Lung cancer drug Patent battle come to end with compromise

LawyerNU Research Team | Update: 17/06/2017

The Honorable Supreme Court on 16 June allowed the withdrawal of Special leave petition against the Delhi high Court in Nov 2015, with the judgment holding that Cipla had infringed F.Hoffmann-La Roch Ltd Patent “erlotinib” This is the drug for lung cancer of Roche marketed under the trade name Tarceva.

Roche patent was granted in Feb 2007 for Lung Cancer Drug trade name as Tarceva (erlotinib)

• Tarceva is prescribed for patients with non-small cell lung cancer (NSCLC) whose cancer has spread to other parts of the body and that has certain types of epidermal growth factor receptor (EGFR) mutations.

• Tarceva is not meant to be used at the same time as certain types of chemotherapy for NSCLC. Tarceva is approved for advanced-stage pancreatic cancer.

• Tarceva in combination with gemcitabine is prescribed for patients with advanced-stage pancreatic cancer whose cancer has spread, grown, or cannot be surgically removed and who have not received previous chemotherapy.

Roche was selling Tarceva at Rs 4800 per tablet, Whereas Cipla made the generic version and marketing with trade name Erlocip at Rs 1600 per tablet.

The division bench of Delhi High court comprising, had in its judgment that Cipla infringed Roche Patent in Tarceva. In the year 2012, Delhi High court dismissed Roche’s plea for interim injunction against Cipla on the ground of public interest with the consideration of Tarceva (erlotinib) is life saving. 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 ask for the reversal of an act. But that was refuse by single Judge order during trial. Later on Cipla and Roche appealed against the single Judge order before to that Divisional Bench of the Delhi High Court. Whereas, Divisional Bench of the Delhi High Court not grant the injunction prayed for Roche against Cipla as the patent going to expire in March 2016, But it inflict for 5 Lakh on Cipla. Now the Supreme court allowed the withdrawal on the ground that the matter had been compromised between both the parties.

Roche and Cipla had joint statement read as ..

“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.”

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