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How Scientists Taught Bacteria to Make Human Hormones

Genentech's 1979 patent on using engineered DNA to force bacteria to produce human proteins like insulin and growth hormones.

Granted 1982ExpiredExpired 1999Owned by Genentech IncInvented by Keiichi Itakura

Original patent title: “Recombinant DNA cloning vehicle

Plain-English explanation by SahiLast reviewed · June 13, 2026

Genentech's 1979 patent on using engineered DNA to force bacteria to produce human proteins like insulin and growth hormones. Granted to Genentech Inc in 1982 with 10 claims and 86 forward citations, and it is now in the public domain.

Key facts

Patent numberUS 4356270
StatusExpired
FieldBiotech & Medicine
AssigneeGenentech Inc
InventorKeiichi Itakura
Filed1979
Granted1982
Expires1999 (expired)
Claims10
Times cited86
LitigationNone on record
Value · $68K$216KModest

Coverage

What does this patent actually cover?

This patent describes a method for inserting synthetic DNA into a bacterial plasmid—a small, circular piece of DNA—so the bacteria acts like a factory. The key innovation is using 'codon optimization,' where the synthetic gene is written using the specific DNA 'language' that bacteria prefer, making them much more efficient at reading the instructions to build human proteins. By placing this gene between specific DNA 'cut sites' (restriction endonuclease sites), researchers could reliably insert and express mammalian hormones like somatostatin or insulin chains within a microbial host.

The gap

What does this patent NOT cover?

  • Does not cover naturally occurring DNA sequences that have not been synthetically modified for microbial expression.
  • Does not cover the use of non-bacterial hosts like yeast or mammalian cell cultures for protein production.
  • Does not cover the specific medical treatments or clinical applications of the hormones produced.
  • Does not cover gene editing techniques like CRISPR that modify DNA in place rather than using cloning vehicles.

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

What made this novel

The inventors realized that bacteria have a 'preference' for certain DNA codes; by rewriting the synthetic gene to use these preferred codons, they drastically increased the amount of human protein the bacteria could produce.

The Patent Drawing

Representative patent drawing for Recombinant DNA cloning vehicle (US 4356270)
Representative figure · US 4356270All figures on Google Patents →
Recombinant DNA cloning vehicle(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

Synthetic human insulin (Humulin)

02

Human growth hormone production

03

Recombinant protein manufacturing platforms

Why it matters

The bigger picture

This patent is a cornerstone of the modern biotechnology industry. It provided the legal and technical framework for producing life-saving human proteins, such as synthetic insulin, which replaced the previous, less-effective method of harvesting insulin from the pancreases of slaughtered cows and pigs.

Filed

November 5, 1979

Granted

October 26, 1982

Market context

Who's building on this

Companies in this space

Genentech, now a member of the Roche Group, remains a major player in this space. Virtually every modern pharmaceutical company, including Eli Lilly and Novo Nordisk, relies on the foundational principles of recombinant DNA technology established by this patent.

Market impact

This patent effectively launched the commercial biotechnology industry. It enabled the transition from animal-derived medicine to laboratory-grown medicine, creating a multi-billion dollar market for recombinant therapeutics and setting the standard for how biological drugs are manufactured today.

Claim 1 — Plain English

What this patent covers

This patent describes a method for inserting synthetic DNA into a bacterial plasmid—a small, circular piece of DNA—so the bacteria acts like a factory. The key innovation is using 'codon optimization,' where the synthetic gene is written using the specific DNA 'language' that bacteria prefer, making them much more efficient at reading the instructions to build human proteins. By placing this gene between specific DNA 'cut sites' (restriction endonuclease sites), researchers could reliably insert and express mammalian hormones like somatostatin or insulin chains within a microbial host.

The clever bit

The inventors realized that bacteria have a 'preference' for certain DNA codes; by rewriting the synthetic gene to use these preferred codons, they drastically increased the amount of human protein the bacteria could produce.

What it does not cover

  • Does not cover naturally occurring DNA sequences that have not been synthetically modified for microbial expression.
  • Does not cover the use of non-bacterial hosts like yeast or mammalian cell cultures for protein production.
  • Does not cover the specific medical treatments or clinical applications of the hormones produced.
  • Does not cover gene editing techniques like CRISPR that modify DNA in place rather than using cloning vehicles.

Patent Journey

From filing to expiry

PatentBrief Score

Impact Score

Strong

Citation count

39/40

Highly cited

Claim breadth

7/20

Moderate scope

Recency

0/20

Older than 20 years

Assignee scale

20/20

Major company or institution

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

$68K$216K

Midpoint $135K · 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

10 claims as filed with the patent office.

Concepts involved

ClaimPrior artNon-obviousnessNoveltySpecificationAssigneePatent term

Citations

Patent lineage

Cites earlier patents

1

earlier patents this invention cites as foundations

View prior art →

Cited by later patents

86

later patents that build on this invention

View patents →

Cite this patent

Itakura, K. (1982). How Scientists Taught Bacteria to Make Human Hormones (U.S. Patent No. 4,356,270). U.S. Patent and Trademark Office. https://patentbrief.org/patent/us/4356270/recombinant-dna-cloning-genentech

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 Scientists Taught Bacteria to Make Human Hormones cover?

Genentech's 1979 patent on using engineered DNA to force bacteria to produce human proteins like insulin and growth hormones.

Who owns patent US 4356270?

Genentech Inc owns this patent, granted in 1982.

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 4356270 cited by?

This patent has been cited by 86 later patents that build on its ideas.

What problem does this patent solve?

This patent is a cornerstone of the modern biotechnology industry. It provided the legal and technical framework for producing life-saving human proteins, such as synthetic insulin, which replaced the previous, less-effective method of harvesting insulin from the pancreases of slaughtered cows and pigs.

What does this patent NOT cover?

Does not cover naturally occurring DNA sequences that have not been synthetically modified for microbial expression.

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Last reviewed: June 13, 2026 · PatentBrief is not a law firm and this is not legal advice.