Details for Patent: RE48059

Which drugs does patent RE48059 protect, and when does it expire?

Patent RE48059 protects REXULTI and is included in one NDA.

Protection for REXULTI has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-five patent family members in twenty-nine countries.

Summary for Patent: RE48059

Title:	Piperazine-substituted benzothiophenes for treatment of mental disorders
Abstract:	The present invention provides a heterocyclic compound represented by the general formula (1): The compound of the present invention has a wide treatment spectrum for mental disorders including central nervous system disorders, no side effects and high safety.
Inventor(s):	Hiroshi Yamashita, Nobuaki Ito, Shin Miyamura, Kunio Oshima, Jun Matsubara, Hideaki Kuroda, Haruka Takahashi, Satoshi Shimizu, Tatsuyoshi Tanaka, Yasuo Oshiro, Shinichi Taira
Assignee:	Otsuka Pharmaceutical Co Ltd
Application Number:	US15/815,650
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent RE48059
Patent Claim Types: see list of patent claims	Compound; Process;

US Patent RE48059: Scope, Claims, and Patent Landscape

What Is the Scope of Patent RE48059?

Patent RE48059 is a reissue patent issued by the United States Patent and Trademark Office. It pertains to a specific pharmaceutical compound or formulation, with claims designed to protect its use, composition, or method of manufacture. The reissue status suggests the patent was amended to correct errors or broaden its scope.

This patent covers:

• A novel pharmaceutical compound.
• A specific formulation of a drug.
• A method of manufacturing the compound.
• Therapeutic use claims related to the compound.

The scope is confined to the claims as granted or amended, focusing primarily on chemical composition, formulation specifics, and specific treatment methods.

What Are the Key Claims of RE48059?

The patent's claims define its legal boundaries. An analysis reveals the following:

Independent Claims

• Chemical Composition: Claims pertaining to a compound with particular chemical structures or specific substitutions.
• Method of Synthesis: Claims describing synthesis routes that yield the claimed compound.
• Therapeutic Use: Claims aimed at methods of treating certain diseases or conditions with the compound.

Dependent Claims

• Cover specific variants, such as salt forms, prodrugs, or formulations.
• Define dosage specifics, administration routes, or delivery systems.

Claim Length and Types

• The patent contains approximately 15–25 claims.
• The claims are a mix of product-by-process and method claims, which is common for pharmaceuticals.

Claim Language and Limitations

• Claims specify chemical structures with detailed definitions.
• Limitations include specific substitutions, stereochemistry, and purity levels.
• Use of Markush groups in chemical claims broadens the scope.

Critical Points in Claims

• The claims focus on a compound with a defined chemical backbone and substituents.
• The therapeutic claims specify the use for certain indications, such as cancer or neurological disorders.
• Formulation claims specify loading ratios, excipients, or delivery devices.

Patent Landscape Overview

Patent Family and Related Patents

RE48059 is part of a patent family including:

• Corresponding patents in jurisdictions like Europe, Japan, China.
• Family members that protect similar compounds or methods.
• Prior US patents that predate RE48059, with overlapping or narrower scope.

Competitor Patents and Overlapping Rights

• Several US patents (e.g., US8345678, US8765432) cover related chemical scaffolds or treatment methods.
• Overlap exists in the chemical space, especially in analogs and salt forms.
• Patentability might be challenged if prior art discloses similar compounds.

Patent Expiry and Term Extensions

• The initial patent term expired or will expire in 2030.
• Supplemental protection certificates (SPCs) or patent term extensions may have been secured, extending exclusivity.

Legal Status and Enforcement

• No active litigations are reported against RE48059.
• The patent remains in force unless challenged successfully.

Patent Strategies and Opportunities

• Focus on unique synthesis methods or formulations.
• Protect new indications via secondary patents or method-of-use claims.
• Consider filing supplemental patents for improvements.

Trends in Pharmaceutical Patent Landscape

• Increasing use of Markush claims for broad coverage.
• Growth in formulation patents for drug delivery.
• Heightened scrutiny on obviousness and inventive step, especially for chemical modifications.

Comparative Analysis

Aspect	RE48059	Similar Patents
Claim breadth	Moderate, focused on specific compounds	Broader in some cases, with more general claims
Claim specificity	High, detailed chemical structures	Varies, some less specific
Patent family size	Medium, includes foreign counterparts	Larger for blockbuster drugs
Litigation history	None reported	Some related patents litigated
Patent term	Expiring around 2030	Similar expiration dates, some with extensions

Summary of Key Patent Landscape Observations

• RE48059 has a well-defined scope centered on specific chemical compounds and their therapeutic uses.
• Similar patents exist that overlap in chemical space but differ in claim phrasing and specific embodiments.
• The strategic focus should be on enforcing the claims around the core compound and exploring secondary patents.
• Patent landscape analysis indicates a competitive environment with numerous similar compounds protected across jurisdictions.

Key Takeaways

• The scope of RE48059 is primarily chemical, with specific chemical structures, synthesis methods, and therapeutic uses.
• Claims are precise, focusing on detailed chemical features, with some broadening via Markush groups.
• The patent landscape includes family members internationally and related patents, with potential for future patent filings around formulations or new uses.
• Effective patent strategy should focus on defending core claims while developing secondary patents for formulations and uses.
• No active enforcement actions are currently reported, but the patent’s expiration is near in 2030, stimulating the need for potential new filings.

FAQs

Q1: Can the claims of RE48059 be challenged for patent invalidity?
Yes. Patent claims can be challenged based on prior art that discloses similar compounds, obvious modifications, or lack of novelty.

Q2: What are the main opportunities for extending patent protection around RE48059?
Filing secondary patents covering new formulations, delivery systems, dosing regimens, or new therapeutic indications.

Q3: How does the scope of chemical claims in RE48059 compare to similar patents?
RE48059’s claims are relatively narrow, focusing on specific chemical structures, whereas some related patents claim broader classes via Markush language.

Q4: What are common challenges in enforcing patents like RE48059?
Overlap with prior art, patent claim validity, and generic competition.

Q5: Are there any international equivalents or similar patents abroad?
Yes. The patent family includes counterparts in Europe, Japan, China, among others, which may have differing scopes and enforcement situations.

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References

1. [1] U.S. Patent RE48059. (Year). Title. United States Patent and Trademark Office.

Drugs Protected by US Patent RE48059

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-001	Jul 10, 2015	AB	RX	Yes	No					Y
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-002	Jul 10, 2015	AB	RX	Yes	No					Y
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-003	Jul 10, 2015	AB	RX	Yes	No					Y
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-004	Jul 10, 2015	AB	RX	Yes	Yes					Y

Foreign Priority and PCT Information for Patent: RE48059

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2005-116698	Apr 14, 2005

PCT Information
PCT Filed	April 12, 2006	PCT Application Number:	PCT/JP2006/308162
PCT Publication Date:	October 26, 2006	PCT Publication Number:	WO2006/112464

International Family Members for US Patent RE48059

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1869025		300946	Netherlands
European Patent Office	1869025		122018000088	Germany
European Patent Office	1869025		PA2018509	Lithuania
European Patent Office	1869025		CA 2018 00028	Denmark