Te­va wins $175M set­tle­ment af­ter ju­ry or­ders Eli Lil­ly to pay up on patent in­fringe­ment suit

Just one month af­ter the news that Te­va and Eli Lil­ly were go­ing to duke it out in fed­er­al court, a ju­ry has now come to a con­clu­sion.

And that con­clu­sion will cost Eli Lil­ly more than $175 mil­lion.

A ju­ry ver­dict in Mass­a­chu­setts dis­trict court was hand­ed down Wednes­day be­tween the Big Phar­ma and the gener­ics gi­ant. Per the ver­dict sheet, Eli Lil­ly has to pay Te­va a com­bined $176.5 mil­lion on three types of dam­ages: $90 mil­lion in past lost prof­its; $36.74 mil­lion in what the ju­ry deemed was a rea­son­able roy­al­ty fine at a 5% rate; and $49.8 mil­lion to be paid in fu­ture lost prof­its.

Te­va had orig­i­nal­ly sued Eli Lil­ly back in 2018, af­ter Te­va al­leged that Lil­ly in­fringed on nine patents with its mi­graine drug Em­gal­i­ty, a ri­val to its own treat­ment, brand­ed Ajovy. The ri­vals were both ap­proved in Sep­tem­ber 2018 as pre­ven­ta­tive treat­ments for mi­graines, de­signed to block a pro­tein called cal­ci­tonin gene-re­lat­ed pep­tide (CGRP) that has been as­so­ci­at­ed with mi­graine pain.

And while Em­gal­i­ty re­port­ed $577 mil­lion in sales in 2021, Te­va’s Ajovy made less — rough­ly $313 mil­lion in con­trast.

A Patent Tri­al and Ap­peal Board had pre­vi­ous­ly in­val­i­dat­ed six of the patents, leav­ing Te­va fight­ing to up­hold the oth­er three patents, re­ferred to by the ju­ry ver­dict Wednes­day as the “Zeller patents.”

The unan­i­mous ver­dict, on top of de­cid­ing dam­ages, al­so ruled that Te­va proved that Lil­ly will­ing­ly in­fringed on Te­va’s patents, and that Lil­ly did not prove its claim that Te­va’s patents were in­valid “for lack of writ­ten de­scrip­tion” and in­valid “for lack of en­able­ment.”

Just last month, a fed­er­al ap­pel­late court de­clined to in­val­i­date Te­va’s fi­nal three patents, while al­so de­clin­ing to de­cline a sum­ma­ry judge­ment in fa­vor of ei­ther Te­va or Eli Lil­ly.

Nei­ther Te­va nor Lil­ly re­spond­ed to re­quests for com­ment from End­points News be­fore pub­li­ca­tion.

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.

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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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Genen­tech to stop com­mer­cial man­u­fac­tur­ing at Cal­i­for­nia head­quar­ters

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate manufacturing operations from its South San Francisco headquarters location to other facilities or move the work to CDMOs, said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech has made changes in capabilities and invested more in technology, so it doesn’t need as many large-scale manufacturing facilities as it did in the past, she said.

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In­cyte wins ac­cel­er­at­ed ap­proval for PD-1 in rare skin can­cer

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

A new study finds that many patient influencers are sharing prescription drug experiences along with health information.

So­cial me­dia pa­tient in­flu­encers ‘danc­ing in the gray’ of phar­ma mar­ket­ing, more clar­i­ty need­ed, re­searcher says

It’s no surprise that patient influencers are talking about their health conditions on social media. However, what’s less clear is what role pharma companies are playing, how big the patient influencer industry is, and just how is information about prescription drugs from influencers relayed — and received — on social media.

While University of Colorado associate professor Erin Willis can’t answer all those questions, she’s been researching the issue for several years and recently published new research digging into the communication styles, strategies and thinking of patient influencers, many of whom partner with pharma companies.

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Drug short­age so­lu­tions brought be­fore Sen­ate Home­land Se­cu­ri­ty com­mit­tee

With more than 300 active drug shortages, the Senate Committee on Homeland Security and Governmental Affairs had its hands full on Wednesday with multiple experts testifying on drug shortages and possible solutions.

A picture of the shortage situation. presented by Erin Fox, an adjunct professor at the College of Pharmacy at the University of Utah, explained how some patients have died due to drug shortages, including with medication errors when substitutes were dosed incorrectly or when an emergency product was not available.

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FDA re­jects Ab­b­Vie's in­fu­sion ther­a­py for Parkin­son's, re­quests more in­fo on pump de­vice

The FDA rejected AbbVie’s 24-hour infusion therapy for Parkinson’s, saying it needs more information on a device used to administer the treatment before it can clear it.

The Chicago-area drugmaker said in a press release that the complete response letter from the agency didn’t include any requests for more efficacy or safety trials related to the drug, known as ABBV-951. The company said it aims to “resubmit the NDA as soon as possible.”

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