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Patentable Subject Matter Reform (CRS Report for Congress)

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Release Date Sept. 8, 2017
Report Number R44943
Report Type Report
Authors Thomas, John R.
Source Agency Congressional Research Service
Summary:

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.