In­dia's patent of­fice has ig­nored the strict safe­guards against ever­green­ing and al­lowed a flood of sec­ondary drug patents


In­dia is ig­nor­ing safe­guards against du­bi­ous patents

THE IRONY, shock­ing in ev­ery way, is that the coun­try which passed unique safe­guards to bar du­bi­ous phar­ma­ceu­ti­cal patents is the one mer­rily al­low­ing such patent claims to go through unchecked. The irony is that In­dia has come un­der tremen­dous pres­sure from the US and the pow­er­ful lobby of the multi­na­tional drug com­pa­nies for these very same laws that the Patent Of­fice is re­fus­ing to ap­ply.

Pri­mar­ily, the is­sue re­lates to Sec­tion 3 of the In­dian Patents Act which lays down what are not in­ven­tions and, specif­i­cally to sub-sec­tions 3d, 3e and 3i. Of these, it is, of course, 3d which has in­vited the ire of the drug giants be­cause it bars patents on: “the mere dis­cov­ery of a new form of a known sub­stance which does not re­sult in the en­hance­ment of the known ef­fi­cacy of that sub­stance or the mere dis­cov­ery of any new prop­erty or new use for a known sub­stance or of the mere use of a known process, ma­chine or ap­pa­ra­tus un­less such known process re­sults in a new prod­uct or em­ploys at least one new re­ac­tant.” Even more than a decade and half af­ter In­dia passed its in­tel­lec­tual prop­erty laws to con­form to wto re­quire­ments, Sec­tion 3d con­tin­ues to be the tar­get of sys­tem­atic lob­by­ing by the drug ma­jors.

Yet, it turns out that In­dia’s Patent Of­fice has been com­pletely lax in ap­ply­ing these safe­guards while grant­ing a vast num­ber of pharma patents. A just re­leased study by a group of aca­demics, IP ex­perts and scientists re­veals that the ma­jor­ity of patents granted for phar­ma­ceu­ti­cals are sec­ondary patents, “granted for mar­ginal im­prove­ments over pre­vi­ously known drugs for which pri­mary patents ex­ist”. The re­port How our safe­guards against ever­green­ing have failed, and why the sys­tem must be re­formed de­tails the dis­mal state of af­fairs at In­dia’s Patent Of­fice.

It iden­ti­fies drug patents granted in likely con­tra­ven­tion of laws against ever­green­ing, that is, ex­tend­ing the life of a patent through mi­nor in­cre­men­tal changes, from a list of 2,293 patents granted be­tween 2009 and 2016. The re­searchers led by Feroz Ali, an ad­vo­cate of Madras High Court who holds the Depart­ment of In­dus­try Pol­icy and Pro­mo­tion (dipp) chair at the In­dian In­sti­tute of Tech­nol­ogy-Madras, scru­ti­nised the pros­e­cu­tion his­tory of some grants and the claim lan­guage of all granted patents to ar­rive at some shock­ing find­ings. As much as 72 per cent were sec­ondary patents granted for mar­ginal im­prove­ments on pre­vi­ously known drugs for which pri­mary patents ex­ist.

This, it turns out, is not the worst of what the re­searchers un­cov­ered. Just a frac­tion (15 per cent) of these sec­ondary patents was sub­ject to proper scru­tiny and is ac­com­pa­nied by a de­tailed writ­ten or­der of the Con­troller. In most cases, the rel­e­vant ex­cep­tion to patentabil­ity was not spelt or cited in de­tail in the fi­nal writ­ten or­der.

It’s a fact that the Patent Of­fice was, till a few years ago, short of ex­am­in­ers. But what would that ex­cuse such gross lax­ity on its part, spe­cially when scru­ti­n­is­ing patent claims un­der the lens of Sec­tion 3d? The re­port is use­ful be­cause it matches the var­i­ous sub­cat­e­gories of patents to the statu­tory ex­cep­tions to patentabil­ity that they vi­o­late.

It’s also true that IP an­a­lysts have found odd in­con­sis­ten­cies in the way the ipo op­er­ates while han­dling claims for dif­fer­ent sec­ondary patents for the same drug, al­low­ing some and re­ject­ing oth­ers with­out elu­ci­dat­ing the grounds for such ac­tion. What it does do is im­pact ac­cess to medicines for a va­ri­ety of diseases.

The re­port’s fi­nal point is that seven out of 10 patents granted by the ipo were “likely granted in er­ror”. And since no claim for a sec­ondary patent made “an ap­pro­pri­ate and valid sub­mis­sion”, all of them con­tra­vene the laws against ever­green­ing. The pharma giants should re­lax. Sec­tion 3d is not the lethal law it’s made out to be.


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