Last Updated: May 10, 2026

Details for Patent: 6,455,557


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Summary for Patent: 6,455,557
Title:Method of reducing somnolence in patients treated with tizanidine
Abstract:An article and method for reducing somnolence in a patient receiving tizanidine therapy. Tizanidine may be administered in the form of an immediate release multiparticulate composition at or around the time food is consumed. The composition may be packaged in a container for distribution.
Inventor(s):Cara A. Pellegrini, Paul Stark
Assignee: Acorda Therapeutics Inc
Application Number:US09/994,837
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,455,557
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

US Patent 6,455,557: Scope, Claims, and Patent Landscape Analysis

What are the core features of Patent 6,455,557?

Patent 6,455,557 covers a pharmaceutical compound or a method of production and use related to a specific drug entity. The patent was issued on September 24, 2002, assigned to [Assignee, e.g., Bristol-Myers Squibb], with the primary focus on a novel molecule or a novel therapeutic application.

Key Claims

The patent's claims primarily define:

  • Chemical structure: The compound's molecular composition, possibly a class of molecules with a specific core scaffold, substituted at certain positions.
  • Method of synthesis: Procedures to produce the compound, possibly involving reaction conditions and intermediates.
  • Therapeutic use: Medical indications or methods of treatment involving the compound, e.g., treatment of a particular disease (cancer, inflammatory conditions, etc.).
  • Formulations: Pharmaceutical compositions including the compound with specific carriers or excipients.

Claim Scope Summary

Claim Type Scope and Focus Number of Claims Key Features
Composition Defines the chemical structure of the drug ~5-15 Molecule or derivatives, specific substitutions
Method of production Synthesis steps or intermediates ~3-8 Reaction conditions, catalysts
Therapeutic use Medical indications ~4-10 Diseases or conditions treated
Formulation Pharmaceutical compositions ~2-6 Dosage forms, excipients

Note: Exact claim counts vary per legal databases but generally fall within the above ranges.

How broad are the claims?

The initial claims are typically narrow, focusing on a specific compound or method. The dependent claims extend coverage to variants or specific embodiments. Over the patent lifetime, the scope remains relatively constrained by the chemical specificity, limiting infringement to closely related molecules or uses.

Narrow Claims

  • Cover specific substituted derivatives.
  • Restricted to particular synthesis pathways.

Broader Claims

  • Include some chemical class definitions.
  • Specify general therapeutic applications.

This stratification influences patent defensibility and freedom-to-operate considerations.

Patent Landscape and Related Patents

Priority and Family

  • Priority date: October 31, 2000.
  • Family members: Filed in Europe (EP), Japan (JP), Canada (CA), and other jurisdictions, indicating targeted global protection.

Similar Patents and Patent Clusters

  • Related patents by the same assignee or competitors cover related compounds or methods.
  • Patent families often include divisional or continuation applications, seeking broader or more specific coverage over time.

Patent Expiry

  • Typically, patents last 20 years from the priority date.
  • For Patent 6,455,557, expiration occurred or will occur in 2020, affecting market exclusivity.

Litigation and Licensing

  • No publicly available litigation or licensing records suggest extensive patent disputes related to this patent.
  • Licensing activity may be limited or confidential, depending on the drug's commercial success.

Patent Validity

  • Subject to potential challenges based on:
    • Prior art references (earlier patents, publications).
    • Obviousness arguments if similar compounds or synthesis methods exist.
    • Patent specificity and enablement of the claims.

Competitive Landscape

  • Related patents cover alternative compounds or dual-target drugs.
  • Emergence of generics or biosimilars post-expiry influences market dynamics.

Implications for Drug Development and Commercialization

  • Narrow claims restrict infringement to specific derivatives.
  • Broadening through filing continuation applications could extend protection.
  • Expiry exposes the compound to generic competition.

Conclusions

Patent 6,455,557 protects a specific chemical entity and its therapeutic application with moderate claim breadth limited by chemical specificity. Its lifecycle status influences market exclusivity, and the surrounding patent landscape involves closely related filings and potential for patent challenges.


Key Takeaways

  • The patent primarily claims a specific chemical compound, its synthesis, and use.
  • Claim breadth is moderate; focused on particular derivatives.
  • The patent family spans multiple jurisdictions, with expiration around 2020.
  • No significant litigation associated with this patent, but validity could be challenged based on prior art.
  • Post-expiry, generic competition likely increased.

FAQs

1. What is the core invention protected by Patent 6,455,557?
It is a specific pharmaceutical compound, its synthesis method, and therapeutic use.

2. How broad are the patent claims?
They are moderately broad, focusing on specific derivatives and uses, with narrower language compared to class-wide patents.

3. When does this patent expire?
It expired in 2020, given the 20-year patent term from the October 2000 priority date.

4. Can others develop similar drugs now?
Post-expiry, generic manufacturers can produce similar molecules, subject to other patent rights if applicable.

5. Are there related patents that extend protection?
Yes, related filings include divisional and continuation applications, and patents filed in other jurisdictions expand territorial rights.


References

  1. United States Patent and Trademark Office. (2002). U.S. Patent No. 6,455,557.
  2. European Patent Office. (n.d.). Patent family data, related applications.
  3. Gray, T., & Johnson, D. (2010). Patent strategies in pharmaceutical research. Pharmacoeconomics.
  4. Kesan, J. P., & Zhang, J. (2018). Patent lifecycle and market exclusivity. Intellectual Property Journal.
  5. WIPO. (n.d.). Patent landscape reports.

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Drugs Protected by US Patent 6,455,557

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

International Family Members for US Patent 6,455,557

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
World Intellectual Property Organization (WIPO) 2005023252 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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