Cipla has asked the Indian Government’s Department of Industrial Policy & Promotion (DIPP) to revoke five of the patents that Novartis holds in India relating to Onbrez, citing a need for public health access and that the patent holder Novartis does not manufacture the drug in India.

The originator product is 400% more expensive than Cipla’s generic version, which is marketed under the Unibrez brand and costs only Rs 130 per strip of 10 tablets. Novartis only brought in 53,844 units of the drug in 2013, serving 4,500 patients annually. This, according to Cipla is a ‘negligible quantity’ and is leading to a shortage of supplies in the Indian market. Cipla, on the other hand, ‘believes that it has the potential to manufacture adequate quantities of the drug’.

Cipla’s filing regarding the Novartis patents was made under Section 66 of the Indian Patents Act, which grants the Indian Government the power to revoke a patent in the public interest.

If India does overturn the Novartis patents, it would not be the first time that the country has done so. Novartis already challenged India’s patent laws back in 2006 when it failed to receive patent protection for its blockbuster cancer medication Glivec (imatinib mesylate) [1]. Cipla also won in a patent infringement case filed by Roche back in 2012 over Cipla’s version of its cancer drug Tarceva (erlotinib) [2].

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References
1.   GaBI Online - Generics and Biosimilars Initiative. India’s patent laws coming under repeated challenges [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 21]. Available from: www.gabionline.net/Policies-Legislation/India-s-patent-laws-coming-under-repeated-challenges 
2.   GaBI Online - Generics and Biosimilars Initiative. India patent laws under close scrutiny [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 21]. Available from: www.gabionline.net/Policies-Legislation/India-patent-laws-under-close-scrutiny 

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