Wednesday, July 22, 2015

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.

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