Monday, September 26, 2016

As Of Last Friday, It Looks More And More Likely That Merck Will ALSO Lose In Delaware -- As It Did In California -- In The Hep C Patent Wars, With Gilead


As of Friday evening, in Delaware's federal US District Court, Gilead had filed its redacted version of the papers which recite why Merck's patent infringement claims should be bounced without need for any trial, there. You'll recall that Merck saw those infringement claims bounced out of court in California's Northern District Court, just a few months back. I foresee much the same outcome here -- especially after this latest filing, from Gilead's legal team.

Here is that memo of law in support of the motion (as a PDF file), and a bit that was not redacted:

. . .[Merck's] problem is that it seeks to limit the claims to a subgenus of effective nucleosides, yet its patents provide no antiviral data or other blaze marks that distinguish between nucleosides that work and those that do not.

[Merck] cannot have it both ways: if the claims are limited in that manner, then the patent must direct the skilled artisan to that narrowed set. [Merck's] main response is to try to use its expert to backfill what the patent lacks, but precedent prohibits that approach. [Merck's] few citations to the patent itself are both legally insufficient and telling: the only supposedly exemplary compounds and data it relies on were not in the original May 2000 application and were added only in May 2001, when [Merck's precursor company] was still just beginning to start testing compounds without yet knowing what was effective. [That precursor company's] patents present nothing more than a research plan that left the real work -- identifying an effective nucleoside like 2’-F down -- to others. The claims, under any construction, are thus invalid as a matter of law. . . .


Now you know. And onward we sail, out into the oncoming cold -- of the frigid shepherd moons' Jovian orbital space -- but not quite so alone, after 2 PM EDT today. . . smile. [Getting ready to watch HRC gracefully lop the GOP nominee's rhetorical head right off, tonight. He so richly deserves it.]

नमस्ते

[U] Europa's "Warm Water": What We've Learned -- At 2 PM EDT -- From NASA's Hubble Team


UPDATED -- 2:20 PM EDT: Plumes of water and water-vapor, rising perhaps 290,000 feet -- or almost 50 miles -- have been spotted by Hubble, on several occasions in 2014. I'll embed a great updated NASA video -- 2 minutes only -- desribing the science behind all of it, immediately below. I will update my now dated graphic, shortly. But the evidence for the warmth of an undulating water ocean -- well below a sienna colored ice exterior shell -- is now nearly conclusive.

Yet again, the most sublime of celestial epiphanies are fittingly "writ in water" -- the stuff upon which we are all based. It is grin-worthy indeed that verdant life may already reside in Europa's (metaphorical) sloshing motherly womb. Astonishing.



[End, updated portion.]

~~~~~~~~~~~~~~~~~~~~~


In an update to this post, of last week. . . I'll go out on a limb this late Sunday evening/early Monday morning, and guess that Hubble has spied more evidence of warm water -- an ocean of it, in fact -- subsisting below an icy shell, on the Jovian moon, Europa.

In a more fantastical iteration (as I wait for sleep to find me), I might guess (though I've not depicted it, at left) that Hubble has seen a recurrence of the 2012-era Europa surface water geysers -- then likely spouting up to ten times the height of Earth's Mount Everest -- or almost 290,000 feet. It seems some times, that which was "writ in water," cannot be forever restrained, nor even contained.

In any event, we will know it all -- at 2 PM Eastern. Onward, as beneath that deep space long ice-chilled shell, there moves an undulating, warm ocean -- and just possibly, an ocean where verdant life will one day again arise -- and that is truly grin-worthy. . . .

नमस्ते

Interstellar Space Science: China Brings The World's Largest Radio Dish 'Scope Online


It seems that -- for me -- space science is lately filling the void of the slow news trickle, out of Kenilworth. For we know nature simply abhors a vacuum. And this latest piece of news is anything but that. Smile.

Eclipsing Arecibo (in Puerto Rico) in dish diameter (nearly doubling it) -- and completely blowing it away in overall sky coverage -- this is an engineering marvel.

It positively buries Arecibo on sky coverage because, as opposed to being fixed into the mountain-side, this Chinese FAST radio dish can "gimbal" almost 40 degrees, in any direction by altering the shape of its parabolic dish's curve -- thus covering a much wider swath of sky. [But as we all remember from Billy Bob Thornton in Armageddon, it is "a big a$$ sky. . . ."]

In any event, this stretches our ability to look back in time, to much closer to when the Universe was first born. Courtesy my lovely eldest daughter, via National Public Radio:

. . . .Xinhua reports the telescope cost $180 million, and displaced 8,000 people from their homes to create the necessary 3-mile radius of radio silence around the facility. It will be used for "observation of pulsars as well as exploration of interstellar elements. . . ."

[FAST will also be used to search for] interstellar communication signals, [which] could be more simply referred to as searching for intelligent extraterrestrial life. "In theory, if there is civilization in outer space, the radio signal it sends will be similar to the signal we can receive when a pulsar ... is approaching us," Qian told Chinese state media. . . .


Indeed. [And perhaps one day, at least possibly, we might -- with this device -- hear a signal. One that might suggest we are not alone in this Universe. I firmly believe we are not -- but as a scientist -- I'd like even just a small hint, of some proof of that idea. That is also why I'll be watching the Europa news, this afternoon.] Be excellent to one another -- for at least for now -- we are all we know we have.

नमस्ते

Saturday, September 24, 2016

"They’ll see how beautiful I am — and be ashamed — I, too, am America." -- Langston Hughes


Yesterday (by the time most of you read this, as I'm late in getting to it), at around noon-time, our 44th President spoke at the opening ceremony of what is certainly the definitive museum of African American History in these United States.

Like the countless stories of the peoples it documents, this project has traveled a slow and winding road. But now, it is open -- in D.C. -- and I will be there very, very soon to see it, with my own eyes.

As President Obama said, it is, in truth a series of stories that is the story of all of America. I might add that -- though tinged with significantly more adversity -- than the average American narrative, as these interlaced series of narratives unfolded over the last four hundred plus years in America -- astonishingly, far more often than not, they brought glory to all the people of this nation. Despite what the Ohio County Chairwoman (now replaced) for the Trump campaign has said, it is a story of immense successes -- against very, very long odds. Odds long stacked primarily by white men, and this nation's laws, against even a chance to read -- let alone advance. But as the museum's collection well-documents, advance so many did.

I'll choose just a small bit of the material that the White House historians themselves have contributed to the museum, as my imagery at right, and pull-quote focal point, below.

I know those of you with a real thirst for a non-sugar coated version of our history -- American history -- will visit in person. So I'll choose just this one smallish glass case that most of the MSM has overlooked, at least for today:

. . . .[The image is. . . the] Fisk Jubilee Singers, a choir from the Fisk University in Nashville, Tennessee that first opened its doors during the Civil War for former slaves, became the first African American choir to perform at the White House in 1882. . . .

The group was originally organized as a fundraising effort for Fisk University. . . . At several points, the university faced serious financial difficulty. To avert bankruptcy and closure, Fisk's treasurer and music director, George L. White, a white Northern missionary, gathered a nine-member student chorus to go on tour to earn money for the university. On October 6, 1871, the group of students, consisting of two quartets and a pianist, started their U.S. tour under White's direction. They first performed in Cincinnati, Ohio. Over the next 18 months, the group toured through Ohio, Pennsylvania, New York, Connecticut, Rhode Island, New Jersey, Massachusetts, Maryland, and Washington, D.C. . . .

After a concert in Cincinnati, the group donated their small profit, which amounted to less than fifty dollars, to the relief to the victims of the Great Chicago Fire of October 1871. As soprano Maggie Porter recalled, "We had thirty dollars and sent every penny to Chicago and didn’t have anything for ourselves. . . ."

The group was awarded the 2008 National Medal of Arts during the Administration of President George W. Bush. . . .


Lovely. Just. . . lovely. Here we learn more about several young people (at least a few of whom were very likely born into bondage) -- sent out on the road -- to try to keep this now storied Nashville institution of higher learning for people of color from going under, in its earliest days. They likely awoke one morning in October, only to read -- in the Cincinnati papers -- of the Chicago Fire of 1871. And they chose to send every penny on, to relief efforts, without any more self-interested thought.

That my friends is the history of America -- this is no separate history museum -- this IS American history. It is right well and good that the narrative be focused there -- on African Americans. Make no mistake (as the President said) -- this museum also shows us that love of country sometimes includes a need to speak out, when she is wrong -- to address her short-comings. That too is patriotic -- and that too is (as Mr. Hughes wrote). . . America. And we know Mr. Trump would be the polar opposite of all of that. I do trust that HRC completely understands how many voices, sometimes even rightfully discordant voices, are what makes America the great place that it is today. Still flawed, true -- but so much progress. So much. I do love America -- and I respect every story she tells.

नमस्ते

WSJ: China's FDA Now Allowing Keytruda® -- But Only On Its Hainan Resort Island Pilot "Medical Tourism" Basis...


It would seem (per the WSJ, yesterday) that the party elites in China (and I suppose wealthy people throughout Southeast Asia, generally) who can afford to fly to Hainan, and stay on the tony resort island, will now be able to get an immuno oncology agent not yet approved by China's FDA -- for its vast mainland population.

I suppose in the grand scheme of things, Kenilworth's Keytruda® (pemrolizumab) was never going to be offered in a setting affordable, on China's mainland, for perhaps 99.999 per cent of its population. And so in my analysis, the Chinese government has made a decision to keep the elites' spending power inside the confines of the broader Chinese economy on this score. Obviously, but unstated in the article -- if wealthy Chinese oncology patients fly to Australia, Hong Kong or the US -- all that spending power departs the Chinese economy, as they go.

[In this regard, while the hospital itself is required to be 100 per cent non-China owned, all the ancillaries -- the resort hotels, meals, clothing and travel purchases made, while on the island (family included) do clearly benefit some set of these same Chinese party elites, in all likelihood.]

So I suppose it doesn't matter all that much, that the elites will fly to Hainan -- instead of taking their money to Hong Kong. But in my opinion, it certainly reminds the world that there are two systems of health care, increasingly globally now -- the system the elites are able to purchase, out of pocket, and the non-system(s) the rest of the world makes due with. Here is a bit from yesterday's Journal:

. . . .An institution affiliated with Hainan Health and Family Planning Committee announced on its account on the WeChat messaging platform late Thursday that Keytruda will be the first imported drug used in a cancer hospital in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan.

Set up in 2013, the zone sets special rules on foreign investment, such as 100% foreign ownership in hospitals and fast-track approvals for new drugs and medical devices. The hospital gained approval from the China Food and Drug Administration to import Keytruda this March, and will import more foreign cancer drugs based on patients’ need, according to the announcement. . . .


I am not so naive as to think the same sort of rationing doesn't occur world-wide -- and it makes economic sense for Merck to play along -- benefitting its shareholders, but it is an uncomfortable feeling, at bottom, I'm left with: those who have will live longer, and generally better, than those who. . . have not (or have less).

And saying it has always been so, doesn't really make it. . . right. Onward, humbly aware that I am blessed to be as comfortable, and healthy, as I am here. Do go be excellent to one another, whenever you possibly can.

नमस्ते

Friday, September 23, 2016

In Pharma PAC-Land, This 2016 Cycle Has Been Unlike Any In Recent Memory -- In Fracturing Members Of PhRMA


This morning, a local New Jersey outlet is explaining how Merck's PAC (in breaking with prior practice, and locking arms with Lockheed -- another big NJ employer -- and defense contractor) did not contribute to the Republican Fund for its Nominating Convention, in Cleveland in 2016. I obviously think that was not a snub of the city, or the fine people of Cleveland(!), or the RNC generally, as the Merck PAC did donate to lots of both GOP and Democratic Senate and House candidates this cycle. As did Pfizer, to be fair.

No, I think Kenilworth's PAC was expressing an opinion (by its omission) on the nominee, himself. I've used the press report as a springboard for a slightly different (but to me, more interesting and nuanced) story -- comparing Merck to Pfizer, led by Ian C. Read -- and that PAC's 2016 patterns.

As my graphic indicates, Pfizer's PAC showed no such compunction. Which is a bit odd, given that both Presidential candidates call Manhattan home (also Pfizer's HQ location). Near as I can tell, the Pfizer PAC did not donate to the Democratic Convention Fund -- at all. In 2012, Pfizer favored Mitt Romney over President Obama (oops, on that!), in this regard -- while Merck made equalized donations.

If Mr. Read is sending a message to HRC, here -- about her stated positions on pharma price reform measures, I'd gauge that mission as decidedly "ill-starred". I'm on record, and remain so -- HRC will be our 45th President. And Merck is wisely looking to partner with her, in a constructive dialogue.

[Ever one to hedge my bets. . . I'm not all the way down with moving my practice, and relaxed life generally, to Europe for four years, should the Trumpkin prevail -- but I could pretty effortlessly do that -- seriously considering it, only to the extent that he has any plausible chance of being elected. Sheesh.] In any event, here's a bit from the short NJ.com article:

. . . .Merck & Co. and Lockheed Martin, who each gave $250,000 to the host committee helping to stage the Republican National Convention four years ago, kept their corporate checkbooks closed this time around when the party gathered in Cleveland to nominate Donald Trump. [My editorial note: To be fair, the GOP Convention in 2012 was held in an important power-base, for both Lockheed and Merck. Not so, Cleveland. . . .]

The companies were absent from the list of contributors that gave $67.4 million to the Cleveland host committee, according to Federal Election Commission filings. . . .


I'll likely offer a few more of these socio-political out-takes, given that we are now in the home stretch of Election Cycle 2016.

In addition, my masthead pull-quotes will almost uniformly express disdain for the Republican nominee's disrespect for our constitutional rights (except the Second Amendment, of course!), abandoning our core founding values -- of pluralism and inclusion, of peoples from all over the globe. Moreover, I am deeply troubled by Mr. Trump's open hostility to our citizenry of color (praising aggressive "stop and frisk" operations under then NYC Mayor Rudy Guiliani, which have since been held unconstitutional -- as violative of the 14th Amendment's Equal Protection clause -- i.e., it turned out that 83 per cent of those stopped and frisked were people of color -- so Mr. Trump's message here is plain -- and disgusting).

Whew. Even so, I enter the weekend with a crinkle-eyed grin. . . out, for some fun!

नमस्ते

Legacy Schering-Plough Federal NuvaRing® MDL: Next Status Hearing Set For January 18, 2017

We mentioned this was scheduled, last week. The parties were in court for about an hour on September 15, 2016, in the Eastern District of Missouri -- discussing next steps for the distribution of the $100 million, and then the ultimate remand of the opt-out cases and plaintiffs -- to their respective home (originating) districts.

The next date for status was agreed as January 18, 2017.

We will keep an eye on that.

Now you know. Onward -- while smiling broadly, under gray skies, for a coming travel weekend. . . .

नमस्ते

Thursday, September 22, 2016

Jupiter's Europa: NASA Press Conference From Hubble Team, Come Monday; Glitch Repaired -- Back Online


Ahem. As often happens, the pending news from/of Europa has put me in mind of a moldingly old poet, from my catechetical youth. [Trivially, it also seems we are fully back in the saddle, with the live updating (and a mobile enabled) stats interface. Sweet.]

To the mold, then: Edgar Allen Poe doth writ, and read quite well (grin!): "I gazed awhile, on her cold smile" and realized I "more admire thy distant [sienna-hued, golden flecked] fire, than the colder, [closer] lowly light. . . ."

Where was I? Oh. Right. NASA's Hubble team will hold a press conference webcast Monday, about developments observed by the great space telescope -- at Europa. It is widely thought that -- due to the unimaginably immense, completely irresistible and constantly pulling, twisting, mashing and crushing tidal forces of Jupiter's behemoth gravity, tugging on the little shepherd moon -- her moon Europa may in fact be very, very warm, underneath that darkly ruddy-sienna ice shelled exterior. Grin. In fact, it likely supports an undulating, rotating, hot water vented ocean. And all of that is not at all unlike what we expect primordial Earth's oceans were once like.

If you cannot already tell, I am going to be glued to that web-cast -- for any hint of primordial microbes, off-planet. But we will take a deep breath, and take one space science step, at a time.

Until Monday, at 2 PM EDT, then -- here is Poe -- in full (imaged, at right).

And so, we do draw -- day by day -- and mission by mission, inexorably closer to proof that at least microbial life exists off-planet. Even right here, in our local neighborhood. Ever onward we drift -- forward, admiring that fire, from afar. . . a fire driven by the laws of attraction. . . on a celestial scale. Smile. Be excellent to one another. The Goddesses would want it that way.

नमस्ते

Wednesday, September 21, 2016

Unfortunate Technical Glitch: Live Updates Off-Line For A Bit


StatCounter is a great free service. I've relied on it for just over four years, to handle most of my live updating abilities, by mobile phone.

At the moment, that server is returning a "DNS error."

It has been off-line, or only intermittently on-line, since early yesterday evening. So, I've had no live data, since 4:30 PM EDT yesterday.

They hope to have it fixed soon -- but I am flying blind here. Thus updates will be hard to come by -- unless I am seated in a perfect environment. Or unless service is restored to the mobile (i.e., cellular, non-wi-fi) environment.

In the mean-time (continuing my fascination with golden flecked watery lit!), let us ponder the enduring mystery of the epitaph on Keats' headstone (of nearly 195 years past):

. . .There’s no doubt that Keats foresaw his death with brutal clarity. The question that begins in the London Keats House and continues in Rome—both at the Keats-Shelley House and at Keats’s gravesite—is how exactly he felt about that. Surely heartbroken, frightened, frustrated, despairing. But the words that he asked his friends to have carved into his gravestone—only these words, not his name—conjure an enigma: “Here lies One Whose Name was writ in Water.”

Is this epitaph an angry protest against the unfairness of a fate that appeared to have deprived him of a chance of immortality, or an almost zen-like statement of resignation and of the impermanence of all existence
?. . . .

Writ in water, indeed. Onward, just the same. Smiling in the pelting rain.

नमस्ते

Tuesday, September 20, 2016

Irregular Merck Update Teleconference: SUNDAY October 9, 2016, 12:30 PM EDT, In Copenhagen -- Accommodating EU Schedules


I will not cover this, as I will be off-grid on that day, and at that time, at an Iron Man, down South (cheering on, not competing -- not yet!), but this one might be worth a listen.

During this call, Kenilworth will take analysts' questions, and press questions, and host listen-ins, as it walks through the new information on immuno-oncology it will offer, at an important European medical conference called ESMO. Here's a bit, from Yahoo Finance, just a moment ago:

. . . .Merck, known as MSD outside the United States and Canada, will host a teleconference for investors following the presentation of data at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark, Oct. 7 – 11. The call will take place on Sunday, Oct. 9 at 6:30 p.m. CEST (12:30 p.m. EDT). Company executives will provide an overview of data presented and address questions. Investors, journalists, and the general public may access a live audio webcast of the call on Merck’s website. . . .

Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 84673546. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 84673546. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call. . . .


Now you know. Onward, on a gorgeous Tuesday morning here. . . .

नमस्ते

Monday, September 19, 2016

A Small Word Of Encouragement -- To The Middle Division's Young Scientists, At Berkeley Prep -- In Tampa, FL...


I used to see these sorts of "educational" traffic spikes, more often around five years ago -- but this will be the first time I've publically remarked on them.

I am doing so, solely to encourage all the young government studies students, and budding pharmaceutical scientists out there, researching for credible blog information on drugs and biologics policies, to keep at it.

The assignment (as your web site materials suggest) is to find blogs that seem unbiased, reliable and documented by research. We hope we fit the bill, on those scores. Smile.

So, here is to all of you -- not just in Tampa, but nationwide -- and in fact world-wide: you young women and men, you who will lead us all into the future -- use your time in class, and out of it, wisely -- make great friends, and make a difference in your communities. Know that we here are rooting for you, to be even more adept scientists, and policy makers, than those out practicing today. Thanks for visiting, and now go do well, in writing up the results of your research. We are proud of you.

नमस्ते

After Striking A "Pay For Delay" Deal With Lilly -- On Lantus® -- Sanofi Now Sues Merck For Infringement: MK-1293


Since early 2014, we'd been watching, and waiting very patiently -- as Merck's MK-1293 candidate was added to the Samsung Bioepis JV mix, and the pair took aim at Sanofi's space in diabetes. Since then, however, Sanofi had sued Lilly for patent infringement, and then settled in early 2016 -- effectively creating a "pay for delay" deal, on a biosimilar version of its insulin glargine construct until at least Christmas 2016, with Lilly, in cahoots.

In August, Merck filed at the US FDA -- on MK-1293 -- its Samsung-partnered biosim version, which might otherwise allow for an as early as Q1 2017 launch date.

So, this morning, it is no surprise to learn that Sanofi has now sued Merck in the federal courts in Delaware, claiming MK-1293 infringes several of Sanofi's Lantus® patents, as well. Thus the Sanofi suit. [This whole convoluted dance is exactly what was contemplated by the Hatch-Waxman amendments to the patent process. Except that US House Reps. Hatch (R) and Waxman (D) did not expect that branded manufacturers would pay to keep biosimilars off market. Oh well -- that's unbridled capitalism at work. Enough editorializing, right? Right.]

Here's a bit -- from The Wall Street Journal, this morning:

. . . .The French drugmaker’s all-important diabetes business is under siege, as a flurry of pharmaceutical companies seek to sell knockoffs of its blockbuster insulin Lantus in the U.S. The expected launch of lower-cost copies of Lantus and growing pricing pressure on diabetes drugs in the U.S. is rapidly eroding earnings at Sanofi’s diabetes division, which accounts for about 20% of the firm’s total revenue. . . .

In January 2014, Sanofi filed a suit against Eli Lilly & Co. to defend its patents on Lantus. It had reached a deal with the U.S. drugmaker nearly two years later, under which Lilly agreed to delay the launch of its insulin to December 2016 and pay royalties to Sanofi. . . .


With the election cycle in full swing, expect to hear only crickets about how some large multinational life-science companies effectively game the system, to keep cheaper generics (and biosimilars, in this case) off-market for years at a time.

Now you know. Onward -- on a sunny Chicago morning.

नमस्ते

Nurse Pauline Cafferkey: Hero -- In Scotland, And Sierra Leone...


I've held this one for Monday morning, to be sure it gets its full and fair due, from all who look in primarily from their office computers.

Make no mistake: Pauline Cafferkey is certainly an international hero. True -- many, many people risked their lives to end the latest Ebola outbreak in Western Africa, but few were so deeply affected by their efforts, personally -- and I can think of none who were then "hung out to dry" by their own home nation, nearly a year after returning. [And still she waits for her bonus.] Here is a bit, from the Sunday Guardian in London:

. . . .Last week Cafferkey was cleared of all wrongdoing by the Nursing and Midwifery Council, but critics have questioned why she was ever brought before the panel when it transpired there was no case to answer.

“I should have been sent to the infectious diseases unit from Heathrow – not allowed to get in a plane to Glasgow. The minute they let me fly they put the health of the public at risk,” she said.

She spent a month fighting for her life in a special unit in the Royal Free hospital in London before being discharged, apparently free of Ebola. Nine months later she relapsed as the virus had not cleared from her nervous system and she was back at the Royal Free with meningitis triggered by the virus. . . .


So -- here is a heart-felt Irish toast to the true health care heroes -- the volunteers, who march right into the path of the storm, where so many others cower in fear. Here's to Scottish Nurse Pauline Cafferkey. Let history (from this past Thursday, onward) record that she is a true international hero. Onward, indeed. Would that we were all so brave, and perserverant.

नमस्ते

Sunday, September 18, 2016

Of Martin Shkreli, "Properly Weighed" -- Connecting The Bi-Coastal Federal Court Filing(s) Dots [Legacy Schering-Plough Executive Echo]...


Ahem. I've recently been prevailed upon, to open yet another side project -- an occasional look at the manifold problems Mr. Shkreli has created at at least three life sciences companies. You may follow it, here.

As often is true -- the longer you live -- the more history tends to rhyme, if not outright echo, at least in the canyons of public companies involved in the life-sciences. And that is why I'm cross-posting it here. You see, Dr. Thomas P. Koestler, of legacy Schering-Plough, is suing in federal court, in Manhattan, to enforce an arbitration award against Mr. Shkreli -- for shares he says he was owed. So, consider this -- as on topic here:

. . .I'm up a little early this perfect Sunday morning, and noticed that as of Friday night, in the federal District courthouse in Brooklyn, Mr. Shkreli's criminal defense attorney had requested a so-called "Bill of Particulars" from the US Attorneys prosecuting his client on eight felony fraud counts -- including criminal securities fraud and wire fraud.

This makes a nearly perfect springboard to (reasonably) speculate that -- in fact -- Dr. Koestler is one of the witnesses the AUSAs intend to call at trial -- about Mr. Shkreli's (allegedly criminal) securities "parking" schemes.

As of Friday, Mr. Brafman is essentially asking the able judge to order the government to "get specific" -- and identify particularly which specific pages (out of a supposed several million), and which people (as witnesses). . . and which transactions (likely including those with Dr. Koestler) are going to be the subject(s) of the US Attorneys' proof of the felony indictments, at trial. Here is that Friday motion in full (as a PDF file).

These latest three filings (two of which are linked in the last two posts, respectively) convince me that PathoPhilia is spot on, when she posits that Dr. Koestler was in fact an early investor in, and was personally promised shares by Mr. Shkreli, individually, in the pubic company that became Retrophin, when it began trading, by means of a complicated reverse merger.

Having practiced securities law for now over 30 years, I can say without reservation that I cannot imagine how (outside of a purely charitable gift -- to the NAACP, UNCF or a local AME church) Dr. Koestler's transactions, as described in this SEC filed Retrophin link at pages 30 and 31, and embodied initially in a "Transfer and Donee Representation Letter" ever represented a legitimate for profit commercial transaction. At least not as would be contemplated in a "Donee representation letter".

I have said openly here and elsewhere before that I am fairly suspicious of Dr. Koestler -- for good reason. In this case, I think his well-documented (but still largely alleged) greed allowed him to be used as a dupe. A dupe for Mr. Shkreli.

The "donee" here would have been Dr. Koestler -- and why Mr. Shkreli would "donate" shares to him, for actual "for profit" consulting work, at Retrophin -- is a complete mystery. In fact, I can state affirmatively that in my 30 plus years in the life sciences doing deals, as a securities lawyer, I have never seen -- nor would I allow -- my client, whether a company CEO, or a scientific consultant to be "gifted" equity -- for any actual services to be performed, for the company involved.

You see, gifts are voidable. Contracts with incentive equity, far less so. That's safer -- for everyone. And it would be almost unheard of for the CEO (here, Mr. Shkreli) to use his personal share count to "pay" a consultant -- unless the consultant (here, Dr. Koestler) was NOT working for the company's interests -- and was only working for the CEO's interests.

In which case, that fact was required to be disclosed under SEC Reg S-K, in the Shkreli era Retrophin SEC filings -- as a "related party" transaction (note pages 93, et seq.) -- and as a potentially conflicted interests transaction.

It was not so disclosed.

So we are back to Square One: This whole transaction with Dr. Koestler smells to high heaven (in my opinion). And it very likely makes for some great proof, for the able US Attorneys, in Brooklyn. It will be entertaining to watch whether the US Attorneys try to paint Dr. Koestler as yet another in a long line of unwitting dupes of Mr. Shkreli's, or as something more sinister. Afterall, Dr. Koestler has held at least ten high ranking public and private life-sciences positions -- as our prior graphics here and at the legacy Schering-Plough site have documented.


Now you know. Onward.

नमस्ते

Friday, September 16, 2016

O/T: As A Harvest Moon Rises, Over The City's Steel And Glass Canyons...


I find myself awash in watery reflections, as I watch her float silently, slowly and gracefully upward, unconstrained by any observable celestial limit, this late evening. . .

The memories come thick as snowflakes, three months hence. . . and I am grateful. Eternally. . . grateful.

Under the Harvest Moon

Under the harvest moon,
When the soft silver
Drips shimmering
Over the garden nights,
Death, the gray mocker,
Comes and whispers to you
As a beautiful friend
Who remembers.

Under the summer roses
When the flagrant crimson
Lurks in the dusk
Of the wild red leaves,
Love, with little hands,
Comes and touches you
With a thousand memories,
And asks you Beautiful, unanswerable questions.

-- Carl Sandburg (1905)


So, sometimes, the physics of shepherded moons, should yield to the. . . mysticisms, of my youth. This is one of those times. Now you know. And she does, too. . . G'night, all.

नमस्ते

Q.: Will President Obama's Closing Of Yet Another US Corporate Tax Loophole Impact Merck's US Effective Tax Rate?


Yesterday, the US Treasury issued a statement finalizing the closing of the so called tax "splitters" loophole.

In short, the IRS rules used to permit US based companies to take a partial credit (against their US tax liabilities) on the taxes paid to foreign tax authorities, for income earned there -- without regard to whether those companies actually returned the foreign earnings to US soil in cash (and paid the repatriation taxes here). As one might imagine, many, many byzantine exceptions and qualifiers applied to that rule. [Just a bit of our 2013 era coverage of this meta-narrative -- on taxation of behemoth global companies -- is available under that link.]

Reading Merck's last two definitive SEC filings on the matter, it is not possible to discern whether Kenilworth took advantage of the so-called "splitting" rules, to lower its US tax rate. We do know that Apple has done so -- and is now concerned about how its Irish tax penalty fight will play out under this new US Treasury rule. That is, Apple may not get the benefit of having paid those lower Irish taxes, unless it pays the EU mandated higher rates, now in full (in order to claim a partial credit here in the US, for unrepatriated foreign earnings).

We will have to watch and see whether Merck and Pfizer and the other biotech- and pharma- (and tech-) majors are in a similar position now -- as a result of the closing of the Treasury "splitters" provision. Here's Reuters on it:

. . . .Acting shortly after a European Union grab for billions of dollars in back taxes from Apple, the U.S. Treasury said it was tightening restrictions on companies' use of foreign tax credits to reduce what they owe in U.S. taxes.

"We are closing another tax loophole that contributes to the erosion of our tax base," Treasury Assistant Secretary for Tax Policy Mark Mazur said in a statement.

The fight for multinational tax revenues escalated on Aug. 30 when the EU ruled Ireland was giving improper state aid to Apple in the form of a deal for low taxes. The EU ordered Apple to pay Ireland 13 billion euros ($14.6 billion) in back taxes, prompting U.S. Treasury Secretary Jack Lew to express concern the EU ruling could undermine the U.S. tax base.

Analysts have speculated whether Apple would be able to cut its U.S. tax bill by claiming foreign tax credits for its extra tax bill in Ireland.

Under normal circumstances, U.S. companies can reduce the taxes they owe the U.S. government by the value of the tax credits they claim for taxes paid abroad on foreign profits. No U.S. tax is due on those profits until they are brought into the United States, or repatriated.

The new rule will prevent companies faced with back tax bills from "splitting," a strategy that allows companies to bring foreign tax credits into the United States without repatriating the income from which they were derived. . . .


We will, of course, keep a weather eye on the horizon on this, as Merck likely now (as of Q3 2016) has over $70 billion parked overseas. Whoosh -- a busy weekend ahead! With huge overnight smiles, as my Cubbies have now clinched -- and and a fond remembrance of four years, now-passed. . . . grin worthy, indeed.

नमस्ते

Thursday, September 15, 2016

YAWN. Yet Another Continuance -- Merck Vs. Merck Federal Lanham Act Name Fight Likely To Settle, Before Trial


Yes, I still strongly suspect a settlement will emerge, and long before trial, here.

As I've said consistently for several years, here -- the two companies ought to update and restate their global agreement(s) -- on naming rights, to take into account the realities of a largely borderless internet enabled 21st Century economic landscape.

And so, as each did last week, the parties are delaying yet another of the routinely scheduled status hearings, overnight, here -- purportedly due to scheduling difficulties -- but this date has been on the books since at least April 2016 (hmmm. . .) -- so I continue to smell the distinctive odor of settlement, wafting on the fall breeezes. Here's the letter text, filed overnight in the federal District Court in New Jersey:
. . . .We, along with Debevoise & Plimpton LLP, represent Defendant, Merck KGaA, in the above matter, and write jointly with McCarter & English, LLP and Hogan Lovells, LLP, counsel for Plaintiffs, Merck & Co., Inc. and Merck Sharp & Dohme Corp., to request that the Rule 16 Conference currently scheduled for October 7, 2016 at 10:30 a.m. be adjourned to either the afternoon of October 17, or October 18, or 24, 2016. We make this request because of schedules of counsel involved in this case.

If this is acceptable to the Court, we request that Your Honor "so order" this letter with the new date and time for the Rule 16 Conference and enter it on the docket.

If the proposed dates are unacceptable to Your Honor, please let us know some alternate dates.

Thank you for your courtesies and consideration. . . .

[Signed by a Blank, Rome partner]


Now you know. Onward. G'mornin' to all the telecommuters out there. . . smile. . . .

नमस्ते

Thirty Five Years Ago. . . This Day -- First Woman Justice Of The US Supreme Court


That Justice O'Connor chose to stand down -- to take care of her then ailing husband (now deceased) tells us as much about her character, as do any of her many published decisions.

Remember, she was (arguably, at least) one of the nine most powerful lawyers on the planet, at the height of her estimable gravitas -- and yet chose to spend her husband's last days with him, primarily as his care-giver, and companion, in Arizona.

For those unaware of her judicial legacy, this link may serve as a nice thumbnail. I disagreed with many of her published opinions, but I did find that her writings, after she left the court, were helpful in illuminating her reasoning. And in particular, her thinking on the Michigan affirmative action cases now makes a little more sense to me.

Let us next hear from the ever-cogent Dahlia Lithwick -- in an earlier SCOTUSblog.com forum on Justice O'Connor's legacy -- as compared to the one Justice Kennedy is still writing for himself:

. . .It seems to me that the difference between Sandra Day O’Connor and Anthony Kennedy as swing voters comes down to two principal questions: how they swung; and on what issues.

O’Connor was unpredictable, certainly, but one always had the sense that her objective was to fix a specific problem; to stake out a middle place, a central position, that would bring together the court’s more extreme visions around her own moderating solution. Even when her proposed tests in religion, affirmative action, and abortion cases felt forced and slightly random to her critics, she was groping for the workable fix. Kennedy similarly finds that middle ground, but his purpose seems to be less to fix things than to lay markers for future cases. Kennedy uses his swing vote to make fierce and high minded pronouncements on fairness and justice and freedom. O’Connor used hers to try to get the trains back on schedule.

O’Connor was also inclined to swing left more often and on more issues, she just did it in a smaller way. She was the crucial fifth vote with the court’s liberals on campaign finance, abortion, religion, and affirmative action. In fact court watchers always marvelled at the ways in which O’Connor’s swing votes tracked public opinion. She somehow voted the polls, at least on hot-button issues. Kennedy is harder to predict and harder to track. Yet it was Kennedy who voted with the court’s liberals on a major gay-rights case and Kennedy who voted with the left to do away with the death penalty for juveniles and the mentally retarded. It’s also Kennedy that does so with an eye to foreign law and what the rest of the world is thinking. That’s why it was Kennedy who was deemed by conservatives “the most dangerous man in America” and targeted for impeachment. Studies show that O’Connor listed leftward on gender and family issues where Kennedy tilts right. Yet Kennedy will vote with the liberals on physician assisted suicide, gay rights, prison overcrowding (“dignity” issues). O’Connor just wanted things to make sense, at least for the one case before her. Kennedy wants things to be just, at least for the rest of human history. . . .


That rings true to my ear. So today, as I sign off -- I'll simply salute her -- as a trailblazer in the same way Hillary Clinton is, this election cycle -- the first, in what we hope will be a long line of many more.

Here's to Sandra Day O'Connor.

[I am wondering whether Merck will ever do anything truly news-worthy in the month of September, now.] Smile.

नमस्ते

Wednesday, September 14, 2016

Fourteenth Librarian Of Congress Sworn In Today -- Carla Hayden: First Woman; First African American


[We plan to feature another first, in the morning, right here as well -- and that will be a look back, thirty five years on, at USSCt Justice Sandra Day O'Connor's swearing-in ceremony.]

But today, in a separate first, Chief Justice John Roberts moments ago presided over another swearing-in -- this time, of the 14th Librarian of Congress -- she is a former long-time champion for the Baltimore Public Library system. She also happens to be the first African American to serve -- since its founding in 1800 -- as the Librarian for the largest (paper) library on the planet -- the Library of Congress. Here is a bit, from local news coverage, this afternoon:

. . . .Hayden becomes the first woman and the first African-American to serve as the Librarian of Congress.

"People of my race were once punished with lashes and worse for learning to read. And as a descendant of people who were denied the right to read, to now have the opportunity to serve and lead the institution that is the national symbol of knowledge is a historic moment," Hayden said at the ceremony.

Hayden has been a champion for Baltimore's Enoch Pratt Free Library for 23 years. She has poured her heart and soul into the city's libraries, leaving a lasting legacy. . . .


Now you know. Smiling broadly -- ear to ear, here -- so much going on -- just so very little of it related to the life sciences, directly. But it happens that way, from time to time. . . grin.

नमस्ते

A Relief-Inducing Epilogue: Scottish Nurse Pauline Cafferkey Cleared Of All Charges; Bonus Due


You may recall that we've been following the arc of her improbable recovery story, as an off-shoot of our coverage of the most-recent African Ebola crisis. [The vaccine used there, with unwavering success, you'll recall, is a Merck product.]

This morning (London-time), sanity made a comeback, and the British health authorities ruled that a feverish, nearly non-conscious nurse could not (even if we were to affirmatively discredit all the eye-witness accounts) have formed the requisite mental state to "dishonestly deceive" UK health authorities (who themselves admit -- they did not follow their own procedures, in deciding to allow her to travel onward, with what turned out to be an Ebola-related fever).

From this morning's Guardian (UK) story, then -- just a bit (do go read it all):

. . . .Pauline Cafferkey has been cleared of professional misconduct by a panel at the Nursing and Midwifery Council (NMC) in Edinburgh following an investigation into her return to the UK after contracting the Ebola virus.

The panel ruled that Cafferkey’s judgment had been so compromised by her developing illness that she could not be held responsible. . . concluding: “In your diminished medical state you were swept along by events.”

Describing Cafferkey as an experienced nurse, the panel concluded she would not have acted against her training unless her judgment had been seriously impaired.

“There was no evidence that you set out to mislead Public Health England by allowing an incorrect temperature to be recorded,” the ruling said. . . .


One would hope that this finding will clear the path to her now long delayed receipt of that £4,000 she is owed -- for having volunteered, and heroically-so, in Sierra Leone. Smiling, but slightly puzzled here (over overnight developments), in the city of big shoulders, as I prepare to walk in under cloud dappled skies. . . Onward!

नमस्ते