Background

Genetic engineer Ananda Mohan Chakrabarty, working for General Electric, had developed a bacterium (derived from the Pseudomonas genus and now known as Pseudomonas putida) capable of breaking down crude oil, which he proposed to use in treating oil spills. General Electric filed a patent application for the bacterium in the United States listing Chakrabarty as the inventor,^[2] but the application was rejected by a patent examiner, because under patent law at that time, living things were generally understood to not be patentable subject matter under Section 101 of Title 35 U.S.C.^[3]

The Board of Patent Appeals and Interferences agreed with the original decision; however, the United States Court of Customs and Patent Appeals overturned the case in Chakrabarty's favor, writing, "the fact that micro-organisms are alive is without legal significance for purposes of the patent law." Sidney A. Diamond, Commissioner of Patents and Trademarks, appealed to the Supreme Court.

The Supreme Court case was argued on March 17, 1980 and decided on June 16, 1980. The patent was granted by the USPTO on Mar 31, 1981.^[2]

Scientific/genetic foundations

In 1972, Ananda Chakrabarty filed a patent for a genetically modified bacterium that was capable of breaking down multiple components of crude oil. He developed this bacterium by engineering a way for multiple plasmids, each of which is able to break down different hydrocarbon components of the crude oil, to be incorporated into a single bacterium. The multiple plasmids would allow bacteria to break down oil from oil spills at a much quicker rate, and they would not be as affected by environmental conditions.

The patent for this genetically modified bacterium that Chakrabarty filed contained three claims: How he produced the bacterium, an "inoculum composed of a carrier material and the bacterium", and the bacterial species itself. The first two claims were accepted, but the claim on the bacteria was rejected, under the grounds that the bacteria are naturally occurring, and as living organisms, cannot be patented.

Why SCOTUS agreed to hear the case

The Supreme Court heard the case because it represented a new, useful composition of matter. This case clearly represented an improvement on a composition of matter. Naturally, this invention is useful in the cleanup of oil spills and in the water purification process. Seeing as the patent holder created the bacteria described in the proposed patent, no legal grounds existed to dismiss the claims. The argument against granting the patent was one of precedence. Historically, no living organism had been patented, but changes in the social climate and technological advances meant that according to the theory of dynamic statutory interpretation, the Supreme Court could update the meaning of patent laws to reflect innovative technology.

Position of plaintiff

After Chakrabarty had appealed his patent's initial rejection, the Court of Customs and Patent Appeals had reversed in his favor, stating that "the fact that microorganisms are alive is without legal significance to the patent law". In response, Sydney Diamond, Commissioner of Patents and Trademarks, decided to take this case to the Supreme Court. Diamond had two arguments which were not well received by the court. The first called the existence of the 1930 Plant Patent Act and the 1970 Plant Variety Act to suggest that there is a congressional understanding about the terms 'manufacture' and 'composition of matter' not referring to living things. The second was that microorganisms cannot qualify as patentable subject matter until Congress authorizes such protection since genetic technology was unforeseen when Title 35 U.S.C. 101 was first enacted.

Position of defendant

Chakrabarty's claim to the bacteria is not to any natural phenomenon, but rather a manufacture or composition of matter, which is characterized as being a product of ingenuity that has "a distinctive name, character [and] use". Diamond's first argument involving the Plant Acts was rejected because during these cases, Congress had observed that distinctions needed to be made between products of nature and non-naturally occurring inventions, rather than between living and non-living things. The second argument was rejected because after thoroughly analyzing the language used by Congress when defining patentable subject matter, the microorganisms clearly are indeed qualified to be patented. The term 'manufacture' is defined as meaning, "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," by the Century Dictionary. Additionally, 'composition of matter' is accepted to include, "all compositions of two or more substances and…all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they can be gases, fluids, powders, or solids". Based on this, the patent law was accepted to be given a wide scope, which included Chakrabarty's micro-organisms.

Decision

In a 5–4 ruling, the court ruled in favor of Chakrabarty, holding that:

A live, human-made micro-organism is patentable subject matter under {{UnitedStatesCode|35|101}}. Respondent's micro-organism constitutes a "manufacture" or "composition of matter" within that statute.

Ruling

Chief Justice Warren E. Burger wrote the decision, and was joined by Potter Stewart, Harry Blackmun, William Rehnquist, and John Paul Stevens.

Burger wrote that the question before the court was a narrow one—the interpretation of 35 U.S.C. 101, which says:

"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."

He wrote:

We have cautioned that courts "should not read into the patent laws limitations and conditions which the legislature has not expressed." United States v. Dubilier Condenser Corp, {{ussc|289|178|1933}}.

Regarding the scope of the original legislation, he wrote:

In choosing such expansive terms as "manufacture" and "composition of matter" modified by the comprehensive "any", Congress plainly contemplated that the patent laws would be given wide scope.

Finding that Congress had intended patentable subject matter to "include anything under the sun that is made by man," he concluded:

Judged in this light, respondent's micro-organism plainly qualifies as patentable subject matter. His claim is ... to a non-naturally occurring manufacture or composition of matter—a product of human ingenuity.

Dissent

The dissenting opinion was written by William J. Brennan, who was joined by Byron White, Thurgood Marshall, and Lewis Franklin Powell.

Brennan's dissent focused on the argument that evidence in the legislative record indicates the United States Congress did not intend living organisms to be patented.

We must be careful to extend patent protection no further than Congress has provided.

Brennan noted, "we do not confront a complete legislative vacuum", and commented on the 1930 Plant Patent Act and 1970 Plant Variety Protection Act, which explicitly allow patents for plants in certain cases:

The Acts evidence Congress' understanding, at least since 1930, that 101 does not include living organisms. If newly developed living organisms not naturally occurring had been patentable under 101, the plants included in the scope of the 1930 and 1970 Acts could have been patented without new legislation.

Therefore:

Because Congress thought it had to legislate in order to make agricultural "human-made inventions" patentable and because the legislation Congress enacted is limited, it follows that Congress never meant to make items outside the scope of the legislation patentable.

And with regard to the specifics of the 1970 act:

Congress specifically excluded bacteria from the coverage of the 1970 Act ... The fact is that Congress, assuming that animate objects as to which it had not specifically legislated could not be patented, excluded bacteria from the set of patentable organisms.

Legal implications

However, this ruling also indicates that entities can now own a life, and sell and manipulate it as they see fit, as they have exclusive rights to the life. This also has not completely clarified what can be patented, which allows the unfair and inconsistent treatments and considerations of future patents. The Courts also "determined a new and important public policy without a public debate and in defiance of a request from Congress to delay the action," which is indicative of the Courts having a higher authoritative influence than that of Congress's. This has the potential to cause entities to seek the approval of the courts more than follow the rules written by Congress, tipping the power in the government to an unbalanced state.

ESLI implications

The Supreme Court decision of Diamond vs. Chakrabarty brought to light some ethical issues. When Chakrabarty received the ruling, a 5-4 decision, in favor of his patent, companies were given leverage to further their research and apply for patents on a variety of biotechnology. A few years after the case came to a close, USPTO announced, "the Patent and Trademark Office now considers non-naturally occurring non-human multicellular living organisms, including animals, to be patentable subject matter within the scope of 35 U.S.C. 101". Since the time of Diamond vs. Chakrabarty, biotechnology has grown due to the removal of barriers on said technology.

The years following the decision of the case have seen close to 50,000 patents that deal with human genetic material, over 3,000 gene patents, and a little less than 20% of the human genome is owned by private parties{{Citation needed|date=February 2017}} . After the Chakrabarty case, the development of the "Harvard mouse" occurred, which was developed by researchers at Harvard{{Citation needed|date=February 2017}}. This development received the first patent in the United States for a transgenic animal ("i.e., an animal created by injecting genes from another species into a fertilized animal egg and then surgically implanting the egg into the mother"). Since this first transgenic animal patent, hundreds more have been issued. While many other countries have followed the United States in allowing the patenting of transgenic animals, Canada has not. The Supreme Court in Canada has ruled it wrong to patent transgenic animals.

Criticisms

When the case closed, some skepticism arose as a result of the ruling.{{cn|date=November 2017}} Some critics were quite concerned about what this ruling entailed for the future and what effects the bacteria may have in the long run. Individuals who were hesitant about the Supreme Court ruling expressed their concern about new patenting guidelines that would have to be formed by Congress and the environmental outcomes of the newly introduced bacteria.

Another common concern was that the ruling would open the floodgates for everyone to patent living organisms as they wished. At the closing of the case, it was stated that this ruling could lead everyone interested in patenting to believing, "Congress had intended patentable subject matter to include anything under the sun that is made by man".

Other critics raised environmental concerns about the effect that the bacteria, which are unaffected by a varying of environmental conditions, could have on the environment once they no longer have oil to break down. The main concern was that once these genetically modified and unnatural bacteria were released in the ocean, there was no way of monitoring the bacteria's growth within the environment and what effects they would have on various marine and terrestrial organisms existed.

See also

• List of United States Supreme Court cases, volume 447
• Genetic engineering in the United States

References