Mer­ck­'s last crack at sal­vaging a $2.5B ju­ry ver­dict in hep C patent show­down is shot down by ap­peals court

In De­cem­ber 2013, Gilead an­nounced the first pill that could cure he­pati­tis C. The same week, Idenix Phar­ma­ceu­ti­cals an­nounced it was su­ing Gilead for patent in­fringe­ment, a law­suit that would even­tu­al­ly de­mand over $2 bil­lion from the US drug­mak­er.

Near­ly six years lat­er, that dis­pute ap­pears to have fi­nal­ly con­clud­ed. In a de­ci­sion that may rip­ple across phar­ma, a fed­er­al ap­peals court ruled Gilead – which ac­quired the hep c drug when it pur­chased Phar­mas­set in 2011 – did not owe dam­ages to Idenix, now a sub­sidiary of Mer­ck. The rul­ing af­firms a 2018 re­ver­sal of a 2016 ju­ry de­ci­sion that orig­i­nal­ly award­ed $2.54 bil­lion to Idenix.

The de­ci­sion re­moves a large thorn from Gilead’s hep-c side and all but ends Mer­ck’s chances of sal­vaging some­thing from their ill-fat­ed $3.9 bil­lion ac­qui­si­tion of Idenix in 2014. (As the hep C mar­ket rapid­ly crowd­ed and sunk, Mer­ck filed a $2.9 bil­lion hit on the hep-c drug it ac­quired). But a de­ci­sion may have a broad­er im­pact than just on the flag­ging he­pati­tis C mar­ket, af­fect­ing phar­ma­ceu­ti­cal in­no­va­tion writ-large said Bri­an Fairchild, a life sci­ences in­tel­lec­tu­al prop­er­ty at­tor­ney at Good­win Proc­tor.

“It con­tin­ues a trend of strik­ing down patent claims that are not nar­row­ly fo­cused on one spe­cif­ic drug,” Fairchild wrote in an email to End­points News. 

Drug com­pa­nies have large­ly used patents to pro­tect from com­peti­tors mak­ing ex­act or very sim­i­lar copies of their drug, but re­cent­ly biotechs and large phar­ma­ceu­ti­cals have tried to use patents to stop oth­er com­pa­nies from hit­ting the same bi­o­log­i­cal tar­gets, Fairchild said. And it’s not yet clear if the law lets them do this.

So far the courts have de­cid­ed against com­pa­nies who have in­ter­pret­ed their IP this broad­ly be­cause of two is­sues in US patent law: “writ­ten de­scrip­tion” and “en­able­ment.”

When Ab­b­Vie sued J&J over Ste­lara, an an­ti­body that binds to IL-12, fed­er­al courts ruled that Ab­b­Vie’s patent failed the “writ­ten de­scrip­tion” re­quire­ment – it did not de­scribe the mas­sive ar­ray of com­pounds that could bind to IL-12. When Am­gen sued Sanofi and Re­gen­eron over the PC­SK9 an­ti­body Praulent, a dis­trict court ruled Am­gen had failed to reach the “en­able­ment” re­quire­ment – the re­quire­ment stat­ing a patent must have enough de­tail for a per­son trained in the field to be able to act on it. Am­gen failed be­cause the patent didn’t give enough guid­ance on which an­ti­bod­ies be­sides Am­gen’s would bind there.  That rul­ing, which came on Au­gust 30, will like­ly be ap­pealed.

The Gilead-Mer­ck case raised sim­i­lar ques­tions for a dif­fer­ent form of drugs, Fairchild said: chem­i­cals. Idenix said that Gilead worked off its key in­sight that a class of mol­e­cules – 2′-methyl-up nu­cle­o­sides – could be used to treat hep C. Gilead ar­gued their patent was “over­ly broad” and “pro­vides no guid­ance in de­ter­min­ing which of the bil­lions of po­ten­tial 2′-methyl-up nu­cle­o­sides are ef­fec­tive.”

Two out of three judges said Idenix failed on both of those re­quire­ments, en­able­ment and writ­ten de­scrip­tion. A third judge dis­sent­ed on the grounds that the orig­i­nal ju­ry had ev­i­dence to sup­port their con­vic­tion, and she said the rul­ing “pro­vides a new path of un­cer­tain­ty and un­re­li­a­bil­i­ty” for patents. Fairchild said that un­cer­tain­ty is re­al but lim­it­ed.

“Col­lec­tive­ly, these cas­es are un­like­ly to af­fect an in­no­va­tor’s abil­i­ty to pre­vent oth­ers from copy­ing a drug,” Fairchild said in an email “but they do call in­to ques­tion an in­no­va­tor’s abil­i­ty to pre­vent oth­ers from mar­ket­ing a drug that is on­ly mod­est­ly dif­fer­ent.”


Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: Mod­er­na sticks to Ju­ly for its Phase III as ru­mors swirl; Fol­low­ing US lead, EU buys up Covid-19 treat­ments

The Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.

A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.

GSK sets the stage for a toe-to-toe mar­ket show­down with Gilead­'s HIV cham­pi­on Tru­va­da

ViiV Healthcare and majority owner GlaxoSmithKline have cleared another important hurdle on a long-running quest to challenge Gilead’s dominance in preventative HIV treatments.

The final analysis of a new study shows the GSK subsidiary’s long-lasting injection, cabotegravir, proved 66% more effective in HIV prevention than Gilead’s breakthrough Truvada pill. And they now intend to carve away some of the blockbuster revenue that Gilead has enjoyed for years.

Stephen Hahn, AP

Trump and Navar­ro press again for hy­drox­y­chloro­quine. Can the FDA stay in­de­pen­dent?

Tuesday morning, economist and Trump advisor Peter Navarro walked onto the White House driveway and promptly brought a political cloud back onto the FDA.

Speaking to a White House pool reporter, Navarro said that four Detroit doctors were, based on a single disputed study, filing for the FDA to again issue an emergency authorization for hydroxychloroquine, the anti-malarial pill that President Trump hyped for months as a Covid-19 treatment over the objections of his own scientists. Then, while avoiding directly calling for the FDA to OK the drug, blasted the agency. He said its decision to pull an earlier authorization “was based on bad science” and “had a tremendously negative effect” on doctors and patients.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Zai Lab inks Chi­na deal with Turn­ing Point with $25M up­front; Xen­cor, Atre­ca team up on bis­pecifics

Zai Lab is paying out a $25 million upfront for the rights to sell Turning Point Therapeutics’ lead drug repotrectinib in Greater China. The San Diego-based biotech is also in line for up to $151 million in milestones, along with mid-to-high teen royalties. Zai plans to add sites to the Phase II trial of the drug, which is designed to treat ROS1-positive advanced NSCLC in patients who were not previously treated with a TKI.