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Roche and India's Glenmark reach truce over generic Tarceva Posted 22/01/2016

The Swiss pharmaceutical company F. Hoffmann-La-Roche AG (Roche) has reached an out-of-court settlement with Indian generics company Glenmark Pharmaceuticals (Glenmark) over its patent for its lung cancer drug Tarceva (erlotinib hydrochloride).

In a joint statement issued to Business Standard, Glenmark and Roche confirmed that patent litigation had ceased on the basis of an agreement that Glenmark would acknowledge Roche’s intellectual property rights and that Roche would relinquish costs and damages from Glenmark.

Roche was granted the patent in India for erlotinib hydrochloride on 23 February 2007, a treatment for advanced or metastatic non-small cell lung cancer. Patent disputes have been ongoing with another pharmaceutical company, Cipla, in a bid to protect its product from generic drugs and hold on to falling sales.

In 2009, the Delhi High Court rejected Roche’s patent arguments allowing Cipla to continue selling its Tarceva copy, Erlocip [1].

In September 2012, Roche’s intellectual property rights for Tarceva were upheld, but it was also found that Cipla’s Erlocip did not violate the company patent as it had a different molecular structure than Roche’s drug [1].

In November 2015, the Delhi High Court ruled that Cipla’s generic version of the drug infringed Roche’s Tarceva’s patent; however, Cipla has been permitted to continue selling the drug until Tarceva’s patent expires in 2016.

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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 2016 Jan 22]. Available from: www.gabionline.net/Policies-Legislation/India-s-patent-laws-coming-under-repeated-challenges  

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