Swiss pharma giant Roche has decided not to pursue its patent for Herceptin, the patent which had come up for extension till 2019, paving the way for biosimilar drug makers to manufacture this drug.
Trastuzumab, sold under the brand name of Herceptin, is used in breast-cancer (and gastric cancer) treatment . “Roche has come to the conclusion not to pursue Indian Patent No. 205534 (the secondary patent for Trastuzumab) and the related divisional applications. This decision takes into account the strength of the particular rights and the Intellectual Property environment in India in general,” a Roche spokesperson said in an email query to Economic Times India.
Roche let the patent for Herceptin lapse in May this year, however, the company had time till November to pay the fee and claim its patent.
Roche said it will continue to enforce all other patents in India and remains committed to working with the Indian government. “We believe ensuring access to innovative medicines such as Herceptin is a complex issue and that significant progress will only be made through ongoing close collaboration between the government, industry and care providers without compromising intellectual property rights or biosimilar approval requirements,” it added.
Incidentally, Herceptin is the same drug which the health ministry had proposed for a compulsory licence under Section 92 of the Indian Patent Act, which allows government to revoke a patent during emergency situation. But the government had hesitated to revoke the patent because it didn’t know if there were other Indian drug makers who were ready with the copy of this drug.
Roche’s decision of giving up its patent is a smart move, say IP experts as there is no Indian company manufacturing this drug due to the complex science involved. So, even after giving up the patent, Roche will be the only company that will be manufacturing this drug, and the company knows it.
“While the patent for trastuzumab may no longer be in force, it is important to note that there are currently no approved biosimilars of trastuzumab in India. We support the Indian government’s leadership in establishing a pathway and guidelines for the introduction of biosimilars onto the market that is based on science and is designed to ensure product quality and patient safety,” said the company.
Biocon-Mylan, Reliance Life Sciences and BDR Pharma are a few companies working on a copy of Herceptin in India.
Multinational drug makers including Roche have come under severe pressure from the Indian government to cut the prices of key anti-cancer drugs as it is beyond the reach of a large number of the patients. Last year, the patent office issued the first ever compulsory licence to Natco Pharma to manufacture the cheaper version of German drug maker Bayer’s kidney anti-cancer drug Nexavar.
Source: Economic Times India