BackNo plans to restore Herceptin patent in India, says Roche
Move marks change in strategy by Roche, which was otherwise aggressive in protecting patents
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Mumbai: Swiss drug maker Roche Holding AG, which missed a patent renewal deadline for its cancer treatment Herceptin in India in May, said on Thursday that the decision to let the patent lapse was part of a new strategy it wants to follow in the local market for the high-value biological drug, and it has no plans to seek a restoration of the patent.
“Regular reviews of our patent portfolio are a routine business practice. In this connection, Roche has come to the conclusion not to pursue Indian patent for trastuzumab," G.K. Raman, director-corporate affairs, market access and compliance officer of Roche India, said in an email.
Trastuzumab is the generic name of the key biotech compound in Herceptin. In April 2007, the drug was granted a patent in India that lapsed when Roche failed to meet a deadline in May to renew it. If Roche does not act to restore the patent in six months through a separate process, copycat manufacturers can legally produce the medicine in the country, Mint reported on 14 August.
Roche in July decided to not pursue two of its applications for patenting new variants of Herceptin in India.
“Trastuzumab’s patent status has no effect on the availability of the product in India.," Raman said.
“We have already introduced a local pricing and branding structure, in partnership with the local company, for a number of our drugs, including trastuzumab, and are currently reviewing the impact of this programme," he said.
Herceptin—one of the most prescribed breast cancer drugs in the ₹ 1,500 crore Indian market, contributed about ₹ 130 crore to Roche India’s revenue in fiscal 2012.
The drug, under patent protection until 2019 in most developed markets, is also a key revenue earner for the Swiss company globally, earnings $6.8 billion in sales last year.
Roche last year tied up with local drug maker Emcure Pharmaceuticals Ltd to locally re-pack Herceptin, which was until then imported to the country from the US facility of the Swiss firm’s biotech subsidiary Genentech Inc.
“We understand that Roche has changed its strategy as far as some of its cancer drugs are concerned, especially in the comparatively complicated biological area. Since they have also reduced the prices and changed the supply models in the local market with outsourcing collaborations, it must be convinced that there is no point in keeping the patent active," said an executive at a rival drug maker, who declined to be identified.
“We shall continue to enforce other patents covering our drugs in India," Raman said.
It’s the first time that a multinational drug maker voluntarily let a valid patent in India lapse. Roche has been otherwise quite aggressive in protecting its patents in India, and it has dragged many Indian generic drug makers to court in the recent past alleging patent infringement.
“Maintaining a patent is costly as the renewal fee is progressive every year and patentees who don’t see much value in retaining the right due to special circumstances in the market in terms of competition, commercial viability, etc., can decide whether they want to retain the right or lapse it," said P.H. Kurian, former controller general of patents.
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