Intellectual Property Rights In Biology

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Professor Dorairajan Balasubramanian (b. 1939) trained as a chemist (Ph.D.1965, Columbia Univ.) and has been working in the area of structural biology at the Centre for Cellular and Molecular Biology, Hyderabad 500007, India, of which he is currently the Director. His work on the molecular changes that occur in the human eye lens with ageing and during cataract formation has been recognized in the form of awards (e.g. The Third World Academy of Sciences Award, the X Kharazmi Award of Iran, the Ranbaxy, FICCI and Bhatnagar Awards), fellowships of all the major science academies of India and of the American Association for the Advancement of Science.

In addition, Balasubramanian actively takes science to the public through newspapers, radio and television. He frequently appears on educational TV programmes, writes a regular fortnightly column called "Speaking of Science" for The Hindu, and is currently Editor of Publications of the Indian National Science Academy.

Professor N. Appaji Rao (loc. cit.) is a biochemist, well-known for his work in enzymology and on the genetic and biochemical profiles of children of consanguineous marriages. He is an Emeritus Scientist at the Indian Institute of Science, Bangalore 560012, India - an institution where he has been working for over three decades. He is currently a Secretary of the Indian National Science Academy.

Dr. Joseph Thomas (loc. cit.) is a plant biotechnologist, who has worked on biological nitrogen fixation at the Bhabha Atomic Research Centre, Mumbai. He moved to Chennai few years ago and established the Centre for Biotechnology at the Southern Petrochemical Industrial Corporation's (SPIC) Science Foundation, and is currently Vice-President, Biotechnology, SPIC and honorary Director, SPIC Science Foundation, Chennai 600032.

The practice of science has undergone a sea change in the last decades. Until two generations ago, doing science was a curiosity-driven, order-seeking and intellectually pleasing enterprise. It was somewhat removed from technology, which was practised by engineers, doctors and farmers. But as the laws of science became increasingly understood, as the walls between subdisciplines of science became porous and crumbled and as the ability to predict became more rigorous, so did the distinction between science and its applications. The scientist became the inventor and the applier, the creator and the craftsman, and the theorist and the technologist. The war efforts in England, United States and parts of Europe produced a greater realization that the ideas of science can be sharply chiselled into generating products through processes that are rational, rigorous and repeatable. Patenting of ideas, processes and products became mainstream activities. Inventions and innovations became to be viewed as intellectual properties. The maverick inventor, be it Edison or Rube Goldberg, and the maker of "gizmos", became accepted and admired as part of the mainstream.

With biology, this change of mindset and the ability to commercialize ideas have come a little later; the advent of molecular biology, genetic engineering, micro-propagation and culture methods, hybridoma and related techniques during the last twenty years have made us think of biology as a business proposition too. Now that it is possible to amplify genes and DNA, to synthesize gene sequences and proteins in the laboratory, to introduce or withdraw chosen genes from an organism and to be able to direct evolution in the laboratory, new biologicals and new microbes, plants and animals can be made to order. This raises the contentious issue of intellectual property rights on items that have so far been thought to be "natural". Biology too falls under the patent rules; one can create biological material that is (a) not prior art, (b) novel and (c) of specific end use and thus qualified for patenting. This has gone to the extreme limit of scientists approaching the patent office with applications to patent DNA sequences that are part of the human genetic heritage.

Given the traditional ignorance (or even disdain) of Indian scientists about intellectual property rights (IPR) and patenting, and the increasing pressure on them to be aware of IPR issues in biology (particularly because of the rich and biodiverse heritage that we have, and the "living genetic laboratory" that India is), the Indian National Science Academy (INSA) felt it would be a good idea to organise a seminar on the topic of IPR in Biology. This is in keeping with the increasing concern and role that INSA has had in enabling its fellowship and the scientific community of the country to address, appreciate and come to grips with issues that go beyond the laboratory and affect citizenry at large.

With this in view, Dr. Varadarajan, President of INSA, along with two of us (Professor N Appaji Rao and Dr. Joseph Thomas) got together a group of experts on the issue and organized a three day seminar on IPR in Biology at the beautiful and lively campus of the Central Food Technological Research Institute (CFTRI) at Mysore during May 22-24, 1996. Dr. V. Prakash, Director of CFTRI, played an excellent host and participated in the Seminar ably. Dr. Varadarajan played a key role in coordinating the topics, contacting the speakers, goading them into focussing on the topics and keeping a strict eye on the clock before and during the Seminar. Our special thanks go to the understanding and hospitable hosts Dr. Prakash and his CFTRI colleagues. Thanks are also due all speakers who cooperated by providing corrected manuscripts shortly after the Seminar was over.

We have taken the liberty of putting together an appendix to the book. This is a "primer" and a "tutorial" session on IPR in Biology that has been prepared by Mr. N.R. Subbaram of the IPRM Unit of the Council of Scientific and Industrial Research of India at New Delhi. For over two decades, the patents unit and Subbaram himself were regarded as an appendix to the CSIR. With the pressure on all of us to come to grips with patents, IPR, the need to convert some of our science into business and the like, Subbaram has grown to be a much sought after man. Over the last couple of years he has been running awareness sessions to CSIR scientists on IPR issues, and these sessions have been appreciated for their value and practical utility. We thank him for gracefully agreeing to let us use two of his lectures in this collection.

The National Institute of Science Communications (NISCOM), New Delhi, which has helped produce this monograph, has been an able and understanding partner and we thank them, particularly Drs. G.P. Phondke and Kaushal Kishore for their understanding and ready help. Mr. R.V. Subba Rao of the Centre for Cellular and Molecular Biology, Hyderabad, is to be specially thanked for producing the final ready-to-press manuscript.

**Contents and Sample Pages**