Friday, June 27, 2008

Cipla Patents Salt and Complex of Blockbuster Drug Substances in India

Mumbai-based Cipla has lately obtained patents for new form of two blockbuster drug substances, namely, esomeprazole and alendronate. In past, Cipla has constantly accused foreign MNCs for ever-greening of patent monopoly and strongly opposed patenting of so-called trivial improvements but in general practicing the same in India. In April 2008, Mumbai Patent Office issued Patent no. 219034 to Cipla for inclusion complex of esomeprazole with cyclodextrins which technically should fall under section 3(d) of the Patents Act, 1970 (that is complexes of known substances). Surprisingly the search report (ISR) of equivalent WO02098423 cited one ‘X’ category reference and eleven ‘Y’ category references against the novelty and non-obviousness of the invention but still Cipla managed to get patent in India. Though Patent Circle went through the WO equivalent but couldn’t find any data suggesting and relating to enhanced or improved efficacy. Also in April 2008, Mumbai Patent Office issued Patent no. 219022 for alendronate monosodium salt which also falls under section 3(d) (that is salt of known substances). In this case also the search report (ISR) of equivalent WO03033508 cited five ‘Y’ category references against the non-obviousness of the invention. Patent Circle also scanned the disclosure of WO equivalent but yet again couldn’t find any data suggesting and relating to enhanced or improved efficacy. Surely it would be really interesting to know on what basis Cipla managed to overcome the efficacy barriers under section 3(d). Unfortunately, Indian Patent Office (IPO) has ill-practice of issuing patent in India if patent for same invention is granted in other country particularly Europe and US and that also without giving any considerable thought. Possibly Cipla too provided copy of granted European/US patent to have patents issued by the Mumbai Patent Office.

Often public health interest organizations criticized patenting of polymorphs or other forms of known substances (considering such improvements as trivial modifications) and keep targeting foreign MNCs of being patent freaks but why avoided same practice against the Indian companies. The only reason they may give that the foreign MNCs will charge excessive price for patented drugs whereas domestic companies will not. Interestingly last year Cipla received Government notice demanding Rs. 24.23 crore for alleged overcharging on antibiotic ciprofloxacin during the period April 2006 to March 2007. Earlier Cipla also received similar notices from the National Pharmaceutical Pricing Authority (NPPA) demanding as estimated Rs. 941.92 crore for alleged overcharging till March 2006 for five drugs, namely, Salbutamol, Theophylline, Ciprofloxacin, Norfloxacin and Cefadroxil. Just note this overcharging is for generic drugs what if Cipla start marketing and pricing patented drugs. Anyhow bottom line of any business is profit (not public health) and it seems difficult to predict whether NGOs are more confidants to Indian generic companies or to public.

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