Chennai Patent Office for Gleevec

The Novartis/ Imatinib/ Gleevec pre-grant opposition saga started at the Chennai patent office.

Natco had filed a pre-grant opposition for this patent application.
The Examiner had issued an order against Novartis.

Here is a copy of that order.

Salient points:
Application in question: 1602/MAS/1998
This application claims: a beta crystal form of methanesulphonic acid salt of 4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-[4-pyridin-3-yl]pyrimidin-2-ylamino]phenyl]-benzamide commercially called as imatinib mesylate.
The base salt – Imatinib was known / disclosed earlier in EP-A-056409, published on October 6, 1993, and its equivalent US5521184.

Main grounds:
a) Anticipation:
The Controller held that the earlier base compound covered the salt form and that the salt form normally exists in the beta crystalline form which is the most thermodynamically stable product.

b) Obviousness:
On the basis of the reports of the Indian Institute of Technology, and Indian Institute of Chemical Technology, the Controller held that the salt prepared using instructions of the 1993 Patent inherently exists in beta crystalline form. Hence the product claims were held to be obvious over the aforesaid technical reports.

c) S. 3(d):
The Controller held that the present claimed product was a only a new form of a known substance without having any significant improvement in efficacy, hence not patentable under section 3(d) of the Patents Act, 1970.

d) Claiming priority from Swiss document:
Switzerland became a Convention Country in September, 1998. Hence no priority can be claimed from a Swiss application prior to this date.

In view of the above, the application was rejected and the Opposition was upheld.