Author: condor

Merck Has Asked For An “Inter Partes” Review, At The US Patent Office, Of Johns Hopkins’ Patents — Ones Hopkins Claims Read On… Keytruda.

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As we have said for several years now, Rahway is not likely to lose patent protection much before 2040, on this ultra blockbuster franchise — and this step, as ably reported by Fierce Pharma, is designed to cement that outcome.

JHU sought four patents, all of which were granted by the USPTO examiner — and all of which, Merck correctly asserts were based on joint research with Merck — and funded entirely by Merck. The patents go to ways of making the agent more effective in a human body (dosing, etc.) which were in fact Merck’s prior art / know-how (unpatentable) from the clinical trials Merck funded and conducted. At best, JHU might argue it deserves a “tip” for filing on them, but it is unlikely that the JHU ‘356 ‘974,’975 and ‘219 patents will ultimately be held to require that Rahway must pay licenses, for them (if ultimately allowed to stand). It was primarily Merck’s effort that led to these method of use patent claims at JHU.

In any event back in 2022, in federal court in Maryland, Merck began litigation to invalidate these JHU patent claims. Here’s the latest, from Fierce:

…Merck is kicking its Keytruda-related clash with Johns Hopkins University (JHU) up a notch by asking the U.S. Patent and Trademark Office (PTO) to weigh in following a 2022 complaint.

The drugmaker last week filed petitions for inter partes review proceedings on four Keytruda-related patents owned by JHU, JD Supra reported March 13.

Inter partes reviews essentially seek a determination on the validity of a patent. In Merck’s case, its petitions propose the patents as being obvious and anticipated by the prior art….

[Ed. nota bene — In Merck’s complaint, it stated “JHU faced repeated rejections (from the PTO) for the use of “wherein” in certain claims requiring an improved outcome comparison. In attempting to overcome the Patent Office’s rejections, JHU referred to the claim limitation, “wherein the patient exhibits an outcome that is improved as compared to a corresponding outcome that would be observed in a reference patient that has been administered pembrolizumab,” and represented that, “this clause” was necessary to prevent the claim from “simply requir[ing] giving an effective amount of pembrolizumab to a patient,” which would “effectively ignor[e] the unexpected relationship between MSI-high/MMR deficiency status and anti-PD-1 antibodies, as described in the specification.”

JHU argued that, to omit this clause from the presented claims, would “ignore a core concept disclosed in the specification: the unexpected relationship between MSI-high/MMR deficiency status and improved relative response to anti-PD-1 antibodies….” But in Condor’s estimation, these are not novel claims as made by JHU.]

Now you know — but at over $22 billion a year in cash revenue now, Merck is going to move forcefully to keep all interlopers off its playing field (even university affiliated ones) — by litigation, inter partes challenges and “evergreening” formula and delivery changes (like subcutaneous injection versions of the therapy)… into the 2040s time frame.

You read it here first. Onward, smiling — happy Pi Day ’24!

नमस्ते

Fascinating: I Would Not Have Thought This Need Be… Ordered.

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I won’t mention in which specific federal case (but it is in a multi-billion dollar, nearly decade-running piece of federal class action litigation) this order was entered, but it seems at least in San Diego US District Courts… there has been a fall-off in the seriousness — with which at least some counsel have treated the federal court orders for “appearances” — when a given hearing is being held over Zoom.

To wit:

“…Chambers staff will circulate the Zoom invitation to all identified participants at least one day prior to the conference.

All participants shall display the same level of professionalism during the hearing and be prepared to devote their full attention to the hearing as if they were attending in person, including by dressing in appropriate courtroom attire. Participants should be prepared to appear on camera and should not be driving or otherwise in a car during the conference. Because Zoom may quickly deplete the battery of a participant’s device, each participant should ensure that their device is plugged in or that a charging cable is readily available during the videoconference.

IT IS SO ORDERED.

Dated: March 13, 2024….”

In so, so many ways, COVID-19 seems to have changed the day to day workings of at least some litigators’ lives.

The idea that someone might wear sweats to federal court, for a hearing… just unimaginable, forever. . . prior to the advent of Zoom hearings.

Now you know. Crazy.

“Space Is Hard” (Again!) — A 59 Foot Privately-Funded Uncrewed Japanese Launch Vehicle (Solid Fueled)… Explodes On Liftoff, Today.

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I must say it is admirable, that private industry continues to try, and try, to reach orbit. Especially our international friends.

But make no mistake… they call it… “rocket science” — for a reason. It is… daunting. Here’s the latest from NBC, after another Japanese private contractor “hard landed” on the moon eleven months ago, in another robotic mission disappointment.

…Space One’s small, solid-fueled Kairos rocket exploded shortly after its inaugural launch on Wednesday as the firm tried to become the first Japanese company to put a satellite in orbit.

The 59-foot, four-stage solid-fuel rocket exploded seconds after lifting off just after 11:01 a.m. (10:01 p.m. Tuesday ET), leaving behind a large loud of smoke, a fire, fragments of the rocket and firefighting water sprays near the launchpad, visible on local media livestreams of the launch on the tip of mountainous Kii peninsula in western Japan.

Space One said the flight was “interrupted” after the launch and that it was investigating the situation. There was no immediate indication of what caused the explosion….

Tokyo-based Space One was established in 2018 by a consortium of Japanese companies: Canon Electronics, the aerospace engineering unit of IHI, construction firm Shimizu and the state-backed Development Bank of Japan. Two of Japan’s biggest banks, Mitsubishi UFJ and Mizuho, also own minority stakes….

Now you know — and our sincere condolences go out to Space1’s whole team. But pick yourself up, and dust yourself off — and try. . . again. Onward.

नमस्ते

Scott Johnson — Full Of Bluster — And Not Much Else.

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Scott seems to forget… he is ostensibly a… US citizen.

Um… Not an Israeli one.

Even so, he ought to take Bibi’s own advice — switched back to remind him where his allegiance ought to first lie (I’ve reversed Bibi’s nouns):

“…Those who elect the president of the United States prime minister of Israel are the citizens of Israel the United States, and no one else. Israel is not entitled to tell the US what it may or may not do, to end the daily atrocities, now in Gaza protectorate of the US but as the US is an independent and democratic country whose citizens are the ones who elect the government.

And the US government will decide how to protect innocent civilians in land that does not belong to Israel. We expect our friends [like Scott Johnson] to act to overthrow end the terror inflicted by IDF regime of Hamas and not the elected government in Israel of the United States….”

Do take heed — and take care — Mr. Johnson. We are watching, and if you don’t like how Mr. Biden conducts foreign affairs, your redress is at the ballot box come November. But over 7 million more Americans sided with Biden’s views last time around, than the Dotard’s.

So until that changes, why don’t you go to Israel and join the fight for Bibi, if hearing the candid assessment of our own intel on the ground around this all… vexes you so?

Thesis: AI (At Least In Its Current Iteration) For Financial Analysis… Is Largely… Useless — Merck Edition.

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But I did find the goofy / freebie graphic (see derivative version at lower right), in an otherwise useless piece of fluff… at least interesting, as a way to think of Merck’s vast financial prowess. [The company generates a 73% gross margin, or over $10 billion cash, each year now.]

The AI generated content / editor was arguing that the flow meant Merck’s dividend was at risk. That’s preposterous, as we’ve said a few times before. But what it does highlight, is mostly the opposite case: Merck’s vast cash flows are largely (and appropriately) managed, globally to minimize tax exposures.

And even so, it generated $10.5 billion in gross income before taxes last year. Were it willing to pay hefty repatriation taxes, a far larger number would flow to the bottom line, and be “brought home” as EPS each year. But it makes more sense to keep investing that money in Europe and the UK and Asia… to grow its overall businesses’ profits in lower-tax jurisdictions.

So, what the AI chart actually shows… is only that, if Merck didn’t mind paying more in income taxes in the US, it could instantly increase (not cut!) the dividend. But its yield is still pretty nice and fat (and has been above 4% for most of the last 12 or so years — that is an early legacy 2012 graphic, at right!), even with the stock sitting above $120/share on the NYSE most mornings, now. So… all in all, a “complete do over” for that AI engine. Cheers.

नमस्ते

Trivia Break — We Always Enjoy a Great Slice… But We’ll Wait Until 1:59 pm, Tomorrow — While Many Others Awaken At 1:59 am, To Celebrate…

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I do love math — yep, I’m a math nerd.

I devour off-kilter coincidences — sometimes found in numbers. So, a small confession: quite a long while ago, while at the hospital awaiting the birth of our middle son (things were stalled at that point, so — while watching Jordan get 45 in the Garden, and the purple M&M introduction turn the Empire State Building that shade)… on a scrap of paper, I started sorting the digits of Pi into a pyramid. And it turns out that… if you break the top nine lines of the “pyramid” at the right spots, the edges are all identical. For at least the first 11 or so lines; and it forms a near perfect triangle, depending on the font.

Then, plainly overjoyed with my second’s arrival, I promptly forgot about that scrap of paper, from the delivery room.

And… several decades later, one of my brothers picked up on the thought — which I mentioned in a passing phone conversation. As he had lots of time on his hands, the mug at right resulted. Okay, now you know.

I won’t rise at nearly 2 am — I will wait until mid afternoon tomorrow — but trust that I will partake of a slice of tart cherry pie, when I do. I’ll wash it down with hot coffee and cream.

And think of the three dimensional pyramids, somewhere still lost to the sands of time — and wonder whether the Egyptians or the Kushites… carved these same repeating-edge digits into the stone blocks on the corners (in some language we can no longer read).

Whoosh. Enjoy, one and all, come tomorrow — whenever you celebrate that most useful of numbers!

नमस्ते

Tangerine Is Highly Likely To Have To Post ANOTHER $550 Million Bond, In A Few Days…

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I. Just. Love. This.

There is no legal or logical basis for letting a fraudster, as found in three separate trials now, offer an IOU — for $550 million, when he claims to be worth “$7 to $12 billion”. None.

His proposed “IOUs” — like his lies about the value of his real property assets — are deserving of withering scrutiny, now. We have judgments.

And, the people of the State of New York must have confidence that they’ll be at the head of the line to collect (“prior in time, prior in right”) — once all the dust settles on all his other manifold legal difficulties.

Here’s Tish James’ take on it, tonight, in a 45 page brief (one citing lots of additional authority):

…To stay enforcement of a set monetary judgment pending appeal, the Legislature has required defendants to post a bond or deposit funds in the full amount of the judgment. That requirement applies to defendant Donald J. Trump and his co-defendants, just as it applies to any other appellant. Resort to the Court’s discretionary or inherent authority to undo the statutory undertaking requirements is neither available nor appropriate.

Securing the full amount of the judgment is necessary to ensure that the Office of the Attorney General (OAG) has a ready fund available to satisfy the judgment after an appeal….

FLAWLESS.

Out.

Tangent Alert: Huge “Energy-Waster” Of A Company… Invests Some Seed Money In “Waste To Energy” Company?! Hilarious!

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From time to time over the prior eight or so years, we’ve discussed this silly “Bitcoin miner” — which is (for now) ’34 Act registered on the NASDAQ. It has never made a penny of GAAP EPS, from continuing operations, life to date — nearly eight years, now. But it has paid executives over $200 million in compensation — to lose perhaps $1.2 billion in that time. Insane, in a word.

So. . . today, Riot Platforms announced that it has dumped some of the cash it doesn’t earn, from EPS it doesn’t produce — as a vast “energy wasting” company… into a company that is actually trying to generate meaningful levels of “reclaimed” energy — from post consumer waste, in landfills — by capturing synthesized methane, down in dusty West Texas.

Got all that?

Good. All this money came directly from rube-shareholders, throwing good money after bad.

And even with Bitcoin above $73,000 (and a new all time high) for part of the day, today — Riot keeps falling, on the NASDAQ.

Hilarious. Here (below) are the specifics (insofar as they’ve been disclosed), but since no dollar amount was disclosed, the actual cash outlay is likely under $15 million, since that would end up below the materiality threshold — which must be disclosed under SEC rules. But I suppose it is equally likely that it is a material amount, and Riot intends to bury it, in some R&D line, rather than as an equity method “investment”.

We shall see:

…Reformed Energy Inc., a Texas corporation, announced today that it has secured a strategic investment from Riot Platforms, Inc. (“Riot”), marking a significant milestone for the company as it seeks to bring its unique plasma gasification technology to full commercialization.

By processing solid and liquid waste streams in its closed plasma gasification system, Reformed Energy can effectively prevent over 99% of the methane emissions and pollution that occurs with traditional waste disposal methods while reducing the physical volume of waste by about 90%. This process yields a versatile synthesis gas that can be utilized downstream for sustainable power generation and synthetic fuel production. In short, the company’s unique technology has the ability to clean up existing landfills and reduce incoming waste streams.

The self-contained system does not require grid interconnection and generates carbon neutral power while actively reducing existing methane emissions….

And yet… Riot remains below $11.60/share on the NASDAQ. Precious — with BTC over $72,000 — a pure bubble figure.

O U C H.

नमस्ते

Pearl Bio Snags A Bio-Bucks Validation Deal With Merck — Could Reach $1 Billion, On Milestones — For “Smart” Biomaterial “Jewels”.

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Rahway continues to wisely invest / use its dividends / payoffs from the cash cow Keytruda, to take multiple, diverse “shots on goal” — for the next big thing in oncology, and bio-science, more broadly.

Today’s news brings a collab with Pearl Bio, which is a spinoff of the work of the legendary George Church (think re-animating wooly mammoths, here!), and some very well-respected Yale biologists (pictured). It is being run through a Series A round by former lawyer Amy Cayne-Schwartz — also with a Yale affiliated pedigree, and has raised quite a bit already. As it is private, of course, exact terms have not been disclosed, but many power players in bio- space are piling in.

Here’s the latest, on the story from Fierce Biotech, but this whole relationship is clearly not (yet) material to massive Merck:

…Merck has signed up to Pearl Bio’s synthetic biology platform, offering up to $1 billion in biobucks for potentially cancer-busting biologics.

The collaboration could pile more biologics onto Merck’s pipeline and serves as validation for Pearl, which emerged from stealth in June 2023 with the backing of Khosla Ventures. Merck is paying an undisclosed upfront fee and offering up to $1 billion in milestone payments for Pearl to identify biologics to treat cancer.

The biotech describes itself as creating “template-directed biomaterials with tunable properties.” Co-founder, Chief Operating Officer and Chief Business Officer Amy Cayne Schwartz elaborated in an email to Fierce Biotech, describing how the platform can “encode synthetic chemistries to tune therapeutic properties (e.g., half-life, drug antibody ratio).” The company is in the process of raising its series A round, she told Fierce….

Onward, into the warming sunshine here, then… smiling. As we’ve said before — we applaud Church’s creativity, but we aren’t sure the world is quite ready for (nor in need of) the “de-extinction” of wooly mammoths, genetically crossed with modern Asian elephants’ DNA.

In any event — ever smiling.

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