Chip­ping away

Why is In­dia back­ing down on its strict patentabil­ity cri­te­ria on drugs and cut­ting ac­cess to life-sav­ing drugs?

Down to Earth - - CONTENTS -

The Union gov­ern­ment is bow­ing to pres­sure from west­ern drug gi­ants and di­lut­ing its drug patentabil­ity cri­te­ria, cut­ting ac­cess to livesav­ing drugs

PRIME MIN­IS­TER Narendra Modi re­cently made an in­ter­est­ing speech on how na­tions that for­get their her­itage lose their iden­tity. The PM re­minded us that na­tions can­not progress un­less they val­ued and cher­ished their his­tory and her­itage, a les­son most In­di­ans are in dire need of be­ing told—again and again. He was not re­fer­ring to the con­tro­versy over the Taj Ma­hal, which his party’s mem­ber of par­lia­ment, the no­to­ri­ously com­mu­nal Sangeet Som, had de­scribed as a blot on In­dia’s cul­ture. Modi was, in­stead, talk­ing about ayurveda, the an­cient sys­tem of medicine.

In­au­gu­rat­ing the All In­dia In­sti­tute of Ayurveda (aiia) in New Delhi on Oc­to­ber 17, he made an oblique at­tack on the Congress Party for not pre­serv­ing In­dia’s tra­di­tional knowl­edge (TK) such as Ayurveda and yoga be­cause of which In­dia had lost to other na­tion’s patents of many things that ex­isted here for cen­turies. Apart from the pub­lic em­bar­rass­ment of watch­ing the PM “in­au­gu­rate” an in­sti­tute that has been func­tional since 2010, Modi’s speech re­vealed a mud­dled un­der­stand­ing of patents and how TK is pro­tected.

The most prob­lem­atic of Modi’s state­ments was his claim that the gov­ern­ment was fo­cused on pro­vid­ing af­ford­able health­care by im­prov­ing af­ford­abil­ity and ac­cess to treat­ment. That claim doesn’t ap­pear to hold. Since the bjp-led nda regime came to power in 2014 there has been a flurry of patent ma­noeu­vres that have not boded well for its stated pol­icy of pro­vid­ing af­ford­able drugs. Not only did his gov­ern­ment rush to set up a point­less in­tel­lec­tual prop­erty (IP) think tank to for­mu­late a new IP pol­icy un­der US pres­sure, it has also done lit­tle to en­sure that mncs do not in­dulge in price goug­ing on new life-sav­ing drugs as other na­tions have done.

More wor­ry­ing is the ap­par­ent pres­sure on the Patent Of­fice to be more le­nient with its scru­tiny of mnc patent claims, spe­cially those from the US. These al­le­ga­tions have been float­ing around for a while now and have been given cre­dence by re­cent de­ci­sions of the Patent Of­fice. In­dia’s laws on the patentabil­ity cri­te­ria for pharma are far stricter than in most other coun­tries be­cause of Sec­tion 3d of the Patent Act which lists all that is not patentable. The US, of course, ab­hors this sec­tion and has been do­ing its ut­most to have the law re­pealed. Multi­na­tional drug firms have found it a tough bar­rier to ev­er­green­ing their patents which is the prac­tice of ex­tend­ing the life of patents by tak­ing out fresh iprs on new forms of a known mol­e­cule. Both the Patent Of­fice and the courts have till re­cently been scrupu­lous in up­hold­ing Sec­tion 3d.

But the ap­proach has been chang­ing and not sub­tly. In Au­gust, the Patent Of­fice stunned the In­dian generic drugs in­dus­try and pub­lic health or­gan­i­sa­tions world­wide by grant­ing a patent to Pfizer’s vac­cine against pneu­mo­nia, or pcv, that it mar­kets as Prevnar13. It was shock­ing be­cause the Pfizer patent had been re­jected by the Euro­pean Union for fail­ing the in­no­va­tion test. All of a sud­den, there has been a role re­ver­sal with In­dia ap­pear­ing keen to re­ward a drug gi­ant with un­mer­ited patents whereas the more lib­eral Euro­pean Patent Of­fice (epo) is ap­pear­ing stricter in grant­ing claims.

Global hu­man­i­tar­ian or­gan­i­sa­tion Médecins Sans Fron­tières (msf) con­tends that the method Pfizer has patented is too ob­vi­ous to get a patent and so has ri­val firm Merck which ar­gued suc­cess­fully at epo against it.

On Oc­to­ber 13, msf filed a pe­ti­tion be­fore the Delhi High Court to over­turn Pfizer’s pcv patent soon af­ter gener­ics maker Panacea Biotech filed a sim­i­lar re­view pe­ti­tion with the Patent Of­fice. This bat­tle is im­por­tant not just from the patent an­gle. In­dia car­ries the heav­i­est bur­den of global in­fant pneu­mo­nia deaths and this un­war­ranted patent makes it more dif­fi­cult to pro­vide ac­cess to life-sav­ing drugs. Is the gov­ern­ment aware of this?


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