The Role Of Patents In The Medical Industry: A Critical Legal Analysis
E. Navya Sri, LLM, GITAM School of Law, GITAM University, Vishakhapatnam
Dr. M. Santhoshraju, Assistant Professor, Vignan Institute of Law, Vignan’s Foundation for Science, Technology & Research, Vadlamudi, Guntur
ABSTRACT
The pharmaceutical industry is one of the most research-intensive industries, requiring substantial financial investment, technological development, clinical research and regulatory approval to develop new medicines and medical technologies. Patents give inventors exclusive rights to a drug for a certain period, which encourages innovation and lets pharmaceutical companies recoup their research and development expenses. However, pharmaceutical patents also raise issues of monopoly, affordability and access to life saving medicines particularly in developing countries. The paper analyses the role of patents in pharmaceutical industry with special focus on need of balance between innovation and public health interest in India1. The paper also addresses the problem of evergreening, where pharmaceutical companies may seek to obtain further patent protection for modifications of existing medicines. The paper discusses some important judicial decisions like Novartis AG v Union of India, Bayer Corporation v Natco Pharma Ltd and Roche Ltd v Cipla Ltd which show the approach of Indian judiciary in matter of pharmaceutical patent protection and public health. It also cites mandated licensing as a way to address concerns over access and affordability. The paper concludes that a functional patent system should protect real pharmaceutical innovation but not at the cost of excessive monopolisation and should ensure the availability and affordability of vital medicines to the public.
