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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Patrick Soon-Shiong (Evan Vucci/AP Images)

Up­dat­ed: Ar­bi­tra­tor awards $157M to Soon-Sh­iong's Im­mu­ni­ty­Bio in dis­pute with Sor­ren­to

Sorrento Therapeutics’ yearslong battle with NantCell and NANTibody has come to an arbitration award, but additional legal proceedings centered around a “catch-and-kill” scheme remain pending.

On Friday, the arbitrator in the dispute between Sorrento and NantCell and Immunotherapy NANTibody LLC issued an award that grants contractual damages and pre-award interest.

The arbitrator awarded NantCell (part of billionaire Patrick Soon-Shiong’s ImmunityBio) nearly $157 million and NANTibody close to $17 million. Post-award, prejudgment interest will accrue at 9% per annum, according to an SEC filing sent in by Sorrento.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.