Details for Patent: 10,351,517

Which drugs does patent 10,351,517 protect, and when does it expire?

Patent 10,351,517 protects SUNOSI and is included in one NDA.

This patent has twenty-three patent family members in fifteen countries.

Summary for Patent: 10,351,517

Title:	Treatment of sleep-wake disorders
Abstract:	This invention is directed to a method of treating Excessive daytime Sleepiness (EDS) in a subject, comprising the step of administering a therapeutically effective amount of a compound of Formula (I): Formula (I) or a pharmaceutically acceptable salt or ester thereof wherein Rx is a member selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, halogen selected from F, Cl, Br and I, alkoxy containing 1 to 3 carbon atoms, nitro, hydroxy, trifluoromethyl, and thioalkoxy containing 1 to 3 carbon atoms; x is an integer of 1 to 3, with the proviso that R may be the same or different when x is 2 or 3; R1 and R2 can be the same or different from each other and are independently selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, aryl, arylalkyl, cycloalkyl of 3 to 7 carbon atoms; R1 and R2 can be joined to form a 5 to 7-membered heterocycle substituted with a member selected from the group consisting of hydrogen, alkyl, and aryl groups, wherein the cyclic compound can comprise 1 to 2 nitrogen atoms and 0 to 1 oxygen atom, wherein the nitrogen atoms are not directly connected with each other or with the ox en atom.
Inventor(s):	Ahnaou; Abdallah (Berchem, BE), Drinkenburg; Wilhelmus H. I. M. (Molenschot, NL), Palumbo; Joseph (Saint Davids, PA), Sporn; Jonathan (Princeton, NJ)
Assignee:	SK Biopharmaceuticals Co., Ltd. (Seongnam-si, Gyeonggi-do, KR)
Application Number:	15/433,660
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,351,517
Patent Claim Types: see list of patent claims	Use; Delivery;

Analyzing the Scope and Claims of United States Patent 10,351,517: A Comprehensive Guide

Introduction

United States Patent 10,351,517, titled "Treatment of sleep-wake disorders," is a significant patent in the field of pharmaceuticals, particularly focusing on methods for treating Excessive Daytime Sleepiness (EDS). This article will delve into the scope and claims of this patent, as well as the broader patent landscape surrounding it.

Patent Overview

Title and Abstract The patent, issued to treat sleep-wake disorders, specifically addresses methods for treating EDS. The abstract outlines the invention's focus on a method to alleviate EDS in subjects, highlighting the therapeutic approach and the compounds involved[5].

Claim Scope

Importance of Claim Scope

The claim scope in a patent is crucial as it defines the boundaries of the invention and the protection it receives. A well-defined claim scope must balance breadth and specificity to ensure the patent is both enforceable and defensible[3].

Claim Structure

For US Patent 10,351,517, the claims are structured to cover the method of treatment, the specific compounds used, and any variations or embodiments of the method. Here are some key aspects:

• Independent Claims: These claims define the broadest scope of the invention. For example, Claim 1 might describe the general method of treating EDS using a specific compound.
• Dependent Claims: These claims narrow down the scope by adding specific details or limitations to the independent claims. For instance, Claim 2 might specify the dosage or administration route of the compound.
• Claim Language: The language used in the claims must be clear and concise, avoiding ambiguity. The claims should be anchored to the embodiments described in the specification to avoid issues like the abstract idea exception[3].

Prior Art and Novelty

Conducting a Preliminary Search

To ensure the novelty of the invention, a thorough search of prior art is essential. Tools like the USPTO's Patent Public Search, Global Dossier, and international patent databases (such as those provided by the European Patent Office, Japan Patent Office, and World Intellectual Property Organization) are invaluable for this purpose[1].

Avoiding Overly Broad Claims

The claims in US Patent 10,351,517 must be carefully crafted to avoid being overly broad, which could lead to invalidation. The abstract idea exception, as seen in cases like Yu v. Apple Inc., highlights the risks of claims that are too broad and do not improve the relevant technology[3].

Patent Quality and Examination

USPTO's Quality Metrics

The USPTO has defined a quality patent as one that is correctly issued in compliance with all statutory requirements and relevant case law. This includes compliance with 35 U.S.C. 101, 112, 102, and 103. The USPTO's Enhanced Patent Quality Initiative ensures that patents meet these standards, which is crucial for the validity and enforceability of patents like 10,351,517[4].

Examination Process

The examination process involves a thorough review of the patent application to ensure it meets all statutory requirements. The time allotted for examination can vary, and the USPTO has increased the time available for certain art units to ensure a more thorough search and review[4].

International Patent Landscape

Global Dossier and International Databases

To understand the global patent landscape, tools like the Global Dossier and international patent databases are essential. These resources provide access to the file histories of related applications from participating IP Offices, allowing users to see the patent family for a specific application and related citation data[1].

Machine Translations and Access

Databases such as esp@cenet from the European Patent Office, the Japan Patent Office, and PATENTSCOPE from WIPO offer machine translations of patents, which can be particularly useful for analyzing international patents related to sleep-wake disorders[1].

Public Search Facilities and Resources

USPTO Public Search Facility

The USPTO Public Search Facility in Alexandria, VA, and Patent and Trademark Resource Centers (PTRCs) provide valuable resources for conducting thorough patent searches. Trained staff are available to assist in using these resources effectively[1].

Online Resources

Online tools like the Patent Public Search, Patent Examination Data System (PEDS), and the Publication Site for Issued and Published Sequences (PSIPS) offer comprehensive access to patent data, which can be crucial for analyzing the scope and claims of a patent like 10,351,517[1].

Key Takeaways

• Claim Scope: The claim scope must be carefully balanced to ensure it is neither too broad nor too narrow.
• Prior Art: A thorough search of prior art is essential to ensure the novelty of the invention.
• Patent Quality: Compliance with statutory requirements and relevant case law is critical for the validity and enforceability of the patent.
• International Landscape: Understanding the global patent landscape through tools like the Global Dossier and international databases is vital.
• Public Resources: Utilizing public search facilities and online resources can significantly aid in patent analysis.

FAQs

Q: What is the importance of claim scope in a patent? A: The claim scope defines the boundaries of the invention and the protection it receives. It must be balanced to ensure the patent is both enforceable and defensible.

Q: How can one ensure the novelty of an invention like that in US Patent 10,351,517? A: Conducting a thorough search of prior art using tools like the USPTO's Patent Public Search and international patent databases is essential.

Q: What are the risks of overly broad claims in a patent? A: Overly broad claims can lead to invalidation due to issues like the abstract idea exception, as seen in cases like Yu v. Apple Inc[3].

Q: How does the USPTO ensure patent quality? A: The USPTO ensures patent quality through its Enhanced Patent Quality Initiative, which includes defining a consistent definition of patent quality and articulating it in agency documents and guidance[4].

Q: What resources are available for conducting a thorough patent search? A: Resources include the USPTO Public Search Facility, Patent and Trademark Resource Centers (PTRCs), and online tools like the Patent Public Search and PEDS[1].

Sources

1. USPTO: "Search for patents - USPTO" - https://www.uspto.gov/patents/search
2. Axsome Therapeutics: "Intellectual Property - Axsome Therapeutics" - https://www.axsome.com/about-axsome/intellectual-property
3. Rimon Law: "The Importance of Getting the Claim Scope Right in a US Patent Application" - https://www.rimonlaw.com/the-importance-of-getting-the-claim-scope-right-in-a-us-patent-application-i/
4. GAO: "Intellectual Property: Patent Office Should Define Quality, Reassess Incentives" - https://www.gao.gov/products/gao-16-490
5. Drug Patent Watch: "Patent 10,351,517. Claims, international patent ..." - https://www.drugpatentwatch.com/p/patent/10351517

Drugs Protected by US Patent 10,351,517

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019		RX	Yes	No	10,351,517					TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	10,351,517					TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)

International Family Members for US Patent 10,351,517

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1890684		301037	Netherlands
European Patent Office	1890684		CA 2020 00016	Denmark
European Patent Office	1890684		122020000015	Germany
European Patent Office	1890684		132020000000040	Italy