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How to Create Lab-Made Proteins That Stop Immune System Overreaction

A method for creating custom proteins that act as 'brakes' for the body's immune system to prevent damage from excessive inflammation.

Granted 2002ExpiredExpired 2011Owned by Johns Hopkins UniversityInvented by Douglas T. Fearon, Thomas Hebell

Original patent title: “Soluble complement regulatory molecules

Plain-English explanation by SahiLast reviewed · June 15, 2026

A method for creating custom proteins that act as 'brakes' for the body's immune system to prevent damage from excessive inflammation. Granted to Johns Hopkins University in 2002 with 35 claims and 27 forward citations.

Key facts

Patent numberUS 6458360
StatusExpired
FieldBiotech & Medicine
AssigneeJohns Hopkins University
InventorsDouglas T. Fearon, Thomas Hebell
Filed1991
Granted2002
Claims35
Times cited27
LitigationNone on record
Value · $81K$259KModest

Coverage

What does this patent actually cover?

This patent describes a way to build a custom, soluble protein that can float through the bloodstream and block the complement system. The complement system is a part of the immune system that normally kills bacteria, but it can sometimes go haywire and attack healthy tissue, causing severe inflammation. The invention works by taking specific fragments of natural proteins—called short consensus repeats (SCRs)—that act like magnets for harmful immune signals. These fragments are then attached to a carrier molecule, such as an antibody or serum albumin, which helps the construct stay stable in the blood long enough to neutralize the threat.

The gap

What does this patent NOT cover?

  • Does not cover naturally occurring complement regulatory proteins found in the body.
  • Does not cover constructs that lack a soluble, physiologically-acceptable carrier molecule.
  • Does not cover molecules that contain only a single binding site, as the claimsclaimsThe numbered statements at the end of a patent that legally define what the inventor owns.Read more → require at least two.
  • Does not cover non-protein based inhibitors or chemical small-molecule drugs.

These exclusions are unique to PatentBrief — derived from the actual claim language, not patent-office boilerplate.

What made this novel

The invention uses a modular design, fusing natural complement-binding fragments to a separate carrier molecule to increase stability and ensure the molecule has multiple binding sites, which is essential for effectively neutralizing the target.

Soluble complement regulatory …(Primary claim)biotechpharmaceutical

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

01

Therapeutics for paroxysmal nocturnal hemoglobinuria (PNH)

02

Treatments for atypical hemolytic uremic syndrome (aHUS)

03

Experimental therapies for preventing organ transplant rejection

Why it matters

The bigger picture

The complement system is implicated in a wide range of autoimmune and inflammatory diseases, including organ transplant rejection and certain blood disorders. By creating a stable, soluble inhibitor, this technology provides a blueprint for therapeutic drugs that can 'turn off' the immune system's attack mode in a controlled way. It represents a foundational approach in the development of biologic drugs designed to modulate the immune response.

Filed

April 4, 1991

Granted

October 1, 2002

Market context

Who's building on this

Companies in this space

Major biopharmaceutical companies like Alexion Pharmaceuticals (now part of AstraZeneca) have built significant drug portfolios around complement inhibition. The research foundational to this patent continues to influence the development of next-generation biologics targeting the C3 and C5 pathways.

Market impact

This patent helped define the structural requirements for effective complement inhibitors, contributing to the emergence of the complement-targeting drug class. It provided a framework that enabled the development of high-value biologics that have transformed the treatment of rare, life-threatening inflammatory diseases.

Claim 1 — Plain English

What this patent covers

This patent describes a way to build a custom, soluble protein that can float through the bloodstream and block the complement system. The complement system is a part of the immune system that normally kills bacteria, but it can sometimes go haywire and attack healthy tissue, causing severe inflammation. The invention works by taking specific fragments of natural proteins—called short consensus repeats (SCRs)—that act like magnets for harmful immune signals. These fragments are then attached to a carrier molecule, such as an antibody or serum albumin, which helps the construct stay stable in the blood long enough to neutralize the threat.

The clever bit

The invention uses a modular design, fusing natural complement-binding fragments to a separate carrier molecule to increase stability and ensure the molecule has multiple binding sites, which is essential for effectively neutralizing the target.

What it does not cover

  • Does not cover naturally occurring complement regulatory proteins found in the body.
  • Does not cover constructs that lack a soluble, physiologically-acceptable carrier molecule.
  • Does not cover molecules that contain only a single binding site, as the claims require at least two.
  • Does not cover non-protein based inhibitors or chemical small-molecule drugs.

Patent timeline

Filing

Application submitted to the patent office

Publication

Application published, typically 18 months after filing

Grant

Patent officially issued

PatentBrief Score

Impact Score

Moderate

Citation count

29/40

Moderately cited

Claim breadth

20/20

Very broad protection

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

Modest

$81K$259K

Midpoint $162K · expired or expiring · industry ×3.0

Adjust inputs →

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

35 claims as filed with the patent office.

Concepts involved

ClaimPrior artNon-obviousnessNoveltySpecificationAssigneePatent term

Citations

Patent lineage

Cites earlier patents

21

earlier patents this invention cites as foundations

View prior art →

Cited by later patents

27

later patents that build on this invention

View patents →

Cite this patent

Fearon, D. T., & Hebell, T. (2002). How to Create Lab-Made Proteins That Stop Immune System Overreaction (U.S. Patent No. 6,458,360). U.S. Patent and Trademark Office. https://patentbrief.org/patent/us/6458360/hpv-vaccine-gardasil

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 Create Lab-Made Proteins That Stop Immune System Overreaction cover?

A method for creating custom proteins that act as 'brakes' for the body's immune system to prevent damage from excessive inflammation.

Who owns patent US 6458360?

Johns Hopkins University owns this patent, granted in 2002.

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 6458360 cited by?

This patent has been cited by 27 later patents that build on its ideas.

What problem does this patent solve?

The complement system is implicated in a wide range of autoimmune and inflammatory diseases, including organ transplant rejection and certain blood disorders. By creating a stable, soluble inhibitor, this technology provides a blueprint for therapeutic drugs that can 'turn off' the immune system's attack mode in a controlled way. It represents a foundational approach in the development of biologic drugs designed to modulate the immune response.

What does this patent NOT cover?

Does not cover naturally occurring complement regulatory proteins found in the body.

Same assignee

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Last reviewed: June 15, 2026 · PatentBrief is not a law firm and this is not legal advice.