Intellectual property rights

Biological Patents, Pharmaceutical patents, Food industry patents, Textile industry patents

1. Intellectual Property Rights Pradeep Singh PhD Scholar, MCM ILBS, New Delhi

2. Intellectual Property Rights (IPR) Intellectual property: According to the World Intellectual Property Organization (WIPO), Intellectual property refers to creations of the mind: inventions, literary and artistic works, and symbols, names, images, and designs used in commerce. The term intellectual property is used for the intangible asset that doesn’t exist in a physical object but has a economic values. Intellectual property rights (IPR) refers to the legal ownership of intellectual property by a person or business of an invention, discovery related to the particular product or processes for the protection of the owner against unauthorized copying or imitations. However , IPR is limited in terms of duration, scope and geographical extent . The importance of intellectual property was first recognized in the Paris Convention for the Protection of Industrial Property (1883) and the Berne Convention for the Protection of Literary and Artistic Works (1886) . Both treaties are administered by the World Intellectual Property Organization (WIPO) .

3. Types of Intellectual Properties

4. Patent: A Patent is the exclusive right granted by a government authority to an inventor to manufacture, use , or sell an invention and prohibit others from making, using, or selling an invention for a limited period of time. D esigns: It is the art or practice of designing object for manufacturing consisting aesthetic aspects and three-dimensional features like shape, surface, patterns, lines, colors or two-dimensional features of objects. Trademarks : It is a symbol, word, or words registered legally or established by use as to represent a company or product . Geographical indications: It is a name or sign used on products which corresponds to a specific geographical location or origin having specific qualities, reputation or characteristics (WIPO ). Copyright: It is a legal rights provided to creators to perform, print, publish, record literary, artistic, or musical materials for its uses and distributions (Wikipedia ).

5. What is the need of IPR? The progress and well-being of humanity rest on its capacity to create and invent new works in the areas of technology and culture . Encourages innovation: The legal protection of new creations encourages the commitment of additional resources for further innovation . Economic growth: The promotion and protection of intellectual property spurs economic growth, creates new jobs and industries, and enhances the quality and enjoyment of life . Safeguard the rights of creators: IPR is required to safeguard creators and other producers of their intellectual commodity, goods and services by granting them certain time-limited rights to control the use made of the manufactured goods. It promotes innovation and creativity and ensures ease of doing business . It facilitates the transfer of technology in the form of foreign direct investment, joint ventures and licensing .

6. India and IPR India is a member of the World Trade Organization and committed to the Agreement on Trade Related Aspects of Intellectual Property ( TRIPs Agreement ) . India is also a member of World Intellectual Property Organization (WIPO) , a body responsible for the promotion of the protection of intellectual property rights throughout the world . In India, currently, the Patents Act 1970 and the corresponding rules govern the grant of patents. Indian Parliament has made several comprehensive amendments to the Patents Act 1970 in 1999, 2002, 2005 and 2018. CGPDT:   Controller General of Patents, Designs & Trade Marks  (CGPDT), (under the Dept. of Industrial Policy and Promotion of Ministry of Commerce and Industry)

7. Patents

8. Year Event 1856 Act for protection of inventions on the basis of British law of 1852 1859 Patent monopolies called exclusive privileges 1872 Patents and Designs Act 1883 Protection for Inventions Act 1888 1888 Inventions and Designs Act 1911-1947 Modern patent era by Patents and Designs Act. First time an authority call Controller General of Patients appointed 1959 Justice Ayyangar’s report 1967 Patent Act Bill introduced in the Parliament 1970 The Patent Act passed by the Parliament 1972 The Patients Act -1970 came into force on April 20, 1972 1994 Amendments by ordinance to include Exclusive Marketing Rights (EMR’s) 1999 Amendments passed by the parliament. New patent amendment bill referred to select committee 2003 Patient Act 1970 with second amendments came into force 2005 Patent Act 1970 (2005 Amendments) comes in to force from 1-1-2005. History of Patents Acts in India

9. Indian Patent Act 1970 The Indian Patent Act 1970 grants the following rights to the patentee: Right to exploit the patent Right to license and assign the patent Right to surrender the patent Right to sue for the infringement of patent.

10. Prerequisites for a patent For patentability, there are only three prerequisites according to the Section 2 ( 1) of the Indian Patent Act 1970 , which are as follows: An invention must be novel . An invention should have an inventive step . An invention should be capable of industrial application . According to the US patent law , Section 101 of the US Patent Act, inventions are patentable when they fulfil the criteria of novelty, usefulness and non-obviousness

11. Indian Patent Act Vs United States Patent Act S.No. Indian Patent Act United States Patent Act 1. Indian patent laws are strict. US patent laws are liberal. 2. The Indian Patent Act quite elaborately describes the non-patentable inventions under Sections 3 and 4. US patent laws allows the grant of patent to anyone who invents or discovers any new and useful improvement in the existing invention. 3. Inventions related to atomic energy are not patentable in India. Inventions related to atomic energy are widely accepted in US. 4. Inventions that are contrary to the public order or morality are not granted patent (e.g. patent or novel design of guns etc.) Inventions that are patentable and novel in design are allowed (e.g. patent or novel design of guns etc.) 5. Indian patent laws grant patent on ‘first-to-file’ basis. US patent laws grant patent on ‘first-to-invent’ basis. 6. Plants are not patentable in India Plants are patentable in the United States 7. Software is not patentable in India; they are copyrightable. Software is patentable in the United States. 8. Patent agent should be Indian. Patent agent from other countries can also practice in United States.

12. Types of Patents awarded in India S.No. Types of Patent Examples 1. Product Patent Substance Composition of matter Devices Chemical compound, Chemical compounds, enzymes, cell lines, plasmids, recombinant DNA, vector-host, microorganisms. Mixture of substances; pharmaceutical composition, food stuffs, composition of fertilizers, lubricant composition Mouse trap, ball-point pen, x-ray tube, fermenter, coffee machine 2. Process Patent Manufacturing process Method of execution Usefulness Method of preparing a substance; preparation of a hybrid plasmid, gene cloning techniques, semi-synthetic penicillin or new azo dyes, downstream process of extraction of plant or animal product Analytical or diagnostic methods of examination; freeze-drying Use of a substance or composition for a particular purpose; utilization of herbicides for combating weeds. 3. Design Patent Design and shape of articles like machine, bottles, vehicles etc.

13. Ministry of Commerce and Industry (Govt. of India)

14. Patent Procedure in India Each application for a patent which is filed with the Indian patent office needs to be accompanied by the   forms provided below: Form 1 – Application for grant of a patent Form 2 – Provisional/Complete specification) Form 3 – Statement and undertaking regarding foreign application under section 8 (only required if a corresponding patent application is filed in another country) Form 5 – Declaration as to inventorship (only to be filed along with the complete application) Form 26 – Form for authorization of a patent agent (only required if you are using a patent agent to help you file the application) Form 28 – To be submitted by startup or small entity (only required if you are claiming startup or small entity status )

15. Special Patents Textile invention: The inventions in textile technology can be related to areas like textile manufacturing, chemical processing, fiber science and technology, textile machines and dyes . Electrical Invention: S emiconductor products are not patentable but the process of making the semiconductor product is patentable under the provisions of the Indian Patent Act 1970. The term of such patent is 14 years . Software Patent: The Indian Patent Act 1970 does not recognize software programs. Computer software is generally protected under the copyright law but software as essential part of the hardware, when connected to hardware can be protected by patents, for example, UV spectrophotometer, automatic fermenters, etc. Patents in Food Industry: Foods that are produced by combining traditional ingredients and using standard cooking or preparation techniques are unlikely to meet the patent requirements. Some new food products are innovative chemical compounds, such as artificial sweeteners and fat substitutes . Pharmaceutical Patents: The Act of 1970 excluded pharmaceuticals and agrochemical products from the grants of patents. TRIPs agreement has placed an obligation on India to grant product patents to drugs by 2005. On the grant of patent protection, the firms that have patented their drugs may either export their drugs to India or may produce them in India through license to firms . Patent for microorganisms: These include traditional or conventional fermentation methods like preparation of curd, idii , dosa or vada pastes, cheese etc . Bio-transformation processes for production of non-living matter like fermentation process of product such as beer, wine, vinegar. Living entity of artificial origin, such as micro-organism, vaccines, transgenic animals and plants etc . Biological materials such as DNA, plasmids, genes, vector, tissues, cells, replicons etc . Process relating to living entities, such as isolation, purification , multiplication, etc . Process relating to biological material . Plant Patent: Plants are not patentable in India.

16. Evolution of Patents in Microorganisms Year Event 1873 1 st patent on microorganisms 1977 Budapest Treaty was signed 1980 Diamond V. Chakraborty case 2001 India joined Budapest Treaty 2002 Dimminaco A.G. case 2005 New Patening Regime

17. Patentable Ingredients in Biotechnology RNA , DNA or Amino Acid Sequences : Random isolated sequences generally will not be patentable if they have no utility, i.e., they have no known use at the date of filing application. For example , ESTs sequenced without any function or utility is non-patentable . DNA & RNA Vectors : Novel vectors created in lab used for cloning or expressing gene sequences may be patentable . Cell Lines : Artificially produced cell lines are patentable . Gene : A gene to which genetic alterations have been made are patentable, a gene in recombinant form or newly isolated gene in pure form is patentable if its utility or function is known . Protein : Patent protection for a protein may be granted if the protein is not previously characterized or has been isolated from a natural resource in pure form. A novel or known protein obtained through RDT may be patentable. For example, hormone expressed from recombinant vector .

18. Patentability of Biotechnology Inventions In India Discovery of any living thing occurring in nature is not patentable subject matter in India . Plant and animals in whole or any part thereof including seeds; varieties, species and essentially biological processes for production or propagation of plants and animals are not patentable in India. Microorganisms and microbiological processes are patentable subject matter . Genetically modified multicellular organisms including plants, animals, human beings and their parts are excluded from patentability in India . Human beings and embryonic stem cells are not patentable. Methods of medical treatment are also prohibited from patentability in India.

19. Biodiversity and IPR Biodiversity is the treasure in a developing country like India. India is classified among the 12 megadiversity centers of the world. India is a member of the Biological Diversity Convention . The Central government has established the National Biodiversity Authority for regulating, transferring and using biodiversity resources at the national level. The Biodiversity Act, 2002 has applicability throughout India. Functions of National Biodiversity Authority ( NBA) The authority grants approval to applications for patents relating to biological research in foreign countries. The authority imposes terms and conditions for paying royalty, secure equitable sharing of benefits that arise out of the use of accessed biological resource and their by-products . The authority gives advice to the Central Government on matters related to conservation and sustainable use of biodiversity. It also advices the State government to choose the areas that can be notified as heritage sites . The authority grants permission to the interested people to acquire biological resource in India, permits them to acquire knowledge related to the biological research and transfer of results related to the biological resource . Basmati case study: RiceTec Inc. is using a stolen name Basmati for rice which is derived from Indian rice but not grown in India, and hence not the same quality.

20. Bioinformatics Patenting During 2000 and 2001, bioinformatics patents were given for computer-based methods of determining the actions of drug candidates on cellar targets, methods for modelling molecular interactions for rational drug design, use of 3D protein structures in rational drug design and bioinformatics database structures . Types of intellectual property protection in bioinformatics involve the following. Patents : Patents act an important incentive for technology development, protection and innovation. Out of the various types of patents, utility patent is very much associated with bioinformatics inventions, and can be obtained for a new, useful and non-obvious process, machine, manufacture or composition of matter or new and required improvement on any of the above process or product. Trade Secret : Trade secrets can be used in the field of bioinformatics for securing the secrets like software code, manuals, databases, factual laboratory data, formulas, processes and algorithms . Copyrights : Copyrights can be used to protect bioinformatics-related material such as software, code , books, scientific articles, web pages, manuals, computer algorithms, graphic networks, multimedia works, manuals, etc. Trademarks : Trademarks in bioinformatics are used to protect the trade names, product names, domain names, service marks or slogans for bioinformatics companies .

21. Gene Patenting In India, 184 patents are held by the Council of Scientific and Industrial Research, 56 by Ranbaxy, and 19 by Dr. Reddy’s Laboratories. Patents on genes have only been granted on isolated gene sequences with known functions. The gene sequence can be utilized in four dif f erent ways . Diagnostic Testing : A DNA sequence can be used as a probe that binds to DNA from an infectious agent and carries a detectable fluorescent molecule, which helps in testing . A Vaccine : Apart from live attenuated bacterium, a vaccine might also consist of a DNA sequence unique to a disease-causing virus or bacterium . Gene Therapy : In gene therapy, a normal gene replaces a malfunctioning gene. Thus, a normal version of gene is required as a treatment measure. Genetic Counselling : It provides information about an individual’s likelihood to develop a specific condition or disease . Between 1981 and 1995, 1175 patents were granted worldwide related to human DNA sequences. T he gene sequence and DNA sequence with unidentified function are non-patentable. There are certain issues like the issue of gene patenting, which are at risk as their patentability af f ects patients, industry , researchers and others .

22. Controversies in Gene Patent S.No. Favouring Gene Patent Against Gene Patent 1 Patents on gene lead to the development of life-saving medicines. DNA sequences/genes are blueprints of life and play a special role in carrying the information to construct a human. 2 Gene patenting will force the disclosure of secret information, e.g. Genentech patent on human insulin gene enabled pharmaceutical company Eli Lilly to develop insulin for diabetics ‘ Humulin ’. Gene is very closely related with species identity, so no parts of it should be controlled by corporate interest. 3 Isolation of gene make it ‘artificial’ as no isolated gene sequence occurs in nature. Thus it should be patentable as not natural. In case of humans DNA is unique and therefor possess intrinsic value of sacred kind. 4 A patented gene differs from its intracellular counterpart in that it is no longer a part of a chromosome and patents claims only the protein coding part of a gene, not the entire gene. DNA bears the image of God and is a product of nature, not human ingenuity. 5 DNA sequence exists with a known function or use, but genetic alteration makes it different from their form inside a cell and should be patentable. Plants, animals and microorganisms comprise life on earth and a part of nature. These species, or their molecules or parts, should not be converted to corporate property through patent monopolies.

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