For the fear of USA

Five govern­ment de­part­ments tossed the ball to each other to avoid a de­ci­sion on re­vok­ing a No­var­tis patent


Five govern­ment de­part­ments tossed the ball to each other to avoid a de­ci­sion on re­vok­ing a No­var­tis patent

WHAT HAP­PENS when a min­istry or a govern­ment depart­ment is faced with a de­ci­sion that would stir up a hor­net’s nest, both at home and glob­ally? The eas­i­est op­tion is to duck the ques­tion. Which is what the Depart­ment of In­dus­trial Pol­icy and Pro­mo­tion ( dipp) did when Ci­pla sought re­vo­ca­tion of the patents granted to Swiss drug ma­jor No­var­tis for its res­pi­ra­tory drug in­dacetrol. For close to two years dipp hemmed and hawed—as did the Union Min­istry of Health, which seems to have put out con­tra­dic­tory com­ments on the is­sue—and kept the gener­ics com­pany’s plea for re­vok­ing the No­var­tis patents in limbo.

The case is in­ter­est­ing be­cause Ci­pla was fir­ing on all fronts against the five patents that No­var­tis held on in­dacetrol. This was in Oc­to­ber 2014, just a cou­ple of years af­ter the hue and cry in the US over the first ever com­pul­sory li­cence (CL) is­sued by In­dia. The new Na­tional Demo­cratic Al­liance govern­ment had made it clear it did not wish to rock the boat and had formed a joint work­ing group with US of­fi­cials to look at in­tel­lec­tual prop­erty (IP) is­sues. In­dacetrol was a pretty ket­tle of fish for dipp to han­dle. Ci­pla had au­da­ciously bro­ken the patents and launched a generic ver­sion of the drug at less than a fifth of the cost at which No­var­tis was sell­ing it un­der the brand name On­brez. At the same time, Ci­pla had made a rep­re­sen­ta­tion to dipp, the nodal agency un­der the Union Min­istry of Com­merce, seek­ing re­vo­ca­tion of the in­dacetrol patents un­der Sec­tion 66 of the Patents Act which al­lows re­ver­sal in the pub­lic in­ter­est.

Ci­pla con­tended that No­var­tis was not work­ing its six-year-old patent in In­dia or mak­ing avail­able ad­e­quate quan­ti­ties of the im­ported drug at a rea­son­able price— Ci­pla’s drug Uni­brez was on of­fer at ` 130 for a strip of 10 pills against ` 677 for On­brez—for a dis­ease which it claimed was “preva­lent in epi­demic pro­por­tions”. The re­vo­ca­tion pe­ti­tion noted that No­var­tis was ful­fill­ing just 0.03 per cent of the re­quire­ment of the drug. But cu­ri­ously, Ci­pla also sought, si­mul­ta­ne­ously, a CL un­der Sec­tion 92 of the law which per­mits the govern­ment to over­ride patents in the event of a health emer­gency.

dipp be­gan ex­ten­sive con­sul­ta­tions on the Ci­pla pe­ti­tion. It wrote to the Min­istry of Health, the Depart­ment of Phar­ma­ceu­ti­cals ( dop), a part of the Union Min­istry of Chem­i­cals and Fer­tilis­ers and the In­dian Coun­cil of Med­i­cal Re­search among oth­ers. It was then that No­var­tis sued Ci­pla for in­fring­ing its patents, adding an­other tan­gle to the knot­ted ques­tion.

Go­ing by news­pa­per re­ports, it ap­pears that the Min­istry of Health was am­biva­lent on the CL for in­dacetrol although The­Hindu said that it had rec­om­mended re­vo­ca­tion of the patents and is­suance of a CL to Ci­pla “from a pub­lic point of view”. dipp put the ball back in the min­istry’s court by ask­ing for a de­tailed ex­pla­na­tion, ac­cord­ing to a re­port in the on­line IP web­site SpicyIP which re­cently got ac­cess to a se­ries of Right to In­for­ma­tion ( rti) queries made on this is­sue. The min­istry did send its com­ments to dipp af­ter many re­minders as did dop which sug­gested that dipp ask No­var­tis why it was charg­ing so much for the drug com­pared to Ci­pla’s rate. It pointed out that In­dia’s Patents Act has a spe­cific in­junc­tion that “patents are granted to make the ben­e­fit of the patented in­ven­tion avail­able at rea­son­ably af­ford­able price”. It was a sug­ges­tion that came more than a year af­ter Ci­pla filed its pe­ti­tion—and one that dipp chose to ig­nore.

In the end it ap­pears to have been a con­scious de­ci­sion by dipp to avoid tak­ing a de­ci­sion that would have the drug multi­na­tion­als up in arms and very likely in­vite the wrath of the US lob­bies. It should come as no sur­prise then that Ci­pla fi­nally with­drew its rep­re­sen­ta­tion in June this year.


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