Biotechnology and the Start-up Era

India’s fastest growing knowledge based industry, the biotechnology sector, has been in the spotlight over the past several years. With a vast talent pool of trained scientists and engineers, world class R&D institutes with access to cutting edge technologies and India’s inherent manufacturing cost advantage, the country’s biotechnology industry is expected to hit an average growth rate of around 30 percent a year and touch $100 billion by 2025.

The optimism and expectation surrounding the industry owes much to the strong focus by Central and State governments on creating biotech hubs to tap the entrepreneurial and innovative talent of industry professionals. The Startup India initiative launched on January 16, 2016 has given a further impetus to the momentum created by the Make in India campaign. The key challenges to biotech innovation were lack of funds, high capital intensity needed to launch startups and the resources required to sustain the long gestation period between ideation and end product manufacture. To meet these challenges, the Department of Biotechnology and the Biotechnology Industry Research Assistance Council (BIRAC) have provided funding support and incentives for the development of biotech incubators. Other noteworthy steps taken to create a nurturing ecosystem include creation of University Innovation Clusters, innovative funding by Small Business Innovation Research Initiative (SBIRI) and Biotechnology Industry Partnership Programs (BIPP) where the Government partners with the industry on a cost sharing basis to support the development of high risk but innovative technology. Results indicate that this concerted effort to ensure that the biotech industry achieves its enormous potential has started paying rich dividends. As per figures published by the Department of Biotechnology, there are more than 240 start-ups and innovators and 89 incubatees in the country.

The Rajiv Gandhi Centre for Biotechnology (RCGB) is an active participant in India’s race towards developing an innovative, versatile and cutting edge biotechnology sector. RCGB-managed Bio-Nest technology and business development incubator at KINFRA Biotechnology Park in Kochi is a 50,000 square foot business incubator where a dynamic environment exists for biotech start-ups. The objective is to accelerate the commercialization of new technologies, nurture emerging ventures and to assist entrepreneurs to forge appropriate link with other biotech companies, academia and government.

Bio-Nest also provides the overheads that start-ups often lack. This includes management, administrative and back office support. Freedom from the nitty-gritty of running an establishment and access to funding, research and technology provided by Bio-Nest gives entrepreneurs and innovators the opportunity to concentrate on product development, marketing and sales. This comprehensive support will help India’s young tech generation to breach new frontiers of innovation in the biotechnology sector.

Biotechnology, Law and Society

A quick peek into the Intellectual Property Rights, Patent Laws and Competition Policies guiding biotechnology research and industry in India.

June 1, 2015 was a much awaited day for biotechnology industry and many pharmaceutical companies, less followed by scientists and oncologists and least aware of by the millions of common people in India. The US based Biopharmaceutical Company Abraxis tying up with Biocon India was denied the patent for marketing its drug Abraxane by the Indian Patent Office (IPO) quoting Section 3(d) for lack of novelty and innovation. Abraxane is nanoparticle albumin-bound (nab) Paclitaxel for the treatment of metastatic breast cancer not responding to combination chemotherapy. Spanning from 2005-2013, Food and Drug Administration (FDA) has approved it for the treatment of advanced breast cancer, pancreatic cancer and non-small cell lung cancers. Phase III clinical trials carried out in India and US had shown that nanoparticle based preparation of Paclitaxel had 33% response rate when compared to the 19% given by solvent based preparations of Taxol because of the better target delivery which prompted scientists and pharmaceutical companies to push the drug to market. Upon denial of patent by IPO back in 2009, Abraxis appealed against the order to Intellectual Property Appellate Board (IPAB) based on which the patent application was reconsidered and the recent decision was taken relying on the Supreme Court verdict on the Glivec case of Novartis earlier.

On the bigger canvas, what does this mean to each of the parties involved? Stating the obvious, for Abraxis this caused a loss of their golden opportunity to market a chemotherapeutic drug in India where breast cancer is the second most common cause of cancer deaths among women. But for indigenous pharmaceutical companies in India like Cipla and Natco that are already producing nab Paclitaxel compounds; it opened a wide arena to market generic drugs at competent prices. For biotechnology industry and all those scientists involved, this was an eye-opener towards the section 3(d) of the Indian Patent Act of 1970. Mere discovery of a new form, component, property or use of a known substance or tool cannot be considered as a patentable invention. This drew crisp borders to the definition of innovation in biotechnology research. As for patients, though the majority in this picture due to the sheer number of people and the gravity of impact (as it definitely involves the quality of their own lives), but quite unaware of the legal battles involved, can expect to get generic drugs at an affordable cost in future.

As researchers in the booming field of Biotechnology in India, we should be aware of the legal guidelines defining, boosting and potentially dampening our works of effort. In this era of personalized medicine, Intellectual Property Rights (IPR) hover over diagnostic and therapeutic research sector augmenting quality, competition as well as rivalry at the same time. When scientific and industrial disciplines work shoulder to shoulder, the laws offer protection as well as limitations to the scope of knowledge in market. The functional competition policies in India, through tight guidelines on acquisitions and mergers have made a considerable gap between science and industry, increasing the extent to which basic science translates to practical use of biotechnological inventions in clinical science. Though the yardstick of success is high quality publications in science and economic turnover in industry, the ultimate aim funnels down to improving the quality of life of people, alleviating suffering, making the life of at least one patient better. Despite the numerous odds arising in the field, India is emerging to make a mark in the scientific map of the world. Let us join hands and work towards a productive tomorrow.

Message From Director

India’s engagement with biotechnology, life sciences and medicine is dynamic and constantly evolving. The Rajiv Gandhi Centre for Biotechnology (RGCB) sees itself a key player in this development process. Our research is focused on understanding disease biology and processing this knowledge for better management and therapeutics. The trademark feature of RGCB is the collaborative and interdisciplinary approach we bring to everything we do. This unique facet and the energetic atmosphere of the institute is our success, also creating by itself an ideal and fertile teaching atmosphere for graduate students and postdoctoral trainees. RGCB does innovative research in cellular and molecular mechanisms of human, animal and plant diseases. These programs are designed to lead discovery and innovation by integrating theory, modeling, simulation and experiential science encompassing disciplines such as cell biology, genetics, chemical biology, immunology and others. Our mission is to understand the underlying biology of human, animal and plant diseases, develop a unique training of individuals in fundamental & translational sciences and promote collaborations between medical, veterinary & agricultural professionals with basic biology scientists. This we hope will serve as a catalyst to translate discoveries effectively to eventual implementation for public benefit. RGCB has outstanding PhD and Post doctoral Programs in Basic, Interdisciplinary and Translational Sciences. The institute also conducts a unique Biotechnology Skills Development Program for engineering and science graduates to make them acquire skills in molecular diagnostics, instrumentation engineering, analytical sciences and bio imaging. Over the past 10 years, the ability of RGCB in making major contributions to understanding the fundamental mechanisms of disease has been greatly improved by support for our core facilities and research by the Department of Biotechnology, Government of India. We are also unique among other research institutions in the country, working out of three campuses, one concentrating on discovery, the second, an innovation focused research facility and the third a Bio-Nest for translation of research into applications and products. Please go through our informative website and visit us to find out for yourself why RGCB is the place to be for disease biology research and explore the wealth of opportunities that exist here.