Bayer mulls challenge to India cancer drug ruling

by Penny MacRae

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.

India's patents chief ruled Monday the price Bayer was charging in the country for the was "exorbitant" and ordered the German firm to give a licence to manufacture the medicine to Indian company Natco Pharma.

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

"We will evaluate our (legal) options to further defend our in India," Bayer spokesman Aloke Pradhan told AFP.

Natco will pay Bayer a six percent royalty on sales of the drug and sell the medicine for 8,800 rupees ($175) a month -- compared to the 280,000 rupees the company charges, which is more than 30 times as much.

The drug is used to extend lives of advanced kidney and liver cancer patients.

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

The decision could pave the way for a rush of other "compulsory licence" applications in India and potentially in other poor nations, allowing access to patented life-saving drugs at a fraction of the cost, patients' groups said.

"This is an event which will cause multinationals to start thinking about differential pricing and how they price products in countries such as India," Rajeshwari Hariharan, lawyer for Natco, told AFP.

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 decision) serves as a warning that when drug companies are price gouging and limiting availability, there is a consequence," said Michelle Childs, a policy director at Medecins Sans Frontieres (Doctors Without Borders).

"The Patent Office can and will end monopoly powers to ensure access to important medicines," she said.

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

Competition among generic manufacturers in India has reduced HIV drug prices by nearly 99 percent since 2000 -- from $10,000 per person per year to $150, Medecins Sans Frontieres said.

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

In a separate case also with important ramifications for access to medicines across the developing world, Swiss pharmaceutical group Novartis is challenging India's decision to not grant patents on medicines that according to the patent law are not sufficiently innovative to merit patent protection.

add to favorites email to friend print save as pdf

Related Stories

Novartis fights patent rejection in Indian court

Sep 06, 2011

(AP) -- In a case that could affect India's role as drug provider to the developing world, the Supreme Court began hearing arguments Tuesday over whether the government had the right to deny a patent to Swiss drugmaker Novartis ...

Recommended for you

Supermaterial gives rejected drugs a new chance

Jul 22, 2014

More than 80 percent of all drug candidates in the pharma R&D suffer from poor solubility and are therefore rejected early in the drug discovery process. Now Uppsala University researchers show that the new ...

Risk of antibiotic overuse in aged care settings

Jul 21, 2014

Antibiotics are being overused in residential aged care facilities (RACFs), and more integrated efforts to improve antibiotic prescribing practices need to be introduced, researchers say. 

Ruconest approved for rare genetic disease

Jul 17, 2014

(HealthDay)—Ruconest has been approved by the U.S. Food and Drug Administration to treat hereditary angioedema, a genetic disease that leads to sudden and potentially fatal swelling of the hands, feet, limbs, face, intestinal ...

NIH system to monitor emerging drug trends

Jul 17, 2014

An innovative National Drug Early Warning System (NDEWS) is being developed to monitor emerging trends that will help health experts respond quickly to potential outbreaks of illicit drugs such as heroin and to identify increased ...

User comments