Patent Battle Over Lung Cancer Drug: SC Disposes Of Cipla’s Appeal Against Roche As Withdrawn

The Supreme Court’s Vacation Bench of Justices R.K.Agrawal and Sanjay Kishan Kaul, on Friday, June 16, allowed the withdrawal of the Special Leave Petitions against the Delhi High Court’s November 27, 2015 judgment holding that Cipla had infringed Roche’s patent over the lung cancer drug, erlotinib hydrochloride.

The bench allowed the withdrawal on the ground that the matter has been compromised by and between the parties.

“In view of the averments made in I.A. No.2 of 2017 supported by an affidavit, I.A. No.2 of 2017 is allowed and Special Leave Petition (Civil) Nos.7664-7665 of 2016 are dismissed as withdrawn”, the bench noted in its order.

The Division Bench of the Delhi High Court comprising Justices Pradeep Nandrajog and Mukta Gupta, had held in its judgment that Cipla had infringed F.Hoffmann-La Roche Ltd’s patent in the lung cancer drug sold under the trade name, Tarceva. Roche was selling Tarceva at Rs.4800 per tablet whereas Cipla marketing its generic version under the name Erlocip at the cost of Rs.1600 per tablet.

In 2012, a single Judge of the Delhi High Court dismissed Roche’s plea for interim injunction against Cipla on the ground of public interest, considering that the disputed patented drug is life-saving. Roche’s patent was granted in February 2007 by the Indian Patent Office. Cipla had contended that Roche’s patent had not complied with full disclosure requirements as required under Section 8 of the Patents Act, 1970, and sought its revocation. This was refused by the Single Judge during the trial. Both Cipla and Roche appealed against the Single Judge’s order before the Division Bench of the Delhi High Court.

The Division Bench, however, did not grant the injunction prayed for by Roche against Cipla as the life of the patent would expire in March 2016. But it imposed a cost of Rs.5 lakh on Cipla.

Cipla’s lawyer, Namrita mentioned the matter before the Supreme Court’s Vacation Bench on Friday, bringing the settlement to its notice, and their decision not to pursue the SLP.

The joint statement from Roche and Cipla reads as follows:

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

But the compromise agreement has not been made public. Observers, therefore, say that the settlement should be reviewed for potential competition law implications, and unless these terms are available, they cannot be unraveled.