Author: Ishani Chakrabarty Symbiosis Law School, Pune
INTRODUCTION
‘Diamond v. Chakrabarty’[1], more popularly known as the Superbug case, is a landmark decision given by the US Supreme Court in the year 1980. It paved the way for modern Intellectual Property law, especially that of patent law.
Dr Ananda Mohan Chakrabarty, a microbiologist, created genetically engineered bacteria capable of breaking down crude oil. He wished to patent this bacterium as it was his invention. A patent examiner rejected his patent claim, stating that these bacteria are living organisms and thus cannot be patented. The United States Patent and Trademark Office Board of Appeals upheld the examiner’s decision that a living thing could not be patented. However, the United States Court of Customs and Patent Appeals, later on, dismissed their judgment, stating that Dr Chakrabarty was entitled to a patent as the bacterium was his creation. As a result, The Commissioner of Patents and Trademarks appealed against the decision of the United States Court of Customs and Patent Appeals. The final decision was to be given by the US Supreme Court.
A BRIEF SUMMARY OF PATENT LAW
One of the most important rules of patent law all around the world is that the subject-matter of the patent must be a new, unheard of idea, invention or creation that the world has never seen or experienced in history. Due to the same, no living, breathing organism could be patented because they are creations of nature and not of humans and thus were not new to the society. No person could claim another autonomous being to be their own and to do so would remove from the public domain something that nature has produced and which nature has intended to be equally for the use of all men[2]. Additionally, to permit the patenting of living things would cause some elements in society to attempt to patent their children, pets and plants, just to name a few.
Due to the belief that living organisms and cells were non-patentable products of nature, the patent protection of biological substances remained a grey area for many years. With the growth of science and medicine came the growth of microorganism-related creations. Even though microorganism-related creations were considered patentable, the micro-organisms themselves could not be patented. Over the course of time, patenting in micro-organisms became more complicated and controversial. The refusal to grant patents for certain organisms encouraged uncontrolled piracy of new inventions. The original creators suffered from economic losses because of low returns on their huge investments in the research to come up with the creation in the first place. This made it necessary to change the face of patents.
THE LEGAL IMPLICATIONS
The Superbug
Dr Chakrabarty’s invented a ‘bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway’. Deemed to be a ‘superbug’, this man-made, genetically engineered bacterium is capable of breaking down different components of crude oil. This capability is seen in no other naturally-occurring microorganism. In biotechnology, an organism that has had its genotype changed by a person is known as a genetically modified organism or a GMO.
Oil spills were, and to this day remain, huge environmental problems that damage the marine ecosystem. Even though oil-metabolising bacteria were discovered, they were ineffective against oil spills. This made Chakrabarty’s invention one of great significance to combat oil spills.
The case
The counsel on behalf of the appellant argued that the Superbug could not be patented as it was a living organism and to patent, it would go against the autonomy that all living beings have. The counsel of the respondent, however, argued that the Superbug was created in a laboratory. 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 possessed no oil-eating capabilities, which was the purpose of getting it patented.
The court reached several conclusions as to whether the bacteria should be considered patentable subject-matter or not. Out of the nine presiding judges, a cut-throat five decided that a patent should be granted to Dr Chakrabarty. Chief Justice Burger held that patents must be available for ‘everything under the sun made by man’ and that only inventions that met the statutory requirements of being new, useful, and non-obvious, can be patented. Only naturally-occurring organisms, laws of nature, natural or physical phenomena and abstract ideas could not be patented, and Dr Chakrabarty’s creation fell under none of the above. Therefore, it was pronounced that human-made microorganisms were indeed patentable subject-matter under section 101 of Title 35 of the United States Code Service and had to be considered a “manufacture” or “composition of matter”.
The TRIPS agreement
The Agreement on Trade-Related Aspects of Intellectual Property Rights, more popularly known as TRIPS, is a legal agreement between various nations of the world. TRIPS makes it compulsory for all its members to protect intellectual property and to extend patents for micro-organisms, non-biological, and microbiological processes. Moreover, altered plants and animals are not explicitly included in the exemption, which means TRIPS may also require patenting of biological organisms.
The TRIPS agreement mandates that patents on inventions which go against ordre public (public order) and morality can be excluded[3]. This provision purports to shield public order by protecting human, animal or plant life or health. Thus, patent examiners in such cases are not able to deal with ethical questions. Additionally, the TRIPS Agreement makes it compulsory to provide patent protection to micro-organisms and non-biological and micro-biological production of plants and animals. This mandate of the TRIPS makes it difficult for the signatories to not grant patent protection to inventions relating to micro-organisms.
Position in India
India is one of the nations that are a part of the TRIPS agreement. Both TRIPS and the Indian Patent Law clearly state that micro-organisms are patentable.
Previously, the Indian Patents Act, section 3(j) of the Act stated that plants and animals, in whole or in part thereof, including seeds, varieties and essentially biological process 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 satisfy the other requirements. Indian law does not allow microorganisms that already exist in nature to be patented and considers them discoveries[4]. It is important to note, however, that genetically modified versions of the naturally-occurring microorganisms that result in their modification or enhancement of its properties are patentable.
Criticism
The branch of Intellectual Property that deals with GMOs is grounded in biotechnology, a subject that has come under fire due to the number of ethical issues. Many animal activists and ethics campaigners condemn the creation and patenting of GMOs, believing that the process allows humans to manipulate a creature’s natural state and profit off the same. If too many animals were to be genetically changed, it could lead to a rapid decline in the genetic diversity of animals and threaten multiple species. If an organism is ever modified dangerously and happens to escape into the wild, this could result in the destruction of nature and possibly the human race.
The main arguments against the patenting of micro-organisms are the social and ethical concerns relating to it, along with the moral question of the extent of ownership that could be extended to other lifeforms. If any micro-organism is just discovered by a person, it will not come under the purview of the patentable subject matters 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 thus be patentable. This gives the deciding authority and the national laws of a country a lot of power in providing patent protection to micro-organisms.
CONCLUSION
With the ever-increasing rate of development and modernization, there exists a need to amend patent laws, especially with respect to GMOs. Earlier, patenting in 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 to biotechnological patents in general. If it were to be restricted, it would have led to large scale economic loss to the owner as there would be unfettered duplication of the invention. What the national laws can provide for in this situation is a way of limiting such patenting of micro-organisms in a way that is not injurious to public welfare and 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. It paved the way for more biotechnology patents. Most importantly, it has given researchers, scientists and developers the right to patent their genetically modified work and thus protects their creative output and hard-work.
[1] 447 U.S. 303 (1980)
[2] Patents Act 1970 S 2(1)(ac)
[3] Srticle 27
[4] Section 3(d).