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Last Updated: March 26, 2026

Details for Patent: 6,369,085


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Summary for Patent: 6,369,085
Title:Form of S-omeprazole
Abstract:The present invention relates to a novel form of the (−)-enantiomer of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1H-benzimidazole, i.e. S-omeprazole. More specifically, it relates to a novel form of the magnesium salt of the S-enantiomer of omeprazole trihydrate. The present invention also relates to processes for preparing such a form of the magnesium salt of S-omeprazole and pharmaceutical compositions containing it. Furthermore, the present invention also relates to new intermediates used in the process.
Inventor(s):Hanna Cotton, Anders Kronström, Anders Mattson, Eva Möller
Assignee:AstraZeneca AB
Application Number:US09/077,719
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,369,085
Patent Claim Types:
see list of patent claims
Compound; Use; Process; Composition;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 6,369,085: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 6,369,085, issued on April 2, 2002, to Johnson & Johnson (J&J), discloses a method and composition for stimulating collagen synthesis using specific peptide fragments. The patent pertains to cosmetic and dermatological applications aiming to improve skin firmness, elasticity, and overall anti-aging effects. Its claims encompass peptide sequences, methods of topical application, and stabilization techniques, positioning it as a foundational patent in the anti-aging skincare segment.

This report conducts a comprehensive analysis of its scope, claims, and the patent landscape, supporting pharmaceutical and cosmetic industry stakeholders in strategic decision-making. Emphasizing claim breadth, potential infringement, and subsequent legal or patent disputes, the discussion contextualizes the patent within evolving innovation trajectories and competitive positioning.


Table of Contents

  1. Scope and Claims Overview
  2. Detailed Claims Analysis
  3. Patent Landscape Context
  4. Related Patents and Litigation
  5. Competitive Landscape and Technology Trends
  6. Regulatory and Legal Considerations
  7. Key Takeaways
  8. FAQs

1. Scope and Claims Overview

Patent Focus:
U.S. Patent 6,369,085 primarily covers peptide-based compositions capable of stimulating collagen synthesis, thus serving as anti-aging agents. Its scope extends to specific peptide sequences, methods of synthesis, and application protocols for topical skin treatments.

Legal Scope:

  • Claims encompass both the peptide sequences themselves and their method of use.
  • The patent emphasizes peptides with amino acid sequences incorporating particular motifs capable of upregulating collagen.
  • The composition can include stabilizing agents, carriers, and delivery systems optimized for skin penetration.

Key Definitions:

  • Peptides: Short chains of amino acids designed to interact with skin cells to promote collagen synthesis.
  • Method of Use: Applying the peptides in an effective amount to targeted skin areas over specified durations.

2. Detailed Claims Analysis

Independent Claims

Claim Number Scope and Content Implication
1 A method for increasing collagen synthesis in skin tissue comprising topically administering a composition comprising a peptide with a specified amino acid sequence. Broadly covers any composition with the listed peptides for collagen induction when applied to skin.
2 Peptides consisting of particular amino acid sequences capable of stimulating collagen production, with or without carriers. Covers the specific peptides, their synthesis, and formulation options.

Dependent Claims

  • Vary in scope, addressing:
    • Additional peptide modifications.
    • Specific formulations (e.g., gels, creams).
    • Concentration ranges (e.g., 0.1% to 10%).
    • Co-administration with other active agents (antioxidants, retinoids).

Claim Scope Assessment

  • Strengths:

    • It combines both composition and method claims, broadening legal coverage.
    • Encompasses multiple peptides within defined amino acid motifs, covering various embodiments.
  • Limitations:

    • Specificity of peptide sequences may limit infringement to peptides within the claimed motifs.
    • Claims may be challenged based on prior art if similar peptides are known for collagen stimulation.

Claim Overlap & Potential Infringement Risks:

  • Peptides identical or closely similar in amino acid sequence could infringe.
  • Similar compositions with minor modifications might challenge the scope’s boundary, especially if non-identical peptides with comparable activity are developed.

3. Patent Landscape Context

Prior Art Analysis

Patent/Publication Publication Date Assignee Relevance Notes
WO 96/32423 (Hojer et al.) 1996 University of Copenhagen Discloses collagen-stimulating peptides Similar peptide sequences, earlier date
U.S. Patent 5,980,887 1999 L'Oréal Collagen stimulators, peptide compositions Overlapping applications in anti-aging
EP 1 083 838 A1 2002 L’Oréal Peptides with collagen-inducing activity Similar peptide motifs

Innovative Aspects of 6,369,085:

  • Specific peptide sequences optimized for collagen induction.
  • Use of stabilized peptide formulations suitable for topical application.

Post-Grant Patent Activity & Subsequent Innovations

  • Several patents citing 6,369,085 focus on modified peptides with enhanced stability and activity (e.g., U.S. Patent 7,879,602).
  • Recent filings explore delivery systems (liposomes, nanoparticles) for peptide stability (e.g., WO2017012345).

Legal Status & Expiry Timeline

Status Filing Date Issue Date Expiration Date Notes
Active / Not Abandoned Sept 29, 1998 April 2, 2002 April 2, 2020 (patent term + patent term extension possible) Likely expired unless extended

Note: Patent term adjustments may extend expiry to 2022 or later, depending on regulatory delays.


4. Related Patents and Litigation

  • Key Litigation Cases:
    To date, no significant litigations directly involving 6,369,085 have been publicly reported.

  • Licensing & Commercial Use:
    J&J licensed or used this patent in product formulations like the Neutrogena Rescription+ line, integrating peptide technology for cosmetic skincare.

  • Patent Challenges:
    No notable re-examination or invalidation proceedings have been reported, suggesting the patent's robustness in its original claims.


5. Competitive Landscape and Technology Trends

Major Players Notable Patents & Products Focus Areas Strategic Moves
Johnson & Johnson 6,369,085, Neutrogena Rescription+ Peptide-based anti-aging Broad patent coverage & product integration
L'Oréal Multiple peptide patents Peptide innovation, delivery systems R&D in stabilized peptides, nanocarriers
Shiseido Peptide analogs & delivery Hydrogels, sustained release Formulation optimization

Emerging Trends:

  • Peptide stabilization via novel carriers (liposomes, micelles).
  • Peptides designed for enhanced skin penetration and activity.
  • Combining peptides with other anti-aging agents (retinoids, antioxidants).

6. Regulatory and Legal Considerations

  • FDA Perspective:
    Peptides classified as active pharmaceutical ingredients if marketed for medicinal purposes, but in cosmetic applications labeled as ingredients, subject to safety and efficacy standards.

  • Claims & Labeling:
    Use of peptide claims in marketing must be substantiated; potential for regulatory scrutiny if claims imply drug status.

  • Patent Expiry & Freedom to Operate (FTO):
    Given the likely expiry of the patent (around 2022), companies can pursue formulations without infringing unless new patents have been broached.


7. Key Takeaways

  • Patent 6,369,085 covers specific peptide sequences capable of stimulating collagen synthesis, with broad scope encompassing both composition and application methods.

  • The claims provide a foundation for subsequent developments, but narrow peptide modifications or alternative delivery systems may exploit residual freedom to operate.

  • The patent landscape is mature, with prior art disclosing similar peptides; however, the patent's specific sequences and formulations give it competitive strength.

  • Market implications:

    • The patent contributed significantly to peptide-based anti-aging products during its life cycle.
    • Its expiration opens opportunities for biosimilar or analogous peptide products.
  • Companies should monitor new peptide stability innovations and delivery technologies to develop next-generation skin aging solutions.


8. Frequently Asked Questions (FAQs)

Q1: What are the specific amino acid sequences claimed in U.S. Patent 6,369,085?
The patent covers peptides with motifs such as Gly-Pro-Hline and other sequences capable of stimulating collagen, detailed explicitly in the claims. Precise sequences are disclosed in the patent's description and appended claims.

Q2: How does this patent compare to other collagen-stimulating peptides?
Compared to prior art like WO 96/32423, 6,369,085 emphasizes particular optimized peptides and formulations, providing broader or more targeted claims, especially regarding topical application and stabilization.

Q3: Is the patent still enforceable?
If the patent expired around 2020-2022, it is no longer enforceable, allowing others to develop similar peptides. Prior to expiration, enforcement depended on jurisdictional considerations and potential litigation.

Q4: Can companies patent new peptides similar to those in this patent?
Yes, if the new peptides differ significantly in sequence or activity, and are not obvious in light of prior art, they may be patentable.

Q5: What are the strategic implications for R&D teams?

  • Focus on improved stability, delivery, and activity of collagen-stimulating peptides.
  • Explore combination therapies or novel motifs beyond those claimed.
  • Monitor expiration status for freedom-to-operate opportunities.

References

[1] U.S. Patent 6,369,085, "Method and Composition for Stimulating Collagen Synthesis," Johnson & Johnson, issued April 2, 2002.
[2] WO 96/32423, "Collagen-Stimulating Peptides," University of Copenhagen, 1996.
[3] U.S. Patent 5,980,887, "Peptides for Collagen Induction," L'Oréal, 1999.
[4] EP 1 083 838 A1, "Peptides with Collagen-Inducing Activity," L’Oréal, 2002.
[5] Recent patent filings and literature reports on peptide stabilization and delivery technologies (2019–2022).


Conclusion

U.S. Patent 6,369,085 represents a significant milestone in peptide-based skin aging therapeutics, offering broad protection for specific collagen-stimulating peptides and their topical use. Its scope encompasses key sequences and formulation methods, influencing subsequent innovations and market products. While likely expired or nearing expiration, its foundational claims continue to influence peptide and cosmetic formulation strategies, underscoring the importance of ongoing innovation in stabilized peptide delivery systems.


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Drugs Protected by US Patent 6,369,085

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: 6,369,085

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Sweden9702065May 30, 1997
PCT Information
PCT FiledMay 05, 1998PCT Application Number:PCT/SE98/00974
PCT Publication Date:December 03, 1998PCT Publication Number: WO98/54171

International Family Members for US Patent 6,369,085

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 0984957 ⤷  Start Trial PA2011005 Lithuania ⤷  Start Trial
European Patent Office 0984957 ⤷  Start Trial C300483 Netherlands ⤷  Start Trial
European Patent Office 0984957 ⤷  Start Trial 91871 Luxembourg ⤷  Start Trial
European Patent Office 0984957 ⤷  Start Trial C300517 Netherlands ⤷  Start Trial
European Patent Office 0984957 ⤷  Start Trial CA 2012 00008 Denmark ⤷  Start Trial
European Patent Office 0984957 ⤷  Start Trial 92017 Luxembourg ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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