Patentability of Biological Subject Matter

The patentability of biological subject matter — living organisms, cells, genes, proteins, and other material derived from nature — turns on a single distinction the U.S. Supreme Court has drawn and redrawn across four decades: is the claimed invention a human-made composition with markedly different characteristics from anything nature already produced, or is it, in substance, a product of nature that a person has merely found, isolated, or purified? Two landmark cases anchor this doctrine, and the fact that they point in what looks like opposite directions is exactly what makes the area easy to get wrong: Diamond v. Chakrabarty (1980) held that a living, human-engineered microorganism is patentable; Association for Molecular Pathology v. Myriad Genetics, Inc. (2013) held that a naturally occurring, isolated human gene sequence is not. Both are correct applications of the same underlying rule — the products-of-nature exclusion from 35 U.S.C. § 101 — not a contradiction.

The Chakrabarty Rule: Living Organisms Can Be Patentable “Manufactures” or “Compositions of Matter”

In Diamond v. Chakrabarty, 447 U.S. 303 (1980), decided 5–4, the Supreme Court considered a patent application by General Electric microbiologist Ananda Chakrabarty on a Pseudomonas bacterium into which he had introduced multiple stable energy-generating plasmids, giving it the ability to break down multiple components of crude oil — a capability no naturally occurring bacterium possessed, and one with an obvious application to oil-spill treatment. The USPTO had rejected the claim on the sole ground that living things are categorically unpatentable. The Court reversed, holding that 35 U.S.C. § 101’s terms “manufacture” and “composition of matter” are broad enough to cover a non-naturally-occurring organism that is “a product of human ingenuity having a distinctive name, character [and] use.” Chief Justice Burger’s opinion invoked the 1952 Patent Act’s legislative history, which described patentable subject matter as intended to include “anything under the sun that is made by man.” Being alive is not, by itself, a bar to patent eligibility — the question is whether a human being changed it into something markedly different from its natural counterpart.

The Myriad Rule: Isolating a Natural Sequence Is Not Inventing One

In Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), decided unanimously (Justice Scalia concurring in part), the Court considered Myriad’s patent claims covering the isolated BRCA1 and BRCA2 gene sequences used in hereditary breast- and ovarian-cancer risk testing. The Court held that a naturally occurring DNA segment is a product of nature and does not become patent-eligible merely because it has been isolated — removed from the surrounding genetic material it sits within on the chromosome. Myriad, the Court reasoned, “did not create anything”; it found the location of a gene and separated it out, which is an act of discovery, not invention. Critically, Myriad drew the same line Chakrabarty drew, applied the other direction: isolation alone does not produce something with markedly different characteristics from the natural original, so it does not clear § 101’s threshold.

Why cDNA Split the Difference

The same Myriad opinion upheld Myriad’s separate claims on complementary DNA (cDNA) versions of the BRCA genes. cDNA is synthesized in the lab by reverse-transcribing a gene’s mature messenger RNA, which omits the non-coding intron sequences present in the genomic original. Because that sequence — exons only, introns removed — does not occur naturally inside a cell, the Court held a lab technician “unquestionably creates something new” when cDNA is made, and that synthetic construct remains patent-eligible even though it encodes the same protein as the natural gene. This is the single most commonly misunderstood part of the ruling: Myriad did not end gene patenting. It ended patent claims on isolated genomic DNA sequences exactly as they occur in the body, while leaving synthetic and engineered nucleic-acid constructs — cDNA, and by extension most modern recombinant and gene-editing work — on the patentable side of the line.

The Sibling Doctrine: Laws of Nature and Diagnostic Correlations

A related but distinct exclusion covers claims directed to a law of nature rather than a product of nature — most consequential in diagnostics and personalized medicine. In Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), decided unanimously the year before Myriad, the Court held that a method claim reciting a naturally occurring correlation between a drug metabolite’s blood concentration and its therapeutic efficacy or toxicity was not patent-eligible, because the claim added only routine, conventional steps (administer the drug, measure the metabolite) to the natural correlation itself, without any further inventive concept. Myriad’s own opinion leans on this same reasoning. Together, Mayo and Myriad are the basis for the Alice/Mayo two-step framework the USPTO and courts now apply whenever a claim is challenged as directed to a law of nature, natural phenomenon, or abstract idea: step one asks whether the claim is directed to one of those three judicial exceptions; step two asks whether, if so, the claim adds an “inventive concept” sufficient to transform it into something patent-eligible. This is now the operative test for § 101 rejections across every technology area, formalized in the USPTO’s MPEP § 2106.

Why This Matters for University Technology Transfer

For a technology transfer office evaluating an invention disclosure in biotechnology, genomics, or diagnostics, the products-of-nature exclusion is not an abstract doctrine — it directly shapes what claim strategy is worth pursuing, and how much a resulting patent will actually be worth licensing:

• Claim what was engineered, not what was found. A disclosure describing the discovery of a novel naturally occurring compound, microorganism, or gene sequence — with no engineered modification — faces a real § 101 obstacle for composition-of-matter claims on the natural material itself, regardless of how much research effort went into finding it. The same disclosure may still support a strong patent if it also covers a synthetic analog, a recombinant or engineered version, a specific diagnostic method with an inventive step beyond the natural correlation, or a novel use.
• Federal funding does not change the § 101 analysis. An invention arising from NIH- or NSF-funded research is still subject to the same subject-matter-eligibility rules as any other invention; the Bayh-Dole Act governs who may elect to retain title to a federally funded invention, not whether that invention clears § 101 in the first place.
• Where a natural-product claim looks weak, other protection may still be available. Some biological material that cannot clear § 101 as an isolated natural product can still be protected as a trade secret (e.g., a proprietary cell line or process kept confidential rather than disclosed in a patent), or the surrounding method, formulation, or engineered variant may independently qualify.
• Timing and disclosure discipline still apply exactly as they do for any other invention. Once a claim strategy clears the § 101 threshold, the ordinary patentability requirements — novelty and non-obviousness against the prior art, examined during patent prosecution — apply in full. A well-drafted disclosure typically leads with a provisional patent application to secure a filing date while claim strategy around the natural-product problem is worked out.

For the broader technology transfer landscape this doctrine sits within, see the tech transfer pillar page.