Hoffmann-La Roche AG is a Swiss multinational health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Roche is the third-largest pharma company worldwide.
Roche sued Cipla in early 2008 over their lung cancer drug Erlocip on the ground that it infringed Patent for ‘A NOVEL
[6, 7-BIS(2- METHOXYETHOXY) QUINAZOLIN-4-YL]- (3-ETHYNYLPHENYL) AMINE HYDROCHLORIDE’ also known as ‘Erlotinib Hydrochloride’ which was licensed to Roche. Roche had been manufacturing this compound as an anti-cancer drug under the brand name ‘Tarceva’ across the world and introduced it in India in April 2006. In the first round of litigation, Roche lost on the question of interim relief on the ground that injuncting against Cipla’s manufacture would be against public interest and hence the balance of convenience was not in Roche’s favour. Cipla Ltd won a landmark patent case against Swiss drug maker F Hoffmann-La Roche Ltd over the Indian company’s generic copy of lung cancer drug Tarceva after a four-year court battle. Cipla’s generic version was a polymorph B variant of Roche’s patented drug and that it didn’t actually infringe any patent in India. While Tarceva costs about Rs.1.4 lakh for a month’s treatment, Cipla priced it at about Rs.25,000 for the same dosage. Roche had introduced patient-access schemes to make the drug available at discounted rates for those who couldn’t afford the high prices
On appeal, the DB upheld the decision, but focussed more on the failure of Roche to establish a prima facie case of infringement which is sine qua non for granting interim relief. It was argued that Erlocip comprised of only the B polymorph of Erlotinib Hydrochloride and hence was not covered by the suit patent which only disclosed a mixture of polymorphs A and B of the compound. The SLP filed by Roche against this decision was also not successful and the parties returned to the Single Judge (trial judge) to commence the trial on the main relief in the suit.
Roche just scored its first big win in its long standing battle against Cipla with the Division Bench of the Delhi High Court (DB) holding that Cipla’s cancer drug ‘Erlocip’ infringes Roche’s patent.
Roche sues Biocon and Mylan over biosimilar version of Herceptin. Genentech is a biotechnology corporation and has been a subsidiary of Roche since 2009. The companies developed the drug trastuzumab in 1990, and after being granted approval by the Drugs Controller General of India (DCGI) in 2002, Roche started importing and marketing the drug in India under the brand names Herceptin, Herclon and Biceltis. Additionally, Genentech obtained a formulation patent for trastuzumab effective from May 3, 1993, and it lapsed on March 3, 2013. Biocon and Mylan have been allegedly selling a biosimilar version of trastuzumab under the brand names Canmab and Hertraz respectively. Trastuzumab is a monoclonal antibody used primarily for the treatment of HER2-positive breast cancer.
In a recent decision in India, biopharma company Biocon and its partner Mylan were allowed to continue marketing a biosimilar breast cancer drug.