Comparative Analysis of Laws concerning biotechnology in India, US, EU

Devanshi Pareshbhai Malkan

Topics Covered in this article

Introduction

‘Biotechnology’ can be broadly defined as the technological applications of biological processes. Bio-technologists utilize living organisms or their (living organisms) body parts to develop a new product or a process which can improve the environment and/or quality of life.  The diverse applications of biotechnology are implemented in agriculture, medicine, energy, industry, and environment sectors. [1]

Bio technology plays an important role in the field of medicine, food, fertilizer, energy, and protection of the environment. Bio Technology concerns living organisms, such as plants, animals and micro- organisms, as well as non-living biological materials, such as seeds, cells, enzymes, plasmids and the like.

According to the Organization for Economic Cooperation and Development (OECD) biotechnology includes any technique that uses living organisms (or parts of organisms) to make or modify products, to improve plants or animals, or to develop microorganisms for specific uses.

The biotechnological inventions can be classified broadly into the following categories:

  1. inventions relating to an organism or material such as living entities of natural or artificial origin (animals, plants, and microorganisms), biological material (plasmids, viruses and replicas, and parts of organs, tissues, cells, and organelles), and naturally occurring substances from living entities, biological material and parts thereof;
  2. inventions relating to the process for the creation of a living organism or production of other biological materials; and
  3. Inventions relating to the use of such organisms or biological materials.[2]

Thus, it becomes necessary to protect the biotechnological inventions in India as well as in other countries.

Biotechnology and patent laws are not of recent origin; they have been present in our society for a long time. However, they became associated in recent years. This association became possible when biotechnology started creating commercial possibilities. Biotechnology, once primarily concerned with the academic field, has been transformed into a commercial industry with immense commercial potential. Recent bio-technological advances have presented unprecedented challenges before the existing patent laws, which have been slow to respond to technological challenges thus far.[3]

The TRIPs Agreement makes it obligatory for the Member States to protect bio-technological inventions but allows them to exclude plants and animals from patentability. However, it is obligatory for them to protect micro-organisms and essentially biological processes for the production of plants or animals.

The Trade Related Intellectual Property Rights System (TRIPS), developing countries can choose to provide patents or develop a sui generis system to protect innovations in agriculture. Under Article 27.3(b) of the TRIPS Agreement, members of the World Trade Organization (WTO) may exclude from patentability plants and animals and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.

Patentability of Biotechnology in the US and EUROPE

In the United States, in Diamond vs. Chakraborty[4], Mr. Anand M. Chakrabarty created a genetically engineered bacterium capable of breaking down multiple components of crude oil and applied for a patent on the ground that his bacterium possessed a trait not found in naturally occurring bacteria, and therefore sought patent protection. The patent and Trademark Office rejected the patent application of Chakrabarty on the ground that the micro-organism were products of nature and as living things non-patentable per se. On an appeal to the Supreme Court, the Court held that microorganism per se was patentable in the United States. This Judgment opened the doors for patenting of animals on the United States.

After the Chakrabarty decision expounded the product of nature doctrine, patents have been granted to various multi-cellular organisms. Patents were granted to polyploid oysters, genetically modified mice, rabbits and so on. Furthermore, in the USA, gene sequences, gene therapies and soon have also been held to be the patentable subject matter. With respect to gene sequences, the extent of their patentability is today before the Court of Appeals for the Federal Circuit, which is the patent appeals court in the USA.

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Though the scope of patentable subject matter is very broad in the USA, human beings are not considered to be the patentable subject matter. A patent application filed by Dr. Stuart Newman of New York Medical College covering fusion of embryonic human and animal cells to create chimeras for medical research was rejected by USPTO and such rejection was later approved by the Court.[5]

The European Patent Office (EPO) came into existence in 1977 and currently handles about 100,000 applications per year. The EPO is regulated by a treaty known as the European Patent Convention (EPC) which provides a system by which a unitary application for patents can be prosecuted for a group of designated countries. When a patent is granted by the EPO it is treated in each of the designated countries as equivalent to their national patent, subject to the provisions of the EPC. European patents are granted for inventions that are susceptible to industrial application, are new and involve an inventive step.

Over the past decade, there have been significant ethical, environmental and economic debates which have affected the development of EPO policy concerning the patenting of biotechnology inventions. The provision of European patent law which allows consideration of an invention’s effect on the public ordure or morality is unique. This concept has provided standing to concerned citizens, empowering them to challenge any patent, before or after it issues, on the grounds that such issuance is morally offensive. This process has allowed European citizens to use the judicial process to shape the laws regulating biotechnology inventions. Although recent decisions of the EPO Technical Board have addressed the exceptions to patent ability in the context of genetically engineered life forms, there is no clear line yet between what is to be considered a paten table “microbiological” process and a non-patentable “essentially biological” process. Further, since there are no binding definitions for these terms in the EPC, the potential exists for differing interpretations and applications of these terms among the various members’ nations’ courts.[6]

In the Harvard Onco Mouse Case the invention is a genetically altered mouse having an activated oncogene inserted into its DNA which gives the mouse a highly increased propensity to develop cancer.

The EPO Examining Division initially rejected the application, interpreting the term “animal variety” in Article 53 (b) to exclude any patent on an animal. This rejection was based on the legislative history behind the drafting of this section which was interpreted to be intended to exclude animals in general from patentability. In addition, some of the claims included the offspring of the genetically altered mice which was an essentially biological process and therefore not patentable.

 In an appeal The Board held that:

  1. The wording of Article 53(b) precludes an interpretation excluding animals in general because both “animal varieties” and “animals” are used in the same provisions; therefore, the legislators could not have intended for the terms to mean the same thing.
  2.  The Board directed the Examining Division to determine whether or not the subject matter of the application was an “animal variety” and suggested a balancing test wherein the interest of the inventor in obtaining reasonable protection should be balanced with society’s interest in excluding certain categories of animals from patent protection. Then, if the invention was not an “animal variety” within the meaning of Section 53(b), it should be determined whether the subject matter is derived from an essentially biological process. Ultimately it was decided that the process of introducing an activated oncogene sequence into the cells of the animal was not a process barred under Section 53(b).
  3. In addressing the issues of morality and public order, the Board suggested a balancing test involving a careful weighing of the suffering of animals and possible risks to the environment on the one hand and the invention’s usefulness to mankind on the other. In this case, the invention’s use as a cancer research tool was found to outweigh concerns about animal suffering or risk to the environment. Therefore, animal research test models appear to be patentable.[7]
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Patentability of Biotechnology in India

The emergence of biotechnology required the law of patent in India ought to be appropriately altered to coordinate the necessities of science and innovation.

The industries that use biotechnology are persuaded that intellectual property protection ought to be possible for the developments that come from research and which have business esteem. The field biotechnology is divided into different sub fields. Those sub fields like genomics, tissue culture of plants and animals which have unique characteristics. The properties, applications, processes, and products in a different area of biotechnology are also different from each other.

The Biotechnology sector is being hailed as the sunrise sector of India. It has been making steady progress over the last few years and has the potential to emerge as a global leader in the biotech industry.

In Indian patent law, the Patents (Amendment) Act, 2002 introduced significant changes with regard to the patentability of biotechnological inventions. By specifically allowing for the patentability of microorganisms, the law complied with the requirement of Article 27.3(b) of the TRIPS Agreement. The (TRIPS) Agreement, to which India is a party as a member of the World Trade Organization (WTO), requires some level of protection of biotechnological inventions, including of plant varieties.[8]

In 15th January 2002, the Hon’ble Calcutta High Court gave a landmark decision for the grant of patents to inventions where the final product of the claimed process contained living microorganisms in a case filed by Dimminaco A.G. against the decision of the Controller General of Patents and Design. The Hon’ble court concluded that ‘a new and useful art or process is an invention, and where the end product (even if it contains living organism) is a new article, the process leading to its manufacture is an invention’. [9]

India joined the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purposes of Patent Procedure on 17th December 2001.[10]

Biotechnology patenting systems were developed in three major areas in[11]:

  1. Agricultural- India is self-sufficient in wheat and paddy, but deficient in other agricultural produce. Agriculture in developing countries is predominantly rural based. Majority of the poor people depend on this agriculture. The new technology will improve the yield or reduce the cost of production will also directly reduce poverty and indirectly help the poor by lowering the price of food and by creating more employment opportunities. The genetically modified (GM) crops have been developed by using input traits (e.g. resistance to insect pests and plant diseases), output traits (e.g. delayed fruit ripening, better taste, nutritious, elimination of saturated fats in cooking oils, elimination of allergens, better delivery of necessary nutrients) agronomic traits (e.g. resistance to drought, salinity, acidity, flood, etc. and increase in crop yield).
  2. Industrial-To encourage inventions by promoting the protection and utilization technologies, so the industries are developed, which contribute to the promotion of technological innovation and to the transfer and dissemination of technology. Biotechnology industries are largely dominated by companies serving both the pharmaceutical and biotechnology products.
  3. Pharmaceuticals- Biotechnology is used for pharmaceuticals and drugs manufacturing through biological processes. These are some of the best drugs used today and certainly among the most expensive. The Indian pharmaceutical industry is a successful, high technology-based industry that has witnessed consistent growth over the past three decades.
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India has emerged as a manufacturing source for high quality pharmaceuticals which are recognized and accepted globally. There is a significant improvement in patent grants for Indian pharmaceutical companies, however, the number of companies with patents is very less when compared to the total number of pharmaceutical companies in India.

Conclusion

A large portion of the biotechnology firms has been concocted in developed nations. Such innovations are yet to profit the developing nations somewhat due to business reasons and furthermore because of the way that they may not generally be connected in their present structure. Development of appropriate biotechnology and their commercialization in developing countries is hindered by the array of existing patents.

In a developing country like India, the Patent Act, 1970 take the features from the Patent Act of the Developed Nations such as the U.S and Europe and the Patent Act does not provide specifically for biotechnology invention and protection.

But the Patent Law in Developed Countries like the U.S and Europe recognized the Protection of Biotechnology from the 1980s. As a result, a significant number of biotech inventions and patent application were applied in the US and EU patent offices and courts, as a result, there was a need for the amendment of Indian patent act to introduce biotech patentability law.

In India, in the year 2002 the patent for biotechnology was being recognized and in the definition of the term “patentable process” also explicitly includes biochemical, biotechnological and microbiological processes.

Advancement of suitable biotechnology also, their commercialization in developing countries like India as compared to Developed Countries like U.S and Europe because it is thwarted by the variety of existing Patents.

To safeguard the Biotechnological invention’s owner in India:

  1. National and universal activities which are being practiced in the U.S and Europe is ought to be taken for appropriate formulation of patent law for protecting biotech items without denying the enthusiasm of everyday citizens.
  2. Backing from other developing nations, unity among advanced/ developed countries and the job of NGOs were additional factors that empowered India to advance its interests in promoting a patent for biotechnological inventions.
  3. The R&D work in the field of biotechnology ought to be supported for investigating new devices and improve the natural frameworks for the enthusiasm of common citizens.
  4. Priority should be given to generation, evaluation, protection and effective commercialization of tangible products of intellectual property in agriculture, environment, and medicine.[12]

Hence in India, the Patent Law for the Biotechnology is still being formulated and is still being modified as it is a new law which requires some time to get accepted by the people of India as compared to U.S and Europe as in these countries such law for biotechnology is already being practiced.


[1] Alok Chandra Samal & Piyal Bhattacharya, Biotechnology Policy in India, ENVIS Centre on Environmental Biotechnology, University of Kalyani, West Bengal, India (June, 21, 2019) https://www.researchgate.net/publication/316989089_Biotechnology_Policy_in_India.

[2] Sujit Bhattacharya, Patenting in Biotechnology, DESIDOC Bulletin of Information Technology (Nov.2007),  file:///C:/Users/ambika/Downloads/143-Article%20Text-333-1-10-20100326.pdf.

[3] Ibid.

[4] Diamond v. Chakrabarty, 447 U.S. 303 (1980).

[5] Knowledge Base, Patentability of Biotech Inventions in USA – Patentable Subject Matter (Dec.27.2010), https://www.bananaip.com/ip-news-center/patentability-of-biotech-inventions-in-4/.

[6] Jane Massey Licata, Patenting Biotechnology Inventions in the European Patent Office, https://www.licataandtyrrell.com/Patenting%20Biotechnology.pdf.,

[7] Ibid.

[8] Ibid.

[9] Dimminaco A.G. v. Controller of Patents Designs (2002) I.P.L.R 255(Cal).

[10] Supra Note 8.

[11] Ibid.

[12] Ibid.