The Hindu Business Line : Natco applies for compulsory licence on Roche’s cancer drug

Product patent
Natco was seeking a CL to export to Nepal. It would take 3 years to get a CL to sell in India.
Cipla’s launch of a similar version of Roche’s Tarceva would be seen as a patent infringement

P.T. Jyothi Datta

Mumbai, Jan. 14 In a fresh test of the three-year-old product patent regime in India — Natco Pharma has applied for a compulsory licence (CL) on Roche’s lung cancer medicine Tarceva, to export the drug to Nepal.

The Hyderabad-based Natco has applied to the patent office in Delhi about four months ago seeking a CL, a pharmaceutical industry source familiar with the development told Business Line. Natco is believed to have offered payment of a royalty to Roche and the two companies will now be called for a hearing at the patent office, the source said.

Confirming the development, Roche India’s Managing Director, Dr Girish Telang, told the correspondent that he was “aware” of the same, though he did not have information on the hearing date.

Tarceva is a novel therapy for patients with locally advanced or metastatic non-small cell lung cancer after at least one round of chemotherapy has failed. It is believed to prolong and improve the quality of life, Roche officials had said, when the drug was launched in India.

Explaining why Natco was seeking a CL to export to Nepal, rather than to sell in the domestic market, the industry source said that there is a provision under the Indian Patent Act that allows a company to seek a CL to export to a least developed country. It would take three years to apply for a CL to sell in India, the source added.

Roche’s Tarceva was launched in India in 2006. It is reported to have got a product patent on the drug in India. But it has been in the thick of action, with local drug-makers like Cipla looking to launch erlotinib, the generic version of Tarceva, in India at a reduced cost.

According to media reports, Roche’s Tarceva costs over Rs 1 lakh per month. The regimen comprises an oral tablet, taken once a day. A product-patent entitles a company to exclusively sell the drug for 20 years, and so Cipla’s launch of a similar version of Tarceva would be seen as a patent infringement, a pharma industry representative observed.

However, Cipla reportedly believes that it has a strong case to oppose the patent, even after it has been granted. Significantly, Natco had opposed Roche’s patent application, before the patent was granted by the Patent Controller’s office.