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

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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.

Mer­ck is tak­ing the ax to its US op­er­a­tions, cut­ting 500 jobs in its lat­est re­or­ga­ni­za­tion

Merck is cutting 500 jobs in its US sales and headquarters commercial teams in its latest effort to find new ways to streamline the operation.

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Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

Jay Bradner has recruited a marquee oncology drug researcher into the ranks of the Novartis Institutes for BioMedical Research. Alice Shaw is jumping from prestigious posts intertwined through Mass General, Harvard and Dana-Farber to take the lead of NIBR’s translational clinical oncology group.

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Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

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Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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Flu Virus (Source: CDC)

FDA ex­pands Xofluza ap­proval as Roche strug­gles to catch loom­ing flu mar­ket

As a potentially powerful flu season looms, so does a big test for Roche and its new flu drug, Xofluza. The Swiss giant just got a small boost in advance of that test as the FDA expanded Xofluza’s indication to include patients at high risk of developing flu-related complications.

Xofluza (baloxavir marboxil) was approved last October in the US, the first landmark flu drug approval in 20 years and a much-needed green light for a company that had watched its leading flu drug Tamiflu get eaten alive by generics. Like its predecessor, the pill offered a reduction in flu symptoms but not a cure.

EMA backs sev­en ther­a­pies, in­clud­ing Mer­ck­'s Ebo­la vac­cine

The first-ever Ebola vaccine is on the precipice of approval after the European Medicine’s Agency (EMA) backed the Merck product in this week’s roster of recommendations.

The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.

The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.

Ronald Herb­st fol­lows Med­Im­mune ex­o­dus to Pyx­is CSO post; Jeff God­dard to suc­ceed CEO of AIT Bio­science

→ The outflow of top execs from MedImmune continues to fill the leadership ranks of smaller biotechs. The latest to take off is Ronald Herbst, the head of oncology research, who’s assuming the CSO post at Pyxis Oncology.  

Herbst was part of the old MedImmune organization AstraZeneca CEO Pascal Soriot restructured earlier this year, reorganizing the company and eliminating the storied subsidiary as a separate organization.

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Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

UP­DAT­ED: J&J's Xarel­to, Amar­in's Vas­cepa are cost-ef­fec­tive, not bud­get friend­ly — ICER

ICER, an increasingly influential cost-effectiveness watchdog in the United States, has concluded in its review of treatments for cardiovascular disease that while the cost of J&J’s Xarelto and Amarin’s Vascepa meet its benchmark for value pricing — the two treatments will not likely treat as many patients as hoped without surpassing the annual budget threshold calculated by ICER for each therapy.