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.

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
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John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Arc­turus ex­pands col­lab­o­ra­tion, adding $30M cash; Ku­ra shoots for $100M raise

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”

UP­DAT­ED: Chica­go biotech ar­gues blue­bird, Third Rock 'killed' its ri­val, pi­o­neer­ing tha­lassemia gene ther­a­py in law­suit

Blue­bird bio $BLUE chief Nick Leschly court­ed con­tro­ver­sy last week when he re­vealed the com­pa­ny’s be­ta tha­lassemia treat­ment will car­ry a jaw-drop­ping $1.8 mil­lion price tag over a 5-year pe­ri­od in Eu­rope — mak­ing it the plan­et’s sec­ond most ex­pen­sive ther­a­py be­hind No­var­tis’ $NVS fresh­ly ap­proved spinal mus­cu­lar at­ro­phy ther­a­py, Zol­gens­ma, at $2.1 mil­lion. A Chica­go biotech, mean­while, has been fum­ing at the side­lines. In a law­suit filed ear­li­er this month, Er­rant Gene Ther­a­peu­tics al­leged that blue­bird and ven­ture cap­i­tal group Third Rock un­law­ful­ly prised a vi­ral vec­tor, de­vel­oped in part­ner­ship with the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter (MSK), from its grasp, and thwart­ed the de­vel­op­ment of its sem­i­nal gene ther­a­py.

Neil Woodford. Woodford Investment Management via YouTube

Wood­ford braces po­lit­i­cal storm as UK fi­nan­cial reg­u­la­tors scru­ti­nize fund sus­pen­sion

The shock of Neil Wood­ford’s de­ci­sion to block with­drawals for his flag­ship fund is still rip­pling through the rest of his port­fo­lio — and be­yond. Un­der po­lit­i­cal pres­sure, UK fi­nan­cial reg­u­la­tors are now tak­ing a hard look while in­vestors con­tin­ue to flee.

In a re­sponse let­ter to an MP, the Fi­nan­cial Con­duct Au­thor­i­ty re­vealed that it’s opened an in­ves­ti­ga­tion in­to the sus­pen­sion fol­low­ing months of en­gage­ment with Link Fund So­lu­tions, which tech­ni­cal­ly del­e­gat­ed Wood­ford’s firm to man­age its funds.

Gilead baits new al­liance with $45M up­front, div­ing in­to the busy pro­tein degra­da­tion field

Gilead is jump­ing on board the pro­tein degra­da­tion band­wag­on. And they’re turn­ing to a low-pro­file Third Rock start­up for the ex­per­tise. But if you were look­ing for a trans­for­ma­tion­al deal to kick up fresh en­thu­si­asm for Gilead, you’ll have to re­main pa­tient.

This one will have a long way to go be­fore they get in­to the clin­ic.

The big biotech said Wednes­day morn­ing that it is pay­ing $45 mil­lion up­front and re­serv­ing a whop­ping $2.3 bil­lion in biotech bucks if San Fran­cis­co-based Nurix can point the way to new can­cer ther­a­pies, as well as drugs for oth­er, un­spec­i­fied dis­eases.

Af­ter watch­ing its share price soar on a Bloomberg re­port and heat­ed ru­mors, Bio­haven stock takes a bil­lion-dol­lar bath

Back in April, Biohaven Pharmaceutical became one hot biotech stock $BHVN based on a report in Bloomberg that some “potential bidders” had been kicking the tires at the biotech, which has a lead drug for migraines. Then the rumor mill really started to smoke when execs canceled a presentation at an investor conference a little more than a week ago.

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