IPO(Chennai) has recently issued an Indian patent IN224314 herein referred to as ‘314 patent to Lilly Icos LLC for Tadalafil particulate form and method of preparation thereof. The said patent is issued against the national phase application (PCT) # IN/PCT/2002/143/CHE claiming priority from US provisional application # 60/147,048 dated August 03, 1999 which later issued as US 6,821,975 and currently listed with the US FDA Orange Book.
Tadalafil is marketed as Cialis by Eli Lilly whic was granted EMR in India against the application # 85/DEL/1995 (the 1995 application) which later got stayed by the Calcutta High Court after a petition made by Mumbai-based Ajanta Pharma. The 1995 application covered claims for Tadalafil per se and process of preparation thereof. A pre-grant opposition was filed by Ajanta Pharma at the Indian Patent Office (Delhi) last year on March 22 wherein the IPO rejected the product claims for Tadalafil per se but allowed process claims. The product claims were found obvious over the US 3,917,599 (the ‘599 patent) issued to CDRI. The ‘599 patent exemplified 2-substituted-1, 2, 3, 4, 6, 7, 12, 12a-octahydropyrazino [2’, 1’:6, 1] pyrido [3, 4-b] indoles which is the base structure of Tadalafil but never suggested to be useful for treatment of erectile dysfunction. Pre grant opposition filed for tadalafil can be found here
Tadalafil is marketed as Cialis by Eli Lilly whic was granted EMR in India against the application # 85/DEL/1995 (the 1995 application) which later got stayed by the Calcutta High Court after a petition made by Mumbai-based Ajanta Pharma. The 1995 application covered claims for Tadalafil per se and process of preparation thereof. A pre-grant opposition was filed by Ajanta Pharma at the Indian Patent Office (Delhi) last year on March 22 wherein the IPO rejected the product claims for Tadalafil per se but allowed process claims. The product claims were found obvious over the US 3,917,599 (the ‘599 patent) issued to CDRI. The ‘599 patent exemplified 2-substituted-1, 2, 3, 4, 6, 7, 12, 12a-octahydropyrazino [2’, 1’:6, 1] pyrido [3, 4-b] indoles which is the base structure of Tadalafil but never suggested to be useful for treatment of erectile dysfunction. Pre grant opposition filed for tadalafil can be found here
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