Victory for Access to Medicines as Bayer Loses Lawsuit in India

An Indian court has stopped the international pharmaceutical company Bayer’s latest attempt to introduce new measures to prevent generic competition in India. By ruling against Bayer on February 9, 2010, the Delhi High Court has refused to undermine measures in India’s patent laws that help ensure access to more affordable essential medicines for patients in need.

“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 MSF’s 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 lifesaving medicines including HIV treatments for millions in India and beyond.”

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 drug 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 sole patent-holding manufacturer. This would have hampered access to essential medicines—as generic competition is the only means to sustainably reduce the price of drugs.

This decision is the latest in a series of moves by pharmaceutical companies and Western governments to dismantle pro-health provisions in patent laws in India, home to a large generic industry that supplies the developing world—and Doctors Without Borders/Médecins Sans Frontières (MSF), which sources more than 80 percent of its AIDS medicines from the country—with more affordable medicines. 

When it joined the World Trade Organization (WTO) in 1995, India agreed to implement stricter patent regulations for medicines brought to market after 2006, but the country included key public health safeguards, perfectly legal measures to ensure access to medicines.  It is these measures that pharmaceutical companies are now seeking to undermine.

The result of stricter patent laws is that many newer medicines will remain out of reach for millions of patients, as companies are able to charge very high prices in the absence of generic competition. Governments can nevertheless take perfectly legal measures, known as the ‘TRIPS flexibilities’, to overcome the harmful effects on access caused by drug monopolies. But had Bayer’s attempt been successful, it would have essentially made the use of some of these flexibilities meaningless in India, notably the use of compulsory licences and the so-called ‘Bolar provision’.

This is one of two major cases currently 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, and having lost its first case in 2007, the Swiss drug company has taken its appeal to the Supreme Court. MSF will continue to closely follow these cases.