Canonical Supreme Court authority establishing patent eligibility for genetically engineered organisms and synthetic biology.
A live, human-made micro-organism is patentable subject matter under 35 U.S.C. § 101 because it has markedly different characteristics from any found in nature.
Enables patent exclusivity for engineered synthetic genomes, chimeric antigen receptors, and modified biological constructs.
Binding SCOTUS Bedrock (Good Law)
“A live, human-made micro-organism is patentable subject matter under 35 U.S.C. § 101. Congress intended patentable subject matter to 'include anything under the sun that is made by man.'”
Ananda Chakrabarty, a microbiologist at General Electric, engineered a genetically modified bacterium (of the genus Pseudomonas) capable of breaking down multiple components of crude oil. The USPTO patent examiner rejected the claims on the grounds that microorganisms are 'products of nature' and living things are not patentable subject matter under 35 U.S.C. § 101.
On writ of certiorari to the United States Court of Customs and Patent Appeals, which had reversed the USPTO's rejection of patent claims to a live, human-engineered bacterium.
Issue: Whether a live, human-made, genetically engineered micro-organism is a patentable 'manufacture' or 'composition of matter' under 35 U.S.C. § 101.
Chakrabarty is the bedrock precedent that launched the modern global biotechnology and synthetic biology industries. It established that genetic engineering, recombinant DNA, and human-modified biological organisms qualify for patent protection, forming the legal baseline for CRISPR-Cas9 patents, mRNA vaccines, and synthetic organisms.
Diamond v. Chakrabarty, 447 U.S. 303 (1980).