Domestic pharmaceutical major Cipla has launched a copycat version of Swiss drug-maker Roche’s anti-infection drug, valganciclovir, in India, even as the drug enjoys patent protection in the country.
This is the second instance of Cipla launching a low-cost version of Roche’s patent-protected drug after India's amended patent law began to recognise product patents or patents for specific drugs instead of protection to the processes through which medicines are produced. While Roche had dragged Cipla to the court on the earlier occasion, it is yet to seek legal remedy on valganciclovir.
Girish Telang, managing director of Roche Scientific Company, the Indian arm of the Swiss multinational, said: “The company will follow the law of the land.” He declined further comment.
Cipla’s joint managing director Amar Lulla confirmed his company has launched valganciclovir under the brand name Valcept in Indian market. While Valcept is priced at Rs 245 per tablet, Roche’s maximum retail price for its medicine branded as Valcyte is over Rs 1,000, trade sources said.
Valganciclovir is used to prevent eye infections in people who have less immune power (HIV/AIDS patients, for instance). Since the medicines are needed for AIDS patients, the civil society groups involved in helping such patients had been on the forefront of opposing the Roche’s patent application on valganciclovir. However, due to technical reasons, the patent office had granted protection to valganciclovir without hearing pre-grant oppositions made by such NGOs.
In June this year, the Delhi Network of Positive People (DNP+), an organization representing the needs of people living with HIV/AIDS (PLHAs), had filed a post-grant opposition against the decision. Cipla’s product launch has come at a time when the patent office is considering the post-grant opposition.
“Unlike the earlier case, Roche cannot approach the court to see legal intervention as the decision of the authority itself is being challenged through a post-grant opposition. The courts will not intervene unless the patent office gives its view on the post-grant opposition,” Gopakumar Nair, a Mumbai-based patent expert, said.
Cipla had in January this year launched a copycat version of erlotinib, a lung cancer medicine, on which Roche has patent protection in India. The price tag was one-third of Roche’s branded medicine Tarceva. Roche had sued Cipla for infringement of patent in the Delhi High Court. The high court, which completed hearing on the case on September 15, is expected to announce its verdict within two months.
