Rick Gonzalez, AbbVie CEO (AP Images)

'What’s wrong with hav­ing lots of patents?' Fed­er­al ap­peals judge sides with Ab­b­Vie in Hu­mi­ra case

A fed­er­al ap­peals court ruled in Ab­b­Vie’s fa­vor on Mon­day, up­hold­ing an Illi­nois court’s de­ci­sion to dis­miss al­le­ga­tions that the phar­ma gi­ant cre­at­ed an un­law­ful “patent thick­et” around its block­buster drug Hu­mi­ra.

Since its first ap­proval in rheuma­toid arthri­tis back in 2002, Hu­mi­ra has be­come one of the in­dus­try’s top sell­ers, snap­ping up a suite of new in­di­ca­tions rang­ing from ul­cer­a­tive col­i­tis to anky­los­ing spondyli­tis. The drug raked in more than $5.3 bil­lion last quar­ter. Its orig­i­nal patent ex­pired in 2016 — how­ev­er, Ab­b­Vie has ob­tained 132 ad­di­tion­al patents re­lat­ed to the drug, the last of which runs out in 2034.

Wel­fare-ben­e­fit plans that pay for Hu­mi­ra filed a com­plaint against Ab­b­Vie back in 2019, al­leg­ing that the com­pa­ny’s patents “scared off the com­peti­tors” and cre­at­ed a mo­nop­oly. The strat­e­gy has earned Ab­b­Vie sev­er­al crit­ics in­clud­ing Sen. Ron Wyden (D-OR), who likened CEO Richard Gon­za­lez’s patent of thick­ets to “Gol­lum with his ring.”

Ear­li­er this year, three Re­pub­li­can and three De­mo­c­rat sen­a­tors called on the US Patent and Trade­mark Of­fice to ad­dress phar­ma patent thick­ets ear­ly on, ar­gu­ing in a let­ter that the prac­tice “im­pedes gener­ic drugs’ pro­duc­tion, hurts com­pe­ti­tion, and can even ex­tend ex­clu­siv­i­ty be­yond the con­gres­sion­al­ly man­dat­ed patent term.”

Frank East­er­brook

A fed­er­al judge dis­missed the case against Ab­b­Vie back in 2020, and judge Frank East­er­brook up­held the de­ci­sion on Mon­day.

“But what’s wrong with hav­ing lots of patents?” he wrote in his opin­ion. “If Ab­b­Vie made 132 in­ven­tions, why can’t it hold 132 patents? The patent laws do not set a cap on the num­ber of patents any one per­son can hold—in gen­er­al, or per­tain­ing to a sin­gle sub­ject.”

The judge not­ed that tech com­pa­nies such as Ap­ple and Mi­crosoft have “much larg­er port­fo­lios of patents,” and “Thomas Edi­son alone held 1,093 U.S. patents.”

“Of course, in­valid patents can­not be used to cre­ate or pro­tect a mo­nop­oly. But our plain­tiffs have not of­fered to prove that all 132 patents are in­valid or in­ap­plic­a­ble to all po­ten­tial biosim­i­lar com­peti­tors, and it is far from clear that pay­ors would have stand­ing to make such an ar­gu­ment,” he wrote.

Ab­b­Vie will see some in­creased com­pe­ti­tion in the near fu­ture, as the com­pa­ny set­tled with biosim­i­lar de­vel­op­er Alvotech ear­li­er this year on when the lat­ter’s adal­i­mum­ab biosim­i­lar can launch. Though the biosim­i­lar has yet to be ap­proved by the FDA, the set­tle­ment re­moves any bar­ri­ers block­ing it from the mar­ket start­ing Ju­ly 1, 2023. The first Hu­mi­ra biosim­i­lar was ap­proved by the FDA in 2016, and Am­gen will be the first to launch its biosim­i­lar in late Jan­u­ary.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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Pros­e­cu­tors fail to ex­tend ex-GSK sci­en­tist­s' sen­tences in trade se­crets case

A federal appeals court on Tuesday denied prosecutors’ attempt to lengthen the sentences of two former GSK scientists who pleaded guilty to stealing trade secrets.

Yu Xue and Tao Li pleaded guilty back in 2018 to conspiracy to steal trade secrets, after they, along with others, formed a pharmaceutical company in China called Renopharma using hundreds of stolen documents from GSK, according to court documents. Xue, a former top chemist at GSK’s Upper Merion, PA, facility, was accused of stealing more than 200 documents, some of which contained trade secrets about pharmaceutical products under development, research data, and development and manufacturing processes.

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.