Bayer challenges India cancer drug ruling

German pharmaceutical giant Bayer AG has challenged a ground-breaking Indian ruling that allowed a local firm to produce a vastly cheaper copy of its patented drug for kidney and liver cancer.

India's patents chief ruled in March the price Bayer charged for the drug, , was "exorbitant" and ordered the firm to give a so-called "compulsory licence" to make the medicine to Indian company Natco Pharma.

"We will rigorously continue to defend our intellectual property rights which are a prerequisite for bringing innovative medicines to patients," Bayer spokesman Aloke Pradhan told AFP in an emailed statement on Saturday.

The patent controller's order "damages the international patent system and endangers pharmaceutical research", Pradhan said.

It was not immediately known when the appeal, filed with the country's Intellectual Property Appellate Board on Friday, would be heard.

Drug firms insist they need patent protection for medicines to recoup costs of long years of research and development.

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.

The Indian ruling in March marked the first time a so-called "compulsory licence" for production of a patented drug had been granted in the country of 1.2 billion, known as a global generics drug powerhouse.

India has long been a key provider of cheap generic medicines to the developing world as it did not issue drug patents until 2005, when it was obliged to adhere to WTO intellectual property regulations.

But after a new patent law was introduced in 2005, newer medicines are increasingly being patented in India, keeping prices high.

Under the ruling, Natco will pay Bayer a six percent royalty on sales of the drug and sell the medicine for 8,800 rupees ($165) a month -- compared to the 280,000 rupees ($5,320) the company charges, which is more than 30 times as much.

Patent controller P.H. Kurian granted the right to Natco to produce the after concluding Bayer's pricing made it "out of reach" of most Indian patients.

Experts have said the Indian ruling could pave the way for a rush of other "compulsory licence" applications in India and in other poor nations, allowing access to patented life-saving drugs at a fraction of the cost.

add to favorites email to friend print save as pdf

Related Stories

Bayer mulls challenge to India cancer drug ruling

Mar 13, 2012

Bayer AG said Tuesday it was mulling ways to challenge a ground-breaking Indian ruling allowing a local firm to produce a vastly cheaper copy of a cancer drug made by the German pharmaceutical giant.

Recommended for you

Determine patient preferences by means of conjoint analysis

Jul 29, 2014

The Conjoint Analysis (CA) method is in principle suitable to find out which preferences patients have regarding treatment goals. However, to widely use it in health economic evaluations, some (primarily methodological) issues ...

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

User comments