Diamond v. Chakrabarty
Can a human-made, living bacterium be patented as a “manufacture” or “composition of matter” under 35 U.S.C. §101?
Quick Summary
A GE scientist engineered a bacterium that eats oil. He asked for patents on the process, an inoculum, and the bacterium itself. The Patent Office allowed the first two but refused the bacterial claim. The U.S. Supreme Court held: a human-made living microorganism can be patented under §101 as a manufacture or composition of matter. Being “alive” does not block patent eligibility.
Issues
- Do living microorganisms made by humans fit “manufacture” or “composition of matter” under 35 U.S.C. §101?
Rules
- 35 U.S.C. §101: patents may be granted for any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.
- Products of nature are not eligible; human-made inventions can be.
- “Alive” vs “not alive” is not, by itself, a bar to eligibility.
Facts (Timeline)
viewEngineering: A GE researcher creates a strain of Pseudomonas putida that can break down components of crude oil. No natural bacteria did this.
Patent Filing: He files three claim sets: (a) process of making the bacterium, (b) inoculum (carrier + bacterium), (c) the bacterium itself.
Office Action: Examiner allows (a) and (b), rejects (c) as a product of nature/living thing not patentable under §101. Board affirms.
Appeals: CCPA reverses, saying “alive” is legally irrelevant if it is human-made. The case reaches the U.S. Supreme Court.
Arguments
Petitioner (Patent Office)
- Living things are not patentable under §101.
- The microorganism is a product of nature and should be excluded.
- Policy concerns: patents on life forms should be left to Congress.
Respondent (Inventor)
- The bacterium is human-made, not naturally occurring.
- It fits “manufacture” or “composition of matter” as written in §101.
- Law should not draw a life/non-life line; the statute’s words are broad.
Judgment
Patent-EligibleThe Supreme Court held that the engineered bacterium is patent-eligible. Section 101 is broad and covers human-made inventions—even if living—so long as they are not products of nature. The patent for the microorganism was ultimately granted.
- Focus is on human ingenuity, not life/non-life status.
- “Manufacture”/“composition of matter” read broadly to include engineered microbes.
Ratio Decidendi
A human-made, non-natural microorganism is a patentable manufacture or composition of matter under §101. The “alive” quality does not, by itself, exclude it from patent eligibility; the product-of-nature bar does.
Why It Matters
- Foundational case for biotech patents worldwide.
- Clarifies the scope of §101 for engineered biological inventions.
- Enabled growth in genetic engineering, oil-spill cleanup tech, and bio-innovation.
Key Takeaways
- §101 covers human-made living organisms.
- Being “alive” is not a bar; being a product of nature is.
- Read statute broadly, unless Congress limits it.
- Draft claims to stress human engineering and non-natural traits.
- Keep evidence showing the organism is not naturally occurring.
Mnemonic + 3-Step Hook
LIFE ≠ NATURAL — Living can be patentable, If human-made, Focus on non-natural traits, Eligible under §101.
- Ask: Is it human-made or a product of nature?
- Show: Structural/functional traits not found in nature.
- Claim: Frame as manufacture or composition of matter.
IRAC Outline
Issue
Are engineered microorganisms patent-eligible under §101?
Rule
Patents for new and useful processes, machines, manufactures, or compositions of matter.
Application
The bacterium was human-made and not naturally occurring; thus within §101’s terms.
Conclusion
Patent-eligible; rejection of organism claim overturned.
Glossary
| Term | Simple Meaning |
|---|---|
| §101 | U.S. law that lists the broad kinds of inventions that can be patented. |
| Manufacture | Something made by humans (a product), not found as such in nature. |
| Composition of Matter | Combination of ingredients or substances, including new ones made by humans. |
| Product of Nature | Something that exists in nature as is; usually not patentable. |
| Inoculum | Mixture that carries and spreads microorganisms for use. |
FAQs
Related Cases
Association for Molecular Pathology v. Myriad
Natural DNA not patentable; cDNA may be—contrasts product of nature vs human-made.
Mayo v. Prometheus
Subject-matter limits under §101 for laws of nature and routine steps.
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