Merck Gets FDA Nod For Sanofi Biosim Insulin Glargine Injection — But Must Now Litigate The Patent, Under Hatch-Waxman

July 20, 2017 - Leave a Response

Merck has (as of January 2017) already been given an EU clearance on this insulin bio-sim, and if I recall correctly, it is on sale throughout the EU. This is part of Merck’s co-venture with Samsung Bioepis, as we’ve long reported.

The news this morning is that Kenilworth cleared FDA (older February 2014 background on it, here; February 2013 backgrounder here), but now must litigate with Sanofi, under the relevant Hatch-Waxman (up to 30 month) stay period. Of course, Merck could win out — in the federal patent case, and launch sooner — we shall see. From the NASDAQ-filed press release then — a bit:

. . . .The U.S. Food and Drug Administration has granted [Merck/Samsung Bioepis] tentative approval for LUSDUNA Nexvue or insulin glargine injection 100 units/mL, a follow-on biologic basal insulin in a pre-filled dosing device. LUSDUNA Nexvue is being developed by Merck with funding from Samsung Bioepis.

With the tentative approval, LUSDUNA Nexvue has met all required regulatory standards for follow-on biologics of clinical and nonclinical safety, efficacy and quality, but is subject to an automatic stay due to a lawsuit from Sanofi claiming patent infringement. . . .

To this moment, we haven’t reported on that piece of patent litigation very closely (as it was immaterial to Merck, until it secured FDA approval) — but now we obviously will cover it — and do so, closely. I’ll get up to speed, on it — with the baby on my lap, in the Loop — tonight. Smile.

To be clear, at least two other life science major players have one bio-sim in the cue — so the field could get crowded (background on Dr. Gottlieb’s new initiative at FDA, here), and prices could drop — pretty quickly.

In fairness to the historical record, Dr. Gottlieb is mostly putting forward a slightly-tweaked version of an early ObamaCare era proposal — one that sort of fell by the wayside, in 2014. The idea is sound, and would benefit US consumers immensely, so I don’t care if a Trump appointee says it is “new” (when it is in truth a revision of a 2012-13 proposed FDA policy) — it remains a good idea, even if I know it was originally conceptualized under Mr. Obama. Now you know. Onward, into the rain — but smiling, just the same. . . . whoosh!


[U] Many Former US Intelligence Officials Weigh In, On 45’s Generally Goofy Supremes Gambit…

July 19, 2017 - Leave a Response

UPDATED @ 3 PM EDT: Well, the Supremes have issued their short order — 6-3 that (as existing immigration/ refugee law has provided for 50 plus years) grandparents are bona fide family. That split is probably how the entire case will play out in the fall. The matter about “bona fide relationships” has now been returned (remanded, technically speaking) to the Ninth Circuit — where it belongs (under any normal reading of federal appellate practice rules). Onward. [Yawn — just as I had predicted this early morning — though FoxNews is saying some entirely. . . silly things about it all. No surprise there.] Here it is — in full: The Government’s motion seeking clarification of our order of June 26, 2017, is denied. The District Court order modifying the preliminary injunction with respect to refugees covered by a formal assurance is stayed pending resolution of the Government’s appeal to the Court of Appeals for the Ninth Circuit. Justice Thomas, Justice Alito, and Justice Gorsuch would have stayed the District Court order in its entirety. [End, update.]

Yet more news, out of the United States Supreme Court, on the ill-starred, and wrong-headed Muslim Ban 2.0, overnight:

The Supremes could — and likely will, very shortly — rule Mr. Trump’s latest goofy USSCt moving papers out of bounds, without any opinion. Just an order. One line.

Or so “I, Condor. . .” predict (heh). The denial and remand order (to the Ninth Circuit) could come at any time today or tomorrow — depending on how well (and where) Justice Kennedy is, in the process of caring for his injured wife, in Saltzburg, Austria. [It is already getting to be later afternoon, there, now.] And while we wait for that expected order — here is what the able former US intel folks are on record about — in this case in a 23 page PDF friend of the court brief (courtesy the highly-esteemed, filed overnight with the Supremes:

. . . .[The Trump Administration’s] narrow interpretation of [the Supremes’ cert. order] in fact would do harm to the security and foreign policy interests of the United States. As amici have explained elsewhere, the Government’s reliance on generalized bans on travelers and refugees without an individualized assessment of security threat is counterproductive from a security perspective. This generalized approach is likely to: endanger U.S. troops in the field, by barring many foreigners who have assisted our troops at great risk to their own lives; disrupt essential counterterrorism, intelligence, and other security partnerships with countries that are critical to our country’s efforts to address the threat posed by terrorist groups such as IS; feed IS’s propaganda narrative, while hindering law enforcement efforts to fight homegrown terrorism by alienating Muslim- American communities; cause serious humanitarian harm; and result in economic damage to the United States, economic sectors such as defense, technology and medicine. . . .

The Government’s narrow interpretation of this Court’s Order suffers from these same flaws. The Government would exclude from the United States any number of individuals with bona fide relationships with this country who create no security risk and would benefit the nation, simply because they are uncles rather than brothers, or have formed a relationship with one entity in the United States rather than another. This approach is at odds with the nation’s contextualized and individualized approach to screening travel to the United States. It also imposes an arbitrary travel ban upon countless individuals in ways that could do real harm to the United States’ national security or foreign policy interests.

[The individuals signing this brief] include a number of officials who have held for extended periods of time the most senior responsibility within the U.S. Government for overseeing the refugee resettlement process. . . .

I expect the Ninth Circuit will also rule against 45 pretty shortly after the regular briefing schedule, in September. Then the Supremes will see briefs, and on and on. . . Now you know — with nothing but truly independent and free. . . happiness in store today, in sunny Chicago.


[U] Hawaii (Unsurprisingly) Tells The Supremes That Grandparents Are “Close Family”… [Trump Is No Gen. MacArthur Edition]

July 18, 2017 - Leave a Response

Here is in a few moments, we will have the latest US Supreme Court filing (a 38 page PDF file, from the “Aloha State” of Hawaii) on Muslim Ban 2.0. More soon. I will note that the able lawyers for the Aloha State have called Mr. Trump’s latest arguments. . . “nonsense“. And I quite heartily agree — see below (and do note — the last bit is 45’s tweet on the OrangeCare implosion).

It is hard to imagine how embarrassing it must be to have a primitive in chief as one’s client:

. . . .The Government asks this Court for emergency relief that is procedurally improper and substantively unnecessary. It seeks to leapfrog its own pending motion and appeal in the Ninth Circuit and obtain an expansion of the stay this Court issued just three weeks ago. And it contends this extraordinary relief is appropriate because the District Court’s recent modification order has “eviscerated” this Court’s stay.

That is nonsense. The District Court faithfully applied this Court’s opinion, holding that “close relatives” like grandparents and nieces are permitted to enter, and recognizing that the charities, non-profits, and churches that have made a formal, contractual commitment to shelter and clothe refugees would suffer “concrete hardship” if those refugees are excluded. . . .

The Government’s complaint boils down to the belief that any interpretation that meaningfully diminishes the practical consequence of its bans must be wrong. But the lower courts and this Court explicitly sought to minimize these practical consequences to the extent they inflict concrete harms on American individuals and entities. . . .

There is no reason for this Court to take the extraordinary step of granting a stay, certiorari before judgment, or mandamus relief. The District Court’s opinion is correct. And, in any event, the Ninth Circuit — where the Government has filed an almost identical set of requests — is fully capable of fulfilling its normal role as the first line of appellate review. The Government’s motion should be denied. . . .

In a remarkable bit of doublespeak, the Government suggests. . . [a section of the INA] supports its distinction between “close” and “extended” family. But the provision explicitly refers to siblings-in-law, grandparents, and grandchildren as “close family”; there is no ambiguity about it.

Other provisions of the INA likewise permit persons in the United States to sponsor their “grandchildren,” “grandparents,” “nieces,” and “nephews” for immigration or naturalization — in each instance indicating that Congress believed such persons have a concrete and cognizable stake in their relatives’ entry. . . .

[SEGUE — Mr. Trump tweets, on stunning health care defeat, 07.17.2017:] . . .We will return. . . .

While we wait for the people’s brief in the US Supreme Court, I must cry out, loud and long — at 45’s overnight tweet on his utter collapse, regarding any health care measure.

He presumably was aware (when he tweeted) that Gen. Douglas MacArthur said “I shall return” — when he escaped the Philippines (as the islands fell tragically into the hands of the enemy), in one of the darker moments of WW II, in the Pacific theater.

How dare he equate his own tiny-handed hubris, and vain political ineptitude — to the deep purple valor, of men who bled and died there, and on Corregidor, to protect Gen. MacArthur’s retreat? [The Allies did eventually retake the islands — but 45 is a. . . pig — for trying to draw any parallel.]

What a complete coward Mr. Trump must be — if he feels the need to equate his own obvious idiocy and endless prevarications, on ObamaCare — to the courageous General’s words, in a real, live battle, with real honorable enlisted men literally dying around him, to help him escape safely, to. . . “fight another day“.

What a. . . small, impotent man-child, indeed. . . . I am well-beyond being disgusted.


[U] Merck Ordered To Pay $12.6 Million Of Gilead’s Legal Fees, For Former Merck Patent Counsel’s “Egregious Misconduct”

July 18, 2017 - Leave a Response

I have been in the wild northern wood — where not even cell-phone coverage exists (as a general rule). [But this is a follow up, from a year past.]

Regretably, and consequently — I missed mentioning on Friday past, that the ever able Judge MayBeth Labson Freeman, in the US District Court in San Jose, California has now finally entered her opinion (as a 17 page PDF file), as to the specific amount of attorneys’ fees to be awarded — and ruled that Merck must pay $12.59 million worth of its opponent’s legal expenses, in the Sovaldi® patent litigation, from last summer.

. . . .Specifically, the numerous unconscionable acts included lying to Pharmasset, misusing Pharmasset’s confidential information, breaching confidentiality and firewall agreements, and lying under oath at deposition and trial. The Court found that any one of these acts — lying, unethical business conduct, or litigation misconduct — would be sufficient to invoke the doctrine of unclean hands; but together, these acts unmistakably constitute egregious misconduct that equals or exceeds the misconduct previously found by other courts to constitute unclean hands. . . .

Gilead is entitled to $12,591,636.53 for the work done by Fish through June 30, 2016.

Since the total amount of reductions is about 9.35% based on Fish’s fees through June 30,2016, the additional fees incurred after June 30, 2016, are subject to the same proportional reduction based on the parties’ agreement. . . .

Gilead is also entitled to fees of $1,365,470 for Deloitte’s work. . . .

The case (overall) is still pending on appeal, in the Ninth Circuit. But the notion that Merck would have to pay for Gilead’s fees was well known — the exact amount of those fees awarded wasn’t known before Friday.

And NOW, you know. Onward — to a gloriously busy week. . . with Saturn D Ring Plunge Number 13 now underway as I post this, twisting as it streaks past, in a near blur — into the dawn “out there. . .” smile. . . .

UPDATED — mid morning: We wish Justice Kennedy’s wife a speedy and full recovery, from her hip fracture. She apparently took a fall, while traveling with the Justice, in Saltzburg, Austria — and (since he is assigned to handle West Coast petitions, during summer recess) that may delay action on the pending clarification request, on Ban 2.0, in the Supremes. Even so, we expect the People of Hawaii will have a brief on file at the nation’s highest court in about two hours, now. We will provide it in a new post, then — at noon Central, today.


Consider the Irony, Here: Merck Taps Texas State Funds For $6 Million…

July 18, 2017 - Leave a Response

In a few moments, I will have a new post up. That post will be a counterpoint to this happy news, from MSD and the Governor of Texas, overnight.

We are updating our April 2017 post — to indicate that Merck has now secured the commitments for the $6.8 million in taxpayer funds it earlier sought.

[Snark] If I were a cynic, I would guess that this announcement was timed to blunt/blot out any coverage (even here, on this meager estate) of the far less favorable Kenilworth news out of San Jose, California. But I am earnestly trying to be. . . less cynical. Truly, I am [/snark]. Per the Austin Statesman, then:

. . . .Gov. Greg Abbott on Monday announced that Merck Sharp & Dohme Corp. will move forward with plans to develop a major technology innovation center in Austin, becoming the key anchor for an innovation district developing around the Dell Medical School.

The global pharmaceutical titan made the announcement after the governor’s office announced it would provide the company a $6 million grant from the Texas Enterprise Fund. That grant comes on top of a 10-year, $856,000 city tax incentives package approved by the Austin City Council in April.

In return, Merck said it will create at least 600 jobs, paying an average annual salary of $84,586, and it would invest almost $29 million to build and equip the new innovation center. . . .

Do see my next post — as we ponder how it is that massive (and wealthy) US companies regularly access the public fisc, even after clear findings of egregious misconduct, and abuse of the legal process.

Ponder that, indeed. I have much to say on it — but will lay rest to the grace in my tongue, this luminous but clear dawn. . . I have much better things to spend my energy on — and others will make this argument more eloquently than I might. Onward.


[U] Grandparents ARE Family — Over Coffee At The Beach…

July 14, 2017 - Leave a Response

That. . . was essentially immediate. Updated: 07.17.17 — The Trump Administration has filed a notice of appeal, in the Ninth Circuit, as well as asked the Supremes to review and clarify. They will not prevail. End, update.

Trump Ban 2.0 thwarted — Again! The law is clear, here:

. . . .Upon careful consideration of the parties’ expedited submissions, the Court concludes that on the record before it, Plaintiffs have met their burden of establishing that the requested injunctive relief is necessary to preserve the status quo pending appeal regarding the definition of “close familial relationship” employed by the Government with respect to Sections 2(c), 6(a) and 6(b) of EO-2.

Plaintiffs have similarly met their burden with respect to refugees with a formal assurance, as it relates to the Government’s implementation of Sections 6(a) and 6(b) of EO-2, and participants in the Lautenberg Program. Plaintiffs’ Motion is accordingly GRANTED in these respects. . . .


Lovely — and just. Sipping hot coffee, at the beach — where I found some cell service. All this — by iPhone (Huzzah!). More later.



Shorter State Of Hawaii Reply — Grandparents Have A “Bona Fide Relationship” — To Their Grandchildren

July 13, 2017 - Leave a Response

Mr. Trump’s policies are “as wrong as they are cruel. . . .” Well put, Hawaii. Well-put.

Do go read it all — whilst I’m outside of cell coverage. Here is the opening bit (of 22 pages filed overnight):

. . . .The Government has spent two weeks carrying out its unconstitutional order against the vulnerable and the weak. It justifies its conduct on national security grounds, excluding people such as a Ukrainian granddaughter trying to reunite with her 93 year-old grandmother, Ex. G at 1 (Decl. of Erol Kekic); a refugee stranded in Malawi while his uncle waits for him here, Ex. H ¶¶ 10-11 (Decl. of John Feruzi); and countless individuals who have been promised housing and resettlement in this country by a dedicated refugee organization. . . .

The Government claims these individuals have no ties to the United States and their exclusion burdens no one. That position is as wrong as it is cruel, and it makes a mockery of the Supreme Court’s directive that any alien with a “bona fide relationship” to this country cannot be denied entry. . . .

Note that the Ukraine is not even one of the six countries putatively the subject of Ban 2.0 — yet the jackboots storm on. . . Now you know — soaring. . . . gliding really, over an improbably hot zone — inexplicable by classical physical laws. It must be the proximity to that long-lost copper goddess — it must be. Smile. Be excellent to one another — I’m the ghost with the most, now. . . .


An Iceberg The Size Of… Delaware. In Antarctica…

July 12, 2017 - Leave a Response

Well — we have been talking about this for two years. Most recently, last week.

The largest iceberg in recorded human history just calved from the Antarctic ice shelf. Here it is — just now, from the Beeb:

. . . .An infrared sensor on the American space agency’s Aqua satellite spied clear water in the rift between the shelf and the berg on Wednesday. The water is warmer relative to the surrounding ice and air – both of which are sub-zero.

“The rift was barely visible in these data in recent weeks, but the signature is so clear now that it must have opened considerably along its whole length,” explained Prof Adrian Luckman, whose Project Midas at Swansea University has followed the berg’s evolution most closely.

The event was confirmed by other spacecraft such as Europe’s Sentinel-1 satellite-radar system.. . .

Now you know. But climate change is akin to flat Earth theory, according to Mr. Trump’s EPA leaders [/snark]. Onward.


Of Martin Shkreli — A Felony Trial Update: “No Remorse” Edition…

July 12, 2017 - Leave a Response

Subtitled as “How ‘Insulting, Contemptuous’ Behavior Differs From ‘Remorse’.”

Overnight, after a very bad day for the defense, in Brooklyn’s federal courthouse, Mr. Shkreli went out to drink expensive champagne at a Milo Y. debauched soirée. Perhaps it was the champagne talking, but he returned to his Murray Hill digs, to say on a YouTube live stream that — if convicted — he will get only three years — citing CFTC v. Park.

This is the take-down of that notion — from our other property, this morning.

The good soul FTD stayed up late (my condolences!) to hear Mr. Shkreli claim in a YouTube live feed that he will (if convicted) only do three years or less. [I would encourage the able AUSAs to pin this to their cork boards, for a possible September sentencing date — this is. . . motivation. And my graphic is sincerely intended to suggest that she is. . . a “saint“, by comparison — to Mr. Shkreli, at least.]

Mr. Shkreli based that on CFTC v. Park — a recent CFTC regulatory case (i.e., not a DoJ/US Attorneys SEC one), stemming from “commodity pool operator” charges — not wire fraud, and “parking” charges, related to public company securities.

Ms. Park never “parked” public company securities — his on the other hand, is an eight count indictment (hers was only seven; some of which were not even felonies — all of Mr. Shkreli’s are), and she agreed to a guilty plea. She wept openly at sentencing, taking full responsibility for her crimes, and expressing genuine remorse — to her victims (mostly friends and family).

Importantly, she is not the subject of a raft of securities class actions, spanning at least two public companies, as a control person — leaving one very ugly public company bankruptcy, in her wake. Oh — and she didn’t menace and threaten the wife and children of one of her employees — with whom she had sought to fraudulently “park” those same securities (essentially hiding her level of control of the involved public company — with the goal of manipulating the entire market for that public company’s shares). That’s all. . . Mr. Shkreli.

And she wasn’t charged with wire fraud — she didn’t act as the kingpin, in a series of schemes in which she allegedly co-opted a lawyer, for cover (my “allegedly” is out of respect for Mr. Greebel’s presumption of innocence).

Most importantly, hers is a CFTC case — not a case involving the market manipulation of an SEC-registered public company. That is, she never controlled a public company, and then defrauded the public shareholders of that ’34 Act company (twice!). That all matters quite a bit. Hers was in no respect an open market fraud on our system of capital raising — and secondary market trading. She was trading commodities which are by definition not. . . securities.

She didn’t force the government to spend enormous resources on a trial; she wasn’t contemptuous of the Judge — didn’t call the AUSAs the “junior varsity”. . . there is much more, but it all gets rather. . . redundant after a bit, no? So I’ll stop with factual analysis, here.

In sum, even if Mr. Shkreli were to plead guilty right now, he’d get a minimum of ten years. He may only do five, with day for day credit, but he’ll get ten.

That’s my guess. But we shall see. . . .

Now you know, on a gray Wednesday morning here. Even so, we still eagerly await image acquisition, of the hot spot, by hovering our “science experment” fingertips over the copper swirls of. . . Jupiter. Smile.


Some Sixteen States Weigh In, Preemptively — To Help Hawaii — In “Re-Establishing” That Grandparents Are… Close Family

July 11, 2017 - Leave a Response

The able USDC Judge Watson will receive the first of 45’s lawyers’ briefs later today, purportedly explaining why — despite a US Supreme Court order plainly preserving existing law, the Administration chose to rewrite the well-settled definition of what constitutes “close family” — in most immigration law settings.

Smartly, almost all the states that have long opposed Muslim Ban 2.0 (or “3.0”, if you prefer — but we will keep the issued retail version, as 2.0 here — since the Supremes haven’t really allowed anything new, beyond existing prior law, to this point), have taken a pre-emptive bite at the apple, by filing as amici as of last night. It is a well-taken bite, too.

Here is a bit, from the 18 pages (PDF) of those sixteen states’ amici brief:

. . . .The States of New York, California, Connecticut, Delaware, Illinois, Iowa, Maine, Maryland, Massachusetts, New Mexico, Oregon, Rhode Island, Vermont, Virginia, and Washington, and the District of Columbia submit this brief as amici curiae to urge this Court to grant the motion of plaintiffs the State of Hawaii and Ismail Elshikh to enforce, or alternatively, to modify this Court’s preliminary injunction (as amended on June 19, 2017, ECF No. 291), in order to ensure that the injunction is implemented in a manner consistent with its purpose and the Supreme Court’s modification as to its scope. . . .

First, the federal government’s interpretation is not supported by the language used by the Supreme Court in leaving part of the injunction in place. The Supreme Court, while staying the underlying injunction in part, broadly held that sections 2(c), 6(a), and 6(b) of EO-2 “may not be enforced against foreign nationals who have a credible claim of a bona fide relationship with a person or entity in the United States.” Trump v. IRAP, 2017 WL 2722580, at *6. The Court made clear that the exclusionary provisions of these sections can be enforced only against those “who have no connection” or “no tie” to the United States. . . .

The [US Supreme] Court’s recognition that a person’s relationship to his or her mother-in-law “clearly” presents a close enough relationship to qualify for protection, id., necessarily implies that the Court viewed the injunction as encompassing a broad category of relationships beyond those found within a traditional nuclear family. . . .

The federal government’s cramped view of what counts as a “close familial relationship” is contradicted both by social science research and by common experience. In particular, the relationship between grandparents and grandchildren is widely recognized as close to — and sometimes a substitute for — the relationship between parents and children. . . .

Indeed. Now you know — and what sweet and sublime honey dripping thermodynamic wonders will we learn, on Thursday night — from the JunoCam? Will we finally have an answer (proof, really) as to why it is that some fingers, floating directly above her copper-occluded storms — radiate, with over three hundred degrees of “extra” heat — far more than we would expect, from the normal (mortal) physical models, alone? I. For. One. Think. We. Will. Smiling now, wryly. . . .