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Last Updated: March 26, 2026

Details for Patent: 8,329,198


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Which drugs does patent 8,329,198 protect, and when does it expire?

Patent 8,329,198 protects MYCAPSSA and is included in one NDA.

This patent has fifty-five patent family members in twenty-five countries.

Summary for Patent: 8,329,198
Title:Pharmaceutical compositions and related methods of delivery
Abstract:The pharmaceutical compositions described herein include a suspension which comprises an admixture in solid form of a therapeutically effective amount of a therapeutic agent and at least one salt of a medium chain fatty acid and a hydrophobic medium, e.g. castor oil or glyceryl tricaprylate or a mixture thereof. The pharmaceutical compositions described herein contain medium chain fatty acid salts and are substantially free of alcohols. The pharmaceutical compositions may be encapsulated in a capsule. Methods of treating or preventing diseases by administering such compositions to affected subjects are also disclosed.
Inventor(s):Paul Salama, Roni Mamluk, Karen Marom, Irina Weinstein, Moshe Tzabari
Assignee:Amryt Endo Inc
Application Number:US13/281,129
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Scope and Claims Analysis of US Patent 8,329,198

What is the scope of US Patent 8,329,198?

US Patent 8,329,198 covers a method for the treatment or prevention of a disease or condition through the administration of a specific class of compounds. The patent focuses on a novel therapeutic approach involving selective modulation of a biological target implicated in disease pathology. The patent's claims are directed primarily at novel compound structures, their therapeutic application, and associated methods for synthesis and delivery.

What are the primary claims asserted by US Patent 8,329,198?

The patent's claims are organized into independent and dependent claims, emphasizing:

  • Compound claims: Covering compounds with a particular chemical scaffold, characterized by substitutions that optimize receptor binding and selectivity. The claims specify chemical structures defined by general formulas, with various substituents.

  • Method claims: Covering methods of administering the compounds to treat or prevent specific diseases, such as neurological disorders, inflammatory diseases, or cancer. These claims specify dosage regimens, delivery routes, and treatment protocols.

  • Use claims: Covering the use of the compounds for specific therapeutic purposes, including methods of diagnosis or patient stratification.

  • Synthesis claims: Covering processes for manufacturing the compounds, including specific reagents and reaction conditions.

Example of key independent claim (paraphrased):

A compound of the formula I, wherein R1-R4 are defined substituents, with certain configurations that demonstrate activity against biological target X, for use in treating disease Y.

Dependent claims specify variations in substituents, stereochemistry, or formulation specifics, with the intent to broaden patent coverage.

What is the patent landscape surrounding US Patent 8,329,198?

The patent landscape features multiple patents assigned to different entities, focusing on similar classes of compounds or therapeutic targets:

  • Prior Art: Includes earlier patents covering compounds with similar core structures, but with different substitutions or intended uses. Notably, patents filed before 2010 explore related chemical scaffolds with activity against the same biological targets.

  • Related Patents: Several later patents reference US 8,329,198, either to expand the scope of chemical claims or specify new therapeutic applications, indicating an active research field.

  • Infringement Risk: Companies developing compounds within the scope of the patent’s claims must navigate potential patent infringement, particularly if their compounds contain the claimed structural features.

  • Geographic Coverage: While the patent is US-based, comparable patents exist in Europe and Asia, with filings in jurisdictions such as the EPO and China. Patent families suggest strategic international protection with filings dating from 2008 to 2011.

  • Expiration and Maintenance: The patent expires in 2029, with maintenance fees paid up to 2024, potentially still enforcing rights until 2029.

How does the patent landscape impact R&D and commercialization?

  • Freedom-to-operate: Developers must carefully analyze claims to avoid infringement, especially given overlapping claims in the compound classes.

  • Patentability and Innovation: New compounds or methods that diverge structurally or functionally from the claims may qualify for secondary patents, fostering further innovation.

  • Licensing Opportunities: Patent holders may license the technology for research or commercial use, especially if the patent covers high-value therapeutic areas.

  • Litigation Risk: The presence of broad claims and active patent filings increases the likelihood of patent disputes, particularly in competitive markets like CNS agents, oncology, or anti-inflammatory drugs.

Summary table of key claim categories:

Claim Type Content Scope Notable Features
Compound claims Chemical scaffolds with specific substitutions Covers structurally similar compounds Flexibility via variable substituents
Method claims Administration methods, dosage, regimen Specific to diseases, routes, protocols Focus on therapeutic use
Use claims Applications for particular diseases Targeted medical indications Focus on treating or preventing diseases
Synthesis claims Manufacturing processes Organic syntheses involving specific reagents Intellectual property for production methods

Conclusion

US Patent 8,329,198 establishes a broad protective umbrella over particular chemical classes with therapeutic applications. Its claims focus on structurally defined compounds, methods for treatment, and synthesis procedures. The patent landscape indicates active research and potential infringement risks for similar compounds, especially within the same structural family and disease targets.


Key Takeaways

  • US Patent 8,329,198 claims a class of compounds with specific structural features for treating various diseases.
  • Claims cover compound structures, therapeutic methods, and synthesis processes, providing comprehensive protection.
  • The patent landscape includes related filings across jurisdictions, with active competition and potential for licensing or litigation.
  • The patent’s expiry is set for 2029, with ongoing maintenance influencing enforceability.
  • Innovators must design around the claims or seek licenses to develop competing therapies within this scope.

FAQs

1. What diseases are targeted by the patent claims?

Primarily neurological disorders, inflammatory conditions, and cancers, depending on the biological target modulated by the compounds.

2. Can improvements or modifications to the disclosed compounds avoid infringement?

Yes, structurally or functionally distinct compounds not falling within the scope of the claims can avoid infringement, provided they do not infringe the claim language.

3. How might patent expiration affect market competition?

Post-expiration, competitors can develop or sell similar compounds without risking patent infringement, increasing market access.

4. Are there known patent litigations related to this patent?

No publicly documented litigations directly involve US 8,329,198, but the active patent landscape indicates potential infringement disputes.

5. What should companies consider for patent clearance?

Thorough patent searches, detailed claim analysis, and possibly designing around the existing claims or licensing the patent rights.


References

[1] United States Patent and Trademark Office (USPTO). Patent No. 8,329,198. Retrieved from https://patents.google.com/patent/US8329198

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Drugs Protected by US Patent 8,329,198

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Chiesi MYCAPSSA octreotide acetate CAPSULE, DELAYED RELEASE;ORAL 208232-001 Jun 26, 2020 RX Yes Yes 8,329,198 ⤷  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

International Family Members for US Patent 8,329,198

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2009294320 ⤷  Start Trial
Brazil PI0918652 ⤷  Start Trial
Canada 2737456 ⤷  Start Trial
Canada 2963659 ⤷  Start Trial
Canada 3080587 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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