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.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,300+ biopharma pros reading Endpoints daily — and it's free.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,300+ biopharma pros reading Endpoints daily — and it's free.

James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,300+ biopharma pros reading Endpoints daily — and it's free.

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,300+ biopharma pros reading Endpoints daily — and it's free.

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,300+ biopharma pros reading Endpoints daily — and it's free.

Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,300+ biopharma pros reading Endpoints daily — and it's free.

President Joe Biden signs the Democrats' landmark climate change and health care bill. From L-R: Sen. Joe Manchin (D-WV), Senate Majority Leader Chuck Schumer (D-NY), House Majority Whip James Clyburn (D-SC), Rep. Frank Pallone (D-NJ) and Rep. Kathy Castor (D-FL). (Susan Walsh/AP Images)

Pres­i­dent Biden signs ma­jor drug pric­ing re­forms in­to law: What's com­ing for bio­phar­ma?

President Joe Biden yesterday afternoon signed into law historic, decades-in-the-making new drug pricing reforms as part of a wider reconciliation bill that will likely take a chunk out of biopharma companies’ profits for some blockbusters just prior to generic or biosimilar competition.

The partisan bill (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations — which won’t kick off until 2026, leaving ample time for a legal challenge — but mandatory inflation-related rebates, and a $2,000 annual cap on what seniors’ pay for their prescription drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,300+ biopharma pros reading Endpoints daily — and it's free.

Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.