Mumbai: In a new twist to the ongoing legal battle between German drug multinational Bayer Healthcare AG and Hyderabad-based cancer drug maker Natco Pharma Ltd over the compulsory licensing of Bayer’s cancer drug Nexavar, the Delhi high court last week dismissed the foreign company’s writ petition as withdrawn. Bayer had in the writ petition challenged the Indian patent office’s decision to publish Natco’s compulsory licensing application for public review as a part of proceedings.
With this, the patent office can now go ahead with the hearing of the compulsory licensing application involving both parties. Compulsory licensing (CL) is the grant of government permission to a drug maker to manufacture a copy of a patented drug. Bayer has the patent for kidney cancer drug Nexavar in India, which was granted three years ago.
Natco had sought compulsory licensing of the drug in August on grounds that Bayer could not meet local demand as it was too costly. Bayer had challenged the patent controller’s decision to publish the CL application on the grounds that it had not been given a hearing on the question of whether Natco’s application is merited. Though Bayer had filed the petition in the Bombay high court earlier, the court had asked the company file it in the Delhi court, as a patent infringement case on the same drug between the two firms is currently pending in the Delhi high court.
Indian patent law allows compulsory licensing of a patented drug if it is established that the patent holder can’t meet the market requirement adequately even after three years of the grant of the patent. Natco has timed the CL application in keeping with that provision and has also mentioned in the application that only 1% of 100,000 patients have access to the drug as the cost is around Rs 2.8 lakh a month per patient. Natco has also stated that it can produce and sell the drug at a fraction of this cost and can price it at Rs 8,880 for a month’s treatment.
Bayer currently imports this drug for sale in the country.
“We have a patient access programme running in the country for Nexavar,” Bayer Health India head Angel-Michael Luna Evangelista said last week. He declined to share details of the price at which the drug is supplied to patients and how many patients were covered under the programme. A Bayer spokesperson declined to comment for this story on Thursday.
Rajiv Nannapaneni, director and chief operating officer, Natco, on Thursday said he was hopeful of establishing a case for the drug’s compulsory licensing.