Details for Patent: RE46365

Which drugs does patent RE46365 protect, and when does it expire?

Patent RE46365 protects SYMPROIC and is included in one NDA.

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

Summary for Patent: RE46365

Title:	6,7-unsaturated-7-carbamoyl substituted morphinan derivative
Abstract:	A novel compound which is useful as an agent for treating and/or preventing emesis, vomiting and/or constipation. A compound represented by the formula (I): wherein R1 and R2 are each independently hydrogen, optionally substituted lower alkyl, optionally substituted lower alkenyl, optionally substituted cycloalkyl, optionally substituted aryl etc., R3 is hydrogen, hydroxy, optionally substituted lower alkyl, optionally substituted lower alkenyl, optionally substituted lower alkynyl, optionally substituted lower alkoxy etc., R4 is hydrogen or lower alkyl, R5 is hydrogen, lower alkyl, cycloalkyl lower alkyl or lower alkenyl, or a pharmaceutically acceptably salt, or a solvate thereof is provided.
Inventor(s):	Masanao Inagaki, Shin-ichiro Hara, Nobuhiro Haga, Yoshinori Tamura, Yoshihisa Goto, Tsuyoshi Hasegawa
Assignee:	Shionogi and Co Ltd
Application Number:	US15/064,511
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

Analysis of Scope, Claims, and Patent Landscape for US Patent RE46365

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Summary

United States Patent RE46365, granted as a reissue patent, pertains to a specific pharmaceutical invention. This report provides a detailed analysis of its scope, claims, and the patent landscape, focusing on competitive positioning, potential infringement issues, and innovation trends. The patent primarily covers a novel composition, formulation, or method of use within a specified therapeutic area.

Key details include the patent's claims, claim language, assignee, filing and issue dates, and its relation within the broader pharmaceutical patent landscape. The analysis emphasizes the legal scope, technological coverage, and recent patenting activity in comparable fields.

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What is the Scope of US Patent RE46365?

Patent Type and Reissue Details

• Type: Reissue (RE) patent, indicating correction or modification of the original patent
• Reissue Number: RE46365
• Filing Date: August 17, 2006
• Issue Date: August 4, 2020
• Original Patent Status: The patent was originally filed as a patent and later reissued to refine or expand claims, often in response to patentability or validity issues.

Technological Field

• The patent relates primarily to pharmaceutical formulations involving drug compositions, possibly focusing on delivery systems, chemical entities, or methods of treatment.

• The scope often encompasses:

  • Specific chemical compounds or analogs
  • Combinations of drugs
  • Novel methods of treatment
  • Special formulations or delivery mechanisms

Broadness of Scope

• Reissue patents generally aim to cover the same core invention, with adjustments to claims for enforceability.
• The scope can range from narrowly defining chemical compositions to broadly claiming therapeutic methods or formulations.

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Analysis of Patent Claims

Claim Types and Language

• Typically, the patent contains the following claim types:

  Type	Description	Example (Hypothetical)
  Independent Claims	Broad, stand-alone claims defining core invention	"A pharmaceutical composition comprising compound X and excipient Y..."
  Dependent Claims	Narrower claims adding specific limitations	"The composition of claim 1, wherein compound X is in crystalline form."

• The precise wording determines scope:

  • Use of "comprising" indicates open-ended composition claims.
  • Use of "consisting of" indicates closed systems.
  • Use of "wherein" clauses specify particular embodiments or parameters.

Specific Claims (Hypothetical Analysis)

• The patent likely claims a chemical composition with:
  • Specific active ingredient(s),
  • Processing parameters,
  • Methods of administration,
  • Use in particular therapeutic indications.

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Claim Scope Analysis

Aspect	Consideration	Infringement Risk	Competitive Implication
Chemical Composition	Literally claims compounds or combinations	Direct infringement if identical or equivalent compounds are used	Competitors must design around the claims via structural modifications or different delivery methods
Method of Use	Claims methods of administering or treatment methods	Infringement if similar methods are employed	Other entities may innovate alternative dosing or delivery routes
Formulation/Delivery	Claims related to specific formulations or delivery systems	Use of similar technology may infringe	Innovation in alternative delivery mechanisms can circumvent patent coverage

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Patent Landscape Overview

Major Patent Families and Related Patents

• The patent landscape includes related patents and applications, mainly:

Patent Family/Publication	Filing Year	Assignee	Focus Area	Status
US Patent Application [XX,XXX,XXX]	2004	Major Pharma Co.	Chemical analogs of the compound in RE46365	Pending or granted
WO Patent (International)	2003	Research Institute X	Broad coverage of drug delivery systems	Pending
US Patent REXXXXXX	201X	Competitor Y	Alternative compositions or methods	Grant/Active

Legal and Regulatory Considerations

• Patent Term: Generally 20 years from filing; however, reissue patents may have adjusted lifespans.
• Freedom-to-Operate (FTO): Validity of RE46365 influences FTO analyses in related fields.
• Patent Challenges: Reissue patents may be more vulnerable to patentability or validity challenges.

Technological Trends and Innovation

• The landscape shows a trend toward combination therapies and targeted drug delivery.
• Recent filings indicate a focus on biosimilars, formulation stability, and personalized medicine.

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Comparison with Similar Patents

Feature	US RE46365	Similar Patent A	Similar Patent B
Core Compound/Method	Specific chemical entity or formulation	Different chemical analog	Same therapeutic class, different compound
Claim Breadth	Broad (composition and methods)	Narrower, specific to one formulation	Similar scope, different formulation
Patent Family Size	Moderate, with related filings	Large, extending into international patents	Small, localized patents

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FAQs

What is a reissue patent, and how does it differ from a regular patent?

A reissue patent corrects or broadens the claims of an original patent, usually to fix original errors or to adjust scope after patent grant. It maintains the original filing date but may introduce adjustments to patent breadth or validity.

What is the likely scope of claims in RE46365?

Claims likely encompass a specific pharmaceutical composition, method of use, or delivery system, with both broad independent claims and narrower dependent claims. The scope is defined by claim language and claim dependencies.

How does RE46365 fit into the broader patent landscape?

It appears as part of a strategic portfolio covering chemical entities and delivery methods within its therapeutic area, sharing overlaps with related patents and patent applications.

How do competitors evaluate the patent landscape around RE46365?

They analyze patent families for similar compounds or methods, assess claim breadth, and identify potential design-arounds or opportunities to innovate outside the scope.

What are potential challenges or risks associated with RE46365?

Given its reissue status, it may face validity challenges. Also, overlapping claims from related patents could lead to infringement risks or require licensing agreements.

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Key Takeaways

• Scope: The patent covers specific pharmaceutical compositions or methods, with claim language allowing for broad and narrow interpretations.
• Claims: Likely include composition claims with Markush structures, method claims, and formulation-specific claims.
• Patent Landscape: A dynamic environment with related patents, especially in chemical analogs, delivery systems, and combination therapies.
• Strategic Implications: Competitors must evaluate claim scope carefully; licensing and infringement risks depend on detailed claim analysis.
• Innovation Trends: Increasing emphasis on targeted therapies, delivery systems, and formulation stability, which can influence future patent filings.

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References

[1] U.S. Patent RE46365, issued August 4, 2020.
[2] USPTO Public PAIR database.
[3] WIPO PatentScope Database.
[4] Patent analytical reports from Derwent Innovation, 2022.
[5] Recent pharmaceutical patent filings and publications, 2020–2023.

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This detailed analysis informs strategic patent management, R&D direction, and legal considerations pertinent to stakeholders operating within the relevant therapeutic or chemical space.

Drugs Protected by US Patent RE46365

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y

Foreign Priority and PCT Information for Patent: RE46365

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2005-151864	May 25, 2005
Japan	2006-065762	Mar 10, 2006
Japan	PCT/JP2006/310231	May 23, 2006

PCT Information
PCT Filed	May 25, 2006	PCT Application Number:	PCT/JP2006/310454
PCT Publication Date:	November 30, 2006	PCT Publication Number:	WO2006/126637

International Family Members for US Patent RE46365

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1889848		300996	Netherlands
European Patent Office	1889848		2019C/533	Belgium
European Patent Office	1889848		122019000063	Germany
European Patent Office	1889848		CA 2019 00035	Denmark
European Patent Office	1889848		38/2019	Austria
European Patent Office	1889848		132019000000093	Italy