Ab­b­Vie’s patent-ag­gres­sive US strat­e­gy for flag­ship Hu­mi­ra pays off, as judge dis­miss­es law­suit al­leg­ing an­ti­com­pet­i­tive ac­tiv­i­ty

Ab­b­Vie has long fierce­ly pro­tect­ed its flag­ship Hu­mi­ra — the world’s best­selling drug — with a patent rain­coat per­haps as durable as a Mack­in­tosh. And while it has made a se­ries of moves for a post-Hu­mi­ra fu­ture, no­tably the $63 bil­lion ac­qui­si­tion of Al­ler­gan, a US judge has ruled in fa­vor of the com­pa­ny against al­le­ga­tions that it en­gaged in an­ti­com­pet­i­tive con­duct to el­bow out ri­vals in the Unit­ed States.

The al­le­ga­tion is hard­ly nov­el. A host of crit­ics, in­clud­ing US law­mak­ers, have long ad­mon­ished the com­pa­ny’s patent-ag­gres­sive ap­proach to in­su­late Hu­mi­ra from US biosim­i­lar com­pe­ti­tion. Ab­b­Vie cur­rent­ly holds more than 100 patents for Hu­mi­ra and through deals it has eked out with ri­vals, the first US biosim­i­lar isn’t ex­pect­ed to hit the mar­ket un­til 2023 — two decades since the drug was first in­tro­duced.

In 2018 alone, the an­ti-in­flam­ma­to­ry bi­o­log­ic raked in peak sales of $20 bil­lion — or the cur­rent mar­ket cap­i­tal­iza­tion of In­cyte. Be­tween 2012 and 2018, it gen­er­at­ed US sales of more than $56 bil­lion.

When Ab­b­Vie’s main patent for Hu­mi­ra ran out in 2016, Ab­b­Vie ap­plied for a raft of new patents — sole­ly for the pur­pose of shield­ing the drug from any biosim­i­lar com­pe­ti­tion in the Unit­ed States, the com­plaint al­leged, adding that the move was fur­ther strength­ened by Ab­b­Vie’s agree­ments with ri­vals Am­gen, Sam­sung Bioepis, and No­var­tis’ San­doz to keep biosim­i­lars off the US mar­ket un­til 2023.

“Ab­b­Vie has ex­ploit­ed ad­van­tages con­ferred on it through law­ful prac­tices and to the ex­tent this has kept prices high for Hu­mi­ra, ex­ist­ing an­titrust doc­trine does not pro­hib­it it, US Dis­trict Judge Man­ish Shah wrote in an or­der dis­miss­ing the law­suit on Mon­day.

The plain­tiffs in the law­suit are in­di­rect pur­chasers of Hu­mi­ra, in­clud­ing the City of Bal­ti­more, an in­sur­ance trust fund for Mi­a­mi po­lice of­fi­cers and a ben­e­fit plan for pipe trade work­ers in Min­neso­ta.

Their al­le­ga­tions, that Hu­mi­ra com­pe­ti­tion was blocked in the Unit­ed States via a so-called “patent thick­et,” al­so high­light­ed that Ab­b­Vie has worked out deals with biosim­i­lar com­pa­nies to launch in Eu­rope de­spite ex­ist­ing patents there. In the first full year af­ter Eu­ro­pean biosim­i­lars launched, Hu­mi­ra’s in­ter­na­tion­al sales fell by 28% to $4.3 bil­lion.

Richard Gon­za­lez Ab­b­Vie

When grilled about Ab­b­Vie’s con­duct at a Con­gres­sion­al drug price hear­ing last year, Ab­b­Vie chief Richard Gon­za­lez said that while some Eu­ro­pean na­tions have bagged an 80% dis­count on Hu­mi­ra, the US price (about $4,500) of the drug and the sales it gen­er­ates is what keeps the com­pa­ny’s R&D en­gine hot.

Ab­b­Vie’s con­duct con­sti­tut­ed a “dis­parate set of ag­gres­sive but most­ly pro­tect­ed ac­tions to al­lege a scheme to harm com­pe­ti­tion and main­tain high prices,” the judge ac­knowl­edged on Mon­day.

But even when the al­le­ga­tions are “con­sid­ered broad­ly and to­geth­er for their po­ten­tial to re­strain trade, they “fall short of al­leg­ing the kind of com­pet­i­tive harm reme­died by an­titrust law,” he said.

His rea­sons for dis­miss­ing the law­suit were twofold — that the plain­tiffs’ the­o­ry of an­titrust in­jury was too spec­u­la­tive, and that Ab­b­Vie is large­ly pro­tect­ed by the No­err–Pen­ning­ton doc­trine.

The doc­trine, which de­vel­oped in the con­text of two US Supreme Court cas­es de­cid­ed dur­ing the 1960s, is a de­fense root­ed in the First Amend­ment. In essence, the doc­trine ren­ders a com­pa­ny or in­di­vid­ual im­mune from an­ti­com­pet­i­tive li­a­bil­i­ty if their ac­tiv­i­ty is a good-faith at­tempt to seek gov­ern­ment ac­tion, even if that ac­tion is in­ju­ri­ous to a com­peti­tor.

In Ab­b­Vie’s case, the com­pa­ny has as­sert­ed there is noth­ing il­le­gal about amass­ing a broad port­fo­lio of le­git­i­mate patents and that, even if a few were is­sued er­ro­neous­ly, the No­err–Pen­ning­ton doc­trine im­mu­nizes it from li­a­bil­i­ty.

The judge agreed.

“Here, the vast ma­jor­i­ty of the al­leged scheme is im­mu­nized from an­titrust scruti­ny, and what’s left are a few sharp el­bows thrown at so­phis­ti­cat­ed com­peti­tors par­tic­i­pat­ing in reg­u­lat­ed patent and bi­o­log­ic-drug regimes,” he said. “Some of Ab­b­Vie’s con­duct was not im­mu­nized by the No­err–Pen­ning­ton doc­trine—in­clud­ing what plain­tiffs al­lege to be the heart of their mo­nop­o­liza­tion claim—but much of what pre­ced­ed and fol­lowed that con­duct was im­mu­nized, which makes the en­tire­ty of al­leged mo­nop­o­liza­tion scheme im­mune, be­cause plain­tiffs’ the­o­ry de­pends on all the com­po­nents of Ab­b­Vie’s con­duct as the means to sup­press com­pe­ti­tion.”

Mean­while, Ab­b­Vie’s plan to fill the Hu­mi­ra-sized hole in its port­fo­lio is in full swing. The Al­ler­gan buy­out, which was con­sum­mat­ed in May, will rel­e­gate Hu­mi­ra to a 36% share of prod­uct sales and 40% of gross prof­it by the end of 2022, com­pared to 58% of rev­enue and 63% of gross prof­it last year, ac­cord­ing to cal­cu­la­tions by SVB Leerink an­a­lyst Ge­of­frey Porges.

The com­pa­ny has al­so se­cured the ap­proval of two fol­low-up an­ti-in­flam­ma­to­ry drugs that have been tapped as po­ten­tial block­busters: Rin­voq and Skyrizi. On Wednes­day, it al­so forked over $750 mil­lion in cash and up to $3.15 bil­lion more in mile­stones to al­ly with Gen­mab on a slate of 7 de­vel­op­ment and dis­cov­ery can­cer pro­grams.

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA’s work­load buck­les un­der the strain, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

President Donald Trump and FDA Commissioner Stephen Hahn (AP Images)

FDA is­sues fi­nal rule al­low­ing im­por­ta­tion of drugs from Cana­da — but al­so keeps the pow­er to re­voke it

Just over a month away from the presidential election, the FDA has issued a final regulation fulfilling President Trump’s promise to let states import certain prescription drugs from Canada.

On Thursday, Trump told a crowd in North Carolina that the new rule goes into effect “today.” But the published regulation states that it won’t take effect for 60 days. And even then, it could be a while before cheaper drugs make it across the border.

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,600+ biopharma pros reading Endpoints daily — and it's free.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”