Conceptual Issues Of Patenting Of Life Forms
Author – Bharat Sharma, Navya Mishra
A patent is an intellectual property right granted to a person to enable him to monopolise his invention to the exclusion of others in exchange for its complete disclosure. Such an invention could include a product or a process but must be capable of industrial application.
The concept of patentability of life forms and the associated issues thereof took root in the late 1900s wherein there was a sudden rise in research surrounding gene technology or biotechnology. As the field of biotechnology grew rapidly, those involved in related studies were able to utilise findings of their research to manipulate the naturally existing life forms to benefit the society on a large scale, leading to the introduction of concepts such as bio-patenting or patenting of life forms.1
At present, this concept is faced with various legal as well as ethical issues as it involves commercial usage and the lack of definite laws regulating the same; further, several terminologies related to bio patenting have not been defined explicitly under the Patent Act of 1970. This article aims to explore the said issues.
Position in India
One of the landmark cases surrounding the patentability of life forms was the Dimminaco A.G case2wherein it was held that the manufacturing of anything involves undergoing a specific process and invariably includes within its ambit a vaccine containing a living organism.
In fact, the application of Article 27 of the Agreement on Trade Related Aspects of Intellectual Property Rights, regarding patentable subject matter, led to significant changes in the definition of invention under the Patent Act of 1970.3
The Act, however, does not detail definitions involving life forms, thereby making the interpretation of the provision quite ambiguous and arbitrary. Further, common words such as “microorganism” and related terminology have been left to the discretion of the interpreter, with occasional reference to the TRIPS Agreement.4
The main issue with patenting life forms in India is the fact that several factors need to be taken into consideration to interpret the provisions of the Act. Aside from holding up tests of novelty, the existence of an inventive step and application in the industry, other factors end up causing a hindrance in granting of patents for inventions involving life forms. For instance, anything that is “against public order or morality” or the “discovery of a living substance” or “inventions directed to methods of agriculture” and many others, forming a list fromSection 3(a) to 3(p) under the Patent Act, require careful consideration and act as barriers to the patentability of life forms or bio-patents.5
In most cases, it has been observed that inventions involving life forms are classified as matter already existing in nature and therefore cannot be considered as patentable subject matter. Moreover, the usage of such naturally occurring matter in the industrial scenario gives rise to numerous legal as well as ethical issues, often associated with being against public interest.
Thus, it becomes important to analyse the conceptual issues that surround the patenting of life forms.
Issues of Patenting Life Forms
The Legal Issues
As per the Patent Act of 1970, a particular product or process can be patented only when it involves some amount of innovation and complete disclosure. However, when one takes into consideration innovations occurring in the field of biotechnology, it becomes apparent that it may be seen as naturally occurring subject matter, thereby falling under the exclusion clauses under Section 3 of the Act.
Further, the utilisation of a substance that is available in nature to the exclusion of the general public can be considered to be against the general interest of the public, thereby excluding it from the ambit of patents. In some cases, they are described as the conversion of “god made natural material to mere private objects using technology”.6
A relevant case referencing the above is Funk Bros. v. Inoculant Co.7, where the question revolved around the culturing of Rhizobia to immunise leguminous plants. It was held by the court that inherent characteristics of bacteria were nothing but a “work of nature”, and hence, not patentable.
On the other hand, when one takes into consideration the case of Diamond v. Chakrabarthy8, it is seen that the Supreme Court of USA adopted a liberal approach and granted patent to a genetically improved bacterial specie. In this case, the Court largely focused on the inventive step that was taken to harness the peculiar capability of the bacteria in question. The Court stressed that the term “manufacture” was wide enough to include everything that was man-made.
Post the above decision, there were several other instances wherein patents were granted, but the aspect of morality was of little to no significance.
The lack of clarity on what instances require examining the invention though the glasses of public morality leaves the question— in what instances is human intervention sufficient enough to classify an invention as patentable, especially when it concerns Genetically Modified Organisms (GMOs)?
Further, varying decisions of courts have failed to set a clear guidelines regarding patentable life forms.
The Moral and Ethical Issues
On several occasions, the introduction of GMOs into the ambit of patentable inventions have led to ethical and moral questions such as the acts constitute playing the part of God and degradation of the “dignity of life” for furthering private interests.9
At this stage, it is important to take into consideration the case of Relaxin10, where the court held that the patenting of a single gene could not be compared to the act of patenting human life itself. The reasoning was that the cloning technology was not at an advanced stage where an entire human itself could be cloned out of a single gene. Further, several inventions are of such importance to the society that their patentability is apparent. In this case, the isolation of relaxin for genetic coding was considered to not be a “mere discovery”.
In another case before the European Courts, the patentability of a genetically modified plant was opposed due to the morality factor. It is at this stage that the Board elaborated what was meant by “morality” and “public order”.11 However, the same varies across nations as the yardstick for what is moral and what is capable of disrupting public order largely depends on the collective conscience of different sections of the society.
In most cases, patenting of life forms to many is considered immoral as the manipulation of genes puts forth a view of life being a mere “article of trade”, used to make profits for private entities or persons.
Another issue that has always been a point of discussion in several instances is the ownership rights over the modified life forms. If the example of T-Lymphocyte is taken into consideration, one can observe that a patent was granted out of an invention from the spleen of a patient suffering from cancer, without his consent or knowledge. The action led to litigation resulting in the question of whether or not it is the responsibility of the researchers to gather express consent to be able to possess ownership rights over genetically modified matter. Further, what would be the benefit that a contributory to the research is entitled to receive.
Despite the above issues, it is important to understand that the overall aim at patenting life forms is the benefit that could arise to humanity at large. The commodity aspect of things is not to be seen in isolation and must be viewed with a clear objective of promoting the interest of the public. It is important to note that research can only be encouraged if there is a fair reward given for the same. The awarding of a patent provides incentives to work towards the development of a better society as a whole, especially when it concerns products or processes aimed at making life better or aimed to revolutionise healthcare and temporary monopolisation is a small price to pay for the same.
Other facets of indignation, however, could be the possible advantages that developed countries have over developing ones and their engagement in theft of biological materials from various sections of society. One of the major examples of this is from the pharmaceutical industry wherein wealthy States derive monetary benefits from others in the form of periodic payments to be able to utilise patented inventions considered necessary for survival.
From the above paragraphs, it can be seen that inventions in the field of biotechnology are faced with multiple conceptual as well as ethical issues. These issues necessitate more precise laws and well-defined boundaries, to be able to tackle them in the right manner. Further, moral issues must be dealt with by introducing the idea of patenting of life forms as a need of the hour.
An extensive patent safeguard structure is desirable to encourage the study and exploration of various life forms, to ensure maximum protection and to prevent misuse of available rights to the detriment of the common man.
1Dhawan, Conceptual Issues in Patenting Life Forms, SUPREMO AMICUS (Jan. 05, 2021 4:00 PM), https://supremoamicus.org/wp-content/uploads/2020/06/A1v18-27v18.pdf.
2 (2002) I.P.L.R. 255 (Cal).
3 Article 27 of the TRIPS Agreement.
4 Dhawan, supra note 1.
5 Patent Act, 1970.
6 Supra note 1.
7 333 U.S. 127.
8 447 U.S. 303 (1980).
9 Supra note 1.
10 T 0272/95
11 Supra note 7.