Supreme Court toss­es Bris­tol My­er­s' bid to re­vive $1.2B CAR-T case against Gilead

In the lat­est set­back for Bris­tol My­ers Squibb in a years-long le­gal tus­sle with Gilead over a CAR-T patent, the Supreme Court of the Unit­ed States has de­clined to hear its pe­ti­tion to re­vive a $1.2 bil­lion ver­dict.

At its core, Bris­tol My­ers claimed that Gilead’s pi­o­neer­ing CAR-T, Yescar­ta, in­fringed on its patent re­lat­ing to the com­po­si­tion of a chimeric anti­gen re­cep­tor — the CAR in CAR-T — that can be ge­net­i­cal­ly en­gi­neered in­to a T cell.

While a fed­er­al court had sided with Bris­tol My­ers and or­dered Gilead to pay $1.2 bil­lion in dam­ages, an ap­peals court re­versed that rul­ing on the grounds that the patent in ques­tion was in­valid be­cause its “writ­ten de­scrip­tion” didn’t cov­er the full scope of the claimed in­ven­tion.

The Supreme Court case was a bid to re­in­state that award.

In its pe­ti­tion, Bris­tol My­ers ar­gued that in in­val­i­dat­ing its patent, the fed­er­al cir­cuit was “de­mand­ing the im­pos­si­ble” as it would re­quire in­ven­tors to out­line an “es­sen­tial­ly in­fi­nite num­ber” of po­ten­tial vari­a­tions in a patent. The de­ci­sion, it added, “rep­re­sents both bad law and bad pol­i­cy” and “may threat­en in­no­va­tion.”

Nei­ther Bris­tol My­ers Squibb nor Gilead was the orig­i­nal hold­er of the dis­put­ed patent or drug. The cen­tral patent, of­ten re­ferred to as ‘190 in court doc­u­ments, orig­i­nat­ed from Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter, which ex­clu­sive­ly li­censed it to Juno Ther­a­peu­tics. Juno first mount­ed the le­gal chal­lenge in 2017 be­fore Yescar­ta’s ap­proval — and be­fore it was ac­quired by Cel­gene; Cel­gene, in turn, was ac­quired by Bris­tol My­ers Squibb. Gilead in­her­it­ed the case when it bought Kite Phar­ma.

Bris­tol My­ers has some catch­ing up to do with Gilead on the mar­ket, earn­ing the first FDA ap­proval for Breyanzi, Juno’s CD19-tar­get­ed CAR-T, for large B-cell lym­phoma in 2021 — more than three years af­ter Yescar­ta first crossed the fin­ish line. Gilead al­so got a two-month head­start on ex­pand­ing the la­bel to in­clude the sec­ond-line set­ting, which it said could dou­ble the mar­ket size.

Gilead record­ed $823 mil­lion in Yescar­ta sales from the first nine months of 2022, while Bris­tol My­ers re­port­ed $127 mil­lion in Breyanzi sales over the same pe­ri­od.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Alzheimer’s drug bites the dust; Re­struc­ture, re­struc­ture, re­struc­ture; Land­mark di­a­betes OK; 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.

Being in the news business can give one a warped sense of time — it feels like quite a while since we published some of these stories below. But next Saturday’s Endpoints Weekly will definitely be shorter, as we take off Thursday and Friday for Thanksgiving. We will still have the abbreviated edition in your inbox at the usual time.

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J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Court KOs REMS-re­lat­ed patent list­ing for Jazz nar­colep­sy drug

A Delaware district court said sayonara to a Jazz Pharmaceuticals patent related to the distribution system for its blockbuster narcolepsy drug Xyrem.

The case at hand involves Avadel CNS Pharmaceuticals, which sought to delist the patent in question, as it related to its restricted distribution system under its REMS.

After listing the patent in the Orange Book, Jazz filed a patent infringement lawsuit against Avadel, triggering a 30-month stay that blocks final FDA approval of Avadel’s competing (and tentatively approved) narcolepsy drug, a once-nightly formulation of sodium oxybate, which compares with the twice nightly Xyrem.

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Karen Aiach, Lysogene CEO (RE(ACT) Discovery Institute)

Gene ther­a­py flunks PhII/III study, but for­mer Sarep­ta part­ner sees a path for­ward — if it can find the cash

The development path for Lysogene’s gene therapy for MPS IIIA has been a rocky one. After the FDA slapped a partial clinical hold on a Phase II/III study, a patient already dosed in the trial died, although it was deemed unrelated to treatment. Then earlier this year, Sarepta pulled out of their three-year partnership due to disagreements on who will handle commercial supply.

And now, Lysogene reported the trial has failed its primary endpoint.

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