Fed­er­al ap­peals court over­turns $137M patent ver­dict against Roche — but the case is­n't closed just yet

A fed­er­al ap­peals court over­turned a $137 mil­lion ver­dict against Roche Di­ag­nos­tics on Fri­day in a Delaware patent in­fringe­ment case — but the phar­ma gi­ant isn’t com­plete­ly out of the woods.

While the court ruled that Roche did not in­duce cus­tomers to use its Cobas di­ag­nos­tics ma­chines in a way that in­fringed up­on three Meso Scale patents, it main­tained that Roche di­rect­ly in­fringed up­on one of its patents, and or­dered a new dam­ages tri­al.

The patents in ques­tion sur­round im­munoas­says that ex­ploit elec­tro­chemi­lu­mi­nes­cence (ECL), or the use of elec­trons and light to de­tect and mea­sure the pres­ence of spe­cif­ic mol­e­cules in a sam­ple — for ex­am­ple, virus mol­e­cules in a blood sam­ple. Roche’s Cobas ma­chines use ECL for a wide va­ri­ety of tests.

Meso ar­gues that IGEN In­ter­na­tion­al grant­ed it ex­clu­sive rights to the patent claims it’s now bring­ing against Roche over the use of its Cobas tests, ac­cord­ing to court doc­u­ments.

In 1998, Roche ac­quired Boehringer Mannheim, which had pre­vi­ous­ly li­censed ECL rights from IGEN. Roche in­her­it­ed Boehringer’s rights, and in 2003, Roche and IGEN formed a new agree­ment that grant­ed Roche nonex­clu­sive rights to the ECL tech in the field of “hu­man pa­tient di­ag­nos­tics.”

IGEN lat­er trans­ferred its rights to BioVeris, which Roche snapped up in 2007 for about $600 mil­lion. At the time, the com­pa­ny an­nounced that it would now own the full patent rights to the ECL tech, and be­gan sell­ing the prod­ucts out­side of its pri­or field re­stric­tions.

But in 2010, Meso sued Roche, al­leg­ing the com­pa­ny breached its 2003 li­cense with IGEN by vi­o­lat­ing the field re­stric­tion.

In 2019, a ju­ry found that Roche in­duced cus­tomers to use the Cobas ma­chines in a way that vi­o­lat­ed three of Meso’s patents, and di­rect­ly in­fringed on one of the patents. The ju­ry award­ed Meso $137 mil­lion in dam­ages — but Judge Leonard Stark tacked on in­ter­est, bring­ing the amount up to $170 mil­lion, ac­cord­ing to a Reuters re­port.

On Fri­day, a pan­el of judges ruled that Meso failed to prove that Roche in­tend­ed for its Cobas users to vi­o­late the patent rights, but up­held that Roche di­rect­ly in­fringed on one of Meso’s patents.

How­ev­er, Judge Pauline New­man dis­sent­ed, ar­gu­ing that “Roche can­not in­fringe patents it owns.”

“In 2007, Roche pur­chased the patents in suit from IGEN In­ter­na­tion­al, via IGEN’s patent-hold­ing com­pa­ny BioVeris Cor­po­ra­tion. Meso Scale Di­ag­nos­tics (MSD or Meso) does not own or have ex­clu­sive rights to these patents, and has no right to con­trol their use in ar­eas out­side of the des­ig­nat­ed Re­search Pro­gram,” she wrote.

Roche has not re­spond­ed to a re­quest for com­ment.

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.

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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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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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 clinicaltrials.gov, 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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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.

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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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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