Intellectual Property Rights In Biotechnology 5c354r

LAW MANTRA THINK BEYOND OTHERS (National Monthly Journal, I.S.S.N 23216417)

“INTELLECTUAL PROPERTY RIGHTS IN BIOTECHNOLOGY”

ABSTRACT The intellectual property rights is the important field in protecting the intellects of a person, it is the exclusive right given to the owner for its intellectual work meaning the hard work and effort for the protection of the inventive work of that person. Here invention means the works which never had existed in nature before which is completely new. Since the IPR protection is only granted to the inventions not for the discoveries, in the case of biotechnology innovation is difficult to say whether the new life formed is in form of gene, DNA, cell etc. is a scientific discovery or technological invention. A substance freely occurring in the nature if merely found or discovered is not patentable. Biotechnology basically deals with genes, medicines, agriculture, and industriesetc., which are of the commercial value. The Indian government has entered into a number of biotechnology co-operation agreements with various countries in an effort to foster additional growth in this sector. Several State Governments such as Karnataka, Tamil Nadu, Andhra Pradesh, and Maharashtra have taken out their specific policies to boost the biotechnology sector in their respective areas. Some of the key steps taken by the State Governments include announcing separate Biotechnology Policy for their States, setting up of Task Forces with experts to guide them on policy issues, setting up of exclusive Biotechnology Parks with agriculture and health biotechnology as key areas. The city of Bangalore, located in the State of Karnataka and known as the emerging as the hub of Biotechnology industry in India. In the given paper we will be dealing with the concept of the biotechnology, kinds of biotechnology protection in IPR and also various case laws dealing with these fields in IPR. The current analysis will be the recent scenario of the IPR laws that are protecting the biotechnology. Keywords: concept of biotechnology, types, legal framework and current analysis

INTRODUCTION

CONCEPT OF IPR IN BIOTECHNOLOGY

IPR is the outlet of law used to describe the law which shelters the application of ideas and information which are of marketable value thus it covers the law relating to patents, copyright, trademark and trade secret and other similar rights.1The role of IPR has a crucial issue to deal on the field of biotechnology, now here comes the question as to what is biotechnology. Biotechnology is the important field where its inventions shall play important role in the future particularly in agriculture, medicines, protection of the biodiversity etc., biotechnology is mainly concerned with the living organisms, the inventions that are made out of the particular parts of these organisms and which further helps or modifies the product to improve the plants or the animalsor develop microorganisms for the specific uses. In normal layman the development of the genetic resources is called the biotechnology. So here comes the question as to what is genetic resources? The genetic resources basically refer to the genetic material of definite or potential value. Genetic material is any plant, animal, microbial or origin containing functional units of heredity. 2 Modern biotechnology is about 50years old and last epochs took anincredible development. Concept of biotechnology involves clean biological science (genetics, microbiology, animal cell culture, molecular biology, bio-chemistry, embryology, cell biology etc.). A noteworthy contribution has been made by the understanding of the ethnic peoples and the traditional farmers in the development of the new crops types and biodiversity conservation, which also an important aspect in the biotechnology development. With regards to the legal protection of biotechnology, it basically has very complex position in general and agricultural biotechnology however no internationally accepted guideline for the supervision of IPR and extensive range of opinion exists regarding the effectiveness of IPR in the area of biotechnology. It has been notified by the department of agriculture and resource economics that the role of intellectual property rights has become a key issue in agricultural and resource economics over the past two decades. The variations in biotechnology and intellectual property protection that have occurred since 1980 make private enterprise possible for the first time in many broad research areas in agriculture and the health sciences. As the scope and power of IPRs in biotechnology has grown, their international reach has expanded. These developments raise many

1

Cornish William , The intellectual property rights ( 5th edition , Thomson 1989) World intellectual office, see: ( http://www.wipo.int/tk/en/genetic/) last seen 10th august 2014

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mesmerizing and important issues optimal patent design and licensing, the implications of IPRs under cumulative innovation, typical of agriculture and biotechnology, the effects of the TRIPS agreement on developing countries, the effects of IPRs on monopolization of key sectors, and the optimal way to ensure that the poor of the world have access to pharmaceutical products including AIDS drugs.3 Types of biotechnology: Biotechnology inventions are basically the inventions of human mind and are generally the result of significant research, innovative effort and the investment in the classy laboratories. Though patenting the biotechnology has been complemented with controversies. 4 Biotechnology includes the changeability amongst living organisms, covering all springs including, inter-alia, terrestrial, marine and other aquatic ecosystems. In the developing countries, which are “capital poor” and “resources rich” plant genetic resources and other forms of biodiversity contribute significantly to this richness. The access to those resources and associated traditional knowledge can substantially benefit formal scientific research centers as well enterprises.5Thus we can divide this particular concept into two categories: 1. Agricultural biotechnology. 2. General biotechnology(industrial, preventive and therapeutic medical, regenerative and genomic medicine, pharma-geomics, bioengineering and nanotechnology, bioinformatics and IT enabled biotechnology, clinical biotechnology and research services)

Agricultural biotechnology: Agriculture is one of the important sector in building up of the country’s economy andother aspects like conservation of biological diversity. It’s for the first time that in many broad research areas in the agriculture intellectual property protection has been occurred. Agricultural biotechnology is increasing in its exclusive nature, the proprietorship of IPR in the agriculture is now an issue in development of products and transfer of the technology to the developing 3

Department of agriculture and resources economics, see: (http://areweb.berkeley.edu/ipr.php) last seen 10th august 2014. 4 Worldwide IPR official website, see: (http://worldwideipr.com/biotechnology.html) last seen 10th august.. 5 AlikhanShahid and MashelkarRaghunath, intellectual property and competitive strategies in 21stcentury (2ndEd.Wolters Kluwer)

countries. Researchers of the biotechnology now need to consider IPR as an important factor in there research especially where the main aim is product development therefore there is necessary for the scientists the developing countries to develop strategic plans in handling there IP concerns.6Protection of breading of seeds, crops etc. can be patented if they are traditionally of commercial value. The most important contrivance for lawfully protecting agricultural innovations are plant breeders rights (PBR) and patents (extended to cover plants animals and microorganisms). Other forms of protection can be provided through trademark, trade secrets and copyrights. Substitutions to these include material transfer agreements (MTAs) of a private contractual nature. If no form of protection is taken, then research results are commonly placed in the public domain, mostly in the form of publications, making fallouts available to all without restraints on use7. a) PBR- the plants breeders right are used to protect new varieties of plants by giving limited marketable rights for about 20 -25 years to market a new variation or its reproductive material. The variety must be “novel, distinct, uniform, and stable.” This protection prevents anyone from growing or selling the variety without the owner's permission. Exemptions may be made, however, for both research and use of seed saved by a farmer for cultivation. b) Patent - A patent is a limited right or exclusive right that is given to an inventor to exclude all others from ‘making, using, selling or offering to sell the invention’ in the country that granted the patent right, and importing it into that country. In agricultural biotechnology, patents may cover, for example, plant transformation methods, vectors, genes, etc. and in countries that allow patenting of higher life forms, transgenic plants or animals. Patents are the most critical form of protection for agricultural biotechnology and considered to be the most powerful in the IP system. Patents are temporary, generally about 20 years, and are country specific (Binenbaum et al., 2000) General biotechnology: Biotechnology in general includes all other substances or elements other than the plants category, includes all other living organisms like micro-organisms animals. Includes in combat of the DNA technology molecular marker in breading of animals. Inventions the commercial 6

International service for the acquisition of Agri-biotech applications, see:(http://www.isaaa.org/resources/publications/pocketk/9/default.asp) last seen- 10th august 2014 7 International service for acquisition of Agricultural-biotechnology application see:(http://www.isaaa.org/resources/publications/pocketk/9/default.asp) last seen- 15th august 2014

exploitation of which would be contrary to order public or morality, such exploitation shall not be deemed to be so contrary merely because it is prohibited by the law or regulation in some or all of the contracting states.8 i.

Industrial biotechnology-Industrial biotechnology is a set of practices that use living cells (such as bacteria, yeast, algae) or component cells like enzymes, to generate industrial products and processes. Products include biomass-based materials such as fuels and chemicals, while processes include the treatment of waste water and energy efficiency measures. For example, microbes (yeast) or enzymes are used to produce beer and wine as well as dairy goods such as cheese. However, biotechnology is being increasingly applied to improve manufacturing processes and to solve environmental problems. Industrial biotechnology can be used to:  Create new products, such as plant-based biodegradable plastics;  Replace petroleum-based feedstock’s by processing biomass using bio refineries to generate electricity, transport fuels or chemicals;  Modify and develop new industrial processes, such as by using enzymes to reduce the amount of harsh chemicals used in textiles and the pulp and paper industry;  Reduce the environmental impact of manufacturing; for example by treating industrial wastewater onsite using biological mediums such as micro  Provide water savings through more efficient processes such as using enzymes to break down chemicals and reduce subsequent washing steps in the textile industry.9

Patentability of microorganisms, the law complied with the requirement of article 27.3(b) of the TRIPS Agreement .The exclusion of inventions which represent .The ‘discovery of any living thing or non-living substance occurring in nature’, consists of ‘traditional knowledge’ or of ‘known properties of traditionally known components’ would lead to the exclusion from patentability of some biotechnology-based inventions. The Patents (Amendment) Ordinance, 2004, later replaced by the Patents (Amendment) Act, 2005 (Act 15 of 2005) introduced the third set of amendments to the 1970 Patent Act. The key modification was the introduction of product patents for fields of technology previously excluded from protection. This Amendment introduced a new provision (section 3(d)) aimed to prevent the grant of patents on ‘minor’ or ‘frivolous’ inventions. Although the main objective of Section 3(d) has been the avoidance of what have become common ‘ever greening’ practices in the pharmaceutical industry, this 8

EPC, article. 53(a) Australian government department of the Industry see:(http://www.industry.gov.au/industry/biotechnology/IndustrialBiotechnology/Pages/default.aspx) last seen15th august 2014 9

provision has apparently not been an absolute barrier against the patenting of variants of existing products, such as polymorphs.10 ii.

Nanotechnology- As an emerging science in its infancy, nanotechnology promises the nano-scale manufacture of materials and machines made to atomic specifications. It is a field at the junction of chemistry, physics, biology, computer science and engineering. Types of IP(intellectual property ) protection that is granted to this Nano technology are patents, copyrights, trade secrets, mask work and trademarks. IP rights are basically to protect under various federal and state legal laws and without protection the property falls under the public domain and may be used by any party without a license.11

PART II

Legislative framework:

A) TRIPS: In the other fields of the technology there is a need for the protection of the biotechnology. The legal needs for the protection of the biotechnological inventions is because these inventions are the result of the man intellectual minds and these are generally the result of a man’s handwork, effort and his keen research in these traditional laboratories. The legal framework is very sensitive and very complex in the case of biotechnology because of the technical and ethical issues involved in it. TRIPS or the trade related aspects had competent patent system in India regarding the fields in the biotechnology , Article 27.3 (b) of TRIPS excludes biological processes for the production of plants or animals as a patentable subject matter, but patents can be granted to the microorganisms, non-biological, and microbiological processes used in the production of plants and animals.12 This covers even the gene sequences, which may be for a particular character, or a marketer or genetic markers or similar ones. With the increase of transgenic exploration both in public and private research organizations, the issues of royalty payments, material transfer agreements (MTA), and legal obligations and covers are to be clearly understood. IPR protection of new life forms 10

TRIPS article 27.3(b) Results of Uruguay round, Article 27 of TRIPS agreement diverging views of developed and developing countries towards patentability of biotechnology 12 WIPO official site on TRIPS agreement, Article- 27.3(b) 11

raises a number of difficult technical and ethical issues because of which the patentability of new biological forms and processes is still not accepted in many countries. Indian Patent Act 1970 defines patentable invention as a new product or process involving an inventive step and capable of industrial application Article 27 (3)(b) of TRIPs agreement allows to exclude from patent protection, plants and animals other than micro-organisms; and biological processes for the production of plants or animals other than microbiological processes.13 TRIPs provide option to member states guarding new plant variety by means of patent or sui generis system or both. India opted for sui generis protection and legislated “Plant Varieties Protection and Farmers Right Act-2000” that enables the farmer to save, use, sow, re-sow, exchange, or share the seeds of protected variety, besides offering protection on farmers' variety, extant variety and essentially derived variety. The Indian Biotechnology sector is poised for a tremendous growth and IP protection is necessary for India to make it to the top as a global competitor. Human health biotechnology products for about 60 percent of the domestic market, while bio-drugs, vaccines and diagnostics have significant market shares as well. Intellectual Property (IP) is central to the biotechnology industry, and brings with it a dimension, facilitating collective activity, whether it is a drug discovery or clinical or marketrelated trials. Essentially, collaborative activity is the synergy between India's ability to provide conditions for research, clinical trials and development, technical lead and capital availability in developed nations. The successful translation of these synergies into commercially viable applications and marketable products critically depends on the compatibility of regulations that deal with the registration and protection of intellectual property, originating from the collaborative process. Affordability and accessibility to the products of biotechnology are also the two key factors central to the advancement of this sector. Policies that foster a balance between sustaining innovation and facilitating technology diffusion has been addressed with substantial progress in of for R&D, human resource generation and infrastructure development.

B) Biotechnology enablement in patent:In India biotechnology protection can only be attended by the help of patent protection14. There are certain characteristics associated with biotechnology that distinguishes it from other forms of patentable subject matter.

13 14

Article 27(3) (b) of the TRIPS agreement. As per the Dua reports

Biological inventions are described more in functional . Patent law was intended to satisfy the requirements of the industrial technology. Industrial technology is mechanistic and an applicant for the biotechnology patent finds it difficult to satisfy the requirements for obtaining the patent protection. With the advancement in the biotechnology development, industrial property laws were to be suitably modified to match the needs of science and the industry. The requirement of filing a specification has to be satisfied in the case of microorganisms as well.15 An application related to the production by the genetic engineering of a polypeptide called interleukin-3, believed to control immune response in mammals. It was held that the correct approach was to consider the description and the claims in specification in the eyes of the skilled persons in the art. Through the applicant need not have to restrict his claims must be properly ed by the description of the invention in the specification. To decide whether the claims are ed by the description, it is necessary to ascertain what is in invention which has been described in the specification.16 A person wishing to make invention will first have to obtain the invention after the research in nature, which might take years. Though this concept proved wrong, the skilled person would only be able to identify the new strain and description will not be sufficient to enable to him to get it. The House of Lords held that the patentee was not obliged to supply the microorganisms that he had described to the public. The claimed invention was a new antibiotic, the process of which required the use of a particular micro-organism as the starting material. The micro-organisms had been deposited in the culture collection before the filing date, but was not made available to the public until and after the filing date and the publication date.17 The deposit of the microorganisms was considered as a supplement the written description. The European patent office (EPC) recognized this need and included provisions in the rules to this effect. It was the EPC which first incorporated the provisions for the deposit of the microorganisms. Microorganisms are patentable under EPC.18

C) Necessity of international treaty and conventions: There are three important treaty for the international protection of biotechnology in the sphere of IPR. The Paris convention for the protection of the industrial property, the

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Verkey Elizabeth, law of patent, (2nd edition: Eastern book company) Schering Biotech corporations application, 1993 RPC 249 17 American Cyanamid co. (Dann’s) patent, 1971 RPC 425 18 EPC, Article- 53(b). 16

Budapest treaty on international recognition of the deposit of the microorganisms for the purpose of the patent procedure, and the patent co-operation treaty. 

Paris convention- the Paris convention was signed in the year 1883 by 11 countries but now majority of the countries are parties to it who have intellectual property rights laws in their country. The convention covers the patent and defines them so broadly that it permits application to any forms of the industrial patents granted under the laws of the convention countries. The most important practical result of the convention is the concept of national treatment that it is possible to claim priority from an application made in a convention country for all the subsequent convention countries within 12 months of the original filing agreement.19



Budapest treaty- Except for US, almost all the countries have early publications of the patent application after 18 months from the priority date. The deposited strain must be available from this time. The applicant has, thus, to make the invention available to the public including his competitors before any assurance that he will obtain the patent protection. A person who obtains a sample of the deposited straight after the early publicationhas to give an undertaking that he would use the strain only for the experimental purpose and would not give it to the third party. Most of the states require, in addition to the deposits, a written description. The treaty allows the deposits of the biological material with an international depositary authority (IDA), which will be accepted by the second country as a valid deposit.20 As a consequence of requirement the TRIPS agreement, The Indian Patent act has been amended providing that, in the case of mentioning biological material in the specification which may not be described in such a way as to satisfy the requirements for the specification, the application shall be completed by depositing the material in IDA under the Budapest Treaty.21 The Budapest treaty was entered into for the international

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Articles of the paris convention , Art-1- definition of industrial property, Art-2-3- national treatment, Art-4- right to priority, Art-4 bis to 5 quarters- patents, Art 5B, 5D, 5bis (1) and 5quiquies- industrial design, Art 5C,5D, 5bis(1), 6 to 7 bis 8, 9, 10ter- trademarks , trade names etc. Art 10bis- unfair competition 20 Budapest Treaty, Art. 3(1)(a) 21 Refer to the Indian Patents Act, 1970, section 10(4). Proviso(2), Indian patent act- sec-10.proviso2- if the the applicant mentions biological material in the specification which may not be described in such a way as to satisfy

recognition of the deposit of the micro-organisms for the patent procedure.22 The Treaty requires the deposit to be accompanied by a written statement stating that the deposit is made under this treaty, name address of the depositor and details of the conditions necessary for the cultivation of the microorganisms, for its storage and for testing its viability. 23 

Patent co-operation treaty- The Patent Cooperation Treaty (PCT) is a multilateral patent law treaty which was entered into in 1970. The PCT protects an originator of a member country by certifying priority for his or her inventions over all or any inventor from countries which are not member. Member countries are not under anduty to file separate applications for their inventions. According to the PCT, the Patent and Trademark Office acts as a Receiving Office (RO) for international applications filed by nationals or residents of the U.S. In accordance with any agreement made between the U.S. and another country, the Patent and Trademark Office may also act as a RO for international applications filed by residents or nationals of such country who are entitled to file international applications. The Patent and Trademark Office also performs all acts connected with the discharge of duties required of a RO, including the collection of international fees and their transmittal to the international bureau. International applications filed in the Patent and Trademark Office should be in the English language. [35USCS § 361]

Part III

CASE LAWS

clauses (a)and (b)and if such material is not available to the public (ii) if the applicant mentions a biological material in the specification which may not be described in such a way as to satisfy clauses (a) and (b), and if such material is not available to the public, the application shall be completed by depositing the material to an international depository authority under the Budapest Treaty and by fulfilling the following conditions, namely:— (A) the deposit of the material shall be made not later than the date of filing the patent application in India and a reference thereof shall be made in the specification within the prescribed period; (B) all the available characteristics of the material required for it to be correctly identified or indicated are included in the specification including the name, address of the depository institution and the date and number of the deposit of the material at the institution; (C) access to the material is available in the depository institution only after the date of the application of patent in India or if a priority is claimed after the date of the priority; (D) Disclose the source and geographical origin of the biological material in the specification, when used in an invention. 22 Budapest Treaty, Art-1 23 Budapest Treaty, Rule 10

The Louis Pasteur received a patent in 1873 claiming a yeast free organic germs of disease as an article of manufacture.24Supreme Court of united stated had Longley granted patent to the living organisms in the year 1980 that was the invention of the scientist Dr.Anandachakroborty which was found to meet the requirement in the patent, i.e. novelty, utility, and nonobviousness. The invention consisted of genetically engineered bacterium which was capable of degrading the oil spills. The invention was new and did not exist in nature. In the early case there was a case Genentech case 25, which dealt with the recombination of the DNA technology and gave rise to the complex discussion. But this was still primarily a case on the patent law and one that dealt with by the patent lawyers. The discussion then moved on to include ethical, moral and environmental issues by the time cases such as Onco mouse26 and plant genetic system came around. Ethical moral and the environmental elements had one way or the other found their way into the debate also into the legal part of it. US patent and trademark offices (USPTO) genetically modifies plant cells, seeds, plant tissue culture which can be patented, the ruling is effectively an extension of Diamond v. Chakrabarty, which dealt specifically with the genetic modification of microorganisms. The patenting of genetically altered plants becomes a practical legal issue requiring deliberation and decision when scientists Kenneth A. Hibberd, Paul C. Anderson, and Pauline Hubbard of Molecular Genetics, Inc. of Minnetonka, Minnesota, apply for intellectual property protection on a variety of corn that has been modified to contain more tryptophan, an amino acid. The Ex parte Hibberd decision results in a patent (No. 4,581,847, "Tryptophan Overproducer Mutants of Cereal Crops") that lays the groundwork for further patenting of GM plants27. In 1897 ExparteAllencase the key issue was the patentability of the polyphonic pacific coast oyster that had an extra sets of chromosomes. Applicant sought patent to the method of inducing polyphonic in oyster as the product by process28. USPTO rejected the patent application on the grounds ofobviousness on 1988 USPTO issued 1st patent on transgenetic non- human animal Harvard mouse.29 Cloning is the recent process of transferring the nucleus of an adult multicellular organism to an unfertilized egg of the same species. The recent experimentation in the science of 24

US patent No- 141072 on July 1873 Genentech Inc’s patent [1989] RPC 147 26 Case T 0019/90-3.3.2, 3rd October 1990,opposition division, case V0006/92,3rdapril 1992,examination division, europen patent no. EP85304490 27 Expartehibberd, see: (www.lifesciencefoundation.org) last seen- 20th august 2014 28 2 U.S.P.Q. 2d (BNA) 1425, see: (http://nopr.niscair.res.in/bitstream/123456789/3613/1/JIPR%2010(1)%204451.pdf)last seen: 20th august 2014 29 US patent no- 4,736,866 25

biotechnology resulting in the creation of the clone of dolly.30Many countries like Japan and US etc. Do not allow the cloning of the embryo of the human beings which will cause chaos in the human society. IPR protection of new life forms raises a number of difficulties technical and ethical issues because of which the patentability of the new biological forms and process is still not accepted in many countries

Part IV

CURRENT ANALYSIS

Though the recent development in biotechnology has tremendous growth in the field of economy, conservation of the biodiversity, plant variety, cell culture etc.., the need for the protection of the biotechnology has become an important focus, India has international protection of the biotechnology by the means of international agreement as discussed above TRIPS, the patent act which has been enacted for the protection of the new inventions, which also includes protection of the micro-organisms plant variety etc. there is a vast change as in growth taking place in this country. Approximately, 60% of the industry is devoted to human health applications, 10% to agricultural biotechnology and 30% to industrial applications, bioinformatics and genomics. The Recombinant DNA (DNA) technology is being successfully used in various sectors such as agriculture, health care, process industry and environment management. The current focus is on genomics, proteomics, transgenic, stem cell research and product development. The opportunities in India has increased Foreign companies may partner with India at the drug discovery stage of research, and use the Indian companies for contract research and manufacturing. This is because an increasing number of large pharmaceutical companies are finding it difficult to conduct the entire drug discovery process-in-house. India on the other hand provides a cheaper infrastructure. This has given rise to contract research organizations specializing in drug discovery services. Contract research services are largely focused on molecular biology, bioinformatics, genomics & stem cell research. Clinical research and trials are expected to grow exponentially over the next 5 years. There are tremendous opportunities in India for data-mining, gene annotation, and the development of 30

1st mammal sheep was created in 1997 by cloning.

software interfaces. These require enormous computing power for which India has established its supremacy. Foreign companies may form t ventures with Indian companies, or enter into technology transfer agreements or strategic research partnerships with key research institutions. The Indian market provides opportunities to produce and sell vaccines and therapeutics that respond to the needs of the millions of poor in India. In the agricultural biotechnology sector, with the approval for commercial release of first genetically modified product (Bt Cotton), India is expected to approve other crops, including mustard, soya-beans, corn and potatoes, in the near future.

CONCLUSION

The growing research and development activities in the field of biotechnology are now the new addition to the intellectual property regime. Very serious efforts are being made in order to increase these inventions which involves more of the living organisms, this has now become the most provocative issue the standard text of the patent laws are obstacle for the grant of these patents to the biotechnology inventions and original. The non-grants of the patent encourages uncontrolled privacy and new inventions and the original owners suffers economic loses. TRIPS agreement seeks to enforce the patent law around the world including the biotechnological inventions. It can be concluded that, genetically modified microorganisms and even higher level animals like mammals can be patentable under the Patent laws of several Countries. The WTO, under TRIPs Agreement seeks to enforce US type patents in all the member countries.

By:- SWETA MISHRA, 5TH YR, BA-LLB, SCHOOL OF LAW-KIIT UNIVERSITY