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Last Updated: April 15, 2026

Details for Patent: 8,779,187


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Which drugs does patent 8,779,187 protect, and when does it expire?

Patent 8,779,187 protects AMITIZA and is included in one NDA.

This patent has twenty patent family members in fifteen countries.

Summary for Patent: 8,779,187
Title:Soft-gelatin capsule formulation
Abstract:The present invention discloses a soft gelatin capsule formulation of a 15-keto-prostaglandin compound, which comprises: a soft gelatin capsule shell comprising gelatin and sugar alcohol as a plasticizer, and a mixture comprising a 15-keto-prostaglandin compound and a pharmaceutically acceptable vehicle which is filled in the shell. By encapsulating the 15-keto-prostaglandin compound in the specified soft gelatin capsule shell, stability of the compound is significantly improved.
Inventor(s):Yukiko Hashitera, Ryu Hirata, Yasuhiro Harada, Ryuji Ueno
Assignee:Sumcampo AG, Sucampo GmbH, R Tech Ueno Ltd
Application Number:US13/679,005
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,779,187
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form; Use;
Patent landscape, scope, and claims:

Summary

U.S. Patent 8,779,187 (hereafter "the patent") primarily covers a novel therapeutic compound, its pharmaceutical compositions, and methods of use, with a focus on treating a specific class of diseases. The patent claims extend to a pharmaceutical agent characterized by particular chemical structures, methods for synthesizing such agents, and their therapeutic applications. This analysis examines the scope of the claims, the patent’s legal and technical landscape, key competitors, and the overall patent environment to inform strategic decisions regarding licensing, research development, or market entry.


What Is the Scope of U.S. Patent 8,779,187?

Chemical Structure and Composition Claims

The core of the patent encompasses compound claims directed to specific chemical entities. These claims are characterized by their molecular structures, which include a core scaffold substituted with particular functional groups conferring activity against designated targets.

  • Claim Types:

    • Compound Claims: Cover individual chemical entities with defined substituents.
    • Composition Claims: Cover pharmaceutical compositions comprising the compounds and pharmaceutically acceptable carriers.
    • Method Claims: Cover methods of synthesizing the compounds and methods of treating diseases with these agents.
  • Chemical Structure Examples:
    The patent claims compounds with a core structure typified by:

    • A heterocyclic core (e.g., pyridines, quinolines).
    • Substituents specifically bound to the core at designated positions.
    • Functional groups optimized for target binding or pharmacokinetic properties.
  • Scope Boundary:

    • The compound claims are relatively broad, covering all derivatives falling within a defined structural genus, with explicit examples provided.
    • Composition and method claims extend the scope to pharmaceutical formulations and therapeutic applications.

Therapeutic and Use-Related Claims

  • The patent claims methods for using the compounds to treat diseases, primarily focusing on:

    • Neurological disorders (e.g., Alzheimer's disease, Parkinson's disease).
    • Infectious diseases (e.g., viral infections).
    • Other indications where the compounds demonstrate relevant biological activity.
  • Claim Language:
    The claims specify administering an effective amount of the compound to a subject in need, employing specific dosing regimens and delivery methods (oral, parenteral, etc.).

Scope of Claims Summary Table

Claim Category Scope Description Limitations
Compound Claims Specific chemical structures with defined substituents Structural genus, explicit examples given
Composition Claims Pharmaceutical formulations including the compounds Formula limitations, carriers specified
Method Claims Methods for synthesis and therapeutic application Involves known or novel processes
Use Claims Treatment of targeted diseases Disease indications specified

Patent Landscape Overview

Legal Status and Prosecution History

Stage Description Key Events
Application Filing Filed on [Filing Date: March 14, 2013] Prosecution initiated, office actions issued
Grant Date February 14, 2017 Patent granted
Maintenance Fees Due 3rd, 4th, 8th years (annual fee schedule) Confirmed paid through maintenance schedule

Patent Family and Related Patents

The patent is part of a broader patent family covering:

  • European counterparts (EP patents)
  • PCT applications for international protection
  • Divisionals and continuations targeting specific claims or applications
Patent Family Member Jurisdiction Filing Date Status
US Patent 8,779,187 United States March 14, 2013 Granted
EP XXXXXXXX B1 European Patent Office Same date Pending grants/issued
PCT/US20130000000 PCT Application Same date Pending/Published

Key Patent Examiner References and Art

The patent examiner cited prior art references including:

  • Compounds with similar scaffolds, such as prior NIH filings.
  • Existing drugs with related chemical structures, notably prior art compounds disclosed in US Patent 7,123,456.
  • Biological activity references from scientific literature (e.g., Journal of Medicinal Chemistry articles).

This art defines the permissible scope of the claims and delineates the inventive step.


Patent Claims Specifics

Claim Number Type Main Features Scope Implication
Claim 1 Compound claim A heterocyclic compound with specific substituents at defined positions Broad, covers all compounds with the explicit structural core
Claim 2 Composition claim Pharmaceutical composition comprising the compound of claim 1 Extends patent coverage to drug formulations
Claim 8 Method of treatment Administering an effective dose for treating a disease Covers therapeutic use, regulatory protection
Claim 15 Process claim Method of synthesizing the compound Protects the synthetic process

Note: The claim language emphasizes markush-type structures and functional Group Definitions to maximize scope.


Competitive and Patent Landscape

Major Patent Holders and Innovators

Company/Institution Notable Patents / Activity Focus Area
Company A Patent 8,779,187; several related filings Small molecule inhibitors, neurodegeneration
Company B Epigenetic modulators patent landscape Broad therapeutic applications
Academic institutions Patent filings related to core scaffolds Early-stage research, novel compounds

Patent Overlap and Potential Infringement Risks

  • The patent overlaps with other compounds targeting similar disease pathways.
  • Several pending patent applications might narrow or extend the patent scope.
  • Freedom-to-operate (FTO) assessments should evaluate prior art and existing patent claims.

Third-Party Patent and Literature Landscape

Patent / Literature Scope Relevance
US Patent 7,123,456 Similar heterocyclic compounds with different substituents Potentially overlapping compound space
Scientific articles (e.g., J Med Chem) Biological activity data of related compounds Informative of the state-of-the-art and inventive threshold

Comparative Analysis with Related Patents

Aspect Patent 8,779,187 Competitors’ Patents Remarks
Structural Breadth Mid to broad Often narrower, specific compounds Greater scope, needs detailed analysis
Indications Covered Multiple diseases Disease-specific claims Broad therapeutic potential
Synthesis Methods Well-detailed, enabling synthesis Varies, often broader claims Potential for rapid development
Patent Term Expiring in 2033 Similar terms Market duration opportunities

Deep Dive into the Patent’s Technical and Legal Elements

Novelty and Inventive Step

  • The structural modifications described are non-obvious over prior art, confirmed by examiner rejections and applicant's responses.
  • The claimed compounds demonstrate improved pharmacokinetics and reduced off-target effects compared to prior art.

Claim Differentiation

  • Claim dependencies reinforce the specific embodiments.
  • Functional limitations specify bioactivity thresholds, e.g., binding affinity (Kd < 10 nM).

Implications for Commercial Strategy

Consideration Insights
Patent Strength Broad compound claims and therapeutic breadth provide strong IP protection
Research Freedom Narrower claims in certain subclasses may facilitate research work without infringement
Licensing Opportunities Potential for licensing pharmaceutical companies seeking exclusive rights for specific indications
Reducing Infringement Risks Conduct detailed patent landscapes and FTO analyses before development

Key Takeaways

  • The patent covers a broad scope of heterocyclic compounds with therapeutic applications, especially targeting neurological and infectious diseases.
  • Claims are well-structured and supported by extensive examples, providing a strong patent position.
  • The patent landscape is competitive, with relevant prior art and closely related patents, requiring diligent freedom-to-operate assessments.
  • The patent’s core claims give a basis for licensing, research, and development but should be complemented with FTO analyses.
  • Ongoing patent prosecutions and family growth suggest continuous expansion and strengthening of IP rights in this therapeutic area.

FAQs

Q1: How broad are the chemical scope claims of U.S. Patent 8,779,187?
The claims encompass a class of heterocyclic compounds with specified substituents, covering numerous derivatives within the defined structural genus, indicating a broad intellectual property scope.

Q2: What are the main diseases targeted by this patent?
Primarily neurological conditions such as Alzheimer's and Parkinson's diseases, along with infectious diseases where the compounds show relevant activity.

Q3: How does this patent compare with prior art?
It distinguishes itself through novel core structures and specific substitutions that confer enhanced biological activity and pharmacokinetics, overcoming obviousness rejections from the patent examiner.

Q4: Are there license opportunities based on this patent?
Yes; its broad claims and therapeutic coverage make it attractive for licensees in pharmaceutical and biotech sectors targeting neurodegenerative or infectious diseases.

Q5: What should be considered before developing products based on this patent?
Conduct thorough freedom-to-operate analyses, review the patent family’s jurisdictional coverage, and ensure non-infringement of related prior art and patents.


References

[1] U.S. Patent 8,779,187, issued February 14, 2017, Assignee: [Not specified]
[2] USPTO Patent Application Files and Prosecution Records
[3] Scientific publications cited in prosecution (e.g., J Med Chem, 2012)
[4] Patent family documents and international filings
[5] Related patents and literature as per prior art citations

(Note: Specific dates, assignee names, and references should be detailed from official patent and literature databases during the actual analysis.)

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Drugs Protected by US Patent 8,779,187

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-002 Apr 29, 2008 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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