Biotechnology and Biosafety, Intellectual Property Right (IPR) and Protection (IPP)
Generally, the physical objects such as household goods or land are the properties of a person. Similarly, a country has its own property. The ownership and rights on the property of a person is protected by certain laws operating in the country. This type of physical property is tangible. On the other hand, the transformed microorganisms, plants and animals and technologies for the production of commercial products are exclusively the property of the intellectuals. The discoverer has the full rights on his property. It should not be neglected by the others without legal permission. The right of intellectuals must be protected and it does by certain laws framed by a country. However, it is important to distinguish between the physical property and intellectual property. For example, seed of a plant is tangible asset; it can be sold in market and money can be made from it. But the intellectual property is intangible asset. Legal rights or patents provide an inventor only a temporary monopoly on the use of an invention, in return for disclosing the knowledge to the others in a specification that is intended to be both comprehensive to, and experimentally reproducible by a person skilled in the art. Others in society may use the knowledge to develop further inventions and innovations (Bull et. al., 1993).
Forms of Protection
The IPR is protected by different ways: patents, copyrights, trade secrets and trade marks.
Patents
The patents in terms give the inventor the right to exclude the others from making, using or selling his invention as disclosed in 'claims' of the patent. Obviously, it is difficult to keep secret the certain inventions such as the fermentation process. Therefore, guidance should be obtained from a qualified patent attorney.
The most important issue of discussion is the operation of State or Federal patent laws. For example, Food and Drug Administration of the US has regulatory purview on patented Pharmaceuticals before permitting for clinical use. Similarly, the Environment Protection Agency of the USA working under the Federal Insecticide, Fungicide and Rodenticide Act permits the release of genetically engineered microbial pesticides. The local 'nuisance ordinances' can minimize the excessive use of genetically engineered inventions. In India, DBT has formulated 'the recombinant DNA safety guidelines' to exercise powers conferred through Environmental Protection Act (1986). The 'genetic engineering approval committee (GEAC) of the Ministry of Environment and Forest has the powers to allow large scale use of GEMs at commercial level, and open field trials of transgenic materials (see preceding section).
The copyright protection is only a form of expression of ideas. One of the best example of copyrights is the books. The authors, editors, publishers or both publisher and author/editor have copyrights. The materials of the book cannot be reprinted or reproduced without written permission from copyright holders. However, it should be clear that patents and trade secrets provide protection of only basic knowhow, whereas copyrights protect the expressed materials viz., materials in printed, video-recorded or taped forms. Biotechnological materials subject to copyright include database of DNA sequence or any published forms, photomicrographs, etc.
The private proprietary information that benefits the owners is called trade secret. It may be of any type, from process to product yield. The most popular example is Coca Cola that has covered its best kept secrets of its formula under this law. It is surprising to know that India does not have trade secrets. There fore, it allows any company to register and protect the details of formulae. Usually, a patent runs out for 10-20 years, but under the law of trade secrets a company will have no obligation to reveal the trade secrets. In India, the limit of trade secrets is at least five years and two years in the USA. If the trade secrets become public before the granted period, the intellectual is paid compensation and unauthorized users are punished by the Court. The trade secrets in the area of biotechnology may comprise of hybridization conditions, cell lines, processing, designing, consumer's list, etc.
A trade mark is an identification symbol which is used in the course of trade to enable the public to distinguish on trader's goods from the similar goods of the other traders. The public makes use of these trade works in order to choose whose goods they will have to buy. If they are satisfied with the purchase, they can simply repeat their order by using the trade mark, for example KODAK for photography goods, IBM for computers, Zodiac for readymade cloths, etc.
The advantages of patents and other forms of IPR are : (i) encouraging and safeguarding intellectual and artistic creations, (ii) disseminating new ideas and technologies quickly and widely, (iii) promoting the investment, (iv) providing consumers with the result of creation and invention, (v) providing increased opportunities for the distribution of the above effects across the countries in a manner proportionate to national levels of economic and industrial development (OECD, Paris, 1989).
The WIPO is one of the specialized agencies of the United Nations. It has provided that the intellectual property shall include rights relating to the following:
(i) Literary, artistic and scientific works, performance of artists, phonograms, broadcast; innovation in all fields of human endeavor; scientific discoveries; trade marks; service marks and commercial names; industrial designs; protection against unfair competition and all other rights resulting from intellectual activity in the area of industrial, scientific, literary or artistic fields.
(ii) The intellectual property is protected by and governed by appropriate national legislation. The national legislation specifically describes the inventions which arc the subject matter of protection and those which are excluded from a protection, for example, methods of treatment of humans or therapy and invention whose use would be contrary to law or invention which are injurious to public health are excluded from patentability in the Indian legislation.
The GATT was framed in 1948 by developed countries to settle the disputes among the countries regarding share of world trade. It is decided by tariffs rates and quantitative restrictions on imports and exports. For a long time benefits from GATT was achieved only by developed countries. In 1988, the US Congress enacted a law the Omnibus Trade and Competitiveness Act (OTCA). As a result of which the USA became powerful to investigate the laws related to trade and check them if not beneficial to its interest. After warning, if the investigated country does not change its law within the desired (period, the US takes action, against that country. In 1992, the US gave warning to India to change some of its laws of IPR, patents and copyrights. India had certain inhibitions to sign on GATT draft. Therefore, there was much debate throughout the country on this issue and bad intension of the US. Professionals, politicians and scientists argued that the total package of TRIPs must guarantee for economic and technological subjugation of the country.
As discussed earlier that different countries have different patent laws which are changed with advent of time. For example, Dr. Anand Mohan Chakrabarty (an India born American scientist) created a superbug by using a bacterium, Pseudomonas which eats upon oils. His superbug could not be patented because the existing US laws before 1980 did not permit to patent the live forms. Later on the patent laws were amended. In 1988 in the US a patent was issued to genetically engineered mouse 'oncomouse' (containing human cancer gene) which is again a live form. Dr. Chakrabarty filed a case in the US Supreme Court and won it. In 1990 the US government allowed him to treat oil spills by using Pseudomonas based superbug.
There has been a debate on the patentable articles and conditions related with them. It is not like that every discovery can be granted patents. Discovery cannot be patented because the discovered article is the product of nature. Yes, the process or techniques used to discover the nature's product may be granted patents. Therefore, patent laws differentiate between discovery and invention, and allow patenting of inventions but not discoveries. The European Patent Office (EPO) has given suggestions that the process developed to isolate the products from nature is patentable. If the product is new and does not have previously existing recognition (e.g. microbial metabolites, antibiotics, alcohols, organic acids, vitamins, enzymes, etc), it is patentable. Therefore, the specific conditions for patent application should be such that qualify for patent i.e. (i) the invention must have novelty and utility for the society, (ii) the product must be inventive i.e. skill has been applied to it, (iii) it must be reproducible (will give similar result after repetition) and disclosed, (iv) scope of protection should be in proportion to the invention, and (v) it must be patentable.
Before filing the patent application the inventor must deposit a sample of officially approved material declaring that it is free from dispute of novelty and can be used by others when becomes legally free. Moreover, the application may be withdrawn before the grant of patent.
As discussed earlier, EPO has suggested to patent the genetically engineered liveforms. Also oncomouse is one of the examples of which initially the patent claims was rejected but on appeal the previous decision was overruled. Similarly, genetically engineered E. coli in which human genes for insulin, growth hormone, tPA, etc have been introduced, have been patented in the USA. Likewise, transgenic herbicide- and bollworm- resistant cotton, and insect-resistant tobacco have been granted patents. Several countries (such as Japan, USA, Europe, etc) have modified the patent laws stating that the transgenic plants and animals can be protected through patent claims.
The Indian Patents Act (1970) emphasizes that any patentable commodity must possess novelty. The Chennai based patent office believes that South Indian delicacies like 'medu vadai', 'rava uppama', 'badam halwa’ 'rice idli', 'rice pongal' and even green pea's “masala” are the novel process. In 1973, patents were granted for these popular preparations to the Dasaprakas Hotel Chain. The Mumbai patent office has granted a process patent to Dilip Shantaram Dahanunkar for the preparation of 'tomato rasam' and custard chili jam spread used as pizza topping. The same person has been given a patent for an improved process for preparation of vitaminised sweet and sour lemon pickle rice and a process for manufacturing banana sauce.