Tuesday, September 19, 2017

If You Care About The Rule Of Law... And Preserving A Constitutional Democracy


. . .please do read the New York and Washington, DC papers of record -- today and tomorrow. Especially the front pages of each lady.

This is a (third party's) nice summary of where we are, in the "shock and awe" criminal investigation of 45 and his campaign:

. . . .[Overnight] the New York Times reported that Mueller told Trump's former campaign chairman Paul Manafort he was going to be formally charged with a crime following a raid on his Virginia home over the summer.

Mueller has also issued subpoenas to Manafort's spokesman Jason Maloni and former attorney Melissa Laurenza to testify before a federal grand jury.

The developments indicate that Mueller's probe "is nearing the litigation stage," said Brookings Institution fellows and legal experts Benjamin Wittes and Susan Hennessey.

"Combined with a flurry of stories about subpoenas, grand-jury appearances and other activity, it’s reasonable to expect that Mueller is moving forward on a number of different fronts and is getting close to entering a litigation phase," wrote Wittes and Hennessey, a former attorney for the National Security Agency.

"The key question is what he will allege, to what extent it will deal with campaign activity, and against whom he will allege it," they added. . . .


Go get 'em, Bobby Three Sticks. Too busy to say much more -- as I dash for the door -- on this soggy but hope filled morning. . . maybe more, tomorrow. Be well, all.

नमस्ते

Sunday, September 17, 2017

How Soon... To Arrival Of Muslim Ban 3.0?


Ahem. It is finally time to say aloud what we've all been whispering about for months now: it may well may be that the travel cases on Muslim Ban 2.0 are dropped from the Supremes' docket after next weekend, entirely.

Several blog-authors (myself included) have tacitly avoided mention of the below topic -- not wanting to give 45 any useful trail-maps on possible paths through the woods he's made for himself.

Today his administration indicated that a new travel ban order is actively being vetted. I say bring it on. What, at bottom, he wants to do. . . cannot lawfully be done by his office acting alone. And as of next Saturday, his current ban expires by its own terms. The Supremes won't decide a moot case, under a couple centuries' worth of black letter precedent. So, without an identically-worded Muslim Ban 3.0, one with a later sunset date, the final outcome will be that Trump lost 13 of 13 cases in which his travel ban was litigated, on the merits.

So, I'd expect an identical Muslim Ban this week, one we will call 3.0. And to be clear, if it is not in every respect (save only expiry date) identical to the last one, applicable precedent will mean that Mr. Trump will have to start re-litigating 3.0 all over again, at the bottom -- defending it in trial courts around the nation, where it too will lose. And so, he won't reach the Supremes again until perhaps election day in 2018. Poetic justice, that.

We will bring it -- with plaintiffs named in original federal constitutional litigation -- all as newly filed complaints, in the USDC of Hawaii, Brooklyn and in DC -- as well as now-likely challenges in San Jose and Chicago. Bank on that. In sum, we will resist. Resist. Resist. Onward.

नमस्ते

Friday, September 15, 2017

Trump Loses Again -- This Time In Chicago -- Just As We Said He Would, Back In August...


Just as we said it would transpire, back in the first week of August, my fair City has brought the small-handed tyrant to heel -- once again. [Muslim Ban 1.0 and 2.0 epic failures being earlier examples.] And it really took very little time -- at all. 45's latest attempt to punish sanctuary cities has now been enjoined, nation-wide.

Since the early 1980s, the City of Big Shoulders has kept in effect one form or another of a "welcoming ordinance". That law "reflects the City’s belief that the 'cooperation of the City’s immigrant communities is essential to prevent and solve crimes and maintain public order, safety and security in the entire City' and that the 'assistance from a person, whether documented or not, who is a victim of, or a witness to, a crime is important to promoting the safety of all its residents'. . . ." In other words, we won't demonize someone simply because that person might arguably lack papers.

Against that specifically humane local law's backdrop, a very able federal District Court judge in Chicago has ruled today that Mr. Trump's attempt to add conditions to a statutory grant, where Congress specifically withheld the right of the President to add such conditions. . . cannot pass muster, and so my City is entitled to a preliminary injunction, stopping Mr. Trump and Mr. Sessions from trying to enforce this extra-legislative attempt at law-making. Here is the finely-reasoned 41 pager -- and a bit:

. . . .The Attorney General’s reading of the statute therefore ignores the ostensibly clear decision by Congress to withhold comparable authority in the Byrne JAG provisions. See, N.L.R.B. v. SW General, Inc., 137 S.Ct. 929, 940 (2017) (noting the expressio unius canon’s application when “circumstances support a sensible inference that the term left out must have been meant to be excluded”) (quotations and alterations omitted). Regardless, it would be quite odd for Congress to give the Attorney General authority to impose conditions on the discretionary grants if it had already provided the Attorney General authority to impose conditions on all grants through Section 10102(a)(6). . . .


On this issue, Mr. Trump is so plainly out of bounds I'll likely not spend a lot of time covering subsequent wins -- should 45 attempt to press forward with this nonsense. If I do, it will be strictly for grins.

So you may henceforth safely assume that Mr. Trump's hare-brained Chicago-aimed scheme (like so many others) has died a simple death, if I do not mention it again. Onward, and goodnight -- wonderful Indian Summer weekend ahead here!

नमस्ते

No Graphic -- But A New Low From 1600 Penn: 45, Insulting Our Ally, During A Terror Strike.


When (in an inevitably understated way) multiple British officials characterize the response of the President of the United States -- to a terror attack inside London's Tubes, early this morning our time, as "unhelpful" -- we should all take pause. This is without a doubt our closest ally telling us our leader is. . . manifestly unfit, in a crisis. Any crisis.

That's all I need say about that.

नमस्ते

Thursday, September 14, 2017

[U] "A Gazing Out, From Far Away... Alone." An Irish Poet's Prescient Verses...


Believing that less is more -- at a time like this (a handful of hours from now) -- we will lay rest to longer strokes on our keyboard, and just sit a moment under the dawn's canopy of stars. And we will look with awe, toward the spot above Saturn -- where Cassini will soon. . . flamed out.

In fact, we will still be receiving transmissions, for 83 minutes after she's gone. It will take that long for the last of the radio waves to reach us here at the dish, in Australia, after she's sprinted into shattered bits, giving her last full measure of devotion, to advancing science. So thank you, sweet Cassini -- oh you, gossamer thing of unwasted grace.

. . . .And after the commanded journey, what?

Nothing magnificent, nothing unknown.

A gazing out from far away, alone.

And it is not particular at all,

Just old truth dawning: there is no next-time-round. . . .


Seamus Heaney, that giant of Irish poems may just as well have been speaking of. . . the swift, lithe, copper-hued Cassini, lo' these 13 years, a shepherded moon-lette, of sorts. [Though cousin Seamus is in need of a smallish revision (as it pertains to Cassini, at least): far from "nothing left unknown" -- yes, so much still to discover -- to explore; to probe; to taste and see. Smile.]

Enjoy your return to primordial star stuff, now Cassini -- as you are heated, and then incinerated down into simpler bits -- primarily atoms of carbon, hydrogen, and oxygen once more -- under the crushing atmospheric pressures and friction, of mighty Lord Saturn.

We do thank you for opening our eyes -- to a wide array of new planetary science wonders, over this last decade.

नमस्ते

Back To The "Power Alley" Of This Blog: FDA & "Preemption", After Wyeth; Merck's Latest Fosamax® Appeals


We have covered -- on and off -- nearly the entire preemption FDA waterfront, starting now almost a decade ago -- all of which led to the Supremes' decision in Wyeth v. Levine. And we have covered a recent interim win, for Merck's opponents -- the Fosamax® plaintiffs -- in the federal appellate courts sitting over New Jersey -- here. That is the Third Circuit.

[Thoughts from a decidedly pro-industry, but very able, blogger may be found here. My backgrounders, by way of slight but substantial contrast, from June 2016, here, and a prior April 2014 one, is here. This matter -- as much as any other -- has also been the subject of at least $100 million of lobbyist efforts, industry wide, over the last decade or so. So it is a cause of particular moment -- as preemption all but closes the court house doors on many, many would be drug products liability class action suits. The most recent Merck prior Third Circuit opinion, in full, is under that link.]

And so we arrive at a moment where the Supremes are being asked to weigh in -- again. Here's a bit, from the current Merck cert. petition before the Supremes, now -- a bit:

. . . .Wyeth v. Levine, 555 U.S. 555 (2009), rejected an argument that the FDA’s mere approval of a drug’s label immunizes the manufacturer from any state tort liability for failure to warn. Rather, only if the FDA would have rejected a warning should the manufacturer be shielded from liability for failure to give it. In the latter scenario, it would truly be impossible to comply with both federal law (blocking the warning) and state law (mandating the warning). In Levine, however, there was no evidence that the FDA had paid more than “passing attention” to the risk at issue; no evidence that the drug manufacturer had provided the FDA with “evaluation or analysis” of the risk; no evidence that the manufacturer had “attempted to give the kind of warning” demanded by the plaintiff; and no evidence that the FDA had ever “made an affirmative decision” against allowing such a warning. Id. at 572-73.

In this case, by contrast, each of those factors is undisputed. Petitioner (“Merck”) submitted data and analysis to the FDA suggesting that its Fosamax drug may be associated with certain bone fractures. Merck also proposed a warning addressing that risk. After back-and-forth, the FDA ultimately rejected the proposed addition, stating that it was not supported by the data. Pet.App.59a-61a. Despite all of this, the Third Circuit held that respondents’ failure-to-warn claims were not legally preempted, because it believed that a jury could infer that the FDA’s objection had been only to Merck’s wording, and thus, as a “hypothetical” matter, that the agency might have approved the warning had it merely been phrased slightly differently. . . .

Unfortunately, the decision below is not unique in its hostility to preemption. Despite Levine’s recognition that preemption would be appropriate if the FDA would have rejected the label demanded by the plaintiff, courts have erected a series of procedural and substantive hurdles to this defense, making it virtually impossible to establish, certainly as a matter of law. This case presents a particularly extreme illustration, with the court inventing a “clear and convincing evidence” standard exclusively for drug manufacturers, demanding “smoking gun” proof of why the FDA had rejected Merck’s on-point warning, and leaving a lay jury to speculate about the intent of a federal regulatory authority. This Court should grant certiorari to revive failure-to-warn branded drug preemption in the wake of the lower courts’ interpretation of Levine. . . .


I certainly think additional clarity would be helpful -- and it is clear that Merck's fact pattern -- in these New Jersey MDL Fosamax® cases -- offers industry a very strong probability of expanding the limits on class action suits announced by the Supremes in Wyeth. So do stay tuned. With Justice Gorsuch firmly in his seat, and taking an activist's "pro-business interests" role -- I suspect the high court will take this case. . . and I additionally suspect the outcome will not be very good for would-be plaintiffs. It ought to be pretty good for Kenilworth though. Now you know -- both five years, and a full decade on. . . . Onward.

नमस्ते

Sentencing Date: January 16, 2018 -- And, That's A Wrap -- On Martin Shkreli.


Well, now that we know his sentencing date -- I will let this incarcerated felony convict's weed-strewn field lie fallow for a bit (as yesterday has a three year echo to it, for me, personally).

As we turn away from the sad farce that is Mr. Shkreli (now known as Inmate No. 87850-053 -- at least until 2 PM EST on January 16, 2018), I found this Washington Post news analysis piece, from a little after midnight this morning -- on the evening's events -- to be pretty cleverly put-together:

. . . .Martin Shkreli wanted to be an Internet supervillain. This time it cost him.

For Martin Shkreli, the acts of ridiculing and trolling weren’t just a solitary hobby. They were a performance for the benefit of his small army of online fans, who loved watching their favorite Internet supervillain get away with it. . . .

He became reviled for the very same behaviors his superfans cheer on: his cocksure displays of immaturity and indifference, and for exuding the impression that he was somehow, always, above reproach. . . .

In his defense, Shkreli’s legal team used a version of the same refrain he’s always used to explain his behavior online: that he wasn’t really serious. Essentially, he’s invoking Poe’s law, the old Internet rule that has to do with the impossibility of proving whether an extreme statement online is earnest or ironic unless you truly know the author’s intent. . . .

In recent years, a version of this rule has become the go-to defense for abusive or offensive online behavior: the claim that it was all just a joke, one that the victim is failing to appreciate. But in this case, [the very able USDC Judge Kiyo] Matsumoto wasn’t buying it. . . .

Shkreli has a habit of live-streaming to his fans after major events in his trial. A day after posting bail following his initial arrest in December 2015, Shkreli spent hours live-streaming, alone, in his apartment. At one point, showing a full view of his computer screen to his viewers, he began to browse the OkCupid dating site, streaming to hundreds of strangers the photos, profiles and messages he could see.

He did it again in August, after he was convicted. . . .


But to be clear, he is now in custody, awaiting a formal sentence, because -- as a previously thrice convicted felon -- he solicited the assault of someone for a $5,000 bounty, and never repudiated the offer of the bounty -- literally on her head (or hair).

It really shouldn't matter (as she's just a private citizen now) -- but that someone happens to have life-time Secret Service protection. So, it is hard to imagine a more flagrantly stupid and childish -- but now likely final -- crime. It was his burden to prove -- by clear and convincing evidence -- that he is no danger to society. He failed to do that last evening.

And so, as Lauren Duca (an astute and capable journalist, and one of his earlier "crime spree" victims) tweeted, he's found himself at "the intersection of karma and justice" -- indeed.

Indeed. Be well, one and all. See ya' next year, Shkreli -- the Infinite willing.

[Subsequent note: this too is a worthwhile read.]

नमस्ते

Wednesday, September 13, 2017

Lest There Be Any Doubt -- About Where Muslim Ban 2.0 Is Generally Headed...


As I earlier said they would, the fine lawyers at the pro bono legal clinic arm of the prestigious Yale Law School have just now (about 14 days later) made available the full unredacted settlement agreement -- in the New York (Brooklyn) federal District courthouse. This is a trial court level agreed settlement. That's significant. No appeal sought by, or available to, 45's lawyers.

Do consider, as you read it, that the Trump Administration has by agreement surrendered a complete win here -- to the people detained at JFK that night. Consider what that means: the government -- just about a week and a half ago, agreed to eviscerate by settlement, the guts of Ban 2.0. That my freinds, is a more candid assessment of where 45's lawyers actually think the Supremes are going to come out, on the bans. Here's just a bit, from that agreement:

. . . .We wrote to you before because you have not entered the United States.

If you still want to travel to the United States, you may contact your nearest U.S. embassy or consulate. You may also contact non-governmental organizations and attorneys that might be able to assist you free of charge. (See attached.)

We wish to advise you that, should you wish to apply for a new visa, Executive Order 13,769 has been revoked and you are free to pursue a new visa application at any time. The previous revocation/cancellation of your visa pursuant to Executive Order 13,769 will not adversely affect a new visa application. . . .

Of course, we are precluded by U.S. law from guaranteeing that you will be found eligible for and issued a visa. We are additionally precluded from providing any guarantee that you will be granted admission at a port of entry should you be issued a visa. Nevertheless, we assure you that any application will be given proper consideration. . . .


Now you know. Onward -- as we await word that one Martin Shkreli (the pocket-sized pharma bro-heem), thrice felony convicted -- has been carted off to the Brooklyn Metropolitan Detention Center -- in about three elapsed hours. This -- as his bond is revoked. There he will stay, until his sentence is pronounced -- that's my prediction. Smile. What a great afternoon, indeed.

नमस्ते

On The Largely Trivial Sideshow -- In Hawaii's Most Recent Ninth Circuit Win...



One cannot expect Fox News to understand the context.

But one might reasonably expect more intellectual curiosity -- from its reporters. Or perhaps. . . not.

Overnight, in a rather smallish surprise, the Supremes have trimmed back a small portion of Hawaii's otherwise complete win, against Trump's Muslim Ban 2.0, in the Ninth Circuit. [That one paragraph PDF is courtesy Lyle Denniston.] But as we've long said -- this is not yet "on the merits" -- at the Supremes. In a little over a month now, the Supremes will hold "on the merits" arguments -- on 45's bans, proper. All the current kerfluffle is about is. . . what the Supreme's shortish grant of cert. order actually meant.

While the Supremes plainly agree that grandparents are and remain close family, the small-ish part of the Ninth Circuit's decision that will be stayed -- until the case is decided on the merits at the high court -- is the notion of exactly how much documentation is needed (between a refugee, and a sponsoring agency) to establish a bona fide relationship, with "a recognized aid agency" -- in the language of prior rulings.

That, in turn, drives whether the refugee is entitled to admission to the US. And the Supremes have simply put a hold on those decisions -- some 25,000 people, at current estimates -- until the court has a chance to hear formal argument in October.

Now you know. But don't expect Fox to explain that. They have an agenda to advance. [My title does not imply that I think any person's status/need to arrive here, as a refugee, is trivial -- far from it. I just still see the outcome as 6-3 striking most of Ban 2.0.] Onward, on another busy morning. And. . . Marty goes to jail in about ten hours now. Smile.

नमस्ते

Tuesday, September 12, 2017

I'll Return To Health Care Tomorrow, I Promise; But Tonight: "This Is What It Means To Be... Young."


Ahem. Read this if you need the background.

It is from a 6 year old science fan's "Goodbye Party for Cassini". . . Excellent!

I simply cannot stop smiling. We are blessed to live in the most amazing, free-est time, for science, in general, and space science in particular -- in the history of the Earth. I simply love NASA -- some things are just that simple. This is one of them. It's that simple. I was this kid. Whoosh.

[Seen, at 6:38 PM CDT local. . . this evening. . . smile.]

नमस्ते

Sunday, September 10, 2017

And Some NASA/JPL Eye Candy -- As We Approach Four Days From Annihilation...


So now we are very near the bittersweet, blazingly fleet-footed end of Cassini:



. . . .The Cassini mission’s epic 13-year exploration of Saturn is coming to a close. On Sept. 15, the spacecraft will make a planned plunge into the atmosphere of Saturn in order to protect pristine icy moons that warrant future exploration. As the mission nears its end, team members reflect on this historic, international collaboration. . . .


Now you know; g'night -- onward -- to a busy new week ahead!

नमस्ते

As 23 And Me's Database Grows... It Turns Out I Am Viking, Too...


About four years ago, I first mentioned that I had agreed to be sequenced at 23 and Me. Now, three and three quarters years on (post learning my results) -- as the genetic database at 23 and Me has grown exponentially, the company is able to provide new ancestry insights to all of us early adopters, based on the increasing depth and breadth of the genome data -- now from approaching a million contributors.

As a result, I've just recently learned, that at some point, likely in the early 1500s, one of my direct line ancestors was 100 per cent Scandinavian. This is as surprising as any of the things I've learned over these years -- as my more recent roots are Irish and English and Hungarian/Ashkenazi.

So it was with keen interest, this past week, that I read about one of the most famous Viking warrior burial sites (known and preserved since the 1880s) -- and the late breaking DNA analysis of one skull, found there.

It was long suspected, but now it is proved: at least one of the warriors, buried with full honors, was a woman. I'll leave it to others to guess at how widespread -- and high ranking -- these women would have been, but it makes no sense at all to assume this was an aberration. Here is the bit:

. . . .New DNA evidence uncovered by researchers at Uppsala University and Stockholm University shows that there were in fact female Viking warriors. The remains of an iconic Swedish Viking Age grave now reveal that war was not an activity exclusive to males -- women could be found in the higher ranks at the battlefield. . . .

The study was conducted on one of the most well-known graves from the Viking Age, a mid-10th century grave in Swedish Viking town Birka. The burial was excavated in the 1880s, revealing remains of a warrior surrounded by weapons, including a sword, armour-piercing arrows, and two horses. There was also a full set of gaming pieces and a gaming board. . . .

"The gaming set indicates that she was an officer, someone who worked with tactics and strategy and could lead troops in battle. What we have studied was not a Valkyrie from the sagas but a real life military leader, that happens to have been a woman," says Charlotte Hedenstierna-Jonson, Stockholm University, who led the study. . . .


Perhaps on a tangent -- but it may only be a matter of time before we will be able to extract DNA from the relics of first century apostles, and perhaps the man revered as Christ himself -- and in Da Vinci Code fashion, establish that there are now living direct descendants of Jesus Christ.

It remains to be seen however, whether the Vatican would allow a DNA extraction -- from any of these reliquaries. But as a recovering Catholic, and more importantly, a man of science -- I will hope the church progresses to the point that her Pope, too, would want the answers. . . . here's to. . . progress! Onward -- for a mountain-bike ride, now.

नमस्ते

Saturday, September 9, 2017

"Leave It To" One Brenton "Beaver" Saunders... Sheesh.


At the head, let me say that I favor strong but fair intellectual property protection policies, for science based companies -- be they tech- or device- or pharma- or bio-science companies. But after a long patent life, such innovations should go generic. That is only fair. [And poor, non-novel, weak or redundant patents ought to be subject to a robust challenge process -- the strong should survive -- in the Darwinian sense. Patents are, after all. . . monopolies (antithetical to most other free market rules). But that is all just background, to this latest nonsense. This nonsense will only last one more year -- as by then the Supremes will have ruled on this topic. Trust that -- this sovereign "game" is short lived.]

While it doesn't surprise me that Mr. Saunders would use a proud Native American tribe as a "token" -- to shore up his patent estate's immunity from generic challenges, it does disappoint me. This is (of course) the same Brent Saunders who called an anti-inversion tax interpretation by the US Treasury in April 2016 "un-American." In his view it was un-American to suggest that his company (with vast US operations and sales revenue) should just pay the same tax rate as all other US operations based companies. Check. Roger that. [A transparently-calculated move of one financial processing center -- over to Ireland -- ought not be enough to avoid or wildly reduce US taxes on one's company.]

So yes -- I should not be surprised that he would opportunistically exploit the sovereign immunity accorded to native peoples, in order to gain advantage over the USPTO. Here's the bit -- from the New York Times, overnight:
. . . .“Indian tribes have sovereignty that is stronger than states,” Mr. White said, pointing to recent Supreme Court cases that have ruled in favor of tribes. “We feel that we have an extremely strong case.”

Michael Carrier, a professor at Rutgers Law School who studies patent law, called the announcement Friday a “concerning” development, in part because the Mohawk tribe played no role in developing the drug. And he said the administrative-review panel served a worthy purpose. “Challenges at the patent office play a crucial role in overturning invalid patents, and that role could be undermined by agreements like this,” Mr. Carrier said. . . .


It does gall me that (as he learned from Fred Hassan -- and as Martin Shkreli learned from Fred Hassan) there is no goal other than minimizing tax, in the US -- and maximizing revenues retained -- with no acknowledgement that the US provides the best, deepest and richest capital market on the planet for fostering the innovations of his kind of science companies. The hypocrisy is. . . stunning.

And yes, Anon. (you know who you are!), your earlier mention of "he, of the high forehead" is why I wrote this on a fine, cool but sunny Saturday morning, over a hot coffee, OJ, banana and a bowl of the last of this Summer's dark and sweetly-ripe cherries. . . smile. Onward. . . time to work out; then a hot stone massage, this afternoon. . . .

नमस्ते

Thursday, September 7, 2017

[U] BREAKING: The Felon Martin Shkreli Has Failed To Meet His Bail Conditions -- "Off To Jail, NOW!" Sez US Attorney...


UPDATED: 09.08.2017 @ 2 PM EDT — The able judge has bumped up the date for the hearing, and the correlative dates for submission of briefs. We are now five days away from Marty’s likely incarceration. I’ve updated the order copy, below. I would say this is a strong indicator that the able judge is putting Martin behind bars. This morning, Mr. Shkreli wrote -- on his Facebook page ". . .Fuck the government. I will never kiss their ring or snitch,” he wrote. “Come at me with you [sic] hardest because I haven’t seen anything impressive yet. . . ." I would expect that there is precious little his defense team can now say to prevent his incarceration.

End update.


We will save celestial wonders for tomorrow -- as breaking news out of Brooklyn may well mean that Martin Shkreli is in jail by a week from tonight. DO read on. . . .

Hat tip to FTD -- for this priceless find!

CNBC has it as well. But here is the motion to immediately revoke his freedom, pending sentencing on his three felony convictions.

Lovely.

Simply lovely -- read it all. It seems the Secret Service has had to increase protection around HRC -- due almost exclusively to his lunacy.

And -- now even his Lauren Duca threats are being cited by the AUSAs:

. . . .Near the end of his trial and since his conviction on August 4, 2017, Shkreli has made at least two public statements harassing specific women. As has been widely reported, Shkreli was banned from Twitter in January 2017 after harassing journalist Lauren Duca.

In early January 2017, Shkreli had sent Duca a message via Twitter asking her to be his “+1” or companion to the inauguration of President Donald Trump. (See Exs. A & B.) Duca publicly rejected the request. In response, Shkreli called Duca a “cold you know what” on Twitter and famously changed his Twitter profile picture to a doctored image appearing to show Duca on his lap on a couch.(Id.). This conduct earned Shkreli a ban from Twitter. On July 27, 2017 — on the eve of the final trial summations — Shkreli made the following statements on Facebook: “Trial’s over tomorrow, bitches. Then if I’m acquitted, I get to fuck Lauren Duca[.]” He added, “And Anna Kasperian, she’s pretty hot,” referring to a political pundit.

Thus, just as the case was to be submitted to the jury, Shkreli made a public threat against two women whom he dislikes and with whom he has feuded in the past. . . .


Here is the order, for the hearing come one week from today, at 4 PM EDT -- in Brooklyn:

. . . .The court will hold a hearing on the government's motion to revoke bail on September 1314, 2017 at 2:00 p.m. at 225 Cadman Plaza East, Brooklyn, N.Y., 11201, Courtroom 6C South, before Judge Kiyo A. Matsumoto. Defendant shall file a response to the government's [362] motion by September 12, 2017 at 5:00 p.m., and the government shall reply by September 1213, 2017 at 5:00 p.m. In its reply, the government shall indicate if it intends to call witnesses, and shall advise the court of the anticipated length of the hearing. Ordered by Judge Kiyo A. Matsumoto on 9/87/2017. . . .

Say bub-bye, Marty. You have likely lost your pre-sentencing temporary freedom -- entirely due to your own idiocy. What a. . . tool.

The AUSAs definitely have a motivational bulletin board somewhere -- with Marty's endlessly threatening Facebook (and now ebay) posts tacked up. Hilarious.

Yep that's your karma calling Marty. Buckle up.

नमस्ते

USDC Judge Derrick Watson (HI) Affirmed: Trump Loses, Again -- 0-12 Now...


As the Martin Shkreli news was breaking, the three member panel of the Ninth Circuit issued its opinion affirming the courageous US District Court Judge Watson.

In sum, Trump's lawyers were told there is no rational basis for excluding grandparents -- and that (as we advised, in June) a letter from any recognized aid organization would be a sufficient reason (in the view of the SCOTUS) to admit a refugee, into the US. Here is just a bit -- but do go read all 36 pages:

. . . .For the reasons that follow, we conclude that in modifying the preliminary injunction to preserve the status quo, the district court carefully and correctly balanced the hardships and the equitable considerations as directed by the Supreme Court in Trump v. International Refugee Assistance Project, 137 S. Ct. 2080, 2088 (2017), and did not abuse its discretion. We affirm. . . .

As the district court correctly identified, a refugee is covered by the preliminary injunction, as modified by the Supreme Court’s stay order, if the refugee has a bona fide relationship with an entity in the United States, meaning a relationship that is formal, documented, and formed in the ordinary course rather than to evade the Executive Order. See Trump, 137 S. Ct. at 2088–89. Applying this standard, the district court held that formally assured refugees have bona fide relationships with resettlement agencies and are covered by the injunction because the assurance is formal, documented, and formed in the ordinary course rather than to evade the Executive Order. Mindful of the narrow standard that governs our review, we affirm, considering the individualized screening process necessary to obtain a formal assurance and the concrete harms faced by a resettlement agency because of that refugee’s exclusion. . . .


Zero for 12, Mr. Trump. Expect much the same -- if you actually do try to do anything (other than impotent, and now waffling bluster) related to the dreamers' status as Americans. Onward on a wonderful if gray Friday -- things are finally looking up. . . even as regions as far inland as middle Tennessee brace for the Irma onslaught next week. Be safe. [I'll tuck this one under the Shkreli news, even though it was written at 8 am Friday. Peace.]

नमस्ते

Merck's Federal Court Name Spat/Lanham Act Proceeding: Proposed Scheduling Order Entered...


This was jointly filed last night, prior to the next status hearing on September 12, 2017 in Newark, New Jersey.

Not much else to say. . . in truth here, I find myself a little bored by it all -- but this is the very slow road toward a comprehensive global settlement -- that remains my opinion. Full scheduling letter (a three page PDF file), plus a bit:

. . . .1. The parties’ production of documents shall be completed by October 31, 2017.

2. The parties need not produce unresponsive family members in the production, but must produce such family members of specifically identified documents by the opposing party upon request in a reasonable time period.

3. All other fact discovery, including depositions of fact witnesses, shall be completed by April 1, 2018.

4. All fact discovery disputes (other than those arising during depositions) shall be filed with the Court in a joint letter pursuant to the Court’s November 7, 2016 Pretrial Scheduling Order no later than December 15, 2017.

5. Plaintiffs’ affirmative expert reports shall be delivered by May 1, 2018.

6. Defendant’s affirmative and rebuttal expert reports shall be delivered by June26, 2018.

7. Plaintiffs’ rebuttal and reply expert reports shall be delivered by July 16, 2018.

8. All expert depositions, including the completion of expert depositions, shall be completed by August 23, 2018. . . .


Now you know. Onward -- with sweet space science to come. . . late this evening!

नमस्ते

Wednesday, September 6, 2017

$2.54 Billion Post Trial Patent Case Motions Hearing In Delaware Tomorrow At 11 AM EDT


The able federal District Court Judge Leonard Stark, sitting in Wilmington, Delaware, just adjusted the time for tomorrow's oral argument on the Hep C patent verdict in favor of Merck, in the amount of $2.54 billion -- and entered against Gilead.

We will let you know what comes of tomorrow's arguments -- but here is the "as adjusted" schedule:

. . . .ORAL ORDER:

IT IS HEREBY ORDERED that:

(1) tomorrow's motions hearing will begin at 11:00 a.m., instead of 10:00 a.m., and at approximately 1:00 p.m. the Court will take a recess of approximately one hour; and

(2) the Court wishes to hear argument on all issues that are ripe for decision, including those presented in Idenix's motion. ORDERED by Judge Leonard P. Stark on 9/6/17. . . .


Do tune in tomorrow -- for the outcome, at end of day -- and also because as we will likely have some sublimely celestial space science news in tow, as well. Smile.

नमस्ते

The Estimable John Carroll, On Today's Smallish EU Immuno-Oncology Acquisition...


True enough, this pathway is still pre-clinical, and yet -- in much the same way as Kenilworth did with Scotland's IO Met in January of 2016 -- by buying in now, Merck gets the tech on the cheap -- in relative terms, at least.

Of course at Phase I the risk is correlatively higher, but the $600 million is immaterial to a company this size -- even if it all vanishes. But I don't imagine that will happen. Here's a bit -- do go read it all:

. . . .Munich-based Rigontec is delivering a solid return for its venture backers. Merck $MRK has struck a rare deal to buy the biotech for $150 million in cash and another $453 million in milestones, snapping up a 3-year-old fledgling that raised just €30 million to get to this point.

For Merck it’s another example of how Roger Perlmutter likes to augment the work being done around its PD-1 superstar Keytruda with the occasional add-on. It’s a small deal for the pharma giant, and he’s clearly impressed with the potential the Bonn University spinout has in activating RIG-I as a key pathway in the innate immune system.

The technology is designed to activate an immune response, just as PD-1 can eliminate a defensive network protecting cancer cells. . . .


Now you know. Onward, on a glorious 70 degree morning here, and I am once again put in mind of new life, and all it holds (from January of 2016). . . smile.

नमस्ते

Tuesday, September 5, 2017

On DACA: This Is What REAL Leadership Looks Like... Thank You, Mr. President!


As he promised he would if 45 made a move to end DACA, our 44th President now breaks his self-imposed silence -- and weighs in, via Facebook.

I will say almost nothing more -- other than to say he is unquestionably in the right. And Mr. Trump is both unquestionably wrong here, from a moral perspective -- and engaging in a cowardly act of political Kabuki theater. But I've said that before, just yesterday. Here is what a real leader sounds like:

. . . .Immigration can be a controversial topic. We all want safe, secure borders and a dynamic economy, and people of goodwill can have legitimate disagreements about how to fix our immigration system so that everybody plays by the rules.

But that’s not what the action that the White House took today is about. This is about young people who grew up in America – kids who study in our schools, young adults who are starting careers, patriots who pledge allegiance to our flag. These Dreamers are Americans in their hearts, in their minds, in every single way but one: on paper. They were brought to this country by their parents, sometimes even as infants. They may not know a country besides ours. They may not even know a language besides English. They often have no idea they’re undocumented until they apply for a job, or college, or a driver’s license.

Over the years, politicians of both parties have worked together to write legislation that would have told these young people – our young people – that if your parents brought you here as a child, if you’ve been here a certain number of years, and if you’re willing to go to college or serve in our military, then you’ll get a chance to stay and earn your citizenship. And for years while I was President, I asked Congress to send me such a bill.

That bill never came. And because it made no sense to expel talented, driven, patriotic young people from the only country they know solely because of the actions of their parents, my administration acted to lift the shadow of deportation from these young people, so that they could continue to contribute to our communities and our country. We did so based on the well-established legal principle of prosecutorial discretion, deployed by Democratic and Republican presidents alike, because our immigration enforcement agencies have limited resources, and it makes sense to focus those resources on those who come illegally to this country to do us harm. Deportations of criminals went up. Some 800,000 young people stepped forward, met rigorous requirements, and went through background checks. And America grew stronger as a result.

But today, that shadow has been cast over some of our best and brightest young people once again. To target these young people is wrong – because they have done nothing wrong. It is self-defeating – because they want to start new businesses, staff our labs, serve in our military, and otherwise contribute to the country we love. And it is cruel. What if our kid’s science teacher, or our friendly neighbor turns out to be a Dreamer? Where are we supposed to send her? To a country she doesn’t know or remember, with a language she may not even speak?

Let’s be clear: the action taken today isn’t required legally. It’s a political decision, and a moral question. Whatever concerns or complaints Americans may have about immigration in general, we shouldn’t threaten the future of this group of young people who are here through no fault of their own, who pose no threat, who are not taking away anything from the rest of us. They are that pitcher on our kid’s softball team, that first responder who helps out his community after a disaster, that cadet in ROTC who wants nothing more than to wear the uniform of the country that gave him a chance. Kicking them out won’t lower the unemployment rate, or lighten anyone’s taxes, or raise anybody’s wages.

It is precisely because this action is contrary to our spirit, and to common sense, that business leaders, faith leaders, economists, and Americans of all political stripes called on the administration not to do what it did today. And now that the White House has shifted its responsibility for these young people to Congress, it’s up to Members of Congress to protect these young people and our future. I’m heartened by those who’ve suggested that they should. And I join my voice with the majority of Americans who hope they step up and do it with a sense of moral urgency that matches the urgency these young people feel.

Ultimately, this is about basic decency. This is about whether we are a people who kick hopeful young strivers out of America, or whether we treat them the way we’d want our own kids to be treated. It’s about who we are as a people – and who we want to be.

What makes us American is not a question of what we look like, or where our names come from, or the way we pray. What makes us American is our fidelity to a set of ideals – that all of us are created equal; that all of us deserve the chance to make of our lives what we will; that all of us share an obligation to stand up, speak out, and secure our most cherished values for the next generation. That’s how America has traveled this far. That’s how, if we keep at it, we will ultimately reach that more perfect union. . . .


And, once again -- we (the collective ACLU "we") will see Mr. Trump's lawyers in court, and answer them there -- on all these topics. And just like Ban 2.0, they will. . . lose. Onward -- and Forward -- as one.

नमस्ते

Merck Scores New EU Approval For Keytruda® -- In Certain Bladder Cancers


I'll use a throwback graphic, from a time when the candidate was known by its chemical name -- and not yet branded. To be certain, this is decidedly good news.

While both Kenilworth and BMS expect important new US FDA indication approvals in the last few days of September of this year (for Opdivo® and Keytruda®), the entrance of additional immuno-oncology agents (from two other competitors) has dampened the significance of any one approval out of FDA. Each of BMS and Merck will make perhaps $5.8 billion in revenue next year on their immuno offerings alone. Here's a bit of the latest EU nod -- for Merck:

. . . .[T]he European Commission has approved KEYTRUDA (pembrolizumab), the company's anti-PD-1 therapy, for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.

Specifically, KEYTRUDA is approved for use as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy, as well as adults who are not eligible for cisplatin-containing chemotherapy.

The approval in patients previously treated with platinum-containing chemotherapy was based on superior overall survival (OS) for KEYTRUDA versus investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine) (HR, 0.73 [95% CI: 0.59, 0.91], p=0.002), as demonstrated in the randomized, phase 3 KEYNOTE-045 trial.

The approval in patients ineligible for cisplatin-containing chemotherapy was based on phase 2 data from the KEYNOTE-052 trial, which demonstrated an overall response rate (ORR) of 29 percent (95% CI, 25-34).

The approval allows for the marketing of KEYTRUDA in these two new indications in all 28 EU member states plus Iceland, Lichtenstein and Norway at a dose of 200 mg every three weeks until disease progression or unacceptable toxicity. . . .


Now you know -- as a shortened office week begins. Onward, after a wondrously languid and long holiday weekend. . . . now a quite busy day ahead, as it is high time to get after Trump (on his unlawful DACA detainers), over at the federal courthouse on Dearborn.

नमस्ते