The term "patentable subject matter" refers to the requirement of Section 101 of the Patent Act of 1952 that an invention must consist of a "process, machine, manufacture, or composition of matter" in order to be patented. Most recently, the Leahy-Smith America Invents Act (AIA) of 2011 stipulated that "no patent may issue on a claim directed to or encompassing a human organism." The AIA also limited the availability of patents claiming tax avoidance strategies. The courts and the U.S. Patent and Trademark Office (USPTO) have historically understood the language of Section 101 to allow an expansive range of patentable subject matter. In particular, laws of nature, natural phenomena, and abstract ideas have been held to be unpatentable. For many years, Section 101 was arguably a coarse filter that was rarely used to invalidate an issued patent or reject an application pending at the USPTO. This situation changed over the past decade due to a series of decisions issued by the Supreme Court of the United States. In each instance the Court concluded that the invention before it was unpatentable under Section 101. Since the Supreme Court issued its decisions, Section 101 has been more frequently invoked to invalidate issued patents and reject pending patent applications at the USPTO. Further, numerous patents granted by the USPTO under earlier standards would likely be held invalid if they were subject to scrutiny by the agency or the courts. Even if these requirements of novelty, nonobviousness, and utility are met, an invention is not patentable unless it falls within at least one category of patentable subject matter. Under this reasoning, human genes consist of patentable subject matter. That test asks (1) whether the claim recites a law of nature, natural phenomenon, or abstract idea; and (2) if so, whether the claim includes additional, inventive elements that indicate the claim applies one of the three excluded subject matters, rather than being a fundamental concept per se . With regard to this second step, the Court will analyze a patent claim to determine if it preempts a field of activity. If a claim covers every practical application of a fundamental concept, then it cannot be patented under Section 101. In addition, the Court does not consider a claim's recitation of routine, nominal hardware—such as a general-purpose computer—to ameliorate concerns over Section 101 eligibility. If the current situation is deemed acceptable, then no action need be taken. As of the date this report was published, no bill has been introduced before Congress addressing the law of patentable subject since the enactment of the Leahy-Smith America Invents Act in 2011. (b) Sole Exceptions to Subject Matter Eligibility .—A claimed invention is ineligible under subsection (a) only if the claimed invention as a whole exists in nature independent of and prior to any human activity, or can be performed solely in the human mind. Similarly, the ABA Section on Intellectual Property asserts that recent Supreme Court decisions "have injected ambiguity into the eligibility determination by requiring courts and the [USPTO] to apply criteria such as 'well known,' 'routine,' 'conventional or obvious,' factors that were previously relevant only to novelty and obviousness, in order to ignore limitations and render a claim patent ineligible and in effect have turned the gateway function of patent eligibility into a patentability test better left to the other statutory provisions.... " For its part, the IPO explains that the Supreme Court's analysis "is contrary to [c]ongressional intent, too restrictive, technologically incorrect, unsound from a policy standpoint, and bad law."
The term "patentable subject matter" refers to the requirement of Section 101 of the Patent Act of 1952 that an invention must consist of a "process, machine, manufacture, or composition of matter" in order to be patented. The Leahy-Smith America Invents Act (AIA) of 2011, P.L. 112-29, additionally stipulated that "no patent may issue on a claim directed to or encompassing a human organism." The AIA also limited the availability of patents claiming tax avoidance strategies.
The courts and the U.S. Patent and Trademark Office (USPTO) have generally construed the language of Section 101 broadly. As a result, inventions from many different fields of human endeavor may be patented, so long as other statutory requirements such as novelty and nonobviousness are met. However, the courts recognize several implicit exceptions to the four statutory categories of patentable subject matter. In particular, laws of nature, natural phenomena, and abstract ideas have been held to be unpatentable.
For many years, Section 101 was arguably used only infrequently to invalidate an issued patent or reject an application pending at the USPTO. This situation changed over the past decade due in large part to four decisions issued by the Supreme Court of the United States since 2010 addressing patentable subject matter. In each instance the Court concluded that the invention before it was unpatentable. The four cases were
Bilski v. Kappos, pertaining to a business method; Mayo Collaborative Services v. Prometheus Laboratories, considering a method of medical diagnosis; Association for Molecular Pathology v. Myriad Genetics, addressing human genes; and Alice Corp. v. CLS Bank, relating to computer software.
These decisions collectively hold that an invention is unpatentable if (1) it consists of a law of nature, natural phenomenon, or abstract idea; and (2) does not include additional, inventive elements that indicate the claim applies one of the three excluded subject matters, rather than being a fundamental concept per se. With regard to this second step, the Court analyzes a patent claim to determine if it covers every practical application of a fundamental concept. Claims with this preemptive scope cannot be patented under Section 101. In addition, the Court does not consider a claim's recitation of routine, nominal hardware—such as a general-purpose computer—to ameliorate concerns over Section 101 eligibility.
Since the Supreme Court issued these decisions, Section 101 has been more frequently invoked to invalidate issued patents in the courts and in certain administrative patent revocation proceedings, and also to reject pending patent applications at the USPTO. Further, numerous patents granted by the USPTO under earlier standards would likely be held invalid if they were subject to scrutiny today.
If the current situation is deemed acceptable, then no action need be taken. However, several stakeholder groups have recommended legislative reforms to Section 101. In general, these proposals assert that an invention should be deemed patentable subject matter unless it exists in nature independently of human activity or it can be performed solely in the human mind. These proposals also state that whether an invention is implemented through conventional means is irrelevant to whether it is patentable subject matter or not. As of the date of publication of this report, legislation has yet to be introduced before Congress addressing reform of the law of patentable subject matter.