In this article we will discuss about:- 1. Definition of IPR 2. Function of IPR 3. Forms 4. Patenting of Biotechnological Discoveries 5. Bio-Piracy 6. Importance in Indian Scenario 7. Forthcoming Laws.
Definition of IPR:
In the common sense intellectual property is a product of mind. It is similar to the property (consisting of movable or immovable things) like a house or a car where in the property or owner may use his property as he wishes and nobody else can use his property without his permission as per Indian laws.
Function of IPR:
World intellectual property organization (1967) one of the specialised agencies of the United Nations system provided that intellectual property shall include rights relating to the following:
(a) Literary, artistic and scientific works, performance of artists, phonograms and broadcast; innovation in all fields of human endeavor; scientific discoveries; trademarks, 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.
(b) The intellectual property is protected by and governed by appropriate national legislations. The national legislation specifically described the inventions, which are the subject matter of protection and those which are excluded from a protection, for example methods of the 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.
Forms of Protection:
The forms of protection are as follows:
(i) Patents:
A patent is a government granted and secured legal right to prevent others from making, using or selling the inventions covered by the patent. A patent is a personal property which can be licensed or sold by the person/organisation like any other property. For example Alexander Graham Bell obtained patent for his telephone. This gave him the power to prevent anyone else from making or using or selling a telephone.
It has been reported that the first patent was granted to Filippo Brunelleschi in the Republic of Florence of the Italian city states in 1421 on the discovery of special hoisting gear used on barges. An ordinance issued in a vential law in 1474 on patents. Later, in England, during 1533-1603, minister.
Lord Burghley (1520-1598) in the ministry of Elizabeth granted a series of patents with a view to inculcate and encourage inventors working in England. In India, the basics of intellectual property rights were first introduced by enacting the Act on protection of inventors in 1856 which was based on British Patent Law of 1852. Later, series of patent legislation established as shown below.
International and national agreements and treaties were founded as given below:
As far as International and Regional agreements/treatises in Intellectual Property Rights are concerned, it began from 1883 with Paris convention for the protection of Industrial Property; Berne convention for the protection of Literacy and Artistic works (1886); Madrid agreement for Repression of false or deceptive indications of source of goods (1891); Hauge agreement concerning the International Deposit of Industrial designs (1925); Nice agreement concerning the International classification of Goods and services for the purposes of the Registration of Marks (1957); Lisbon agreement for the protection of appellation of origin and their International Registration (1958); Rome convention for the protection of performers, producers of phonograms and broadcasting organizations (1961); Locarno Agreement establishing an International classification for industrial designs (1968); Patent cooperation treaty (PCT in the year 1970); Strasbourg agreement concerning the International Patent Classification and Geneva convention for the protection of producers of phonograms against unauthorized duplication of phonograms (1971); Vienna agreement establishing an international classification of the figurative elements of marks (1973); Brussels convention relating to the distribution of programme carrying signals transmitted by satellites (1974); Budapest treaty on the International Recognition of the Deposit of Microorganisms for the purposes of patent procedures (1977); Nairobi treaty on the protection of Olympic symbol (1981); Protocol relating to the Madrid agreement concerning the International Registration of Marks (1989); Trademark law treaty and trademark related Intellectual property Rights (TRIPS) 1994; Community Trademark (1996), Documents for the diplomatic conference on certain copyrights and Neighbouring Rights (1996), WIPO Copyright Treaty WCT) and WIPO Performance and Phonograms Treaty (WPPT).
In India, the Controller General of Patents Designs and Trademarks (CGPDT) functioning under the Department of Industrial Development Control grant the patents, designs and trademarks. The Ministry of Human Resources and Development is in-charge of copyright board.
(a) Conditions for patentability:
An invention or process is patentable if it is new, involves an inventive step (i.e. it is not obvious) and is industrially applicable.
(b) Test of novelty of patents:
Patents specifications should be made before the date of filling of the application with complete information. Any other document published in India or elsewhere before the date of the filling of the applicants complete specifications. This will cover forcing specifications whether publishing in India or not and text books and periodicals published any where related to the art in question. The only limitations being that they should be published before the date of the filling of the applicants complete specifications.
The economic and competitive position of a fermentation process depends on several factors such as yields, research costs, and size of the market, profit potential, and patent or secret, process position of the fermentation process or product. Patents are granted to inventors in return for a public disclosure of their inventions.
This disclosure and the knowledge of the respective art help to advance the state of that art. The patent in terms gives the inventor the right to exclude others from making, using or selling his particular invention as disclosed in the “claims” of the patent. Obviously, in case of certain inventions secrecy is difficult to maintain, for example in the process of fermentation.
The individuals working in an industrial research laboratory or any laboratory in which fermentation process of potential economic value are under study should know about how to read a patent in order to be able to determine the points of the invention which are actually protected by the patent.
He should also understand the types of information’s that are required for filling a patent application so that research can be directed towards obtaining information. As we shall see claiming too little or too much about the process or product can be disastrous. Guidance in these problems can be obtained from a qualified patent attorney.
(c) Composition of a patent:
A patent consists of three parts, the grant, specifications and claims. The grant is filled at the patent office and is not published. It is signed document and is the agreement that grant patents right to the inventor. The specifications and claims are published as a single document which is available to the public at a minimum charge from the patent office.
The specification section is narrative description of the subject matter of the invention and of how the invention is carried out; the claims section specifically defines the scope of the invention to be protected by the patent that which other may not practice. Thus, a patent stands of falls depending upon the statements included in the claims section.
Recently, Madras High Court dismissed the petition by the Swish Pharma, Novartis challenging the constitution of Section 3(d) of Indian Patents Act. The petition was rejected. The company was seeking the patent for incremental innovations done on the decades old medicines.
The Section 3(d) of the new Patent Act stipulates that incremental innovations or any of modifications must enhance the efficacy of the drug substantially to quality for fresh patenting. There is no logic for prolonging the patent period after its expiry just on account of frivolous charges. Madras High court properly interpreted it and did not allow its approval. This will stop the exploitation by minor inconsequential modifications in the original patent.
(ii) Copyrights:
Copyrights broadly include literacy works, musical works, including any accompanying works, dramatics works, including any accompanying music pantomimes and choreographic works, pictorial graphics and sculptural works.
Recently an expression called neighboring rights has been added to the concept of copyrights. The expression neighboring rights is the abbreviated form of the rights neighboring on copyright.
The following three types of rights are covered by the concept of neighboring rights:
(a) The rights of performing artists in their performance
(b) The rights of producers of phonograms in their phonograms
(c) The rights of broadcasting organizations in their radio and television broadcasts.
(iii) Trade Mark:
A trade mark is an identification symbol which is used in the course of trade to enable the public to distinguish on trader’s good from the similar goods of 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 and IBM for computers. Zodiac for readymade clothes, etc.
(iv) Design:
Design means only the features of shape, configuration, pattern or ornament applied to any article in any industrial process or means whether manual, mechanical, chemical, separate or combined, which is the finished form appeal to end or judged solely by the eye. By registration under the designs act, the features are protected as design.
Genetic information’s can also be used to cure a disease, for example using the technology of gene therapy with a specific gene vector. The direct use of proteins as therapy is well established, and these products may be patented, though we should note, in general, that medical procedures have not been patented for ethical and practical reasons.
A patented product that reaches the commercial market gives the inventors some compensation for the time they spent in research for the development. In the USA, the average time required for biotechnology medicine to be approved for commercial scale of food & drug administration is 21.4 months after requests of trial based on chemical tests and it should be ten years after identifying the substance.
Once a product is patented the sales can bring about high income for the company that produces it and this includes return for the inventors. The system is self sustaining; if patents are awarded, companies will invest time in research and if not, these will be less incentive for companies to do research.
Without patents it may be easy for other companies to copy the techniques soon after introducing and take a share of the commercial market, especially because they do not need to bear the cost of the long period of research for product development.
Some system of reward is required to encourage commercial research, which is responsible for a significant number of biotechnology applications. The international recognition of intellectual properly rights (patents variety rights) is thus a basic concern.
The ethical principle of beneficence can be applied here. Does commercialization of biotechnology leads to more benefits than a bar on it? The benefits should be in terms of general, medical or agriculture developments, rather than the economic prosperity of one company or country over another.
Patenting is not permitted useful information otherwise becomes trade secrets, or if plant variety rights are not recognized seeds may not be made widely available. However, property rights are not absolutely protected in any society because of the principle of justice, and for the sake of “public interest”, “social need,”; and “public-utility”, societies can confiscate intellectual property.
People arguing for patenting claim that patent laws regulate inventiveness and not commercial uses of inventions. However, there was recent controversy regarding the commercial monopoly held by the company which was able to protect the first HIV/AIDS treatment, which enable to obtain large projects while it held a monopoly.
It also meant that the drug was prohibitively expensive for developing countries. Another arrangement is that if other countries support patents, our country needs to if our biotechnology company is to compete; however, the reverse arrangement that some countries do not permit similar patents, is also used to justify exclusions.
(v) Know-how:
Know-how is another important form of intellectual property generated by R&D institution that does not have the benefit of patent protection. This could be in the form of an aggregations of known procedures and accumulation of data. A secret formulation or a combination of any of these know-how is often transferred together with licensing of patent.
Patenting of Biotechnological Discoveries:
The question arises what properties must a product have in order for it to be patentable? Actually, there is some debate about whether living organisms should be patented.
Following characters are to be considered to qualify for a patent:
(a) Novel invention,
(b) Non-obvious,
(c) Usefulness.
In the case of natural products, details of four molecules or coding nucleic acid sequence may have lost its novelty and non-obviousness. Patents are granted on molecules which have medical uses if the chemical structure or the useful activity was novel when the patent was applied for methods of gene-sequencing, mapping or expression, can be invented or patented.
The process for making ‘oncomouse’, a mouse that contains activated oncogenes sequences that are; therefore, sensitive to mutagens or carcinogens was patented in 1998 in the USA. Protected by copy right law is creativity in the choice and arrangement of words against those who ‘copy’; who take and use the form in which the original work has expressed by the author e.g. such as books, photographical works, paintings etc.
Bio-Piracy:
There has been growing discontent amongst developing countries about this bio-piracy i.e. unfair exploitation and monopolization of public domain knowledge and resources. Most of the industries of developed nation’s recent losses come from counterfeit goods and pirated technology in the developing countries.
A new drug generally takes a decade or so involving several lakhs of rupees to develop. Intellectual Property Rights (IPRs) are justified to protect this enormous amount of investment. On the other hand, developed countries freely acquired most of its live material including crops from its neighbours.
Developed countries also looted medicinal plants, dyes, spices, etc. from developing countries leading to discovery and conquest of India, S. America and S.E. Asia. For example, new drug like resperine used against hypertension. Derived from an Indian Plant sarapagandha (Rauwolfia serpentina) has enormously enriched foreign drug companies.
Similarly, genes from the Pattambi rice variety in Kerala (S. India) have been used to introduce to pest resistance in paddy. Now seed companies have started exploiting this character without giving any advantage to farmers. The developed countries have never paid for the benefits obtained from the developing countries.
On the other hand, they get raw material of basic knowledge from developing countries but selling back on a very high price. Since, IPRs protect only the commercial inventions; the domestic and ongoing use of bio-resources is not prevented. Thus, grand parents or ayurvedic practitioners can continue to use of market churan or decoctions as usual. However, they are not entitled for the claim from the profits out of these items.
Industrial Property:
Industrial property includes inventions (process, products, apparatus); industrial designs (shapes & ornamentation); and Marks and Trade names to distinguish goods. Recently, the scope of industrial property has been expanded to include among others, the protection of distinctive geographical indications (in particular appellation of origin), plant varieties and the layout designs (topographies) or integrated circuits as well as the repression of unfair competition, including the protection of trade secrets.
Importance in Indian Scenario:
A US patent granted for use of turmeric powder (haldi) as a wound healing agent to the University of Mississippi, Medical Centre, US, has been revoked following objections by the Council of Scientific and Indian Research (CSIR), New Delhi.
The revocation order was passed on August 13, 1997, two years after the grant of patent in March 1995. It was a legal battle on turmeric powder which is used in India for ages now as a wound healing agent among other things, and was not a discovery of the US patentee.
Now patents have already been granted for food stuffs like idli, dosa, vada, churan, pickle, halwa and pizza topping. The Indian patents Act 1970 stresses that any patentable commodity must possess novelty. Apparently, the Chennai Patent office believes that South Indian delicacies like “medu vadai”. “rava-uppuma”, “badam halwa”, “rice idli”, “rice pongal”, and even Green Peas Masala are novel process. Patent rights for these popular preparations were granted to the Dasaprakash hotel chain in 1973.
The Mumbai office of the Patents has granted one Dilip Shantaram Dahanunkar, a process patent for the preparation of tomato rasam and a custard chilli jam spread used as a 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.
The purpose of patenting common products seems to improve their marketability rather than to protect “inventions”. Accordingly, inventors blindly exploit legal loopholes to patent age-old products.
According to Calcutta based patent and trademark attorney, D.P. Ahuja and company the Patents Act, 1970 states that a patent can be given for a novel article or a process even if it results in an old product.
On 30 September 1997, the European Patent Office (EPO) delivered a favourable interim judgment on the challenge of a European patent on the fungicide effects of neem oil (Patent No. 436 257 BY) owned by W.R. Grace & Co. The opposition division of the EPO issued a provisional statement on the basis of the European Patent convention (EPO) and delivered favourable interim judgment on opposition to Neem Patent, in favour of Dr. Vandana Shiva, Ms. Magda Alvoet (MP of the European parliament) and other NGOs of Neem campaign.
Recently, another controversy has arisen regarding patenting of ‘Basmati Rice’ by U.S.A. Indian Govt. filed reexamination request for the patent on Basmati rice lines and grains (US Patent no. 5666484) granted by US PTO , and Ricetech Co. from Texas has decided to withdraw the specific claims challenged by India.
There is problem on the grant of such patents linked to the indigenous knowledge of the developing world that needs to be addressed jointly by the developing and the developed world. Actually, the available data bases of different items available in patent international offices are to be considered by patent examiners while granting the patents.
They search non-patent literature database that deal with traditional knowledge, captured electronically and placed in the appropriate classification within the international patent classification systems so that it can be easily searched and retrieved in the international patent office. This would help prevent the patenting of the products that have been based on the traditional knowledge of the developing world.
The Indian Govt. has taken a step to create a Traditional Knowledge Digital Library (TKDL) on traditional medicinal plants and systems, which will also lead to a Traditional Knowledge Resource Classification (TKRC).
Such information shall fill up the gap between the knowledge contained in an old sanskrit shloka and the computer screen data of a patent examiner in Washington. This will eliminate the possibility of granting wrong patents since the Indian rights to that knowledge will be known to the examiners. Some of the countries are in process of securing patents (Table 1.3).
Above data for the year 1995 is based on The Express Magazine, May 3, 1998.
Forthcoming Laws:
New laws to be enacted by government of India so as to bring India closer to the international patents regine.
New laws relating to intellectual property rights that the government proposes to enact, are given below:
(i) Trade Marks:
This Act will allow the registration of service marks and collective marks. The service mark will allow the entire service industry to register its logos that identify a firm while the collective mark will allow entrepreneurs from a certain region that is famous for a particular region. For example, all makers of footwear from Kolhapur will be able to register the name Kolhapuri so; anyone manufacturing chappals outside the town shall not be allowed to use its name.
(ii) Geographical Indicators:
Basmati is the suitable example which allows a country to register all products whose quality, reputation or other characteristics are essentially attributable to their geographical regions.
(iii) Industrial Designs:
India’s industrial design law dates back to 1911. It badly needs to be updated.
(iv) Layout/Designs of Integrated Circuits:
India has a role to play in world’s electronic market. The protection of integrated circuits is crucial to the development of the electronic industry. This is essential so that efficiency and the capability of each circuit is maintained.
(v) Trade secrets:
This is something great that India does not have trade secrets. It will allow a company to register and protect formula details or processes. A patent usually runs out in 10-20 years, but under this law a company will have no obligation to reveal its secret. Coca-Cola, for example has covered its best-kept secret of its formula under this law.