Natco’s Nexavar clone plea hearing on Jan 6

The Controller General of Patents, Designs and Trademarks has posted an application filed by Natco for making a copycat version of Bayer’s cancer drug Nexavar in the country for hearing to January 6.

Bayer has opposed Natco’s moves at various fora from the time it filed the application, though it withdrew a petition filed against the Hyderabad-based company in Delhi High Court last month.
Natco had filed an application with the patent office in August this year, seeking approval to manufacture and market the generic version of Nexavar — sorafenib — in India on the grounds of its availability and affordability.

The company had stressed on the cost of the drug being imported and sold in India by Bayer and the number of patients going without access to the drug. “There are at least 1 lakh patients in India suffering from different forms and types of renal cell carcinoma and hepatic cell carcinoma. On an average, about 30,000 patients are added to the patient pool. Over 24,000 patients die in India every year on account of these diseases,” its application read.

Sorafenib is administered as 200mg tablets and the dosage per day is 800mg, which translates to four tablets in a day. The tablets must be consumed till the tumour progression/ intolerable toxicity. Normally, patients with renal carcinoma may be covered and may receive insurance cover for nephrectomy.

However, patients do not receive any cover/assistance from insurance companies for use of the drug sorafenib, which has to be taken by the patient lifelong.

Going by Natco, the drug regimen costs about `2.80 lakh a month.
Natco has also raised the issue of limited supply of the drug by Bayer by importing it from its overseas facilities and selling it in select cities. “It is estimated that though the Patentee sells the product, it reaches less than 1% of patients and almost 99% of patients who are unable to afford the drug are left to die every year,” it said.    

The Hyderabad-based company contended that Bayer, which was granted a patent on the compound on March 3, 2008, has not taken any step to manufacture the drug in India even after three years. “The applicant, having known the plight of the cancer patients and the difficulties faced by them, has decided to develop, manufacture and sell the said product sorafenib to such needy patients irrespective of their location in India, at the lowest possible price so that access and availability of the drug is improved,” it said.

Natco also claimed that it would manufacture 2 million tablets of sorafenib a day, or 60 million tablets per month, against the current need of 480,000 tablets a day. It said the cost of the tablets would be brought down to about `74 each, taking the monthly cost of medication to `8,880.

Natco officials were not willing talk on the issue considering the scheduled hearing at the patent office.

Sources, however, said the arguments and the outcome at the patent office would be a trend-setter for many such drugs that are still being sold at exorbitant prices by multinational pharmaceutical companies in India.