Composition of Matter

A 'composition of matter' is one of the four statutory categories of patentable subject matter under 35 U.S.C. § 101, alongside processes, machines, and manufactures. A composition of matter includes chemical compounds, molecules, mixtures, alloys, and combinations of materials — anything from a new pharmaceutical compound to a novel polymer to a genetically engineered organism. Compositions of matter have been interpreted broadly by courts: Diamond v. Chakrabarty (S.Ct. 1980) held that a genetically engineered bacterium capable of breaking down crude oil components was a patentable composition of matter — 'anything under the sun that is made by man' can be patentable. The key boundary is that PRODUCTS OF NATURE — compositions that exist naturally in the world, unchanged — are not patentable, because they were not made by man.

No — isolated genomic DNA is not patentable. Association for Molecular Pathology v. Myriad Genetics, Inc. (S.Ct. 2013): Myriad discovered the precise location and sequence of the BRCA1 and BRCA2 genes and sought patents on isolated DNA segments comprising those genes. The Supreme Court (unanimous, Thomas J.) held: ISOLATED GENOMIC DNA is NOT patentable — it is a product of nature. The fact that a technician isolates the DNA from surrounding chromosomal material does not make it a new or markedly different composition — it retains the same nucleotide sequence and genetic function as the naturally occurring DNA. CDNA (complementary DNA) IS patentable — cDNA is synthesized from mRNA and contains only the coding sequences (exons), excluding introns. cDNA does not exist naturally, so it is not a product of nature. Practical result: Myriad's claims to isolated BRCA1/BRCA2 genomic DNA were invalidated; claims to synthetic cDNA survived.

PATENTABLE COMPOSITIONS: (1) New chemical compounds (drugs, agrochemicals, materials not found in nature); (2) Combinations and formulations that produce markedly different properties; (3) Purified forms of natural products if the purification produces markedly different properties; (4) Synthetic/recombinant molecules that do not exist naturally (e.g., cDNA, fusion proteins, novel polymers); (5) Genetically engineered organisms that do not exist in nature (Diamond v. Chakrabarty). NOT PATENTABLE (products of nature): (1) Isolated naturally occurring genomic DNA (Myriad); (2) Isolated naturally occurring minerals, elements, or compounds that are not markedly different from their natural form; (3) Natural phenomena, laws of nature, and abstract ideas (Mayo Collaborative Services v. Prometheus Laboratories, S.Ct. 2012). The 'markedly different characteristics' test: even a naturally occurring substance can be patentable if it has been chemically or structurally modified to have properties markedly different from its natural state.

Mayo Collaborative Services v. Prometheus Laboratories (S.Ct. 2012) — while primarily a method-of-treatment case — articulated the two-step framework (Mayo/Alice) that applies to all § 101 analyses, including composition of matter patents. Step 1: Is the claim directed to a law of nature, product of nature, or abstract idea? Step 2: Does the claim contain an 'inventive concept' — elements individually or as an ordered combination that transform the nature-based element into something significantly more, amounting to significantly more than the exception itself? For compositions, the key is whether the claimed composition, as a whole, is markedly different from any natural product — in structure, function, or properties. A claim to the isolated BRCA1 gene (Myriad) fails at Step 1 (product of nature). A claim to a novel antibody targeting BRCA1, synthesized in a way not found in nature, would likely survive both steps. Formulation patents (drug + excipient) must show the combination's properties are not merely the sum of natural properties.

Yes — if the compound has been purified or modified to have markedly different characteristics from its naturally occurring form. Historical example: Parke-Davis & Co. v. H.K. Mulford Co. (S.D.N.Y. 1911, Learned Hand J.) — pure adrenaline (epinephrine) was held patentable because the purified compound had therapeutic properties fundamentally different from the impure mixture as it exists naturally in the adrenal gland. The 'markedly different characteristics' test (from the post-Myriad USPTO guidance) asks: does the isolation/purification/modification produce a product with: (1) different biological or pharmacological properties? (2) different chemical properties (stability, solubility, bioavailability)? (3) different utilities not present in the natural product? Simply isolating a compound — removing it from its natural context without changing its properties — is NOT sufficient (Myriad on isolated DNA). Substantially purifying a compound that exists only in trace amounts in nature, resulting in a pure form with enhanced utility, may be sufficient.