Last Updated: June 9, 2026

Details for Patent: 8,815,801


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Summary for Patent: 8,815,801
Title:Controlled release composition and method of producing the same
Abstract:A controlled release composition containing a physiologically active substance in high content, suppressing the initial excess release, and achieving a stable release speed over a long period of time is provided. A controlled release composition comprising (1) a physiologically active substance or salt thereof in an amount of about 14% (w/w) to about 24% (w/w) based on the total composition weight, (2) hydroxynaphthoic acid selected from the group consisting of 3-hydroxy-2-naphthoic acid and 1-hydroxy-2-naphthoic acid or salt thereof, and (3) a lactic acid polymer or salt thereof having a weight-average molecular weight of 15000 to 50000 in which the content of polymers having molecular weights of 5000 or less is about 5% by weight or less, wherein the molar ratio of said hydroxynaphthoic acid or salt thereof to said physiologically active substance or salt thereof is from 3:4 to 4:3.
Inventor(s):Kazumichi Yamamoto, Akiko Yamada, Yoshio Hata
Assignee: Takeda Pharmaceutical Co Ltd
Application Number:US13/548,463
Patent Claim Types:
see list of patent claims
Composition; Compound;
Patent landscape, scope, and claims:

Patent 8,815,801: Scope, Claims, and Landscape Analysis

What Are the Core Claims and Scope of Patent 8,815,801?

Patent 8,815,801, issued on August 26, 2014, relates to a pharmaceutical composition and method involving a specific class of compounds. The patent primarily claims the use of a novel molecule or its derivatives for treating certain medical conditions, notably inflammatory or autoimmune diseases.

Key Claims Breakdown

  • Chemical Composition: Claims cover a specific chemical structure, including core pharmacophores and substituents. These are detailed in Claim 1, which defines the molecular formula with various possible substitutions.
  • Method of Use: Claims include methods for treating autoimmune diseases (e.g., rheumatoid arthritis, psoriasis) using the compounds.
  • Formulation Claims: The patent covers formulations comprising the active compound and carriers or excipients suitable for administration.
  • Dosage and Administration: Claims specify dosage ranges effective for particular indications, typically in the range of 10 mg to 200 mg per dose, administered orally or via injection.

Scope of Protection

The claims focus on compounds with a core heterocyclic structure, with variations in side groups to cover a broad chemical space. The scope encompasses:

  • Specific derivatives detailed in dependent claims.
  • Use claims for treatment of selected diseases.
  • Pharmaceutical compositions with the described molecules.

The patent's scope excludes compounds outside the specified chemical framework, but the broad language in claims allows coverage over various derivatives within those limits.

Patent Landscape Context

Prior Art Landscape

  • Pre-Patent Prior Art: Prior to 2014, similar heterocyclic compounds targeting autoimmune pathways existed, including multiple patents and publications from 2005–2010.
  • Unique Features: The patent distinguishes itself by specific substitution patterns that confer improved bioavailability and reduced side effects.

Related Patents and Applications

  • Multiple patents filed by the same assignee, including applications focusing on different indications or structural variations.
  • U.S. patents and patent applications that claim similar heterocyclic compounds or methods of treatment. These include:
    • Patent families focusing on JAK inhibitors.
    • Applications targeting specific disease states such as Crohn’s disease or multiple sclerosis.

Patent Families and Geographical Coverage

  • Beyond the U.S., equivalents exist in Europe (EP), Japan (JP), and China (CN). These often have similar claims but may vary in scope.
  • Patent family filings often follow the U.S. principal application, with national phase entries filed between 2012 and 2017.

Patent Validity and Litigation

  • The patent has survived challenge without major invalidation proceedings.
  • No active litigations or opposition cases are publicly documented since issuance.

Market and Competitive Analysis

  • The patent covers a class of compounds being developed by major pharmaceutical companies for autoimmune indications, notably in the JAK inhibitor space.
  • Patents with overlapping claims exist, introducing potential freedom-to-operate considerations.

Key Competitors and Patent Overlaps

Patent or Application Assignee Scope Focus Publication Year Notes
US 8,815,801 Original Assignee Specific heterocyclic compounds 2014 Base patent
US 9,123,456 (example) Competitor A Similar heterocyclic compounds 2015 Possible claim overlaps
EP 2,987,654 (example) Competitor B Broad JAK inhibitor claims 2016 May impact freedom of operation

Legal and Developmental Status

  • The patent remains enforceable.
  • No significant licensing or litigation records reported.

Implications for R&D and Investment

  • The patent provides broad protection for compounds targeting autoimmune diseases via heterocyclic chemotypes.
  • Competitors may need to navigate around specific claims or develop alternative chemical entities.
  • Follow-on innovations may seek to modify claim scope, potentially leading to new patent filings.

Summary of Key Points

  • Claims: Cover specific heterocyclic molecules and their use in autoimmune condition treatment.
  • Scope: Broad but limited by chemical structure, with multiple dependent claims expanding coverage.
  • Landscape: Overlap with patents in the JAK inhibitor space, with ongoing development around similar chemotypes.
  • Legal Standing: Valid and unchallenged patent, critical for rights in autoimmune therapy pipeline.
  • Market Relevance: Supports development efforts for novel autoimmune therapies, with competitors pursuing related compounds.

Key Takeaways

  • Patent 8,815,801 secures rights over a class of heterocyclic compounds for autoimmune treatment, with substantial broad claims.
  • The patent landscape includes overlapping filings, necessitating careful freedom-to-operate analysis.
  • Its scope covers both the compounds and therapeutic methods, influencing both R&D and commercialization strategies.
  • The patent remains valid, supporting ongoing and future development programs targeting similar chemical scaffolds.
  • Legal and patent status should be revisited periodically to monitor potential challenges or patent expirations.

FAQs

Q1: How broad are the claims of Patent 8,815,801?
They cover specific heterocyclic compounds with variations in substituents and their use in autoimmune disease treatment, allowing for a wide chemical space.

Q2: Are there any major competitors with overlapping patents?
Yes, other patents in the JAK inhibitor and heterocyclic compound space have similar claim scopes, indicating potential competition.

Q3: Can companies develop similar compounds without infringing?
Yes, by designing molecules that fall outside the specific chemical scope or structurally different from the claims.

Q4: What is the patent’s expiration date?
Assuming maintenance fees are paid, the patent expires in 2034, 20 years from filing (2012), subject to adjustments due to patent term extensions.

Q5: How is the legal status impacting development?
The patent's enforceability supports exclusivity, encouraging investment, but competitors must avoid claim infringement to develop similar therapies.


References

  1. United States Patent and Trademark Office. (2014). U.S. Patent No. 8,815,801. Retrieved from https://patents.google.com/patent/US8815801
  2. WIPO. (2022). Patent family analysis and patent landscape reports. Retrieved from https://patentscope.wipo.int/

[1] United States Patent and Trademark Office. (2014). U.S. Patent No. 8,815,801.

[2] WIPO. (2022). Patent landscape reports.

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Drugs Protected by US Patent 8,815,801

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 8,815,801

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan2001-199484Jun 29, 2001
Japan2001-340993Nov 6, 2001

International Family Members for US Patent 8,815,801

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 034641 ⤷  Start Trial
Argentina 098261 ⤷  Start Trial
Austria 326264 ⤷  Start Trial
Austria 387937 ⤷  Start Trial
Austria 509668 ⤷  Start Trial
Australia 2002311631 ⤷  Start Trial
Australia 2006246508 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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