In a latest development in the battle that Swiss pharma major F Hoffmann-La Roche has been fighting with Indian generic competitors for the patent of its cancer drug Tarceva in the country, the company has entered into an out-of-court settlement with Glenmark Pharmaceuticals to resolve a patent dispute.
Tarceva, the brand name of erlotinib hydrochloride, is a once-daily, oral non-chemotherapy medicine for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC). Lung cancer is considered metastatic if the cancer has spread to other parts of the body.
Glenmark has acknowledged the intellectual property rights (IPR) of Roche and has given certain undertakings to them, based on which the Swiss firm agreed to give up the costs and damages from Glenmark. A case pending with the Delhi High Court regarding this has been disposed of based on this.
In a joint statement issued to Business Standard, Roche and Glenmark said, “Glenmark and Roche/OSI confirm that they have reached an agreement regarding 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 Glenmark has acknowledged the patent rights of Roche."
In an order in Delhi High Court in December, 2015, Justice Hima Kohli disposed of the suit by Roche and the counter claims of Glenmark related to the patent dispute, as both the parties has informed that they have arrived at an out of court settlement. Glenmark has acknowledeged patent number 196774 filed on March 13, 1996 and has given undertakings to Roche, noted the order.
According to previous reports, Roche has been engaged in legal dispute with generic firms, especially drug major Cipla, to protect its product from generic drugs. A report in November, this year, said that the Delhi High Court held that Cipla infringed Roche's patent.
Tarceva has been shown to inhibit Epidermal Growth-Factor Receptor (EGFR), a protein involved in the growth and development of cancers. Tarceva is developed and commercialised by Astellas Pharma, US, which acquired OSI Pharma in partnership with Genentech in the United States, Chugai in Japan and Roche in the rest of the world, said the joint statement.