The 14th Amendment's Equal Protection Clause, Reinvigorated: A Joyful Noise, Arises!

As I predicted, there is, in the U.S., henceforth -- an inalienable right for children of same sex couples -- to enjoy the full measure of inheritance that a lawful marriage confers. If nothing else, a just society should not penalize children for how their parents came to love one another.

And thus -- this is on topic, for a health care blog. We celebrate!

. . . .The nature of injustice is that we may not always see it in our own times. The generations that wrote and ratified the Bill of Rights and the Fourteenth Amendment did not presume to know the extent of freedom in all of its dimensions, and so they entrusted to future generations a charter protecting the right of all persons to enjoy liberty as we learn its meaning. When new insight reveals discord between the Constitution’s central protections and a received legal stricture, a claim to liberty must be addressed. . . .

The fundamental liberties protected by this Clause include most of the rights enumerated in the Bill of Rights. See Duncan v. Louisiana, 391 U. S. 145, 147–149 (1968). In addition these liberties extend to certain personal choices central to individual dignity and autonomy, including intimate choices that define personal identity and beliefs. . . .

The idea of the Constitution “was to withdraw certain subjects from the vicissitudes of political controversy, to place them beyond the reach of majorities and officials and to establish them as legal principles to be applied by the courts.” West Virginia Bd. of Ed. v. Barnette, 319 U. S. 624, 638 (1943). This is why "fundamental rights may not be submitted to a vote; they depend on the outcome of no elections. . . ."

Onward -- from sunny California! [Please forgive formatting glitches -- all posted by iPhone.]

UPDATED -- 06.27.2015 No matter what the dissenters wrote, the Constitution was intended to be a living document, that liberated and yet protected the people in ways the founders had not yet imagined. So do not buy the suggestion that if the founders didn't think of it, as a right -- it does not exist. [Consider that many founders "owned" other humans, and yet here we are.] So this right to marry is just the embodiment of a general principle, made clear by passing history. And our Union is more closely perfected, thereby:

SCOTUS Watch -- ObamaCare Upheld! 6 to 3!

There will only be opinions in two cases announced today. More soon.

But -- with all due modesty -- I told you so. Any person in any exchange is eligible for federal subsidies. Not just those created by the states, separately. The President's health care reform measures are. . . constitutional. Again. Hopefully the tea partiers will stop -- with these nonsense appeals. I buried my lead, here, earlier -- this is VERY GOOD NEWS for Kenilworth, as the nationwide insurance subsidies' availability will drive significant new drug sales -- for all of pharma. From Scotusblog.com just now:

. . . .Buzzer has sounded -- two boxes today. . .

First opinion: Fair Housing -- Court holds that there is a disparate impact claim under the FHA as a matter of statutory interpretation, but it the Court cautions that remedial orders in disparate impact cases that impose racial targets or quotas could be unconstitutional. . . .

Second opinion: Decision of the Fourth Circuit is affirmed in King v. Burwell. 6-3 . . . .

Majority opinion: "Congress passed the Affordable Care Act to improve health insurance markets, not to destroy them. . . . In this instance, the context and structure of the Act compel us to depart from what would otherwise be the most natural reading of the pertinent statutory phrase. . . ."

Quite so. Onward -- to the plane -- and California, now!

Ed -- at Pharmalot 3.0 -- Catches Up To Our Fosamax® Femur Fracture MDL Post -- Of Last Week

My buddy Ed is on this -- using the New jersey Law Journal feed for his squib -- in the Wall Street Journal.

As our readers know, we had this last weekend, on Saturday morning. It happened last Friday.

. . . .A federal judge in Trenton, N.J., dismissed the last remaining 570 cases [Editors' NOTE: Femur Fracture Cases ONLY] in multidistrict litigation over Merck’s osteoporosis drug Fosamax, but the cases could be reinstated if plaintiffs win an appeal pending before a federal appeals court, The New Jersey Law Journal writes. . . .

So it goes. Onward. Ever, and ever. . . onward.

Something. . . Wonderful -- Perfect, In Fact -- From 2009

Tonight, I'll simply reprint my December 6, 2009 post -- from long before the latest travails. And. . . this update belongs here because henceforth, the Merck Manuals will be digital only.

There will be no more printed versions -- after over 100 years. And that's the kind of change -- that's a good thing. Onward.

December 6, 2009: I spend a lot of time on this blog scrutinizing the moves of New Merck (as the successor-in-interest to Schering-Plough, as of November 4, 2009), but this -- I must say -- is at least one thing that Merck has gotten absolutely right.


Perfect, in fact.

For a year or so now, Merck's Manual has been available as an application for PDAs. The iPhone version is both beautiful, and elegantly functional. [The image above is courtesy AgilePartners; you may puchase it there as well -- via this link.] Having it around, in digital form, at a moment's tap, whether one is in the high Andes, in the rolling hills of northwestern Ireland, or the deserts of Arizona -- or even on the southern tip of Florida Keys -- is far easier than traveling with that hard-copy, wonderful, but weighty tome in tow.

So -- well done, Merck -- spot on! Highly recommended:

. . . .Based on the world's most widely used textbook of medicine—The Merck Manual—but written in everyday language by 300 outstanding contributors. . . .

Not entirely unrelated aside: The New York Times is running a very long article this afternoon -- on how Apple's App Store has so completely overwhelmed older methods of distribution -- that now each competing smartphone (or software platform) is offering its own App Catalog (Palm; WebOS), Windows Marketplace for Mobile (Microsoft; WindowsME), Android Marketplace (Google; Android) and Owners' Lounge (Blackberry; RIM).

And each of these is sure to soon have (or already does have) the Merck Manuals in smartphone-accessible forms. Well, nothing exceeds like. . . excess, eh?

And so. . . all of life. . . is about moving toward -- or away -- from something, or someone. I'm. . . out.

No ObamaCare Opinion -- From The Supremes. . . Yet. Maybe This Thursday.

The issued opinions have all been unboxed, opened, and read -- in paper format, this morning (yes the Supremes are still very. . . old school) -- and no decision in King v. Burwell was in those boxes. So, Christmas morning is still as much as week off, yet.

There may yet be a bonus opinion day, later this week. UPDATED: Thursday of this week will be the "bonus" day. Oh well. I'll be off-grid, on an airplane. Or we may get the decision on next Monday the 29^th -- also while I'm off the grid. In any event, I still confidently predict an ObamaCare win -- authored by Chief Justice Roberts, with Kennedy joining the usual four who will support it. So I see it as a 6-3 decision.

. . . .Opinions this term still left unpublished: Texas Fair Housing Act, Arizona redistricting commission, King v. Burwell, Michigan v. EPA, Johnson v. US, Obergefell v. Hodges and Glossip v. Gross. . . .

Amy Howe (at Scotusblog.com): There will definitely be orders on 6/29; I would be surprised if there weren't opinions on the 29^th as well, because it's hard for me to imagine that they would release all seven remaining opinions on Thursday. . . .

Do stay tuned. Onward.

The End Draws Nigh, For Fosamax® Femur Fracture MDL Claims -- Materially Good News For Merck

We have expected this, for quite a while now. The femur claims (as distinguished from the ONJ ones) MDL is likely to come out as a complete win for Merck -- we have been following it since 2010.

I post yesterday's ruling so that the kind and gentle folks following the federal Propecia^® MDL litigation will be able to see -- by analogy -- how important the label warnings have become, after the Supremes decided Wyeth v. Levine. From the full order, then (an 18 page PDF file):

. . . .On March 26, 2014, the Court entered judgment as a matter of law dismissing the claims of hundreds of Plaintiffs who allegedly suffered femur fractures prior to September 14, 2010 on preemption grounds. See In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., MDL 2243, 2014 WL 1266994 (D.N.J., Mar. 26, 2014) (the "Preemption Ruling"). The Preemption Ruling is now on appeal to the Third Circuit. . . .

On June 17, 2014, the Court granted summary judgment in favor of Merck in the Gaynor case and found that the 2011 Fosamax warning regarding atypical femur fractures is adequate as a matter of law because it "is accurate, clear, consistent and as a whole conveys a meaning that is unmistakable as it relates to AFFs." Gaynor v. Merck Sharp & Dohme Corp., Nos. 12-1492, 08-08, 2014 WL 2738224, at* 11 (D.N.J. June 17, 2014). The Gaynor Plaintiff has appealed this ruling to the Third Circuit. . . .

Following the dismissal of Gaynor, the PSC advised the Court by letter and during telephonic status conferences that to the best of their knowledge no Plaintiff is alleging that the 2011 Fosamax label was a proximate cause of his or her injuries and that the adequacy (or inadequacy) of that label has not been placed at issue by any Plaintiff. On November 5, 2014, the Court ordered those Plaintiffs whose cases had not previously been dismissed by the Preemption Ruling and who claim that the warning about AFFs in the January 2011 Fosamax label was inadequate and a proximate cause of their alleged injuries to show cause why their claims should not be dismissed in light of the prior rulings by the Court (the "November 5, 2014 Order")(Dkt. 3927). The November 5, 2014 Order further provided that if any Plaintiff did not make such a claim, then they would be forever barred, precluded, and estopped from claiming that the January 2011 Fosamax label was inadequate and a proximate cause of their alleged injury. . . .

[T]he Court has determined, after consultation with the PSC, that the claims of all remaining Plaintiffs in this litigation are based on the alleged inadequacy of the pre-2011 Fosamax label. Because the adequacy of the pre-2011 Fosamax label is the issue currently being decided [on appeal] by the Third Circuit, the decision on appeal will determine whether the claims of the remaining Plaintiffs in this litigation (identified in Appendix I hereto) remain viable or not. Consequently, IT IS on this 19th day of June, 2015, ORDERED that the claims of all Plaintiffs listed on Appendix I against Merck are hereby conditionally dismissed without prejudice pending the decision by the Third Circuit on the appeal of the March 26, 2014 Preemption Ruling. . . .

So it goes. So too -- on a cool, quiet Saturday -- we are actually quite melancholy -- about the lunacy of white domestic terrorists/supremecists our nation's NRA lobby refuses to address in any constructive way. But the mouthpieces for the NRA are first to the fore, when the terror threat is browner, or not born on our soil. Ironic -- and tragic. Will the NRA condemn these latest photos of Mr. Roof spitting on, and burning, the stars and stripes? I won't hold my breath. In fact, one NRA board member blamed the pastor of Mother Emanuel -- for the death of the other eight church-goers. That puts NRA Board member Charles Cotton on a par -- with the terrorist, himself -- in my view. I won't repeat the tortured reasoning by which Cotton justified his deplorable libel.

At least on Father's Day, please be better to one another than this. Please. . . .

Say A Prayer For Charleston. . .

UPDATING | 06.19.2015: It looks as though this massacre was not just a hate crime, but also domestic terrorism. It seems completely improbable to think that Dylann Storm Roof was unaware that he had chosen the evening of June 17 to commit this particular act of terrorism, at this particular church -- a clear ringing, of the bells of historical memory -- all the way back, to 1822. From today's New York Times, then -- a bit:

. . .So, meeting in [founding lay pastor and former slave Denmark] Vesey’s Bull Street home and within the walls of the Emanuel [AME, the place of this current massacre], Vesey and his lieutenants called for domestic slaves to kill their masters in their beds and fight their way to the docks, where they would seize ships and sail south. Originally, the plan was set for July 14, 1822 — Bastille Day — but the plot began to unravel, and Vesey moved the plans forward to the night of June 16. The uprising would begin when the city’s churches tolled midnight, meaning that the actual black exodus out of Charleston would take place on June 17. [The revolt failed, and Vesey paid for it with his life, as did 34 others -- and 34 more were deported from the country.] Either the shooter in Charleston yesterday knew the importance of this date, or the selection of June 17 was a ghastly coincidence. . . .

The depravity of the 21 year old Mr. Roof is completely unfathomable, to my mind, at least.

Jon Stewart is. . . spot on:


END, UPDATED PORTION.

We will fall silent this day. We may return tomorrow -- hoping that all people of good will seek both answers -- and justice.

From our 44^th President's reflections, on the hate crime -- just now:

. . .Mother Emanuel is, in fact, more than a church. This is a place of worship that was founded by African Americans seeking liberty. This is a church that was burned to the ground because its worshipers worked to end slavery. . . .

When there were laws banning all-black church gatherings, they conducted church services in secret. When there was a nonviolent movement to bring our country in closer line with our highest ideals, some of our brightest leaders spoke and led marches from this church's steps.

This is a sacred place in the history of Charleston and in the history of America. . . .

At some point, we as a country will have to reckon with the fact that this kind of mass violence does not happen in other advanced countries. It doesn't happen in other places with this kind of frequency. . . .

It is in our power to do something about it. . . .

Sadly, so true. . . Pax tecum one and all.

Why Merck MAY Be "Of Two Minds" -- About The Pending TPP "Fast Track" Measures

At the outset, let's note that a blog post (like this one!) is almost certainly not the best format, or forum, for a breezy top-level discussion of a complex, manifold international trade agreement.

But let's take a stab at it anyway, shall we? Yes, let's. We all know that Merck (like Pfizer, Lilly, GSK and AZ) makes far more from its branded pharmaceuticals and biologics, than it ever will from its "authorized" generics -- even taking into account the huge market opportunities in the BRIC nations -- India, Russia, China and Brazil -- for example. However, Kenilworth has acknowledged that some medications -- like sitagliptin in India for the 63 million diabetics there -- need to be made more affordable to the common people of India. So Merck has an arrangement with Sun Pharmaceuticals -- to make the non-branded version of Januvia^®/Janumet^® available, at a relatively modest discount.

Here is the rub, though -- others, including Glenmark and Aprica, are making non-authorized versions in India, creating havoc for Merck's branded efforts. Now, enter TPP -- a measure Merck has been staunchly supporting -- as has PhRMA -- because it will give the branded producers greater ability to knock out these unauthorized generics, and bio-similar manufacturers.

I write this morning then, to simply point out that this might come at the expense of some existing revenue streams Merck already enjoys. Those being the authorized generics, around the globe -- so, as I say, Merck may be of two minds about the fast track. And, in a bit of grandstanding here -- I do think it is fair to say that TPP is less about open trade, and more about forcing trading partners to respect patents, trade secrets -- and yes, trademarks. [That is -- of course -- why big tech is also so intently throwing money behind TPP passage, as well -- in my estimation. And that is not inappropriate, in my view -- as an end goal. I just think we should have a more candid, and open debate about the notion that TPP is more about property rights protection, than free trade.]

In any event, the below quoted bit would put real teeth into IP protection in the countries signatory to TPP -- making the TRIPS 2005 protections the law -- in all of them. This is from the leaked "IP protections" portion of the TPP bill, then:

. . . .Each Party shall notify the WTO of its acceptance of the Protocol amending the TRIPS Agreement done at Geneva on December 6, 2005.

5. Each Party shall make all reasonable efforts ratify or accede to the following agreements by the date of entry into force of the Agreement:

(a) Patent Law Treaty (2000); and

(b) Hague Agreement Concerning the International Registration of Industrial Designs (1999).

6. A Party may provide more extensive protection for, and enforcement of, intellectual property rights under its law than this Chapter requires, provided that the more extensive protection does not contravene this Chapter.

7. In respect of all categories of intellectual property covered in this Chapter, each Party shall accord to nationals*1* of the other Parties treatment no less favorable than it accords to its own nationals with regard to the protection*2* and enjoyment of such intellectual property rights and any benefits derived from such rights.

8. A Party may derogate from paragraph [7] in relation to its judicial and administrative procedures, including requiring a national of the other Party to designate an address for service of process in its territory, or to appoint an agent in its territory, provided that such derogation is:

(a) necessary to secure compliance with laws and regulations that are not inconsistent with this Chapter; and

(b) not applied in a manner that would constitute a disguised restriction on trade.

9. Paragraph [7] does not apply to procedures provided in multilateral agreements to which any Party is a party and which were concluded under the auspices of the World Intellectual Property Organization (WIPO) in relation to the acquisition or maintenance of intellectual property rights.

10. Except as it otherwise provides, including in Article __ (Berne 18/TRIPS 14.6), this Chapter gives rise to obligations in respect of all subject matter existing at the date of entry into force of this Agreement that is protected on that date in the territory of the Party where protection is claimed, or that meets or comes subsequently to meet the criteria for protection under this Chapter.

11. Except as otherwise provided in this Chapter, including Article ___ (Berne 18/TRIPS 14.6), a Party shall not be required to restore protection to subject matter that on the date of entry into force of this Agreement has fallen into the public domain in its territory.

12. This Chapter does not give rise to obligations in respect of acts that occurred before the date of entry into force of this Agreement.

13. Further to Article ___ (Publication), and with the object of making the protection and enforcement of intellectual property rights transparent, each Party shall ensure that all laws, regulations, and publicly available procedures concerning the protection or enforcement of intellectual property rights are in writing and are published,*3* or where publication is not practicable, made publicly available, in a national language in such a manner as to enable governments and right holders to become acquainted with them. . . .

Finally, I'll note that Democratic 2016 front-runner Hillary Clinton said on the campaign trail recently that she feels big pharma should have to give more -- on pricing negotiations here in the US, with Medicare and Medicaid -- in order to win these global protections, from price erosion (due to lax IP enforcement).

That will make the debate very interesting, if the back and forth on this TPP measure bleeds into 2016 -- as many smart observers now predict it will. As the New York Times noted, it also puts Mr. Obama in a tough spot -- because he is sure to push for passage, as is -- not with more give-backs by branded pharma. And yet he will want to buttress Mrs. Clinton's base -- and her base (a la Elizabeth Warren) will want to see big pharma have to negotiate on price with the government payers here.

So. . . pop the popcorn -- it will be good theater!

O/T Space Science: Rosetta/Philae Planning -- And Activities -- Accelerate, At ESA

At the outset, lest anyone be confused: Merck once had a subsidiary (long since divested -- but originally acquired, circa 2001) called Rosetta, a company that worked in genomics; but this narrative bears no relation to that.

No, this is about "the little comet lander that could." Or, if you prefer, "the boy of the three year nap." Okay -- Philae was out only six months, but you get the gist of it. Philae is transmitting periodically, and charging at least 135 minutes per 12 hour cycle, on comet. So we should start to see more data arrive, and soon. The graphic at right depicts where, it is thought, Philae now rests -- in the shadows, upper right. We soon should have tighter data on that as well. Here is the latest from ESA -- and a bit -- do go read it all:

. . . .A second, smaller burst of lander data was received on Sunday, 14 June, at about 21:26 GMT, lasting just a few seconds. These data were confirmed to give the current status, showing the lander’s internal temperature had already risen to –5ºC. . . .

The telemetry downloaded [from Philae] covered the lander’s status for a full night–day cycle of the comet, which is helping ground teams to understand how the Sun is shining on the lander. The solar panels appear to be receiving power for over 135 minutes in each illumination period. . . .

The new orbit will be flown by Rosetta starting after 23:25 GMT on 16 June until 19 June, aiming to enable more and longer contacts with Philae, especially towards the end of this period. . . .

We are grinning ear to ear, here. He's a cool little buddie!

We Were Told Whitehouse Station Was "Under Contract" -- Was Google One That Passed, On The Site?

There are local stories this morning in New Jersey suggesting that the Mayor of Readington has said publicly that Google looked into occupying/buying some or all of Merck's former Global HQ, at Whitehouse Station earlier this year. Recall that in early May 2015, we were told the property was "under contract."

Even if that is so, there is still not firm indication as to whether a for profit entity will turn out to be the contracted for buyer of the facility. And that is very important to the local tax base -- think about preserving adequate levels of tax funding for local schools, snowplows, trash collection and public park spaces, here. And so, we will keep a weather eye on this one -- but I for one will be surprised if Google turns up as the ultimate buyer.

The geography doesn't really fit the needed, or available workforce profile, in my opinion. From NewJerseyHills.com's Hunterdon Review, then:

. . . .Mayor suggests Google "looked at" site. . . .

Onward.

Astra-Zeneca Snags Merck's Overall Business Leader -- In China -- A Coup!

While almost all multi-national pharma concerns have experienced their fair share of bumps in the road, in China -- most often related to procurement, and contracting -- and several are still under DoJ investigation (for alleged FCPA irregularities) here state-side, Ms. Cheng had kept Merck's nose quite clean, in that regard. So I expect it will take more than a minute to fine a worthy successor, to report in to Kenilworth, from Beijing or Shanghai. In time, Mr. Frazier will find the right person -- but it will take some time. So, this is a coup for AZ.

From Pharmacy Times, then -- a bit:

. . . .AstraZeneca today announced that Pam P. Cheng has joined the Company as Executive Vice President, Operations and IT. Pam will succeed David Smith, who is retiring after nearly ten years with AstraZeneca. Pam will be responsible for manufacturing operations and supply chain, procurement and information technology globally. In the role she will oversee continued progress in driving efficiency and delivering excellence in these areas. . . .

Ms. Cheng was a 17-year veteran of Merck & Co., most recently serving as President of MSD China, covering a wide functional scope which included commercial, R&D, manufacturing and various business support organizations. Prior to serving as President of MSD China, Ms. Cheng served as Senior Vice President, Global Supply Chain Management for Merck in New Jersey, with overall end-to-end supply chain oversight for its human health, vaccines, and consumer care businesses globally. . . .

Just now recovering in full, from a late Blackhawks festivities night. . . but onward, we go. I'll have a note up later today, about an update on one of the potential buyers (a for profit business) for Whitehouse Station. So, stay tuned, buckaroos.

Slightly O/T -- Monday "History Of The Law": The Great Seal And Writ Turns 800 Today

To be sure, the bulk of the Magna Carta is about preserving the property rights of the nobles, then at odds with the Crown. Even so, you need not join U. of C. law professor Tom Ginsburg in vilifying the Writ. Why? Because more than any proclamation or coherent set of ideas before -- especially at Sections 38 through 40, and 44 to 45, of that aged sheet of vellum -- are the beginnings of our nation -- ruled by, and of laws -- not men. In sum, Tom is simply. . . wrong¹.

From those three to five sections (quoted below, in blue) comes eventually the right to trial by an impartial jury of peers, the right to confront ones' accusers in open court and. . . most importantly, what we now call "due process of law" -- what the English called then a "right of justice". [Prior to Magna Carta, it was something the Crown could sell, and then refuse to enforce, at its whim. But today, that same Crown will celebrate this 800^th birthday.]

. . . .No bailiff for the future shall, upon his own unsupported complaint, put anyone to his "law", without credible witnesses brought for this purposes. . . .

No freemen shall be taken or imprisoned or disseised or exiled or in any way destroyed, nor will we go upon him nor send upon him, except by the lawful judgment of his peers or by the law of the land. . . .

To no one will we sell, to no one will we refuse or delay, right or justice. . . .

Men who dwell without the forest need not henceforth come before our justiciaries of the forest upon a general summons, unless they are in plea, or sureties of one or more, who are attached for the forest. . . .

We will appoint as justices, constables, sheriffs, or bailiffs only such as know the law of the realm and mean to observe it well. . . .

So -- despite all her flaws (including perniciously singling out "the Jews" for onerous treatment), the grander ideas embedded in Magna Carta -- and carried to the New World, via her ancient DNA, flow through to the birth this nation's rights and privileges, down to this very day. Without these starts at the lofty ideas of Magna Carta, there would have been no Bill of Rights, no Civil Rights Act of 1964, and no Voting Rights Act of 1965, as just three examples.

Onward -- and. . . now, go Hawks!

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

_{1. Tom also points out that women couldn't testify in certain trials, under the writ. What that fails to acknowledge, is that women COULD, after the writ, at least testify in trials about the death of their husbands. Prior thereto, there was no guarantee that any woman's word would be accepted into evidence at trial -- in any matter. So, yes -- the law was flawed, and primitive in 1200. But this was a halting step. . . forward. Under Section 8, a woman could not be thrown off the land simply because her husband had died -- and she would not be required to remarry, in order to keep their lands. That too was a step forward. So, I think Tom is wrong to vilify Magna Carta, with his benefit of hindsight.}

Space Science "Sunday Fare": Rosetta's Comet Lander, Philae, Is. . . AWAKE!

We all (goofy amateurs who follow matters of space science, generally) optimistically expected that -- as the comet drew closer in, toward a distance about equal to the orbit of Mars, and began to warm up, more and more of the ice would melt, and my little buddie Philae's solar panels would get some sunlight. We hoped it might get more than just some. And, that has in fact occurred!

You may recall the European Space Agency's mission scientists thought, back in November of 2014, that little Philae ended up stuck under an icy crevice, tipped to one side, and thus was suffering from shadows obscuring all sunlight, for most of the "days" -- on that comet's surface. And so. . . its batteries died. But this morning, it phoned (radioed) up to Rosetta -- and Rosetta just relayed the call home. Per ESA, then:

. . . .For 85 seconds Philae "spoke" with its team on ground, via Rosetta, in the first contact since going into hibernation in November.

When analysing the status data it became clear that Philae also must have been awake earlier: "We have also received historical data – so far, however, the lander had not been able to contact us earlier."

Now the scientists are waiting for the next contact. There are still more than 8000 data packets in Philae’s mass memory which will give the DLR team information on what happened to the lander in the past few days on Comet 67P/Churyumov-Gerasimenko.

Philae shut down on 15 November 2014 at 1:15 CET after being in operation on the comet for about 60 hours. Since 12 March 2015 the communication unit on orbiter Rosetta was turned on to listen out for the lander. . . .

Now, mission scientists will adjust Rosetta's orbit around the comet, to get more "talk time" -- with my lil' buddie, on the surface. It will be an exciting science summer, through to October of 2015, at least. Excellent; and Onward!

Propecia® MDL UPDATE: Dr. Imperato-McGinley Agrees To Deliver Requested Finasteride Clinical Trials Documents

UPDATED | 06.13.2015 @ 8 PM EDT: In response to Mr. I -- here is the letter/order mentioned below, as a PDF file. I obtained all of this from the US Courts' PACER electronic filing desk -- you need to sign up at the PACER virtual window, and pay ten cents a page for each download, via a valid credit card. As to putting the narrative together, it helps a lot to know what to look for -- and how to read the context, into what turns up. Note that the PDF contains the case file number at the top of each page, in blue. That's how you track a case's progress -- remotely. As to the substance, I actually suspect not much new will turn up, in the good doctor's files -- at least not anything the plaintiffs' lawyers haven't already sourced from Merck directly, in all likelihood. Now you know. Now. . . GO Hawks! End, Updated portion.

The June 19, 2015 previously-scheduled conference (and potential contempt of court hearing) in the US District courthouse, for the Eastern District of New York (Brooklyn) is now postponed -- to August, by agreed order.

The good doctor has agreed to turn over her documents. And the parties are speedily resolving their other production differences, we are told. There may still be some motion and briefing practice, as to a few of the issues remaining, but we will learn about that at the August 2015 conference. So, all as I predicted: no open fights, in Brooklyn in the near term.

. . . .An agreement has been reached with Dr. Imperato-McGinley, on the delivery of documents. . . .

So it goes. Onward. [Jurassic World was good fun, quite late last night.]

Saturday Musings: Who Is Entitled To The Couple's Jointly-Created DNA? Who Is Responsible? 21st Century Law Reflections -- When Couples Split

I've seen a flurry of articles -- mostly about lawsuits -- on what happens when modern couples split -- but have DNA stored, jointly. So I've decided (over coffee and a banana, and fresh OJ) this fits with Merck's legacy Schering-Plough/Organon reproductive medicines and family planning lines of business (or. . . it is at least as good an excuse as any, to write on the topic).

Let's start with the basics: while every state presumes that married male-female couples are both considered the parents of any child born into the marriage, every state now allows any outsider to the marriage (upon competent evidence) to file a suit and present that evidence -- to establish that the child is "made up of/from the DNA" of that stranger to the marriage. Absent a donor agreement (which would nullify these parental rights), or surrogacy contract -- any person's DNA -- found to be present in a child, to 95 per cent probability of parenthood, would be enough to allow visitation, and would correlatively allow the married couple to seek support payments, and perhaps even allow the stranger to enforce joint custody arrangements (in every state in the Union, if memory serves). This is true, regardless of whether there is a separate, conflicting, contemporaneous marriage. That's the boring, straight black letter law, here. [And so, many traditionalists will need to expand their views of what makes a collectively shared DNA group. . . a blended "family", in my opinion.] Now let's take a look at a few of the variations, all of rather recent vintage:

In a high profile Arizona case, two WNBA players (apparently using a sperm donor, and a written donor agreement) to get pregnant -- while married -- are splitting, at the insistence of the non-pregnant spouse. The non-pregnant soon to be ex-spouse wants to avoid the implications of having a child jointly, by annulling the marriage. The pregnant spouse intends to carry to term, and seek support. This is so, even though the spouse she will seek support from has no DNA in common with the baby-to-be, nor any adoption papers, nor any agreement to jointly raise the donor's DNA. That one will make new law, for certain.

In another case, a female MD who, while fighting cancer, along with her then-boyfriend, long ago banked fully fertilized eggs, in cryo-storage (i.e., DNA from both of them -- an embryo), in the hope she'd survive the cancer -- and upon her return to health, wanted to have a surrogate carry that embryo to term. Her efforts were held in limbo, until yesterday, when a judge ruled in her favor -- basing his ruling on the fact that a written agreement exists, which to allows her to proceed, in his view. The ex-boyfriend had sued in Chicago -- to keep her from using their three fertilized eggs -- for just the purpose described in the agreement. He says the storage facility agreed in writing not to do anything with the embryos without both of the "parents'" consent. And he's not. . . consenting. But of course, the storage facility's written agreement meant only that it could not sell the embryos -- to a third party stranger.

Finally, a female actor/model wants to prevent her ex-fiancé's attempt to create a jointly-shared DNA life, from an embryo they banked, while together -- and so, she has waged a long-running legal battle to prevent him from implanting the joint DNA into a surrogate, post the relationship. So, onward it goes.

From the Gray Lady's coverage of the WNBA case, then -- a bit:

. . . .In a petition for annulment filed June 5, Ms. Griner, a center for the Women’s National Basketball Association’s Phoenix Mercury, said their marriage of less than a month was "void based on fraud and duress. . . ." Ms. Johnson, the court papers said, pressured Ms. Griner into marrying her with "threatening statements. . . ."

Ms. Griner’s divorce filing in Maricopa County Superior Court in Phoenix came the day after Ms. Johnson announced on Instagram that she was pregnant -- with a photo of a cake shaped like a bun going into an oven. . . .

And, from the actor/model's case:

. . . .Two people fall in love and want to have children. For whatever reason, they try in vitro fertilization, which successfully results in embryos ready to be brought to term at their discretion. But they fall out of love. One person still wants those embryos to become children, and the other person does not.

This very personal battle has in recent weeks become public for the actor Sofia Vergara and her ex-fiance, Nick Loeb, as he claimed in tabloid newspapers that she wanted to destroy frozen embryos they had created. On Thursday, he brought this battle to the New York Times, which ran his editorial about why their two embryos "have a right to live. . . ."

I may offer more on this, as these -- and other cases -- progress. [Graphic/image, above right, derived from a Wiki-Commons photo of a sculpture. Fair use claimed.] Onward -- to a cool, clear, fun Saturday!

The Latest Delaware Federal District Court Challenge -- To Gilead's Win, At The USPTO On Interference -- Is Likely To Be Summarily Dismissed

Still remaining are several other suits underway -- on the broader IP issues here -- but this most recent one (just filed in May 2015) looks like a loser, for Merck (via its purchase of Idenix).

Gilead's lawyers just filed a motion to dismiss this latest suit -- for lack of subject matter jurisdiction. And it looks to me like a clear winner. In fact, Merck's lawyers indicate (via footnote) that they do not oppose this motion. A very recent appellate case has found the interference challenge arguments of Idenix, and therefore, Merck -- to be out of bounds, here. A case called Biogen (involving that company) has established this pretty firmly. So now you know:

. . . .On May 7, 2015, the United States Court of Appeals for the Federal Circuit affirmed the district court’s holding in Biogen and held unequivocally that “the AIA eliminated district courts’ subject matter jurisdiction under pre-AIA 35 U.S.C. § 146 to review decisions in interference proceedings declared after September 15, 2012.” Biogen, 2015 WL 2109812, at *10.

Despite that ruling, two weeks later, on May 21, Idenix filed its complaint in this case, seeking review of the PTAB’s decisions in the ’981 interference pursuant to 35 U.S.C. § 146. Idenix acknowledged the Federal Circuit’s Biogen opinion, but disagreed with its holding and stated that it filed its complaint “to exercise and preserve [its] right to pursue a Section 146 action.” (D.I. 1, at Footnote 1.) Idenix also informed this Court that it would be simultaneously appealing this same interference to the Federal Circuit under § 141. (Id.) Indeed, the next day, Idenix filed a second “Notice of Appeal” seeking review of the same rulings in the same interference in the United States Court of Appeals for the Federal Circuit pursuant to 35 U.S.C. § 141. . . .

We will keep you updated -- on all the other facets of this potentially multi-billion-dollar series of claims and counterclaims, in litigation, which now sprawl across courtrooms in most of the developed world. But that's for another day -- as it is truly lovely out -- and, off I go.

An Intriguing Matt Herper Piece -- In Forbes -- With Merck's "Three Times FDA JILTED" Candidate Bridion® -- As Its Poster Boy

As we last noted around St. Paddy's 2015 -- sugammadex (a former 2008-09 "Fast Fred" Five Stars candidate) has been repeatedly left at the altar, by FDA staffers and the associated Advisory Committees. That is probably wise, in my estimation. [It is however approved -- and on sale in a handful of countries around the world -- as Bridion^®.]

The latest? Today, Matt Herper re-ignited the engines -- on calls to require companies to disclose precisely why FDA repeatedly bounces certain drug candidates. He offers great analysis of a new British Medical Journal study -- one that lays bare how far off the mark most companies are, when describing the "why" behind repeated "complete response letters" (that's the modern term for a rejection letter, at FDA). Here's a bit -- do go read all of Matt's fine writing:

. . . .Current FDA regulation means that the agency does not publish its rejection letters, known as complete response letters. But FDA researchers led by Peter Lurie, the Associate Commissioner for Public Health Strategy and Analysis at the FDA and a former researcher at the consumer gadfly group Public Citizen, found a clever way around this restriction. They broke up the complete response letters, resulting press releases, and filings to the Securities and Exchange Commission into discrete statements. Then, they counted how often the statements in the press releases (or, in a separate analysis, the SEC filing) matched what was actually in the rejection letter.

Twenty one percent, or 13, of the press releases did not contain any of the details from the letters. Press release statements matched only 93, or 14%, of the 687 statements about reasons for rejection contained in the complete response letters. This increased to 101, or 15%, when the analysis of SEC filings was concluded. . . .

And so -- the fate of Bridion may dribble now into 2016 -- and that's eight full years beyond Fred Hassan's "most conservative" predictions. Maybe it is just not such a great drug, afterall, on the safety vs. efficacy/perceived OR benefit, as a co-plotted dimensional x-y chart. Onward -- have a stellar weekend, one and all!

UPDATED: Plaintiff's Answer Date Extended To June 25, 2015 -- In "What Makes A Bully?" FMLA Post Trial Motion

Please take the poll at top left margin. As a reader, what do YOU think? Was this a bit of bullying/overreach, or prudent post trial motion practice -- to seek return of what would putatively be the Merck shareholders' $68,000 (which effort I've noted may cost well over $100,000 in additional legal fees -- to ultimately recover the $68,000, from a. . . mom)? You may have your say. See at left.

I write a smallish update to this item, this morning, simply to indicate that the very able Judge Chesler has granted the plaintiff some additional time to answer Merck's motion for taxation of costs, here.

And, as I said on Monday, the law plainly allows this sort of odious post trial motion practice behavior -- I just find it. . . a little over the top, and immoral, truthfully.

As I said before, she is an individual, facing down a global public company with annual revenues of well over $40 billion a year.

And, as I said before, she made out a good faith case. The jury didn't find her way, but it was clearly a good faith case (in my opinion -- and federal District Court (NJ Dist.) Judge Chesler's -- based on his prior rulings).

. . . .So Ordered: Answer In Opposition Now Due June 25, 2015. . .

I will also note that in the wake of her loss, several members of Congress are again calling for new legislation to afford moms (like her) greater protections, at law. And that bastion of old line capitalism on Wall Street, Goldman Sachs & Co., just expanded its paid paternity/maternity leave policies on Tuesday -- though I'd be cautious about drawing a direct connection to the outcome in this case -- as to the Goldman movements. Previously, Virgin Atlantic had granted a full year, to its employees -- as well.

Onward, then. Still not sure how to handle your disclosures -- about potentially blended/entangled parenthood, here.

Merck's 2014 Sirna/RNAi Divestiture Epilogue, Of Sorts: "The Merck 6"?!

From my perspective, I'll take the side of Dicerna -- and trust that it did, in fact -- as it says -- appropriately investigate Alnylam's concerns in January, and conclude that it had firewalls in place, to keep trade secrets of Alnylam (which were acquired by Alnylam, from Merck, in 2014) from being used inappropriately at Dicerna, by the so-called Merck Six.

I suppose (on balance) I fall on the side of freedom of contract -- the freedom of scientists to find gainful employment, here in the US. I do also respect intellectual property rights, but saying that six former Merck scientists (who I'll speculate were likely facing a downsizing after Merck essentially exited this area of research and development), are unable to work anywhere in their chosen field of endeavor. . . seems decidedly. . . un-American. Smile. Yes -- that is tongue in cheek.

In any event, here is a bit of Dicerna's response press release this morning. Do also go read Derek Lowe (at In The Pipeline) on the topic.

. . . ."Dicerna’s technology is built firmly on its own research and innovation" noted Douglas Fambrough Ph.D. chief executive officer of Dicerna "Dicerna focuses on serious life-threatening diseases involving the liver and genetically defined cancers for which patients have few or no treatment options available. Our RNAi-based therapeutics utilize our proprietary RNAi technologies and not prior Merck research. We stand behind these technologies and the company's record and practices for respecting IP rights in order to develop and deliver life-changing therapies as efficiently as possible. . . ."

Earlier this year Alnylam indicated it was concerned about unspecified aspects of Dicerna’s GalNAc delivery technologies. Dicerna then conducted a thorough investigation and confirmed that there has been no use of Merck/Alnylam confidential information at the company. Dicerna communicated the results of its investigation to Alnylam (one of many facts omitted from the complaint). Likewise Dicerna communicated to Alnylam facts demonstrating that many of the insinuations in the Alnylam complaint are simply false and others are unfounded speculation. . . .

My prior background (circa March 2014) on the unwinding of Merck's interest in RNAi tech, is here. Here was yesterday's version of Alnylam's original complaint in state court in Massachusetts. I will predict that unless this all settles very quickly, the suit will be removed to the federal courthouse in Boston, by Dicerna's counsel. Both are Delaware companies, and both have executive offices in Massachusetts, but I still see that as being likely -- if this is to go to trial. But we shall see. Onward. Missing your soft lips, miss. . . .

Is This Proof That The J&J Versus Merck Remicade® Arbitration Settled On Very UNFRIENDLY Terms? I Think So.

This morning, Kenilworth and a bio-similars development subsidiary of the Samsung Japanese entities announced some encouraging Phase III results (prior coverage of that relationship here). Among other things, they announced that the pair's joint study of a bio-similar to infliximab, the agent branded as Remicade^® around the world [and marketed by both J&J and Merck(!)], has shown good results -- and will likely allow a filing with non-US, non-EU (i.e., "rest of world") drug regulators later this year.

This is fascinating. Our readers will likely recall that -- as a result of less than perfect lawyering, in the Schering-Plough reverse merger transaction -- Merck was forced into an arbitration -- against J&J -- over the global rights to Remicade. That arbitration ultimately settled with J&J getting US rights, and Merck getting EU, Turkish and Russian rights to market the medicine. That left all the rest of the world as "open territory". Now Merck is going to sell knockoffs of the stuff, wherever it is not prohibited by license from doing so. I suspect J&J is none too pleased about this development.

Why? It will eat into future market expansion plans of J&J, for the branded product -- and (to my eye at least) this is Kenilworth effectively thumbing their collective noses -- in the general direction of J&J. [Of course, as we've reported, Merck is presently suffering "generic" introductions in parts of the EU, which would lead me to now wonder aloud -- whether J&J is quietly "helping out" with that competitive set of efforts.] Hilarious. From the presser then:

. . . .The portfolio includes biosimilar candidates in immunology, oncology and diabetes. There are five candidates in Phase 3 development [Merck partnered territories]:

· SB4 Enbrel (etanercept) [worldwide ex-U.S./EU/Japan]

· SB2 Remicade (infliximab) [worldwide ex-EU/Russia/Turkey]

· SB5 Humira (adalimumab) [worldwide ex-EU/Russia/Turkey]

· SB3 Herceptin (trastuzumab) [worldwide]

· MK-1293 Lantus (insulin glargine) [worldwide]

Each of these five biosimilar candidates is expected to be filed with regulatory authorities around the world between 2015 and 2016. . . .

Do go read all of the FierceBiotech item on the studies, and regulatory filing plans too. Because of the manifold geography limitations, these deals may not turn out to be of much material import, overall -- to Merck. Onward we trudge -- or forge, depending on our mood.. . . missing you, and those almond eyes.

EU First Impression Trademark Ruling: In Favor of MSD, Against Parallel Importer Orifarm

At the risk of slipping into the admin-is-trivia of internal EU regional trademark rulings, I'll post just a short note -- on a recent Danish Supreme Court decision (across the pond) -- which held that a parallel importer must mark its OWN wares, with the following magic words: "[Trademark Name XXX] is a registered trademark of Merck (or MSD)", to escape infringement liability. This outcome is somewhat surprising, because earlier EU zone decisions had been less inflexible on such matters. The idea was -- until now -- that it was hard to argue that the foregoing (i.e., missing) words damaged Merck's own proprietary marks, in any meaningful way. [My prior reporting on related spat history, from four years ago, may be read here.]

But now the decision is out there, and importers must deal with the risk of omitting the magic words (and thus being held liable for trademark reputation damages). The involved MSD products included Nuvaring^®, CeraZette^®, Diprophos^® and Singulair^®, in Denmark.

A bit, then from the very fine local Danish law firm newsletter, on this decision:

. . . .The 2015 decision confirms the degree of care that must be taken by parallel importers when using third-party trademarks. As the main purpose of a trademark is to function as an indication of origin, third-party marks cannot be used in a way which confuses the consumer as to its origin. However, hitherto, repackaging which informed consumers of the parallel importer and the name of the manufacturer was deemed by many to be sufficient. This decision illustrates that the reputation of a trademark can also be damaged by omitting a trademark statement along with use of the trademark.

The Supreme Court decision appears to be the first to consider this specific question in the European Union. Similar proceedings are pending in other EU jurisdictions and it will be interesting to see whether the judgment will affect these proceedings. . . .

So now you know. Off to the North -- but not quite into the Danish woods -- just a road trip, tonight! I want to see your golden-flecked almond brown eyes -- so, so much. . . .

What Makes A Giant Into. . . "A Bully"? Merck's Jury Win -- Then It Seeks Its Costs, From Mom, With Kids

UPDATED: Noon, EDT -- Please take the poll at top left margin. As a reader, what do YOU think? Overreach, or prudent -- to seek return of the shareholders' $68,000 (which may cost over $100,000 in additional legal fees -- to ultimately recover).

The law plainly allows this sort of odious behavior -- I just find it. . . a little over the top, and immoral, truthfully.

From Judge Chesler's earlier opinions, it was clear that the claimant -- a mom with more than one child -- made out a prima facie case. She repeated in good faith and truthfully, what was said to her, regarding her pregnancy -- and leave.

In the end, the jury found that her termination was not primarily due to her pregnancy status, nor her decision to take a protected family leave.

But now, Merck (and more likely -- the individual defendants) have caused their lawyers to file a motion (that's a full text PDF file) with Judge Chesler, in New Jersey federal District Court, to have the mom pay THEM about $68,000 in costs they say they incurred. To be clear, these are not the attorneys' hourly fees -- just charges for photocopies, messengers, court transcripts, and the like. Even so -- this seems to me to be bullying behavior.

For the record, I will note that both of the individual defendants almost certainly had D&O coverage from Merck, as a self insurer at this level of expense, for all these funds.

That is, no one -- except a multinational corporation with well over $42 billion in revenue last year -- is out $68,000, here. And that could easily be half of the mom's annual cash salary, in her new job, after taxes. Mr. Frazier -- please instruct your lawyers to withdraw their motion -- it is redolent of the dank odor of overreach.

Here endeth the sermon.

As We Reported In April 2015 -- TECOS Results Lend Merck's Januvia®/Janumet® A Modest Boost

Back in April 2015, Merck saw a one-day four percent increase in its NYSE indicated stock price, as quoted after-hours on the NASDAQ. I called that an overreaction.

The stock quickly drifted back to current range bound levels, thereafter. I expect much the same tomorrow, when the NYSE formally opens trading in the name. The full TECOS publication just really means that Merck may pick up some of the slack spooling at AZ's feet, now -- that, related to AZ's Onglyza^® diabetes medication. As I said in April, the larger issue for the Kenilworth franchise here, is "genericization" of sitagliptin, which is leading to price erosion, globally. TECOS removes a smallish overhang for the franchise. Nice, just the same -- here is Reuters, on it all -- about 20 minutes ago:

. . . .Details of a large heart safety study presented on Monday appear to give Merck's diabetes drug Januvia a clean bill of health, possibly setting the stage for a return to sales growth for the drugmaker's biggest product.

Merck in April said the study, called Tecos, of 14,724 patients with type 2 diabetes and a history of heart disease demonstrated that adding Januvia to usual care did not increase major heart problems any more than adding a placebo, removing a cloud that has been holding back sales of the medicine and the company's share price.

Januvia, an oral medication known chemically as sitagliptin that helps lower blood sugar levels, had sales of about $4 billion in 2014, plus another $1.8 billion for the related combination product Janumet. . . .

Not surprising, and all of this news is certainly baked into tomorrow's Merck NYSE price. So. . . off to the Symphony -- for some Antonin Dvořák, now -- but do go 'hawks, tonight!

Merck Gets Narrow Label (End-Stage) Melanoma Clearance -- In Canada -- for Keytruda®

This morning -- our gentle neighbors to the north are catching up, with their new monoclonal antibody approvals, here. Canada will -- starting today -- allow melanoma patients, already in nearly end stage catharsis, to receive pembrolizumab -- branded as Merck's Keytruda^®. To be sure, the anti PD-1L inhibitor has shown strong efficacy in clinical trials, in that subsegment of the US and European oncology wards.

This is good news for Kenilworth, but there is likely to be significant pressure on the reimbursement rates, up north. So. . . I'll notch it as only mildly positive. If memory serves, Nivolumab^® (by BMS) is already available in Canada as well. Here's the Merck presser -- and a bit:

. . . .Keytruda is indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor. The product has been approved in Canada under the Notice of Compliance with Conditions (NOC/c) policy on the basis of promising evidence of clinical effectiveness and pending the results of trials to verify its anticipated benefit.

"All of us at Merck Canada are thrilled with Keytruda being available in Canada for the treatment of advanced melanoma, as it provides new therapy to patients facing this difficult-to-treat cancer," said Chirfi Guindo, Managing Director, Merck Canada Inc. "This new product embodies Merck's unwavering commitment to be at the forefront of scientific discovery and innovation to help Canadian patients. . . ."

Smallish good news, there -- but good, nonetheless. Onward.