An Indian court ruling has halted the international pharmaceutical company Bayer’s latest attempt to introduce new measures to weaken competition in drug manufacture in India. By ruling against Bayer on 9 February 2010, the Delhi High Court has refused to undermine measures in India’s patent laws that help ensure access to more affordable essential medicines.
When India joined the World Trade Organization in 1995, it agreed to implement stricter patent regulations for medicines brought to market after 2006, but the country included key public health safeguards to ensure access to medicines. These provisions in India’s patent laws have led to the development of a large industry in generic drug production, which supplies much of the developing world, and Médecins Sans Frontières, with affordable drugs. For example, MSF sources more than 80 per cent of its AIDS medicines from India.
One result of stricter patent laws is that many newer medicines remain out of reach for millions of patients, because pharmaceutical companies are able to charge high prices in the absence of competition from other manufacturers. Governments can nevertheless take perfectly legal measures, known as the ‘TRIPS flexibilities’, to overcome the harmful effects on access caused by drug monopolies. It is these measures that pharmaceutical companies are now seeking to undermine.
Bayer was seeking to create a new barrier to generic competition by delaying the approval process that generic drugs are required to follow in order to be sold in India. The company was aiming to prevent the Indian regulatory authorities from starting the registration process for generic versions of patented medicines before the patents had expired. Delaying registration until after patent expiry would prevent the timely entry of new competitors, and extend the monopoly of the patent-holding manufacturer. This would have hampered access to essential medicines because generic competition is the only means to sustainably reduce the price of drugs.
Bayer’s action was the latest in a series of moves by pharmaceutical companies and Western governments to dismantle pro-health provisions in patent laws in India. Had it been successful, it would have essentially made the use of some of these TRIPS flexibilities meaningless in India.
This is one of two major cases currently being brought by pharmaceutical companies against Indian authorities in a bid to enforce greater patent protection in India. In a separate case, Novartis is challenging another vital public health safeguard. Having lost its first case in 2007, the Swiss drug company has taken its appeal to the Supreme Court. MSF will continue to follow these cases closely.
“We are delighted that Bayer’s lawsuit was rejected. At the moment in India we are seeing a number of multinational pharmaceutical companies trying to use litigation to stifle generic competition,” said Dr Tido von Schoen-Angerer of Médecins Sans Frontières’ Campaign for Access to Essential Medicines. “By rejecting Bayer’s appeal, the Indian courts have ensured that public health safeguards can be used to open up generic production of life-saving medicines including HIV treatments for millions in India and beyond.”