NCEs Outside the Scope of Sec. 3(d), Efficacy Data not Required - II

Continued from our last post where we briefly discussed about the rejection of pre-grant opposition filed by Cipla for the Application Number 3003/CHENP/2004 for anti-cancer drug Nilotinib which later matured into issued Patent Number 237430. The opposition proceedings was fought on the grounds of lack of (1) inventiveness u/s 25(1)(e) and (2) enablement u/s 25(1)(g).

Interestingly during the opposition proceedings Cipla argued against the narrowing of claims which the Controller clearly opined that narrowing of claims are well permissible within the patent law. Cipla also relied on two documents (one of which suggested that polymorphic form B of nilotinib was used for further drug development) published well after the filing date of the Application to contest the utility of the Nilotinib which the Controller rightly rejected from considering to decide the patentability of the Application.

Here again Cipla tried to take the Chennai Patent Office for a ride the way it took the Delhi High Court in infamous Tarceva patent litigation where it convinced the learned Judge that Cipla’s generic Tarceva tablets contain polymorphic form of Erlotinib whereas the patent issued to Roche protects Erlotinib per se and hence non-infringing. Now here Cipla went the opposite way arguing that when the Nilotinib drug development contains polymorphic form B (disclosed in pending Application Number 9925/DELNP/2007 for which pre-grant opposition decision is pending) then patent should not be issued to Nilotinib per se. In other words, if the marketed drug contains polymorphic form of active ingredient then patent should not be granted to active ingredient per se. However, the Chennai Patent Office rightly applied its reasoning rather getting carried away by Cipla’s arguments. 

To be continued…