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…

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... 

Cipla knocks down key patent blocking i-pill

In another post-grant opposition decided earlier this month, the Mumbai Patent Office revoked Indian Patent Number 202297 issued to Richter Gedon protecting emergency contraceptive pill containing 1.5mg Levonorgestrel, the active ingredient of Cipla’s money spinner i-pill (recently sold to Piramal Healthcare) and Mankind’s Unwanted 72. The ‘297 patent was issued against the Indian Patent Application Number 1119/MUMNP/2003 filed on December 09, 2003. The post-grant opposition was filed by Cipla on February 05, 2008 and hearing was fixed on May 03, 2010. During the hearing, Cipla contested the novelty, prior public use, lack of inventive step, section 3(d), section 3 (e), enablement requirement and failure to disclosed information u/s section 8. The Controller found Cipla’s arguments regarding novelty, lack of inventive step, section 3(d) and section persuasive and subsequently ordered revocation of the ‘297 patent. The ‘297 patent is one of the two patents protecting 1.5mg Levonorgestrel, other is IN206098 issued against the Application Number 75/MUMNP/2004.

Novartis loses DULERA patent in India

Earlier this month, the Swiss Multinational Novartis lost DULERA post-grant opposition to Mumbai-based Cipla as the Chennai Patent Office revoked Indian Patent Number 202350 on the ground of obviousness/lack of inventive step. The ‘350 patent protecting FORMOTEROL FUMARATE and MOMETASONE FUROATE inhalation aerosol combination, the active ingredients of lately approved fixed-dose combination asthma drug DULERA (marketed by Merck) was issued against the Indian Patent Application Number IN/PCT/01/1168/CHE filed on August 20, 2001. The post-grant opposition was filed on February 04, 2008 and hearing was made on July 07, 2010. During the hearing, Cipla argued that the ‘350 patent lacked inventive step as the combination of bronchodilators and steroids for the treatment of an inflammatory or obstructive airways disease are well taught in the art and obvious to a person skilled in the art. Interestingly, the similar combination (having different dose quantity than that of DULERA) was approved in India on December 30, 2009.