The Director General of the OPPI, Tapan Ray. has also been reported to have stated in great detail that the reason for the Cipla case in the first place is a procedural flaw on the part of the DGCI.
However, as reported by the Financial Express, patent attorneys point out that the MNCs’ demands are not viable especially since the any procedural requirement claimed by them are all part of the US law [The FDA Orange Book contains the approved drug list by active ingredient, proprietary name, applicant holder or applicant number and concurrently updated with publication of annual edition or the cumulative supplements] and do not have any binding force in India.
Perhaps it is a good idea for the Pharma MNCs to first know which law is actually applicable in this country and then take a look at prior Spicy posts where Shamnad has urged for transparency. Maybe it’s a better idea to begin from scratch and build a strong system on our own rather than based on borrowed methods.
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Kruttika,
I presume that you have not actually seen an application that is sent to DCGI for marketing / manufacturing a drug.
The application for permission to import or manufacture a New Drug in India to be submitted by a manufacturer, has a section on patent status.
So, a generic/ innovator company ‘should’ submit patent information.
It is another matter that neither side submits this information and importantly, at least for generic companies, getting this info. is next to impossible considering the search capacity at the Indian patent office.
http://genericpharmaceuticals.blogspot.com/2008/03/india-erlotinib-injunction-not-issued.html