No­var­tis los­es patent ap­peal for block­buster MS drug, open­ing the door to gener­ic ri­vals

A US ap­pel­late court ruled against Swiss megaphar­ma No­var­tis in a patent in­fringe­ment dis­pute over its block­buster mul­ti­ple scle­ro­sis drug Gilenya, mak­ing room for gener­ics play­ers to swoop in and claim mar­ket share.

The US court of ap­peals for the fed­er­al cir­cuit hand­ed down the rul­ing in a 2-1 vote — re­vers­ing its own rul­ing from Jan­u­ary in the process. The case sur­rounds an AN­DA that HEC Pharm, a pri­vate Chi­nese out­fit, had filed with the FDA in an at­tempt to bring a gener­ic form of Gilenya to mar­ket. Gilenya had made the Big Phar­ma more than $2.7 bil­lion in sales last year and has been one of the phar­ma’s most prof­itable drugs in neu­ro­science.

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