Mumbai: Hyderabad-based cancer drug maker Natco Pharma Ltd, which shook up India’s patent regime earlier this year by filing the country’s first compulsory licence application, withdrew its plea on 26 September.
Natco has asked India’s patents regulator controller general of patents, designs and trademarks, or CGPDT, to drop the petition, said an official who declined being named as the development is yet to be made public.
The application was a first since India implemented a product patent regime for pharmaceuticals in 2005, and had sought permission to manufacture and export copy versions of two patented drugs: F Hoffman La Roche Ltd’s lung cancer drug Tarceva, and Pfizer Inc.’s kidney cancer drug Sutent.
A compulsory licence sets aside a patent in the larger interest of the public, or to tackle a national emergency, besides in a few other situations. Natco’s application was the first case under section 92A of Indian patent law that deals with exports. Natco sought the compulsory licence in March to export these drugs to Nepal, using a provision in the patent law that allows local firms to make a patented drug for export to less developed countries.
Natco’s application stirred strong debate as multinationals, which hold most such patents, feared it would trigger provisions in the country’s newly amended law to circumvent patents granted to them.
Roche was granted a patent in India last year for Tarceva, the chemical name of which is erlotinib. The Natco executive said the company has asked the office of CGPDT to drop the case as the company had not yet received an import requisition from the Nepal government for the drugs.
A senior Natco executive had in March confirmed to Mint that the company had approached the controller seeking a manufacturing licence for these drugs in India for the local market as well as to export it to least developed countries. Under Indian patent law, if a company wants to sell a generic version to a less-developed country, it should have an order for the drug and a declaration by that country stating its urgent need for the medicine. However, the law is unclear on whether the patent controller should hear arguments from both the applicant and the patent holder.
India also provides an option for generic companies to apply for a compulsory licence for domestic manufacturing and supply. But under this provision, a generic company has to wait at least three years after a patent is granted and should prove that the drug is in short supply and that needs of patients are not being met.
When the CGPDT started hearing the case in March this year, Natco had objected to its hearing the patent holders, saying a World Trade Organization provision under the trade-related intellectual property rights regime did not require it. Natco approached the Delhi high court questioning the legality of the controller hearing the patent holder, but did not get a favourable ruling.
A Roche executive said the company or its patent agent has not received any official communication regarding the withdrawal of the application. Executives of Pfizer were not available for comments on the weekend. In an earlier statement to Mint in April, Pfizer had said that it was in the process of registering Sutent, its brand name for sunitinib, in Nepal.
The company had launched the drug in India in January this year. It costs around Rs1.96 lakh for a 45-day treatment in India. The price tag in Nepal is not known.
In that statement, Pfizer had said that it had already launched a patient access programme under which the drug would be available at a concession to deserving patients in India, and that it would extend the programme to Nepal.