Covid vac­cine patent land­scape heats up as Pfiz­er's part­ner sues Ar­bu­tus and Genevant

The patent land­scape around the two top Covid-19 vac­cines is get­ting more com­plex and con­test­ed by the day.

Most re­cent­ly, Cana­di­an biotech Acuitas sued Ar­bu­tus and Genevant, two com­pa­nies that Acuitas be­lieves are mak­ing base­less claims about be­ing near the heart of Pfiz­er and BioN­Tech’s and Mod­er­na’s wild­ly suc­cess­ful Covid-19 vac­cines.

The suit comes as Acuitas’ LNP, or lipid nanopar­ti­cle, tech­nol­o­gy is used to de­liv­er Comir­naty via an es­tab­lished part­ner­ship. But the com­pa­ny says that “the de­fen­dants here, Ar­bu­tus and Genevant, had noth­ing to do with that suc­cess,” ac­cord­ing to a fil­ing Fri­day be­fore the US Dis­trict Court for the South­ern Dis­trict of New York.

Suf­fice to say Acuitas is not hap­py with Ar­bu­tus and Genevant’s claims.

“Ar­bu­tus and Genevant seek the ben­e­fits flow­ing from Comir­naty with­out hav­ing borne any of the bur­den of de­vel­op­ing it. Their claim to rights in— and pay­ment for— Comir­naty is base­less,” Acuitas added in their fil­ing.

The re­tort is sim­i­lar to one made by Mod­er­na last week as RNAi gi­ant Al­ny­lam Phar­ma­ceu­ti­cals has al­so sued the Boston biotech and Pfiz­er over sim­i­lar LNP in­tel­lec­tu­al prop­er­ty — seek­ing a “fair roy­al­ty” as com­pen­sa­tion. Ar­bu­tus and Genevant al­so sued Mod­er­na late last month in Delaware dis­trict court for patent in­fringe­ment over patents re­lat­ed to the com­pa­nies’ nu­cle­ic acid-lipid par­ti­cles and lipid vesi­cles. Ar­bu­tus and Genevant al­so ex­pressed their de­sire for a “rea­son­able war­ran­ty” from Mod­er­na’s Spike­vax sales.

For its part, a Mod­er­na spokesper­son has pre­vi­ous­ly told End­points News “we are con­fi­dent that Mod­er­na’s COVID-19 vac­cine is not cov­ered by those claims. Mod­er­na is a pi­o­neer of mR­NA-based vac­cines, and we have de­vel­oped our own pro­pri­etary LNP-de­liv­ery tech­nol­o­gy.”

In Acuitas’ 42-page com­plaint, the biotech is ask­ing the court to rule that Comir­naty does not in­fringe on any valid claims of any of Ar­bu­tus’s patents and that the court in­val­i­date the com­pa­ny’s re­lat­ed patents.

Genevant is a par­tial sub­sidiary of Roivant Sci­ences, which owns 84% of Genevant and Ar­bu­tus owns the rest. Roivant, Vivek Ra­maswamy’s for­mer firm, has al­so made in­vest­ments in­to Ar­bu­tus, in­clud­ing a $117 mil­lion in­vest­ment back in 2017.

Acuitas said in its fil­ing that Genevant and Ar­bu­tus had sent let­ters to Pfiz­er head­quar­ters back in 2020 and 2021, threat­en­ing to sue the big phar­ma and as­sert their patents.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

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One of the paintings from Gilead's latest campaign making AI art to help MBC patients be 'seen and heard.'

Gilead com­bines ar­ti­fi­cial in­tel­li­gence and art to draw at­ten­tion and hope to MBC

What if you could “see” the emotions and feelings of people living with metastatic breast cancer? That’s what Gilead Sciences’ agency VMLY&R Health did last year, using artificial intelligence and sound analytics to turn the interviews of three women living with metastatic triple-negative breast cancer into works of art.

Using the sound waves, a robotic painting device translated their stories of struggle and hope into colors, contours and brush strokes. The result? An art exhibition called “Paintings of Hope” that was first displayed at ESMO in September in Paris, but has since traveled to hospitals and medical conferences in Europe and Spain.

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