Multinational drugmakers have welcomed the decision by the Drugs Controller General of India (DCGI) not to accept marketing approval applications for generic versions of drugs which are covered by patent protection in the country.

The Delhi High Court is currently considering such a case, brought by Swiss drugmaker Roche after Indian firm Cipla launched a generic version of its cancer drug Tarceva (erlotinib), which is patent-protected in India.

While research-based firms applauded the clarification by the DCGI, Surinder Singh, that patent infringement was not permissible, domestic firms claimed that his decision was without legal foundation. However, Mr Singh stressed the importance of reassuring the industry that patents are honoured in India. He has asked drug companies to provide details of patents granted for their new products and, whenever a second application seeking marketing approval for the same product is made, the details will be passed on to the patent office for an expert opinion, he said.

Roche’s patient-infringement lawsuit over Tarceva was countered by Cipla’s claim that the patented product was simply a “tweaked” version of a product in existence before 1995, when India became a member of the World Trade Organization (WTO) and was given 10 years to bring its patent legislation into line with the WTO Trade Related Intellectual Property Rights (TRIPs) agreement. Therefore, Cipla argued, Tarceva was not eligible for patent protection in India. The court dismissed Roche’s suit, but the Swiss firm has now lodged an appeal.

- Meantime, Mr Singh is also investigating allegations by a distributor for Roche in India that Cipla is promoting its version of Tarceva, which it calls Erlocip, for unlicensed indications.

Tarceva is approved in India for the treatment of non-small cell lung (NSCL) cancer and pancreatic cancer, while Cipla’s version is licensed for the treatment of lung cancer only. However, the distributor, Taksal Pharma, says Cipla is promoting Erlocip not only for NSCL and pancreatic cancers but also for neck and head and colorectal cancers.