Details for Patent: 10,220,023

Which drugs does patent 10,220,023 protect, and when does it expire?

Patent 10,220,023 protects PONVORY and is included in one NDA.

This patent has seventy-eight patent family members in thirty-six countries.

Summary for Patent: 10,220,023

Title:	Dosing regimen for a selective S1P.sub.1 receptor agonist
Abstract:	The present invention relates to a dosing regimen for (R)-5-[3-chloro-4-(2,3-dihydroxy-propoxy)-benz[Z]ylidene]-2-([Z]-propylim- ino)-3-o-tolyl-thiazolidin-4-one.
Inventor(s):	Dingemanse; Jasper (Allschwil, CH), Hoch; Matthias (Harston, GB), Krause; Andreas (Allschwil, CH)
Assignee:	ACTELION PHARMACEUTICALS LTD (Allschwil, CH)
Application Number:	15/534,929
Patent Claim Types: see list of patent claims	Use;

Understanding the Scope and Claims of United States Patent 10,220,023

Introduction

United States Patent 10,220,023, issued on March 5, 2019, is a significant patent in the pharmaceutical industry, particularly in the field of immunomodulatory therapies. This patent, assigned to Actelion Pharmaceuticals Ltd., pertains to a dosing regimen for a selective S1P1 receptor agonist. Here, we will delve into the details of the patent, including its scope, claims, and the broader patent landscape.

Patent Overview

The patent titled "Dosing regimen for a selective S1P1 receptor agonist" describes a specific dosing regimen for the compound (R)-5-[3-chloro-4-(2,3-dihydroxy-propoxy)-benz[Z]ylidene]-2-([Z]-propylimino)-3-o-tolyl-thiazolidin-4-one, hereinafter referred to as "Compound 1"[4].

Inventors and Assignees

The inventors listed on the patent are Jasper Dingemanse, Matthias Hoch, and Andreas Krause. The assignee is Actelion Pharmaceuticals Ltd., a company known for its innovative approaches in treating diseases associated with an activated immune system[2][4].

Claims

The claims section of the patent is crucial as it defines the scope of protection for the invention. Here are some key aspects of the claims:

• Dosing Regimen: The patent claims a specific dosing regimen for Compound 1, which includes an initial titration phase followed by a maintenance dose. This regimen is designed to minimize adverse effects during the initiation or re-initiation of treatment[4].
• Therapeutic Use: The claims specify the use of Compound 1 in the treatment and/or prevention of diseases or disorders associated with an activated immune system, such as multiple sclerosis[4].
• Pharmacological Effects: The patent describes the pharmacological effects of Compound 1, including its ability to reduce the number of peripheral blood lymphocytes in a consistent, sustained, and dose-dependent manner[4].

Specification

The specification section provides a detailed description of the invention, including:

• Related Prior Art: A discussion of previously issued patents and other publications relevant to the invention.
• Description of Drawings: Although not required for process or method inventions, any drawings included must conform to patent office guidelines and clearly illustrate the technical details of the invention[1].
• Technical Problem: The specification explains how the invention solves a specific technical problem, in this case, the need for an effective and safe dosing regimen for a selective S1P1 receptor agonist.
• Preferred Embodiment: The preferred embodiment of the invention is described in sufficient detail so that anyone of ordinary skill in the same technical field can understand and replicate it[1].

Patent Landscape

The patent landscape surrounding US 10,220,023 is complex and involves several related patents and exclusivities:

• Related Patents: Other patents held by Actelion Pharmaceuticals Ltd. include those related to thiazolidin-4-one derivatives and their use in treating immune system disorders. These patents, such as US 8,273,779 and US 9,000,018, also expire at different dates, with some expiring as early as November 2024[2].
• Exclusivities: The FDA grants exclusivity periods that can run concurrently with patent protection. For the drug related to this patent, a new chemical entity exclusivity period is set to expire on March 18, 2026[2].

Genus Claims and Enablement

In the pharmaceutical and biotechnology industries, genus claims are common but have become increasingly challenging due to recent jurisprudence. The Federal Circuit’s heightened test for enablement and the broader application of the written description doctrine have created uncertainty. For patents like US 10,220,023, the scope of claims must be carefully drafted to ensure they are neither too broad nor too narrow, as both scenarios can lead to significant issues in patent protection[3].

Patent Expiration and Impact

The patent is set to expire on December 10, 2035. This expiration date is significant because it marks the end of the exclusive rights granted to Actelion Pharmaceuticals Ltd. for this specific dosing regimen. After expiration, generic versions of the drug could potentially enter the market, provided they meet the FDA's bioequivalence requirements and do not infringe on any remaining patents or exclusivities[2].

Clinical and Commercial Implications

The dosing regimen described in US 10,220,023 has clinical and commercial implications:

• Treatment of Diseases: The regimen is designed to treat diseases associated with an activated immune system, such as multiple sclerosis. This provides a specific treatment option for patients and a market opportunity for the pharmaceutical company.
• Competitive Landscape: The patent protection and exclusivity periods give Actelion Pharmaceuticals Ltd. a competitive advantage in the market. However, as patents expire and generic versions become available, the competitive landscape may change[4].

Key Takeaways

• Specific Dosing Regimen: The patent describes a specific dosing regimen for a selective S1P1 receptor agonist to minimize adverse effects.
• Therapeutic Use: The invention is used to treat diseases associated with an activated immune system.
• Patent Landscape: The patent is part of a broader landscape involving related patents and FDA exclusivities.
• Expiration Date: The patent expires on December 10, 2035, which will impact the exclusive rights of Actelion Pharmaceuticals Ltd.
• Clinical and Commercial Implications: The patent has significant implications for both clinical treatment options and the commercial market.

FAQs

Q: What is the main subject of United States Patent 10,220,023? A: The main subject is a dosing regimen for a selective S1P1 receptor agonist, specifically the compound (R)-5-[3-chloro-4-(2,3-dihydroxy-propoxy)-benz[Z]ylidene]-2-([Z]-propylimino)-3-o-tolyl-thiazolidin-4-one.

Q: Who are the inventors listed on the patent? A: The inventors are Jasper Dingemanse, Matthias Hoch, and Andreas Krause.

Q: What is the assignee of the patent? A: The assignee is Actelion Pharmaceuticals Ltd.

Q: What is the expiration date of the patent? A: The patent is set to expire on December 10, 2035.

Q: What are the clinical implications of this patent? A: The patent describes a dosing regimen for treating diseases associated with an activated immune system, such as multiple sclerosis.

Cited Sources

1. How to Read a U.S. Patent - Research Guides, Queens University Library.
2. Generic Ponvory Availability - Drugs.com.
3. Eviscerating Patent Scope - DigitalCommons@NYLS.
4. US10220023B2 - Dosing regimen for a selective S1P1 receptor agonist - Google Patents.

Drugs Protected by US Patent 10,220,023

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-001	Mar 18, 2021		RX	Yes	Yes	10,220,023					TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-002	Mar 18, 2021		RX	Yes	No	10,220,023					TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-003	Mar 18, 2021		RX	Yes	No	10,220,023					TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-004	Mar 18, 2021		RX	Yes	No	10,220,023					TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-005	Mar 18, 2021		RX	Yes	No	10,220,023					TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-006	Mar 18, 2021		RX	Yes	No	10,220,023					TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE

Foreign Priority and PCT Information for Patent: 10,220,023

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	PCT/EP2014/077469	Dec 11, 2014
	PCT/EP2015/058202	Apr 15, 2015

PCT Information
PCT Filed	December 10, 2015	PCT Application Number:	PCT/EP2015/079208
PCT Publication Date:	June 16, 2016	PCT Publication Number:	WO2016/091996

International Family Members for US Patent 10,220,023

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3256125		301174	Netherlands
European Patent Office	3256125		PA2022505	Lithuania
European Patent Office	3256125		2022C/515	Belgium
European Patent Office	3256125		LUC00262	Luxembourg
European Patent Office	3256125		122022000027	Germany
European Patent Office	3256125		CA 2022 00026	Denmark