent Infringement Lawsuits

The number of patent infringement lawsuits has fluctuated over the years, with significant increases noted in certain periods. For example, the number of lawsuits increased by about a third from 2010 to 2011, partly due to the anticipation of changes in the AIA[4].

Small Claims Patent Court

There have been discussions and studies on the feasibility of a small claims patent court to handle lower-stakes patent disputes more efficiently.

ACUS Study

The Administrative Conference of the United States (ACUS) conducted a study on the potential for a small claims patent court, engaging with various stakeholders and considering legal, policy, and practical aspects[5].

Practical Steps for Analysis

Step 1: Locate the Patent

Use the Patent Public Search tool or the Global Dossier service to find the patent document for United States Patent 10,888,558.

Step 2: Review Claims

Analyze the independent and dependent claims to understand the scope of protection.

Step 3: Examine Prior Art

Use the CCD application to review prior art cited by various IP Offices.

Step 4: Assess Legal and Policy Implications

Consider the impact of the AIA and other legal changes on the patent.

Step 5: Evaluate Litigation Risks

Understand the trends in patent infringement lawsuits and the potential for litigation.

Key Takeaways

• Patent Claims: The claims define the scope of protection and are crucial for understanding the patent.
• Prior Art: Reviewing prior art is essential for determining novelty and non-obviousness.
• Legal Landscape: Changes in the patent system, such as those introduced by the AIA, can significantly impact the patent.
• Litigation: Understanding trends in patent infringement lawsuits is vital for assessing the patent's enforceability.
• Small Claims Court: The potential for a small claims patent court could change how lower-stakes disputes are handled.

FAQs

Q: How can I find the full text of United States Patent 10,888,558?

A: You can use the Patent Public Search tool or the Global Dossier service provided by the USPTO to find the full text of the patent.

Q: What is the significance of independent and dependent claims in a patent?

A: Independent claims define the invention, while dependent claims further limit the independent claims, providing additional specificity.

Q: How does the Common Citation Document (CCD) help in patent analysis?

A: The CCD consolidates prior art cited by all participating IP5 Offices, allowing users to visualize search results on a single page.

Q: What impact did the Leahy-Smith America Invents Act (AIA) have on patent litigation?

A: The AIA introduced changes that affected the number of defendants in lawsuits and introduced new proceedings, which in turn affected patent litigation trends.

Q: Is there a proposal for a small claims patent court in the U.S.?

A: Yes, the Administrative Conference of the United States (ACUS) has conducted a study on the feasibility and potential structure of a small claims patent court.

Sources

1. USPTO - Search for patents: https://www.uspto.gov/patents/search
2. USA.gov - U.S. Patent and Trademark Office (USPTO): https://www.usa.gov/agencies/u-s-patent-and-trademark-office
3. USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
4. GAO - Assessing Factors That Affect Patent Infringement Litigation: https://www.gao.gov/assets/gao-13-465.pdf
5. ACUS - U.S. Patent Small Claims Court: https://www.acus.gov/research-projects/us-patent-small-claims-court

Drugs Protected by US Patent 10,888,558

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
60 Degrees Pharms	ARAKODA	tafenoquine succinate	TABLET;ORAL	210607-001	Aug 8, 2018		RX	Yes	Yes	10,888,558					FOR THE ORAL PREVENTION/PROPHYLAXIS OF MALARIA IN ADULTS, COMPRISING A THREE-PHASE DOSING REGIMEN CONSISTING OF A LOADING/INITIAL DOSE, A MAINTENANCE/EXPOSURE DOSE, AND A TERMINAL/POST-EXPOSURE DOSE

International Family Members for US Patent 10,888,558

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015358566
Australia	2020270452
Canada	2968694
China	107683278
European Patent Office	3212621
Hong Kong	1243704
Singapore	11201704154Q