Tuesday, November 20, 2007

AstraZeneca's Iressa patent application rejected in India

AstraZeneca's filed its patent application at the Indian Patent Office for its drug Iressa [Gifitinib/ Gefitinib] in 1996 and the same was under going pre-grant opposition proceedings by generic companies - Natco Pharma Ltd and J M Pharmaceuticals Ltd.

The Patent Office has now issued a rejection for the patent application, based on the submission of the generic companies that the drug has been in the public domain before the company filed its patent in India.

News report from Mint, here.

A little sleuthing shows* the following:
The Orange Book shows that Iressa has 3 listed patents.
I believe that the Indian application could* be the one corresponding to the 3rd OB patent [US 5770599]. That being the case, I think* that the Indian application [currently rejected] is 841/DEL/1996.
The rejection of this product patent is not the end. My research suggests that there are at least two more process patent applications:
1419/DEL/2003 &
1420/DEL/2003
that cover processes to make
Gifitinib/ Gefitinib.

* = Please note that the above are at best, guesses, since neither side[s] nor the Indian patent office has as yet declared the application number that was rejected.
I will be obliged if any of you readers can send me details/ copy of the decision or any additional information.

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