GENENTECH INC. Vs. DRUG CONTROLLER GENERAL OF INDIA

JUDGEMENT

(1.) Leave granted.

(2.) This appeal has been preferred against the interim order dated 18.09.2019 passed by the Division Bench of High Court of Delhi in C.M. Application No. 22510/2016 in FAO (O.S) No.181/2016. Under the impugned order, the Division Bench allowed the application filed by respondent No.3-M/s Reliance Life Sciences Pvt. Ltd. 1. The CS(OS) No. 3284/20152 before the High Court of Delhi was filed by appellant no.1- M/s Genentech Inc. together with appellant nos. 2 and 3 namely Roche Products (India) Pvt. Ltd. and F. Hoffmann-La Roche, AG 3 respectively.

(3.) Plaintiff no.1- M/s Genentech Inc. claimed themselves to be the innovators of the monoclonal antibody drug 'Trastuzumab' which is manufactured by the plaintiff no.3- F. Hoffmann-La Roche and is being marketed in India by plaintiff no.2- Roche Products (India) Pvt. Ltd. under the brand name HERCEPTIN, HERCLON and BICELTIS. The drug 'Trastuzumab' is approved globally for treatment of cancer. The suit before the Delhi High Court came to be filed seeking to inter alia restrain respondent No.3-M/s Reliance Life Sciences Pvt. Ltd. from launching, marketing or selling 'TrastuRel', the biosimilar version of the appellants drug 'Trastuzumab'. In the suit, the approval granted by respondent no.1-Drugs Controller General of India 4 to M/s. Reliance Life Sciences Pvt. Ltd. for the manufacture and marketing 'TrastuRel', was also challenged. The suit was filed at a stage when respondent no.3 was yet to introduce their drug in the market. The appellants had obtained patent for the drug 'Trastuzumab' but the same had lapsed on Reliance Suit Plaintiffs in O.S. No. 181/2016 DCGI 3.5.2013 but they sought to restraint respondent no.3 from representing their product 'TrastuRel', as biosimilar to 'Trastuzumab'