Guardant Health fires back at Il­lu­mi­na suit, claim­ing re­tal­i­a­tion over its role in FTC an­titrust in­ves­ti­ga­tion

Two months ago, Il­lu­mi­na sued Guardant Health’s two co-founders (and ex-Il­lu­mi­na em­ploy­ees), Helmy El­toukhy and Ami­rali Ta­lasaz, al­leg­ing the pair stole trade se­crets, and used Il­lu­mi­na ser­vices and equip­ment to set up the com­pa­ny. At the time, Guardant hit back — claim­ing it was re­tal­i­a­tion.

“Il­lu­mi­na filed a law­suit against Guardant to pro­tect its in­tel­lec­tu­al prop­er­ty rights,” an Il­lu­mi­na spokesper­son wrote at the time. “There is no mer­it to Guardant’s claim that the law­suit was filed to sup­press com­pe­ti­tion in the mar­ket.”

Now Guardant Health has filed a mo­tion to dis­miss the case.

Filed on Wednes­day, the mo­tion is be­ing heard in the US Dis­trict Court in Delaware. The 32-page doc­u­ment starts to lay out Guardant’s first ar­gu­ment about the tim­ing of the case and delves head­first in­to its own ar­gu­ments for why the law­suit from Il­lu­mi­na was an act of re­tal­i­a­tion.

Ini­tial­ly, Il­lu­mi­na and Guardant have both been work­ing on de­vel­op­ing liq­uid biop­sy screen­ing tests to po­ten­tial­ly de­tect can­cer ear­li­er. And on this front, the com­pa­nies had been in a part­ner­ship to­geth­er — with Il­lu­mi­na sup­ply­ing se­quenc­ing in­stru­ments to Guardant, up­on which “Guardant’s can­cer de­tec­tion test­ing tech­nol­o­gy is built,” ac­cord­ing to Guardant.

The biotech fur­ther added in its open­ing mo­tion that this sup­ply part­ner­ship had been go­ing on for al­most a decade at this point, and ac­cord­ing to Il­lu­mi­na’s spokesper­son when the law­suit was first filed, the busi­ness re­la­tion­ship will re­main un­in­ter­rupt­ed.

Fast for­ward to 2021, Il­lu­mi­na spent $8 bil­lion to ac­quire Grail, which ac­cord­ing to Guardant is its main com­peti­tor. And while Eu­ro­pean and Amer­i­can reg­u­la­tors ob­ject­ed — with the FTC su­ing to try and stop the deal cit­ing po­ten­tial an­titrust law vi­o­la­tions, ac­cord­ing to the fil­ing — Il­lu­mi­na com­plet­ed the deal. And then it was short­ly a few months af­ter that deal of­fi­cial­ly closed that Il­lu­mi­na filed suit against Guardant. And from Guardant’s view, that tim­ing is an is­sue.

From the fil­ing:

The tim­ing of this law­suit re­veals Il­lu­mi­na’s true mo­tives. Il­lu­mi­na’s law­suit comes short­ly af­ter Guardant co­op­er­at­ed with the FTC in its an­titrust in­ves­ti­ga­tion of the pro­posed Il­lu­mi­na-GRAIL trans­ac­tion, and just two months af­ter two Guardant ex­ec­u­tives pub­licly tes­ti­fied against the trans­ac­tion dur­ing the FTC’s ad­min­is­tra­tive tri­al.

At­tor­neys for the de­fen­dants went on to say that Il­lu­mi­na ad­mits it knew about the al­leged “mis­ap­pro­pri­a­tion of con­fi­den­tial in­for­ma­tion since at least June 2019,” and said that Guardant’s own pub­lic patent ap­pli­ca­tions had been on­go­ing for longer than that. And ac­cord­ing to Guardant, wait­ing un­til re­cent­ly to file the law­suit makes clear that it is re­tal­ia­to­ry.

Fur­ther, the at­tor­neys claim that Il­lu­mi­na’s claims of mis­ap­pro­pri­a­tion are “time-barred” and must be dis­missed since the con­tent that Il­lu­mi­na is su­ing for was is­sued more than three years be­fore the suit was filed.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Sen. Maria Cantwell (D-WA) (Drew Angerer/Pool via AP)

Sen­ate com­mit­tee ad­vances PBM bill as bi­par­ti­san re­forms gain trac­tion

Pharmacy benefit managers are beginning to see enemies on both sides of the aisle: On Wednesday, a US Senate committee advanced to the full chamber a bill to increase PBM transparency and crack down on what lawmakers and critics say are deceptive practices.

The Senate Committee on Commerce, Science and Transportation advanced the bill by a bipartisan 18-9 vote, after hearing testimony last February documenting how PBMs control several key areas of the drug distribution and payment system. The Pharmacy Benefit Manager Transparency Act, introduced by committee chair Maria Cantwell (D-WA) and Budget Committee ranking member Chuck Grassley (R-IA), would make it unlawful for PBMs to engage in:

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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