MSF Takes Pfizer and Govt to Court Over Grant of Patent for Pneu­mo­nia Vac­cine

Aid or­gan­i­sa­tion wants to over­turn nod, claims Preve­nar13 is priced out of reach of many

The Economic Times - - Companies & Economy - Our Bu­reau

New Delhi: Two months af­ter US drug gi­ant Pfizer re­ceived a patent for its block­buster vac­cine to pre­vent cases of pneu­mo­nia, global aid or­gan­i­sa­tion Médecins Sans Fron­tières has moved the Delhi High Court to over­turn the de­ci­sion. The move sets in mo­tion one of the long stand­ing con­tentions of In­dia’s in­tel­lec­tual prop­erty law—that of in­cre­men­tal in­no­va­tion.

In Au­gust, the In­dian patent of­fice granted Pfizer a patent for its vac­cine PCV13 (13-va­lent pneu­mo­coc­cal con­ju­gate vac­cine), sold here un­der the brand ‘Preve­nar13’ for over 10 years.

Preve­nar13 vac­cine helps pre­vent pneu­mo­coc­cal pneu­mo­nia and in­fec­tions caused by 13 strains of strep­to­coc­cus pneu­mo­nia bac­te­ria, ac­cord­ing to Pfizer. It is ap­proved for chil­dren be­tween 6 weeks to 5 years and adults over 50 years of age, ac­cord­ing to the firm.

MSF has filed a pe­ti­tion with the Delhi High Court to set aside this patent, which it claims has “dashed hopes for im­proved ac­cess to an af­ford­able PCV13.” This is be­cause the patent would give Pfizer ex­clu­sive ac­cess to the In­dian mar­ket for this vac­cine un­til 2026.

The Delhi High Court has asked the gov­ern­ment to sub­mit a re­ply to MSF’s pe­ti­tion be­fore the next date of the hear­ing on Novem­ber 20, the or­gan­i­sa­tion’s coun­sel, Anand Grover, told ET.

“We aren’t aware of any pro­ceed­ings filed. How­ever, mean­ing­ful patent pro­tec­tion is vi­tal as it en­cour­ages med­i­cal progress, fur­ther in­vest­ment into dis­cov­ery and de­vel­op­ment of newer and ef­fec­tive medicines and vac­cines that ad­dress un­met med­i­cal needs of pa­tients in In­dia,” a Pfizer spokesper­son told ET.

MSF In­dia said it has ap­proached the high court be­cause the patent of­fice has “er­ro­neously” granted the patent to Pfizer, dis­re­gard­ing the ev­i­dence the hu­man­i­tar­ian aid or­gan­i­sa­tion pro­duced when it had op­posed the patent be­fore it was granted.

The phar­ma­ceu­ti­cal ma­jor’s claim to this patent is “spu­ri­ous” and the mere ad­di­tion of serotypes (the strains of the bac­te­ria) to an al­ready es­tab­lished 7-va­lent vac­cine was not a tech­ni­cal ad­vance­ment, stated the or­gan­i­sa­tion. “It was merely a tac­tic to pre­serve Pfizer’s mo­nop­oly for many more years,” stated MSF in a re­lease.

The vac­cine is priced out of reach of many par­ents, gov­ern­ments and treat­ment providers due to lack of suf­fi­cient com­pe­ti­tion from de­vel­op­ing coun­try vac­cine man­u­fac­tur­ers, said MSF. In the pri­vate mar­ket, Preve­nar 13 is priced at .₹ 3,800 per dose and three doses are re­quired for each child, ac­cord­ing to in­dus­try in­sid­ers.

Serum In­sti­tute and Panacea Biotec Ltd were ex­pected to be work­ing on more af­ford­able PCV vac­cines and Panacea had op­posed Pfizer’s patent ap­pli­ca­tion be­fore it was granted.

Preve­nar13 is cur­rently sup­plied by the Global Al­liance for Vac­cines and Im­mu­ni­sa­tions (GAVI) to In­dia at a sub­sidised rate of around $10 (.`641) for all three doses for its Univer­sal Im­mu­ni­sa­tion Pro­gramme. The brand cur­rently holds15% share of the In­dian vac­cines mar­ket, down from 18% the pre­vi­ous year, but still “leads” the pneu­mo­coc­cal vac­cines seg­ment here with 59.6% mar­ket share, ac­cord­ing to Pfizer’s 2017 an­nual re­port.

The patent ap­proval is ex­pected to give Pfizer a stronger foothold in the ₹ 1,700-crore pri­vate In­dian vac­cines mar­ket.The In­dian pneu­mo­coc­cal con­ju­gate vac­cines (PCV) mar­ket was val­ued at ap­prox­i­mately ₹ 400 crore in 2015 and was the high­est among pri­vate vac­cines, ac­cord­ing to a re­port com­mis­sioned by the Con­fed­er­a­tion of In­dian In­dus­try (CII).

In In­dia, Preve­nar13’s over­all rev­enue recorded a Com­pound An­nual Growth Rate of 25.4% in the 20142017 pe­riod, strongly driven by pri­vate mar­ket up­take in pe­di­atric & adult seg­ments, ac­cord­ing to Pfizer Ltd’s re­port. Pneu­mo­nia is one of the lead­ing causes of deaths of chil­dren un­der five years of age, with nearly a mil­lion deaths of chil­dren in this age group recorded in 2015 alone, ac­cord­ing to the World Health Or­gan­i­sa­tion. In­dia has seven pneu­mo­nia re­lated deaths per 1,000 live births, ac­cord­ing to the 2016 Pneu­mo­nia and di­ar­rhoea Progress Re­port by John Hop­kins Bloomberg School of Pub­lic Health.

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