Friday, February 23, 2018

Will Kenilworth Look Outside The Company -- For Its Next General Counsel?

GE announced this afternoon that Michael J. Holston, the general counsel of Merck since mid-2015, is joining that vast industrial conglomerate -- as the next GC.

He had been brought in to Merck, as essentially a new hire -- from the outside, in 2012 -- (with credentials as a former US Attorney, and Morgan Lewis partner) to handle compliance at then Whitehouse Station, after the mis-steps attached largely to the Hassan-era Schering-Plough, and the yard sale that Merck (mostly) cleaned up, then and there.

So. . . will Mr. Frazier promote from within (he certainly knows the whole senior team well -- as he was the GC in an earlier incarnation)? And the need for an ex-government clean-up guy is now all but abated, so. . . who will it be?

We shall see -- I'll root for a promotion of some diverse talent from within Merck (there are several good candidates), but I imagine Mr. Frazier will select someone from outside the company, again.

Have a peaceful, productive weekend, one and all -- I know I will. . . . Grin.


[U] Placed In The Friday "Crazy Trump" File...

I am not vexed by any of this any longer -- I've come to expect that our leader is afflicted with a scattered, mostly lost mind. . . just what his personal Drumpf gene pool dealt him (it is plain he has done nothing to improve the meager estate he was granted between his ears, by Darwinian chance). No, it is now largely just a matter of observing. . . the patient, um. . . patiently. [And, of course taking action when and where warranted, peaceably.]

Even so, I must note this lunacy (solely for grins): our 45th said yesterday he might pull federal ICE (immigration) support employees "out" of California. Of course, any such act would require an amendment to the US Constitution (and would thus need to win passage, in a super-majority of all state legislatures, as well). . . but I want to focus on just how. . . unhinged a notion that is -- not the "practicalities" of it.

If California were declared (as Trump apparently wishes) a separate sovereign country, its economy would eclipse the United Kingdom and become the fifth largest on the planet, behind only the US, China, Japan and Germany. [That's ahead of the UK, Russia, France, Canada and India, BTW.]

Of course, 45 is miffed about the Golden Bear state becoming a sanctuary state, as are a growing number of larger metropolitan areas around the nation.

He doesn't even pause long enough to realize that he would lose about one fifth of the federal (tax) budget, if California were excluded from his. . . oligarchy. He would preside over a wasted, and dying, economy -- without any avocados for his toast.

Gosh -- just imagine. . . .

Onward, on an otherwise glorious Friday (hoping there is no flooding there). We may see the Gates plea deal, today (now confirmed -- two felonies -- with a 2 PM Eastern hearing set in DC federal district court).


Thursday, February 22, 2018

[U] BREAKING: New 32 Count Superseding "Speaking Indictment" -- Against Manfort; Gates To Plea Out...?

Well. . . Paul Manafort is having a very bad afternoon. Couldn't happen to a nicer guy.

Here is a new 37-page "speaking indictment" -- just filed by Team Mueller. The way it is crafted, it seems clear Gates will be largely a cooperating witness, to this speaking indictment -- and help prove it all up -- for the Special Counsel. He personally did most of this, right along with Manafort. Yet Gates is described as a mild mannered middle class fraudster, while Manafort is clearly painted (and accurately so) as an elite, disloyal to his country, aristocratic capitalist prince of darkness. This new speaking indictment will put enormous pressure on. . . both of them.

I have to run to a client dinner post haste, but will be back to explain why this tightens the cuffs around Donnie Jr., Jared and ultimately. . . 45's tiny wrists. Here's a bit:

. . . .When they were flush with Ukraine funds, MANAFORT, with the assistance of GATES, used their offshore accounts to purchase and improve real estate in the United States. When the income from Ukraine dwindled in 2014 and 2015, MANAFORT, with the assistance of GATES, obtained millions of dollars in mortgages on the United States properties, thereby allowing MANAFORT to have the benefits of liquid income without paying taxes on it.

MANAFORT and GATES defrauded the lenders in various ways, including by lying about MANAFORT’s and DMI’s income, lying about their debt, and lying about MANAFORT’s use of the property and the loan proceeds. For example, MANAFORT and GATES submitted fabricated profit and loss statements (P&Ls) that inflated income, and they caused others to provide doctored financial documents. . . .

A speaking indictment is one tough document: it uses a clever and devastating narrative device, to lay out the overall theory of the case. It is meant to terrify the indicted -- as they see how the AUSAs, at trial, will paint them, in front of the jury. How their families -- children too -- will be told, they really are. More later That's all for tonight -- be excellent to one another.


[U] "The CEO Who Stood Up To Donald Trump" -- Ken Frazier & NYT Do Our Democracy A Service

UPDATED, late on 02.21.2018 -- Mr. Frazier also spoke about his experiences, in a more fullsome way, to the Harvard Business Review -- just published this week. Do go read or listen to it all, at that link. But consider this: ". . .[Being black] absolutely is different. As a young lawyer in a law firm, very large Philadelphia law firm, I had to learn how to become user-friendly for partners and clients who are not prepared to understand really who I was or where I came from or my experiences in life. And you know, I’m not saying that’s fair. But learning how to get along with people who are white was a critical success factor in my life. . . .

I needed to learn how to socially integrate myself into the firm, because law is a relationship business, at the end of the day. And you never get those relationships of trust and confidence if people are not at ease with you socially. I think it’s fascinating to look at investment banking firms. You look at the people who are on the public or municipal finance side of the house, there’s a lot of diversity. Why? Because the mayors are diverse. You look on the private side, it’s not diverse at all, because the clients on that side tend not to be diverse, and they don’t demand diversity in the people who are servicing them. . . .

[W]hy is it the case that most people, if you ask them, who their friends are, I think most people who are white in this country, if they were honest, would say, I actually don’t have many friends who are African American. And so you bring that to the workplace, or your experiences socially become your experiences in the workplace. Most of my diversity conversations are had with the majority population, because frankly, those people are the people who have the most influence over everybody’s career. . . .
" [Ed. Note: end update -- but quite heady stuff. This (below) was originally published on the morning of February 19, 2018.]

I won't spoil it -- use one of your free articles each month to click this link, and read the story of Ken Frazier's decision-making this past summer. [And we will reprise our masthead, from that time in August 2017, for today -- as our nation celebrates three great Presidents. Appropriate.]

Do go read it all -- it tells a series of truths far too few high-end US based business executives have the courage to voice.

. . . .Mr. Frazier, the grandson of a man born into slavery, was the first of a series of chief executives to distance himself from the president. “I feel a responsibility to take a stand against extremism,” he wrote on Merck’s Twitter account at the time. . . .

The events that led to Mr. Frazier’s confrontation with the president unfolded over a tense summer weekend, as white nationalists gathered in Charlottesville to protest the removal of a statue of Robert E. Lee. Bloody fighting broke out as they clashed with counter demonstrators, one of whom was killed when a self-described neo-Nazi drove his car into a crowd of people.

“I saw what was happening on that Friday night, and then I heard the horrible news about what had happened on Saturday with the young woman being killed, and others being run down by a person who was sympathetic to people who held views that I consider personally noxious,” Mr. Frazier said. “And then I heard the president’s response.”

Mr. Trump, speaking at a veterans’ event at one of his golf clubs, condemned the violence but did not criticize the white nationalists chanting neo-Nazi slogans, blaming “hatred, bigotry and violence on many sides, on many sides.”

“In this case, we were not talking about politics. We were talking about the basic values of the country. . . I think words have consequences and I think actions have consequences. I just felt that as a matter of my own personal conscience, I could not remain. . . .”

“What happened that weekend I think was not a Democratic issue or a Republican issue,” he said. “I think that really went to the core of who we say we are as Americans. . . .”

Axios has chunks of it as well, if you have used up your ten free articles at the NYT for the month already.

It is now time -- for the sake of the sheer survival of our democratic republic way of governing -- for all people of good will (regardless of party affiliation) to rise up and peaceably resist 45. Trump is a man who, this past weekend, faced with overwhelming evidence that Russian state actors tampered with our electoral process -- chose to say the Russian state actors are "are laughing their asses off at us" (and quickly deflect blame, to others) -- rather than defending his own democracy. [This fits the pattern in the article, above.] Where, indeed is HIS condemnation of what the Russians indisputably did from 2014 to 2018? Where?

What exactly does he owe Mr. Putin's cut outs?


Wednesday, February 21, 2018

At Luminous Dawn -- Looking At An Anti-Viral Approach To Immuno-Oncology: Merck's Latest M&A Foray...

At the head, we would note that this acquisition of a smaller Australian public biotech is immaterial -- to Merck's finances.

Even so, it may well extend Kenilworth's overall lead in immuno-oncology, should Viralytics' Cavatak® candidate prove out, in clinical trials -- as a "viral vector" approach to helping solve the timeless, and often tragic riddle. . . of cancer, in humans. Cavatak is now under study primarily as a intra-tumoral, intravenous and intra-vesicular agent for melanoma, lung and bladder cancers.

Because the target is a public company in Australia, applicable law requires that the deal be conditioned on no higher bid (or bidder) emerging -- as a matter of fiduciary duty, on the Viralytics board's part. At a 160 per cent premium to recent Australian trading prices, per share, I think Merck chances of losing the deal to some interloper are. . . remote.

I suppose the primary, and logical, third party bid possibility might come from BMS (as a future potential add on to Optivo®, just as this is a future potential add on -- for the Keytruda® franchise, for Merck), but I put that as beyond Bristol's risk appetite, for its relative size, at this point.

We will keep you apprised, but here is a bit from the pre-dawn (US time) Reuters item:

. . . .Merck will pay 1.75 Australian dollars per share for the Sydney-based biotech company, which uses viruses to infect and kill cancer cells.

The deal represents a premium of 160 per cent to the average stock price over the past month. It is conditional on no better offer emerging from a counter-bidder. . . .

And so it is. . . that at dawn, all things are luminous -- and yet clear(er). Smile. Onward -- and a river runs through it. My eldest son is off to London rather soon -- on biz -- so proud of him. Grin-worthy, and so like his pops, indeed.


Tuesday, February 20, 2018

File This Under "Life... Will Not Be Denied": The Taíno People Live On... And I Grin, Broadly...

The prior western history orthodoxy had always taught that within decades of the Spanish reaching what we now know as the Dominican Republic -- the Taíno indigenous people were wiped from the face of the Earth -- by genocide, enslavement and venereal disease. And true enough, all those horrific events indisputably occurred.

But the part of the story only now being revealed. . . is that the proud Taíno people do in fact live on. They live on, in New York City, Puerto Rico and throughout the Caribbean islands, it turns out. The Darwinian spirit to live on -- to continue -- to replicate, to persevere. . . cannot (it seems) be denied. And the DNA of these fine Americans now proves it. Here is the bit:

. . . .“These indigenous communities were written out of history,” says Jada Benn Torres, a genetic anthropologist at Vanderbilt University in Nashville who studies the Caribbean’s population history and has worked with native groups on several islands. “They are adamant about their continuous existence, that they’ve always been [on these islands],” she says. “So to see it reflected in the ancient DNA, it’s great. . . .”

[T]wo lines of evidence suggest that around 2500 years ago, the woman’s ancestors migrated from the northern coast of South America into the Caribbean, rather than reaching the islands via the Yucatan Peninsula or Florida. It seems that once people arrived, they didn’t stay put. Archaeologists know that ceramics and other goods were traded between islands, indicating frequent trips. Moreover, the Taíno woman’s genome doesn’t contain long repetitive sequences characteristic of inbred populations. Her community, therefore, was likely spread out across many islands and not confined to 500-square-kilometer Eleuthera. “It looks like an interconnected network of people exchanging goods, services, and genes,” says William Schaffer, a bioarchaeologist at Phoenix College in Arizona who helped excavate the remains in Preacher’s Cave.

Estevez, who founded the cultural organization Higuayagua Taíno of the Caribbean, didn’t need an ancient DNA study to tell him who he is. Thanks to his family’s oral history and cultural practices, he says, he has always had a strong connection to his indigenous ancestry. But he hopes the new study will convince skeptics that Taíno people are alive and kicking. “It’s another nail in the extinction coffin,” he says. . . .

And so -- no matter that 45 demonizes these fine Americans (as "bad hombres") -- they were in fact here. . . first. And it is 45, and his early 20th Century ancestors who are the. . . interlopers. Just to keep the truth of it all. . . straight. Facts -- backed by DNA. . . matter.


Sunday, February 18, 2018

Still Rolling... 5,000 "Martian Days" -- Or Sols: NASA/JPL Opportunity Rover Style!

I must mark this stunningly audacious milestone, if only in brief:

Overnight, NASA/JPL's Opportunity Mars rover logged its 5,000th "Sol", on Mars (each "Sol" on Mars is about two-thirds of an hour longer than an Earth day, due to the distance Mars is from the sun -- and the differing speeds of rotation -- compared to Earth's rate of rotation, from the moment of one sunrise, to the next sunrise).

It was expected by JPL and NASA to survive 90 Martian "days" -- or sols. That would have been a success -- but it is well past fifty-five times that in service duration record, now. Opportunity has driven over 28 miles away from its landing site -- and is about one-third of the way down "Perseverance Valley," a shallow channel incised from a crater's rim. The rover has returned about 225,000 images, all promptly made public online.

That's a well-engineered rig.

And I am beaming, ear to ear, about it.

Now, with a clip of some poetry by Mr. Atkinson (in the image). . . here's to the future, what Sweet Will called. . . the "undiscovered country". . . . it too, calls forever to me. Sweetly haunts me, in fact. Grin.


Saturday, February 17, 2018

As I Long Predicted -- Gilead Was Never Likely To Pay Any $2.54 Billion Patent Infringement Verdict

mrk-alt-gil-verdict-hep-c-12-15-16 The single largest patent verdict in the history of the US court system. . . was just struck down, overnight. [My now prescient 2016 prediction on that; and a September 2017 one as well, here.]

To be fair, Merck's NYSE trading price never reflected an expectation that $2.54 billion would be paid to it, by Gilead. So its stock should be unaffected on next week’s NYSE open -- but Gilead's may rise modestly, with this news, as most of the uncertainty -- over levels of profitability on Gilead's largest single franchise, Sovaldi®/Harvoni®. . . is clearing.

And now, the central question is whether and when Merck will have to pay the $15 million in legal fees it has been ordered -- at the trial level -- to pay to Gilead, in California, on these same patents.

The able judge back in Delaware has ruled that the prior in time Merck patent (via the Idenix acquisition) is invalid essentially for being too vague to teach a skilled scientist how to make the specific compound that became Gilead's (via the acquisition of Pharmasset). . . Harvoni®/Sovaldi®. Here is a pertinent bit -- but do go read it all (some 52 pages, if you are so inclined!):

. . . .Only in March 2005 -- two months after the publication of U.S. Patent Application No. 2005/0009737 (DX371), issued to Pharmasset[/Gilead's] Jeremy Clark (more on him below), had been distributed at Idenix[/Merck] -- did Idenix[/Merck] first succeed in making and testing 2'-methyl up 2'-fl-µoro down. (DX359; DX0274.0119, 0122; Wang Tr. at 1196, 1198-1200 (stating that in March 2005 Idenix[/Merck] first successfully synthesized "an unprotected 2'-methyl-2'-fluoro nucleoside" and recognized it had done so); Standring Tr. at 1831-33)

In short, the undisputed record shows that, between 2002 and 2005, Idenix[/Merck] tried and failed to make and test a 2'-methyl up 2'-fluoro down nucleoside, and only succeeded when [Idenix/Merck's] Dr. Griffon "us[ed] information from a published Pharmasset[/Gilead] patent application. . . ."

The only reasonable finding, based on the trial record, is that Gilead met its burden to prove non-enablement by clear and convincing evidence. The trial revealed that there are no genuinely disputed material facts with respect to enablement. Accordingly, Gilead is entitled to judgment as a matter of law that the asserted claims of the '597 patent are invalid due to lack of enablement. . . .

While Merck will appeal this loss to be certain, I think the most likely final outcome is that Merck pays Gilead's legal bills in California, and does not win any royalty on Gilead sales.

We shall see -- but likely so ends the largest patent infringement award in US history. Back to championship basketball, in the gym. . . .


155 Years Ago This Morning In Genevé -- What Became The International Red Cross Was Founded...

This morning, we resolve anew, to bend the arc of history -- once again, toward. . . progress.

And so, in Genevé, Switzerland, 155 years ago this day -- a Swiss businessman named Henry Dunant founded the "Committee of the Five" -- with members of five other prominent Swiss business families. He was moved to do so after witnessing first hand the horrific aftermath of the battle of Soferino on June 24, 1859 -- a battle in the Second Italian War of Independence -- in which as many as 40,000 men in a single day of fighting were left dead or dying on the battlefield, with essentially no triage or treatment.

Within a few days of forming the Committee of the Five, the Swiss business leaders renamed it the "International Committee for Relief to the Wounded", which in turn grew in time to become the International Red Cross movement. By 1864, the first use of the Red Cross icon, as a protective banner for medical personnel, occurred -- in an armed conflict during the Battle of Dybbøl, in Denmark.

In parts of the world where the cross might be a misinterpreted iconography (or misunderstood as a purely religious allegiance, and thus less welcome), it now also operates in appropriate geographies as the Red Crescent.

. . . .Directly following the establishment of the Genevé Convention, the first national [Red Cross] societies were founded in Belgium, Denmark, France, Oldenburg, Prussia, Spain, and Württemberg. Also in 1864, Louis Appia and Charles van de Velde, a captain of the Dutch Army, became the first independent and neutral delegates to work under the symbol of the Red Cross in an armed conflict. Three years later in 1867, the first International Conference of National Aid Societies for the Nursing of the War Wounded was convened. . . .

And so it began on February 17, so so long ago. Though the American Red Cross has seen its share of administrative and fundraising controversies, the overall international organization does invaluable humanitarian work.

So let us each remember this weekend, today in particular, to celebrate the birthdays. . . of the good. I am off to the 50th annual local charity middle-school championship basketball game, and pancake breakfast benefit, in just a bit -- and here's to 50 more, for this particular support organization, focused on at-risk youth. Smile.


Friday, February 16, 2018

Donald Trump's Loony Friday Afternoon "Russia Denial" Tweet -- After 15 People/Companies Indicted; And Three Felony Guilty Pleas, Just To Date.

Well, Mr. Mueller has added 14 more scalps this afternoon, to his previous totals.

Almost in passing, I simply must point out that 45 cannot possibly have any rational basis -- for the bolded statement in his most recent tweet, below.

He simply cannot. No one will ever know -- so we may safely (once again!) call him. . . a liar.

. . . .Russia started their anti-US campaign in 2014, long before I announced that I would run for President. The results of the election were not impacted. The Trump campaign did nothing wrong - no collusion!. . . .

Unless 45 has Marty McFly's DeLorean (and a working flux capacitor, built by Doc Emmett Brown) -- and then actually does go back to "Alternate 2014 to 2016" -- we may safely call him. . . a bold faced liar. Because he. . . is.

Now off, for a sublimely great weekend! Do be excellent to one another. . . .


Impertinent Friday Questions Dept.: Is Gates Likely Entering A Plea Deal Tonight, Or Next Week?

Several major outlets (including CNN, which first broke the story) have now reported -- citing anonymous sources -- this bit of salacious but fascinating speculation. So. . . I too, will oblige, and add my take on it all.

The D.C. federal District Court's latest docket entries likely confirm that reporting (see below).

Specifically, Mr. Gates is presently arguing pro se (without much success), to keep secret his problems surrounding the recent motion for withdrawal -- by his defense counsel.

And the court has suspended the current deadlines in the cases of Manafort and Gates, pending "further order". This almost certainly means Mr. Gates will plead guilty to crimes, and agree to cooperate with Mr. Mueller -- and the announcement of this development could come as early as late today:


The Current Briefing and Hearing schedules that were established at the Status Conference held on 1/16/2018, and in the Minute Order issued on 1/17/2018 are suspended pending further Order of the Court. The government's [155] Motion to Modify the Court's Schedule for Rule 404(b) Notice and Briefing remains under advisement. SO ORDERED. By Judge Amy Berman Jackson on 2/14/2018. . . .

Now you know -- Bobby Three Sticks is certainly tightening the ropes here. My prediction? Manafort will be crushingly pressed by this development -- and will have to rat out 45, to avoid a potential 30 year sentence (essentially life, given his age and health), on his own. There will be no slack for 45, in the end.

And in closing, in a Merck-related footnote/bit of marginalia, British intelligence is confirming that the "Not Petya" hack of the spring of 2017 was in fact sponsored by Russian state actors. Of course, under Trump's thumb, we may confidently predict only this very bland US assessment will see the light of day, until Herr Trump is deposed -- but Mr. Frazier should be encouraged to know that most cogent analyses suggest his company was largely collateral damage in yet another Russian sponsored cyber-terror plot. As such, there is little he could have done to avert it -- especially with a President reticent to call Putin out, for his high-price tag cyber chicanery.



I Will Reserve Judgment -- But This Seems "A Bridge Too Far": Rofecoxib, Which Cost Merck Over $4.85 Billion, In Settlements...

I've felt ambivalence, all day, about even mentioning this development, here (as I genuinely do not want to hurt the mentioned company's chances). But I do feel it needs to be said, at least to keep a complete record, on rofecoxib. [So I'll say it at night -- late -- where Poe's immortal words still profoundly echo, off carmel-colored marble hallways. . . smile.]

It seems that in the last few days, a smallish privately-held Cambridge drug firm raised $5 million. It raised the money, with an express plan to bring the drug that Merck called Vioxx® (rofecoxib). . . back to market.

This time, though -- to be fair to the people at Tremeau -- the drug will be prescribed (if and when it clears FDA) for an exceedingly small number of patients -- people with otherwise untreatable pain from hemophilic arthropathy. [The buzz is also a bit about non-opioid pain relief.] Here is a bit of the presser -- do go read it all:

. . . .About TRM-201

TRM-201 (rofecoxib) is a highly potent cyclooxygenase-2 (COX-2) selective non-steroidal anti-inflammatory drug (NSAID) with a well-established efficacy profile and is the first and only product granted orphan designation status for the treatment for hemophilic arthropathy. Rofecoxib is a non-narcotic analgesic, has no effect on bleeding time relative to placebo, and is the only COX-2 selective NSAID ever approved in the U.S. to demonstrate a reduced risk of gastrointestinal bleeding versus a traditional NSAID in a controlled trial. . . .

Yes, Merck did license this out. And yes, if it gives a small base of rare disease patients some relief -- even at some increased cardiac event risk -- I suppose that is a discussion best had between each patient, and his/her treating doctor. . . not the regulator, per se. Vioxx always did provide good pain relief, but in ordinary cases, with other alternatives, Merck itself decided to pull it from the market voluntarily, fourteen years ago. Now you know.

And I do fully-understand the counter-argument. Be excellent to one another. . . as I am out -- completely out, as Mr. Trump has refused to release the photo from January of 2017, of his signing a law that made it easier for the mentally ill to get weapons (repealing an Obama measure) -- weapons including those like the ones used yesterday in Parkland, Florida. What a coward -- 45 won't even own his public, and entirely notorious prior (and recent) supplications to the NRA, and its lobbyists. Ugh.



Thursday, February 15, 2018

As Expected, The Fourth Circuit Joins The Ninth, And Rules 9 to 4 That The Muslim Ban 3.0 Injunction Out Of Maryland Should Continue...

No surprise -- and (of course, as we've always said) all of this will ultimately be decided by the Supremes, come late summer, or early fall of 2018 (and my January 2018 backgrounder).

But 45 has yet to win a single matter on the merits, in any federal court. In fact he is now like 0-17, on procedural matters, related to his three would-be Muslim Bans. And make no mistake, folks -- he has openly said that is what he intends them to be. Here's a bit -- of the once again towering language of the opinion, just released by the Fourth Circuit (285 pages of PDF goodness!), this morning:

. . . .“The First Amendment mandates governmental neutrality between religion and religion, and between religion and nonreligion.” Epperson v. Arkansas, 393 U.S. 97, 104 (1968); accord Larson v. Valente, 456 U.S. 228, 244 (1982) (holding that Establishment Clause prohibits “one religious denomination [from being] officially preferred over another.”).

“When the government acts with the ostensible and predominant purpose of advancing religion, it violates that central Establishment Clause value of official religious neutrality, there being no neutrality when the government’s ostensible object is to take sides.” McCreary Cty. v. ACLU, 545 U.S. 844, 860 (2005). “[T]he Establishment Clause forbids subtle departures from neutrality, ‘religious gerrymanders,’ as well as obvious abuses.” Gillette v. United States, 401 U.S. 437, 452 (1971) (quoting Walz v. Tax Comm’n, 397 U.S. 664, 696 (1970)). Similarly, “any covert suppression of particular religious beliefs” is unconstitutional. See Bowen v. Roy, 476 U.S. 693, 703 (1986) (plurality opinion). . . .

Plaintiffs here do not just plausibly allege with particularity that the Proclamation’s purpose is driven by anti-Muslim bias, they offer undisputed evidence of such bias: the words of the President. This evidence includes President Trump’s disparaging comments and tweets regarding Muslims. . . .

The Government does not -- and, indeed, cannot -- dispute that the President made these statements. Instead, it argues that the “statements that occurred after the issuance of [Muslim Ban 2.0] do not reflect any religious animus” but reflect “the compelling secular goal of protecting national security from an amply-documented present threat.” We cannot agree.

Rather, an objective observer could conclude that the President’s repeated statements convey the primary purpose of the Proclamation -- to exclude Muslims from the United States. In fact, it is hard to imagine how an objective observer could come to any other conclusion when the President’s own deputy press secretary made this connection express: he explained that President Trump tweets extremist anti-Muslim videos as part of his broader concerns about “security,” which he has “addressed. . . with. . . the proclamation. . . .”

Onward -- to the Supremes, with a smile. Trump loses -- again. And. . . I am debating whether to add the latest Florida 17 (school kids, for God's sake) to the grim totals I've been tracking -- just since 45 took office. We are nearing 700 dead and injured, now (almost all these shooters are white males, with automatic weaponry). When is it going to be enough, for the Big Cheeto?


Wednesday, February 14, 2018

Courtesy The Oh-So-Kind Anon: Nice Reversal, At Swords, Ireland, Since November 2013...

As we somberly reported back in November of 2013, this entire Merck Ireland facility was slated to close forever.

Between the ongoing, and dragged out Brexit shifts, and improving bioscience (immuno-oncology) pipeline deliveries, Merck's MSD subsidiaries are now expanding in and near London, as well as in Dublin -- one of my favorite places on the green Earth. Smile. Here's the bit, from Irish Times:

. . . .MSD’s US parent, the drug giant Merck, is looking to ramp up global manufacturing capacity for its blockbuster cancer therapy Keytruda. At present the group has only one immuno-oncology manufacturing base, with the rest of its supplies delivered by contract manufacturing partners.

Ger Brennan, managing director of MSD Human Health, said the company expected “significant growth” in immuno-oncology over the coming years.

“We need to have confidence in supply,” he said.

MSD expects the new facility to be operational in 2021 and fully certified by 2022. “It’s a bold statement by MSD,” said Mr Brennan, “but that’s our target.”

The Swords investment will be a “significant component” of the €4 billion capital expenditure plan outlined by the US group earlier this month, Mr Brennan said, although MSD did not disclose the amount of its investment. . . .

Now you know -- smiling, as quite leprechaun-like. . . I vanish.


Four Stories I Missed -- While Looking For Something... That (Apparently) Never Existed.

Here is the Verubecestat story -- from Bloomberg. This outcome was widely telegraphed to the NYSE by this and other outlets, back in February of 2017 (while I was still looking -- into April and May of that year) and again in January of 2018, as we noted here. So it goes. More than five years. . . wasted.

Heh. Next, a tiny (by capitalization) sub of Merck called StayWell has acquired a small start up called Provata Health -- in Portland, Oregon -- to do digital health. No needle mover there, either.

Third, as of year end 2017, and as expected -- Merck has completely sold off its stake in BeiGene, since it had gone public, and made that orderly liquidation process. . . easy. At one point in 2016 (continuing into 2017), Merck related entities owned more than 10 per cent of this rising bioscience star.

And the final "missed" story, with nearly no chance to harm Merck's NYSE trading price, is simply. . . bizarre. A long time chemist for Merck was apparently interested in killing rodents in his alley, and inexplicably stole an entire industrial size bottle of cyanide from an area of Merck's labs he was not authorized to be in -- and was observed by other employees removing the cyanide. Crazy. Here's a local story, on it all:

. . . .Richard O'Rourke, 60, of Warrington, Bucks County, told authorities that he dumped 219.79 grams of potassium cyanide into a stormwater inlet in Bucks County in December after his employer at the time, Merck & Co., became suspicious that he had taken it and an investigation was launched. The lethal dose for potassium cyanide is 200-300 mg.

The alleged incident sparked a two-week period of testing and monitoring stormwater systems, outfalls, retention, waterways and their tributaries in the Philadelphia area earlier this winter, according to an affidavit from the Upper Gwynedd Township Police Department.

But officials said the significant rainfall that fell several days after O'Rourke allegedly dumped the chemical should have been able to flush it out of any stormwater inlet. . . .

No large employer can reliably prevent any employee -- especially a quiet one, who clearly had a screw loose -- from (without warning) doing this sort of irrational nonsense. Now you know -- and. . . sometimes it is better to "freeze nearby, than to burn at a distance," it seems.


Monday, February 12, 2018

Also While Off Grid Dept: Four Years Running -- Vanguard Group AGAIN Upped Its Merck Holdings In 2017

Playing more catch up here, tonight. . .

It is a strong vote of confidence -- in Merck's management and business acumen -- that for the last four years in a row, Vanguard has bumped up its stake on a percentage basis of the company's shares. Here's the SEC filed Schedule 13G, from from late last week -- and a bit:

. . . .197,466,971 shares -- 7.24%. . . .

Pretty solid stuff. Now you know -- and my golden dog and I are smiling at the southern view(s). . . . as the Winter Games roll by our screens. . . .


Federal Propecia® MDL Status Update: While I Was Off-Grid Last Week, More Individual Cases Dismissed...

As was true last month around this time, once again this month (as of the 9th, actually) -- another bolus of cases has been dismissed by the able Judge Brian Cogan in Brooklyn, for failure to comply with expert opinion/discovery orders, among other things.

And by way of additional background, here's a link to the end of December's installment, on this topic. If any or all of this interests you, you may review the entire eight page PDF of the latest filing here, to see if your name is included, there. Here's a bit of the lead in:

. . . .On May 9, 2017, the Court issued PPO 16. That Order directed the Plaintiffs’ Executive Committee in this consolidated litigation to review the plaintiffs’ experts’ opinions on general causation for the claims, and to review what evidence the experts deemed necessary to establish facts consistent with their proffered opinions (that is to say, what facts a hypothetical plaintiff would have to prove to prevail against defendants). The Order then directed counsel for each plaintiff to review the experts’ opinions and to inform their clients whether their factual claims fit within the experts’ stated theory – i.e., whether those clients were likely to have a viable claim in this litigation. . . .

Some have apparently failed to clear that hurdle, according to their own lawyers. Though some have been given additional time, since the problem was procedural, not substantive -- if you are curious -- do take a look.

Now you know. Onward, into the bright but cold afternoon sunshine we go -- replacing the masthead momentarily. Smiling, all the while. . . with a big sweet golden dog, this week, as my house guest. . . grin. . . .


Sunday, February 11, 2018

Ahem. Time To Shovel Out -- About Fourteen Inches...

Let's caption this one "the lying (by way of material omissions) continues". . .

I'll be back after I'm settled in, and shoveled out -- but do go read this latest Denver Post exposé (linked in that post, on one of my other properties), all on Riot Blockchain.

Be excellent to one another.


Friday, February 9, 2018

On Vacation; Just Quoting The Opinion -- Analysis Next Week: Nasonex® Wasn't Infringed Via Amneal's Mometasone Furoate Monohydrate...

I am out to a Friday evening dinner, but here it is -- the appellate level Federal Circuit panel has ruled against Merck's patent defense -- to Amneal's pending introduction of a generic mometasone furoate monohydrate, the active ingredient in a nasal product (which Merck sells as Nasonex®).

Here is the full 18 page PDF of the opinion -- but this likely means Kenilworth won't seek the Supremes' review, as Nasonex is already being sold as a generic, by others -- if my unaided memory serves.

. . . .Following a bench trial, the district court found that Merck failed to prove by preponderant evidence that Amneal’s ANDA product will infringe the ’353 patent. On appeal, Merck argues that the district court abused its discretion by not compelling Amneal to produce additional samples of its ANDA product for testing before trial.

Merck also argues that the district court’s noninfringement finding must be reversed because it was not based on Amneal’s final commercial product. Merck also challenges the district court’s fact-finding that a Raman spectroscopy three-peak analysis was required to confirm the infringing form of mometasone furoate in Amneal’s product.

For the reasons explained below, we conclude that the district court did not abuse its discretion in denying Merck’s request for additional samples and a new trial. Further, we hold that the district court did not err in finding that Merck failed to demonstrate that Amneal’s ANDA product, which formed the basis for the district court’s noninfringement finding, was not representative of Amneal’s final commercial product. Finally, we conclude that the district court did not clearly err in finding that three Raman peaks were required to prove infringement. Accordingly, we affirm. . . .

Now you know -- stay warm and stay snuggly, as we all watch the opening ceremonies, on demand (and on a slight delay, tomorrow night). Smiling here -- as ever, as I enjoy a 75 degree evening outdoors. . . .


Friday Fare: Of "Gifted Pioneers" -- Satchel Paige -- The Best Pitcher In The History Of ALL Baseball...

Forty-seven years ago this day, Leroy "Satchel" Paige was inducted to (white) MLB's Hall of Fame. He was the first Negro Leagues player to have been so honored.

But that is really only the smallest of footnotes, to his literally jaw-slacking career -- both in terms of his brilliance, across decades, and the notion that he was still a dominating pitcher in the majors, in his late 40s. We salute you, Mr. Paige:

. . . .In 2010, sportswriter Joe Posnanski, writing for Sports Illustrated, named Paige as the hardest thrower in the history of baseball. He based this, in part, on the fact that "Joe DiMaggio would say that Paige was the best he ever faced. Bob Feller would say that Paige was the best he ever saw. . . . Hack Wilson would say that the ball looked like a marble when it crossed the plate. Dizzy Dean would say that Paige's fastball made his own look like a changeup. . . .

Paige was a right-handed pitcher, and at age 42 in 1948, he was the oldest major league rookie while playing for the Cleveland Indians. He played with the St. Louis Browns until age 47, and represented them in the All-Star Game in 1952 and 1953. He was the first player who had played in the Negro leagues to pitch in the World Series, in 1948, and was the first electee of the Committee on Negro Baseball Leagues to be inducted in the National Baseball Hall of Fame, on February 9, 1971. . . .

And this morning, I am feeling very fortunate to be about 1,100 miles away from the foot of snow now falling in the former home of the Chicago American Giants -- for a time, Mr. Paige's Negro League club. . . smile.