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Emerging Market Environment in the Indian Pharmaceutical Industry after TRIPS

Emerging Market Environment in the Indian Pharmaceutical Industry after TRIPS. Sudip Chaudhuri Indian Institute of Management Calcutta Roundtable Symposium on: The Emerging Legal and Policy Landscape of Intellectual Property Protection for Pharmaceuticals in India 17 and 18 March, 2012

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Emerging Market Environment in the Indian Pharmaceutical Industry after TRIPS

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  1. Emerging Market Environment in the Indian Pharmaceutical Industry after TRIPS Sudip Chaudhuri Indian Institute of Management Calcutta Roundtable Symposium on: The Emerging Legal and Policy Landscape of Intellectual Property Protection for Pharmaceuticals in India 17and 18 March, 2012 National Law University, Jodhpur

  2. Pharmaceutical Industry in India • Product patent regime: • Till 1972 • No product patent protection • 1972 to 1995 (2005) • Again product patent regime • Since 1995 (2005)

  3. Situation till 1972 • Litigation – patent infringement cases to prevent the Indian firms from manufacturing • Underdeveloped industry, import dependence • MNC domination • Monopoly and high prices

  4. Situation after product patent abolition • Rise and growth of the industry • Self sufficiency and export surplus • Competition and low prices • Indian domination • No litigation

  5. Post-TRIPS: Some implications • M&As and tie-ups and rising MNC share • Manufacturing • Imports • Exports • R&D • Market structure and prices

  6. Patent protected monopolies in anti-cancer drugs (December 2010)

  7. Cost of treatment (per person per year) • Dasatinib (anti cancer): • Price Rs 3905, 70 mg tablet • Cost of treatment Rs 2 million (100 mg daily) comparable to UK price of GBP 30,477 suggesting no differential pricing

  8. Exports • Spectacular rise in exports • But the prospect of huge gains in the patent expired markets in developed countries particularly in USA have not materialized • Significant price erosions • Value added markets increasingly difficult • Some companies which have aggressively pursued growth in foreign markets with high costs and stakes have not always succeeded

  9. R&D for new drugs • R&D activities have diversified • But Indian pharmaceutical firms are yet to prove their competence in innovating new products • No NCE has yet been developed for marketing – neglected diseases neglected • There have been several setbacks and the partnership model has not always worked properly • What Indian companies have really demonstrated is the ability to develop generics – an ability which they acquired and improved during the pre-TRIPS period.

  10. Policy focus • Initial optimism of Indian generic companies have not really materialized • Required space of operations of generic companies • Compulsory licensing • Interest in and importance of Section 3(d), patent pool etc should not divert attention from the fundamentally important task of having a user-friendly CL system • Limit data protection • Price control • South-south collaboration for innovation

  11. For comments sudip@iimcal.ac.in

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