Roche abandons Herceptin patents in India
pharmafile | August 19, 2013 | News story | Medical Communications, Sales and Marketing | Biocon, GSK, Herceptin, India, Nexavar, Roche, biosimilar
Roche has decided not to pursue its Indian patent application for its blockbuster breast cancer drug Herceptin, opening the door for cheaper copies in the country.
The company said: “This decision takes into account the strength of the particular rights and the IP [intellectual property] environment in India in general.”
Herceptin (trastuzumab) was Roche’s second best-selling drug in 2012, with global sales of over $6.4 billion, an 11% increase on the previous year. Its Indian patent was expected to last until 2019.
But the move is unlikely to have a significant impact on the biotech giant’s bottom line as the Indian market accounted for just 0.2% of its global sales last year.
As the UK newspaper the Financial Times reports, about 1,500 year-long courses of the treatment, which cost just under $8,000 (£5,110) each, were sold in the region over the past twelve months.
Furthermore, because Herceptin is a complex monoclonal antibody, not a chemical compound, it is not easily replicated by generic drug makers. The development of a biosimilar treatment could prove costly and time-consuming.
Currently, Biocon is the only Indian company known to be at a reasonably advanced stage in that process, with approval of their product expected by 2014.
Authorities in India have adopted an increasingly hard line on IP entitlements among Western pharma companies attempting to make inroads in the region.
Roche’s announcement pre-empts an anticipated decision by the government to issue a compulsory licence on Herceptin, which would have essentially overridden its patent anyway.
In 2012, the government issued a compulsory licence to a domestic drug maker for the production of sorafenib – a drug to which Bayer holds the patent and markets as Nexavar in other regions.
This year, Novartis lost an Indian Supreme Court appeal for patent protection of its cancer treatment Glivec (imatinib). And more recently, the patent on GSK’s Tykerb/Tyverb (lapatinib) salt derivative was revoked for not offering significant ‘enhanced therapeutic efficacy’ over its original pill form.
India’s stance has drawn criticism from US officials, with both US secretary of state John Kerry and vice president Joe Biden raising the matter during visits in June and July, respectively.
However, campaigners for affordable medicine, such as Médecins Sans Frontières and Oxfam, have greeted the developments, which in principle make expensive treatments more accessible to the world’s poorest people.
Hugh McCafferty
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