1. Waterfalls Institute of Technology Transfer (WITT) was commissioned by the Department of Biotechnology (DBT) to submit a report on "Probing Emerging Issues in Intellectual Property Rights in Biotechnology". A committee of Experts who examined the draft report recommended that in continuation of the study, several other areas of concern should be examined and the present status clearly identified. In response to this WITT submitted a proposal to the Department of Biotechnology giving a broad outline of the work that required to be completed in ten specific areas. These areas were:

1. Evolving a Sui Generis System for Protection in Biotechnology.
2. IPR in Biotechnology in Addition to Patents.
3 IPR Protection: Concerns in Medicinal Plants.
4. Traditional Knowledge and Intellectual Property.
5. Genetically Modified Food: Probing Emerging Concerns.
6. Relationship between R&D Investments & Cost of Protecting Intellectual Property.
7. Strategies for Companies to Manage IPR in Emerging Markets.
8. Patenting of Micro-organisms in the Growth and Competitiveness of the Indian Industry.
9. Transgenic Animals in the Pharmaceutical Industry.
10. Comparative Study of Protection - Biotechnology Inventions in Several Countries.

2. The DBT after due consideration of the proposal commissioned the Waterfalls Institute of Technology Transfer to undertake these studies in September 2000.

3. The Institute held consultations with several experts in the different areas. It collected several papers and reports which could provide leads to make a state of the art report on the different topics. Waterfalls Institute of Technology Transfer corresponded with several organizations and also visited several websites, often conducting searches at these websites to access relevant information. The information so collected formed the background material from which the study proceeded.

4. The Institute engaged several Senior Research Fellows and a few senior officials as Advisors or Joint Directors to prepare reports relating to the study under the overall supervision of Chairman, WITT. The research team thus included: Mr S S Kalra, Joint Director; Dr K Narayanaswami, Advisor; Dr Shelly Lahiri, Senior Research Fellow; Dr Anuradha Sinha, Senior Research Fellow; Dr Sadhna Srivastava, Consultant; Ms Pooja Sakhuja, Senior Research Scholar and Mr Arvindo Mukerji, Consultant. Certain hurdles were to be overcome in getting qualified research staff at short notice and for short periods. However, the staff who were associated gave a committed performance enabling the work to be assembled inspite of other difficulties associated with a study on intellectual property matters.

5. By about December 2001, the draft reports were assembled and in consultation with the Department of Biotechnology a suitable date for the Interactive Meeting was fixed (7th February 2002) at India International Centre, New Delhi.

6. The draft reports on the ten topics were grouped into four volumes covering over 800 pages of documentation. Copies of the four volumes were sent to over 30 invited experts in Delhi. The meeting took place as planned on 7th February 2002 and very valuable inputs were received enabling to improve the compilation as well as in identifying suitable follow-up action. It was decided that in addition to the four volumes a brief summary report could be prepared reflecting the discussions in the interactive meeting as well as providing other supplementary information related to the various topics.

7. The summary report contains the executive summary of the ten topics and these are presented in Chapter 2 of the summary report. A record note of the discussions of the interactive meeting together with the action points for follow-up is provided in chapter 3 of the summary report. The additional material incorporated in the four volumes of the report is included for convenience and ready reference as chapter 4 of the summary report.

8. The Institute wishes to place on record its thanks to several experts and organisations who provided inputs and relevant material in undertaking the study. Thanks are also due to several Research Scholars and Research Fellows who sincerely worked on the topics assigned to them. The Institute is grateful to the experts who participated in the interactive meeting held on 7th February 2002 and for the valuable contributions they made. Special thanks are due to some of the experts who provided written comments and suggestions and also for editing the draft reports on some of the topics; in particular Mrs Lakshmi Balasubramaniyam, the former Chief of IPD of CSIR and currently with Corporate Law Group, Dr Sudhir Kochhar- Assistant Director General, Indian Council of Agricultural Research, Mrs Sunita Sridharan of M/s Anand & Anand Advocates, Dr Ravi Dhar of the National Institute of Immunology and Mr Upadhyaya of National Research Development Corporation gave very valuable information which were used in finalising the record note of discussions of the interactive meeting and preparing certain appendices in the summary report.

9. The Institute is deeply indebted to the DBT for assigning the study as well as for the constant encouragement in overcoming some of the obstacles from time to time. In particular Dr (Mrs) Manju Sharma, Secretary DBT very kindly addressed the interactive meeting and the Institute would like to place on record her support and guidance. Dr Arora, formerly Advisor DBT and currently of the School of Information Technology JNU steered the progress of the project in its early stages. Thanks are also due to Dr Gulshan Wadhwa, Programme Officer DBT for his inputs from time to time in the progress of the study.

10. The Institute is conscious of the very rapid changes that are taking place in the subject of biotechnology and the constant pressure these advances put on the limits of the procedures and practices in protecting the intellectual property rights. The Institute hopes that the current study will be useful as a convenient reference from which further developments can be traced on the topics covered in the study.

2.1 EVOLVING SUI GENERIS SYSTEM FOR PROTECTION OF IPR ON BIOTECHNOLOGY

Technological developments are taking place at a faster speed, ahead of the IPR system that can barely cope up and give adequate protection to these new inventions in biotechnology. For over 60 years, different forms of protection of new plant varieties through systems of Plant Breeders Rights (PBR) have been in existence in industrialized countries. New legal systems were evolved. In the process many countries find it difficult to re-adjust their legal requirements to the advances in life sciences area, new ideas and the resulting inventions nor to exclude those adopted traditionally. Alternatives are sought for to suit to their national needs and requirement rather than adopt an alien system that allows protection on plant variety, but excludes the traditional food and the medical systems and the treatments followed. However, WTO agreement on TRIPS, require effective protection of IPR in all fields of technology including those on plant varieties either by patents or by an effective. Sui generis system or a combination thereof.

2. The report takes into consideration the criteria evolved under TRIPS for the protection of Intellectual property in general, namely the novelty, inventive step and utility and the special requirements seen for protection of plant varieties such as distinctiveness, uniformity and stability (DUS). TRIPS however, does not specify what exactly is to be understood under protection requirement of a patentable subject matter. This may lead to and present serious impediments to the patenting of plant genetic material.

3. Next, the role of community gene fund is recommended as a measure to enhance the socio-economic and indigenous technological development of the community as they contribute critical value addition component towards successful breeding of plant species.

4. Recognizing the diverse approaches exercised in different parts of the world in the matter of giving protection to inventions on plant and plant varieties the report makes a study of legislations in USA, Europe, Thailand, Australia and Canada, with respect to intellectual property regime available in those countries and on the sui generis system on plant varieties.

5. The study advances towards specifying the standards for effective sui generis system. According to Mr Peter Sutherland, former DG (GATT) this is a special system of protection that gives to patent breeders to protect plant varieties under the International convention, such as UPOV and other systems such as CBD and FAO on benefit sharing and equity. Sui generis systems has the flexibility to confer on the holders an additional right which WTO members do not make it explicit in relation to plant varieties as to other obligations given under TRIPS on patents and as such the scope of protection reflected upon DUS criteria is not obligatory.

6. The report examines the UPOV convention which began as an alternative to afford protection for plant varieties in lieu of patents. The convention addressed the important issues relating to encouragement of plant breeders and is regarded as a sui generis system. It outlines the special requirements in the field particularly the aspects relating to standards such as distinctiveness, uniformity and stability (DUS) in a variety. Further, the report explains the changes brought forward under UPOV 78 and the later version of the UPOV 91 that strengthens the rights of the inventor towards effective protection.

7. The next chapter of the report deals with the concepts related to Farmer's Rights, recognizing their contributions; the role of the farmer could be that of a cultivator, conserver or even as trader of plant genetic resources. In the same fashion, the community rights regime is exemplified as they nurture the land races and genetic diversity which provide the basic new material for modern plant breeders and biotechnology.

8. Currently there exists a concern that sui generis option should not be taken as an opportunity to establish right forms over biodiversity or traditional knowledge and WTO is set to review the enforcement provisions relating to plant varieties protection and the status for such a review is outlined.

9. The study refers to typical court cases decided to resolve issues that arise under sui generis protection on the experience of UPOV member nations as they will be useful in formulating the future course of action needed under the new system and to reinforce the position relating to certain standards on plant varieties protection.

10. The report further explores the standards and requirements that need to be dealt under sui generis protection system in the field of biotechnology. In arriving at this, the study utilises the results of the work completed by OECD member nations relating to sui generis protection in plant and plant variety. The questions posed in the OECD study and the responses received are presented in a tabular form. The survey addresses the questions relating the availability of plant variety protection under the sui generis system with the member nations, accession to UPOV protection system, patent protection on plant varieties, concurrent protection and the protection of a variety with patented gene.

11. In the end, the report includes the Bill introduced in the parliament "Protection of Plant Varieties and Farmer's Rights" for protecting inventions relating to plant varieties under the sui generis system taking into consideration of national needs and the requirement. This bill has now received the assent of the President.

2.2 IPR IN BIOTECHNOLOGY IN ADDITION TO PATENTS

1. Biotechnology holds immense potential for applications in environment, agriculture and human health. Many of the inventions in these fields are on living objects and live materials which hitherto had been kept outside the scope of patentability. The developments resulting on new invention in the area pose as a challenge to the existing legal systems of IP protection while countries are getting ready to meet the growing new situations. Moreover, countries are trying other alternatives to protect inventions in the absence of full range of protection available through patents.

2. For the present, three other options of protecting intellectual property in biotechnology subsist that have been commonly used. These are trade secrets, copyright and sui generis system.

3. Sui generis system is evolved to meet situations that require special considerations to protect the items and innovations of the past, present and those that arise from time to time to meet specific situations. Dual protection concept has also been considered to protect the human gene inventions by patent, so long as they meet all the standard criteria required and on the sequences comprising data bases of the gene, a distinct right protection is evolved by virtue of selection, arrangements of the content that involve intellectual efforts.

4. With the above reference frame, the study examines IPR protection by methods other than patents to meet the challenges brought about with current advances in biotechnology. Initially, the report deals with trade secret protection which is equally important in biotechnology as it is in any other commercial domain. As an alternative, towards protection in biotechnology domain, the subject matter suitable for trade secret protections most often overlap with options for patenting as this could also provide ways to produce products in manufacture.

5. It is recognised that trade secrets protection can be effective only if the patentable matter cannot be reverse engineered from the product legally made available in the market. The ability of the owner to keep a secret is another important factor as there exists no legal remedy once the secret is lost for lack of adequate measures to maintain it as fool-proof system which prevails as one of the factors that is in-built in the TRIPS agreement. At the same time trade secrets do not provide adequate protection on products against independent discovery.

6. The next option being Copyright, a different type to prevent copying by others is examined on its potential for certain class of biotech inventions. It is mainly to cover protection of expressions and not to ideas themselves. Functionality is not required. The possibility of protection is weak as ideas can be expressed in one or only in a few ways.

7. The study points out that the major potential for copyright protection in biotechnological inventions relate to the option that DNA sequences might be protected in the way software is protected. Since copyright protects only against copying and not independent discovery, its appeal is not as strong as in patenting. "Expression sequence tags" involving large number of cDNA sequences represent copyrightable expressions as these might prevent others from pirating sequencing work already done. This however would not prevent the use of independently recovered forms of relevant genes and pests.

8. The use of data bases in biotechnology involve two distinct rights - one a copyright for databases that arise by virtue of selection, arrangement of the contents, constitute the own intellectual creation and the other an extraction or reutilization right of those databases involving substantial investments. The database treaty provides a "fair use" option for extraction and not for reutilization of parts of database and also incorporates the obligations concerning import of protection-defeating devices on such rights. The study concludes that the development of a sui generis system which will also be appropriate for protection in the event of the existing legal system do not fit-in appropriately.

9. In the end, the suitability of a sui generis system is briefly addressed as a means to protect and deal with traditional methods and knowledge on one hand and the other with the new advances, particularly those dealing with live matter for which current IPR protection seems to be inadequate. It is mentioned that sui generis system protects it own class and is flexible enough to protect local communities while conforming to international standards and treaties. It confers on the holders an additional right in relation to plant varieties and serves as an additional IPR within the meaning of TRIPS.

2.3 IPR PROTECTION: CONCERNS IN MEDICAL PLANTS

1. India is a one of the important resource collection centres of the world for plant materials and rich source of traditional knowledge. The recognition of plant genetic resources has gained economic importance with the progress on biotechnology and plant genomic analysis. Plants are protected by patents in USA and plant varieties under UPOV convention 78/91 in many countries.

2. The background of the study related to a large number of patents that are now being taken not only in India but in other countries concerning medicinal plants. The concern for India is particularly on whether MNCs take this knowledge known only in India and commercialise them against our interest. There is also some concern on benefit sharing arising from their development for which some sort of intellectual property protection is essential.

3. The study briefly provide analysis of medicinal plants in industry. It is noted that 80% of the population in developing countries relay on drugs based on medicinal plants and also depend on 25% on synthetic analogues. The data also reveal that the World Trade on Drugs is 60 billion US dollars per year. The statistics show that India has 800 species of traditional medicine (T-M) plants and about 90-95% are collected from wild species while 20% or less are done under special cultivation. There is an urgent need to protect and conserve endangered and rare species.

4. It is apparent that MNC pharmaceutical giants have the capability of speedy screening of resources derived from developing countries and the capacity to identify the isolated therapeutic compounds quickly. In contrast, India lacks state of the art technologies though endowed with mega diversity of Medicinal plant species.

5. Having analysed the strength and weakness of medicinal plant industry, the study examines the different IPR regimes and issues related to medicinal plants in India. In this context, the patenting of neem, turmeric and edible herbal anti-diabetic agent in USA, is mentioned which are based on indigenous medicinal plants known for medicinal properties in India for long and unfolds conserted Indian efforts have gone into their revocation. They expose the inadequacy of TRIPS Art 27.3 being not effective to contain the appropriation of TK for commercial uses.

6. As a follow up, the study explores various avenues available for IPR protection of medicinal plants. In particular it has focussed on:
(i) TRIPS provision allow patents or effective sui generis or both towards protection of plant varieties including medicinal plants.
(ii) India has developed its own PVP law consistent with TRIPS drawing from UPOV 1978 convention and on invocation of Art 15 of CBD to protect the national interest and farming community.
(iii) Providing benefit sharing under the FAO international undertaking
(iv) It also uses TRIPS article on Geographical Indications to protect the medical and other species belonging to the specific region in the country.
(v) And also to include possible amendments for collective ownership of TK on medicinal plants.

7. In the concluding observations, the report recommends that the following initiatives would facilitate to convert the potential of our medicinal plants into economic wealth and also to preserve and propagate the rare, endangered or endemic species.
(i) R&D efforts to cover all aspects of collection towards utilisation.
(ii) Legislation for biodiversity conservation.
(iii) Proactive approach on IPR protection.
(iv) National TKDL.
(v) Invocation of Geographical Indication Act.
(vi) Sui generis system for PVP.
(vii) Trade Secret protection for TK.

2.4 TRADITIONAL KNOWLEDGE AND INTELLECTUAL PROPERTY

Traditional knowledge has become economically important. There is a growing realisation and concern to evolve various policy measures to protect traditional knowledge. IPR issues have assumed great significance in the context of large-scale exploitation of medicinal knowledge and wide range of folklore and folklore expressions. They retain invaluable source of accumulated knowledge mostly undocumented and passed on from generations to generations which has provided solutions to diverse problems.

2. The communities who are the actual store-house of this traditional knowledge and culture are at a disadvantage and at a loss over the improper and unchecked, appropriation of this knowledge. Therefore, the need has arisen for systematic study on finding effective measures to protect these areas of traditional knowledge. In this context, there exists enormous potential towards information collection, authentication and codification of the data in the field. Since they are not documented others can bring them under patent domain. The value of such knowledge base is presently recognised and the types of intellectual property that may be relevant to their protection is required. There is no clear established mechanism of IPR to provide protection and check unfair exploitation by the unscruplous agencies. The study examines the limitations in the present IP system to adequately protect the traditional knowledge.

3. The report underlines the importance of traditional knowledge in two distinct fields related to medicinal applications and in the folklore expressions.

4. The study points out some of the experiences in different countries as well as the work of the recently established group under the WIPO. The position with respect to China, Sri Lanka, India and some of the African countries has been briefly reviewed. China holds the view that the strong intellectual property protection systems for traditional medicine will encourage the development of a sound Chinese medicine industry while protecting the legitimate rights of the inventors. It will focus on the loss of traditional secrets of mature formulations, policy on secrecy and copying activity of new modified medicines. Sri Lanka intends to develop national guidelines for IP-related aspects; in particular access and benefit sharing by the traditional knowledge holders. In India, the need for rewarding those working in the field and those who built them up are well recognised and the option of IPR has emerged strongly to make legislations to reap the benefits of the traditional knowledge for commercial gains.

5. The next two chapters focuses on the new initiatives taken in the country to protect traditional knowledge related to medicine, medicinal formulation under structured system for quick search, retrieval of information on establishment of TKDL (Traditional knowledge digital library) as a documentation source.

6. Informal IP-like regimes protecting certain subject matter in the field of traditional medicine to distinguish the different codified systems of medicine and of those that falls under non-codified category such as indigenous and tribal medicines are explained. The status in African countries such as Uganda, South Africa, Nigeria and Ghana are examined. The felt need to protect their traditional knowledge for a variety of objectives namely traditional remedies and healing methods, preservation of cultural heritage and to safeguard country's wealth resources in this area is ascertained.

7. The study reviews the existing IP forms of legal protection available to traditional knowledge associated with the wide range of folklore and folklore expressions. It explains that South Asia, Africa, North America and Arabian countries follow existing legal mechanisms, namely copyright law, heritage/custom-related legislation or sui generis protection measures before a suitable alternative is evolved suited to their needs. Documentation initiatives to protect their cultural heritage is part of the new measures taken by them.

8. Some of highlights that emanate from the analysis are:
(i) Traditional knowledge based innovations expressed by patents provide certain guidelines such as disclosure and policy framework on concurrent research for value addition and registration for local innovations to protect the interest of TK patent holder and benefit sharing on them.
(ii) To improve protection of traditional knowledge design especially on folk designs such as prints in cloth, fabric sarees and on decorations under Industrial designs as referred under TRIPS agreement is suggested.
(iii) The need to bring the traditional Music Performers Rights under copyrights and related rights and to improve on them, is pointed out providing licensing guidelines such as time limits and indicating the actual beneficiaries.
(iv) Community related traditional knowledge practice and those arising from cultural heritage which is common to a region could come under the Geographical Indications to protect the community rights.
9. The study focuses on the benefits and beneficiaries of IP protection through the existing form in traditional knowledge systems. In case of South Asian countries the recommendations advance to further the equity of the patent system. In the process it excludes certain codified TK systems from patentable subject matter while making it obligatory to provide evidence in patent applications for TK based inventions or biological resources appropriated. Legal and financial assistance is suggested to traditional knowledge holder to challenge the patent claims in different fora.

2.5 GENETICALLY MODIFIED FOOD:

PROBING EMERGING CONCERNS Genetic Engineering techniques help to create transgenic crops and animals with specific engineered traits. The study attempts to bring about that GM food represents a mixed bag of opportunities and concerns. The transgenic plants appear to offer viable option to meet the food needs of developing countries and products having special desirable properties. On the other hand, all implications towards safety of human and animal health, impact on environment and socio-economic status of farming community are not fully understood. Reports of certain disturbing elements happened in UK and few other places have become a cause for considerable concern. However, it is very clear that in any large scale commercialisation of GM food, IPR will have an important role to play. The study focuses on IPR issues relating to genetically modified food.

2. With the above background, the report describes the variety of modified foods and their prevalence in society. Globally 40 billion hectares are covered by transgenic cotton, maize, conala and soyabean while 40 million hectares are devoted to GM modified cereals. GM food is playing a major role in developing countries and it is tuned to the needs of local people.

3. The study highlights the potential benefits arising from GM Technology on Agriculture to increase food production in a number of ways, towards ensuring food security for the abounding millions. GM food promise the advantages of evolving cereal varieties having pest, disease resistance and those having tolerance to a biotic and biotic stress. In this context, the varieties having cold, draught and salinity tolerance is mentioned. Another area which forms enormous benefit is to improve the yield and nutritional content of the crops where people rely on a single crop such as rice as the main stable diet. Vitamin A deficiency and Iron deficiency is made up with transgenic rice having elevated levels of beta-carotene and Iron content. Following these developments, the study focuses on GM fruits and vegetables having extended storage life, delayed and uniform ripening time. The study touches on edible vaccines where GM technology offers the potential to produce vaccine and pharmaceuticals in plants and milk of transgenic animals. In addition the study refers to engineered food ingredients on diary products such as chymosin and on transgenic fish having antifreeze protein genes for cold tolerance and those on disease resistance.

4. Following the above developments, the report examines the area of public concerns in regard to genetically modified food. Most concerns about GM food fall into three categories mainly on, Human and Animal health risks, Environmental Hazards and the socio-economic impact.

(i) To date, no human health problems associated specifically with the ingestion of transgenic crops or their products have been reported. However, concerns have been raised on the potential for allergenic reactions of food products consumed, the possible introduction or increase in levels of toxic compounds and the anti-biotic resistance as markers used in the transformation process.

(ii) It is equally seen that the potential hazard to environment arise, from the fear that pollen-drift from modified plants with pest resistance gene such as B.t. into the plants in neighbouring fields may cause unintended harm to non-target species feeding on them and also insects becoming resistant to B.t. gene. Another concern is that crop plants engineered for herbicide tolerance may cross-breed with weeds resulting into unmanageable super weed.

(iii) The third aspect relating to the socio-economic impact is the patented new food crops won't be within the reach of farmers to buy the GM seeds in the 3rd world countries nor those varieties patented with suicide gene. Another aspect relates to cross pollination of crops with GM pollens of that variety leading to patent infringement unknowingly, ending as burden on innocent farmers.

5. The study points out typical court decisions that have been reported in the recent past. This include:
(i) The patent enforcement could be difficult as farmers may claim that they inadvertently raised engineered strains on cross pollination of genetically modified plants landing in their farms. It was a case 'Roundup Ready' seeds of canola with Canadian farmer.

(ii) In another instance, the case involves broad patenting claim on genetic engineering of tomato with delayed ripening and tastier characteristics, using the antisense technology. (CalGene Vs Enzo Biochem).

(iii) The principle of GURT technology related to the Intellectual Property Rights and the monopoly production of GM crops by a few multinational companies is also cited. 6. With the above concerns in mind, the study points out the importance of food safety and regulatory status of GM products that they do not contain substantially increased levels of toxic substances, new allergens and to the compliance with applicable legal requirements.

7. For full a appreciation of the subject matter the study briefly surveyed in some detail the intellectual property issues involving genetically modified food. 8. The study ends with details of a number of selected list of patents on GM foods in recent years. It also provides published patents on specific areas of GM foods with abstracts. These covers selected recent patents in the field, with the details thereon with respect to cereals transformation, pathogen resistant patents, method of increasing protein content in plants, modifying the sweetness in fruit tissues, production of parthenocarpic fruits and vegetables (seedless variety), Transgenic bovines to increase milk production and the transgenic fish with GM genes.

2.6 RELATIONSHIP BETWEEN R&D INVESTMENTS & COST OF PROTECTION INTELLECTUAL PROPERTY

This part of the report deals with Relationship between R&D Investments and Cost of Protecting Intellectual Property. It attempts to assess the utility of a patent and its commercial potential. A comparative investigation of relationship between R&D cost and cost of IPR protect countrywise and sectorwise has also been attempted in order that it may help in evolving a strategy and a viable and effective system of IPR protection. This report incorporate comparative study of six selected advanced nations - USA, Japan, Germany, France, UK and Australia with India.

2. In a R&D environment it is usually easy to measure input than output, as outputs are partly intangible in nature and cannot be qualified readily. In addition there are certain conceptual difficulties to define the output of R&D in clear and unambiguous terms. Nevertheless, one can make an attempt to collect data on output parameters like patents and know how developed and utilized, royalties and fees received from the processes sold out, research papers and other publication which might directly or indirectly measure the outcome of R&D.

3. It is well accepted that R&D cost has increased enormously in recent years and in certain segments it is indeed very high. In many such areas, investment in R&D is possible only when IP generated can be protected and benefits recouped through intellectual property assets. Inventions arising from the creative/inventive work of human beings acquire considerable commercial value in view of the possibility of their use by large sections of society not only within the country but also in other countries. Intellectual Property protection granted to such inventions enables industry to make investments aid build on such inventions and later reap adequate returns. The absence of such intellectual property protection inhibits the industry from taking the risk to make large investments on new inventions.

4. R&D cost in selected countries have been compared countrywise and sectorwise. It is found that US incurs the highest R&D expenditure, followed by EU, Japan and Germany. Regarding sectorwise R&D expenditure, most of countries spend higher percentages of their total R&D expenditure in Telecom, Electronics and Electric Industry.

5. As for R&D expenditure of developed and developing countries, it is observed that percentage share of R&D expenditure by developed countries in the total R&D expenditure is more than 90% and by developing countries, it is less than 10%.

6. As regards Intellectual Property Protection such important aspects as assessing value of IP, insurance for IP and technology, licensing right and patent score card have been briefly covered in the study. To explain patent scorecard data of biotech industry, aerospace industry and computer industry have been taken. The biotech/ pharmaceutical patent score card highlights the world wide growing interest by companies in biotechnology. The Technological strength of Glaxo, SmithKline Beecham is high in biotech industry. In Aerospace industry the patent score card lists Lockheed Martin the highest in Technological Strength and in computer IBM holds the top position.

7. An attempt has been made to find percentage of patent cost to R&D cost. It is observed that percentage of total patent cost to R&D cost is upto 10%. In Europe patent cost to R&D cost is high; specifically in UK patent cost to R&D cost is 9.68%, Germany (7.64%) and France (5.57%) followed by USA (6.37%), Japan (4.74%) and India (0.2%).

8. In order to understand if there is any broad relationship among the inputs and resultant patents, an attempt has been made to derive a possible correlation between the various constituent parameters in different countries. Since the main constituent parameters vary widely from country to country no uniform pattern could be observed. However to afford some idea in this regard parameters like R&D Expenditure, number of Patent Grant, Man Years in getting a patent and Amount Spent in creating a patent have been compared.

9. The global scenario for science and technology indicates the R&D in developed countries are 200 times more than in India. To make India come to a position at par with the developed countries effort must be made to increase investments in R&D. Also proper care must be taken that more and more inventions come under suitable intellectual property protection. Man years expended to create a patent, are required in India is around 250. Tremendous efforts bring down the number of man years per patent to compare well on global standards.

10. The various strategic steps that need to be taken by a country for protecting its intellectual property rights effectively have been indicated in this report. Briefly there are many measures to which a company could give attention in protecting its intellectual property rights and it could well be that a combination of some of the measures could prove effective in a particular case.

2.7 STRATEGIES FOR COMPANIES TO MANAGE IPR IN EMERGING MARKETS

1. This part of the report deals with "Strategies for Companies to Manage IPR in the Emerging Markets".

2. In the Indian economic and industrial scenario, small scale industries play an important role, contributing 40 percent of the total production and 30 percent of the total exports of manufactured products. Therefore, when India is in the process of harmonizing its laws with the requirements of TRIPS, it is opportune time to tune SMEs to upgrade their products and evolve IP asset management strategies to protect their intellectual property rights to compete successfully in the emerging open global market.

3. IP asset management comprises such important aspects as IP Audit, IP/Technology Agreements, Offensive and Defensive Patent Filing, Surveillance, Technology Forecasting, Litigation Management, and so on. These aspects encompass minimizing intellectual property liability, identifying, perfecting and protecting the appropriate IP assets; avoiding unplanned IP litigation through diligent compliance process; maximizing returns of IP assets through aggressive and focussed asset management processes, and protecting organiation's competitiveness position.

4. It makes a good economic sense for an organisation to conduct defensive patent reviews and patent searches before committing resources to R&D technology innovations. It is also important to adopt offensive measures through robust invention disclosure and preparing and filing a comprehensive patent application.

5. Patenting of biotechnological products and processes became an international issue when it was included in TRIPS agreement of WTO. Though there has been a demand to have a uniform system of IPR protection, under TRIPS agreement compromise formula has been adopted in view of opposition from different countries. The provisions under TRIPS, so far as biotechnological inventions are concerned, and the legal scenario obtaining in various other countries with regard to patentability of inventions, are briefly covered.

6. New ideas and innovations have to be marketed just like any other product or property. The larger and potentially more rewarding the market for the inventor's industrial property is, the more vigorous and professional his selling efforts should be. While assessing and evaluating the market the emotional relationship between the inventor and his invention should be guarded against and the key qualities of objective approach must be adopted.

7. All the time, it is necessary for a company or the inventor to realize that what counts in any market is not the ingenuity which has found expression in the invention, its technical merit or the aesthetics of the product, but the projected bottomline economic result that means that one of the essential elements before marketing an invention is a proper and thorough assessment of the product and the market.

8. The technologies emerging from the application of biotechnology provide a vast potential for industries based on the new inventions. Most of these inventions fall within the fields of agriculture, food, drugs and medicines.

9. As regards agriculture, India ranks among the leading nations both in production and export. India is the largest producer of ginger, turmeric and accounts for 65 percent and 76 percent respectively of the total world production. India produces oleoresins from almost all spices. India rank first in mango and banana production. The five fruits, i.e., mango, banana, citrus, guava and apple account for 75 percent of the total fruit production in the country.

10. Modern biotechnology has revolutionised and contributed in a big way to the food industry. Many organisations, big and small, are involved in developing and patenting biotech based technologies applicable to the food sector. The product focus of most of them is geared not only towards foods, but many of them also produce enzymes that are useful to certain specific areas of food industry. Both in the case of the top-rung companies and other organisations, almost one-third of their food patents applications pertain to biocatalysts, and one-third to genetic engineering, the remaining being in other areas of food.

11. The strategy adopted by these two types of companies, i.e., big and small, in patent applications, is that these companies generally prefer taking individual patents, and approximately 20 percent of their patents are international patents. Further, smaller organisations prefer regional protection and are inclined equally towards firm-firm and firm-lab collaboration. On the other hand larger organisations are more inclined towards firm-firm collaborations.

12. Recently, there have been major changes in the perceptions of people both in India and the world over about healthcare and they want to know more about the functionality of every food product and inherent health benefits of each. India, with its rich biodiversity and traditional knowledge has vast potential for developing numerous processed and functional foods with health benefits. Thus important question here would be how to protect inventors interests as well as the traditional knowledge. Since most of the things in this area are in the public domain, patent protection can be sought in the process of isolation, purification and mechanisms of incorporation provided there is novelty and uniqueness.

13. Keeping in view the trends in the area of genetically modified foods and the changing laws in IPR, one can expect many changes in the patentability aspects relating to functional foods in the near future.

14. The global herbals market holds a tremendous potential as more and more people and countries look towards sources for natural sources for therapeutics. While supplies of raw materials from wild sources of medicinal plants are rapidly depleting, the demand for herbal ingredients is soaring gradually. It has been rightly recognised that the emergence of the new intellectual property regime will pose a number of challenges and play a significant role in this sector. If we add value to the medicinal plants and their extracts in India, IPR will have larger role in our exports in the next decade.

15. The current global resurgence in the use of plant based drugs offer an ideal opportunity for India to emerge as a major player. With estimated 45000 plant species, 7500 being endemic to India, India is a unique depository of natural wealth. Its Ayurvedic system of traditional medicine, the area of bioactive natural products is particularly pertinent. Under TRIPS, novel microorganisms, fermentation processes, and microbial metabolites are patentable as also the novel constituents of plants and animals which meet the requirements for inventions. Thus with enhanced opportunities, Ayurveda can aim to provide medicines that are standardised and proven, discover novel delivery dosage forms, and thereby harvest rewards from patentable Ayurvedic products. In fact, a number of patents derived from turmeric, kava, amla, neem, tamarind, taxol and other herb-based products have been taken.

16. In view of the importance of IP and its crucial role in the prevailing competitive industrial and commercial environment, building effective strategies around IP is essential as it has the inherent qualities of giving a business a strong and sustainable market advantage. Using a range of protective measures, like that getting a patent on a product, registering designs and developing brand strategy based on registered trademarks will strengthen market pressure on sales volumes.

17. A typical action plan in this regard could include: identifying IP associated with a particular business; checking who really owns the IP or has the right to use it; listing registered IP and placing financial value on the assets; listing unregistered IP and design at a value; identifying key staff involved in developing, maintaining and protecting IP and getting them sign agreement relating to confidentially and competition; developing an infringement strategy and considering insuring IP against infringement; searching IP databases, literature to ensure novelty of ideas and avoiding infringing other rights; and maintaining secrecy and being the first in the market.

18. On the national front, the strategies that could be considered are: update intellectual property legislations; modernize IP infrastructure and administration; build awareness of the legal and economic foundations of the IP system for sustainable development in the knowledge based millennium; integrate domestic economy with global economy; and promote innovative, inventive and creative activity for enhancing growth process; forging linkages between SMEs, R&D institutes and universities; protecting traditional and collective knowledge of communities, in relevant fields, like indigenous systems of medicines, agriculture, food products, and developing human resources.

2.8 PATENTING OF MICRO-ORGANISMS IN THE GROWTH AND COMPETITIVENESS OF THE INDIAN INDUSTRY

Many biotech industries are based on microorganisms related inventions and the strength of the industries lies on the IPR protection on those inventions. The industries employ both modern and conventional techniques to produce products in different sectors.

2. At the outset, the framework depicts that microorganisms are integral part of the biodiversity along with flora and fauna. The conventions on biodiversity stipulate that they do not cause damage to the environment and the states have sovereign right over their biological resources. Consequently, there exists a concern that exclusive ownership may prevent others from using the biological resources and limiting the principle of sovereign right. On the other hand, it is explained that under TRIPS agreement inventions on microorganisms should be through patents, though it neither defines the microorganisms nor provides guidelines, on what all is included under this term. Hence, there prevails an apprehension, about patenting of microorganism that science will start intervening in the basic life process and then the products of nature or a constituent of nature and draw the resulting invention into the exclusive domain of few. Nonetheless, several cases decided has paved the way for clearing patents on microbiological inventions and on parts of microorganisms setting aside these apprehensions. This has led to the development of transgenic microorganisms and many patents have been taken in the recent past having considerable importance. They relate to pharmaceutical products and specialty materials like enzymes, cultures and nutrients.

3. Subsequently, the study has focused on an analysis of the patents taken in this field over the last 10 years and highlights specific product applications involving microbial technology in the fields of pharmaceutics, environment and on enzymes having industrial utility.

4. The analysis of patents determines their overall commercial potential in the appropriate fields. These are grouped in five sections A, B, C, D and E.

5. Section A examines the recent patents granted and their potential application in the pharmaceutical field. The highlights are:

(i) Conine corona virus vaccine that has unique antigen activity against susceptible animals prone to infection by the virus CCV.
(ii) Cloning and expression of Toxaplasma antigens that are rendered useful as diagnostic immune assays and as components on vaccine preparations.
(iii) Cell lines are employed for pharmaceutical purposes and this patent is obtained for rapid and functional expression of high voltage activated calcium channels.
(iv) Algae species labosphearia has been developed which is useful for preparing a novel enzyme - Trehalese that find multiple application in pharmaceutical and food industries.
(v) US patent on culture of eupencillium Brefeldianum strain has been given that has shown antitumor activity against P388 leukemia.
(vi) The vector plasmid having superior properties that facilitates the production of antibodies reactive to a wide assortment of oncogenous elements, on expression of proteins in bacteria.
(vii) A novel mycoplasma strain and of those having antigenic determinants for the detection of specific antibodies. In the sera of human patients and animals and for production of vaccine against mycoplasms is included.

6. Section B examines the field of microorganisms in environment; the study points out the potential applications of microorganisms in the environmental sector and illustrate them by specific patents.

(i) They relate to degrading plant cell walls and complex hydrocarbons such as plastics and plastic byproducts.
(ii) The patent describes a biopesticide - pesticidal formulations based on biological activity, applicable against those pests which have rapidly developed resistance to presently available chemical pesticides.
(iii) Another area where the weeds create environmental problem exhausting the nutritionally rich soil resulting on reduction of yield of crops. The invention relates to a fungus possessing herbicidal activity against sicklepod and coffee senna.
(iv) The prevention of aflatoxin contamination in cereals and nuts are effected by a novel strain of bacillus subtilis on which a US patent is granted.
(v) A method for decomposing an organic compound accumulating in a contaminated environment by a unique microorganism which precludes the need of addition of substrate chemicals in the conventional process.

7. Section C reveals the potential application of enzymes derived from specific microorganisms of select patents:

(i) The patent describes the isolates of pestalatiopsis funerea and pestalatiopsis neglect which produce an enzyme glucomylase that digest starch without cooking.
(ii) The strain belonging to genus bacillus microorganism produce extracellular heparinase possessing advantages such as stability, optimum temperature range for growth and biological activity find numerous applications including anticoagulants in drug industry and use in bioassays.
(iii) The plasmid encoding pseudomonas mednocina toluene monoxygenase gene expressing enzyme and proteins that provide more efficient means of conducting bioconversions specifically dependant on this enzyme system.
(iv) A US patent granted to Novo Nordisk relates to protease enzyme having stability advantage at high temperature and alkaline pH in the presence of surfactants, isolated from closely related to bacteria, bacillus firmus, has excellent commercial potential in detergent industry.
(v) The enzyme obtained from microorganism peudomonas chlororaphis is used to degrade and clean up the non-degradable polymethane accumulation in the environment and also the waste arising from the use of polymethane paints.

8. Section D lists the patents that has direct industrial application:
(i) In this context, novel microorganism isolated from cabbage leaves has been identified for its usefulness in cosmetic industry. The microorganism torulopsis bombicola produces sophorase, a disaccharide useful as a substrate, capable of promoting the production of cellulose as an ingredient for cosmetics.
(ii) The next item in this series, is the production of edible good quality mushrooms, utilising biologically pure mushroom culture on an industrial scale in a short span of time.
(iii) In the end, the study refers to high carotenoid content producing culture using a unicellular algae nespongiococcum excentrum for the production of xanthophylls.

9. The study in the end explores the overall commercial potential of microbial inventions in the pharmaceutical and environmental sectors. Though the inventions act as intangible assets, the companies commercial capability rests on factors such as R & D capability, access to microbial collection library and judged through the appropriated intellectual property rights which ultimately have an impact on development of biotech industries. The scope encompass the entire spectrum of diagnostic technologies application, production technologies, process and purification methods for enzymes and peptides and genetechnologies for specific applications in Agriculture, pharmaceutical, environmental sectors. The study concludes citing some microbial inventions which have important role in their contribution to the rapid growth of pharmaceutical industry, environmental sector and enzyme applications.

10. The inventions covered in health area, include viral sectors for gene therapy, salmonella based bacterial vector for anti cancer therapy, pseudomonas for fabric and cystic diseases and microorganisms in gastric and ulcer diagnosis and also the technology of production of edible vaccine and purification process.

11. The potential of new inventions that involve microbial technology having applications on environmental sector are microbial decomposition of nonylphenols, monitoring bioremediation, degradation of toxic industrial wastes and use of microorganisms for toxicity test on environment samples and GM foods, biofertilisers, DNA testing and genetic alteration of pathogenic microorganism in environment.

12. The study exposes the scope and commercial potential for enzyme applications that widen as gene laboratories engage in developing special industrial enzymes and on production of microbial enzymes.

2.9 TRANSGENIC ANIMALS IN THE PHARMACEUTICAL INDUSTRY

The background of the study was that animals have been used in the trials for new drugs and medicines for many decades. The potential for rare disease-free animals for research is now possible as bio factories. Transgenic animals provide a very viable method for rearing animals not only for research but also for producing active pharmaceutical compounds for human use.

2. Following the developments starting from oncomouse to Polly and more recent animals, the scope for them have opened up opportunities in many facets of pharmaceutical industry.

3. Furthermore, the concept of transgenisis is explained on the techniques employed in creating the transgenic animals. The subject being an animal (oncomouse) whose genetic make up is altered due to the inclusion of selected foreign gene with genetic defect and the model being used to test material suspected of being a carcinogen by exposing the animal to the material and studying the physiological changes of neoplasm. This test has been extremely sensitive because of the propensity of transgenic animals to develop tumors.

4. Another technique in this class is nuclear transfer cloning employed on Dolly experiment. The technique involved is to strip out its chromosomes of the unfertilized egg cells and then fuse it with a cell which donates its nucleus to the emptied egg cells. The egg cell is implanted and then activated so that it starts dividing and developing into an animal.

5. A novel method, the Honolulu technique emerged as Dolly left many ethical queries and very many failed attempts at nuclear cloning method. The mice produced by this technique involve transfer of the donor nucleus of adult ovarian cumulus cells by microinjection into the egg whose nucleus was previously removed. Culturing and placing the resulting cells into a surrogate mouse and allows the clone to develop into a full grown animal. By repeating the process, second and third generation of identical mice are created. This method of cloning experiment promises to provide both scientific and commercial rewards.

6. As for patenting, it is observed that the role of IPR with regard to transgenic animals in the pharmaceutical sector is not only very interesting scientifically but also important financially in the emerging scenario in the health care and treatment market. The report attempts a comprehensive investigation as related to transgenic animals and assesses the critical role of IPR in contributing to the growth and development of the pharmaceutical industry.

7. The study touches upon the controversies that have arisen on the ground of moral and ethical issues of biological patents, especially those cover human genes and cell, apart from the results on mammal species and the technical disputes related to transgenic inventions.

8. The relative study covers the countrywise status on the most critical issue in IPR towards patenting of life forms. It is seen the criteria of patentability varies from country to country especially in life forms and transgenic animals, on the ground of its applicability and human intervention while some countries have excluded on moral and ethical considerations. In USA, transgenic animals are patentable. Japan, Hungary, South Africa and Korea follows the pattern like USA but in Canada such animals are not patentable. As far as EPC is concerned it is still undecided.

9. Subsequently, the study highlights the significant role of transgene animals in the production of recombinant proteins that are very useful for drug discovery and they could be obtained in absolutely pure form. It is found that collagen, interferon, erythropoeitin, hemoglobin are some important proteins which have been obtained from animals genetically designed to bring forth the desired proteins.

10. In addition, the study refers to the extensive use of the animals in the realm of diagnosis, treatment and prevention. Cancer, AIDS, Alzheimer, Coronary thrombosis, Parkinson's are diseases where the created animals have contributed enormously to understand the etiology of disease.

11. Apart from the use of animals for testing in medical field, xenotransplantation that is utilization of organs from non-human donors, has shown promising results in organ transplantation with the successful use of genetically modified organs from primate donors.

12. The dream to create a cornucopia of spare parts for the human body is becoming a reality. Tissue engineering is another approach on organ transplantation to overcome the shortage of transplant organs. Designing and growing living replacement body parts is known as tissue engineering. Tissue engineering is an extension in this field for medical use such as application of fabricated skin, cartilage, bone, ligament and tendons. Engineering the important parts, such as blood vessels, bladder, liver, kidney and heart are under the process of experimentation by this method. Ultimately, any method for building new human organs will have to meet the legal requirements and standards in manufacturing process.

13. The report lists large number of recent patents granted in various countries as related to recombinant protein, growth harmone and growth factor, nucleotide sequencing, vectors, regulatory element, immune system, diagnostic/therapeutical and gene expression and also abstracts of recent patents in the field.

2.10 COMPARATIVE STUDY OF PROECTION - BIOTECHNOLOGY INVENTIONS IN SEVERAL COUNTRIES

1. With the rapid developments in Biotechnology and the human genomic analysis, the patent system protecting Intellectual Property has gained importance with the R&D Community and Industry. As a result, the Business World found accentuated economic relations and increased trade contacts among nations. These developments facilitated the patenting of new inventions in several countries under PCT to obtain simultaneous protection and priority date subject to the assessment practices followed within the respective states.

2. Having noted the increase in the number of applications filed on biotechnology inventions both in developed and developing nations under PCT, International organisations such as OECD, WIPO made studies on practices followed in patent and PVP systems among member states. The patent offices (USPTO, EPO and JPO) also examined under a trilateral study, the practices followed among them focusing the subject matter to specific fields such as `Biotechnology Patent Practices', `Patentability of DNA Fragments, Nucleic acid molecule related inventions'.

3. The information from the above survey and studies were summarized on select developed nations (5) and developing countries (6) and analyzed to see whether they lead to certain broad conclusions on examination practices on subject matter related to inventions in biotechnology. The comparative study may/may not reveal the full extent of similarity on all practices related to IPR in Biotechnology due to differences in the legal and judicial systems that are not identical in all jurisdictions.

4. Obtaining patents presupposes compliance with certain basic principles universally accepted such as patentability, novelty, inventive step, utility and also norms related to claims, disclosure, prior art, etc. Applications endowed of these concepts on inventions in biotechnology present a host of issues and difficulties in interpretation of the results. The issues are invariably settled either by administrative or judicial decisions especially on the crucial question of claims and infringement. Here again, the precise formulation of the decisions on issues would be different according to the legal provisions in a country. However, these legal interpretations seem to have many common factors. As such these decisions are useful as guiding principles to facilitate the broad appreciation of the basics involved in patenting inventions in biotechnology in general and, nucleic acid related patents, in particular.

5. The comparative study involves subject matter related to protection of biotechnological inventions and the issues that arise in practice in select developed (Australia, USA, UK, Japan and European Union) and developing nations (Brazil, China, Korea, Malaysia, Mexico, Thailand). The grouping is done on matters of substantive interest covering basic issues on practices under 6 major heads.

i) Patentability of Inventions.
ii) Standards and procedure.
iii) Deposit of biological material.
iv) Disclosure and claims.
v) Claim Interpretation and Infringement.
vi) Plant Variety Protection Issues.

They emerge on the basis of a questionnaire formulated by OECD, WIPO and that of a Trilateral study by the JPO. The response received from each of the select developed nations and developing countries are collated for Inter se comparison and analysis within each group of nations respectively.

6. Under patentability of biological inventions, the practice followed in each category (product patents, process methods) has been brought out in a tabular form for easy comparison among select developed countries and of those included among developing nations. They reveal the areas where patent is allowed and those left under exclusion. It includes examples of chemical structure composed of nucleic acid/protein sequences that correspond in part, whole or through the redundancy of the genetic code. It contains living organisms per se, methods of treatment of humans and animals encompassing diagnosis, surgery and gene therapy. The living unicellular organisms per se are patentable in all jurisdictions. Patents have been granted on plants/animals per se, in these countries. However, inventions on plants or animals identical to those in its natural stage are not eligible for patenting. Plant varieties are excluded in UK, EU, China and Thailand. USA allows patentability of plants/animals per se, parts and varieties without restrictions whatsoever. Humans themselves, are not considered as patentable subject matter, parts of human body and human organs are not patentable. However parts and products isolated from the human body including cell lines are patentable unless they are objected to as being contrary to public policy or morality. Methods of treatment of humans by diagnosis, surgery, therapy are not eligible for patenting. They are termed medical acts. All treatments in vivo are ineligible as they encompass acts which are performed on the living body itself. The above methods of treatment of animals are however eligible for patenting in Korea. Essentially, biological processes for their production are excluded. It also deals on subject matter like genetic engineering of plants and animals. No distinction is made as to the source of genetic information on nucleic acids or amino acid sequences as patentable matter.

7. The section on patentability standards and procedure presents the basic requirements to obtain a patent namely novelty, inventive step/non-obviousness and utility. In biological inventions, the utility aspect is construed to comprise only of technical teachings which may be used to satisfy a human need of some kind. Hence it seems essential that the specification indicates specific area of usefulness for the claimed invention. New uses of a known substance- (a biological material) obtained from Human/Animal is patentable. A mere DNA fragment without indication of a function or specific asserted utility is not a patentable invention unless such use is not self evident, especially so when the invention is directed to a therapeutic application. Novelty question is addressed in a negative way by considering whether the claimed invention, exhibits in prior art the subject matter disclosed, or the prior art reference anticipates a claimed invention when the claimed invention contains each and every claim element without any limitation specified. The inventive-step is determined by the problem-solution approach, whether the claimed invention would have been obvious with a reasonable chance of success by a person skilled in that art. The other factors such as long felt need, commercial success, overcoming a technical prejudice, markedly superior effect, legal presumption of non-obviousness are also considered in certain situations.

8. The section on deposit of biological material discusses the criteria to support enablement of invention, amendment to accession number and handling of applications involving large number of chemical structures. The special interest here is search systems for carrying out nucleic acid/amino acid sequences in order to determine their `novelty' and `inventive step' on the basis of homology. A DNA fragment obtained by conventional methods which is part of a structural gene based on high homology with a known DNA encoding protein with a known function, is not a patentable invention.

9. Under the relationship between claims and disclosure explains the specific instances in which a patent may be granted when an application contains functional and structural claims. Functional and structural claims are acceptable if the claims include all the essential features of the invention. A functional claim would be acceptable if the specification provides adequate directions to enable a skilled worker to produce all the products which have the claimed function and they are all part of the same inventive step. Structural claims are acceptable if the function can fairly be said to be an inherent property of products containing the claimed structure whose function is implicit in the claim. In other words the common technical feature in the claims is the determining factor for unity of inventions concept. The practice related to adequacy of disclosure when the description of the invention contains enablement requirement is also detailed under sufficient and insufficient circumstances.

10. The section on claim interpretation highlights the scope of claim related issues to find whether infringement has occurred in specific cases. The judicial decisions take into account the functional and use limitations, claim language, whether the scope of the claims are clear and definite and are supported by disclosure. In deciding infringement of patent cases, the doctrine of equivalents is applied to prevent unfair infringement.

11. To conclude, the chapter on plant variety protection discuss the countrywise practices when dealing with issues related to

(I) whether botanical genera and plant species excluded from Plant Variety Protection could enjoy patent protection,
(ii) concurrent protection could be obtained for the identical plant variety,
(iii) commercial exploitation could be admitted on a variety that enjoins a patent right for an entity and is in force and
(iv) eligibility of a new variety developed containing the patented gene for grant of PVP.

Current Concerns in Intellectual Property Rights in Biotechnological Applications - Interactive Meeting on 7th February, 2002 at Conference Room I, India International Centre, New Delhi.

A. OPENING OF THE MEETING

1. Dr K V Swaminathan, Chairman WITT opened the meeting with a welcome to all members. He expressed deep appreciation to Dr Manju Sharma, who had made special adjustments in her schedules to be with the Committee. He briefly recalled the background to this study and also the programme planned for this meeting.

2. The Department of Biotechnology, Ministry of Science and Technology has taken several initiatives in dealing with Intellectual Property Rights in Biotechnology and in some of these the Waterfalls Institute of Technology Transfer (WITT) has been associated. In particular, the Department is sponsoring a bi-monthly publication WISTA IPR - Biotechnology since early 2000. The Department had also commissioned a study with WITT on evolving a curriculum suitable to biotechnologists wishing to obtain a post-graduate diploma or degree in the field of Intellectual Property. Another study titled "Probing Emerging Issues in Intellectual Property Rights in Biostechnology" was commissioned by the Department and WITT had submitted its final Report in February, 2000. In the process of finalizing this report WITT had organized an Interactive Meeting on 7th January, 2000 to discuss that draft report. The Committee had then identified several topics which need to be further studied keeping in view the increasing concerns on several aspects of Intellectual Property, some of them particularly important to biotechnological inventions. WITT keeping in view these observations had submitted a proposal to the Department as above some time in March, 2000 in which ten specific topics were identified for a further study. The Department, after due consideration had commissioned WITT to undertake these studies some time in September, 2000.

3. The study undertaken on these ten topics is now grouped into four volumes and draft reports prepared are distributed well in advance to selected experts who can make contribution on the subject. List of persons invited for the meeting is enclosed. WITT is particularly thankful to the various experts who have agreed to participate in the meeting. The ten topics covered (grouped into four volumes) deal with those issues which are very specific and in elaboration of the first report that was discussed in January, 2000. One may recall that the report of February 2000 had focussed on five topics namely Patentability in Biotechnology; Broad Patenting; Patenting Micro-organism; Genetically Engineered Plants and Patents in Drugs and Pharmaceuticals. One would notice that these five topics had broadly covered the major issues directly concerned with the patentiability of Biotechnological Inventions. In view of this, the current study in all the ten topics assumed that the patentability issue in biotechnology has already been covered and is not repeated in detail in any of these sections.

4. In grouping these ten topics it was felt that Part I could by and large deal with intellectual property issues of a general nature and as such three topics (units) namely 1, 2 and 10 are grouped in Part I. Part II deals with substantially with aspects relating to medicinal plants, the traditional knowledge and genetically modified food. These by and large focus more on the applications of bioagriculture. Part III in a way deals with management aspects relating to intellectual property. The Unit 6 deals with the cost of protecting intellectual property and Item 7 Strategies of Companies to manage them particularly keeping in view the small scale industries and agricultural produce and products. Part IV broadly deals with the medical applications of biotechnology and this part contains two sections - one relating to micro-organism which has a very broad range of application of concern to Indian industry, some of them being much wider than the domain of medicine. The section 9 deals with transgenic animals in the pharmaceutical industry. This deals with biotechnology in the current phase of development and its future application for human health.

5. One may point out that the studies undertaken by WITT are mainly to study the interface of intellectual property rights in the area of biotechnological inventions. The Institute recognises that there will no be need for dealing with fundamentals or too much of the details relating to biotechnology per se. In fact the Institute recognises that the experts assembled here are themselves specialists in certain areas of biotechnology and as such the Institute has to concentrate on intellectual property aspects that border them or even engulf them.

6. The purpose of this interactive meeting is to get broad inputs and contributions from the experts to whom the reports have been sent earlier with a view to eliminate possible errors in draft report; the errors could be both typographical or technical. We also recognise that it might not have been possible for all the experts to go through all volumes of the reports and send their comments in advance to us. However, today they may kindly write down their broad comments and give the same to us which we can take into account in finalising the report. In view of the limited time available for discussing the reports today, it is suggested that editorial mistakes and corrections can be noted and passed on to the WITT secretariat who will deal will them and these need not be discussed or pointed out. Technical errors could follow the similar process but being technical in character it will be desirable if that specific point is explained by the speaker to ensure that the appropriate corrections can be incorporated suitably. It is possible that some points may need some more elaboration or some of them may quite well be abridged. Suggestions to those are welcome. If any other source or a source not indicated in draft report is known to any of the members, they may kindly point this out and if WITT cannot procure them it will be appreciated that the relevant pages of these may be sent to WITT for being suitably dealt with.

7. In a subject which is very rapidly evolving it is quite likely that a point of view presented in the report may not be acceptable to some of the members present here. At the outset the views presented in the report are not that of WITT and are actually, as claimed in the reports they have referred to. On such matters it is submitted that any speaker may mention his point of view and give a suitable note for being taken into account in the report. WITT will try to provide in toto the different views expressed on the same points for the benefit of the future readers. It is recognized that in a meeting of this nature such controversial issue cannot be resolved by discussing in this meeting.

8. The procedure that is perhaps to be followed in dealing with these reports would briefly be as follows. After a very brief introduction by the Chairman he would call on one of the persons who was associated with the work to give a brief presentation highlighting the study, subjects followed and the results presented. After this the report is open for discussion and the speaker will be requested by the Chairman to give their views. Since about ten reports are to be covered in about four hours of discussion and presentation time, some rationing of the time may be required and as such the initial presentation will be limited to 8 minutes only.

9. During the discussions or immediately thereafter the Institute will be seeking inputs to a few questions such as the following:

(i) Whether they would like to get copies of the revised report which will incorporate the previous study completed relating to biotechnological patentability or otherwise.
(ii) Whether the report can be processed further with a view to have them printed for wider circulation. If yes, they could give some indication as to how many copies may be produced for use in the country.
(iii) Are there any specific segments which should be studied further (not necessarily by WITT) so that the trend of probing deeper and deeper in the domain by the DBT could fruitfully continues.
(iv) Whether they would consider in their respective organisation to organise any specialised training programme based on the substantive document produced by WITT. If yes, the possible outline of such a programme - for example a one day or a two day programme. 10. Chairman, WITT thanked the DBT for entrusting the study to WITT, in particular his appreciation for Dr Manju Sharma, Secretary DBT. He also thanked several Research Scholars of WITT who agreed to work on this subject inspite of the limitation and constraint. He acknowledged the benefit he had derived from the consultation had with several experts, some present here, in pursuing the studies. He concluded by observing that he would look forward to their continued inputs in completing this work, and many others in the near future.

B. ADDRESS OF DR (MRS) MANJU SHARMA, Secretary DBT

1. Dr (Mrs) Manju Sharma, Secretary DBT, extended a warm welcome to the members present at the meeting. The members were introduced to her. She expressed appreciation to the members for making it convenient to be present at the meeting and to share their thoughts in discussing the reports prepared.

2. Dr Manju Sharma mentioned about the Committee established in the DBT (BPSC) for which Dr Swaminathan is the Chairman. This committee interalia examines applications from scientists seeking the support for securing intellectual property protection. She expressed her thanks to Dr. Swaminathan for guiding the activities of this committee. She also expressed her appreciation on the present study completed by the Waterfalls Institute of Technology Transfer (WITT).

3. She opened her address by recalling the enormous impact biotechnology is making in every walk of life and pointed out that in many many areas patents in the field have come about in a remarkable manner. It is very necessary that these patents need to be followed up to explore what would be applicable to us in our country and take thereafter immediate follow-up actions. She reminded the group that biotech is indeed an area of intense curiosity in many parts of the world. Perhaps every second a new gene is identified. In this area of science there is tremendous expectation in our country, be it directed to agriculture, environment, medicine or employment.

4. Every funding agency in the country is very anxious to ensure that their funding, particularly in the life science areas, should give useful results and are striving as to whether they are going to get a new product or a new process. In this connection she mentioned that the DBT had prepared a Vision Document which gives a 10 year perspective with respect to the activities and ultimately the target. Honorable Prime Minister had released this document in September 2001 and perhaps DBT is the first department which has put out such a Vision Document. She pointed out that IPR issues figure in every section of this Document.

5. There is always the question as to how the scientists will be rewarded as well as whether large section of the society will be benefited. Bottle neck will be faced and perhaps by about 2005 the current issues would have been studied and this will facilitate their further utilization. This will of course be influenced by the effectiveness of the IPR in the country. We may also in the very near future expect definite actions to emerge after the Patent Statute is amended. One should examine what will be needed immediately after the Bill will come out in a new patent regime. One will have to check out the direction in the next 3-4 months, which will involve policy issues, institutional mechanisms, and HRD issues.

6. Dr Manju Sharma suggested that some of the points she would now mention could be given thought/kept in view during the discussions in the today's meeting:

(i) There is an urgent need for training in patent courses. She recalled her contacting several Universities, National Law School in Bangalore, JNU and others with a view to evolve well structured training courses. These should be prepared in a well structured and graded form so that these could be taken up in a phased manner by the students and faculty. She regretted that adequate response has still not been received due to several constraints. One of them related to not having adequately trained staff in these organisations to conduct these programmes. In this connection a study has been made by the Waterfalls Institute of Technology Transfer and a report submitted to DBT. She pointed out that she is pursuing the matter with the WIPO and is hopeful of getting their assistance or getting a guest faculty for a certain period who can then reinforce such training programmes in this country leading to a master degree. We have however to take a view as to whether we could have a one year programme or short term programme to suit specific requirements.

(ii) A brief summary of the report, say 10 pages, be prepared after this meeting indicating some of the points that can be taken in this field, for further action. This could include putting this report in website so that many others would be able to refer to this.

(iii) It was noticed that for the meeting over 30 persons have been invited from Delhi. Perhaps we could organise a bigger consultation in which some 100 experts in this field from different organisations in the country could be invited and have a detailed one day meeting which will serve on one side to disseminate the information relating to this study and its contents and on the other receive their inputs. This will also assist in sharpening an action plan on which DBT can take further action.

(iv) She pointed out that relating to genomics and functional genomics the department will be having an allocation of over Rs 300 crores. She mentioned that stem cells research and its implication on IPR could be an area of considerable importance. She, in particular, raised the query on when a new cell line is established as to the possible sharing of benefits arising from such work.

(v) She pointed out the need for help in plant biotechnology networks, particularly involving transgenic research. When industrial applications are received in India it is necessary to make adjustment to suit the crops anticipated and evolve suitable criteria for their protection. She also mentioned about the modifications carried out in the transgenic plant and after a few cycles how to address the ownership rights. This is because the modifications are carried out involving a patented imported gene but after a few cycles the resulting product is so different from the one that was patented. Here problems arise as to who is the current beneficiary.

(vi) She also referred to the Bt cotton gene. It appeared that considerable further studies are required in the country to determine the overall impact it will have in the country.

(vii) She also mentioned that the website of the DBT has been redesigned and lot of information of general interest to the public are now readily available.

7. She concluded by referring to the fact that our present Patent Act is undergoing revision and on several aspects the DBT had given inputs to them, particularly covering micro-biological organisms and material, biological processes, etc. She anticipated that in the next few months when the new Act comes into being the country will have to take full advantage of the same and comply with their requirements in dealing with the new inventions in this field.

8. Dr Manju Sharma clarified certain points raised by the members with particular reference to the future activities in this field.

9. She hoped that the members present will have fruitful discussion on the reports and she assured full support in the implementation of the recommendations and suggestions of the Committee.

1   Dr (Mrs)  Manju Sharma Secretary, Department of Biotechnology   2   Dr Gulshan  Wadhwa Programme Officer Department of Biotechnology   3   Mr T K Viswanathan Member Secretary Law Commission   4   Mr R B S  Rawat Chief Executive Officer Deptt. of Medicinal Plants Board Min. of Health   5   Dr J R Arora School of Information Technology Jawaharlal Nehru University   6   Dr S R Nair Managing Director Biotech Consortium India Limited (BCIL)   7   Dr Sudhir Kochar Assistant Director General Indian Council of Agriculture Research   8   Dr Sadhana Srivastava Indian Council of Medical Research (ICMR)   9   Dr Shrishendu  Mukherjee International Centre for Genetic Engineering  & Biotechnology   10 Dr Ravi Dhar National Institute of Immunology   11 Mr Jagdish Singh Scientist `G’ Department of Scientific & Industrial Research