The final patent-related hearing on Bayer's advanced kidney cancer drug Nexavar, following Natco's plea for a compulsory license on the medicine, concluded on Tuesday at the Patent Office.
The outcome of this case is a benchmark, as it tests the compulsory licensing (CL) provision of the amended Indian Patent Act.
The CL provision allows for a generic drug company, Natco in this case, to make and sell, a similar version of the innovator's (Bayer) drug, on the payment of royalty to the innovator. A CL is granted by a Government on health grounds, where patients are unable to access life-saving medicine.
Bayer had not adequately worked the patent as the price of the drug in India was too high for patients, Natco's counsel said. Bayer, however, countered that its price was in line with the research-costs that it had incurred in developing the drug. Bayer had received a patent on Nexavar in India, in 2008.
The drug had been imported even earlier, but then, Cipla got into the fray under-cutting Bayer's price and selling it at one-tenth Bayer's price, the counsel for Bayer added. Bayer had imported about 4,000 units, but sold only 400, he said.
Bayer's Nexavar costs a patient Rs 2.8 lakh for a month's medicine. Cipla sells its version of generic Nexavar at Rs 28,000 per month and Natco's generic similar is pegged at Rs 9,000.
Administered in the final stages of kidney and liver cancer, Nexavar helps extend life by a few months, the counsels said. About 8,000 patients in advanced stages of renal cancer need the drug, Bayer's counsel added.
Cipla launched generic Nexavar in India in April 2010. Bayer had subsequently taken them to the Delhi High Court, over patent-infringement.
Bayer has now offered to give Nexavar at a subsidised Rs 30,000 to patients certified by an oncologist.
Natco's counter is that the case related to the market price and not confined to a patient access programme. A judgement on the case by outgoing Patent Controller Mr P.H.Kurian is expected shortly.