Il­lu­mi­na strikes $325M deal to end years-long patent bat­tles

Af­ter spend­ing the last 10-plus years in court, Il­lu­mi­na and BGI Group have reached a $325 mil­lion set­tle­ment to re­solve a num­ber of patent and an­titrust claims across the US cen­tered around the com­pa­nies’ DNA se­quenc­ing tech­nol­o­gy.

Il­lu­mi­na is fork­ing over the $325 mil­lion to set­tle claims fol­low­ing two re­cent ju­ry de­ci­sions in Delaware and Cal­i­for­nia, as well as an an­titrust case in Cal­i­for­nia, ac­cord­ing to a state­ment on Thurs­day from MGI Tech, a BGI af­fil­i­ate.

As part of the deal, each par­ty will drop any chal­lenges to the Cal­i­for­nia and Delaware ju­ry de­ci­sions, and Il­lu­mi­na gets a li­cense to the fam­i­ly of patents that BGI as­sert­ed in Delaware.

In 2010, Il­lu­mi­na filed a com­plaint in Cal­i­for­nia against Com­plete Ge­nomics, an MGI sub­sidiary, al­leg­ing that the com­pa­ny in­fringed on three of its DNA se­quenc­ing patents with the lat­ter com­pa­ny’s “Com­plete Ge­nomics Analy­sis Plat­form.” In re­sponse, Com­plete Ge­nomics as­sert­ed that Il­lu­mi­na had “at­tempt­ed to achieve mo­nop­oly pow­er in genome se­quenc­ing tech­nol­o­gy.”

In a lat­er Delaware case, Com­plete Ge­nomics ac­cused Il­lu­mi­na of in­fring­ing on its own patents with “two-chan­nel” se­quenc­ing sys­tems, kits to pre­pare DNA frag­ments for se­quenc­ing and kits to im­mo­bi­lize, am­pli­fy and se­quence frag­ments. The com­pa­ny al­so filed an an­ti­com­pet­i­tive suit against Il­lu­mi­na in Delaware last year.

Back in No­vem­ber, a fed­er­al ju­ry ruled that four of Il­lu­mi­na’s five patents in the Cal­i­for­nia case were valid, award­ing it $8 mil­lion, ac­cord­ing to a Law360 re­port. But in May, a Delaware ju­ry de­cid­ed that Il­lu­mi­na owes Com­plete Ge­nomics more than $333 mil­lion for in­fring­ing on two patents, court doc­u­ments state.

This lat­est set­tle­ment should put an end to the storm of law­suits — at least for a while. Ac­cord­ing to MGI’s state­ment:

The par­ties al­so agree to a three-year pe­ri­od of peace with re­spect to claims of U.S. patent in­fringe­ment and vi­o­la­tions of any an­titrust or un­fair com­pe­ti­tion laws of the Unit­ed States, dur­ing which time they will not sue each oth­er or re­spec­tive cus­tomers in the Unit­ed States or ac­crue li­a­bil­i­ty for ex­ist­ing plat­forms.

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

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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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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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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.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.

Stanley Erck, Novavax CEO (Andrew Harnik/AP Images)

No­vavax pulls out of Covid-19 vac­cine al­liance with Gavi

Novavax is pulling out of its Covid-19 vaccine deal with Gavi, the Vaccine Alliance, a global partnership tasked with ensuring vaccine access in lower-income countries, following an alleged contract violation.

The Maryland-based company claimed on Friday that Gavi failed to purchase at least 350 million doses of its protein-based vaccine Nuvaxovid by the end of the year, per an advanced purchase agreement. Gavi, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI) are co-leaders of COVAX, an effort to ensure that all participating countries, regardless of income levels, have access to vaccines.

Fu­ji­film to build $188M man­u­fac­tur­ing plant in North Car­oli­na’s re­search tri­an­gle

As the Japanese conglomerate Fujifilm continues to invest heavily in its CDMO arm, one of its manufacturing divisions is teeing up a major investment.

Fujifilm Irvine Scientific announced on Tuesday that parent Fujifilm is making a $188 million investment to build a cell culture media manufacturing site in the Research Triangle Park in North Carolina. The new site will mark Fujifilm Irvine’s fifth manufacturing site globally and its second in the US.