ArtI.S8.C8.4.2 Patent-Eligible Subject Matter

Article I, Section 8, Clause 8:

[The Congress shall have Power . . . ] To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.

In addition to the novelty, nonobviousness, and utility requirements, the claimed invention must be directed at patent-eligible subject matter.1 By statute, an inventor may patent “any new and useful process, machine, manufacture, or composition of matter.” 2 The Supreme Court has observed that Congress intended “anything under the sun that is made by man” to be patentable.3 Nonetheless, despite the broad statutory language, the Court has held that three types of discoveries are categorically nonpatentable: “laws of nature, natural phenomena, and abstract ideas.” 4 The Court has reasoned that to permit a patent monopoly on the “'basic tools of scientific and technological work’ . . . might tend to impede innovation more than it would tend to promote it.” 5

For example, a person who discovers a previously unknown product of nature (say, a plant with medicinal properties) cannot obtain a patent on this discovery.6 On the other hand, a genetically engineered bacterium with “markedly different characteristics than any found in nature” may be patented.7 Similarly, laws of nature—basic physical principles, like Einstein’s mass-energy equivalence (E=mc2) or the law of gravity—are not patentable, even if newly discovered and useful.8 However, a new and useful application of a law of nature, such as the use of a physical law in a novel process for molding uncured rubber, may be patentable,9 so long as the application is not “conventional or obvious.” 10 Lastly, abstract ideas are not patentable. For example, the Supreme Court has held that patents on a method for converting binary-coded decimal numerals into pure binary numerals11 and a business method for hedging risk against price fluctuations12 claimed nonpatentable abstract ideas.

In the 2010s, the Supreme Court decided a trio of cases that set forth the modern standards for patentable subject matter. These cases established a two-step test. The court first “determine[s] whether the claims at issue are directed to” ineligible subject matter such as a law of nature, natural phenomenon, or abstract idea.13 If so, the claimed invention is nonpatentable unless the patent claims have an “inventive concept” that transforms the nature of the claim to a patent-eligible application, with elements “sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.” 14

In Mayo Collaborative Services v. Prometheus Laboratories, the Court addressed the scope of the “law of nature” exception.15 The patent in Mayo claimed a method for measuring metabolites in the blood to calibrate the dosage of thiopurine drugs in the treatment of autoimmune disorders.16 The Court found the patent claims were directed to a law of nature: “namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.” 17 Because the claims were little “more than an instruction to doctors to apply the applicable laws when treating their patients,” the patent lacked any inventive concept and the Court held it to be patent ineligible.18

The second decision in the trilogy, Association for Molecular Pathology v. Myriad Genetics, Inc., concerned the applicability of the “natural phenomena” exception to the patentability of DNA.19 The inventor in Myriad discovered the precise location and genetic sequence of two human genes associated with an increased risk of breast cancer.20 Based on this discovery, the patentee claimed two molecules associated with the genes: (1) an isolated DNA segment; and (2) a complementary DNA (cDNA) segment, in which the nucleotide sequences that do not code for amino acids were removed.21

Myriad held that isolated DNA segments were nonpatentable products of nature because the patent claimed naturally-occurring genetic information.22 The Court held, however, that cDNA, as a synthetic molecule distinct from naturally-occurring DNA, was patentable even though the underlying nucleotide sequence was dictated by nature.23

Lastly, Alice Corp. v. CLS Bank International examined the scope of the “abstract idea” category of nonpatentable subject matter.24 Alice concerned a patent on a system for mitigating settlement risk (i.e., the risk that only one party will pay) using a computer.25 The Court first held that the invention was directed at “the abstract idea of intermediated settlement.” 26 Although the invention in Alice was implemented on a computer (which is, of course, a physical machine), the patent lacked an inventive concept because the claims merely “implement[ed] the abstract idea of intermediated settlement on a generic computer.” 27

Because the statutory standard for patent-eligible subject matter has remained essentially unchanged for over two centuries, see generally Kevin J. Hickey, Cong. Rsch. Serv., R45918, Patent-Eligible Subject Matter Reform in the 116th Congress (2019),, it can be difficult to discern the extent to which the Supreme Court’s patent-eligible subject matter cases are motivated or required by the IP Clause, or are merely a construction of the patent statute. See Bilski v. Kappos, 561 U.S. 593, 649 (2010) ( “The Court has kept this ‘constitutional standard’ [of the IP Clause] in mind when deciding what is patentable subject matter under § 101. For example, we have held that no one can patent ‘laws of nature, natural phenomena, and abstract ideas.’” (quoting Diamond v. Diehr, 450 U.S. 175, 185 (1981)) (Stevens, J., concurring in the judgment). back
35 U.S.C. § 101. back
Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) (quoting S. Rep. No. 82-1979 (1952); H.R. Rep. No. 82-1923 (1952)). back
Diehr, 450 U.S. at 185. back
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71 (2012) (quoting Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). back
Chakrabarty, 447 U.S. at 309; Fred Funk Seed Bros. Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948). back
Chakrabarty, 447 U.S. at 310. back
Id. at 309. back
Diehr, 450 U.S. at 190–91. back
Parker v. Flook, 437 U.S. 584, 590 (1978). back
Gottschalk v. Benson, 409 U.S. 63, 67 (1972). back
Bilski v. Kappos, 561 U.S. 593, 609–12 (2010). However, the Court declined to hold that business methods are categorically nonpatentable. See id. at 606–09. back
Alice Corp. Pty. v. CLS Bank Int’l, 573 U.S. 208, 217 (2014). back
Id. at 217–18 (quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 72–73 (2012)). back
Mayo, 566 U.S. at 77. back
Id. at 73–75. back
Id. at 77. back
Id. at 79. back
Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580 (2013). back
Id. at 579. back
Id. at 580–85. back
Id. at 591–94. back
Id. at 594–95. back
Alice Corp. Pty. v. CLS Bank Int’l, 573 U.S. 208, 212 (2014). back
Id. back
Id. at 218. back
Id. at 225. back