Bayer Makes Challenge on Mandatory License in India

Bayer Makes Challenge on Mandatory License in India

May 7th, 2012 // 12:47 pm @ jmpickett

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In a move that was largely expected, Bayer late last week challenged a compulsory license awarded two months ago by India’s Patent Office to a generic drugmaker to make a copy of the Nexavar kidney and liver cancer med. The landmark decision, which covers only domestic distribution, was made on the grounds that the Bayer drug is inaccessible to most patients due to cost – the price is expected to drop from $5,500 per person each month to $175, a 97 percent decline.

”We will rigorously continue to defend our intellectual property rights which are a prerequisite for bringing innovative medicines to patients,” a Bayer India spokesperson tells Health India. The patent order “damages the international patent system and endangers pharmaceutical research.” There was no comment from Natco, the generic drugmaker that was awarded the license.

The drug generated $934 million in global sales in 2010, according to India’s Patent Office, which also noted, however, that Nexavar was barely sold in India and called this “neglectful” (back story). Under the World Trade Organization’s TRIPS Agreement, which governs trade and intellectual property rules, compulsory licences are a legally recognised means to overcome barriers in accessing affordable medicines.

Patient advocacy groups and non-governmental organizations called the decision, whic was reaffirmed last Thursday (see here) to issue the license a game changer. The move prompted Cipla, another Indian generic drugmaker, to reduce the price of three cancer drugs by 80 percent, making them cheaper than the Natco version. Meanwhiel, Roche announced plans to sell two of its cancer drugs, Herceptin and Mabthera, at lower prices.

Last week, though, the US Trade Representative cited the compulsory license in its decision to maintain India on its Priority Watch list for companies that fail to provide “an adequate level of intellectual property rights protection or enforcement, or market access for persons relying on intellectual property protection (see page 35 here). The list is updated each year.

In response to the Bayer appeal, Brook Baker, a professor in the Program on Human Rights and the Global Economy at the Northeastern University School of Law, and a member of Health Gap, Global Access Project, argues that Bayer makes a cynical argument that R&D will be inhibited and other roadblocks exist that prevent poor patients in India from accessing its medicine, because some do not receive non-patented medicines on the essential drug list in the country.

“This is the trivial argument Big Pharma has been making for years to cover the impact of its monopoly pricing policies,” he writes. “Of course, there are other barriers to access, but does Bayer want to seriously argue that medicine priced 60 times more than the newly announced Cipla price doesn’t adversely impact access?… Bayer should at least be honest in touting its attempt to hold on to the patent goose that lays the golden egg – “we want to maximize profits, India be damned, full stop.”