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

Patent Circle earlier posted the issuance of Indian Patent Number 237430 to Novartis against the Application Number 3003/CHENP/2004 for anticancer drug Nilotinib, globally marketed as Tasigna. Like Imatinib and Erlotinib, Nilotinib too belongs to the class of tyrosin kinase inhibitors which is extensively discussed on our blog (read here, here and here). Notably, the Application for Nilotinib before maturing into an issued patent overcame a pre-grant opposition brought by Cipla. The opposition filed at the Chennai Patent Office is one of the well-reasoned and matured decisions (till date) ruled by the Indian Patent Office which is worth discussing here.

The opposition was filed on February 16, 2009 and hearing was held on September 15, 2009. Cipla opposed the Application on the grounds of.

1. Prior publication
   
2. Lack of inventiveness
   
3. Not invention u/s 3(d)
   
4. Lack of enablement
   
5. Failure to disclose information u/s 8
   

However, during the opposition proceedings Cipla dropped most of the grounds and focused on (1) lack of inventiveness u/s 25 (1) (e) and (2) lack of enablement u/s 25 (1) (g). Cipla argued that the use of nilotinib to treat imatinib resistant patients was not disclosed in the specification and was suppressed by or not known to the Applicant at the time of filing the Application. In response, the Applicant argued that the Application is not directed to salts or polymorphs but is directed to New Chemical Entity (NCE) and further argued that the invention is not improving the efficacy of the known compounds but relates to new compounds. Responding to Cipla’s argument, the Asst. Controlled Dr. S.P. Subramaniyan opined that the technical details and use of present invention is clearly described in the specification in accordance with Sec. 10(4) of the Act. He further added that efficacy data is required where substance of any claimed invention falls within the scope of Sec. 3(d) but the present invention is related to New Chemical Entity (NCE) and therefore efficacy data are not required for NCEs.

Patent Circle unquestionably agrees with the reasoning of the Asst. Controller that the NCEs fall outside the scope of Sec. 3(d) and does not require efficacy data to qualify for patent protection within the Indian patent law but the problem lies in Sec. 3(d) itself. In absence of proper guidelines and technical explanation, Sec. 3(d) time and again is used against the NCEs in the shadow of ‘other derivatives of known substance’ used in explanation part of Sec. 3(d). Now can anybody explain that in hardcore synthetic chemistry are there any compounds which are not derivative of known substance (structure)? Even a chemistry graduate can acknowledge the fact that every synthetic compound, whether old or new, are derived from one or the other known substances. In fact, in the drug discovery process the selection of ‘lead’ substance also starts from known substances (not necessarily marketed drug substances). Does that mean identifying a potent drug substance (NCE) from thousands or millions of compounds make NCE a mere derivative and put it in Sec. 3(d) test?

If drug discovery and NCE identification would have been so easy (the way it is portrayed in pre-grant and post-grant oppositions) then one out of every fifth Indian pharma company would have already rolled out their own new drug candidates. Frankly, a country which is still waiting to witness its first indigenous drug candidate to hit the market should not make a patent law that makes drug discovery or NCE identification look like child's play for a person skilled in the art. I wonder does the case of ERLOTINIB and GEFITINIB similar to the case of AMLODIPINE and (Z)-4-[(2-{[4-(2-chlorophenyl)-3-(ethoxycarbonyl)-5-(methoxycarbonyl)-6-methyl-1,4-dihydro-2-pyridinyl]methoxy} ethyl)amino]-4-oxo-2-butenoic acid (AMLODIPINE AMIDE DERIVATIVE) as disclosed in US Patent Number 6,602,893? Are both these cases fall within the scope of derivative? If yes then what is the threshold limit to distinguish NCEs from the derivatives covered in Sec. 3(d)? Obviously one cannot expect the Indian Courts to distinguish NCEs from derivatives especially when they failed to understand even a simple concept that polymorph cannot circumvent compound patent. There is no doubt that the word ‘derivative’ is loosely used in Sec. 3(d) without giving a proper thought about its meaning and scope, which now need explanation about its scope and threshold limit. In fact, the MNCs lately met and asked PMO officials to review and clarify the scope of Sec. 3(d).

To be continued...