IN TEL LEC TUAL PROP ERTY RIGHTS IN BIO TECH NOL OGY—AN OVERVIEW
M.K. Tripathi1, S.P. Singh2 and Ashok Ahuja21
De part ment of Plant Mo lec u lar Bi ol ogy and Bio tech nol ogy, Col lege of Ag ri cul ture, RVSKVV, Gwalior 474002 M.P. 2
CSAUAT–Agricultre Re search Sta tion, Kalai, Aligarh (U.P.) 3*Ex Chief Scientist CSIR-IIIM: [email protected]
ABSTRACT
IPR is grant of exclusive rights in a form of patents for a limited time in respect of a new and useful invention. The exact requirements for grant of a patent, the scope of protection it provides and its duration differs depending on national legislation. However, generally the invention must be of patentable subject matter, novel (new), non-obvious (inventive), of industrial application and sufficiently disclosed. A patent will provide a wide range of legal rights, including the right to possess, use, transfer by sale or gift and to exclude others from similar rights. Duration will be for around 20 years. These rights are generally restricted to the territorial jurisdiction of the country granting the patent and thus an inventor wishing to protect his/her invention in a number of countries will need to seek separate patents in each of those countries. Most of the countries now provide some form of patent protection, but patent protection for biotechnology is by some countries only. The reasons for this may differ, but generally it has been because biotechnology has been thought inappropriate for patent protection, either because of technical or practical reasons, or for one or more ethical, religious or social concerns. In all the National Patent Offices of the various countries where patents are granted for biotechnology there is a considerable backlog of pending applications. Reason being in those countries where patent protection to biotech is provided, the type and extent of that protection is different in nearly every national system. There are three international intellectual property treaties which are of particular importance for the protection of biotechnology: the Paris Convention for the Protection of Industrial Property (the Paris Convention); the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (the Deposit Treaty) and the Patent Cooperation Treaty (PCT). In biotechnological interventions, for obtaining patent, substantive utility of substances in description is essential. There should not be any need of further experimentation to establish utility and utility should be sufficiently disclosed for a person skilled in the art and it should be practical/ actual utility and not be merely for research purpose. Isolation process of microorganism or gene sequence from its natural environment and Gene sequences manufactured synthetically are also patentable. If any biological substance is known for the first time and it can be characterized by the process by which it is obtainable may be claimed for the patent. However, EST’S & SNP’S are not patentable since they are not novel, naturally occurring and not having any industrial application other than research purpose. In the present paper some Indian legislations, what is currently patentable and not patentable in biotech and some of case studies of biotechnology shall be discussed in detail.
Key words : Farm ers rights, GATT, IPR, legal pro tec tion, medicinal plants, TKDL and WT
Though inventions in biotechnology category filed were mostly of the foreign origin but there was considerable increase in Indian applications. Most of the inventions were mostly in the area of recombinant DNA molecule, recombinant vaccine, monoclonal antibodies, recombinant therapeutic molecules, diagnostic kits, stem cells, recombinant vectors, isolated nucleic acid encoding a gene, method of preparation of recombinant hormones, DNA related inventions such as preparing plasmids, vectors etc, bioleaching, biotransformation, biological treatment of waste, gene and somatic cell therapy, pluripotent stem cells derived from regenerative tissue, recombinant microbes expressing chimeric HIV protein, regulation of cell mediated immune response, recombinant interleukin IL-18 inhibitors, plastid transformation vectors, waste water and sewage treatment using microorganism, conjugate vaccine against cholera and tetanus, peptide based immunotherapy for atherosclerosis, mixed cell gene
therapy, bone regeneration by gene therapy and treatment of flower. Biotechnological tissue culture procedures and media formulations have also been protected as national and international patents.
Intellectual Property Rights, IPR and Varous Legal Protection Mechanism : IPR is grant of exclusive rights in a form of patents for a limited time in respect of a new and useful invention. The exact requirements for grant of a patent, the scope of protection it provides and its duration differs depending on national legislation. However, generally the invention must be of patentable subject matter, novel (new), non-obvious (inventive) of industrial application and sufficiently disclosed. Patents provide a wide range of legal rights, including the right to possess, use, transfer by sale or gift, and to exclude others from similar rights. Duration will be for around 20 years. These rights are generally confined to the territorial jurisdiction of the country granting the patent and thus an inventor wishing to protect his/her invention in a number of Volume 12 (3) : 271-275, (2017) in Agriculture and Technology
countries has to seek separate patents in each of those countries.
Most of the countries now provide some form of patent protection, but patent protection for biotechnology is by some countries only. The reasons for this may differ, but generally it has been because biotechnology has been thought inappropriate for patent protection, either because of technical or practical reasons, or for one or more ethical, religious or social concerns. In all the National Patent Offices of the various countries where patents are granted for biotechnology there is a considerable backlog of pending applications. Reason being in those countries where patent protection to biotech is provided, the type and extent of that protection is different in nearly every national system (1-2).
There are three international intellectual property treaties which are of particular importance for the protection of biotechnology: the Paris Convention for the Protection of Industrial Property (the Paris Convention); the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (the Deposit Treaty) and the Patent Cooperation Treaty (PCT).
Agriculture has become subject to IPR only after the creation of World Trade Organization (WTO) after General Agreement on Tariffs and Trade (GATT) Uruguay Round agreement. To provide protection mechanisms to harness the benefit in country’s interest are
Protection of Plant Varieties and Farmer’s Rights Act 2001 : In order to provide for the establishment of an effective system for protection of plant varieties the rights of farmers and plant breeders and to encourage the development of new varieties of plants it has been realized to safe guard the rights of the farmers in respect of their contribution made at any time in conserving, improving and making available plant genetic resources for the development of the new plant varieties. Moreover to accelerate agricultural progress, it is necessary to protect plants breeders’ rights to promote investment for further research and development for developing new plant varieties. This protection will help the growth of the seed industry and ensure the availability of high quality seeds and planting material to the farmers. India after ratifying the Agreement on Trade Related Aspects of the Intellectual Property Rights has to make provision for giving effect to Agreement. To give effect to the aforesaid objectives the protection of Plant Varieties and Farmers’ Rights Act, 2001 has been enacted in India. For the purposes of this Act, Protection of Plant Varieties and Farmers’ Rights Authority has been established and is located at New Delhi (3).
Most of the MAPs that are in cultivation, are farmers’ varieties and an instrument is available now to safe guard these varieties from piracy by registration. However, much benefit can not be achieved in MAPs by the farmers because rule states that all the extant varieties are tobe registered within the three years from the date of enforcement of this Act. According to the Act, extant varieties include farmers’ varieties also. Only option available now is to register the farmers’ variety as new variety, since provision is available for the farmers also to register new varieties.
Biological Diversity Act, 2002 : The Biological Diversity Act 2002 was born out of India’s attempt to realize the objectives enshrined in the United Nations Convention on Biological Diversity (CBD) 1992 which recognizes the sovereign rights of states to use their own Biological Resources. The Act aims at the conservation of biological resources and associated knowledge as well as facilitating access to them in a sustainable manner and through a just process. For purposes of implementing the objects of the Act it establishes the National Biodiversity Authority in Chennai. The Biodiversity Act is a federal legislation enacted by the Parliament of India for preservation of biological diversity in India and provides mechanism for equitable sharing of benefits arising out use of traditional biological resources and knowledge. The Act was enacted to meet the obligations under Convention on Biological Diversity (CBD) to which India is a party. The Biodiversity Act was passed by the Lok Sabha on 2nd December 2002 and by the Rajya Sabha on 11th December 2002. Relevant definitions under the Act : Biodiversity has been defined under Section 2(b) of the Act as “the variability among living organisms from all sources and the ecological complexes of which they are part and includes diversity within species or between species and of ecosystems”.
Biological resources as “plants, animals and micro-organisms or parts thereof, their genetic material and by-products (excluding value added products) with actual or potential use or value, but does not include human genetic material.”
Bio-survey and bio-utilization : Means survey or collection of species, subspecies, genes, components and extracts of biological resources for any purpose including for characterization, inventories and bioassay.
Commercial utilization : Means using biological resources as drugs, industrial enzymes, food flavors, fragrances, cosmetics, emulsifiers, oleoresins, colours, extracts and genes used for improving crops and livestock through genetic intervention.
recognized by the Act. Even after developing IPR by using the country’s MAPs bio-resources through proper legal permission, one has also to take approval from the National Biodiversity Authority (NBA) for filling an application for any form of IPR to take care of the benefit sharing due to utilization of these Biological Resources for commercial purpose.
Geographical Indications of Goods Registration and Protection Act 1999 : Geographical indications (GI) is a sui generis Actof the Parliament of India for protection of geographical indicationsin India. India as a member of the World Trade Organization (WTO) enacted the Act to comply with the Agreement on Trade-Related Aspects of Property Rights (1). GI tag ensures that none other than those registered as authorized users (or at least those residing inside the geographic territory are allowed to use the popular product name. Darjeeling (Tea) became the first GI tagged product in India, in 2004–05.With the Geographical Indication of Goods (Registration and Protection) Act 1999, the varieties from which the medicines prepared from certain genotypes and at a particular location having a good quality can be protected after registering it under this act with the Controller Designs and Trade Marks. There are few examples existing in medicinal plants that a product is known because its location such as Trinvelly- senna, Java-citronella, Neemach -Aswagandha, etc. Some of the Indian plants where patents have been filled and granted are enlisted.
Patent Protection : MAPs varieties developed using modern plant breeding techniques cannot be patented as such as per the Indian patent law. But the process developed utilizing such varieties can be protected through patents. Process developments by using MAPs and usages of MAPs for new purposes are patentable subject matter in the national law if they meet the standards of novelty, inventive steps and industrial applicability.
Biotechnology Patenting Activity in India : Indian patent practice and jurisprudence with respect to the patenting of biological materials are relatively new and thus not so well settled and/or uniform. There are several outstanding deficiencies within the substantive law that needs addressing. Apart from narrow standards of patentability, biotech products are faced with certain additional hurdles like mandatory disclosure of biological material, prior approval from the Biodiversity Board and access and benefit issues under the Indian Patent regime.
While TRIPS does not allow exclusion of inventions that are novel, non-obvious and industrially applicable en masse, the Indian law has a long list of exceptions to patentability:
TRIPS consistent - Naturally occurring components, animate or inanimate from biological material or their parts; process to obtain such components; isolation of live material, genetically modified or transgenic organism, cell parts; process for the isolation and modification; use/application of biological material. moreover, plants and animals as a whole or parts thereof; varieties of plants and animals, seeds, essentially biological processes of propagation.
Criteria not found in TRIPS – e.g., frivolous, simple combination of known elements.
Criteria inconsistent with TRIPS – e.g., Inventions based on methods of agriculture, horticulture; methods of business; methods for curative & prophylactic treatments; traditional knowledge considered as not patentable.
New requirement not found in TRIPS - New use of a known substance considered non-patentable. Salts, Esters, ethers, Polymorphs, Metabolites, Pure form, Particle size, Isomers, mixtures of isomers, complexes, composition, derivatives too are considered non-patentable ‘unless they differ significantly in properties with regard to efficacy’ or if they ‘do not result in the enhancement of known efficacy of the substance’. mere admixture – e.g., root-nodule bacteria of leguminous plants, use in combination does not improve natural functioning; additional disclosure of source and origin biological materials for grant of patent (Further amendments to section 25 (j) & Section 64 (p) of 1970 Act non disclosure of origin and source of biomaterial -widens the scope of grounds for opposition and revocation).
Restriction on scope of Patentability - Encompassing bio-chemical, bio- technological and micro-biological processes in chemical processes by way of explanation for the purpose of product patent.
Its pertinent to mention that in order to give effect to TRIPS Article 27(3) (b), a sui generis law Protection of Plant Variety and Farmer’s Rights Act 2001 has been passed to provide for effective system for protection of the rights of plant breeders (PBRs) and farmers and to encourage the development of new varieties of plants.
inventions. Clause 3(c) states that “The mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or nonliving substances occurring in nature” will not be considered as patentable invention. This provision of non-patentability is common to patent laws of other countries. The Clause 3(j) states that “Plants and animals in whole or any part thereof other than microorganisms including seeds, varieties and species and essential biological processes for production or propagation of plants and animals as non-patentable invention”. This provision differs from the patent laws of countries like the US, the European Union, and Japan, who follow liberal patent standards and where patents are also granted to genetically modified organisms and plant varieties. This exception of non-patentability is allowed as per TRIPS Agreement provided member countries provide alternate effective system for protection of plant varieties (sui generis system).
Though inventions in this biotechnology category filed were mostly of the foreign origin but there was considerable increase in Indian applications. Inventions were mostly in the field of recombinant DNA molecule, recombinant vaccine, monoclonal antibodies, recombinant therapeutic molecules, diagnostic kits, stem cells, recombinant vectors, Isolated Nucleic acid encoding a gene, method of preparation of recombinant hormones, DNA related inventions such as preparing plasmids, vectors etc, bioleaching, biotransformation, biological treatment of waste, gene and somatic cell therapy, pluripotent stem cells derived from regenerative tissue, recombinant microbes expressing chimeric HIV protein, regulation of cell mediated immune response, recombinant interleukin IL-18 inhibitors, plastid transformation vectors, Waste water and sewage treatment using microorganism, conjugate vaccine against cholera and tetanus, peptide based immunotherapy for atherosclerosis, mixed cell gene therapy, bone regeneration by gene therapy and treatment of flower [8-10].
As in other jurisdictions, in India too, the subject matter claimed as the invention, must be new, non-obvious, industrially applicable and requires sufficient disclosure. When the existence of a new compound or element in nature is discovered, one can not obtain a patent on it because the form as it exists in nature is not new. Further to translate the discovery into a patentable subject matter, the discovered component must be substantially changed through human intervention into a form in which it does not occur in nature, or employed in a process resulting into technical advancement and/or economic significance [11].
Non Patentable Inventions
Order public and mortality exception–section 3(b) : As per the section an invention would not be patented if it is immoral or against public order harmful to human animal or plants life or environment as a whole.
Discovery of living things or non-living substances– Section 3c : Plants and animals in whole or in part thereof other than microorganisms but including seeds, varieties and species section 3(i)
Essentially biological processes for production or propagation of plants and animals. section 3(j)
Cell per se?
Any process for the medical Surgical curative prophylactic diagnostic oorthereapeutic or other treatment of human or animals to render them free of disease or to increase their economic value or that of their products –Section 3(i)
New use or new property of known substance-Section 3(d)
Method of agriculture or horticulture-section 3(h)
Traditional knowledge section 3(p)
Following are some instances of non-patentable subject matter per se; however fulfilling certain criteria like functions and the biotechnological inventions are patentable.
New use of known substance/process : Polymorphs, esters, salts, combinations, derivatives that do not show enhanced therapeutic efficacy over known main substance.
Mere admixtures (as opposed in synergistic mixtures) and processes thereof
Method of treatment of human beings/animals
Plants, animals parts thereof
New use of known substance/process
Polymorphs, esters, salts, combinations, derivatives that do not show enhanced therapeutic efficacy over known main substance
Mere admixtures (as opposed in synergistic mixtures) and processes thereof
Method of treatment of human beings/animals, plants, animals parts thereof
considered to be the same substance, unless they differ significantly in properties with regard to efficacy.
Examples : Toxic – non-toxic and Stable – shelf life
A substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof
Patentable Inventions : The MPPP regards claims to genetically modified genes.
Gene sequences/Amino Acid sequences a method of expressing the sequence, an antibody against the proteins, a kit containing such antibody/sequence as having inventive concept and capable of being granted a patent.
Gene sequence, DNA sequences without having disclosed their functions are not patentable for lack of inventive step and industrial application.
Living entitities of artificial origin as microorganisms, vaccines are patentable.
Biological materials such as rDNA, plasmids are patentable provided they are produced by substantive human inventions.
Process for producing chemical and biological substances using microorganisms including lower plants and animals are patentable.
Modified Microorganisms and process therefrom
Process for modification/isolation of microbes.
Isolated nucleic acids encoding gene, first time isolated of molecules, novel peptides, analogs, proteins, vaccines, antibodies, recombinant DNA, RNA, Amino acid antibodies primers, recombinant oligonucleotides and primers, genes and process there for; DNA related inventions such as preparing plasmids, vectors etc :composition/formulations thereof.
· Cell line is patentable if artificially produced.
· Hybridoma : Technology but not on protoplast fusion
· rDNA, cDNA, r-RNA, r-antibodies
· Expressed sequence tag’s, or ESTs, are small fragments of genetic material
· Obtained by reverse transcriptions of messenger RNA (mRNA) from expressed genes.
· The gene sequence or expressed sequence tags (ESTs), can be patented if it has a use such as if it works as a probe.
· Bioprobes, biosensors
· Diagnostic/Equipment kits, Research Tools
· Methods of enzyme purification.
· Environment cleaning using biological materials such as solid or liquid waste.
· Industrial/domestic treatment, water treatment, mitigation of air pollution, bio-remediation
· Treatment of plants.
CONCLUSION
India being one of the bio-diversity rich countries, it would, thus, be prudent to protect biotechnological inventions as that would help Indian biotechnology research to compete globally. India needs to reap the due benefits from its rich bio-resources with an enabling provision for patent protection in biotechnological innovations and inventions.
REFERENCES
1. National Biodiversity Authority website.www.nbaindia.org
2. Conservation of Bio-diversity Act 2002 and Biological Diversity Rules, 2004.
3. The Patents Act (1970) as amended by The Patents (Amendment) Act, 2005 along with The Patents Rules, 2003 as amended by The Patent (Amendment ) Rules. 4. Biotechnology and Patent Law-patenting living
beings-Dr.Sreenivasulu, N.S., Dr.Raju, C.B. (2008). 5. Biotechnology and Patent Law-patenting living
beings-Dr.Sreenivasulu, N.S., Dr.Raju, C.B.(2008).
6. Biotechnology Patenting in India: Will Bio-Generics Lead a “Sunrise Industry” to Bio-Innovation? (January 2008) by Janice M. Mueller.
7. The Patents Act 1970, 1999 & 2002, along with The Patent Rules, 2001.
8. “Patentability of Biological Material(s) - Essentially, Therapeutic Antibodies - in India”, (2008).
9. Universal Guide to Patents Law, Manish Arora. 10. Patent Law by P Narayanan-fourth edition.
11. R.A. Mashelkar et al., Report of the Technical Expert Group on Patent Law Issues, Dec. 2006.
