Trivial Courtroom Cleanups: Next Status Conference On Federal NuvaRing® MDL Is Set For April 18, 2017

January 18, 2017 - Leave a Response

From 11:35 AM CST, to a little after the noon hour, on Wednesday, there was an all hands status conference in the Eastern District of Missouri federal district courthouse, related to these Merck (legacy Schering-Plough) NuvaRing® putative federal products liability proceedings.

Now you know, and the next one will be in three months’ time:

. . . .IT IS HEREBY ORDERED that a status conference set in this matter on April 18, 2017 at 10:30 a.m. in Courtroom 16 South. . . .

The parties shall file a proposed agenda no later than April 14, 2017. . . .

Onward. [This is an automated (entirely unmonitored) robo-post; it was experimentally-generated by a self-written routine, while I am likely off the grid, for one reason or another. The macro/algorithm collects federal filings I monitor and makes automatic posts from them. Please excuse transcription, auto-insertion and/or syntax glitches. Grin.]


In Which A Former Hassan Protégé’s M&A Non-Disclosure Decisions… Draw A Stern Rebuke, At SEC — Causing A $15 Million Civil Fine…

January 17, 2017 - Leave a Response

This breaking SEC enforcement news should come as no surprise, whatsoever — not to our regular readers, at least. This afternoon, by agreed order, the SEC has imposed a $15 million civil penalty/fine on the company then run by this former Fast Fred Hassan protégé. The charge (and agreed infraction)? Failure to timely and adequately disclose the status of ongoing M&A negotiations.

Sounds. . . familiar, doesn’t it? Indeed it does. . . . Here’s a bit — from the agreed SEC “cease and desist” order, of this afternoon:

. . . .On June 27, 2014, after receiving the Tender Offer on June 18, Respondent’s chief executive officer sent an email to Company A’s chief executive officer, setting up a call to speak. They spoke on July 1, 2014 about a potential acquisition of Company A by Respondent and agreed to meet in person. On July 29, 2014, Respondent proposed to acquire Company A for $180 per share, subject to the satisfactory completion of due diligence. This was the first time that Respondent had made a proposal to purchase Company A for a specific price. . . .

Respondent never disclosed or otherwise amended its June 23, 2014 Schedule 14D-9 to provide shareholders with information about its negotiations with Company A. . . .

Now you know. Some things just never change. But some things. . . do. Smile. . . .


Is 45 To Be Believed? If So, Good For Pharma — Or… (Maybe) Not So?

January 17, 2017 - Leave a Response

img_5923 Even if we are to believe 45 — about his desire for health insurance “for everyone” (and high-quality, but magically rainbow like “cheap” health care delivery, as well!), it is quite unclear that Congress (Speaker Ryan in particular) will ever send him a bill that achieves all (or even most) of that.

If Congress does, and 45 signs it, then he will have essentially taken the HRC 1994 model, and implemented it. And that will be very good for pharma and bio-science companies, here in the US. However, ALSO if he is to be believed, he wants to force pharma to negotiate on price with the US governmental payers. Again, that is something Congress may not allow him (as the Congress is still beholden to PhRMA lobby money). But if 45 achieves that, again, he will have implemented an old 1994 HRC plan — and that will be decidedly bad news for pharma, and life science companies in the US.

So — we return to the opening question: what to believe? Should anything Mr. Trump says about health care payment and policy, here in the early days — be taken seriously? I suspect not. But I also suspect the Congress will be politically unable to repeal — without a “replace” — for the 20 million only recently newly-insured people in the US. Here’s a bit — do go read it all at PennLive:

. . . .In an interview over the weekend, Trump appeared to promise something similar to Obamacare, or even more expansive, regarding how many people will be fully covered. . . .

“We’re going to have insurance for everybody,” Trump told the Post in a telephone interview late Saturday. “There was a philosophy in some circles that if you can’t pay for it, you don’t get it. That’s not going to happen with us.” People covered under the law “can expect to have great health care. It will be in a much simplified form. Much less expensive and much better.”. . .

Will HRC see her ideas — from 23 years ago — essentially enacted? We shall see. I for one am unlikely to take anyone’s word alone very seriously, throughout 2017. Except possibly Speaker Ryan. It seems to me that he will ultimately be the gate-keeper on the oddly misshapen Zoo that is the Trump Administration. Onward. I’ll be on the West Coast (with clients) — after tomorrow night, so the blogging forecast calls for. . . light coverage. Smile. . . .


[U] From NASA — For Monday…

January 14, 2017 - 9 Responses

life-lewis-selma-2017UPDATED Sunday morning: I write on a King Weekend entirely unlike any I’ve seen in a generation.

This is a Rev. Dr. Martin Luther King Day weekend that saw the President-elect choose to deride-by-tweet Georgia Rep. John Lewis, a senior Congressman whose skull was fractured by police during a civil rights march, in Selma, Alabama with Dr. King — over a half century ago. In fact, after Rep. Lewis exercised his right to resist the President-elect’s legitimacy (citing the Russian influence concerns), and said he would not attend the inaugural, Mr. Trump insulted him as a man who is  “all talk, talk, talk — no action or results.” Recall here that as Rep. Lewis was being beaten on the bridge in Selma, to win us all the freedom of our full civil rights, Mr. Trump was dodging the draft at a privileged private school, in upstate New York. [And that was only when Trump wasn’t discriminating against people of color — in his father’s rental empire. Talk? Meet action. . . .] untitledThis is also however, a weekend that saw Jennifer Holliday decide she could not be part of any endorsement of 45, or his policies — and after first waffling a bit — declined to sing on the night before the inaugural. So, I still remain optimistic.

I am optimistic because Rep. Lewis’s book has sold out in stores around the nation, in response to 45’s hateful, demeaning rhetoric. I am optimistic that people will simply turn off their TVs on Friday (as Cher has asked by tweet) — as ratings are the only numbers 45 seems to value. I am optimistic that the crowds arriving by over 1,200 buses cleared into DC for Saturday next — for the Womens’ Protest March — will dwarf the crowds delivered by those 200 buses cleared for the inaugural itself, on Friday.

I think Dr. King would say this is a time for peaceful, non-violent action — but a time for action, no doubt.



BMS Vs. Merck (Keytruda®) Patent Spats: Delaware Federal Ono Litigation Status Conference Now Reset To February 23, 2017

January 11, 2017 - Leave a Response

Separately (but of greater import), I’ll note that Keytruda® has been granted FDA accelerated review (with a May 10 expected action date) — in lung cancers, in combination with chemotherapy. And that is good news; however, 45-Elect just said that drug companies are “getting away with murder” — on drug pricing (in a live press conference in front of the world; not by late night tweet) — and that is the pharma related bad news, of the morning. Expect more of that sort of mercurial (unthinking) volatility in remarks — from the incoming Administration. [He may very well be a bigger threat to Kenilworth’s revenues and business model — than HRC ever was.]

In any event, here’s the full text of the Ono Delaware order, of this morning. [Background on that litigation, here.]

. . . .The teleconference with Judge Thynge set for 1/17/17 at 10:00 AM Eastern Time has been rescheduled to 2/23/17 at 11:00 AM Eastern Time. Plaintiffs’ counsel to initiate the teleconference call. Ordered by Judge Mary Pat Thynge on 1/11/17. . . .

Now you know. And I can scarcely imagine a more stark contrast, planet wide, than that seen in Chicago last night, compared to the press conference this morning. What has become of. . . statesmanship? I simply shudder to think — how must the world now see us?


Off-Topic: Meryl Streep — Patriot And Hero

January 9, 2017 - Leave a Response

life-ot-streep-trump-despot-2017If 45-Elect thinks she is “over-rated” — that is all I need to hear. It makes me all the more eager to see what she had to say.

Do watch the Washington Post’s annotated version. It is excellent.

. . . .Streep accepted the Cecil B. DeMille Award — basically a lifetime achievement award — but didn’t say much about her career. Instead, she spent the minutes allotted to her to speak critically of the current political climate and Trump, although she did not mention the president-elect by name.

“There was one performance this year that stunned me,” she said. “It sank its hooks in my heart. Not because it was good. There was nothing good about it. But it was effective, and it did its job. It made its intended audience laugh and show their teeth.

“It was that moment when the person asking to sit in the most respected seat in our country imitated a disabled reporter. Someone he outranked in privilege, power and the capacity to fight back. It kind of broke my heart when I saw it. I still can’t get it out of my head because it wasn’t in a movie. It was real life. . . .”

Onward now on a warming Monday here — looking forward to BHO 44’s farewell address tomorrow, and a DePaul Vs. Marquette matchup this weekend. “Hidden Figures” tied “Rogue One” on a snowy weekend for most of the nation, as the top grossing film, too. . . Smile. . . .


Minor Update: New Italian Research Suggests Ebola May “Hide” — And Replicate — In Host’s Lungs

January 7, 2017 - Leave a Response

life-ebola-lung-2017First: this is no cause for alarm. It was already known that the virus could reside in a dormant fashion in a host’s eye fluid, and semen, long after being undetectable in the blood.

But this will help WHO’s pandemic response teams, for the next time there is an Ebola viral outbreak, in human populations. Thankfully we now have a working vaccine — for rings of contact — as they emerge.

So there is much to be hopeful about. But we should not kid ourselves — there will be another outbreak — that’s how evolutionary biology works. Per MedPage Today — do go read it all:

. . . .A healthcare worker recovering from Ebola virus in Italy showed evidence of persistent viral infection in his lungs days after the virus was no longer detectable in his blood, researchers reported.

The case study, appearing in the journal PLOS One, represents the first direct evidence of potential replication of the virus in the lungs, suggesting that the respiratory system may play a more significant role in the pathogenesis of Ebola than previously recognized.

It also suggests the possibility of respiratory transmission of the virus, wrote Mirella Biava, of the National Institute for Infectious Diseases in Rome, and colleagues.

“The presence of viral replication markers here reported adds some support to this possibility, although the evidence is far from being conclusive, due to the absence of recovery of infectious virus in respiratory secretion,” the researchers wrote. . . .

[We should hope that there will be no mutation of the basic viral structure or function, in animals, in the mean time that renders the vaccine ineffective — as to any new strains.] To be clear — there is cause to be optimistic here as well, as the approach Merck and NewLink employ for vaccination is to insert, in a genetically engineered simian “container“, some of the killed virus. Should the virus re-emerge in a mutated fashion, Merck ought to be able to insert that sample into a new batch of the vaccine simian “containers” — and see similar efficacy. So we will keep a positive thought, here — as well.

Now, I will have to settle for watching our outgoing President’s farewell on TV, Tuesday. The lines for tickets in Chicago — in sub-zero wind-chills this morning, no less — were staggering. So it goes; an era started together — will end. . . together in a continued chorus of “Yes, we can“. Smile.


A Very Cool (IBM Sponsored) AR iPhone App — “Out-Think Hidden”: Free Downloadable!

January 6, 2017 - Leave a Response

I am keenly aware that much of the Middle-South is struggling with a freakish winter storm tonight, but if it is safe to do so, I highly encourage you to get out and see “Hidden Figures” — it opened nationwide, today.

If you have youngsters about, I encourage you to download the free “Outthink Hidden” App from Google Play or the App Store. Then, as I did out my office window this afternoon, at right, you can render 3-D statues of the heroes of NASA’s early “S.T.E.M. on Fleek” programs — any place you tape up the little OCR code blocks — and hear, read and watch all about them, while connecting their pioneering work, to that of space science more generally. IBM and its diversity initiatives are to be credited for this tie in. [There! Now there’s something you can do, without ever leaving the warmth of home and hearth, this weekend. Smile. . . .]

Additionally, and non-trivially, while binge-watching the NBC series called “Timeless” — I saw a generally very strong Season One episode (called “Space Race“) featuring none other than Katherine Johnson, as the mathematics hero — yet again. In this one (in an alternate 1969) she is needed to save Apollo 11 and Neil Armstrong, from disaster on the Moon’s surface. Do watch it on demand under that link — when you have a chance.

But most of all — please encourage all your youngsters, boys and girls, black, brown, yellow and white — to become interested in the sciences. They will dream up, and then create, the futures we can’t even imagine tonight. We need them. We need them all. With gratitude, I wish you safe and light travels then this weekend. I’m out!



Off Topic — But I Cannot Remain Silent: The Abject Failure Of 45’s “Leadership” — Prior To His Inaugural, Even

January 5, 2017 - Leave a Response

untitledUPDATED: 01.06.2017 @ 9 AM EST — This was expected, at least by me. Woolsey is a solid intel policy wonk. So, a consensus intel report is soon to be released in DC — in which the operatives of the Russian government thought responsible for the DNC e-mail leaks (and for the ultimate transfer to Julian Assange) will be named. And so, the man the President-elect had tapped to run his national security portfolio for him has. . . resigned, even prior to the inaugural. Amid tension over the president-elect’s vision for intelligence agencies, R. James Woolsey Jr. said he did not want to “fly under false colors. . . .” Expect to see more of this, as true patriots stand to be counted. [End, updated portion.]

True — I did fiddle with my masthead overnight (on the main blog), and in truth, I have had Senator McCain’s hearings on in the background all day, in the office. [It has been over a decade since I ran a blog that touched on national security matters. Even so, I cannot just look the other way at key moments, in our republic’s history, on this topic. We may disagree about certain matters of national security and methods of gathering intelligence, but we should never disparage the patriotism of our intelligence officers, in Langley, Virginia — or in the field.]

That said, I thought this would all have sorted itself out, by now. But it has not. Director Clapper is right: “A dose of skepticism is healthy. But disparagement — is not.”

The notion that the incoming President would take a Wiki-Leaker at his word, alone — when it is painfully obvious that said Wiki-Leaker cannot even credibly guess at who might have been the conduit through which he received the DNC e-mails, is in itself jaw-slacking.

But it is quite-nearly treasonous for 45 do do so, in the face of unbiased, credible, and consensus views of our entire intelligence community — those with assets deployed across the globe — with access to many more sources and methods than Julian Assange would ever have, as a simple “drop-ship point” — for what were almost certainly Russian government sourced bulk e-mail deliveries.

Let me say that again — the incoming President is inclined to take the word of a “drop ship recipient” of a hack — a man holed up in the Ecuadorian Embassy in London, working aloneINSTEAD of the CIA, FBI and NSA. [Where on Earth is 45’s patriotism?]

In this matter, the notion that 45 would continue to give V. Putin any “benefit of the doubt” is. . . disgusting. Senator McCain (a man whose other politics I’ve long disagreed vehemently with — but a man whose patriotism is absolutely beyond reproach) would be right to call that wrong-headed enough to be “treasonous“. Here endeth the sermon.



USPTO, On “Cabilly” Patents: Merck Loses One Inter-Partes Review — But Is Allowed To Join Another…

January 5, 2017 - Leave a Response

life-mrk-cabilly-keytruda-uspto-inter-partes-2017Back in November, we reset the table on this series of patent disputes, related to the basic methods, and composition, of the immuno-oncology treatments now revolutionizing solid organ tumor therapies.

The USPTO’s PTAB has just issued its long awaited inter-partes review decision. It held that Merck’s standalone petition on the ‘415 (or “Cabilly I”) patent had been previously considered, and so denied it. However, the body allowed Merck to join a pending inter partes review filed by Amgen (and others), on the so called Cabilly II and III patents. That means this part of the wrestling match simply awaits another US PTAB decision, likely to be issued later this Spring.

So, once again, we wait for decision(s) on these fronts — in a perhaps $20 billion a year oncology revenue market, in the US alone. These same basic issues are also the subject of several pending federal suits in Delaware, and California. Here’s a bit from the latest US Patent and Trademark Appeal Board decision (a ten page PDf file):

. . . .Although Petitioner may have sound reasons for raising art or arguments similar to those previously considered by the Office, the Board weighs petitioners’ desires to be heard against the interests of patent owners, who seek to avoid harassment. See H.R. Rep. No. 112-98, pt.1, at 48 (2011) (AIA proceedings “are not to be used as tools for harassment or a means to prevent market entry through repeated litigation and administrative attacks on the validity of a patent. Doing so would frustrate the purpose of the section as providing quick and cost effective alternatives to litigation.”). All of the challenged claims require an immunoglobulin molecule. As Patent Owner notes (Prelim. Resp. 20), Axel is the only asserted reference that discloses an immunoglobulin molecule, i.e., an antibody. Axel was explicitly considered by the Office during reexamination of the ’415 patent. . . .

We determine, therefore, that Axel, the only reference that Petitioner relies upon to disclose an immunoglobulin molecule, was previously presented to, and considered by, the Office in the same substantive manner as Petitioner now advocates.

Moreover, as noted by Patent Owner, Petitioner in the instant proceeding filed a second Petition (IPR2017-00047) seeking joinder with IPR 2016-00710, which was instituted on September 8, 2016. Prelim. Resp. 28. We have instituted trial in IPR2017-00047, and joined it with IPR 2016-00710, concurrently with the instant decision. As Petitioner has agreed to abide by the Scheduling Order in IPR 2016-00710, a final written decision will be entered in that case well before a final written decision would be entered in the instant proceeding. . . .

Now you know — we will (of course) continue to monitor this. We would expect an update in the material litigation section of Merck’s forthcoming 2016 Year-end SEC Form 10-K. We begin our walk in, under cloudless but frigid skies — as wind-chills hover near minus ten. But our hearts — they be warmed. . . as a quick trip out to L.A.’s sunshine, looms for later next week. . . smile.