Am­gen, GSK, Re­genxbio and oth­ers urge SCO­TUS to re­view 'dam­ag­ing' de­ci­sion on bio­med­ical patents

The Supreme Court should weigh in on a re­cent Fed­er­al Cir­cuit de­ci­sion that “de­fies his­to­ry and prece­dent” and could up­end the en­tire bio­phar­ma in­no­va­tion ecosys­tem, a group of drug­mak­ers and re­search in­sti­tu­tions told SCO­TUS in am­i­ci briefs this week, back­ing Bris­tol My­ers Squibb’s bid to re-re­view a case against Gilead’s Kite Phar­ma.

The case in ques­tion cen­ters on a CAR-T ther­a­py patent first ob­tained by Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter, which then com­mer­cial­ly de­vel­oped the ther­a­py un­der an ex­clu­sive li­cense to Juno, a com­pa­ny lat­er bought by Cel­gene for $9 bil­lion, and then ac­quired by BMS. But an­oth­er, sim­i­lar CAR-T ther­a­py was de­vel­oped with­out such a li­cense by Kite.

Drug­mak­ers and sev­er­al re­search in­sti­tu­tions are now back­ing BMS’ SCO­TUS re­quest, ex­plain­ing how the Fed­er­al Cir­cuit in­val­i­dat­ed Sloan Ket­ter­ing’s patent by ap­ply­ing an “un­work­able ” stan­dard that “strays from the statu­to­ry text.”

BMS asked SCO­TUS last month to re­in­state its $1.2 bil­lion ju­ry win against Kite, ar­gu­ing that the Fed­er­al Cir­cuit went too far in re­quir­ing that this “writ­ten de­scrip­tion of the in­ven­tion,” which it said must demon­strate the in­ven­tor’s “pos­ses­sion” of “the full scope of the claimed in­ven­tion,” in­clud­ing all “known and un­known” vari­a­tions of each com­po­nent.

“The CAR tech­nol­o­gy at is­sue in this case is em­blem­at­ic of the valu­able life­sav­ing re­search com­ing out of aca­d­e­m­ic re­search in­sti­tu­tions, whose fur­ther de­vel­op­ment ef­forts may be stymied by the de­ci­sion,” sev­er­al re­search and aca­d­e­m­ic cen­ters wrote in sup­port of BMS.

Am­gen, GSK, Bavar­i­an Nordic, Corn­ing and oth­ers al­so sup­port­ed BMS, ex­plain­ing how this de­ci­sion could make bio­med­ical com­pa­nies jump through new hoops and spend sig­nif­i­cant sums to meet this new “pos­ses­sion” re­quire­ment:

To even try to show that they have full ‘pos­ses­sion’ of their in­ven­tion, in­no­va­tors may have to ex­pend tremen­dous re­sources pro­duc­ing an ex­haus­tive cat­a­logue of every vari­a­tion of the in­ven­tive prod­uct. And when one con­sid­ers the cu­mu­la­tive ef­fort re­quired for every in­ven­tor to per­form that work for every patent ap­pli­ca­tion, the costs im­posed on the in­dus­try are tru­ly stag­ger­ing. That wastes re­sources that could be spent on fur­ther in­no­va­tion. And it adds noth­ing to the store of sci­en­tif­ic knowl­edge

Re­genxbio sim­i­lar­ly called the Fed­er­al Cir­cuit de­ci­sion a “mis­ap­pli­ca­tion” that “lessens in­ven­tors’ like­li­hood of re­coup­ing the cost­ly in­vest­ments nec­es­sary for ground­break­ing biotech­nol­o­gy and bio­med­ical in­no­va­tion, and it im­pedes the ob­jec­tive of the patent sys­tem to pro­mote the progress of the use­ful arts.”

Bi­o­log­ics and oth­er re­lat­ed in­ven­tions can of­ten be mod­i­fied in count­less mi­nor ways, the com­pa­nies note, with­out af­fect­ing their func­tion, which means they face spe­cial chal­lenges in meet­ing this new writ­ten-de­scrip­tion stan­dard.

The drug­mak­ers fur­ther note how this de­ci­sion could cre­ate more of an al­ready fer­vent me-too cul­ture among the bio­phar­ma in­dus­try.

“Com­pa­nies will in­creas­ing­ly es­chew high risk re­search that ad­dress­es the most press­ing and chal­leng­ing med­ical prob­lems in fa­vor of chas­ing cer­tain re­turns in the form of re­dun­dant ther­a­peu­tics to known bi­o­log­i­cal tar­gets. But with­out any in­vest­ment or ap­petite for in­no­va­tion, the stock of new ther­a­peu­tics to repli­cate will dry up,” the com­pa­nies’ lawyers wrote.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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David Reese, Amgen R&D chief

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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Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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Anna Protopapas, Mersana CEO

In $1.36B biobuck deal with GSK, Mer­sana touts 'biggest pre­clin­i­cal ADC deal ever'

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.

Steve Paul, Karuna Therapeutics CEO (Third Rock)

Karuna's schiz­o­phre­nia drug pass­es a close­ly-watched PhI­II test, will head to FDA in mid-2023

An investigational pill that combines a former Eli Lilly CNS compound with an overactive bladder drug was better than placebo at reducing a scale of symptoms experienced by patients with schizophrenia in a Phase III trial.

Karuna Therapeutics’ drug passed the primary goal in EMERGENT-2, the Boston biotech said early Monday morning, alongside quarterly earnings. The study is the first of Karuna’s four Phase III clinical trials to read out in schizophrenia and will provide the backbone to the biotech’s first drug approval application, slated for mid-2023.

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Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.