Category: Uncategorized

My Buddy Ed Silverman Has A Nice Piece — On The Merck/Halozyme Patent Developments (Which Favor Merck)…

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As I’ve repeatedly said, there is much in the wrangling of US patent laws that Rahway can and will undertake, to push the generification out to about 2032 minimum.

Chief among these moves is one called “product hopping”. Merck will introduce a subcutaneous version of pembrolizumab — which only requires four visits a year to a hospital, as opposed to weekly IV drips. Halozyme has claimed its patents cover this tech, but the USPTO has agreed to re-evaluate the breadth of the claims in that patent. This likely means Merck will (at a minimum) owe Halozyme nothing, to produce the subcutaneous version — and stay in the driver’s seat on a perhaps $30 billion a year revenue stream through the early 2030s. Here’s Ed’s fine piece at his subscription only STAT property (and a bit):

…In a boost for Merck, a U.S. Patent and Trademark Office panel agreed to reconsider a patent granted to another company that could affect plans to broaden use of its franchise product, the Keytruda cancer treatment.

The dispute with Halozyme Therapeutics occurs as Merck plans to sell a new [subcutaneous] injectable version of Keytruda that the company is betting will sustain a medicine that has accounted for nearly half of its sales. Patent protection for the treatment, which is currently administered intravenously and generated $29.5 billion in revenue last year….

Nominally, the generics may enter at 2028 — but practically they will be largely thwarted through 2032 or so. There Ed and I diverge slightly in our analysis of the matter. Onward, smiling.

नमस्ते

It ALSO Exhibits (Actually, Re-affirms) Trump’s (Almost Precious) Naïveté, In Matters Of State…

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Aside from its manifest legal infirmities (see, the various Supreme Court opinions on Versions 1.0, 2.0 — and 3.0), his racist penchant on display here again… is going to be idiotically ineffective — at achieving his claimed goals.

After all, if a would-be terrorist is able to find the means to travel across the world (and have the connections to bomb-makers needed), s/he will undoubtedly have the backing of well-heeled terror sponsoring forces. [Doubly so, for would be drug- or sex-trafficking “king-pins“.] These people, in turn, are — without a doubt capable of sourcing very convincing forged passports, from plausible (and non-banned) nations. The terror will slip in on an Egyptian passport/visa — or the like.

Meanwhile, the best and brightest honest students from these nations (all of whom will doubtlessly comply with this goofy “law”) will NOT come to the US — nor will their scientist/engineer parents or aunts and uncles. The best minds — as immigrants have always fueled US life-science advances — will in the main go to the EU, UK or Japan or Australia — to escape the repressive conditions of their place of birth.

And thus, the US economy will be further harmed (on top of his 19th Century tariff lunacies he’s pushing — and reversing, week by week) by the lack of international spending onshore. It is hard to posit a more malignantly “misguided” set of “policies”.

Which would suggest that it is Stephen Miller, the young dyed in the wool racist / avowed misogynist (from Tangerine 1.0), who is whispering all this nonsense in Trump’s ear, each day. Tangerine has always lacked a well-trained and disciplined mind, of the sort that might discern that it all simply makes him look… impotent, before the sentient world community.

Damn. See you in court, Mr. Tangerine 2.0.

नमस्ते

Y A W N. Tangerine 2.0 Comes Up With “Muslim Ban 4.0” — It Will Fail — The Same Way The Other Three Versions Did.

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Tonight the doddering cartoon villain decided to make a fourth run, at banning certain peoples from even being considered for arrival in the US. It all gets rather stupidly repetitive at some point. Yawn.

His other three versions, in the first go ’round (2017-2020), all failed (except for a very limited subset, inside the third one). Then… that third one was rescinded on Mr. Biden’s first day on the job.

The guy never learns. But now, you know. You know bettah.

I’ll likely just watch silently, as the federal courts bang him down — into the dust, once again here.

I won’t say a whole ton more about it — unless he’s found much smarter lawyers to work it for him (i.e., not likely). Out.

नमस्ते

A New Case, Here: Mr. Peter Mosoko Ikome, Struggling To Avoid Being Sent Back (To Torture) For… Some 30 Years. Now Supremes Will Review Fifth Cir. — For Errors.

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Today, the Supremes have agreed to take a new look — at what appears to be a clearly erroneous Fifth Circuit immigration opinion. [They did so by denying a stay, and doing so at the same time they took Mr. Ikome’s case up, for review.]

It is a new one, to us here — but we will follow it, from now on. It concerns a man born on the African continent — Cameroon, specifically — who arrived here in 1992. [He credibly feared torture in his place of birth, as a then-dissident.] Let that sink in: he’s been struggling in the US immigration law system (or non-system, more precisely) for over three decades — to follow our methods to secure a more permanent home for him, here.

To understand the very long convoluted battles — and the tangled, winding nature of his case, you’ll need to read the (errant) appellate opinion, from this particular ultra right wing panel — of the Fifth Circuit (a Circuit often overruled at the Supremes of late), out of New Orleans.

Here’s the errant Fifth Circuit opinion. We will have to wait a beat, to read how the Supremes specifically feel about it.

How the Fifth Circuit thought it was an acceptable / just / even remotely logical answer, to bounce Mr. Ikome, after 30 plus years of proceedings, by only now holding that the courts lacked jurisdiction over his case — all while saying his daughter (age 21 years) didn’t act with “due diligence” — by taking about nine months to file a petition for his continued stay in the US — also after the court’s own on-and-off delays of about 30 years, as well(?!). [Her petition became necessary, because his petitions, previously filed by his second wife (US born)… were failing, due to her lack of cooperation with the process — and her apparent estrangement from him.]

So his daughter — born here — became eligible to petition for him, when she herself turned 21. She did so within nine months, upon learning that the “spouse” petition was likely going to fail. Yet the court / government waited 30 plus years to decide it lacked jurisdiction — all while Mr. Ikome pursued his rights in the courts. Had he been made aware that he was in the wrong court, he could have long ago remedied that defect.

So, forcing him out — due to the court’s own errors (lasting 30 plus years)… seems outrageous. I suspect this is where the Supremes are headed — with this one. Excellent!
नमस्ते

And Mr. Abrego Garcia Will Be Allowed To Argue For Monetary And Other Sanctions, Against Noem / Rubio / Tangerine 2.0 — For Abuse Of Process, In Maryland!

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The losses are gonna’ start really piling up, now. And lead to awards of perhaps seven figures, on each case — cases that Noem has willfully mismanaged. Trampled the detainees’ rights — willfully.

Over two months ago now, the US Supreme Court ordered Noem / Rubio / Tangerine 2.0 to “facilitate” Mr. Abrego Garcia’s prompt return to the USA. He was sent to an El Salvadoran hell-hole in what even Noem admits was a terrible “mistake“.

Yet, as we’ve documented here — in over 20 posts, Noem has been dragging her feet — and more or less ignoring binding court orders. So, it is time for a sanctions hearing. Here’s that — even so, it doesn’t free Mr. Abrego Garcia — to return to his waiting Maryland family (now in hiding, due to MAGA death-threats). Damn:

…Plaintiffs’ request at ECF No. 177 for leave to file a motion for sanctions pursuant to Federal Rule of Civil Procedure 37 is GRANTED. Plaintiffs shall file their motion no later than June 11, 2025. Defendants shall file their response within seven days of the motion’s filing. Signed by Judge Paula Xinis on 6/4/2025….

This is the sort of lawlessness we might expect from… Vlad Putin (if he ever met a judge willing to enforce the clear Russian laws). Until Trump 1.0 and now 2.0, the US hadn’t seen this sort of corruption since before the Civil War. Yet and still, onward — resolutely.

नमस्ते

It Seems Noem Et Al., Are More Interested In “Padding” Their “Arrest” Stats — Than Moving A Meritorious Defense Of Removal Case Out Of Active Litigation: Chung Matter

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Ms. Chung (the human Noem is trying to pressure to leave the US, for First Amendment protected activity!) has been arrested and detained once already. She has counsel of record. She is no flight risk; she wishes to remain enrolled at Columbia University, as a fine honors student.

And in this letter to the able USDC Judge in Manhattan overnight, the Noem / Tangerine 2.0 lawyers refuse to let her counsel of record accept the notice to appear in court for the commencement of the immigration case, to try to remove her from the US.

The only plausible explanations for this are as follows: (i) Noem’s orders are to be as non-cooperative as possible, and/or (ii) the government is trying very hard to “pad” its numbers (of arrests made, per Trump’s own numerical quotas — which were pulled from thin air, and so are racist on their face).

This way, they can (AGAIN!) “arrest” her in the street, and hand her the notice to appear — as opposed to serving it electronically, on her well known counsel. Damn — here’s the full text of this lateest a$$-hattery — from Noem:

…This Office represents the government in the above-referenced matter. At the hearing held on May 29, 2025, the Court asked whether U.S. Immigration and Customs Enforcement (“ICE”) would agree to serve a Notice to Appear (“NTA”) on Yunseo Chung’s counsel rather than through personal service effectuated after an arrest.

The answer is no. ICE has broad discretion over actions and decisions to conduct arrests and initiate removal proceedings, including the manner in which it serves an NTA. Separately, the Court had asked for a copy of Chung’s NTA. ICE has confirmed that an NTA has not yet been issued for Chung, as ICE typically issues and serves the NTA during processing that occurs after an arrest is made.

While the Department of Homeland Security (“DHS”) is required to serve the NTA on the alien, see 8 U.S.C. § 1229(a)(1), that act alone does not commence removal proceedings. Rather, the commencement of removal proceedings occurs when DHS files the NTA with the immigration court. See 8 C.F.R. § 1003.14(a) (“Jurisdiction vests, and proceedings before an Immigration Judge commence, when a charging document is filed with the Immigration Court by [DHS].”); see also 8 C.F.R. § 1239.1 (“Every removal proceeding… is commenced by the filing of a notice to appear with the immigration court.”); Banegas Gomez v. Barr, 922 F.3d 101, 111 (2d Cir. 2019)….

[This allows ICE to potentially hold her overnight, until a bail hearing can be arranged, as well.] I get the being a hard stick — as against murderers and hardened, violent drug traffickers (whether “fifth-generation born here” Americans, or recent arrivals).

But she is the opposite — a grad student who happened to attend the Columbia protests. No other part of her life even suggests any whiff of criminal behavior. This is… again, abuse of legal process — by Noem. Out.

नमस्ते

A Minor Thing, Really — But It Is Already… “Lame Duck” Season, At 1600 Penn. And I Love It!

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Well… I think I had earlier guessed the honeymoon would be over, and these two narcissistic ego-maniacs… would be at each other’s throats — by the end of Summer 2025. I was too optimistic, it seems. By Summer’s beginning it is. Sweet.

Calling the MAGA tax cut and spend on billionaires bill… a “disgusting abomination” — it seems Elon actually believed his $320 million bought HIM the de-facto preznit. As with everything Trump, the welsher is going back on his (apparent) word. Actually, both of them are / have:

…Elon Musk blasted President Donald Trump’s“big, beautiful bill” of tax breaks and spending cuts as a “disgusting abomination” on Tuesday, testing the limits of his political influence as he targeted the centerpiece of Republicans’ legislative agenda.

The broadside, which Musk issued on his social media platform X, came just days after the president gave him a celebratory Oval Office farewell that marked the end of his work for the administration, where he spearheaded the Department of Government Efficiency.

“I’m sorry, but I just can’t stand it anymore,” Musk posted on X. “This massive, outrageous, pork-filled Congressional spending bill is a disgusting abomination. Shame on those who voted for it: you know you did wrong. You know it….”

I’ll admit that I for one am highly entertained — but only because Elon is smart enough to do this as a conscious threat, to the Senate GOP (his PACs will pull their GOP donation schedules), to force the changes Elon wants… on through. And that too is trivial, because the rest of Trump’s West Wing is so deeply dysfunctional, and consumed with infighting… that nothin’ is really gonna’ get done — at all.

But it doubtless belittles Tangerine 2.0 — without a any doubt at all.

And we know tomorrow’s Truth Social platform blasts will be aimed at Elon — to a certainty. Trump hates being embarrassed before the world — even when it is what he so richly deserves.

And. I. Am. Here. For. It. All. Woot!

नमस्ते

Here’s A Nice Summary, Of Why Harvard Will Likely Win Out On Summary Judgment In Mass. Fed. Court: These Are Truly Loco Trumpian Attacks On It…

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Anyone who ever saw Tangerine as a free speech absolutist (in like 2015-16-ish) must now admit: he is the opposite of it.

He’s a stupidly malign oppressor, exclusively — one who wants HIS (and only his) version of a Musk-controlled federal government to invade your classrooms, your bedrooms (whom you may love; and how they may refer to themselves) and yes, your basic science / research labs. He wants to dictate what may be read, and studied — and thus… what you are allowed… to think.

Obviously he will lose in this quest. Here’s the latest, in the form of a very well-put memo (from the lawyers for Harvard) to support the bouncing of Trump, out of court, summarily:

…Since Harvard’s founding nearly 400 years ago, its students, faculty, and researchers have worked to identify and solve some of society’s most pressing problems. They have developed novel drugs to fight Parkinson’s and Alzheimer’s diseases, engineered nanofibers to protect American military servicemembers and first responders, supported American astronauts in space, and designed an artificial intelligence system that can be used to diagnose and treat cancer. These pathbreaking and life-saving advancements are due in part to the longstanding collaboration between the Government and research universities such as Harvard. Generations of Americans are healthier and safer as a result.

Over the last two months, the Government has abruptly — without any process or reasoned explanation — ended that longstanding partnership in a manner that flagrantly violates the First Amendment multiple times over. On April 11, 2025, citing concerns about alleged antisemitism and ideological bias at Harvard, the Government identified a list of “conditions” that Harvard must satisfy to continue receiving federal funding. . . .

All told, the tradeoff put to Harvard was clear: Allow the Government to micromanage your viewpoints and your academic institution or jeopardize your ability to pursue medical breakthroughs, scientific discoveries, and innovative solutions.

Because Harvard would not allow itself to be taken over by the Government, Harvard rejected the Government’s demands on April 14, 2025….

The [Tangerine 2.0] Government’s actions are unlawful for multiple reasons. First, the Government’s actions violate the First Amendment. They are unconstitutional retaliation against Harvard for exercising its First Amendment rights to decide what to teach, to express certain views, and to petition the courts to defend itself.
The Government’s actions also impose unconstitutional conditions that seek to “interfere with private actors’ speech to advance [the Government’s] own vision of ideological balance,” Moody v. NetChoice, 603 U.S. 707, 741 (2024), and “‘to achieve the suppression’ of disfavored speech,” Nat’l Rifle Ass’n v. Vullo, 602 U.S. 175, 189 (2024) (citation omitted).

The Government’s content- and viewpoint-based attempt to coerce and control Harvard is blatantly unconstitutional….

So at least here — for readers of this property — it will be no surprise when Harvard wins, hands down. Onward, resolutely.

नमस्ते

Power Alley Returns; Rumor Edition: Is Mr. Davis Interested In Immuno-Oncology Candidate Sonelokimab?

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As ever, the caveats, first — as always: even though this has been very widely reported since early last weekend, there is no independent confirmation that any talks have restarted, or even that talks occurred. But MoonLake stock has surged almost 38 per cent on the NASDAQ, since the published reports of these rumors.

True, as a follow on to the Keytruda® franchise — at some point in time, likely in the mid-2030s — Merck might favor this lead MoonLake candidate called sonelokimab.

And I suppose ~$3 billion (on a discounted for probability of FDA clearance basis) is as good a guess as any — as to what might be a fair price today, for something that might one day be a $20 billion a year franchise. The best story to keep these breathless rumors in context was offered yesterday by Fierce (naturally!):

…The Financial Times reports Merck submitted a nonbinding offer that valued MoonLake at more than $3 billion earlier this year. The offer was rejected, but talks could be revived, the Financial Times said. MoonLake’s market cap was $2.6 billion when trading stopped yesterday [Friday] but climbed on news of Merck’s interest, with the stock rising almost 18% in premarket trading to send the biotech’s share price up to $48.50.

Buying MoonLake would give Merck ownership of sonelokimab, a molecule that could provide a source of revenue growth to help offset the anticipated emergence of biosimilar copies of Keytruda in 2028. [Condor’s nota bene: the date will be more like 2032, though. Just watch the wrangling — under the US patent laws.] The biotech is aiming to report primary endpoint data from phase 3 trials of sonelokimab in September….

The MLTX symbol traded as high as $49-something yesterday, when it was at about $34-something as recently as last Thursday, before the rumors started swirling. We shall see, but it would be true that both AstraZeneca and Bristol Myers Squibb would be likely potential suitors, as well. Onward — for a gloriously warm bike ride by the lake, now… smile. [One and all — be excellent to your mothers; your time with them is precious… and surprisingly fleeting, at least with their full faculties, as the decades roll on.]

नमस्ते

While I Was Gone, US Rep. McIver Was Released With Essentially No Conditions, On The Strength Of Her Own Word.

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Again, while I was MIA, we got a clear sense of how little the able federal NJ judge thinks of Alina Haba’s purported criminal case, against a sitting member of Congress, while she was conducting oversight of mistreatment of human beings (via ICE and DHS actions) at a contract prison. She has been set essentially completely free, with no bond — just her signature — that she will return.

She is free to travel the US — without any restriction. Should she have official duties that take her out of the country, she should notify pretrial services and the court. That is all. What a weak sauce pile of purported felonies / BS Ms. Haba has cooked up. [And the able judge knows it.]

Other than the notice before heading to the EU — she is free to go.

And over the weekend, in another unrelated case, the for profit private prison company running that Newark (detention of undocumented people) facility where she was arrested… has motioned a judge, to be called (preposterously!) a derivative “sovereign” — like a quasi-governmental entity — so it may avoid suits for violating the rights of people who are un-, or under-documented. In fact, the owner of the GEO Group is a huge Tangerine donor, and he wants the “immunity” Tangerine enjoys, directly. And this is all after Trump awarded him a highly profitable federal contract to house ICE and DHS detainees. Damn.

That will NEVER happen. These goons assaulted the Mayor of Newark, after refusing to accept a notice of non-compliance, as a private for profit business, inside the Mayor’s city. Then they arrested the Congresswoman for defending the Mayor’s rights, before the contract rent-a-cops. That CEO is going to pay out large damage awards — for interfering with the Mayor’s duties (and Congressional oversight).

These guys (at least pretend to) understand almost nothing of the bedrock laws, over the last three-quarters of a century. Just… Damn — out, and onward — resolutely.

नमस्ते