Patentable subject matter in the United States information

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Patentable subject matter in the United States is governed by 35 U.S.C. 101. The current patentable subject matter practice in the U.S. is very different from the corresponding practices by WIPO/Patent Cooperation Treaty and by the European Patent Office, and it is considered to be broader in general.

The US Constitution gives the Congress broad powers to decide what types of inventions should be patentable and what should not be, as long as patenting of these inventions "promotes the Progress of Science".^[1] Uncontroversially, patenting of research tools, scientific discoveries and scientific theories is excluded, since it would inhibit rather than "promote the Progress of Science".^[2]

However, besides research tools etc. there is another (and more controversial) question of whether some patent claims can be too broad and may pre-empt all uses of a particular discovery. The Alice-Mayo test discussed below aims to address this issue.

Since the enactment of the subject matter requirement ca. 1970, the interpretation of the statute changed multiple times. Although Section 101^[3] of Title 35 U.S.C. reads:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

and, thus, does not say what is patent-eligible and what is not, US courts felt that some inventions should not be subjected to patent monopoly at all (supposedly because certain claims may be too broad and may pre-empt all uses of a particular discovery), and used U.S.C. 101 as an excuse to enforce their own believes (and not of the US Congress). To quote the SCOTUS in Myriad: "Without this exception, there would be considerable danger that the grant of patents would ‘tie up’ the use of such tools and thereby ‘inhibit future innovation premised upon them.’"^[4]

The two particularly contentious areas, with numerous reversals of prior legislative and judicial decisions, have been computer-based (see Software patents under United States patent law) and biological inventions.^[5][6] While these two areas present different types of challenges:^[7]

(a) the problem with biological inventions is where the discovery of Nature's work ends and where a human invention begins, i.e. patent monopoly should not encompass a "natural phenomenon or a law of nature".

(b) the problem with the software inventions (such as “mathematical algorithms, including those executed on a generic computer,... [and] some fundamental economic and conventional business practices")^[8] is that the scope of such claims is incommensurably broad compared to their contribution to "the Progress of Science" (quid pro quo),

the US Courts rejected early attempts to develop different set of rules for the two challenges and instead tried to find a common approach to these, as well to potential other subject matter eligibility challenges in the future. One amicus curiae plainly called this approach "one attempt [at] a universal framework via amorphous and misguided patent eligibility requirements."^[9]

Nevertheless, this approach, known as Alice- Mayo framework, was developed by the SCOTUS in 2012–2014, and has been used by the USPTO and by US courts since. The unified Alice-Mayo approach to subject matter eligibility requires (1) the newly discovered Law of Nature or mathematical formula to be assumed as known, (2) an additional "inventive concept", that limits the application of (1) to a specific and non-trivial use.

There is an important relationship between patent eligibility and non-obviousness tests in the US patent law. The non-obviousness criterion can be easily met, if a claim is based on a discovery of new natural phenomenon/principle/law. In the patentable subject matter analysis, however, this "discovery" is assumed to be prior art, and an "additional inventive concept" must be present in the claim.^[10]

Although the details are discussed below, the net result as of year 2023 can be summarized as follows:

Things (including living organisms and nucleic acids) found in nature are not patent-eligible (Funk Bros. Seed Co. v. Kalo Inoculant Co.) even, when isolated from their natural environment (e.g. a protein-encoding gene from a chromosome), but things (even alive) "made by man" may be (Diamond v. Chakrabarty, Association for Molecular Pathology v. Myriad Genetics, Inc.), provided that they are different in a useful manner from their natural predecessor(s).

In the case of computer-implemented methods, the algorithms (even new and non-obvious) per se are not patentable (Gottschalk v. Benson, Parker v. Flook), but their new and useful applications may be patentable (Diamond v. Diehr).^[5]

The Mayo, Myriad and Ariosa v. Sequenom patents are similar in being based on a "discovery" of a natural phenomenon or a mathematical law (as in Gottschalk v. Benson), that assures the novelty and non-obviousness of the patent claims. Yet, when this "discovery" is assumed to be a prior art (as the Mayo-Alice test requires), a patentable claim must have an additional "inventive concept"^[11] or "inventive application".^[9] The purpose of this requirement is to prevent monopolization of all (or many) uses of the "discovery". One legal commentator wrote, that the additional "inventive concept" requirement is reminiscent of the inventive step requirement of the Patent Cooperation Treaty and of European Patent Convention, and that some of US patent rejected due "subject matter eligibility" had their foreign counterparts rejected for the lack of inventive step.^[12]