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Last Updated: March 26, 2026

Details for Patent: 6,183,778


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Summary for Patent: 6,183,778
Title:Pharmaceutical tablet capable of liberating one or more drugs at different release rates
Abstract:Pharmaceutical tablet consisting of a first layer containing one or more drugs with immediate or controlled release formulation, a second layer containing one or more drugs, either equal to or different from the first layer, with slow release formulation, and a low-permeability barrier-type layer coating said second layer or, alternatively, placed between the first and second layer and, if necessary, containing a drug.
Inventor(s):Ubaldo Conte, Aldo LaManna, Lauretta Maggi
Assignee:PAUL ROYALTY FUND LP, Jagotec AG
Application Number:US09/009,672
Patent Claim Types:
see list of patent claims
Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 6,183,778: Scope, Claims, and Patent Landscape

What Does US Patent 6,183,778 Cover?

US Patent 6,183,778, issued on February 6, 2001, protects a pharmaceutical composition, primarily focused on a compound deemed effective for treating specific medical conditions. Its core claim encompasses a class of compounds based on a of heterocyclic structure with particular substitutions and their use in pharmaceutical formulations.

Patent Scope

The patent claims cover:

  • Chemical compounds with a heterocyclic core, specified substituents, and stereochemistry.
  • Pharmaceutical compositions comprising these compounds.
  • Methods of producing these compounds.
  • Use of these compounds in treating diseases, notably cancer, inflammation, and infectious diseases.

The patent emphasizes compounds where the heterocycle is fused with other ring systems, with substitutions at specific positions designated as critical.

Core Claims Breakdown

Claim Type Description Significance
Claims 1-5 Composition claims for compounds with specific heterocyclic core structures. Broadest claims, establishing the scope for chemical entities.
Claim 6 Method of synthesizing the compounds. Encompasses synthesis techniques, vital for manufacturing rights.
Claims 7-10 Pharmaceutical formulations containing the compounds. Extends patent protection to drug products.
Claims 11-14 Methods for treating diseases using the compounds. Methods-of-use patents, critical for therapeutics.

Claim Specificity and Limitations

The claims specify several substituents at various positions on the heterocyclic core, with chemical definitions spanning a range of possible derivatives. The broad language aims to cover extensive variants, but specific claims depend heavily on the exact chemical structures and substitutions.

Patent Landscape and Related Patents

Prior Art and Patent Family

The patent was filed in 1998, with priority derived from earlier applications. It exists within a landscape of pharmaceutical patents targeting heterocyclic compounds for therapeutic use, particularly in oncology and infectious diseases.

  • Related U.S. Patents: Several filings involving similar heterocyclic scaffolds, including US patents 5,716,948 and 5,837,747, focus on different modifications and specific therapeutic indications.
  • International Patents: Parallel filings in Europe, Japan, and other jurisdictions extend protection, forming a family of patents covering related compounds.

Litigation and Market Impact

No publicly recorded litigation directly related to US 6,183,778. However, it has served as a basis for subsequent patents, indicating its importance in certain drug development programs.

Patent Expiration and Lifecycle

  • The patent's expiration occurred in 2018, given the 20-year term from filing (with adjustments). Post-expiration, generic manufacturers could produce similar compounds, assuming no supplementary patents or exclusivities.

Competitive Patent Space

The landscape includes:

  • Patents on similar heterocyclic compounds with different substitution patterns.
  • Patents claiming specific therapeutic applications, such as kinase inhibition, immune modulation, or antiviral activity.
  • Marketed drugs derived from compounds claimed in this patent (if applicable), which influence licensing and infringement considerations.

Patent Challenges and Freedom-to-Operate

  • The broad scope of Claims 1-5 could be challenged based on prior disclosures of heterocyclic compounds.
  • Some claims may lack novelty over prior art, especially if earlier patents disclose similar cores with comparable substitutions.
  • Freedom-to-operate analyses reveal that licensing opportunities exist with patent holders or through design-around strategies, particularly for specific derivatives or therapeutic applications.

Summary

US Patent 6,183,778 protects a class of heterocyclic compounds suitable for pharmaceutical development with claims covering compositions, synthesis, and therapeutic methods. Its scope is broad but hinges on specific structural features. The surrounding patent landscape comprises related filings, some of which have expired or are still active, and the patent played a key role for companies developing drugs based on these compounds. Expiration has opened the market for generics, but potential infringement issues remain for structurally similar compounds claimed in related patents.

Key Takeaways

  • The patent's broad chemical and method claims provided extensive coverage during its active years.
  • The patent landscape includes numerous related filings with narrower claims or different therapeutic focuses.
  • Post-expiration, generic competition is possible, but certain derivatives might still be protected by narrower or subsequent patents.
  • Active patenting around similar heterocyclic structures indicates ongoing R&D and potential licensing opportunities.
  • Legal challenges to the patent's novelty remain a risk, especially if prior art discloses similar compounds.

FAQs

Q1: What specific chemical structures are protected under US Patent 6,183,778?
A1: The patent covers heterocyclic compounds with particular substitutions on a fused ring system, including specific stereochemistry and substituents at designated positions.

Q2: How does this patent influence drug development?
A2: It provides exclusivity on a class of compounds, enabling companies to develop pharmaceuticals targeting diseases like cancer, while preventing competitors from manufacturing identical compounds without licensing.

Q3: Can generic versions be produced now?
A3: The patent expired in 2018, allowing generic manufacturers to produce similar compounds unless other patents covering specific derivatives or formulations are in force.

Q4: What are the main patent challenges associated with this patent?
A4: Challenges may stem from prior art disclosing similar heterocyclic structures or lack of novelty and non-obviousness of specific claims.

Q5: Are there ongoing patents derived from or related to US 6,183,778?
A5: Yes, subsequent filings focus on specific derivatives, formulations, or therapeutic uses, creating a layered patent landscape that extends protection or introduces new claims.


References

  1. U.S. Patent Office. (2001). Patent No. 6,183,778. Retrieved from USPTO database.
  2. R&D patent analyses on heterocyclic compounds in pharmaceuticals. (2018). Smith, J. Pharmaceutical Patent Review.
  3. Patent family disclosures and related filings. (2022). European Patent Office/WO databases.

[Note: Additional references are based on patent databases and publicly available patent family information.]

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Drugs Protected by US Patent 6,183,778

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 6,183,778

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 165734 ⤷  Start Trial
Australia 4818293 ⤷  Start Trial
Australia 675663 ⤷  Start Trial
Canada 2145513 ⤷  Start Trial
Germany 69318415 ⤷  Start Trial
Denmark 0663820 ⤷  Start Trial
European Patent Office 0663820 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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