Author: condor

As The Two Begin Mediation, Merck (US) Seeks Updated Financial Performance Information, From The German Merck…

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We recently hailed — as very good news — the disclosure in court that these two massive international public companies were set to conduct a mediation with a preeminent but retired federal judge “as referee“, to try to work out a “win/win” settlement — without a “winner take all” federal Lanham Act trial in the NJ federal courts, and high likelihood of… truly jaw-slacking damages — for one of the parties.

To make those discussions meaningful, both sides need to know just how much the other is making in the US off of the name, wordmark and branding called “Merck” — as two separate companies are employing the same one. Here’s that request, from the US company, for updated US finanacial performance info, and a bit:

…Merck’s request is simple and falls squarely within the heartland of Federal Civil Procedure Rule 26(e). Merck asks only that defendant Merck KGaA (“KGaA”) update the documentary evidence (compiled in four spreadsheets) that it previously produced concerning its sales and expenses in the United States. This information is relevant to Merck’s request to recover “defendant’s profits” as “compensation” for KGaA’s misconduct, as the Lanham Act expressly authorizes the Court to grant. 15 U.S.C. § 1117(a). Merck’s request is fully consistent with ordinary litigation practice. Damages numbers are routinely brought forward in intellectual property cases before trial to avoid giving a defendant a free pass for misconduct in the period since the close of discovery. The information requested is entirely within KGaA’s control. It is routine business information of a kind that KGaA already has produced, and that both sides’ experts have already used to calculate KGaA’s U.S. profits….

KGaA’s representation that Merck has not alleged continuing harm (ECF No. 320 at 30:21-22) is belied by the Pretrial Order. For example, Merck’s Disputed Facts section on liability emphasized the continuing nature of KGaA’s misuses, and the harm it causes Merck. See, e.g., ECF No. 311 at 73 ¶ 72 (“Defendant’s intentional illegal use of the ‘Merck’ name has caused and will cause continue to cause irreparable and ongoing harm to Plaintiffs’ trademarks, reputation, goodwill, and business in the future…. This harm is ongoing and capable of being repeated.”). In the damages section, Merck stated that its reported disgorgement calculations are understated due to the limited scope of KGaA’s prior financial disclosures. See id. at 76 ¶ 4 (“These numbers are limited by the financial data that Defendant produced through fact discovery, and do not reflect additional damages incurred due to Defendant’s unlawful rebranding to date.”). These points are not new: Merck has always maintained that KGaA’s misuse is continuing….

Merck respectfully requests the Court order KGaA to produce updated U.S. sales and expenses figures to complete its production of “[d]ocuments sufficient to show, on a monthly basis, the marginal costs, fixed costs, and profit margins for each of the goods or services sold in the United States by or on behalf of Defendant since January 1, 2006….”

Now you know, Condor predicts this letter motion will be granted. And so — onward — with summer-like weather here at elevation: gonna’ be in the 70s today, while it was below 18, with deep snow, until just two days ago. Blue skies ahead… Woot!

नमस्ते

Two (Or Three) Abiding — If Trivial — Passions, This Morning: 3.14159 (Belated) And The Saint… Remembered.

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No health care, life science, space science, STEM, R&B or constitutional law and politics — on this particularly fine sunny soon to be 65 degree Tuesday in the Rockies.

Nope.

And if you must, go get a wedge of cherry-, or your favorite… pie — on lunch (we missed it while in the air on last Saturday).

Of course by Thursday morning, we will also post our bracketology — as compared to that of BHO 44. Onward, grinning… ever, grinning. Be excellent to one another.

नमस्ते

Just A Monday Squib, Confirming My Lilly Analysis… Looks Good, Through 2029, At Least. Get It While It Is Below $1,000…

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As we mentioned yesterday (but of course, do your own due diligence here!), Lilly has been on a nice-heater, with the weight-loss franchises — and now it is set to market an oral weight loss challenger, to compete with Novo-, as early as Q2 2026.

That bodes well for Lilly though at least 2029. Here’s that blurb — and yes this is power alley stuff, but I don’t follow the weight loss drugs closely — as I am a lil’ concerned about potential longer-term side effects. [All of which we just haven’t seen the drugs on mass-market long enough — to really get a read-out on. Like over several hundred thousands of patients, over a decade, or more — and we are still about four years away from having that longitudinal data, post hoc.]

…After losing significant ground to rival Eli Lilly in the GLP-1 space over the past two years, Novo Nordisk is defending the one arena it now dominates — oral therapeutics. But with Lilly preparing to launch its obesity pill orforglipron as early as the second quarter, can Novo’s grip on the oral market last?

This year got off to a rocky start for the Danish pharma giant. The company said last month it’s expecting a drop in sales and profits in 2026 as it faces federal pricing constraints, and fierce competition from Lilly and compounding pharmacies….

Now you know — from snow yesterday to mid-60s later today and bright sunshine! Welcome to Spring weather in the Rockies. Heh….

नमस्ते

The Final Leg Of This Series (For Now): The Smaller Lilly Spend — In 2025…

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Since I am mostly out of pocket this week — we will wait to detail the Amazon spend until around the middle of the following week.

And as you can see, Lilly tends to spend less than the other majors, concentrating its efforts on the preserving and defending its blockbuster weight-loss franchises:

…Issues related to intellectual property protection and market access within current trade negotiations. Canada IP; USMCA implementation; Mexico patent linkage; Special 301; Trade talks: US-Japan, US-China, US-EU, US-UK, US-India, and US-Brazil; US Tariffs….

Patient protection; Pharmaceutical supply chain issues and shortages; Drug pricing, coverage, value, access and quality; Transparency; Intellectual property; Health insurance accessibility; Implementation of the “Inflation Reduction Act” (HR.5376); Prescription drug approval; Policy matters related to Artificial Intelligence in health care; One Big Beautiful Bill Act (HR.1)….

Intellectual property; 340B Program; Medicare & Medicaid prescription drug reimbursement pricing, coverage, value and access; Implementation of the “Inflation Reduction Act” (HR.5376); CMS National Coverage Determination on Alzheimer’s disease; One Big Beautiful Bill Act (HR.1)….

Multi-lateral threats to IP and the biopharmaceutical industry; Drug importation; Prescription drug value, access and quality….

Pharmaceutical intellectual property issues….

Implementation and extension of the Tax Cuts and Jobs Act; Domestic manufacturing tax incentives; Expensing of research and development costs; Global minimum tax; Pension and retirement benefit issues; round-tripping; One Big Beautiful Bill Act (HR.1)….

Hospital discounts; 340B program; Prescription drug value, access, quality and compliance with Drug Quality and Safety Act….

Snow… now, all shoveled, but it is still drifting down in big wheeling flakes, here… almost lazily. Heh.

नमस्ते

“The Big Apple” Now Sees First Clade 1b Case Of Mpox — Travel-Related; But Do Be Cautious!

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This strain of mpox is the one to be most concerned about. It is generally associated with the severe symptoms, upon taking hold in a host human.

So, as so many others — including this outlet have said — the 12 or so months since Trump cut USAID funding off… has led, and will continue to lead, to entirely avoidable adverse public health consequences, even here at home — right in Manhattan:

…New York City health officials have confirmed the city’s first case of a more severe strain of the mpox virus than the one that drove a global outbreak in 2022.

The case is travel-related, and the city’s Department of Health said there is no known local transmission at this time.

Mpox, formerly known as monkeypox, spreads through close or intimate contact, including hugging or cuddling. It’s not classified as a sexually transmitted infection, but in the United States the disease has primarily spread among the LGBTQ+ community through sex between men and other forms of close contact….

Onward — and although it was sunny and 70, yesterday — I’ve got about three inches of new white stuff to shovel this morning, at 8,500 feet. A real live Currier & Ives affair. Grin….

नमस्ते

And Next — Check Out The Mega-Lobby-Spending, By Amgen, Over Last Three Years…

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As with the others, the figures are annual, but the text describes only Q4 2025 activity — for earlier periods, just search the words “lobby spend” in the search dialogue box.

Amgen has really taken the lead dog role, in spending — right behind the overall pharma trade association, as a group (PhRMA). Here’s a sample of what they jaw-boned Congreass about — in Q4 2025:

…Issues related to drug pricing; Issues related to cardiovascular disease awareness and treatment; Issues related to FDA; Issues related to patient affordability issues, including copay cards, copay accumulators, copay maximizers, National Benefit Payment Parameters; Issues related to biosimilars reimbursement; Issues related to Supply Chain; Issues related to 340B; Issues related to pharmacy benefit managers; Issues related to biosimilars regulatory standards; Issues related to bone disease awareness and treatment; Issues related to Public law 117-1769 Inflation Reduction Act; Issues pertaining to the implementation of PL 97-414 “Orphan Drug Act,” all provisions; HR 946 Optimizing Research Progress Hope and New Cures Act; HR 1492 Ensuring Pathways to Innovative Cures Act; HR 1672 Maintaining Investments in New Innovation Act; HR 1 One Big Beautiful Bill Act (An Act to provide for reconciliation pursuant to title II of H. Con. Res. 14); S 1954 Biosimilar Red Tape Elimination Act; HR 5526 Biosimilar Red Tape Elimination Act; HR 2214 DRUG Act; H.R.1968 – Full-Year Continuing Appropriations and Extensions Act, 2025; HR 5509 Safe Step Act; HR 5256 340B Access Act; HR 4581 340B Patients Act; S 2296 NDAA FY2026 National Defense Authorization Act, issued related to Biosecure Act; H.R. 6703 Lower Health Care Premiums for All Americans Act; S 3345 PBM Price Transparency and Accountability Act; H.R. 6166 Lowering Drug Costs for American Families Act; S.3019 No Big Blockbuster Bailouts Act; H.Res. 928 Affirming support for most-favored-Nation drug pricing for United States patients
S 3349 PBM Disclosure Act; HR 4317 PBM Reform Act; S 3510 Biosimilar Inspection Modernization Act….

Issues related to drug pricing; Issues related to Public law 117-1769 Inflation Reduction Act; Issues related to cardiovascular disease awareness and treatment; Issues related to reimbursement for biologics/biosimilars; Issues related to PBM reform; Issues related to bone disease awareness and treatment — HR 946 Optimizing Research Progress Hope and New Cures Act; HR 1492 Ensuring Pathways to Innovative Cures Act; HR 1672 Maintaining Investments in New Innovation Act; HR 1 One Big Beautiful Bill Act (An Act to provide for reconciliation pursuant to title II of H. Con. Res. 14); H.R.1968 – Full-Year Continuing; Appropriations and Extensions Act, 2025; S.3345, PBM Price Transparency and Accountability Act; H.R. 6166, Lowering Drug Costs for American Families Act; S.3019 – No Big Blockbuster Bailouts Act; H.Res. 928 – Affirming support for most-favored-Nation drug pricing for United States patients; S 3349 PBM Disclosure Act; HR 4317 PBM Reform Act….

Issues related to corporate and international tax, including regarding Public Law 115-97, Tax Cuts and Jobs Act; Issues related to Puerto Rico; Issues related to OECD negotiations on the taxation of global income; Public Law 119-21, One Big Beautiful Bill Act (An Act to provide for reconciliation pursuant to title II of H. Con. Res. 14); Issues related to patents and taxes….

Federal Trade Commission related issues, no specific bill; Issues related to the Patent Act, no specific bill; Issues related to March-In/Bayh Dole, WTO/TRIPS waiver, no specific bill; Issues related to patent thickets/product hopping; Issues related to obviousness/ double patenting; Issues related to FDA/PTO coordination; Issues related to skinny labeling; Issues related to patents and taxes; S.1041 A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes; S.1040 — A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; S.2296– NDAA (FY 2026 National Defense Authorization Act — BIOSECURE language); S 708/ HR 1574 — Realizing Engineering, Science and Technology Opportunities by Restoring Exclusive Patent Rights Act of 2025 (RESTORE); S.1553/HR3160 — Promoting and Respecting Economically Viable American Innovation Act (PREVAIL); S. 1546/ HR 3152– Patent Eligibility Restoration Act of 2025 (PERA); S 2276 / HR 3269 Eliminating Thickets to Increase Competition Act (ETHIC Act); HR 6485 Skinny Labels Big Saving Act….

There you have it. Onward — with big winds — and snow, ahead! Grin….

नमस्ते

By This Hinderaker Means… He Doesn’t Believe In… Due Process. At All. Except For… For His Friends.

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John complains that the specious attempt by MAGA-nuts at DoJ, to make the Fed Chair criminally responsible — for very slight cost over-runs, in building renovations… has failed.

I see that as an impeccably ethical man… getting only the fair and complete process he is due, under our Constitution and the federal rule of law.

[Unlike with every supposed federal project Tangerine 2.0 starts, there is not even a whiff in this one that anyone connected to Mr.Powell benefited from the overrun. These were competitively bid contracts. OTOH, practically every single contract Trump awards is to a close crony of his, and it is a near certainty that some form of kickback or another is being paid back to his campaign coffers.] Yet, John never makes so much as a peep — about any of that.

Sit down, John.

And shut up.

Now, Merck’s Q4 2025 Lobbying — With Three Year Data, Merck v. Pfizer — 2023 Was A More “Normal” Spend, At $14 Million — For Pfizer.

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The detail below is just from Q4 2025 — but the figures are for the full years, in each case.

Overall, Pfizer is now well below its prior pace, for the last two years — for the decade preceding these last two years, $14 million a year was normal. [Afterall, it is about 40% larger than Merck on asset size, and footprint.]

Here and now, though — by comparing Merck, to last night’s Pfizer summary disclosure listings, you will notice that either Merck describes its efforts in more rigorous detail, or Pfizer is slightly cutting corners, by not really disclosing the precise sorts of suasion it seeks, on the various pieces of pending legislation. Do take a look — they spent essentially the same amount in 2025 — at $11 million (and this year Amgen is up nearer $13.5 million):

…[Both chambers of Congress:] H.R. 3, (117th Cong.) Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19, (117th Cong.) Lower Costs, More Cures Act of 2021; H.R. 830, Help Ensure Lower Patient (HELP) Copays Act; H.R. 1503/S. 2916, Prescription Information Modernization Act of 2023; H.R. 2679, Pharmacy Benefits Manager Accountability Act; H.R. 2691, Transparent Prices Required to Inform Consumer and Employers (Transparent PRICE) Act; H.R. 2816, Pharmacy Benefit Manager Sunshine and Accountability Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; H.R. 2940/S. 1355, Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act (PASTEUR) Act of 2023; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; H.R. 3285, Fairness for Patient Medications Act; H.R. 3633, PREVENT HPV Cancers Act of 2023; H.R. 4368/S. 2131, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 H.R. 4895, Lowering Drug Costs for American Families Act; H.R. 5376/S. 2474, Share the Savings with Seniors Act; H.R. 6283, Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 7174, To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; H.R. 7635, The 340B PATIENTS Act of 2024; H.R. 8467, Farm, Food, and National Security Act of 2024; S. 150, Affordable Prescriptions for Patients Act of 2023; S. 1339, Pharmacy Benefit Manager Reform Act; S. 1895 (116th Congress) Lower Health Care Costs Act; S. 2333, Pandemic and All-Hazards Preparedness and Response Act; S. 2543 (116th Congress) Prescription Drug Pricing Reduction Act of 2019; S. 4229, Reducing Drug Prices for Seniors Act….

Issues relating to 340B program integrity; 340B of the Public Health Services Act; 340B issues; 340B drug pricing program; Drug pricing; Drug pricing and reimbursement issues; Anti-microbial Resistance; Cost and value of medicines; Respiratory Syncytial Virus (RSV) immunization; Vaccines catch up; Vaccines issues; Package inserts, labeling issues, and E-Labeling authorization legislation; Pharmaceutical Supply Channel issues; Drug shortage issues; Inflation Reduction Act (P.L. 117-169), issues relating to drug pricing provisions; Issues related to the Patent and Trademark Law Amendments Act (PL 96-517); FY-2024 Budget and Appropriations Legislation; Intellectual property protection and trade issues; WTO IP Waiver for COVID therapeutics; Animal Health; Animal Health Technology Issues; National Institute of Standards and Technology (NIST) draft Interagency Guidance Framework for Considering the Exercise of March-In Rights Animal Health Policy Issues: ADUFA & Funding for Electronic Animal Traceability; One Health Issues; General pharmaceutical issues; Vaccine Injury Compensation Program (VICP); Diversity in clinical trials; Accelerated approval reform; Pharmacy Benefit Manager (PBM) policy issues; Pharmacy Benefit Manager reforms; Food and Drug Administration issues; Public Health Issues….

[Various Agencies:] Issues relating to Medicare; Medicare Part B and D drug pricing issues; 340B program integrity; 340B of the Public Health Services Act; 340B drug pricing program; Drug pricing; Drug pricing and reimbursement issues; FY-2024 Budget and Appropriations Legislation; Medicaid drug rebate program (MDRP); Medicare coverage of COVID antiviral medicines….

Issues relating to Tax reform and tax policy, generally; Tax Cuts and Jobs Act of 2017 (P.L. 115-97); Inflation Reduction Act (P.L. 117-169), provisions relating to budget reconciliation and taxes….

There you have it — I’ll get to Amgen and Lilly on the plane — as I’m on a jet early tomorrow, to the Rockies — baby-grrls here all afternoon and evening tonight! Woot!

नमस्ते

This Profoundly Saddens Me — And Raises Very Important Privacy And Civil Liberties Questions… [Spoiler Alert.]

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As many will recall, we have thrilled to Banksy’s many artistic and social commentary endeavors — on a global basis.

For now, I won’t even reveal the name of the news organization that has done it (let alone link it), but one of the news agencies has released the true name of Banksy. Google it at your considerable own risk — to the mystery and wonder that has been the hallmark of his art installations, over the decades.

In many ways, this doxxing is… a fundamental violation of his right to put out the art he most desires: should he stencil subversive art in any non-free nation (and maybe even in several “free” ones) — his life will be in grave danger.

So — as an Anon., myself — I am deeply disappointed. This would be one time (since his art killed no one) where I highly question the public’s “right to know“… his name and movements.

In the internet age — and with Mossad, MAGA and the KGB on the rise — this one piece of “journalism” may already force him into a self-imposed exile.

Were I Banksy, I might find a tropical island — and retire from bricks and mortar art — launching from inside an entirely foil-clad room, in a non-extradition country — and digital artworks, exclusively. That is, unless he can transmit the same to willing “helpers” — not previously associated with him, to carry on the work — just as DaVinci kept a studio full of artisans.

Damn — maybe we will set up… a volunteer sheet. Grin — pharma lobbying updates, next.

नमस्ते

Very Tardy — With Full Year 2025 Lobby Spend Disclosures, Here — Before Q1 2026 Disclosures Appear In A Few Weeks. Grin…

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It is like wedding gifts, right? Emily Post told me I had a full year to get these out… so I am, now.

More substantively, now — there will be a series of comparisons — to Amgen, Libby and likely Baxter and Abbott — and maybe even Amazon’s health units. [Depends on how ambitious I get in the Rockies — while she naps.]

Here is what Pfizer spent on in Q4 — the prior three quarters were detailed here, in more or less real time. Just use the search box, if you are abidingly curious. But I’d call this a spending tie, between Merck and Pfizer (spoiler alert: Amgen blew them both away in 2025 — over $13 million, or by almost 30%). Here is the detail, on Pfizer:

…[Senate:] Vaccine Policy, Coverage and Access; Executive Order 14297 – Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients; H.R. 5256 – 340B Access ACT; Inflation Reduction Act (IRA): Maximum Fair Price (MFP) Effectuation, Biosimilars Special Rule; Drug Pricing; PBM Reform; H.R. 4581 – 340B PATIENTS Act of 2025; H.R. 5509 – Safe Step Act; S. 2903 – Safe Step Act; S. 2296 – National Defense Authorization Act (NDAA) for Fiscal Year 2026; S. 1053 – FIGHT China Act; Cancer Research; Centers for Disease Control and Prevention (CDC) Policies….

[US House:] H.R. 5256 – 340B Access ACT; Inflation Reduction Act (IRA): Maximum Fair Price (MFP) Effectuation, Biosimilars Special Rule; H.R. 4581 – 340B PATIENTS Act of 2025; 340B Reform; 340B HHS Pilot Program Model; Insurance Coverage of Prescription Drugs; Direct-to-Patient Prescription Drug Purchase Platforms and insurance coverage; PBM Reform; P.L. 117-169 – Inflation Reduction Act (IRA) of 2022; Drug Pricing; Medicare/Medicaid….

….
[Various Agencies:] International Supply Chain; Global Access; Market Access; Most Favored Nation Policies; Tariffs; Generics; Foreign Freeriding Issues; Non-Tariff Trade Barriers; Trade Issues….

Now you know. Merck, tomorrow — then Amgen; then… Lilly. Grin.

नमस्ते