Roche is an exclusive licensee for Erlitinib hydrochloride in india and patent details are below:
Granted patent: IN196774
Grant Publication: 14/Sep/2007
Corresponding patent: US5747498 [Orange Book listed]
US expiry: 30/Mar/2015
Erlotinib was developed jointly by OSI pharma and Pfizer, later pfizer granted developmental and marketing rights to OSI pharma for royalty free. OSI started clinical development and clinical studies alliance with roche and genentech. This mail-box application of erlotinib was opposed by Natco pharma (Indian drug company) before grant and lost in the pre-grant opposition.
Cipla, indian drug company, announced lunch of generic version of erlotinib (Tarceva) even when patent is in force in india. As expected Roche file infringement suit against lunch of generic version of Erlotinib by cipla and asking injunction to stop manufacture, sale and distribution in Delhi High court.This awaited judgement of delhi high court came on 20th March 2008, allowing Cipla to continue the manufacture of drug till a final ruling on the case. Court declined the temporary injunction against cipla in the view of public interest or as the Mint put it – ‘irreversible damage to the patients’ since the cost of Cipla’s generic version is one-third that of Roche’s patented drug.Elabarate blog article on judgement in SpicyIP: http://spicyipindia.blogspot.com/2008/03/patents-vs-patients-ciplas-victory-and.html
After this judgment, there was a news in economic times that Natco plans to lunch of generic version.
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