The Hindu Business Line : Natco files another petition on Roche’s Tarceva

Natco had filed an “interlocutory petition” at the Patent Office, saying that Roche should not be privy to the compulsory licence hearing that takes place between the Patent Office and Natco.

Our Bureau

Mumbai, Feb. 28 The Hyderabad-based Natco Pharma’s application for a compulsory licence (CL) on Roche’s lung-cancer drug Tarceva would be taken up by the patent office in Delhi, only after the latter gives its directive on another petition filed by Natco earlier this week.

Natco had filed an “interlocutory petition” (IP) at the patent office on Monday, saying that Roche should not be privy to the compulsory licence hearing that takes place between the Patent Office and Natco, a pharma industry source familiar with the development told Business Line.

The IP, essentially a miscellaneous petition came up for hearing on Thursday, where Natco presented its case. The next hearing is on March 11, when Roche would respond, the source said. Only after the patent office gives its direction on the IP, can it take up Natco’s application for a compulsory licence.

Natco has applied to the patent office in Delhi late last year, seeking a CL to export the generic Tarceva (erlotinib) to Nepal. Natco had even offered to pay a five per cent royalty to Roche, the source said.

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. Roche got a patent on the drug in India in 2007.

Natco was seeking a CL to export to Nepal, rather than sell in the domestic market as 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 said.

Roche-Cipla case

In the Roche-Cipla case, judgment is awaited. Roche’s Tarceva was launched in India in 2006. But the drug has also seen some activity with local drug makers such as Cipla looking to launch erlotinib, the generic version of Tarceva, in India at a reduced cost.

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 is being seen as a patent infringement, a pharma industry representative said.

Meanwhile, Roche has approached the Delhi High Court to restrain Cipla from making and selling the drug locally. A lawyer familiar with the development said that Roche had also sought a preliminary damages amount of Rs 1 crore. The case is now poised for a judgment from the Delhi High Court.

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