Diamond v. Chakrabarty

Diamond v. Chakrabarty, 447 U.S. 303 (1980), was a United States Supreme Court case dealing with whether genetically modified organisms can be patented.
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, 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.
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.
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:
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:
He wrote:
Regarding the scope of the original legislation, he wrote:
Finding that Congress had intended patentable subject matter to "include anything under the sun that is made by man," he concluded:
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.
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:
Therefore:
And with regard to the specifics of the 1970 act:
Legal implications.
The legal implications are both potentially positive and negative. The case has clarified what is patentable and what is considered: that section 101 still has limits, newly discovered products of nature cannot be patented, and that "claims directed to or encompassing a human organism [are excluded] from patentability". The ruling of this case has also created consistency for patenting living organisms, setting up the premise for the patenting of genetically modified microbes, plants, and animals. 
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. 
After the Chakrabarty case, the development of the "Harvard mouse" occurred, which was developed by researchers at Harvard. 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.
The years following the decision of the case saw close to 50,000 patents that deal with human genetic material, over 3,000 gene patents; however, in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), it was ruled that genes themselves cannot be patented, as they are found in nature. Only synthetic DNA, in which the sequence was designed in a lab and "not" found in nature, may be patented. This invalidated over 4000 patents that had previously been patented.
Criticisms.
When the case closed, some skepticism arose as a result of the ruling. 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.