Roche let the patent for Herceptin lapse in May 2013, however, the company had until November to pay the fee and claim its patent. The company did say that it would continue to enforce all other patents in India.

Roche has decided ‘not to pursue’ patent No. 205534 (the secondary patent) on the drug, which had come up for extension till 2019, based on ‘the strength of the particular rights, and the [intellectual property] environment in India in general’.

Herceptin, which is indicated for a particularly aggressive form of breast cancer, is Roche’s third biggest seller, with global sales in the first half of 2013 of Swiss Francs 3.08 billion (US$3.30 billion).

Roche’s decision is perhaps a pre-emptive strike by the company, as the Indian Government has been considering issuing a compulsory licence for Herceptin [1], with the only thing delaying it reported to be the fact that there are currently no approved biosimilars of trastuzumab in India. Several companies, however, including Biocon-Mylan, Reliance Life Sciences and BDR Pharma, are reported to be working on creating biosimilars of the drug.

Major drugmakers, including Roche, have been coming under increasing pressure from both lobbying groups and the Indian Government to cut the prices of key anti-cancer drugs to increase access, with claims that the prices of these blockbusters are prohibitive to most of the population in India.

In March 2012, the Indian Government granted a compulsory licence to India-based generics firm Natco Pharma enabling them to produce generics of Germany-based Bayer’s cancer drug Nexavar (sorafenib) [2]. Bristol-Myers Squibb’s Ixempra (ixabepilone), which is used as a chemotherapy drug in breast cancer, and Sprycel (dasatinib), which is a leukaemia treatment, are also under consideration for compulsory licensing [1].

Related article

Bayer loses Nexavar compulsory licence appeal

References

1.  GaBI Online - Generics and Biosimilars Initiative. India issues more compulsory licences [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Aug 30]. Available from: www.gabionline.net/Policies-Legislation/India-issues-more-compulsory-licences

2.  GaBI Online - Generics and Biosimilars Initiative. Indian government issues first compulsory licence [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Aug 30]. Available from: www.gabionline.net/Generics/General/Indian-Government-issues-first-compulsory-licence

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