It Turns Out That PhRMA’s Amicus Brief Is A Quite Narrow One, In The Mohawk Tribe Patent License Flap…

January 31, 2018 - Leave a Response

Almost two weeks ago now, I mentioned that “the high foreheaded one” had convinced PhRMA to author what I assumed would be a professional-grade-crazy obstruction, by endless patents brief, in the Federal Circuit.

I am pleased to report that this is no such animal.

It was sealed for nearly two weeks, but is as of this very morning, now available as a 21 page PDF. In fact, it treads very well worn and largely prosaic law. It simply argues about what should be accepted — as evidence of obviousness — in follow-on patent cases, like the Allergan one (invalidated below). Here’s a bit:

. . . .Hence, in the context of an improvement patent, to prove that its product was a commercial success the patentee must establish that the success of the invention is attributable to the improvement. The patentee should be required to show no more than that. As Judge Lourie, joined by Judges Michel and Newman stated, in dissenting from denial of en banc rehearing in the Merck case:

Commercial success is a fact question, and, once it is established, as found here by the trial court, the only other question is whether the success is attributable to the claimed invention (“nexus”), rather than to other factors such as market power, advertising, demand for all products of a given type, a rising economy that ‘lifts all boats,’ etc. It is not negatived by any inability of others to test various formulations because of the existence of another patent. Success is success. . . .

Merck & Co. v. Teva Pharm. USA, Inc., 405 F.3d 1338, 1339 (Fed. Cir. 2005). Judge Lourie criticized the decision in Merck as “especially unsound in the context of an improvement patent, as here, because it holds in effect that commercial success for an improvement is irrelevant when a prior patent dominates the basic invention.” Id.

Once the patentee has demonstrated that the claimed invention is a commercial success and that the requisite nexus exists between that success and the invention, the patentee should not be required to prove more to gain the benefit of that objective evidence of nonobviousness. Here, the district court’s decision improperly nullified Allergan’s evidence regarding commercial success and long-felt need and should be reversed. . . .

I still think Allergan will be put out on its ear here, on appeal — but I am gratified to see that PhRMA did not advance a crazily pro-Saunders (anti-competitive researchers’) position. Onward, with a wide grin. . . seen, before lunch, indeed!



The US Is Not A “Net Exporter Of Energy”: Real Math & Science.

January 30, 2018 - Leave a Response

I did not watch, but I understand that 45 made the claim that we are a “net exporter” of energy.

We are not.

Real math matters — as does real science. Thus the new masthead.


Bezos-Dimon-Buffett “Plan”? I’ll Remain Cautiously Optimistic — If It Turns Out As Truly Non-Profit…

January 30, 2018 - Leave a Response

The nation’s papers and airwaves are simply agog with this — a something that amounts to. . . very amorphous news.

But I will offer the three my encouragement — just the same. If, for example, people who sign up for their privatized plan would agree to curtailed rights to sue providers, in return for much lower premiums, and access to proven medications at more sensible price points — and doctors would agree to charge less, since their malpractice premiums would decline. . . this could work. But that’s a whole raft of “ifs” — on what is just an idea, at this point (from The New York Times):

. . . .The three companies provided few details about the new entity, other than saying it would initially focus on technology to provide simplified, high-quality health care for their employees and their families, and at a reasonable cost. They said the initiative, which is in the early planning stages, would be a long-term effort “free from profit-making incentives and constraints. . . .”

Here’s to hoping, just the same (from CNN). But (to be certain) the for profit folks at Aetna, HCA and Andersen Cancer Centers — among others, should feel a twinge — a cold chill — on the backs of their necks, this morning. The fair market is coming for you.

And even without affirmative help from this administration, the cost of health care must be tackled in the US. That much is sure. Onward — clear and cold, here.


One Hundred And Seventy Three Years Ago Tonight… Of Immortality.

January 29, 2018 - Leave a Response

Depicted at right is a much later illustration from Poe’s immortal Raven [along with a cashmere muffler that I have never stopped wearing].

It is my favorite winter thing — without any peer. Warm, soft and comforting, in the icy blasts that are January in Chicago. . . just as so many of the lines of this poem have. . . comforted me.

Amazing that it has been just unser one and a three quarters centuries, since the below first appeared in The New York Evening Mirror, tonight. My. . . how time flies:

. . . .Ah, distinctly I remember it was in the bleak December;
And each separate dying ember wrought its ghost upon the floor.
Eagerly I wished the morrow; — vainly I had sought to borrow
From my books surcease of sorrow — sorrow for the lost Lenore —
For the rare and radiant maiden whom the angels name Lenore —
Nameless here for evermore.

And the silken, sad, uncertain rustling of each purple curtain
Thrilled me — filled me with fantastic terrors never felt before;
So that now, to still the beating of my heart, I stood repeating
“’Tis some visitor entreating entrance at my chamber door —
Some late visitor entreating entrance at my chamber door; —
This it is and nothing more. . . .”

Then this ebony bird beguiling my sad fancy into smiling,
By the grave and stern decorum of the countenance it wore,
“Though thy crest be shorn and shaven, thou,” I said, “art sure no craven,
Ghastly grim and ancient Raven wandering from the Nightly shore —
Tell me what thy lordly name is on the Night’s Plutonian shore!”. . . .

“. . . .Be that word our sign of parting, bird or fiend!” I shrieked, upstarting —
“Get thee back into the tempest and the Night’s Plutonian shore!
Leave no black plume as a token of that lie thy soul hath spoken. . . .

Nameless for evermore. . . smile. I like that too. Onward.


Chairman and CEO of 3M, Inge Thulin, To Be Added To Merck’s Board March 1 — Total Now 14…

January 27, 2018 - Leave a Response

I’m a little tardy in putting this one up — but it is not effective until March 1, so no harm, in truth.

And I’ve been unable to find the source of that lighthouse quote. . . so I’ll keep searching. That’s what I do — I keep on; I never give up. . . Smile. From the Friday SEC filing then:

. . . .Merck. . . announced that Inge Thulin, chairman of the board, president and chief executive officer of 3M, will join the company’s board of directors effective March 1, 2018. Mr. Thulin will stand for election with the company’s other directors in connection with Merck’s Annual Meeting of Shareholders on May 22, 2018. With the addition of Mr. Thulin, the Merck board will include 14 members.

“We are pleased to add Mr. Thulin to the Merck board and look forward to benefiting from his extensive experience as a global leader of an innovative and science-based company,” said Kenneth C. Frazier, chairman and chief executive officer, Merck.

Mr. Thulin is chairman of the board, president and chief executive officer of 3M, a company that applies science in collaborative ways to improve lives and create solutions to global problems. 3M has also been widely recognized for its commitment to sustainability and diversity. Mr. Thulin began his career with 3M in Europe in 1979 and since then has assumed several key roles of increasing responsibility, most recently serving as chief operating officer prior to his current role.

Mr. Thulin earned degrees in economics and marketing from the University of Gothenburg in Sweden. He is a National Committee on U.S.-China Relations Honoree, has received the Peter G. Peterson Business Statesmanship Award from the Committee for Economic Development, the Lucia Trade Award from the Swedish-American Chamber of Commerce and the Hendrickson Medal for Ethical Leadership. . . .

Now you know — nice dinner out, and then comedy club tonight, then collegiate hoops by road trip early tomorrow. Smile. Be excellent — to all those you truly love.


And Some Of The Stuff Pfizer Lobbied On, In Q4 2017…

January 26, 2018 - Leave a Response

Here’s the other bookend — to mine, of Wednesday — now setting out the bulk of the matters that Pfizer, for its part, lobbied on during the last quarter of 2017.

This is simply a trivial clean up post, then:

. . . .Trans Pacific Partnership Negotiations; Trans-Atlantic trade & Investment Partnership; Canada IP/Trade Issues; South Africa IP Issues; China IP; Indonesia IP; Thailand IP; Korea Pricing Issues; United Nations Health Panel; G7/G20; APEC; OECD; Australia Market — Size Damages; WTO “Zero for Zero” Pharmaceutical Agreement; NAFTA. . . .

Drug Pricing; Biosimilars Reimbursement; Antibiotic Resistance; Drug Shortages; Reimbursement for products treating Sickle Cell Disease; Creates Act [What is this? I’ll come back to it. . . . but Sen. Leahy has a good idea here.]

Medicare Part D; Medicare Part B CMMI Demo; Medicare Part B Reimbursement; Non-Interference; Importation; Prescription Drug Abuse meausres. . . .

Comprehensive Tax Reform; Territorial Systems; Border Adjustability Tax. . . .

Now you know — have a great weekend — clear, and in the 50s here now, so I am off on a walkabout.


A Cool, Quiet Friday… Before A Weekend Road Trip — No. 1 Villanova Vs. Marquette, Sunday At Noon…

January 26, 2018 - Leave a Response

But first, the Kenilworth news: BlackRock (perhaps one of the best large investors on the planet) held steady again this year with Merck.

Well — actually, it added about a million shares, but on 184 million shares already owned, that’s essentially steady state. The solid, leveled trend to stay the course between 6.6 and 6.9 per cent. . . has persisted since about 2014, when Mr. Fink first bumped Merck up — to over the magical 7 per cent holdings level, after nearly a decade. . . of not doing so.

So the news here is that BlackRock holds on to its optimism — about Merck.

Now — to the truly fun stuff: a quick road trip looms, for floor seats, to watch the nation’s D-1 current number one college hoopsters, from ‘Nova (the national champs two years ago, as well), take on my son’s promising but likely overmatched Marquette squad (after an early brunch) on Sunday, at noon. Always great to be up north with him — and his significant other.

So I’ll be smiling expectantly, all day today — as temperate sunshine splashes off the glass and steel canyons. Be excellent to one another. . . .


[U] Almost $22 Million — Not A Bad Payday, Five Years On, For An “Abandoned” Drug Candidate…

January 25, 2018 - Leave a Response

To be sure, the legacy companies may have spent well north of $100 million in the early development efforts, before the candidate was declared a non-priority, at old Merck, as it swallowed up Schering Plough. . . . so we should not get too wild-eyed here.

Even so, in 2012, the company was able to collect $1 million in cash for the candidate, from Menlo on an outbound license.

But the real payday just emerged: Menlo’s IPO just went effective with the SEC overnight, at an indicated $17 per share. And Kenilworth holds over 10 per cent of the now public company.

Thus Merck’s stake equates to about $20.89 million, before paying capital gains rate taxes — and before adding back the earlier $1 million.

So — resurrecting almost $22 million — from a “discarded” pile, now over five years later. . . showed some real corporate licensing/development savvy.

And patience. Now you know — I’ll endeavor to do. . . likewise. . . smile.

Patience is the watchword here, now. . . . and as an smallish literary update, that latter thought has put me in mind of a quote I read some years back — at least 20 years ago, this winter — that described the exhilaration that flows from the patience of a reader taking one’s time, in reading. . . any great poem. I can no longer recall the author, but the thought remains that being patient, in the act of reading — of participating fully and presently, in the emotion the poem conveys, is a sublime reward, indeed.

The specific metaphor (one I contemporaneously shared with. . . immortal beloved) is that the reader, long gone from her multi-story home, on a voyage. . . returns in inky-darkness, to begin reading — and as she progresses, line by line, and page by page — it is as though the lights are being magically switched on, in each story of the home, from bottom to top, slowly and patiently. . . and by the time the cupola is lit, the entire home — and the souls dwelling within — are very nearly. . . ablaze.

I like that notion quite a bit. And that is why patience is. . . a virtue, in my humble opinion. I’ll see if I can find the original source for that quote.

Namaste to all of good will.

Pfizer’s Q4 2017 Lobby Spend Nearly Doubled Merck’s… At $2.73 Million Vs. $1.35 Million

January 24, 2018 - Leave a Response

Not surprising, as Pfizer has certainly lobbied long and hard for the tax package that cleared both chambers at year end.

I’ll focus on where Merck spent most of its efforts, below:

. . . .H.R. 1 (Tax Cuts and Jobs Act). . . .

Medicare Part D (general education, no specific bill); LIS Co-Pays (general education, no specific bill); Independent Payment Advisory Board (general education, no specific bill), Medicare Part B (general education); Medicaid (no specific bill); Antibiotics/stewardship; Hospital Outpatient Prospective Payment proposed rule (CMS); Center for Medicare and Medicaid Innovation (CMMI) demonstration. . . .

340B (no specific bill), Hepatitis C (general education; no specific bill), Vaccine policies (general education; first dollar coverage; preventative services), antimicrobial resistance (general education), biosimilars (no specific bill), cost and value of medicines (no specific bill), women’s health (general education), Affordable Care Act, general pharmaceutical issues (transparency, formulary design, prescription drug coverage), Implementation of P.L.114-255 – 21st Century Cures Act; PAHPA (Pandemic and All Hazards Preparedness Act). . . .

NAFTA; KORUS and Budget Appropriations. . . .

Now you know — recovering enough to ride the train in for a full day, today. Smile.


Over A Million People Turn Out, Nationwide — Women’s March 2.0

January 20, 2018 - Leave a Response

Here in the City of Big Shoulders, the local turnout total was reliably estimated at 50,000 stronger than last year’s march — hitting 300,000. And unsurprisingly, almost all were chanting that 45. . . has to go:

That (above) is reality, in near real time — in stark contrast to Trump’s trolling tweets of this afternoon. Onward.