Intellectual Property Rights Notes | Biotechnology

Read this article to learn about the intellectual property rights of biotechnology

What is Intellectual Property Rights (Biotechnology)

Biotechnology intellectual property rights is the legal ownership of an interest in a patent, trademark or trade secret. This means that another company cannot use those assets without permission of the company established as the official owner. In health care, intellectual property rights give their owners exclusive use of pharmaceuticals, brand names and more. Intellectual property rights are often the primary driver of value for these companies, particularly in biotech.

Forms of Protection

The IPR is protected by different ways: patents, copyrights, trade secrets and trade marks.

Patents:

Patent is a special right to the inventor that has been granted by the Government through legislation for trading new articles. A patent is a personal property which can be licensed or sold by the person/organization just like any other property. For example, Alexander Grahm Bell obtained patent for his telephone. This gave him the power to prevent engine from making or using or selling a telephone elsewhere. In some European countries the monopoly rights were granted only to the inventors so that they may develop new articles beneficial for the society. In the USA the maximum limit of this monopoly is for 17 years. In India the Indian Patent Act (1970) allows the 'process patents' but not the 'product patent', and the maximum duration of patent is for 5 years from the date of grant, and 7 years from the date of filing the patent application. The least duration between five and seven years is applicable for patents. The conditions of patents are given in the preceding section.

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.

A patent consists of three parts; the grant, specifications and claims. The grant is filled at the patent office which is not published. It is a signed document which is actually the agreement that grants patent right to the inventor. However, the specification and claims are published as a single document which is made public at a minimum charge from the patent office. The specification part is narrative in which the subject matter of invention is described how the invention was carried out. The claim section specifically defines the scope of the invention to be protected by the patent to which the others may not practice.

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).

Copyrights

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.

Trade Secrets (Knowhow)

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.

Trade marks

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 World Intellectual Property Organization (WIPO)

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.

General Agreement of Tariffs and Trade (GATT) and Trade Related IPRs (TRIPs)

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.

The then Director General of GATT, A. Dunkel came to India for discussion on this issue. Certain provisions were suggested to include in GATT draft that India will not give any kind of subsidies for the production of oilseeds and pulses as the international price is more than that in India. India assured to change its patent laws by 2003. In the changed patent it will introduce the 'product patent’ and enhance patent duration. It will open the market to foreign patent holders also, and open the agriculture to patent technology. Even there are several groups and organizations that have rejected this draft of suggestion and opposed the decision taken by the government.

Patenting of Biological Materials

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.

Conditions for Patenting

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.

Patenting of Liveforms

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.

Significance of Patents in India

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.

In 1995, the USA had granted a patent to the Medical Centre, University of Missisippi (USA) for use of turmeric (haldi) powder as a wound healing agent. Council of Scientific and Industrial Research, New Delhi (India) objected this patent. Consequently, the patent grant was revoked following serious objection in an order passed on August 13, 1997. In 1997, the EPO has given a favorable interim judgment on the challenge of a European patent on the fungicidal effect of neem oil owned by W. Grace & Co. The challenge to neem patent was done by Dr. Vandana Shiva Ms Magda Alvoet (M.P. of the European Parliament) and the other NGOs of neem campaign. Recently, die US government has patented the Indian 'Basmati' rice as 'Ricetech’. The Government of India is trying to revoke the patent claim of the US and restore its patentability just like turmeric.