In a 5-page order dated November 20, 2012, the Chennai Patent Office has refused to grant a patent to Novartis in its application 2208/CHENP/2006 on "A PHARMACEUTICAL COMBINATION FOR BRAIN DEGENERATIVE DISEASES”.
The amended Claim 1 read as follows:
l. A pharmaceutical combination comprising
a) a first agent which is 2-amno-2-12-(4-octylphenyl)ethyl[propane-1,3-diol in free form or in a phannaceutically acceptable salt form, or FTY72O-phosphate, or 2-amino-2-f2,-(4-octylphenyl)ethyl]propane-l,3-diol hydrochloride, and
b) a second agent useful in the alleviation or teatment of brain degenerative diseases or progressive dementia, selected from an AIvIPA receptor agonist, a noobopic agent such asi cinnarizine, nimodipine, donepezil hydrochloride, rivastigmine. galantamine hydrobromide, dihydroergotoxin, nicergoline, piracetame, extacts from Ginkgo leafs, pentiffllh, pyritinol, vincamine or vinpocetine, and a Painkiller.
The application appears to have been rejected on grounds that the amended claim (pursuant to objections in the FER) did not have adequate support in the specification, and lacked clarity. Further, the invention claimed in the application was deemed as being obvious in light of the prior art, and deficient in exhibiting synergistic effect of the combination of ingredients used.
Again, the absence of a detailed discussion on the prior art cited by the Patent office makes it difficult to critique/appreciate the order.