Generic for Roche's Herceptin unlikely to hit market anytime soon

Even though three divisional patent application by Swiss multinational Roche for its sub inventions of a popular breast cancer drug trastuzumab, marketed under brand name Herceptin, was abandoned recently and the government is evaluating options to issue compulsory licence on the drug, experts say generic version of the drug is unlikely to hit the market anytime soon. This would mean the drug would continue to cost the same failing generic penetration in the market.

According to trade sources, the drug is currently sold by Roche at around Rs 1,24,000 per vial, which narrows down to around Rs 92,000 after some discounts. The company also sells the medicine under a different brand name through another Pune based drug maker Emcure, which sells the product at around Rs 70,000 per vial.

The Kolkata patent office recently abandoned three divisional applications filed by Roche seeking multiple patents. The applications were treated 'as withdrawn due to non-filing of Request for Examination within the prescribed time or abandoned due to incorrect filing' by the company, the Patent Office said in a detailed note released on Monday.

This triggered expectations that generic drug makers may now be allowed to develop and sell low priced version of the drug. However, industry experts and patient groups opine the Kolkata patent office's decision will not help generic inflow because the company retains the compound patent on the drug.

In fact, domestic drug maker Glenmark had filed a post grant opposition in Kolkata Patent Office in 2008 challenging the compound patent for the drug trastuzumab composition, which was granted to Genentech Inc., a member of the Roche group, in April 2007. While the patent is due to expire in 2020, the post grant opposition filed by Glenmark is still pending for a hearing.

Meanwhile, the health ministry’s recommendation for issuance of compulsory licence to allow generic penetration of the drug has also met with several roadblocks. Sources say, Department of Industrial Policy and Promotion (DIPP), the administrative ministry for intellectual property related issues, is now evaluating whether generic makers are ready with the drug to be able to supply it in case the government notifies compulsory licence under section 92 of Patent Act. The provision allows generic manufacturers to directly apply for marketing licenses for such patented medicines, instead of first seeking permission from the innovator company.

The DIPP’s move has been ridiculed by various patients groups as well by the industry who say that generic manufacturers would need assurance from the government that their products will be allowed, before making any investment to develop and manufacture it.

'Herceptin is a biotechnology product and developing a generic or biosimilar of the product would require huge investment and time. Companies will be required to do clinical trials not only on the generic but also on the original product and have to compare both data to prove safety and efficacy. Beside technical bottlenecks, there are regulatory bottlenecks also,' an industry official said.

KM Gopakumar of Third World Network, an international non-profit organization, says it is ridiculous to imagine that generic manufacturers would  invest in something as complex like biosimilars without any guarantee or commitment from the government that they will be allowed to launch it. 'The compulsory licence has to be granted first, for generic manufacturers to start investing in low-priced versions of the drug,' he said.

According to the industry official, a generic drug maker would also run risk of patent infringement litigation if it applies for marketing approval without a compulsory licence in place.