How to Use Modified Cells to Produce Insulin-Regulating Proteins in the Body
A method for taking a patient's own cells, modifying them with DNA to produce GLP-1, and putting them back into the body to treat metabolic conditions.
Original patent title: “In vivo production and delivery of insulinotropin for gene therapy”
A method for taking a patient's own cells, modifying them with DNA to produce GLP-1, and putting them back into the body to treat metabolic conditions. Granted to Transkaryotic Therapies Inc in 2003 with 13 claims and 2 forward citations.
Key facts
Coverage
What does this patent actually cover?
This patent describes a gene therapy approach where a patient's own somatic cells (like skin or blood cells) are removed and modified in a lab. Scientists insert a DNA construct that carries instructions for the cell to produce a specific protein, specifically GLP-1 (glucagon-like peptide 1) or its derivatives. These modified cells are then grown into a clonal strain, which means they are multiplied to create a large, consistent population. Finally, these cells are reintroduced into the patient's body, where they act as a living factory to continuously produce the desired protein.
The gap
What does this patent NOT cover?
- Does not cover direct injection of synthetic GLP-1 drugs like semaglutide or liraglutide.
- Does not cover viral-vector gene therapy where DNA is delivered directly into the body without cell removal.
- Does not cover the use of embryonic stem cells or germline cells.
- Does not cover the production of proteins other than GLP-1 or EPO.
These exclusions are unique to PatentBrief — derived from the actual claim language, not patent-office boilerplate.
What made this novel
The innovation lies in using the patient's own primary cells to create a stable, clonal cell line that can be expanded in the lab before being returned to the body, effectively turning the patient into their own drug-manufacturing plant.
Schematic visualization of the patent's claim structure. Hand-drawn diagrams in progress for each landmark patent.
Where you've seen this
Real-world examples
Experimental ex-vivo gene therapy for metabolic disorders
Autologous cell-based protein delivery systems
Why it matters
The bigger picture
This patent represents an early effort to turn the patient's own cells into a therapeutic delivery system, moving away from the need for frequent injections of synthetic hormones. While the specific approach of ex-vivo cell transplantation for GLP-1 has faced significant hurdles compared to modern injectable GLP-1 agonists, it highlights the foundational research into personalized medicine and cell-based therapies that continue to influence current biotech development.
Filed
August 16, 1999
Granted
March 11, 2003
Market context
Who's building on this
Companies in this space
Companies focused on cell therapy and ex-vivo gene modification, such as those working on autologous cell transplants, continue to refine the underlying techniques for cell isolation and genetic modification. The field has largely shifted toward more advanced viral and non-viral delivery mechanisms for gene therapy.
Market impact
This patent contributed to the early intellectual property landscape for cell-based gene therapy. It helped define the procedural steps for creating and reintroducing modified somatic cells, which remains a core methodology in the development of personalized cell-based treatments for chronic diseases.
Claim 1 — Plain English
What this patent covers
This patent describes a gene therapy approach where a patient's own somatic cells (like skin or blood cells) are removed and modified in a lab. Scientists insert a DNA construct that carries instructions for the cell to produce a specific protein, specifically GLP-1 (glucagon-like peptide 1) or its derivatives. These modified cells are then grown into a clonal strain, which means they are multiplied to create a large, consistent population. Finally, these cells are reintroduced into the patient's body, where they act as a living factory to continuously produce the desired protein.
The clever bit
The innovation lies in using the patient's own primary cells to create a stable, clonal cell line that can be expanded in the lab before being returned to the body, effectively turning the patient into their own drug-manufacturing plant.
What it does not cover
- Does not cover direct injection of synthetic GLP-1 drugs like semaglutide or liraglutide.
- Does not cover viral-vector gene therapy where DNA is delivered directly into the body without cell removal.
- Does not cover the use of embryonic stem cells or germline cells.
- Does not cover the production of proteins other than GLP-1 or EPO.
Patent timeline
Application submitted to the patent office
Application published, typically 18 months after filing
Patent officially issued
PatentBrief Score
Impact Score
Limited data
Citation count
10/40
Early citations
Claim breadth
9/20
Moderate scope
Recency
0/20
Older than 20 years
Assignee scale
0/20
Independent or smaller assigneeassigneeThe entity that owns the patent — usually the inventor's employer or a company.Read more →
PatentBrief Impact Score — based on citation count, claim breadth, recency, and assignee scale. Not a legal assessment.
Heuristic Value Estimate
What this patent might be worth
$17K – $54K
Midpoint $34K · expired or expiring · industry ×3.0
Heuristic only — blends forward/backward citation counts, claim scope, time remaining, litigation history, and CPC-derived industry baseline. Real valuations need a professional appraisal.
The original legal language
Original claims
13 claims as filed with the patent office.
Concepts involved
Citations
Patent lineage
Cite this patent
Heartlein, M. W., Selden, R. F., & Treco, D. (2003). How to Use Modified Cells to Produce Insulin-Regulating Proteins in the Body (U.S. Patent No. 6,531,124). U.S. Patent and Trademark Office. https://patentbrief.org/patent/us/6531124/xolair-omalizumab
Auto-generated from the patent record. Double-check author order and the issue date against the official USPTO document before submitting.
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Common Questions
Frequently Asked Questions
What does How to Use Modified Cells to Produce Insulin-Regulating Proteins in the Body cover?
A method for taking a patient's own cells, modifying them with DNA to produce GLP-1, and putting them back into the body to treat metabolic conditions.
Who owns patent US 6531124?
Transkaryotic Therapies Inc owns this patent, granted in 2003.
When does this patent expire?
This patent has expired and is now in the public domain — anyone can use the invention freely.
What is patent US 6531124 cited by?
This patent has been cited by 2 later patents that build on its ideas.
What problem does this patent solve?
This patent represents an early effort to turn the patient's own cells into a therapeutic delivery system, moving away from the need for frequent injections of synthetic hormones. While the specific approach of ex-vivo cell transplantation for GLP-1 has faced significant hurdles compared to modern injectable GLP-1 agonists, it highlights the foundational research into personalized medicine and cell-based therapies that continue to influence current biotech development.
What does this patent NOT cover?
Does not cover direct injection of synthetic GLP-1 drugs like semaglutide or liraglutide.
Patent monitoring