In an extremely surprising development, which was first reported by Vikas Dandekar of PharmAsia, in an article available over here, Roche (which owns Genentech) has announced that it will no longer “pursue” its Herceptin patents in India.
In his statement to PharmAsia, Roche’s spokesperson was quoted as saying that Roche will “not pursue its Indian Patent 205534 and the related divisional applications”. All of these patents and applications which are owned by Genentech have been in trouble for the last few months.
First, there was the news of the Patent Office refusing to allows three divisional applications filed by Genentech from the parent 205534, on the grounds that the Genentech had missed several deadlines. The divisionals themselves were under attack from Indian generics like Glenmark, which had filed post-grant oppositions and also Mylan, which was the first company to point out that Genentech had been missing statutory deadlines.
Then there was news, first reported on SpicyIP, that Genentech had not paid its annuity for the main 205534 patent. The Patent Office at the time had confirmed to us that the patent had indeed lapsed, although the message from the Patent Office indicated that it would be open to considering a request for extension up till November, 2013. Although we were skeptical about the Patent Office’s interpretation of the 6 month rule for extension, there was no denying that Genentech did have a right to file an application for restoration provided that it had a valid enough reason for letting the patent lapse.
Roche has however surprised the industry by deciding to not fight these battles. I think it was a smart move on their part, especially since these Herceptin patents had the potential to slide into a PR disaster of ‘Glivecian’ proportions. That the Government was interested in issuing a CL for the drug didn’t really help their cause. Given the political climate, Roche correctly guessed that it would not receive any mercy for missing deadlines. In the circumstances, it was probably a good idea to let the patents go especially since there are no bio-similars on the horizon. Readers may remember the revocation of the Pegasys patent last year owned by Roche. Despite the patent being revoked by the IPAB, there is no biosimilar in the Indian market for Pegasys, which earns Roche a significant Rs. 50 crores.
Herceptin sales in India have brought Roche Rs. 130 crores (or $23 Million dollars) last year despite dropping the price of its product substantially. This may appear to be pretty low by Western standards but given the ultra-competitive Indian market, $23 million dollars for a single drug is a pretty good deal.
According to Vikas Dandekar, Biocon is in advanced stages of trials with its biosimilar of Herceptin and maybe poised to be the first entrant in India provided it gets regulatory approval. Herceptin would not be the first bio-similar to be given the regulatory approvalin India but it is likely to be the focus of intense scrutiny. Similarly, the Indian regulatory process for biosimilars will also be in the spotlight of foreign companies who have so far had the monopoly in the biologics space. Any mistake by Indian regulators will cost the entire Indian industry. Hopefully the regulator will avoid any such disaster through a transparent decision making process.