Fed­er­al judges ban Al­ler­gan’s sov­er­eign im­mu­ni­ty scheme in a slap­down that will bol­ster in­ter partes re­view for years to come

Al­ler­gan ex­ecs had thought they had found a clever way to dodge the threat of in­ter partes re­view of the patents for their big block­buster Resta­sis. In the end, they $AGN paid a pret­ty price to bol­ster IPR, shut­ting and lock­ing the door to the path they took — all while stew­ing in some in­tense pub­lic in­dig­na­tion over the ef­fort.

A fed­er­al ap­peals court pub­lished their rul­ing Fri­day, con­clud­ing that the le­gal ar­gu­ment adopt­ed by Al­ler­gan and its al­lies at the St Reg­is Mo­hawk tribe that the tribe’s sov­er­eign im­mu­ni­ty pro­tect­ed it from IPR didn’t ap­ply here. Rather than a pri­vate dis­pute, the three-judge court con­clud­ed, IPR was more of an “agency en­force­ment ac­tion than a civ­il suit brought by a pri­vate par­ty, and we con­clude that trib­al im­mu­ni­ty is not im­pli­cat­ed.”

The lengthy rul­ing spelled out in ex­act­ing de­tail all the ear­li­er le­gal de­ci­sions that in­flu­enced their de­ci­sion, re­viewed My­lan’s as­ser­tion that the tribe was sim­ply rent­ing out their im­mu­ni­ty, and reached a sim­ple bot­tom line that may as well be writ­ten in neon: No phar­ma com­pa­ny can skirt IPR through the trib­al sov­er­eign im­mu­ni­ty scheme.

It was un­like­ly any­body else would give it a try, though.

Brent Saun­ders AP Im­ages

Click on the im­age to see the full-sized ver­sion

The mo­ment Al­ler­gan CEO Brent Saun­ders stepped for­ward as the com­pa­ny’s cham­pi­on for this, com­plain­ing of the dou­ble jeop­ardy pre­sent­ed by IPR on top of a con­ven­tion­al patent chal­lenge af­ter pay­ing the tribe $13.5 mil­lion to take the Resta­sis patents — and then es­sen­tial­ly leas­ing them back for $15 mil­lion a year — they guar­an­teed them­selves a pro­longed pub­lic beat­ing. 

It had every el­e­ment of a clever lawyer’s trick aimed sole­ly at guard­ing the fran­chise’s $1.5 bil­lion in an­nu­al rev­enue. Saun­ders’ de­ci­sion to act as the com­pa­ny’s chief spokesper­son, talk­ing up their role in fun­nel­ing bad­ly need­ed cash to a poor In­di­an tribe, was a dis­as­trous PR move. And it was all so ob­vi­ous. The fact that the Mo­hawk tribe op­er­ates a gam­bling casi­no in up­state New York sim­ply of­fered a bit of col­or no writer could ig­nore.

It all smelled of cyn­i­cism and greed — ex­act­ly what the in­dus­try needs to avoid as it con­fronts a di­rect chal­lenge over pric­ing pow­er. If the in­dus­try wants to jus­ti­fy rel­a­tive­ly high prices for new drugs, then the lead­ers have to show that they can re­lin­quish their ag­ing block­busters in fa­vor of cheap knock­offs. Here, we get an­oth­er ex­am­ple of want­i­ng it both ways.

Al­ler­gan has now been hand­ed re­peat­ed slap downs over this is­sue, along with the prospect of lengthy and cost­ly lit­i­ga­tion. The Patent Tri­al and Ap­peal Board shrugged off the trib­al claims last Feb­ru­ary. US Dis­trict Judge William Bryson said last fall he had some ma­jor con­cerns about the whole thing. Four gi­ant US re­tail­ers sued Al­ler­gan in May, claim­ing the com­pa­ny’s “an­ti­com­pet­i­tive” le­gal strat­e­gy had pre­vent­ed gener­ic com­pe­ti­tion for the past 4 years al­ready. And Sen­a­tor Claire Mc­Caskill, a De­mo­c­rat from Mis­souri, joined Re­pub­li­cans in brand­ing it all as a sham at­tempt to ex­ploit a le­gal loop­hole.

Al­ler­gan rep­re­sen­ta­tives aren’t com­ment­ing on the rul­ing, pre­fer­ring too late to stay mum about what they call con­tin­u­ing lit­i­ga­tion. But this fight is over, and Al­ler­gan lost. Gener­ic com­pe­ti­tion is like­ly to evis­cer­ate the fran­chise in a mat­ter of months.

Bio­phar­ma com­pa­nies that mar­ket brand­ed drugs hate IPR. But they can thank Al­ler­gan for clar­i­fy­ing its le­gal foun­da­tion in a way that guar­an­tees the re­view process will re­main a pow­er­ful weapon in the hands of gener­ics com­pa­nies.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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