Merck v. Merck: Likely Multi-Billion Dollar Name Litigation — Grinding Slowly To A Trial Date, In The New Jersey Federal Courts.

As we most recently mentioned just a week ago, it seems the settlement talks in this high stakes name fight have hit an impasse. So now this long running case (with satellite cases dotting the globe — in Japan, the EU, Britain and various South American geographies, to name just a few) is being served up, on a final trial prep calendar.

The trial proper, is not likely to begin much before early 2025 — and, of course — we may yet see settlement talks resume. Here’s the latest, though:

…TEXT ORDER:

The protocol for in limine motions is as follows: At the outset, each side will be allowed to file a maximum of three in limine motions. Each in limine motion will be filed as its own application, and not as part of a larger omnibus motion.

The maximum page limits are as follows: moving brief-15 double-spaced pages; opposition brief-15 double-spaced pages; reply brief-7 double-spaced pages. However, any in limine motion challenging Philip Green and/or Dr. Dominique Hanssens shall be limited to moving brief-30 double-spaced pages, opposition-30 double-spaced pages, reply-15 double-spaced pages.

The parties will not file the motions until they are fully briefed, at which time the entire set of motion papers shall be filed. Accordingly, the movant shall serve, but not file, all moving papers on the adversary by May 3, 2024. The opposing party will serve, but not file, the opposition papers by June 3, 2024. On or before June 24, 2024, the movant will file all papers in support, opposition, and in reply, for the motion with the Clerk of Court.

No further in limine motions may be filed without leave of the Court, which application shall not be made before the Court has resolved the motions authorized by this Order.

So Ordered by Magistrate Judge Michael A. Hammer on 3/6/2024….

I think the two experts — named, and linked — above, will testify on ongoing US and global marketplace effects, and whether confusion is evident in the minds of customers, suppliers, shareholders and providers; as well as whether intellectual property laws are being bent (or broken) here — and whether they (or the Lanham Act) fashion a workable remedy.

Now you know — and confidential to Hinderaker: yes, I think Mr. Biden will win populist “hearts & minds” tonight, by announcing an expanded push to use market incentives to reduce average selling prices of life-saving meds, as well as a new “billionaires’ taxes” scheme. So, buckle, up now — onward, into the Thursday morning sunshine… grin.

नमस्ते

Merck + Gilead: Still Only Prelim. Results, In An Open Label HIV+ Two Therapy Combo (Once A Week)… But Very Encouraging.

As we mentioned exactly three years ago, here — these are early days, in an entirely new way of approaching HIV+ patients. The loading is only once per week, and it is all oral (thus higher compliance). A huge step forward, with these two heavy-weights, cooperating since March 2021.

And now, the companies are showing very impressive real world sustained reductions in viral loads. Here’s the latest, from Fierce (but not quite a material development yet, for gargantuan Merck):

…Early results show that a weekly combination of Merck & Co.’s islatravir and Gilead’s approved HIV med Sunlenca maintained a high rate of viral suppression in patients with HIV, and just one patient out of 100 missed on the primary endpoint that measured viral load.

The open-label phase 2 study is testing islatravir 2 mg and lenacapavir 300 mg once a week against Gilead’s oral Biktarvy daily in 104 virologically suppressed adults….

[The dosing combo] maintained a high rate of viral suppression with 94% of the group reporting less than 50 copies/ML. This shows that patients who switched to the weekly combo, compared to Biktarvy’s daily dosing schedule, maintained comparable rates of HIV suppression, the companies explained.

No patients in the Biktarvy arm of the study had viral loads of more than 50 copies/ML at week 24.

Now you know. From a certain death sentence — in the 1980s and early 1990s. . . to long hospital stays and injections, in the late ’90s and early 2000s… to now, a full and active — and long life, here over forty years later. Wow… that’s… some seriously excellent life-science progress. Smile….

नमस्ते

The Mystery Of GN-z11 — From Monday Night — An Early Universe Epoch Story.

First — a bit of a primer on the graphic at right: In the top portion, at the far right, a small box identifies GN-z11 in a field of galaxies. The middle box shows a zoomed-in image of the galaxy. The box at the far left displays a map of the helium gas in the halo of GN-z11, including a clump that does not appear in the infrared colors shown in the middle panel. In the lower half of the graphic, a spectrum shows the distinct “fingerprint” of helium in the halo. The full spectrum shows no evidence of other elements and so suggests that the helium clump must be fairly pristine, made of hydrogen and helium gas left over from the big bang, without much contamination from heavier elements produced by stars. It is a complex topic, thus a complex graphic from the JWST team.

What it sets out is fairly simple, though: the first galaxies after the big bang have long been assumed to have been almost exclusively made of helium and hydrogen. Those, it was assumed, then collapsed, and re-ignited to form the complex multi-element galaxies like our modern Milky Way. But no observational proof existed for those Type II galaxies. Until now.

The new next gen space ‘scope has identified GN-z11, one of the oldest ever observed — and it is surrounded by an almost pure helium halo. That observation of infrared spectra is almost certainly from under 200 million years after the big bang. Here’s the full NASA / ESA story, and a bit of it:

…[Researchers have verified a pristine] gaseous clump of helium in the halo surrounding GN-z11 [one of the farthest, and thus oldest galaxies ever observed].

“The fact that we don’t see anything else beyond helium suggests that this clump must be fairly pristine,” said Maiolino. “This is something that was expected by theory and simulations in the vicinity of particularly massive galaxies from these epochs — that there should be pockets of pristine gas surviving in the halo, and these may collapse and form Population III star clusters.”

Finding the never-before-seen Population III stars — the first generation of stars formed almost entirely from hydrogen and helium — is one of the most important goals of modern astrophysics. These stars are anticipated to be very massive, very luminous, and very hot. Their expected signature is the presence of ionized helium and the absence of chemical elements heavier than helium.

The formation of the first stars and galaxies marks a fundamental shift in cosmic history, during which the universe evolved from a dark and relatively simple state into the highly structured and complex environment we see today….

Bit by bit, we are unraveling the darkly mysterious fabric of our earliest epochs, deep at the edge of the known universe. What a time to be… alive! Onward… with baby girls here later this afternoon — grin.

नमस्ते

Justice Alito Agrees: Texas Cannot Create Its Own CBP. Stayed Texas SB-4, Yesterday.

The Supremes’ “Time Out, on Texas SB-4” expires on March 14, 2024. But by then, the Fifth Circuit will have begun expedited processes to hear argument. And until it publishes a decision, SB-4 will remain in limbo.

Chalk one more up — for sanity.

From the Fifth Circuit papers filed tonight, then:

…For 150 years, the Supreme Court has been clear that no state can create an immigration system of its own. S.B. 4 defies this principle. It authorizes state officials to criminally punish people for that state officials determine to be an unlawful entry into the United States and unilaterally order people removed to Mexico. And it does so irrespective of the federal government’s view or the non-citizen’s federal statutory rights to remain in this country….

In S.B. 4, Texas has established a new state immigration system that entirely bypasses Congress’s comprehensive statutes. Texas has regulated and criminalized entry into the United States; chosen for itself who will be permitted to remain in the country, what statuses will qualify as defenses to removal, and what procedures will apply; and claimed the power to deport noncitizens by ordering them to depart the United States on pain of severe additional punishment. But immigration is an exclusively federal power, and Congress has long occupied the field of entry and removal. Thus, as the district court held, S.B. 4 is field preempted….

DAMN.

Who is this feckless would-be dotard — named Abbott?

Onward, Grinning.

In Which Merck, And Mr. Becerra, Exchange Dueling Letters, Characterizing The AstraZeneca Loss — For The DC District Court…

As we expected, each side has cited the case out of Delaware, and urged opposite results be reached, in the District of Columbia. HHS points up what I see as the better argument: that no one is forcing Merck to do anything here.

Merck, for its part, claims that the problem stems from HHS and CMS forcing it to “speak” — when it would rather… not.

That seems a lil’… too cute. It would actually RATHER just keep selling Januvia® to CMS and HHS and the VA at high prices. It is not required to speak, or sell, at any price — let alone the one the government asks most ardently for (as these ongoing negotiations make plain). It remains free to “not speak” — by not selling — if it feels the price is unfair.

But as we’ve long said, the company seems to only half-believe its own arguments here — and keeps participating. So — I’ll quote the government letter below:

…[T]he court reached the merits of the due process claim and determined that it “fails as a matter of law” because—among other things—“[n]either the IRA nor any other federal law requires AstraZeneca to sell its drugs to Medicare beneficiaries.” AstraZeneca, 2024 WL 895036, at 41. “On the contrary,” the court held, “participation in the Medicare program is a voluntary undertaking.” Id. at 41 (citing Livingston Care Ctr., Inc. v. United States, 934 F.2d 719, 720 (6th Cir. 1991); Dayton Area Chamber of Com. v. Becerra….

Notably, the court reached this conclusion over the plaintiffs’ objection that Medicare accounted for such a large part of the “potential market for prescription drugs” that they had “a powerful incentive” to participate. Id. at 43. Access to Medicare, the court observed, is not a “gun to the head” but rather “is a potential economic opportunity that [the plaintiffs are] free to accept or reject….”

Now you know. Onward, grinning into a warmer sunny afternoon here. Bike time!

नमस्ते

Juno Mission Is Able To Refine Our Estimate, On Oxygen Produced Daily — At Icy Moon Europa: ~1,000 Tons Per Day…

As we’ve indicated many times before, we are privileged to be alive at a time of near-daily discoveries — in the space sciences, as our advancing technology peels back the cover of darkness that previously obscured our “knowings”.

This time, it comes from around mighty Jupiter, and its potentially-life supporting moon Europa — where a subsurface ocean may be naturally-packed with lots of oxygen, as a result of natural ionization in the surface ice shell, and its plumes, which are blasted by Jupiter’s vast plasma/radiation fields. Here’s the latest:

…Scientists with NASA’s Juno mission to Jupiter have calculated the rate of oxygen being produced at the Jovian moon Europa to be substantially less than most previous studies. Published on March 4 in Nature Astronomy, the findings were derived by measuring hydrogen outgassing from the icy moon’s surface using data collected by the spacecraft’s Jovian Auroral Distributions Experiment (JADE) instrument.

The paper’s authors estimate the amount of oxygen produced to be around 26 pounds every second (12 kilograms per second). Previous estimates range from a few pounds to over 2,000 pounds per second (over 1,000 kilograms per second). Scientists believe that some of the oxygen produced in this manner could work its way into the moon’s subsurface ocean as a possible source of metabolic energy.

With an equatorial diameter of 1,940 miles (3,100 kilometers), Europa is the fourth largest of Jupiter’s 95 known moons and the smallest of the four Galilean satellites. Scientists believe a vast internal ocean of salty water lurks beneath its icy crust, and they are curious about the potential for life-supporting conditions to exist below the surface….

“Europa is like an ice ball slowly losing its water in a flowing stream. Except, in this case, the stream is a fluid of ionized particles swept around Jupiter by its extraordinary magnetic field,” said JADE scientist Jamey Szalay from Princeton University in New Jersey. “When these ionized particles impact Europa, they break up the water-ice molecule by molecule on the surface to produce hydrogen and oxygen. In a way, the entire ice shell is being continuously eroded by waves of charged particles washing up upon it….”

Now you know — onward grinning up, some 500 million miles into the night sky, at Lord Jupiter and its shepherded moons.

नमस्ते

Paul’s Sanguine Tone — About GOP Prospects In ‘24… Is So Precious!

I don’t really care, but Mr. Mirengoff tonight tries to whistle past not just the local bone-yard… but even dance on his own grave.

Yep. Today marks the day that the Supremes signed the death warrant for the traditional GOP. With Tangerine eligible in all 50 states, the Republicans have no choice but to run him in the general.

And he will lose — and lose badly. By nearly 10 million votes, this time. In the process, he’ll spend all the RNC’s money, and further alienate most college educated people of good will.

As Mr. Biden coasts to reelection (on real wins, like lowering drug prices for working class Americans, and) on a generally solid economy… Trump will scorch the GOP Earth, and may even be incarcerated by January 2025.

So ends the GOP, Paulie: in a whimper.

Nice try, though. The Trump 2.0 Paradox is… real.

Out.

And So, Merck (Among Other Drug Cos) Has Made A Counter-Offer — To HHS And CMS — On Prices, For Januvia®…

Mr. Biden has indicated that he will have some more searching thoughts on this topic in his address to the nation on Thursday evening. [It is a lil’ rich that some of them are suing their biggest customer, here.]

He is correct to point out that all of the companies are continuing negotiations — since in most cases, the federal government is the largest single buyer of any given medication on the list of ten. No matter how you slice it, this will be a benefit to people of limited means who need the meds, just to survive. Here’s the latest:

…All of the manufacturers whose drugs were chosen for the federal government’s Medicare price negotiation program have sent back counteroffers for what they consider to be a maximum fair price, the White House said Monday.

President Biden confirmed in a statement Monday that all companies are continuing to engage in the negotiation process, despite the host of legal battles brought by a few, to block the program….

Talks are expected to go through Aug. 1, when negotiations officially end, per CMS guidance. The maximum fair prices are scheduled to be published Sept. 1 and are set to go into effect at the start of 2026….

As we indicated repeatedly here, there is no constitutional problem with saying a manufacturer must at least negotiate in good faith. And the IRA contemplates that no manufacturer must sell at any specific price to the government. So this will, like the ACA of 2010… pass muster in the Supremes, in my experienced opinion. Onward.

नमस्ते

Hinderaker Revisits His Manifestly Racist / False Tropes — Citing Crime Data Without Adjusting For Portion Of Whole Population, In US.

And again, he takes Heather Mac Donald’s BS at face value.

Neither of them take into account that people of African decent are a small portion of the overall population in the US, yet are far more likely to live below the poverty line than their Whyte cohorts.

Far fewer whytes (proportionately) commit property crimes than people of color — in no small measure because… they are far more likely to live without need for any material thing.

As to homicides and violent crime — many many of these arise in self-defense situations, and again, far fewer whytes (proportionately) live in the danger-filled () streets. And it cannot be seriously disputed that law enforcement is far more likely to approach a person of color violently, than an analogous whyte.

We’ve proved this literally hundreds of times, to John over the prior two decades.

I’ll not waste any more breath, tonight, on his lost soul.

Out.