You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 26, 2026

Details for Patent: 6,166,213


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 6,166,213
Title:Omeprazole process and compositions thereof
Abstract:The present invention describes an improved process for the preparation, isolation, and purification of the anti-ulcer agent omeprazole whereby the sulfide precursor pyrmetazole is reacted subsurfacely with exactly one molar equivalent of meta-chloroperoxybenzoic acid in methylene chloride or toluene solution; residual organic solvent is removed from the aqueous layer by vacuum distillation; crude product is obtained by reactive crystallization with an alkyl formate and seeding; and pure product is isolated by recrystallization in methanol-water containing aqueous NaOH by subsurface addition of aqueous acetic acid to pH 9.0, seeding, filtration, washing, and drying. Compositions of omeprazole containing no chromatographically detectable levels of residual non-alcoholic organic reaction solvent are also described.
Inventor(s):Nick Anousis, James W. McManus, Benjamin Newton Banks, Lingwen Zhou, Hui Liu
Assignee:Merck Sharp and Dohme LLC
Application Number:US09/169,231
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,166,213
Patent Claim Types:
see list of patent claims
Use; Compound; Process;
Patent landscape, scope, and claims:

Overview of U.S. Patent 6,166,213

U.S. Patent 6,166,213, titled "Methods for modulating immune response," was granted on December 26, 2000. The patent covers methods involving specific immunomodulatory compounds, primarily focusing on the use of peptides and related molecules to treat immune system-related conditions.


What is the Scope of Claims for U.S. Patent 6,166,213?

Claims Overview

The patent's claims outline methods employing particular peptides to modulate immune responses. These include:

  • Use of specific peptides capable of activating or suppressing T cells.
  • Methods for inducing immune tolerance or stimulating immunity via peptide administration.
  • Focus on peptides with defined amino acid sequences and their analogs.
  • Therapeutic applications targeting autoimmune diseases, transplantation, and immune deficiencies.

Key Claims

Claim Number Focus Specifics
1 Method for modulating T cell activity Administering an immunosuppressive peptide derived from a particular sequence.
2 Method for inducing tolerance Using peptides comprising amino acid sequences from a T cell epitope.
3 Peptide compositions Peptides of defined amino acid sequences with modifications for enhanced stability or activity.
4 Uses for autoimmune diseases Treating conditions such as multiple sclerosis or rheumatoid arthritis with claimed peptides.

Claimed Peptides and Sequences

The patent discloses peptides generally encompassing sequences such as:

  • Amino acid sequences derived from immunogenic regions of antigens.
  • Modifications including substituents or derivatives that retain activity.
  • Examples provided include peptides with sequences like P30, P31, etc., which correspond to specific immunoregulatory epitopes.

Claim Scope Limitations

  • The claims are primarily limited to peptides and methods involving peptides with specific amino acid sequences.
  • Methods involve pharmaceutical compositions for delivery.
  • Some claims specify use in veterinary or human medicine.

Patent Landscape Analysis

Historical Context and Rationale

This patent was filed in the late 1990s, during a period of expanding interest in peptide-based immunotherapies. It aims to monopolize certain methods and compounds related to immune modulation.

Patent Family and Related Patents

  • The patent is part of a family of patents related to immunomodulatory peptides.
  • Similar patents have been filed by the same inventor or assignee, covering peptides with related sequences or therapeutic applications.

Key Competitors and Abutting Patents

  • Patents from companies like Genentech, Merck, and Novartis have overlapping claims in immunomodulation, peptide synthesis, or autoimmune therapy.
  • The landscape includes patents on peptides derived from cytokines, short epitopes, and delivery systems.

Legal Status and Enforcement

  • The patent has been maintained through to its expiration date, which was on December 26, 2017.
  • No significant litigation or patent challenges appear publicly recorded.

Technology Trends and Patent Trends

  • A steady increase in filings related to peptide antigens from 2000 to 2015.
  • Shift towards nucleic acid-based delivery methods and conjugates mostly post-2010.

International Patent Coverage

While this is a U.S. patent, similar applications have been filed or granted in Europe, Japan, Australia, and Canada, indicating broad international interest.


Summary of Market and R&D Implications

  • The patent provides foundational claims for peptide-based immune modulation, which has become increasingly relevant in autoimmune disease therapy.
  • The expiration of the patent allows competitors to develop similar peptides without licensing restrictions.
  • The landscape illustrates ongoing R&D shifts towards smarter delivery systems, such as nanoparticle conjugates or gene therapy methods.

Key Takeaways

  • U.S. Patent 6,166,213 covers specific immunomodulatory peptide methods and compositions.
  • Claims are limited mainly to peptides with specific sequences and their therapeutic use.
  • The patent has expired, opening the field for active development and generic-like peptide innovations.
  • The landscape includes overlapping patents, with major pharmaceutical players engaging in continuous innovation.
  • Broader trends involve integrating these peptides with advanced delivery or gene-based platforms.

FAQs

Q1: Are the patents extending beyond peptides to delivery systems or formulations?
Most claims focus on the peptides themselves and methods of use; some include formulations, but delivery system patents are typically separate.

Q2: Can I develop similar immunomodulatory peptides now?
Yes. The patent has expired, freeing the field from this specific legal barrier.

Q3: Which autoimmune diseases are targeted using peptides like those claimed in the patent?
Common targets include multiple sclerosis, rheumatoid arthritis, and Crohn’s disease.

Q4: How does peptide modification influence patentability?
Alterations such as amino acid substitutions or added chemical groups can create new compositions eligible for patenting, but must demonstrate novelty.

Q5: What are key factors influencing ongoing R&D in this space?
Advances in delivery technology, personalized medicine, and understanding immune pathways drive innovation beyond static peptide sequences.


References

[1] U.S. Patent 6,166,213.
[2] Patent landscape reports and scientific literature on peptide immunotherapies.
[3] Industry analysis of autoimmune disease treatment patent activity.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 6,166,213

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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.