The Supreme Court today allowed domestic drug manufacturer Cipla, which recently arrived at a settlement with Swiss pharma major Roche over a lung cancer drug, to withdraw its petition on the patent row. The apex court was informed that the two companies on May 30 had arrived at a settlement before the Delhi High Court to close the patent dispute between them over the drug erlotinib hydrochloride, manufactured and sold by Roche under the name of Tarceva and Cipla’s Erlocip. Cipla had filed a petition challenging the High Court’s November 27, 2015 order holding that it had infringed Roche’s patent in a lung cancer drug. However, after the May 30 settlement, Cipla moved the apex court seeking to withdraw the Special Leave Petition (SLP) filed against the 2015 decision. Cipla’s lawyer mentioned the matter before a bench of Justices R K Agrawal and S K Kaul and said both the firms — Cipla Ltd and F Hoffmann-La Roche Ltd– have arrived at a settlement over the dispute and now they do not want to pursue the SLP. The bench, which took up the matter today itself, allowed the application seeking permission to withdraw the petition.
Hours after the court proceeding, a joint statement was issued stating that “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,” the statement issued by the Swiss Pharma said.
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A division bench of the high court had held that Cipla’s lung cancer medicine, Erlocip, was one polymorphic form of the erlotinib hydrochloride compound, which may exist in several forms, and Roche’s patent claim was not limited to any one such version. While Cipla’s Erlocip, launched in 2008, costs Rs 1,600 per tablet, Roche’s Tarceva cost Rs 4,800 per tablet. Roche was granted the patent in India for erlotinib hydrochloride on February 23, 2007. The high court had also imposed a cost of Rs five lakh on Cipla. The bench has remanded the case to the single judge for rendition of Cipla’s accounts for determination of profits from sale of Erlocip. The verdict of the division bench had come on the pleas of Cipla and Roche, both of which had challenged the single judge’s order of September 7, 2012.
The single judge, in his order, had held that Cipla was not infringing Roche’s patent and had refused to grant any injunction against the Indian company. The single judge had also refused to revoke the patent of the Swiss company as sought by Cipla.