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.