Cipla settles patent infringement case with Roche over cancer drug Tarceva

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Cipla on Thursday said it withdrew from the ongoing patent dispute with Swiss pharmaceutical giant Roche related to anti-cancer medicine Elontinib Hydrochloride after it reached an out-of-court settlement acknowledging the later’s validity of patent rights over the drug.

“Cipla and Roche/OSI confirm that they have reached an agreement regarding the ongoing patent disputes relating to the anti-cancer medicine Erlotinib Hydrochloride,” Cipla said in an email statement.

“As part of the agreement, the companies have ceased all relevant patent litigation on this product and Cipla has acknowledged the validity of the patent rights of Roche,” the statement added.

Cipla didn't disclose the details of the agreement.

Typically, in-patent infringement settlement cases end up with the challenger getting a licence to launch authorised generic for a royalty payment to the innovator.

The drug-maker earlier this week has withdrawn the special leave petition (SLP) it filed in the Supreme Court against the Delhi High Court Order of 2015.

Roche has filed patent infringement case against Cipla after the Indian drug maker started selling its own version of Erlotinib Hydrochloride from late 2007 at third of innovator’s brand price.

Roche sells the drug used in treatment of non-small cell lung cancer (NSCLC), pancreatic cancer and several other types of cancer under brand name Tarceva that cost around Rs 1.4 lakh at month’s dosage.

“This is a surprising development, considering this was one of the biggest cases where mediation was initially advised by the DHC and had failed,” wrote Maitreyee Dixit on SpicyIP, the intellectual property legal blog.

“This settlement possibly marks the close of the first pharma patent case in India in the post TRIPS era, bringing a monumental chapter of India’s patent law to an end,” Maitreyee added.