Pop­u­lar­ity of In­dia's patent law has not gone down well with the US


T0 HAVE ONE coun­try chal­lenge the main­stream view on in­tel­lec­tual property rights (ipr) may not be such a threat. It is quite an­other mat­ter when more na­tions be­gin to fol­low suit. Then you are look­ing at the be­gin­nings of a global in­sur­rec­tion that could un­der­mine the ba­sis of Western supremacy. Or so the US be­lieves. This helps ex­plain why the US trade au­thor­i­ties and pow­er­ful busi­ness lob­bies tar­geted In­dia on its ipr regime.

That the en­tire trade ma­chin­ery of the world’s might­i­est econ­omy should have been gal­vanised just be­cause two Euro­pean firms ran afoul of In­dia’s patent laws stretches credulity. The cel­e­brated cases in­volve Basel-based No­var­tis which was de­nied a patent for its cancer drug Glivec be­cause it lacked nov­elty and Bayer of Ger­many on whose costly Nex­avar cancer drug a com­pul­sory li­cence was is­sued.

So why were the Amer­i­cans mak­ing such a ruckus over In­dia’s patent law which is fully com­pli­ant with global rules on iprs? Ad­mit­tedly, some key pro­vi­sions of the land­mark Patents (Amend­ment) Act of 2005 have raised the bar for multi­na­tional drug com­pa­nies want­ing to ex­tend their patents be­yond the orig­i­nal 20 years on in­cre­men­tal changes to a mol­e­cule they have dis­cov­ered. But the true rea­son for the on­slaughts on In­dia’s patent regime are to be found in the tes­ti­mony of Roy F Wal­dron,chief in­tel­lec­tual property coun­sel of US-based Pfizer. In a writ­ten sub­mis­sion to the House ways and means sub­com­mit­tee, Wal­dron had let the cat out of the bag when he said that

In­dia’s lead­er­ship in this sphere was mak- ing US com­pa­nies ner­vous. “Since many other coun­tries look to In­dia as a leader and an ex­am­ple, In­dia’s ac­tions re­ver­ber­ate far be­yond its borders. We have seen sev­eral coun­tries adopt poli­cies sim­i­lar to In­dia’s, which are leading to a world­wide de­te­ri­o­rat­ing trend on in­tel­lec­tual property.”

The last bit, of course, is an ex­ag­ger­a­tion. There is the United States Trade Rep­re­sen­ta­tive’s (ustr) hec­tor­ing an­nual re­view of the ipr record of trad­ing part­ners that forces most coun­tries to fall in line. And yet, a sig­nif­i­cant clutch of coun­tries ap­pear to have been in­spired by In­dia’s clear-cut norms on what is patentable to change, chop and al­ter their own reg­u­la­tions on pharma patents. This be­comes clear from the ustr’s Su­per 301 Re­port which com­plains about the rules in coun­tries as di­verse as Brazil and Canada.

The most trou­ble­some of the In­dian pro­vi­sions for drug multi­na­tion­als is Sec­tion 3d which bars patents for in­cre­men­tal changes to an ex­ist­ing drug un­less these can prove en­hanced ef­fi­cacy. It is this key safe­guard that ap­pears to have in­spired a hand­ful of other coun­tries to de­fine patentabil­ity of drugs in no-non­sense terms. Ar­gentina, for in­stance, has tight­ened the cri­te­ria for the grant­ing of patents by putting com­po­si­tions, dosages, salts, es­ters and ethers, poly­morphs, and other derivates of a mol­e­cule un­der a strict scan­ner.The guide­lines used by the South Amer­i­can na­tion are a car­bon copy of In­dia’s Sec­tion 3d. Then there is Brazil whose ac­tions are mak­ing the US dis­tinctly edgy. Its health author­ity, the Na­tional San­i­tary Reg­u­la­tory Agency, has been au­tho­rised to re­view drug patent ap­pli­ca­tions for patentabil­ity re­quire­ments. Canada ap­pears to have gone a step fur­ther with its ju­di­ciary im­pos­ing height­ened util­ity re­quire­ments for patents.

It is ab­so­lutely vi­tal that more such coun­tries band to­gether to es­tab­lish a bal­anced ap­proach to patents be­fore a lethal trade agree­ment is con­cluded.Un­der ne­go­ti­a­tion is the Trans-Pa­cific Part­ner­ship treaty through which the US is seek­ing to ad­vance its most am­bi­tious IP max­i­mal­ist agenda.It goes way be­yond what the World Trade Or­ga­ni­za­tion rules de­mand and it needs to be stopped.


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