Patentable Subject Matter

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Patent Act §101

§101: Inventions Patentable reads as follows:

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 therefore, subject to the conditions and requirements of this title.

As is usually the case, this short, simple statement has been the subject of innumerable debates, discussions, and lawsuits. Of course, it is a bit more specific than the Constitutional provision authorizing Congress to pass laws such as these.

Essentially, the four listed categories in §101 can be seen as two broad categories. The first consists of processes while the second consists of machines, manufactures, and compositions (collectively referred to as “products”). The type of patent issued in these cases is called a utility patent.

A process under §101 is a manner or means of achieving a certain result, or arriving at a certain goal. In order to be patentable, either the process must be inventive or it must be an inventive way of achieving a result which itself might not be inventive. We might also distinguish between processes which are an inventive way of using something and those which are an inventive way of making something.

The products categories are far easier to define, and we will limit our discussion of patent law to the law as it applies to products.  

• A machine is a concrete mechanical device (or combination of devices) which fulfills some function and produces some result. See Corning v. Burden, 56 U.S. 252 (1854).
• A manufacture is “the production of articles for use from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand-labor or by machinery.” Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980) (citing American Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1, 11 (1931)).
• A composition of matter “includes all composite articles, whether they be results of chemical union, or of mechanical mixture….” Shell Development Co. v. Watson, 149 F. Supp 279 (D.C. Dist. 1957) (citation omitted). Compositions of matter are not limited to any physical form or element: solids, powders, liquids, and gases all qualify.

Note that the language in §101 which permits patents for “any new and useful improvement” of an existing process or product is limited to the new use. The patent for the original process/product is referred to as the dominant patent while the patent for the new use is the subservient patent.

Judicial Exceptions & Limitations

In 1980, the Supreme Court reiterated the rule that

“laws of nature, physical phenomena, and abstract ideas have been held not patentable.” -Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).

The precise boundaries of these exceptions to patentable subject matter must be understood, however, because the exceptions are not as broad as they appear.

The rule that laws of nature are not patentable goes back at least as far as the Supreme Court case of O’Reilly v. Morse, 56 U.S. 62 (1854). Morse wanted to obtain patents for the Electro-Magnetic Telegraph (the original email) and for electro-magnetism. The case, which includes a fascinating, if somewhat long-winded and detailed, explanation of the workings of the telegraph, resulted in upholding the patent for the telegraph but not for electro-magnetism. Morse reached too far in this latter request, and according to the Court (at 112):

He claims the exclusive right to every improvement where the motive power is the electric or galvanic current, and the result is the marking or printing intelligible characters, signs, or letters at a distance.

This, then, is the heart of the "laws of nature" exception. If Morse had been granted a monopoly on the powers of electro-magnetism, invention would have been stifled rather than encouraged. The existence of electro-magnetic fields in nature cannot be patented by anyone. Only novel uses of this natural phenomenon for process or product can be patented.

EXAMPLE: Mike discovers that lemons will rot when they drop from a tree. He finds that if he squeezes the rotten lemons it produces a liquid which he can sell to people whose taste buds never properly developed. This novel use for rotten lemon juice can be patented, but the law of nature that fruit rots cannot be patented.

Products of nature, like laws of nature, cannot be patented. But not every living thing is a product of nature.  In Diamond, the issue before the Supreme Court was

“whether a live, human-made micro-organism is patentable subject matter.” Diamond at 305.

“a nonnaturally occurring manufacture or composition of matter - a product of human ingenuity,”

“discovery of the handiwork of nature,”

which is not patentable, such as was the case in Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1972).

In Funk Bros., the bacteria produced through combination of six species of bacteria did nothing different from the original species, and did exactly what they would have done absent the patentee’s efforts. See Funk Bros. at 131. In Diamond, however, the Court found that the new bacteria had

“markedly different characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature's handiwork, but his own; accordingly it is patentable subject matter under § 101.” -Diamond at 310.

New creations through genetic engineering of plant life are specifically patentable under The Plant Patent Act of 1930 and the Plant Variety Protection Act of 1970. This is not to the exclusion of other genetically engineered transformations of nature (see Diamond at 311-312).

"Congress… recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions." -Diamond at 313.

Therefore, although products of nature are not patentable, the fact that one seeks to patent a living organism, be it animal, vegetable, or mineral, is not, in itself, cause to reject the patent application. Human-modified products of nature which serve a purpose different from the naturally-occurring product of nature and which have characteristics different from the original may be patented. 

EXAMPLE: Arthur Tick is an amateur horticulturist. He has recently developed a new strain of yellow corn. As the plant grows, the genetically engineered corn develops an arm-like appendage which attaches itself to nearby objects. By placing stakes in the ground in corn fields, this new appendage can attach itself and support the stalk, allowing for larger ears of corn and a greater yield-per-acre. Because the genetically modified corn has characteristics different from naturally-found corn, the modified strain is patentable. I wonder how it tastes…

In addition, the Supreme Court has recently ruled unanimously that DNA/genetic sequences of genes are not patentable, as the sequences are information found in nature. See Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 576 (2013). However, man-made genetic sequences may still be patentable.

In Mayo v. Prometheus Labs, 566 U.S. 66 (2012), the Supreme Court held that the personalized medicine dosing process invented by Prometheus is not eligible for patent protection because the process is effectively an unpatentable law of nature.

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