Cipla V Roche Case Note

Cipla v Roche – Generics Industry Rejoices! For the last two years, the Delhi High Court has been the battle ground for a pharmaceutical war between Roche and Cipla over Roche's patent for the anticancer drug ‘erlotinib’, sold by Roche as 'Tarceva'. On 24 April 2009, the Division bench of the Delhi High Court dismissed Roche's appeal against the refusal of a single judge to grant an injunction restraining Cipla from manufacturing, offering for sale, selling and exporting its generic version of ‘erlotinib’. Both Roche and Cipla drugs are based on a compound that goes by the name of ’Erlotinib Hydrochloride‘. This case is regarded as a very important case in a series of high profile patent battles between multinational pharmaceutical companies and Indian generic drug companies. Facts of the case Roche, along with Pfizer (as a joint applicant), claimed that it had been granted a patent in February 2007 for ’erlotinib’, the molecular [6, 7-bis (2-methoxyethoxy) quinazolin-4yl]-(3-ethynylphenyl) amine hydrochloride. The patented product, which Roche introduced onto the Indian market in 2006, was marketed under the brand name TARCEVA. In December 2007 and January 2008, Indian newspapers reported Cipla’s plan to launch a generic version of ‘erlotinib’, and soon after Roche commenced patent infringement proceedings. In response to Roche’s claims, Cipla filed a detailed defence and counterclaim arguing that: 1. It had been selling its drug under the brand name ERLOCIP since December 2007 2. Roche’s patent was invalid because ‘erlotinib’ was a derivative of Quinazolin, which had been used in cancer treatment. Pursuant to s.3(d) of the Indian Patents Act, a derivative of a known compound is not patentable 3. Roche’s invention, as disclosed in the complete specification and claims was obvious or did not involve any inventive step, having regard to what was publicly known or publicly used in India, or what had been published in India or elsewhere before the priority date 4. The