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.

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.”

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.

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.

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.