Al­ler­gan and its Mo­hawk al­lies pitch their sov­er­eign im­mu­ni­ty case to SCO­TUS. And the tim­ing could­n't be worse

Al­ler­gan {AGN} is tak­ing its case against in­ter partes re­view all the way to the Supreme Court — pro­vid­ed SCO­TUS agrees to hear their at­tor­neys.

Bioreg­num Opin­ion Col­umn by John Car­roll

The biotech com­pa­ny made its pitch to the Supreme Court along­side the Mo­hawk tribe that took the patents on Resta­sis, Al­ler­gan’s big block­buster, as the com­pa­ny tried to wall it­self off from gener­ic man­u­fac­tur­ers. But the courts, in­clud­ing a fed­er­al ap­peals court, have ruled against the com­pa­ny and the tribe.

That leaves one last stop to see if the high­est court in the land will back them up.

There’s no guar­an­tee­ing that Al­ler­gan will get its day in the Supreme Court. The court still has sev­er­al weeks to de­ter­mine if they want to put it on the cal­en­dar. But its at­tor­neys are giv­ing it their best shot, ar­gu­ing that the fed­er­al ap­peals court over­looked key de­ci­sions by the Supreme Court that they be­lieve back their case. They al­so asked the court to pro­vide some clar­i­ty on the ex­tent of sov­er­eign im­mu­ni­ty that In­di­an tribes ppos­sess, which the Mo­hawks used in their le­gal gam­bit to ward off the gener­ic ri­vals.

Al­ler­gan and the Mo­hawks have made lit­tle progress in their heat­ed quest against IPRs, which they be­lieve cre­ates a kind of dou­ble jeop­ardy for drug de­vel­op­ers try­ing to pro­tect their drugs. Their ar­gu­ment in­volv­ing the Mo­hawks — that the tribe con­trols the patents and they are im­mune to the IPR process — has been ridiculed by law­mak­ers who back the no­tion that Al­ler­gan CEO Brent Saun­ders was sim­ply leas­ing out sov­er­eign im­mu­ni­ty to guard its biggest drug fran­chise.

In the pitch to the Supreme Court, though, Al­ler­gan as­sert­ed that the trans­ac­tion — pay­ing $13.75 mil­lion up­front for the deal with $15 mil­lion a year due in quar­ter­ly in­stall­ments — isn’t a sham. The tribe, for ex­am­ple, has the re­al au­thor­i­ty to con­duct tri­als of its own us­ing this drug for oth­er in­di­ca­tions out­side the patent. But this pitch along with many of their oth­er ar­gu­ments have test­ed the creduli­ty of long­time ob­servers — as well as judges — watch­ing the case pro­ceed.

The tim­ing couldn’t be worse for the in­dus­try.

Right now there’s grow­ing ev­i­dence that the phar­ma in­dus­try is one of the least-liked groups in the coun­try. Ar­gu­ing to SCO­TUS about deals with In­di­an tribes to pro­tect brand­ed drugs, while boost­ing the price of their top ther­a­pies by 9.5%, is ex­act­ly the kind of event phar­ma would like­ly pre­fer to live with­out in 2019.

For the in­dus­try, the on­ly thing worse about mak­ing this case would be win­ning it.


Im­age: Brent Saun­ders. AP IM­AGES

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While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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