E-DRUG: Roche drops patent application for Trastuzumab in India
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[1 lakh =100,000 In Rupees. $US1 = Approx 55 Rupees
1 crore = 10 million ]
Swiss drug major Roche to drop anti-cancer drug Herceptin patent in India
By DIVYA RAJAGOPAL, ET Bureau | 16 Aug, 2013, 03.26AM IST
MUMBAI: Swiss drug major Roche has decided not to pursue its patent for
anti-cancer drug Herceptin, the patent which had come up for extension till
2019, paving the way for generic drug makers to manufacture this drug.
Trastuzumab, sold under the brand name of Herceptin, is used in
breast-cancer treatment and costs close to Rs 1 lakh [approx US$1,600] for a month.
"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 ET.
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.
Herceptin contributes close to Rs 127 crore to Roche's annual turnover,
according to industry estimates. 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.
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's kidney anti-cancer
drug Nexavar.
"Wilbert Bannenberg"
Co-moderator
<wjb@wxs.nl>