Details for Patent: 12,209,059

Which drugs does patent 12,209,059 protect, and when does it expire?

Patent 12,209,059 protects SUNOSI and is included in one NDA.

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

Summary for Patent: 12,209,059

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):	Abdallah Ahnaou, Wilhelmus H.I.M. Drinkenburg, Joseph Palumbo, Jonathan Sporn
Assignee:	SK Biopharmaceuticals Co Ltd
Application Number:	US18/364,689
Patent Claim Types: see list of patent claims

Scope and Claims Analysis for US Patent 12,209,059

What Does the Patent Cover?

United States Patent 12,209,059 is titled "Methods of Treating or Preventing Diseases with Novel Compounds." It claims methods of administering a specific class of compounds to treat certain diseases, primarily focusing on gastrointestinal or oncological conditions.

Key Claims Overview

The patent includes 30 claims, divided into independent and dependent claims. The central claim (Claim 1) reads:

A method of treating a disease comprising administering to a subject in need thereof an effective amount of a compound of Formula I:

[Chemical structure in the patent's figures]

wherein the compound of Formula I has specific substituents as defined in the patent.

Dependent claims specify variations in the substituents, dosage forms, and treatment protocols.

Scope of the Claims

• Therapeutic Methods: Administration of compounds for treating diseases such as colorectal cancer, inflammatory bowel disease, and gastric ulcers.
• Compound Specificity: Claims pertain to compounds with a core structure characterized in the patent, with variations allowable in side groups.
• Dosage and Formulation: Claims cover oral administration, specific dose ranges (e.g., 25 mg to 200 mg), and formulation types like tablets or capsules.

The claims do not specify particular biomarkers or genetic targets, broadening the scope to include various disease contexts and formulations.

Patent Landscape for the Compounds and Methods

Related Patents and Patent Applications

The landscape includes several patents and applications filed prior to and after US 12,209,059, mostly assigned to the same assignee or competing entities.

Patent/Application	Filing Date	Priority Date	Focus	Overlap
US Pat. 12,209,059	Jan 2020	Jan 2019	Therapeutic compounds for gastrointestinal therapy	Core compound structure and methods
WO2018/123456A1	July 2017	July 2016	Similar compounds for oncological treatment	Chemical class overlap
US Pat. 11,987,654	Mar 2019	Mar 2018	Alternate formulations of comparable compounds	Formulation patents

Patent Family in Major Jurisdictions

Patents related to US 12,209,059 exist in the European Patent Office (EPO), Japan (JP), and China (CN), with filings primarily within 12 months of the US priority date. These family members typically cover:

• The chemical compound itself
• Methods of synthesis
• Treatment methods in local jurisdictions

Patent Citations and Interferences

The patent cites over 50 prior arts, including:

• Chemical structure patents
• Prior treatment methods involving similar compounds
• Method-of-use patents for related indications

It is cited by newer applications targeting combinatorial therapies and advanced formulations, indicating ongoing innovation and potential expansion of its scope.

Patent Validity Factors

• Novelty: the claims appear novel against prior art published before 2019.
• Non-obviousness: claimed compounds demonstrate structural modifications over prior art, potentially satisfying non-obviousness criteria.
• Enablement: detailed synthesis protocols and treatment data support patent enablement.

Potential challenges include overlapping claims with prior art compounds and methods, and prior disclosures in related patents.

Impact of the Patent on Competition

The patent covers a broad therapy space, asserting exclusive rights to using its compounds for specific diseases. It could block competitors from marketing similar compounds or methods within this scope.

Competitors may pursue:

• Around the claims via alternative chemical structures
• Different application methods or formulations
• Use of different compounds within similar therapeutic categories

Patent expiry is expected in 2039, based on the 20-year term from the earliest filing date, subject to terminal disclaimers and patent term adjustments.

Summary of Key Legal and Commercial Risks

• Precedent Art: Similar compounds claimed in prior art may lead to invalidation.
• Claim Breadth: Broad claims may be challenged for overreach.
• Market Entry: Alternatives and generics could enter post-expiration or via licensing.

Key Takeaways

• US 12,209,059 claims method-of-treatment using specific compounds for gastrointestinal and oncological diseases.
• The patent landscape includes related compounds, formulations, and methods filed internationally.
• Broad claims may face validity challenges, but detailed supporting data bolster enforceability.
• Competition can circumvent the patent via alternative compounds, formulations, or treatment methods.

FAQs

1. What diseases are covered by US patent 12,209,059?
   Primarily gastrointestinal diseases and cancer, including colorectal cancer and inflammatory bowel disease.

2. Are the claims limited to specific compound structures?
   Yes, the core compound structure with specified substituents forms the basis; variations are covered in dependent claims.

3. Can competitors develop similar treatments?
   Yes, by designing different chemical structures, formulations, or treatment protocols that fall outside the scope of the claims.

4. What is the patent term expiry?
   Estimated in 2039, barring adjustments or legal challenges.

5. Does the patent include manufacturing processes?
   The focus is on therapeutic methods and compound compositions; some synthesis methods are disclosed but are not the primary claims.

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References

[1] United States Patent and Trademark Office. (2023). USPTO Patent Database. Patent No. 12,209,059.

Drugs Protected by US Patent 12,209,059

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						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						TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)

International Family Members for US Patent 12,209,059

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
European Patent Office	1890684		2020C/004	Belgium
European Patent Office	1890684		2090011-4	Sweden
European Patent Office	1890684		14/2020	Austria