HC Re­verts Sta­tus of Roche’s Case Against Bio­con, My­lan

On Apr 25, court had or­dered pack­ag­ing changes to copies of Swiss co’s can­cer drug

The Economic Times - - Companies: Pursuit Of Profit - Vikas.Dan­dekar@ times­group.com

Mum­bai: A divi­sion bench of the Delhi High Court has re­verted the sta­tus of the case where Swiss biotech gi­ant Roche had sued Bio­con and My­lan over copies of block­buster breast can­cer drug Tras­tuzumab sold in In­dia. The case is to be heard on May 10. On April 25, the Delhi High Court sided with Roche and or­dered cer­tain la­belling and pack­ag­ing changes to the prod­ucts of Bio­con and My­lan while ques­tion­ing the reg­u­la­tory ap­proval process for the drug. How­ever, with the lat­est de­ci­sion of the bench, the sta­tus will be back as it ex­isted be­fore the re­lease of the April 25 or­der, ex­perts noted.

Ac­cord­ing to le­gal sources, the divi­sion bench ex­ten­sively quizzed both the op­pos­ing sides.

Sources said the coun­sel for My­lan strongly ar­gued that the April 25 or­der of the sin­gle-judge bench had in­tro­duced is­sues like data ex­clu­siv­ity (clin­i­cal test data sub­mit­ted to the reg­u­la­tory agency for ap­proval of the prod­uct), which was not part of the present le­gal pro­vi­sions in In­dia.

As part of the April 25 or­der, the sin­gle- judge bench had held that “un­less the gov­ern­ment of In­dia frames pol­icy to de­clare as to whether af­ter ex­piry of patent, the data in public do­main can be used as path­ways or not, the reg­u­la­tory au­thor­ity can nei­ther dis­close nor rely upon the first ap­pli­cant’s data at the time of grant­ing mar­ket­ing ap­proval to the sub­se­quent ap­pli­cants. It is for the gov­ern­ment to de­cide that such pro­tec­tion for cer­tain fixed pe­riod to the in­no­va­tor should be granted or not”.

That apart, le­gal rep­re­sen­ta­tives for Bio­con and My­lan backed the ap­proval pro­cesses fol­lowed by the In­dian reg­u­la­tory au­thor­ity, not­ing that gener­ics and biosim­i­lars are ap­proved across the world by fol­low­ing an ab­bre­vi­ated path­way.

In a note to ET, Roche main­tained: “De­spite to­day's de­vel­op­ments, the sit­u­a­tion for pa­tients and physi­cians re­mains un­changed as there is still no ev­i­dence that th­ese prod­ucts have met the re­quire­ments of the biosim­i­lar frame­work or any other reg­u­la­tory path­way in In­dia”.

Coun­sel for My­lan ar­gued April 25 or­der in­tro­duced data ex­clu­siv­ity, which was not part of present le­gal pro­vi­sions in In­dia

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