This article has been written by Poorva Joshi, pursuing a Diploma in Advanced Contract Drafting, Negotiation and Dispute Resolution from LawSikho and edited by Shashwat Kaushik.
It has been published by Rachit Garg.
Introduction
In Diamond vs. Chakraborty (1980), a U.S. Supreme Court case that is considered a landmark case, the judges in this case expanded the application of the U.S. Patent Act, which had an impact on the biotechnology industry. This is a landmark case because the Supreme Court agreed and held on June 16, 1980, that a live, human-made micro-organism is patentable subject-matter under 35 U.S. Code §101 and that the respondent’s micro-organism constitutes a “manufacture” or “composition of matter” within that statute.
Facts of the case
Anand Chakraborty was working for General Electric as a genetic engineer. During his employment, he created a bacterium (scientifically known as “Pseudomonas putida”). This newly developed bacterium was capable of breaking down crude oil. Anand Chakraborty proposed using this bacterium for oil spills. General Electric filed a patent application for creating the bacterium in the United States, stating Chakraborty as the inventor.
The application was rejected by the patent examiner and the Board of Patent Appeals and Interferences, stating that under 35 United States Code Service (“U.S.C.”) 101, the microorganisms were not patentable. General Electric and Chakraborty appealed the decision of the Board of Patent Appeals and Interferences to the United States Court of Customs and Patent Appeals. This time, the United States Court of Customs and Patent Appeals overturned the previous judgements and held that Anand Chakraborty had created this bacterium and was entitled to a patent. The Commissioner of the Patent Office, Sidney A. Diamond, filed an appeal against the order given by the United States Court of Customs and Patent Appeals to the Supreme Court.
Judgement of the Court
The main issue in this case was whether a man-made living organism can be patented under the US Patent Act. Out of the nine presiding judges of the Supreme Court, five judges ruled in favour of Anand Chakraborty and upheld the decision given by the United States Court of Customs and Patent Appeals.
Opinions of the majority
Under 35 U.S.C. Section 101, it is stated that whoever invents or discovers any new and useful process, machine, manufacture or composition of matter may obtain a patent.
In view of the above section, Justice Warren E. Burger, along with the majority, held that the Congress intended that the words “manufacture” and “composition of matter” were to be given broad scope. Judges added that the bacterium was developed and made by Anand Chakraborty. The Court’s precedents in Funk Bros. Seed Co. vs. Kalo Inoculant Co. (1948) rejected the appeal for the patent, stating that the patentee had only discovered the existence of naturally occurring bacteria that may be used to improve crops more than 50 years prior. While Anand Chakraborty had himself created the bacterium and had evolved and changed it for a particular purpose. The U.S. Supreme Court, however, further held that the scope of the above mentioned words cannot be interpreted in a very broad sense and will not be extended to “laws of nature, actual events and conceptual ideas.” Anything under the sun that is man-made is patentable, subject to such inventions meeting the statutory requirements of being new, useful, and non-obvious.
The reason for granting the patent rights to Anand Chakraborty was that the micro-organism is not a natural phenomenon but a non-naturally occurring manufacture or composition that has a distinctive name, character and use.
Even though it was technically a living thing, the form in which it was to be patented did not occur naturally, i.e., it inherently did not possess oil-eating capabilities, which was the purpose of getting it patented.
Opinions of the dissenting judges
Out of the nine presiding judges, four judges, i.e., Justice William J. Brennan Jr., Justices Byron White, Thurgood Marshall, and Lewis F. Powell Jr., dissented from the Court’s ruling. The judges state that the courts should take into account the intent of Congress while drafting the Patent Act. Living organisms have been excluded from the scope of the Patent Act.
The dissenting judges mentioned that the Court had only one issue to decide whether Congress had the intention under the Act to give any kind of monopoly over a living organism in terms of how the living organism is produced or used. It is the role of Congress and not of the Court to broaden or narrow the scope or interpretation of a particular law or act, especially when the matter could possibly be of public concern.
Referencing the Plant Patent Act, 1930 and the Plant Variety Protection Act, 1970, the judges stated that the Congress intended to grant patent protection to certain asexually reproduced plants. In the Plant Variety Protection Act of 1970, the Congress extended the protection to certain new plant varieties that are capable of sexual reproduction. Under these two acts, Congress addressed the problem of patenting animate inventions while at the same time limiting the language in such a manner as to exclude specific other discoveries. The enactment of these acts supports the fact that Congress intends to limit bacteria’s patentability.
Impact of the judgement
In 2018, Time mentioned this decision as one of 25 important moments in American history. Professor Gerardo Con Diaz stated that the decision allowed “inventors at private and public institutions alike to obtain patents for genetically modified organisms—from plants and animals for laboratory research to many foods available in supermarkets today”—and allowed biotechnology firms to protect their developments in new ways. In IP Watchdog on the decision’s 30th anniversary, Gene Quinn called the decision a “turning point for the biotech industry” and praised the Court’s ruling as “emblematic of the need for an expansive view of what is patentable subject matter.” Likewise, the Biotechnology Innovation Organisation praised the decision as being “instrumental in spurring the creation of a dynamic and flourishing biotech industry.” Nature noted that, according to industry participants, “without Diamond vs. Chakrabarty, commercial biotechnology based on recombinant DNA technologies would not exist today.”
Criticism of the judgement
The main concern under this was the monopoly over a living organism, as there are many ethical issues around it. Many animal activists and ethics campaigners condemn the creation and patenting of genetically modified living organisms, believing that the process allows humans to manipulate a creature’s natural state and gain profit from the same. There might arise a scenario wherein the genetically modified organism could cause the destruction of nature and humans. These genetically modified organisms might also affect the balance of nature and the genetic diversity of animals.
If any micro-organism is just discovered by a person, it will not come under the purview of the patentable subject matter; it will be considered a mere discovery and not an invention. However, when the micro-organism is genetically modified to exhibit a new characteristic that is useful to humankind, it will be deemed an invention and will be patentable.
The courts continued to grant the right of biotech industry developers to claim ownership of altered biological life but provided some limits, as in Mayo Collaborative Services et al. vs. Prometheus Laboratories, Inc. (2012) and Association for Molecular Pathology vs. Myriad Genetics, Inc. (2013). However, since the Anand Chakraborty case, the courts have provided safeguards like forbidding the patenting of “limited DNA sequences”.
Position in India
India is part of the TRIPS agreement. Both TRIPS and the Indian Patent Law clearly state that micro-organisms are patentable. Previously, Section 3(j) of the Indian Patents Act, 1970, stated that plants and animals, in whole or in part thereof, including seeds, varieties and essentially biological processes for the production of plants and animals, are excluded from what can be patented. However, after the 2002 Amendment Act, microorganisms were allowed to be patented as long as they satisfied the other requirements. Indian law does not allow microorganisms that already exist in nature to be patented and considers them discoveries. It is important to note, however, that genetically modified versions of the naturally-occurring microorganisms that result in their modification or enhancement of their properties are patentable.
Analysis and conclusion
Following this case, the patent office dramatically expanded the kinds of inventions it was willing to patent, to include plants, animals, some computer technology, and business methods. Neither Congress, the Supreme Court nor other courts have stopped this expansion. “This entire patent qualification question-which was so plain and obvious, was reasonably implementable and perceived, and gave life to our whole biotech area after Chakrabarty,” as per Judge Randall Rader. Judge Rader replied as follows when he was asked whether the Congress should clarify the issue in the judgement given in this case. He said “assuming the regulation was the composed regulation that was being understood by the Supreme Court, we wouldn’t need an official correction”.
Earlier, patenting life life-forms was not allowed anywhere in the world. With the advent of technology, however, patent protection had to be given to inventions relating to micro-organisms. In the past few decades, there has been a dramatic shift in the approach to patenting in micro-organisms and biotechnological patents in general. If it were to be restricted, it would have led to a large scale economic loss to the owner as there would be unfettered duplication of the invention. What the national laws can provide in this situation is a way of limiting the patenting of micro-organisms in a way that is not injurious to public welfare or interest. The concepts of invention and discovery must be clearly distinguished in national laws.
The case of Diamond v. Chakrabarty revolutionised the field of intellectual property. Most importantly, it has given researchers, scientists and developers the right to patent their genetically modified work, thus protecting their creative output and hard-work.
References
- https://supreme.justia.com/cases/federal/us/447/303/
- https://lawessential.com/ip-case-laws/f/diamond-v-chakrabarty-447-us-303-1980 https://www.casebriefs.com/blog/law/intellectual-property-law/intellectual-property-keyed-to-merges/patent-law-intellectual-property-keyed-to-merges/diamond-v-chakrabarty/
- http://digital-law-online.info/cases/206PQ193.htm
- https://www.thelegalvidya.in/the-superbug-case-an-analysis
- https://repository.law.umich.edu/cgi/viewcontent.cgi?article=1202&context=book_chapters
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