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After Losing In Trial Court, US Merck Also Loses On Appeal, In The UK…
November 24, 2017

This was not. . . unexpected. After all, US Merck soundly lost — at trial — in England. So Kenilworth will next file an appeal in the Supreme Court of the United Kingdom. Background here. And the US case continues, as well, separately. As does an EU action; and a German case.

Here is the full 87 page PDF decision, if you are curious. It nicely addresses the notion that a US website may reach out to visitors across the globe — rendering any 1970s (i.e., before the webbed world) agreement on naming and branding. . . antiquated —
if not extinct, entirely. As I have long said, these folks need to work out an entirely revamped agreement — one that contemplates the intricacies of an electronic world less and less governed by geopolitical lines — on some paper map. And a bit:

. . . .The Court of Appeal confirmed the High Court’s decision of 15 January 2016 that use in the UK by MSD of “Merck” alone either as a trade mark or company name breached a 1970 agreement with Merck KGaA, Darmstadt, Germany.

The dispute centred on Merck KGaA, Darmstadt, Germany’s claim that MSD’s online use of “Merck” in the UK breached a co-existence agreement between the parties and infringed trade mark rights in the UK. At the heart of the litigation was how an agreement originally negotiated in 1955 applied to use on the internet and social media. . . .

MSD also appealed the finding that the uses on the “Merck” branded websites and social media pages were uses in the UK. They claimed they were directed at US and Canadian citizens, jurisdictions where MSD was permitted to use MERCK alone under the Agreement.

The Court of Appeal took the opportunity to review the law on whether use on websites and social media was targeted at the UK. It summarised the general principles which emerged from CJEU and UK first instance decisions. In particular they noted that the mere fact a website is accessible in the UK is not sufficient basis for concluding that an advertisement is targeted at the UK, and that the issue of targeting is to be considered objectively from the perspective of average consumers in the UK. The Judgment goes on to say that the intention of the trader to target consumers in the UK may be relevant as may other circumstances beyond the website itself, for example, the nature and size of the trader’s business and the number of visits made to the website by consumers in the UK.

When applying these principles to this case, Lord Justice Kitchin held that MSD conducted its healthcare business in many countries around the world, including the UK and that business was at all material times supported and promoted by the websites in issue. They constituted an integrated group of sites which were accessible by and directed at users in the UK and other countries in which MSD trades. A person seeking information about MSD on a particular topic would be directed or linked to one of the websites from which that information could be derived. This allowed MSD to target inventors and scientists in the UK, to recruit people in the UK, to solicit suppliers, to seek licensing opportunities in the UK and to provide purchase order terms and conditions applicable to the UK. The social media activities of MSD were also directed at persons and businesses in the UK in just the same way as the websites. . . .

Do go read it all. And enjoy your long weekends!

नमस्ते

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Another Thanksgiving, Another Old Legacy Merck Property For Sale…
November 22, 2017

At Thanksgiving 2016, we were discussing the fact that the Whitehouse Station former Merck HQ sale had fallen through.

Here at Thanksgiving 2017, Merck has relisted a nearby (or a part of the same?) property — 154 acres, in all — with Jones Lang LaSalle. The full article is behind a registration wall, so if any readers out there want to chime in with more detail, that would be great. I’ve used a Google Maps image of the corner where the parking entrance is, as my graphic, at right. But is this the other half/parcel of the since-divided old Merck HQ lots? The one million or so square foot building that was HQ is still listed (I believe) with Cushman — is/was this part of that?

Hmmm. . . is this the “rest” of that tract — the more prosaic, and industrial complex part of it? It seems so (unless my memory is faulty, here two decades on), by the iconic sandwich shoppe, down the street, on the corner — from those “bad old days“, flying in and out, to meet with Merck. [I used to snag lunch there, when I flew in and out for the day, to do licensing and M&A deals (on behalf of another life science company) with various factions of Merck. . . gosh, how time flies. . . . In any event, do let me know. . . what you know, dear readers.] It should be quiet around here for a bit.

And do have a safe and happy turkey feast, one and all. I’m out until Monday night, barring an unforeseen event in the land of the crazy that is 45. Which is to say — I am sure he will do something. . . nutty. Sheesh. Smile — just the same.

नमस्ते

[U] A “Tumbling, Reddish Brown, Mount Blanc Pen” — Blazing By @ 196,000 MPH — Just Flew In, And Out, Of Our Solar System…
November 21, 2017

UPDATED — Dawn in Italy, on Tuesday 11.21.2017: I bumped this back up to the top. We could all use some happier-science infused ju ju, here. [End, updated portion.]

Let’s just have the sublime ESO video do the ‘splainin’, shall we? [She’s been named “Oumuamua“, by her discoverers — which translates from the native Hawaiian as “first arriving messenger, from afar“.] Yes. . . let’s. See below.

It is highly unlikely that this object will ever see her arc bend backward, and twist, toward our sun again — she is passing through our lives but once. Like so many odd, yet preciously graceful, things. . . indeed.

. . . .Astronomers have recently studied an asteroid that has entered the Solar System from interstellar space. Observations from ESO’s Very Large Telescope in Chile (and other observatories around the world) prove that this unique object was travelling through interstellar space for millions of years before its chance encounter with our star system. It appears to be a darkly reddish (red-bone!), highly-elongated, high-metal-content object. . . .

As ever — the idea of a dusky metallic visitor — from near the “time, before time“. . . at least relative to our own local group. . . fires my imagination. No doubt (being a man of science, after all!), under this graceful, roughly Mount Blanc pen-shaped metal, are the vestiges of one or more timeless raindrops — and under those raindrops, are the words — and some of those words, are mine to you. Travel well — and do travel light.

नमस्ते

UPDATED, X2: Trump’s Lawyers Are REALLY Behind The Eight Ball, Once Again — CA DACA Developments This Afternoon
November 20, 2017

Moving swiftly, the plaintiffs in the California DACA litigation have correctly noted, in a brief filed a few minutes ago — that Trump’s lawyers don’t even understand the posture of their case — which is (politely) to say nothing of the merits, here.

But in a show of equanimity, coupled to a thoughtful expediency, the lawyers for the kids are willing (but only in the federal trial level court in San Francisco) to allow the Trump Administration to wait until Christmas week 2017 to deliver the full discovery materials it owes them — because it is likely (they rightly surmise) that one court or another will enjoin Trump on the merits by or before then. Lovely. Here’s a bit, from the 11 page PDF, just filed:

. . . .As it happens, the plaintiffs here agree that it would be sensible at this particular juncture for the district court to temporarily stay its orders requiring completion and filing of the administrative record by November 22, although not in exactly the manner sought by defendants. Plaintiffs’ motion for a preliminary injunction and defendants’ motion to dismiss are now pending in the district court, and will be fully briefed and argued by December 20. A temporary stay until after the district court rules on those motions would allow the parties to focus on the most immediate issue of whether defendants’ decision to rescind DACA should be enjoined from taking effect while this litigation proceeds. The district court’s ruling on those motions could also either moot or clarify some of the arguments proffered by defendants in support of the extraordinary interlocutory relief that defendants sought from this Court and have now indicated they otherwise intend to pursue immediately in the Supreme Court. A temporary stay would perhaps also obviate any perceived need for defendants to further multiply proceedings in this case.

For all these reasons, on November 19 (Saturday) plaintiffs themselves (the kids!) filed a motion in the district court seeking a stay tailored to the circumstances of this case. See D.Ct. Dkt. No. 190. This morning, the district court issued a tentative order that would delay defendants’ obligation to file the augmented administrative record and stay discovery until December 22, two days after the scheduled hearing on plaintiffs’ motion for preliminary injunction and defendants’ motion to dismiss. . . .

Gentle readers: this is what it looks like — when one side is so far ahead on the merits, in important litigation: they (the kids) turn their cards all face up — and offer to be. . . kind. It clearly illuminates just how preposterous Trump’s lawyers are being. And I love this style — both economical, and devastating, all in one. Well-done!

[45’s lawyers will have their say, later this evening — such as it is. I’ll post it late tonighthere it is. YAWN. That’s some weak sauce, indeed. Smile.] 11.21.2017 — 8 PM EST: Told ya’. Here is the Court’s order.

नमस्ते

I Still Think There Will Be No Tax Package In 2017 — Or 2018 — Until After The Mid-Terms…
November 20, 2017

. . .But on the small chance that 45 signs some ill-starred, and mean spirited piece of legislation that takes from the middle class, in order to increase tax breaks on private jets, and repeals the estate tax for the wealthiest one-one-hundredth of one per cent of all Americans, as well as vastly benefits his real estate driven empire. . . I will commend this piece in The Atlantic to the readership.

Do go read it all — it correctly argues that even if a bill is signed into law, most sensible corporations will not change their longer term plans, on a measure they well-know may be repealed or greatly scaled back — come midterms in late 2018. That is only one year away. Corporate strategists at the tax line think in longer terms. Frum is right — do go read it all, but here is the concluding bit:

. . . .A rationally conservative party of business and enterprise could, and should, have written a corporate tax reform compelling on the merits. The slowdown of U.S. productivity growth would be the country’s leading problem if U.S. constitutional democracy were not being attacked from the White House at the same time. The GOP submitted to Trump in 2016 very largely to reach this moment. The ironic outcome is that his success that year doomed the very prize for which his party sold its soul. . . .

Indeed — succinctly, and perfectly put. [After the holiday, in a look across the pond, as it were — I plan to update the thinking here, on the likely now increasing delays, looming over any Brexit. As I long said, it may end up being almost. . . nothing. The weekend walkout — on Merkel’s latest, coupled to May’s troubles — may mean 2020 or later for any soft Brexit.]

Now. . . as more and more of my usually-geographically-scattered family arrives, I will grow increasingly silent here — until mid next week, in all likelihood. Be excellent to those you love — so much to give thanks for, here. Smile.

नमस्ते

[U] The Trump DACA Defendants In Northern California May Seek USSCt Review Of Thursday’s Order…
November 19, 2017

UPDATED: Monday Morning — I should have mentioned late last night how unusual the ending of the below order, in blue is. I laughed out loud when I read it (but then promptly forgot to mention it!), for you see, it takes the extraordinary step of pointing the US Solicitor General. . . to the existing law (for it seems he is unaware of it). In the case the court mentions by name — the Ellis case, the appellate court held that a stay of a denial of mandamus is properly to be addressed in the court in which it was entered, or the trial court — in this case. Or, as the court points out — by cert. to the Supremes, directly. Hilarious. The Ninth Circuit is teaching what amounts to rudimentary, basic federal procedural law to Trump’s Solicitor General (which tells you something about the calibre of his Administration). These are fascinating — if sort of sad — times. [End, updated portion.]

Should Trump’s lawyers do so, it will likely be a vain act. Here is our coverage — from Friday, of last Thursday’s order.

The standard of review at the Supremes would be “was the District Court’s order (asking for production of more than 14 documents — 11 of them published court opinions — to explain a major change in policy) clearly erroneous?”

Unless it was clearly erroneous, the Supremes will let the Ninth Circuit order stand, and the trial level court in San Francisco will order Trump to provide documents from the dozens of other officials who — in press interviews — indicated that they too had a role in making these decisions — including Trump himself. He personally turned over zero documents, yet he took credit for making the change. We must hold people in power to the standards of the law as it exists — otherwise we are. . . Russia.

Here is the Saturday afternoon order — with briefs due by Monday afternoon, Eastern time.

. . . .The court has received the government’s November 17, 2017 emergency stay motion. The response to the motion is due Monday, November 20, 2017, at 12:00 p.m. PST, and the optional reply is due Monday, November 20, 2017, at 5:00 p.m. PST. . . .

In addition to all other issues the parties wish to raise in the response and reply, the parties shall address whether this court has jurisdiction to grant a stay of proceedings, or whether the motion for a stay should instead be filed in the district court. See Ellis v. U.S. Dist. Court, 360 F.3d 1022 (9th Cir. 2004) (en banc). . . .

Now you know. I hope the new week brings. . . a newly joyful “magic carpet ride’s” attitude — to all those who travel in good will, toward this holiday of gratitude. Smile.

नमस्ते

Ninth Circuit: Trump Administration Simply MUST “Comply With The Law” — In California DACA Case
November 17, 2017

At the head — I’ve been watching this piece of litigation, since it quite closely tracks one I’m involved in here in the federal courts in Chicago. But I’ve not reported on it until today. Out west, it has reached the Ninth Circuit on appeal, and has now articulated anew the unsurprising principle that Mr. Trump must comply with existing law.

Mr. Trump has claimed the right to end DACA without showing all the documents his administration relied upon to make a change in policy that impacts 800,000 Americans directly. He offered only 256 pages of previously public materials. That sort of opacity is most usually seen in. . . tyranical oligarchies (Cough. Russia).

By way of contrast, here we are a government “of the people, for the people, and by the people. . . .” So the Judicial Branch has effectively told him to obey the law, on transparency, and separation of powers doctrines — and thus to explain the real basis (as opposed to his odious political subterfuge) for his decision.

That an appellate level federal court must spend 18 pages and much research, crafting a formal written and published opinion of law, and has wasted oral argument time, as well as the plaintiffs’ (and the taxpayers’ money and time) on legal fees. . . all to reiterate what has been clear law for nearly 75 years, is — well. . . astonishing. But that is Trump — and here is a bit of the decision:

. . .At the initial case management conference before the district court, the government agreed to produce the complete administrative record on October 6, 2017. On that date, the government submitted as “the” administrative record fourteen documents comprising a mere 256 pages, all of which are publicly available on the internet. Indeed, all of the documents in the government’s proffered record had previously been included in filings in the district court in this case, and 192 of its 256 pages consist of the Supreme Court, Fifth Circuit, and district court opinions in the Texas v. United States litigation. . . .

Faced with this sparse record, and on the plaintiffs’ motion (opposed by the government), the district court ordered the government to complete the record to include, among other things, all DACA-related materials considered by subordinates or other government personnel who then provided written or verbal input directly to Acting Secretary Duke. The district court excluded from the record documents that it determined in camera are protected by privilege. . . .

Put bluntly, the notion that the head of a United States agency would decide to terminate a program giving legal protections to roughly 800,000 people based solely on 256 pages of publicly available documents is not credible, as the district court concluded. . . .

The district court identified several specific categories of materials that were likely considered by the Acting Secretary or those advising her, but which were not included in the government’s proffered record. For example, the record contains no materials from the Department of Justice or the White House—other than a one-page letter from Attorney General Jefferson B. Sessions—despite evidence that both bodies were involved in the decision to end DACA, including the President’s own press release taking credit for the decision. . . . Nor does the proffered record include any documents from Acting Secretary Duke’s subordinates; we agree with the district court that “it strains credulity” to suggest that the Acting Secretary decided to terminate DACA “without consulting one advisor or subordinate within DHS. . . .”  And the proffered record contains no materials addressing the change of position between February 2017—when then-Secretary John Kelly affirmatively decided not to end DACA—and Acting Secretary Duke’s September 2017 decision to do the exact opposite, despite the principle that reasoned agency decision-making “ordinarily demand[s] that [the agency] display awareness that it is changing position” and “show that there are good reasons for the new policy.” FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009).

At oral argument, the government took the position that because the Acting Secretary’s stated justification for her decision was litigation risk, materials unrelated to litigation risk need not be included in the administrative record. Simply put, this is not what the law dictates. The administrative record consists of all materials “considered by agency decision-makers,” Thompson, 885 F.2d at 555 (emphasis added), not just those which support or form the basis for the agency’s ultimate decision. See also, e.g., Amfac Resorts, LLC v. U.S. Dep’t of Interior, 143 F. Supp. 2d 7, 12 (D.D.C. 2001) (“[A] complete administrative record should include all materials that ‘might have influenced the agency’s decision,’ and not merely those on which the agency relied in its final decision.”) (quoting Bethlehem Steel v. EPA, 638 F.2d 994, 1000 (7th Cir. 1980)). . . . 

The district court’s decision to require a privilege log and evaluate claims of privilege on an individual basis before including documents in the record was not clearly erroneous as a matter of law. . . .

Now you know. Onward, in the district court in San Francisco, for discovery, and then back to the Ninth Circuit — to a likely 45 loss, on the merits on its revocation, in the DACA decision. Sunny and crisp and cool here — a great Friday shaping up, overall — with my baby girl due in this weekend. Smile.

नमस्ते

In Which Merck Pays A T-Cell R&D Upfront Fee: To Tiny Cue Biopharma; Full Financial Terms Not Disclosed
November 16, 2017

It seems today was a day for announced dealmaking, in the longer term developmental space, for Kenilworth.

Of course, Merck itself would never announce something this small — but it has given permission to Cue to do so. The vote of confidence is immensely helpful to smaller outfits like Cue — in future collaboration and fund-raising efforts.

[Like this morning’s Spero announcement, Cue is headquartered in Cambridge Massachusetts, as well.] This pull quote below is from the presser — and I’d personally bet that the upfront was less than $10 million. To get to a third of a billion dollars in payments from Kenilworth, Cue will have to deliver on all research milestones — but that is the way all smart deals of this kind are now done:

. . . .Cue Biopharma, an immunotherapy company developing a novel, proprietary class of biologics engineered to selectively modulate the human immune system to treat cancer and autoimmune diseases, today announced a strategic research collaboration and license agreement with Merck, known as MSD outside of the United States and Canada. Under the terms of the deal, the CUE Biologics™ platform will be leveraged to develop biologics engineered to selectively modulate disease-relevant T cell subsets for the treatment of autoimmune disease. The multi-year collaboration will encompass multiple disease targets across certain primary disease indication areas. . . .

While specific financial arrangements are not being disclosed, Cue Biopharma will receive an up-front payment. Cue Biopharma is also eligible to earn up to $374 million in research, development, regulatory and commercial milestone payments in addition to tiered royalties on sales, if all pre-specified milestones associated with multiple products across the primary disease indication areas are achieved. . . .

Now you know — with some more, of a “look back” set of tunes — on the repeat button. . . smile. Onward. Ever, onward. Never buckle; never fall. . . onward.

नमस्ते

Spero Therapeutics Sports Some Heavy-Hitters — As Major Shareholders: IPO Follow-Up
November 16, 2017

Obviously, Merck’s research arm has invested through a fund because the burgeoning pipeline of Spero dovetails with its much earlier acquisition of Cubicin, and the Gram negative antibacterial products previously developed by the former Cubist Pharmaceuticals.

It is also true that Cubicin is under pressure due to generic manufacturers seizing on prior patent maneuvers, to bring a copycat to market.

So this “informational” 5 per centers’ pipeline is likely a toe-hold to picking up additional anti-infectives, for Kenilworth — and keeps it even with GSK and Google’s Alphabet in the “pipeline info” wars. Do go see the whole run-down here — but you’ll need to read the footnotes, to that table on page 162, to figure out that the holders listed there are actually investment vehicles/funds controlled by Glaxo, Merck and Google’s Alphabet, respectively.

Quite an array of the “Masters of the (Anti-Bacterials) Universe”, that. I’ll close by listing just a bit of what the capable team at Spero is chasing:

. . . .We are a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multi-drug resistant bacterial infections. Our most advanced product candidate, SPR994, is designed to be the first broad-spectrum oral carbapenem-class antibiotic for use in adults to treat multi-drug resistant, or MDR, Gram-negative infections. Treatment with effective orally administrable antibiotics may prevent hospitalizations for serious infections and enable earlier, more convenient and cost-effective treatment of patients after hospitalization.

We also have a platform technology known as our Potentiator Platform that we believe will enable us to develop drugs that will expand the spectrum and potency of existing antibiotics, including formerly inactive antibiotics, against Gram-negative bacteria. Our lead product candidates generated from our Potentiator Platform are two intravenous, or IV,-administered agents, SPR741 and SPR206, designed to treat MDR Gram-negative infections in the hospital setting. In addition, we are developing SPR720, an oral antibiotic designed for the treatment of pulmonary non-tuberculous mycobacterial infections. We believe that our novel product candidates, if successfully developed and approved, would have a meaningful patient impact and significant commercial applications for the treatment of MDR infections in both the community and hospital settings. . . .

The IPO priced on November 1, and Merck filed an SEC Form 13G last night. Now you know — for my part, I grow excited to have my goofy, vibrant, successful adult children home for the holidays, starting this weekend. Smile — ever Macy Gray “I Try”. . . onward.

नमस्ते

UPDATING 11.16.17: Most Direct Marburg Viral Contacts Will Clear The 21 Day Observation Period At Midnight, Local — In Kenya And Uganda
November 16, 2017

We will hold our breath until after midnight in New York — in the hope that all of Kenya and Uganda reach an “all-clear” (the expiration of a 21 day observation period) — as to the recent Marburg virus outbreak.

Here is the November 15, 2017 update, from WHO in full — and just a little bit of it (detailing the method of transmission into Kenya):

. . . .Prior to his death, the second confirmed case travelled to Kenya where he visited his relatives in West Pokot County, as well as a traditional healer in Trans Nzoia County. On 29 October 2017, the Ugandan MoH notified WHO and the Kenyan MoH of these high-risk contacts. The traditional healer tested negative for Marburg virus disease on repeated blood specimen analyses performed at the Kenyan Medical Research Institute (KEMRI) in Nairobi. She and her family were monitored for 21 days. The two relatives from West Pokot, as well as other contacts in the same county, also completed their 21 days of follow up.

Active case search, death surveillance, safe and dignified burials and community mobilization are ongoing in Kween and Kapchorwa districts. In Uganda, of the 339 contacts listed, 283 have completed 21 days of follow-up and 56 are still being monitored. Contact follow-up is ongoing in Kween for the 56 contacts, while In Kapchorwa District, all the listed contacts have completed the 21 days follow-up period. All remaining contacts are expected to complete 21 days of follow up on 16 November 2017. Enhanced surveillance activities will continue until 7 December 2017. . . .

Now we watch, and wait. And listen to Ms. Chanté Moore in the mean time, to keep our spirits upsleep well, one and all:

नमस्ते