Ci­pla's chal­lenge

Why gener­ics maker Ci­pla has asked gov­ern­ment to re­voke No­var­tis patent on res­pi­ra­tory ail­ment drug


Swiss phar­ma­ceu­ti­cal No­var­tis in a fix after Ci­pla asks gov­ern­ment to re­voke its patent on drug to treat lung ail­ment

Ilargest phar­ma­ceu­ti­cals company NDIA'S FOURTH Ci­pla has thrown a bomb­shell. It has made a generic ver­sion of a patented No­var­tis drug used to treat chronic ob­struc­tive pul­monary dis­ease (copd) and has, at the same time, asked the gov­ern­ment to re­voke the five patents that the Swiss company holds on the drug In­dace­torol.

It is an au­da­cious move. Ci­pla has not op­posed the patent or chal­lenged it in court. Nor has it sought a com­pul­sory li­cence that would have al­lowed it to over­ride patents. In­stead, it has thrown a bold chal­lenge to the Swiss drug ma­jor at a time when the US pharma in­dus­try is bay­ing for In­dia’s blood claim­ing that its patents laws do not pro­tect in­no­va­tion.

The big­ger chal­lenge is to the gov­ern­ment. Ci­pla’s pe­ti­tion to the Depart­ment of In­dus­trial Pol­icy and Pro­mo­tion (dipp) which is the arm of the Min­istry of Com­merce deal­ing with in­tel­lec­tual prop­erty is­sues is in­ter­est­ing on sev­eral grounds. It has asked dipp to re­voke the In­dace­torol patents in pub­lic in­ter­est un­der Sec­tions 66 and 92 of the In­dian Patent Act.

Ci­pla en­joys an iconic rep­u­ta­tion for its pi­o­neer­ing role in pro­vid­ing cheaper gener­ics of life-sav­ing drugs.In the early 2000s it brought down prices of an­tiretro­vi­ral drugs used to treat hiv/aids dra­mat­i­cally. Thanks to Ci­pla’s ef­forts, which were fol­lowed by other In­dian gener­ics man­u­fac­tur­ers, the cost of treat­ment fell from $12,000 per pa­tient per year to $300 and saved thou­sands of lives across the world. That was be­fore In­dia in­tro­duced prod­uct patents for phar­ma­ceu­ti­cals. The company is us­ing the same ar­gu­ments to get the Swiss drug ma­jor’s patents re­voked.

Sec­tion 66 states that if the gov­ern­ment be­lieves a patent or the man­ner in which it is used is “mis­chievous to the State or gen­er­ally prej­u­di­cial to the pub­lic”, it should make an of­fi­cial dec­la­ra­tion to that ef­fect and re­voke the patent after giv­ing the paten­tee a hear­ing. Sec­tion 92 al­lows the gov­ern­ment to grant com­pul­sory li­cences if there is a na­tional emer­gency or in cir­cum­stances of ex­treme ur­gency or in case of non-com­mer­cial use of a patent.

Ci­pla has put to­gether strong ar­gu­ments to force the gov­ern­ment to act on all th­ese grounds.It says copd af­flicts about 15 mil­lion peo­ple in In­dia and that In­dace­torol “is one of the pre­ferred med­i­ca­tions”. copd is a chronic lung ail­ment that is char­ac­terised by a per­sis­tent block­age of air­flow from the lungs and could be fa­tal if un­treated or in­cor­rectly di­ag­nosed.

It points out that No­var­tis, de­spite get­ting a patent in 2008, was not mak­ing the drug here. In­stead, it had cho­sen to im­port the drug through its li­cencee, Lupin, another generic man­u­fac­turer.But th­ese im­ports were so in­signif­i­cant that it could meet just 0.03 per cent of the de­mand—a cal­cu­la­tion based on data given by No­var­tis to the Patent Of­fice—at a time when copd “is be­ing clas­si­fied as an epi­demic”. Although al­ter­na­tive drugs were avail­able, th­ese “are not ad­e­quate to deal with …the grow­ing scale of the ad­vance of copd”, the pe­ti­tion says.

The other rea­son Ci­pla cites is cost. In­daceterol, im­ported and sold by Lupin un­der the trade­mark On­brez, is priced around 2,000 per month per pa­tient, whereas

` Ci­pla’s pro­posed drug, uni­brez, would be about 400.

` dipp says it has re­ceived the Ci­pla pe­ti­tion and is look­ing into the mer­its of the case, ac­cord­ing to an agency re­port. In­dia has twice be­fore re­voked patents in pub­lic in­ter­est: a process patent granted to US firm Agrace­tus for ge­net­i­cally en­gi­neered cot­ton cell lines in 1997,and more re­cently for a patent given to Avestha­gen which turned out to have been based on tra­di­tional knowl­edge. In­dace­torol, how­ever, will be dy­na­mite to han­dle.


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