Roche and Cipla will Battle it out in the Court: Mediation Over Erlotinib Fails

One of the most keenly watched mediations in the country has failed to materialize. The Roche-Cipla dispute over the lung cancer drug “Erlotinib” was the first patent case in the country to have been referred for mediation by the Delhi High Court earlier this year, and the outcome was keenly awaited.

The Delhi high court-appointed mediator has already submitted its “failure” report after various options was discussed but could not materialize. Now the case will be heard all over again by the division bench of the Delhi High Court.

The dispute initially began when Cipla announced its intent to launch a generic version of Roche’s drug, Erlotinib at Rs 1,600 a tablet, compared to the innovator’s selling price of Rs 4,800 per tablet. In January 2008, Roche sued Cipla for patent infringement. Roche had been granted a patent in India on Erlotinib in 2007. Cipla argued that Roche’s patent was invalid and its own generic version didn’t infringe the innovator’s patent.

In September 2012, the Delhi high court delivered a questionable judgement according to which the validity of Roche’s patent was upheld and at the same time Cipla was acquitted of the charge of infringing Roche’s patent. The infringement analysis in the flawed judgement evaluated Roche’s patented drug against Cipla’s generic version of the product; instead of evaluating the scope of the patent claim against defendant’s product.

Between 2009 and 2010, Roche also sued a number of other generic drug firms, including Natco Pharma, Dr Reddy’s and Glenmark, among others. Simultaneously, the Roche-Cipla legal tussle went into trial. In 2012, the Delhi high court held that Cipla’s generic version of Roche’s patented product did not infringe the Roche’s Indian Patent, and hence it was denied a permanent injunction. Roche then appealed against the decision before the division bench, which eventually referred the matter for mediation but to no avail and the case has once again commenced in court.

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