Non-Market Strategy for Big Pharma Companies as a Response to India’s Protectionist and Discriminatory Policies

Leading Pharmaceutical companies have, in recent times, been alarmed by the some adverse regulatory rulings in India. First in a landmark decision in March 2012, the Indian Patent Office allowed a domestic company (Natco Pharma Ltd.) to sell a generic version of Bayer AG's cancer drug ‘Nexavar’ on the grounds that the German company’s drug not affordable to the local populace due to cost reasons. Then in March 2013, the Honorable Supreme Court of India denied patent protection to Novartis’s blockbuster cancer drug ‘Gleevac’ stating that Novartis had resorted to ‘evergreening’ in an effort to extend their monopoly beyond the standard patent period. The Indian ruling has attracted global attention especially from the Big Pharma companies here in the U.S. The view is that India has scant disregard of intellectual property (IP) and pharmaceutical patent polices and the rulings are geared to favor local generic drug makers by way of issuing compulsory licenses. Pfizer’s Chief IP counsel Roy F. Waldron had, in written testimony before the US House Committee hearing on US-India trade relations in March 2013, accused India of being anti-IP rights. In his testimony he mentions that the “Business environment (in India) for innovative industries has deteriorated significantly in recent history” and “India has taken steps that call into question the sustainability of foreign investment and the ability of American companies to compete fairly.”
The TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement, administered by World Trade Organization (WTO), defines the minimum Intellectual Property Rights (IPR) standards that enable the member nations to implement measures to protect IP while ensuring that these measures do not become barriers to trade. These minimum standards are viewed differently by developing and developed countries. The ‘rich’ countries perceive the TRIPS agreement as a basic provision for further expansion. At the same time, Pharmaceutical

References: