Patentability Of Biotechnological Invention
Author: LawSphereX
Category: Intellectual Property
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PATENTABILITY OF BIOTECHNOLOGICAL INVENTION
Thara James, Christ (Deemed to be University), Bangalore
ABSTRACT
Intellectual property rights are real assets and much more valuable and important than are materialistic assets like house, motor car, and so on. Patents are given for inventions which fulfil few important conditions, such as novelty, inventiveness, industrial application, and written description. Significantly, biotechnological invention involves monopoly over life or living beings or living processes, and morally and ethically these are considered to involve tinkering with life or nature. However, today, biotechnological inventions are patentable because of their benefits and utility to the industry. Intellectual property is an intangible property which is created by the human mind. In this competitive world it is very important to protect intellectual property. Man uses the science and technology as an instrument of development.
The progress in biotechnology has profound implications on the relationship between humans and the environment. Biotechnology is the science where biological systems and living organisms are used to create new products or processes. Biotechnology will substantially shape drug discovery, delivery, diagnostic methodology, clinical trials, and to a large extent the major lifestyle of human society once the availability of the human genomes traced. The biotechnological invention in the patent system includes biological, microbiological, genetics, medical and agricultural inventions. Inventions relating to biological processes are not limited to developments in genetic engineering but also include compounds derived from microorganisms, plants, insects, and animals.
Article 27 of the Trade Related Aspects of Intellectual Property (TRIPs) agreement covers the patenting of living organisms and living processes. TRIPs are an international agreement administered by the World Trade Organization that determines minimum standards of Intellectual Property regulations applicable to member countries of world trade organization. In India, patentability of the invention is covered by Indian Patent Act 1970. At the beginning it had nothing specific addressing the biotechnology inventions and protection but later by witnessing massive increase in the biotechnology invention and application for the Patent, the demand to amend and introduce patentability of biotechnology gained voice in India which resulted in alteration of section 3(j) of the Patent Act. This paper mainly focusing upon the criteria for patenting, subject matter of the
patents and ethical issues involved in patentability of biotechnological inventions. Keywords: Intellectual property, Patents, Biotechnology, Invention, Microorganisms, Ethics.
INTRODUCTION
Patent is an exclusive right to use or exercise an invention, granted to a person by the State for a limited period in consideration of the disclosure of the invention. It excludes others from doing certain acts in relation to that invention for a specific period of time. Further, like the owner of patent or patentee, assignee and licensee could also do some acts and exercise certain rights in relation to such invention. The economic growth and development has highly impacted the technology and sparked the competitiveness in every field. This resulted in rapid technological advances on the worldwide trade and business environment. There are three dimensions to the evolution of biotechnology in advanced industrialized countries i. e. the science and technology on which biotechnology is based, biotechnology-related companies and government policies1.
Biotechnology can be referred to as one of the fastest-growing technology. The science of biotechnology involves the manipulation of living organisms using biological systems and living organisms to create new or modified products and processes. 2 The product of biotechnology is neither naturally occurring in living organisms nor the product of nature. But they can be called an invention if it involves inventive steps and can be applicable in industry along with satisfying the criteria of patentability. It is important for companies to develop biotechnological patents so that they can develop, life-related products. By granting IP rights for a limited period of time, patents provide companies an opportunity to recover investment in developing the patented invention and launching the new products into the market, or licensing or transferring the rights to other companies.
3 But countries like India are not completely accepting the concept of biotechnological patenting and addressing it as an unethical practice.
RESEARCH OBJECTIVES
The aim of this Research is;
1 V. Sita, Intellectual property rights in biotechnology - an empirical analysis in Andra Pradesh,
INTELLECTUAL PROPERTY RIGHTS, 87,91 (2008)
2 Dr. Jayanta Lahiri, Lectures on IP laws,118 (R. Cambray &co pvt. Ltd. 2009)
3 Alfredo Mateos García, Key Points in Biotechnological Patents to be Exploited, RECENT PATENTS ON
BIOTECHNOLOGY,84, (2013).
To identify the position of the patentability of biotechnological inventions. • To understand the difference between biotechnological patenting and other invention patenting. • To trace out and examine the ethical issues. • To provide better possible solutions to the existing issues for the better policy formation and the regulations thereof.
RESEARCH QUESTIONS
Does patent law differentiate between Biotechnological inventions and other inventions? • Whether our country has any policy framework in the field of biotechnology patenting? • Whether the patenting of biotechnology will be ethical?
STATEMENT OF PROBLEM
The problem of patentability in biotechnological inventions lies in the complexity and rapid advancements in the patent field. The challenges posed by the patenting of genetic material, bioengineered organisms, and therapeutic techniques. The conceptual issues in patenting the biotechnological inventions.
HYPOTHESIS
The criteria under which biotechnological inventions were granted patent needs review. • Biotechnological inventions are not completely ethical.
RESEARCH METHODOLOGY
The methodology adopted in this paper is doctrinal that is purely based on the secondary sources like books, journals, articles and internet sources. Selected books and other materials referred in this research paper. It ensures a thorough examination of the patentability of biotechnological inventions from multiple perspectives, providing a well-rounded understanding of the issues.
CONTENT ANALYSIS
I.
Evolution of biotechnology patenting in India.
In India, patent act was enacted in the year 1970. It does not mention anything about biotechnological invention because during that time biotechnology was not developed in India. Evolution and expansion of biotech industry sparked the grant of patent for different biotechnological invention in United States and European Union, the demand spread worldwide including India to adopt the same approach and significance. It also paved the way for the adoption of international conventions like Trade related Aspects of intellectual property rights (TRIPs) agreement and changed the history of patent law4. Trade related Aspects of intellectual property rights (TRIPs) is an agreement administered by the World Trade Organization (WTO). It formulates the minimum standards for intellectual property regulations for all the member countries of WTO.
TRIPs ratification prompted India to amend its intellectual property laws including patent law in order to patent biotechnological inventions. Indian patent act 1970 amended in the year 2002 for the second time after first amendment in 1999. This second amendment brought major amendments by permitting patenting of products of chemical, biochemical, biotechnological and microbiological. India, after recognizing Budapest treaty, facilitated the deposits of biotechnological inventions. Further, the third amendment of 2005 omitted section 5 of the original act which restricted patents only to the process of manufacture. Now both products and processes are patentable in the field of biotechnology. Inventions such as micro-organisms, genetically modified plants and animals and processes to manipulate living beings are patentable.
5 Section 3 of the Indian Patent Act 1970 mentions nonpatentable inventions, such as an invention which is frivolous or which claims anything obviously contrary to well-established natural laws, intended use or exploitation of which would be contrary to public order or morality or which causes serious prejudice to human, animal, or plant life or health or to the environment. 6 This means that only those biotechnological inventions are patentable in India which are useful to society, hence any invention which is harmful to law of nature or human, animal, or plant life or health or to the environment is nonpatentable in India. In Dimminaco AG vs Controller of Patents and Design,7 the Kolkata High Court held that the process of preparing a commodity which contains a
4 Dr. Sreenivasulu N.S.& Dr. Raju C.R., biotechnology and patent law,56, (Manupatra 1st ed. 2008)
5 Supra 3 ,59
6 Management of Intellectual Property Rights in India. Available from:
http://www.pfc.org.in/workshop/workshop.pdf [accessed on December 2, 2014]
7 IPLR 2002 Jul 255 (Cal)
living substance is also covered under the purview of manufacture. Accordingly, process patent was issued to the applicant by the patent office. It is important to mention here that there are not yet much judicial decisions in India about patenting of biotechnological inventions. II.
Criteria for grant of Patent 1. Novelty Novelty is the first requirement that need to be fulfilled. Section 2(1)(j) of the Indian patent act states the invention must be new and different from the ‘prior Art’. Inventions which have already been published in any form anywhere before filing a patent application will ceases to be new. 8 In Bishwanath Prasad Radhe Shyam v. Hindustan Metal Industries9the Supreme Court held that patent will be granted only if the invention is new. In case of genes and gene products, it is easy to meet the principle of novelty as they are chemical entities that are able to be patented in most patent office once, they are isolated and purified from the original form appearing in nature. 10 2. Non-Obviousness Section 2(ja) of patent act deals with non-obviousness.
It states an invention that involves a technical advance over existing knowledge, or is economically important, or both, and that makes the invention not obvious to someone skilled in the field. The obviousness that a particular gene having a particular nucleotide sequence exists in principle, but whether it would be obvious to one skilled in the art to identify and isolate it. 11 3. Utility Patent must possess utility. Product should have some capacity to perform some kinds of work. The invention should be applicable to relating industry. Economists say whatever commands the price in marketplace will holds good in utility test. Suppose process used to isolate not previously known partial complementary DNA sequences, then these partial cDNA sequences may be patentable if it satisfies the utility test. 12
8 S.K. Singh, intellectual property rights law, 146 (central law agency, 1st ed. 2009)
9 Bishwanath Radhe Shyam v. Hindustan Metal Industries, AIR 1982 SCC 1444
10 Malati Lakshmikumaran, patenting of genetic invention, 48, JOURNAL OF INTELLECTUAL PROPERTY
RIGHT, (2007)
11 Jidesh kumar, biotechnology patenting, 474, JOURNAL OF INTELLECTUAL PROPERTY RIGHTS, (2004
12 Ibid
4. Inventive step
The invention must contain technical steps which should not be obvious for the skilled person. Inventive steps can be said as the step which makes an invention unique. III.
Patenting biotechnological invention Biotechnology is a study relating to the practical application of living beings in different fields or relating to living organisms in the industrial utilization. Biotechnological invention involves monopoly over life or living beings or living processes, and morally and ethically these are considered to involve tinkering with life or nature. Significantly, patenting life was never considered possible because life is a creation of nature and human beings cannot get exclusive right over it. 3 However, developments in science and technology, especially in biotechnology, have created nonnatural living beings and the application, utility, and benefits of such nonnatural living beings or nonnatural living processes forced our system to broaden the base of patent law, and hence biotechnological inventions became patentable.
Therefore, natural life is a creation of nature and hence nonpatentable, whereas nonnatural life is creation of man which involves the application of human ingenuity or intelligence to natural living beings and hence patentable. Significantly, eight countries have reviewed their patent laws to provide protections to biotechnological inventions which include both developed and developing countries. Besides the United States (US), members of European organizations and Japan, other countries like Korea and Thailand, have done commendable work of harmonizing their patent laws and practice in respect of biotechnological inventions. 13 IV.
Ethics in patenting biotechnological invention In India ethics and morality plays an important role because here in India ethics and morals are respected and adhered to at the same level as the law. The concept of morality is related to the belief where one behaviour is considered as right and the other one wrong. This belief is based on the accepted norms which are ingrained in the particular culture. Indian culture is well known for worshipping plants and animals by consider them as God. Many people consider this concept of patenting life as an unethical practice therefore they are not in favour of this. The objection raised by them lead to 13 Pal Prankrishan, Intellectual Property Rights in India General Issues and Implications, Regal Publication New Delhi, (2008), p. 71
potential structural changes in the agricultural industry that could result from biotechnology, especially if large corporations acquire legal rights to the advancements being made. 14 The ownership of living beings is discouraged in India because there has been a longstanding tradition of not encouraging private ownership over living and natural things. But India being a member of TRIPs agreement must adhere to it in patenting of inventions like micro-organisms and other inventions which are produced through microbiological, non- biological or biotechnological process. 15 According to the amendment, any invention that is contrary to public order or morality or may result in serious harm to human or animal health or environment cannot be patented.
It also cleared that plants, animals, and essentially biological processes for production of plant and animals are not patentable on the basis of ethics. V.
Research question answers with reasoning. • Does patent law differentiate between Biotechnological inventions and other inventions? No, the procedure for patenting of biotechnological invention is same as that of any other invention. The invention must fulfil the criteria of novelty, utility and nonobviousness but along with that there is an additional requirement of sufficient disclosure for which the invention is needs to be deposited at an authorized Depository Authority. • Whether our country has any policy framework in the field of biotechnology patenting? Yes, the department of biotechnology which was set up by the government of India within the Ministry of science and technology has established a “Biotechnology patent facilitation Cell (BPFC)” which look after the issues relating to biotechnology patenting. • Whether the patenting of biotechnology will be ethical?
We cannot say it is completely ethical. Because India being a traditional country and which values ethics and morals is actually against the biotechnological invention but
14 Archana K, Do We Need Patent Protection to Biotechnology Inventions? 01, INTERNATIONAL JOURNAL
OF SCIENTIFIC AND RESEARCH PUBLICATIONS,(2013).
15 Supra 3, 223
there are certain convincing factors which ensures it will not hurt the ethical values of the country and such inventions can be considered as ethical. VI.
Recommendation The biotechnological patenting is under controversy because of ethical issues involved in it and ethical issues differ from country to country, so local laws must be modified by providing clarity regarding ethical issues. The time period of granting of patents must be reduced. Because biotechnology being rapidly developing technology may overlap on the inventions. Expert committee on patenting of biotechnology must be constituted to assist, adjudicate and enforce the invention. Strict laws must be adopted and grant of license should be made mandatory on satisfying the required conditions. Bio-safety measures must be adopted to ensure safe production, use, storage, transfer and exploitation. BPFC must make its policy framework more efficient and ensure good governance. VII.
Conclusion Today, biotechnology is a driving force of modern world, and patent law has reached unprecedented and unforeseen destination as nonnatural lives, or nonnatural living being, and nonnatural processes are patentable. The inventions of biotechnology, which involve addition of human intelligence to the natural processes in producing nonnatural and genetically modified living beings, range from nonnatu ral microorganisms like bacteria, plasmid, nonnatural plant, nonnatural animal, and nonnatural human genetic material which are undoubtedly patentable in the present scenario. Biotechnology has become increasingly significant for the growth and development of developing nations like India. An unpredicted evolution of biotechnology has been accompanied by a long struggle for recognition and reward. It wasn't easy, as there were negative and positive phases of progress.
There is no doubt that the biological materials or substances that are designed in the labs and weren't available in the natural environment have earned some rights to patentability. As a result, biotechnological patenting was introduced in India to protect the inventor's interests and right to patent. A biotechnological invention, which results from the application of man’s creativity to a biological process, must deserves patent protection. But one must make sure that the invention is not harming any moral values or is unethical.
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