Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

Ab­b­Vie has so far been suc­cess­ful in shoo­ing away com­pe­ti­tion to its megablock­buster Hu­mi­ra, de­ploy­ing a num­ber of patents and set­tle­ments to keep biosim­i­lars off the US mar­ket un­til 2023. But one Ice­landic drug­mak­er doesn’t want to wait — and on Tues­day, it filed a law­suit chal­leng­ing what it called a patent “mine­field.”

Alvotech has ac­cused Ab­b­Vie of try­ing to “over­whelm” and “in­tim­i­date” it with “an out­ra­geous num­ber of patents of du­bi­ous va­lid­i­ty,” ac­cord­ing to court doc­u­ments. The com­pa­ny is cur­rent­ly seek­ing ap­proval for its Hu­mi­ra copy­cat AVT02, which Ab­b­Vie says would in­fringe up­on 62 patents.

“Every com­pa­ny that has even hint­ed at chal­leng­ing Ab­b­Vie’s port­fo­lio in court has been threat­ened with at least 60 patents from Ab­b­Vie’s ‘mine­field,’ and each has set­tled with­out the mer­its of any sin­gle patent be­ing ad­dressed in court, with Ab­b­Vie se­cur­ing years of ad­di­tion­al time for its mo­nop­oly,” the com­plaint states.

If ap­proved, Alvotech says AVT02 would be the on­ly biosim­i­lar to match the strength of Ab­b­Vie’s lat­est Hu­mi­ra for­mu­la­tion (100mg/ml as op­posed to an ear­li­er 50 mg/ml ver­sion), which the phar­ma mar­kets as less painful. The drug­mak­er is re­quest­ing a de­clara­to­ry judge­ment that would ren­der the patents-in-suit in­valid and un­en­force­able.

Ab­b­Vie did not re­spond to a re­quest for com­ment.

The two com­pa­nies’ lawyers are al­ready well-ac­quaint­ed. Back in March, Ab­b­Vie filed suit against Alvotec, ac­cus­ing the Ice­landic drug­mak­er of steal­ing man­u­fac­tur­ing se­crets to cre­ate its copy­cat.

The al­leged scheme re­volves around the hir­ing of Rongzan Ho, a for­mer Ab­b­Vie team leader of Hu­mi­ra’s up­stream man­u­fac­tur­ing, who Ab­b­Vie ac­cused of email­ing “trade se­cret in­for­ma­tion” to his per­son­al email ac­count be­fore leav­ing the com­pa­ny for Alvotech. At the time, Alvotech said it “strong­ly dis­putes” the al­le­ga­tions, adding it’s been three years since the “pur­port­ed date of the al­leged wrong­do­ing,” and the em­ploy­ee in ques­tion no longer works for Alvotech.

In the new com­plaint, Alvotech called Ab­b­Vie’s law­suit “im­prop­er,” and said it start­ed de­vel­op­ing its man­u­fac­tur­ing process years be­fore Ho even start­ed at the com­pa­ny.

Ab­b­Vie has been called out by a host of crit­ics, in­clud­ing US law­mak­ers, for its patent-ag­gres­sive strat­e­gy to pro­tect Hu­mi­ra. When Ab­b­Vie’s main patent for Hu­mi­ra ran out in 2016, the com­pa­ny ap­plied for a raft of new patents — a move that was fur­ther strength­ened by agree­ments with Am­gen, Sam­sung Bioepis, and No­var­tis’ San­doz to keep biosim­i­lars off the US mar­ket un­til 2023.

The drug raked in more than $16 bil­lion in US sales in 2020 alone.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Janet Woodcock, acting FDA commissioner (Al Drago/Bloomberg via Getty Images)

New Alzheimer's drug ap­proval fall­out: Pub­lic Cit­i­zen seeks re­moval of FDA's Wood­cock, Cavaz­zoni and Dunn

As Capitol Hill begins to wake up to the financial and scientific mess behind the FDA’s approval of Biogen’s new controversial Alzheimer’s drug Aduhelm, nonprofit watchdog Public Citizen is now calling for the top three FDA officials who are responsible to be removed from their positions.

In a letter to HHS Secretary Xavier Becerra on Wednesday, the group highlighted the “litany of flaws” in the FDA’s approval of the new drug, including the “unprecedented, inappropriately close” collaboration between the FDA and Biogen in the analysis of key trial data, basing approval on an unvalidated surrogate endpoint, not following the advice of its expert advisory committee (3 members of which have since resigned), and the wide label that the agency granted.

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Aus­tralian spin­out eyes the clin­ic with a pro­phy­lac­tic nasal spray for Covid-19

Whether patients are immunocompromised or just don’t like needles, one fledgling Australian biotech says it has an alternative to Covid-19 vaccines that doesn’t involve a jab in the arm — and on Tuesday, it pulled in a fresh round of funding to take it into the clinic.

ENA Respiratory, which spun out of ENA Therapeutics last year, has pulled in nearly $24.7 million (AU $30 million) to advance its nasal spray for respiratory viral infections, the company said Tuesday.

Someit Sidhu, JATT

An­oth­er life sci­ences SPAC has popped up from a small biotech CEO with the help of Take­da, No­var­tis vet­er­ans

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

The SPAC train has slowed down since the extraordinarily high levels from late 2020 into early this year, but Tuesday saw the filing of a new blank-check company targeting the life sciences industry.

Jatt Acquisition submitted its SEC paperwork Tuesday, penciling in an estimated raise of $120 million as it sets its sights on a reverse merger partner. The SPAC is run by Someit Sidhu, a co-founder of Pathios Therapeutics, as well as CEO of Akaza Bioscience and Izana Bioscience. Sidhu will control about 97% of the blank-check company’s shares, per the S-1.

In a first, Re­gen­eron's an­ti­body cock­tail re­duces deaths for a sub­group of hos­pi­tal­ized Covid-19 pa­tients

Scientists have come up with the first evidence that Regeneron’s antibody cocktail, which has so far only been authorized for the outpatient setting, may reduce deaths of hospitalized Covid-19 patients — albeit only a subset.

The combination of casirivimab and imdevimab is the subject of the latest data cut from RECOVERY, the large-scale UK-based trial testing a variety of potential treatments. In total, 9,785 patients hospitalized with Covid-19 were enrolled in this arm of the study and were randomly assigned to receive either usual care plus the intravenous combo or usual care alone.

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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CEO Harith Rajagopalan (Fractyl)

Af­ter a decade in the type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”