Author:Vishal v v

Occupation:Advocate

Abstract

While Diamond v. Chakrabarty (1980) is frequently taught as the case permitting the United States to issue patents for genetically modified bacteria, the legal commentary has largely overlooked the fact that the ‘Chakrabarty,’ at the center of this 5-4 Supreme Court case, is Ananda Mohan Chakrabarty, a scientist from rural Birbhum, West Bengal, India, who was completely educated within Indian universities, and who later received India’s Padma Shri for the invention that the Patent Office in the United States had rejected as ‘not a manufacture.’ This article is different from the American case law commentaries, as it provides additional information on the Indian litigation case in question on how a son of Sainthia influenced the law on biotechnological patenting around the world, on how the Indian judiciary developed similar reasoning in Dimminaco A.G. v. Controller of Patents (2002) without referring to Chakrabarty, and on the retrospective effect that the 2002 change in Indian patent law, in compliance with the TRIPS Agreement, had on Section 3(j) of the Indian Patents Act, 1970, in embedding the ‘human ingenuity’ test exemplified in the Chakrabarty case. This dual-jurisdiction case commentary enables the reader to gain unique insight into an area of biotechnological patenting law that is otherwise very difficult to find.

To the Point

A microbiologist at the research laboratory of General Electric in New York applied for a patent in 1972 for a genetically modified microorganism created by him to break down crude oil in order to solve the environmental problems created due to oil spillage. However, the U.S. Patent and Trademark Office declined this application. The argument put forward by the patent office is rather simple: organisms, according to 1930 Plant Patent Act and 1970 Plant Variety Protection Act, cannot be patented because life forms have never been considered within the scope of normal patenting.

This particular scientist is Dr. Ananda Mohan Chakrabarty. He was born on April 4, 1938 in Sainthia, a tiny town in Birbhum district of West Bengal, youngest among seven siblings of a small Bengali household. He pursued his education through the Indian education system where he attended Ramakrishna Mission Vidyamandira and graduated with B.Sc. from St. Xavier’s College in Calcutta while doing his M.Sc. and Ph.D. in biochemistry from University of Calcutta in 1965. Thereafter, he moved to the USA and embarked upon a legal battle which would lead to granting him a patent besides changing the biological world of property law forever. .

Use of Legal Jargon

Patentable Subject Matter under 35 U.S.C. § 101: The statute allows a patent on ‘any new and useful process, machine, manufacture, or composition of matter.’ The whole point of the case was whether a live bacterium created by humans could be considered a ‘manufacture’ or ‘composition of matter.’

The Product-of-Nature Doctrine: An ancient common-law doctrine according to which ‘laws of nature, physical phenomena, and abstract ideas’ cannot be patented because these are manifestations of nature, which belong to everyone. The Patent Office’s argument was that Chakrabarty’s bacterium was merely a product of nature. 

The ‘Human Ingenuity’ or ‘Human Hand’ Test: In the current legal case, the doctrine proposed is that the differentiation should not be made between living things and inanimate objects, but between natural products (in whatever way humans worked to discover them) and the manufacture that are ‘non-naturally occurring’ and that come about due to genetic engineering. The Chakrabarty bacterium, with its plasmids that were not naturally found in any Pseudomonas, was such an invention of human skill.

Section 3(j), Indian Patents Act, 1970: The Indian statutory equivalent of this debate. It states that plants and animals whole or in part other than microorganisms and essentially biological processes are not patentable and implies that micro-organisms not being ‘essentially biological’ or genetically engineered products of human intervention are patentable. This particular clause was inserted by the Patents (Amendment) Act, 2002 in response to the TRIPS provision at Article 27.3(b) and is the late codification by the Indian legislature of the ‘human hand’ principle itself enunciated by the Chakrabarty Court over two decades ago. 

The Proof

Chakrabarty asserted (1) a claim for the method of producing the bacteria, (2) a claim for an inoculant carrying the bacteria on a floating carrier material and (3) a claim for the bacteria itself as a new composition of matter. The patent examiner allowed the first two but rejected the third on the grounds that micro-organisms were ‘products of nature’ and as living things were not patentable subject matter under the law at that time. The Patent Office Board of Appeals upheld the rejection.

The Court of Customs and Patent Appeals reversed, stating that the fact that an organism is alive has no legal significance for patent purposes. Sidney A. Diamond, the Commissioner of Patents, then asked the Supreme Court for a writ of certiorari. The case was heard on March 17, 1980 and decided on June 16, 1980. Chief Justice Warren Burger wrote the opinion for a slim five-justice majority, joined by Justices Stewart, Blackmun, Rehnquist, and Stevens. Justice Brennan dissented, joined by White, Marshall, and Powell.

The seismic global impact of this ruling is evidenced not just by the subsequent explosion of American biotechnology  the case is widely credited with sparking the U.S. biotech industry by making genetically engineered inventions commercially protectable  but its quiet, undeniable incorporation into Indian law two decades later. India excluded micro-organisms from patentability altogether at first. Only the 2002 TRIPS-compliance amendment that inserted present Section 3(j) brought Indian patent law into substantial doctrinal alignment with the very ‘manufacture versus nature’ distinction Chakrabarty had drawn. Indian patent commentary today routinely credits the ‘human hand’ test from this American case as the conceptual ancestor of India’s own microorganism patent regime.

It is equally telling that Chakrabarty himself did not disappear into American academia after his case. He was named a Distinguished Professor of Microbiology at the University of Illinois at Chicago, advised the United Nations Industrial Development Organization on the creation of the International Centre for Genetic Engineering and Biotechnology, gave lectures on the patent law of biotechnology to judges in various countries, and in 2007, twenty-seven years after his triumph in the Supreme Court, was awarded the Padma Shri, India’s fourth-highest civilian honor, by the very country whose patent system had not yet caught up with the doctrine he had established abroad.

Case Laws

Diamond v. Chakrabarty, 447 U.S. 303 (1980)  U.S. Supreme Court

Held, 5-4, that human-made micro-organism is patentable subject matter within the meaning of 35 U.S.C. § 101, as it is a “manufacture” or “composition of matter.” The Court rejected the argument that the Plant Patent Act and Plant Variety Protection Act implied Congressional intent to exclude all living things from patent law, holding instead that these statutes addressed specific practical obstacles to patenting plants, namely the difficulty of written description and the then-prevailing belief that plant reproduction was not “human-made,” neither of which applied to bacteria. Burger, C.J. famously said that the distinction drawn by Congress was ‘not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions. 

Dimminaco A.G. v. Controller of Patents and Designs (2002) Calcutta High Court

Fittingly decided in Kolkata, Chakrabarty’s own home state, this is India’s closest doctrinal cousin to the American case. A patent application for a process for preparing a live infectious Bursitis vaccine was refused on the ground that a process that produced a living end product could not be said to be a manufacture. The Calcutta High Court reversed this and held that a process that results in a vendible, useful product containing a living organism is not excluded from the meaning of manufacture simply because the end product is alive. Although the Court did not explicitly refer to Chakrabarty, the Court’s logic that patentability is based on novelty, utility and industrial applicability rather than biological status is consistent with Chakrabarty’s ‘human ingenuity’ logic to the letter, making Dimminaco the unacknowledged Indian sibling of the American ruling.

Novartis AG v. Union of India (2013)  Supreme Court of India

This case, while decided on Section 3(d) grounds (rejecting a patent for the cancer drug Glivec for not possessing enhanced therapeutic efficacy over a known substance), illustrates the limiting principle India has adopted in addition to its Chakrabarty-inspired openness to biotech patents: human ingenuity alone is not enough  India also requires genuine technical advancement, not merely incremental modification, representing a more cautious, public health-conscious adaptation of the American ‘human hand’ philosophy.

Diversity-Oryza Sativa & Monsanto Technology LLC v. Nuziveedu Seeds Ltd. (2019) — Supreme Court of India

The case involved the micro-organism exception in Section 3(j) for Bt cotton seed technology in the context of genetically modified seed, showing how India has continued to litigate the precise contours of the “human intervention versus natural/essentially biological process” line that Chakrabarty initially drew for bacteria, extending the same conceptual battleground to transgenic plants four decades later.

Conclusion

The stories of Diamond v. Chakrabarty are almost entirely American stories: a 5-4 split, a biotech industry born, a doctrine of ‘human ingenuity’ established. What this familiar narrative omits is that the man at its core carried Sainthia and Calcutta University in his mind into that courtroom, and that for the next twenty-two years the country of his birth would quietly absorb the very logic he had fought to establish  first through the judiciary in Dimminaco, then through Parliament in the 2002 TRIPS amendment to Section 3(j).

This is then less a question of the binary of ‘living vs. non-living’ and more a deeper, more enduring legal question: where does human creativity end and the work of nature begin? Forty-five years later, that question feels even more pressing, in CRISPR gene editing, synthetic biology, and AI-assisted protein design, all of which challenge the “human hand” test that Chakrabarty pioneered far more severely than a single oil-eating bacterium could ever do. India’s own biotech and pharmaceutical sector, today a global leader in generics and vaccines, owes an intellectual debt to a legal battle fought in Washington by a scientist from rural Bengala debt Indian legal education rarely acknowledges, and one this article attempts, in part, to set right.

FAQs

Q1. Was Ananda Chakrabarty an Indian citizen when he won the case?

No. Chakrabarty emigrated to the United States in 1965 after completing his Ph.D. at the University of Calcutta, and was working at General Electric as a naturalized American resident at the time of the case. However, he remained closely connected to India throughout his life, was awarded the Padma Shri by the Government of India in 2007, and continued advising Indian and international institutions on biotechnology law until his death in 2020.

Q2. Did India follow Chakrabarty’s reasoning directly, or independently?

Both, in different ways. The Calcutta High Court’s 2002 Dimminaco judgment arrived at strikingly similar reasoning — that a ‘manufactured’ living product is patentable — without expressly relying on Chakrabarty. However, India’s 2002 Patents (Amendment) Act, introducing Section 3(j) to comply with TRIPS Article 27.3(b), is widely understood by Indian patent scholars and practitioners as a legislative response shaped by the global doctrinal shift Chakrabarty initiated in 1980.

Q3. Can natural, unmodified micro-organisms be patented in India today?

No. Section 3(j) of the Indian Patents Act, 1970 continues to exclude naturally occurring biological material and ‘essentially biological processes.’ Only micro-organisms that are genuinely the product of human genetic intervention — engineered, isolated, or modified through deliberate scientific effort — qualify, mirroring precisely the line Chakrabarty drew between nature’s products and human-made inventions.

References

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18. Novartis AG v. Union of India, (2013) 6 SCC 1 (Supreme Court of India).

19. Monsanto Technology LLC v. Nuziveedu Seeds Ltd., (2019) 3 SCC 381 (Supreme Court of India).

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