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.