Issues related to Patentability of Biotechnological Inventions

Biotechnology is the process of modifying the living organisms in such a way that they become more productive for the humans. The recent trends in biotechnology techniques i.e. recommendations DNA, cell fusion, and monoclonal antibody technology have raised fundamental social and moral questions and created problems in intellectual property rights. Over the last 25 years, the sector of biotechnological inventions has experienced growth. It is an extremely dynamic area wherein there have been constant innovations. One of the most important sectors in biotechnology is DNA. Scientists have been able to use the DNA of some living organisms and cloned the same.

Article 27 of TRIPS discusses about the agreed international norms on patentability of the inventions. It states that any product or process shall be patentable if the said product or process is new, involves an inventive step and has industrial application. This criterion is same in all countries that are signatories of the TRIPS Agreement. According to Article 27.2, inventions against public order or morality or which would cause serious prejudice to the plant, animal and human health and life can be excluded from patentability provided that such exclusion is not made merely because the exploitation is prohibited by their law. According to Article 27.3, therapeutic, diagnostic and surgical methods as well as plants and animals except microorganism cannot be patented. Also, it has been agreed that the protection may be extended to the plant varieties through a sui generis system or patent etc.

To be a patentable invention in India, the requirement of novelty, inventive step and industrial application must be met. Also, it should not fall within the criteria mentioned in Section 3 and 4 of the Patents Act, 1970. In case of biotech patents, the following inventions are excluded from patentability:

  1. An invention would not be patentable if it is immoral or against public order, harmful to human, animal or plant life or harmful to environment.[1]
  2. Discovery of living things or non-living substances in nature[2]
  3. Plants and animals in whole or any parts thereof other than micro-organisms but including seeds, varieties and species.[3]
  4. Essentially biological processes for the production or propagation of plants and animals.[4]
  5. Any Process for the medicinal, surgical, curative, prophylactic, diagnostic or therapeutic or other treatment of human beings or animals to render them free of disease or to increase their economic value or that of their products.[5]
  6. New use or new property of known substance.[6]
  7. Methods of agriculture or horticulture.[7]
  8. Traditional knowledge.[8]

Issues surrounding ownership of genes and genetically modified humans, moral and identity dangers inherent in human cloning and genetic modification of human beings, suffering to animals due to genetic intervention, potential hazards to environment due to genetic manipulation, ecological balance are some of the serious issues related to granting patents on biotech inventions. Therefore, despite being a useful area to the scientists, procuring a patent in biotechnology at times is rather tricky in India.

Patenting of Genetically modified Microorganisms

Section 3(c ) of the Patents Act, 1970 precludes patenting of discovery of any living thing or non- living substance occurring in nature. This means an isolated naturally occurring gene is not patentable but a genetically modified gene would be considered as patentable if it is new and inventive having industrial application. As per Section 3(j) Plants and animals in ‘whole’ or ‘any part thereof’ is not patentable. Although, microorganisms are excluded from non-patentability list, a conjoined reading with Section 3 (c) of the Patents Act, 1970 implies that only modified microorganisms, which do not constitute discovery of living thing occurring in nature, are patentable subject matter under the Act. Besides the claims on Plants and animals in ‘whole’ or ‘any part thereof’ the claims relating to essentially biological processes of growing plants, germination of seeds, of development stages of plants and animals are objected under Section 3 (j) of the Patents Act, 1970. In 2002 Dimminaco A.G., applied for an invention patenting the process for preparation of a live vaccine for Bursitis, an infectious poultry disease. The invention involved a live vaccine to combat the disease. The Patent Office refused the application on the ground that the process didn’t constitute an invention under the Indian Patent Act, 1970. On appeal, the Calcutta High Court ruled that there is no statutory bar to accept a manner of manufacture to be patentable if the product contains a living organism.[9]

Patenting Animal Cloning

Section 3(j) precludes patenting of biological processes for production or propagation of plants and animals. Further, as per Section 3(b) of the Patents Act, 1970, the invention must not be contrary to public order, morality or causes serious prejudice to human, animal or plant life or health or to the environment. The most serious issue with animal cloning is the adverse health effects as they have been observed in sheep and the other mammals that have been cloned. These include an increase in birth size and a number of defects in important organs such as the liver, brains and heart. Besides these there has been premature aging and problems with the immune system.

Patenting Stem Cells

Section 3(j) of the Patents Act 1970 states that ‘plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals’ are not patentable. Stem cells are considered to fall under the phrase ‘any part thereof’ and hence are excluded from patentability. However, in vitro methods of differentiating, isolating/purifying and culturing of stem cells may qualify as patentable subject matter, provided it is novel, involves an inventive step and has industrial applicability.

In addition, Stem cells invention may also be objected under Section 3(b) of the Act, which states that an invention, the primary or intended use or commercial exploitation of which could be contrary public order or morality or which cause serious prejudice to human, animal or plant life or health or to the environment, are not inventions.

Patenting Genetically Modified Seeds

Biotechnology has helped for the improvement of plants. Example, genetic engineering helps introduce new genes with desirable traits such as insect resistance. The Patents Act, 1970 prohibits any patent on plants, plant varieties or seeds, but it does not exclude man made gene sequences that are present in Genetically Modified Seeds. Under the Protection of Plant Variety and Farmers Right Act, 2001, the creation of a new plant variety, which may include its propagating material i.e. the seeds and includes within its ambit transgenic varieties is protected. However the Patents Act, 1970 permits biotech companies to patent their artificially engineered genes and use them to create transgenic seeds in a lab and selling the same. Seeds can’t be patented in India. This is because a patent is an exclusive right granted to an inventor to prevent others from making, using, producing, selling and distributing the patented invention. A patent on seeds would prevent farmers from saving and exchanging seeds.

With respect to the expression ‘essentially biological process’, the Patent Office has not officially defined the said expression neither in the statute nor through judicial decisions. The biological guidelines issued by the Indian Patent Office in March 2013, does not have any reference as to what constitutes ‘essentially biological processes’. There are a number of examples in relation to Section 3 (j) of the Patents Act, one such example states that a claimed method involving the step of cross-breeding for producing pure hybrid seeds, plants and crops would be an essentially biological process and thus not allowable under Section 3(j). But there is no clarification if there is substantial human intervention, will the method be patentable.

The field of biotechnology is progressing at a very high speed. Along with this rigorous progress come many ethical and moral issues with respect to the patentability of the same. Moreover, it has been considered whether the inventions fall under the scope of the Patent Act, 1970 or not. In fact the patent system stimulates the development of technology rather than control it. As per the annual report 2016-17 issued by the Controller General of Patents, Designs and Trademark, 876 patents applications in relations to biotechnology were filed out of which 355 patents were granted. Hence, among the developing countries, India has immense potential to utilize biotechnology to solve some of its most intractable problems of productivity, health and environment.

Article by Sagarika Kapur (1st published on IP Link).