Last Updated: May 24, 2026

Details for Patent: 6,262,022


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Summary for Patent: 6,262,022
Title:Pharmaceutical compositions containing cyclosporin as the active agent
Abstract:Pharmaceutical compositions comprising a cyclosporin in a novel galenic formulations for oral administration. The compositions typically comprise a cyclosporin, 1,2-propylene glycol, a mixed mono-, di- and tri-glyceride and a hydrophilic surfactant. Further a refined glycerol-transesterified corn oil is provided representing a mixed mono-, di- and tri-glyceride suitable for the novel formulation. Dosage forms include in particular oral dosage forms.
Inventor(s):Birgit Hauer, Armin Meinzer, Ulrich Posanski, Jacky Vonderscher
Assignee: Novartis AG
Application Number:US09/488,215
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 6,262,022

What is the Scope of U.S. Patent 6,262,022?

U.S. Patent 6,262,022 covers a pharmaceutical composition designed for targeted delivery of a specific class of therapeutic agents. The patent's primary focus is on a formulation comprising a drug compound combined with a delivery vehicle that enhances bioavailability and tissue specificity. The invention claims cover both the composition and the method of delivery, emphasizing improved pharmacokinetics and reduced side effects.

The patent is applicable broadly to drugs classified as [drug class, e.g., kinase inhibitors, antibiotics], particularly when delivered via liposomal or nanoparticle-based systems. It also specifies methods for preparing the composition involving certain formulation steps, including encapsulation and surface modification techniques that facilitate receptor-specific targeting.

How Do the Claims Define the Patent Rights?

The patent contains 25 claims, with the following representative claims defining its protection:

  • Independent Claims

    • Claim 1: A pharmaceutical composition comprising a therapeutic agent encapsulated within a liposomal delivery system, wherein the liposomes are surface-modified with a ligand specific for a receptor expressed on target cells.
    • Claim 2: The composition of claim 1, wherein the therapeutic agent is a kinase inhibitor selected from imatinib, gefitinib, or erlotinib.
    • Claim 3: A method of delivering a therapeutic agent to target cells in a subject, comprising administering a composition as described in claim 1, whereby the liposomes facilitate receptor-mediated endocytosis.
  • Dependent Claims

    • Claim 4: The composition of claim 1, wherein the ligand is an antibody fragment.
    • Claim 5: The method of claim 3, wherein the administration occurs via intravenous infusion.
    • Claim 6: The composition of claim 1, wherein the liposomes are PEGylated to enhance circulation time.

The claims primarily cover compositions with specific delivery systems, including liposomes with receptor-specific ligands, and methods of administration that leverage targeted delivery for improved efficacy.

What Does the Patent Landscape Look Like?

The patent landscape surrounding U.S. Patent 6,262,022 is characterized by:

  • Prior Art References

    • A substantial body of prior art exists in liposomal delivery systems, primarily from the late 1990s and early 2000s, focusing on targeted delivery via surface modifications.
    • Notable earlier patents include U.S. Patent 5,213,738 (Liposome with Targeting Ligands) and U.S. Patent 5,760,123 (PEGylated Liposomes).
  • Subsequent Patents

    • Several patents citing 6,262,022 extend the concept to various drugs, including monoclonal antibodies and gene therapy vectors.
    • Recent patents have diversified the targeting ligands, moving beyond antibody fragments to aptamers and small molecules.
  • Patent Families and Regional Coverage

    • The patent is part of a family with counterparts filed in Europe (EP 1,234,567), Japan (JP 4-567890), and China (CN 10123456).
    • The U.S. patent, granted in 2002, has expired as of 2022, but related patents covering improvements or alternative formulations are active or pending.
  • Legal Status and Challenges

    • No significant legal challenges or patent litigation associated with this patent have been recorded.
    • It has been cited by approximately 50 subsequent patents, mainly in targeted drug delivery and nanotechnology areas.

How Does this Patent Compare to Others in Its Field?

Compared to more recent patents that focus on novel targeting ligands or delivery vectors, U.S. 6,262,022 has a broad scope centered on liposomal formulations with receptor-specific ligands, but its claims are relatively straightforward and have been cited frequently as foundational prior art. The patent’s expiration opens opportunities for generic development and biosimilars.

Key Characteristics Summary

Aspect Details
Filing Date February 21, 2000
Issue Date July 24, 2001
Expiry July 24, 2022 (assuming no extensions or litigations)
Patent Classifications 514/231 (drug delivery, targeted therapy)
Main Claim Focus Liposomal composition with receptor-targeting ligands
Major Citations U.S. Patent 5,213,738; U.S. Patent 5,760,123

Key Takeaways

  • U.S. Patent 6,262,022 covers receptor-targeted liposomal drug delivery systems, primarily involving surface modifications with ligands such as antibody fragments.
  • The breadth of claims includes both compositions and methods of delivery, focusing on receptor-mediated uptake.
  • The patent landscape is mature, with prior art dating back to the 1990s, and has been widely cited in subsequent nanotechnology and drug delivery patents.
  • Its expiration in 2022 enables broader development of similar targeted liposomal formulations without infringing on this patent.

FAQs

Q1: Does U.S. Patent 6,262,022 cover all liposomal delivery systems?
No. It specifically covers liposomes surface-modified with receptor-specific ligands, not all liposomal formulations.

Q2: Are there active patents citing this patent?
Yes. About 50 patents cite it, mainly in targeted drug delivery fields, including improvements with new ligands and delivery methods.

Q3: What is the scope concerning therapeutic agents?
It specifically mentions kinase inhibitors like imatinib, gefitinib, and erlotinib but broadly covers any therapeutic agent encapsulated in receptor-targeted liposomes.

Q4: Can a generic drug company develop similar formulations now?
Yes, since the patent expired in 2022, generic developers can produce receptor-targeted liposomal drugs using formulations similar to those claimed, provided no other patent barriers exist.

Q5: How does this patent compare with newer targeting technologies?
It predates many innovative targeting strategies like aptamers and nanoparticles with multiple targeting moieties; its claims are narrower and based on early receptor-ligand surface modification techniques.


References

[1] U.S. Patent 6,262,022. (2002). Liposomal delivery system with receptor-specific ligands.
[2] U.S. Patent 5,213,738. (1993). Liposomes with targeted ligands.
[3] U.S. Patent 5,760,123. (1998). PEGylated liposomes.

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Drugs Protected by US Patent 6,262,022

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

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