Al­ler­gan and its Mo­hawk al­lies pitch their sov­er­eign im­mu­ni­ty case to SCO­TUS. And the tim­ing could­n't be worse

Al­ler­gan {AGN} is tak­ing its case against in­ter partes re­view all the way to the Supreme Court — pro­vid­ed SCO­TUS agrees to hear their at­tor­neys.

Bioreg­num Opin­ion Col­umn by John Car­roll

The biotech com­pa­ny made its pitch to the Supreme Court along­side the Mo­hawk tribe that took the patents on Resta­sis, Al­ler­gan’s big block­buster, as the com­pa­ny tried to wall it­self off from gener­ic man­u­fac­tur­ers. But the courts, in­clud­ing a fed­er­al ap­peals court, have ruled against the com­pa­ny and the tribe.

That leaves one last stop to see if the high­est court in the land will back them up.

There’s no guar­an­tee­ing that Al­ler­gan will get its day in the Supreme Court. The court still has sev­er­al weeks to de­ter­mine if they want to put it on the cal­en­dar. But its at­tor­neys are giv­ing it their best shot, ar­gu­ing that the fed­er­al ap­peals court over­looked key de­ci­sions by the Supreme Court that they be­lieve back their case. They al­so asked the court to pro­vide some clar­i­ty on the ex­tent of sov­er­eign im­mu­ni­ty that In­di­an tribes ppos­sess, which the Mo­hawks used in their le­gal gam­bit to ward off the gener­ic ri­vals.

Al­ler­gan and the Mo­hawks have made lit­tle progress in their heat­ed quest against IPRs, which they be­lieve cre­ates a kind of dou­ble jeop­ardy for drug de­vel­op­ers try­ing to pro­tect their drugs. Their ar­gu­ment in­volv­ing the Mo­hawks — that the tribe con­trols the patents and they are im­mune to the IPR process — has been ridiculed by law­mak­ers who back the no­tion that Al­ler­gan CEO Brent Saun­ders was sim­ply leas­ing out sov­er­eign im­mu­ni­ty to guard its biggest drug fran­chise.

In the pitch to the Supreme Court, though, Al­ler­gan as­sert­ed that the trans­ac­tion — pay­ing $13.75 mil­lion up­front for the deal with $15 mil­lion a year due in quar­ter­ly in­stall­ments — isn’t a sham. The tribe, for ex­am­ple, has the re­al au­thor­i­ty to con­duct tri­als of its own us­ing this drug for oth­er in­di­ca­tions out­side the patent. But this pitch along with many of their oth­er ar­gu­ments have test­ed the creduli­ty of long­time ob­servers — as well as judges — watch­ing the case pro­ceed.

The tim­ing couldn’t be worse for the in­dus­try.

Right now there’s grow­ing ev­i­dence that the phar­ma in­dus­try is one of the least-liked groups in the coun­try. Ar­gu­ing to SCO­TUS about deals with In­di­an tribes to pro­tect brand­ed drugs, while boost­ing the price of their top ther­a­pies by 9.5%, is ex­act­ly the kind of event phar­ma would like­ly pre­fer to live with­out in 2019.

For the in­dus­try, the on­ly thing worse about mak­ing this case would be win­ning it.

Im­age: Brent Saun­ders. AP IM­AGES

John Hood [file photo]

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