Nuvaring® MDL Update: Next Status Conference Now September 15, 2016 — July 6 Conference Scrubbed

July 1, 2016 - Leave a Response

Just a minor bit of Friday litigation house-keeping here, as the NuvaRing settlement wends its way toward payouts:

. . . .IT IS HEREBY ORDERED that the status conference set in this matter on July 6, 2016 is continued to September 15, 2016 at 10:30 a.m. in Courtroom 16 South. The parties shall file a proposed agenda no later than September 8, 2016. . . .

Now you know. Keep a good thought for our twisty copper-colored NASA Juno spacecraft — that its 400 pound titanium “strong-box” will adequately protect the processor circuits and motherboards from Jupiter’s raging irradiation torrent — and that we will get good data, imagery even, of the sub-cloud-top features of this immense gas giant, with a spinning metallic hydrogen “sea”, beneath, come Monday night, around 11:45 PM CDT. I’ll stay up to watch NASA-TV. Smile. Onward!

At Noon Central Today: Webcast Press Event — At NASA/JPL, Regarding Juno’s Jupiter Orbit Insertion

June 30, 2016 - Leave a Response

If this sort of fare isn’t your cup of tea, do feel free to scroll on by — but I’ll tune in at noon, and again at 1 PM CDT, so you won’t have to — as it portends to be fascinating (at least to me!).

Here’s a bit, from NASA:

. . . .During the evening of July 4, Juno will perform a suspenseful orbit insertion maneuver, a 35-minute burn of its main engine, to slow the spacecraft by about 1,212 miles per hour (542 meters per second) so it can be captured into the gas giant’s orbit. Once in Jupiter’s orbit, the spacecraft will circle the Jovian world 37 times during 20 months, skimming to within 3,100 miles (5,000 kilometers) above the cloud tops. . . . providing new answers to ongoing mysteries about the planet’s core, composition and magnetic fields. . . .

At about 12:15 pm PDT today (2:15 p.m. CDT), mission controllers will transmit command product “ji4040” into deep space, to transition the solar-powered Juno spacecraft into autopilot. It will take nearly 48 minutes for the signal to cover the 534-million-mile (860-million-kilometer) distance between the Deep Space Network Antenna in Goldstone, California, to the Juno spacecraft. While sequence ji4040 is only one of four command products sent up to the spacecraft that day, it holds a special place in the hearts of the Juno mission team.

“Ji4040 contains the command that starts the Jupiter Orbit insertion sequence,” said Ed Hirst, mission manager of Juno from NASA’s Jet Propulsion Laboratory in Pasadena, California. “As soon as it initiates — which should be in less than a second — Juno will send us data that the command sequence has started.”

When the sequence kicks in, the spacecraft will begin running the software program tailored to carry the solar-powered, basketball court-sized spacecraft through the 35-minute burn that will place it in orbit around Jupiter.

“After the sequence executes, Juno is on autopilot,” said Hirst. “But that doesn’t mean we get to go home. We are monitoring the spacecraft’s activities 24/7 and will do so until well after we are in orbit. . . .”

Also today, NASA announced a collaboration with Apple that will serve to enhance the agency’s efforts to inform and excite the public about dramatic missions of exploration like Juno. “Destination: Juno” is a synergy between two seemingly disparate worlds: popular music and interplanetary exploration. The works resulting from this collaboration showcase exploratory sounds from artists who have been inspired by Juno and other NASA missions. . . .

Sailing right along now, entirely care-free, with one other copper colored, twisting shepherd moon-lette. Smile.

UPDATED: 1 PM CDT — Apple has partnered with NASA/JPL and the Juno Mission team to create highly-inspired art — music and videos, from the likes of the Oscar® winning duo Trent Reznor and Atticus Ross (and music by Corinne Bailey Rae, GZA, Jim James featuring Lydia Tyrell, QUIÑ, Weezer, Zoé and Brad Paisley) — all of whom call young artists and scientists to the wonders of space exploration. Go see the full video at Apple Music. This trailer of it was released at the second briefing — now underway, as of 1 PM CDT (the team will replay the full long form video at 4 PM EDT, on NASA TV):

Merck MDL Update: Fosamax® “Failure To Warn” In Femur Cases Before Third Circuit Today

June 30, 2016 - Leave a Response

Just a minor appellate update squib here — this flawless holiday morning, over hot coffee & cream, fresh-squeezed OJ, and a banana — whole cherry yogurt coming up, next — smile.

Recall that the trial courts have dismissed all the Fosamax® femur MDL “failure to warn” claims. That July 2014 ruling reduced the number of femur MDL claimants from over 1,000, to under 20. The MDL steering committee has appealed the able Judge Pisano’s ruling to the Third Circuit. A full two years later now, that appeal will be heard today, it seems.

Here is the Reuters item noting it.

We will report if anything newsworthy transpires. Onward — on a mountain bike — on a glorious morning, eyes a-glow. . . .

Merck Vs. Gilead: What Use Should Be Made Of Hague Convention (French) Depositions, In Delaware Federal Patent Fights?

June 29, 2016 - Leave a Response

When one litigates high-stakes matters in several courts around the globe, simultaneously — about one core set of dispositive issues (here a patent fight, on a pro-drug that ultimately became sofosbuvir, the central active ingredient in Gilead’s Hep C wonder cures Sovaldi and Harvoni) — it often happens that there emerges a whole host of “derivative” disputes, among the parties, about what use may be made of items adduced (testimony and documents, primarily) under the rubric of other countries’ civil legal systems.

This is one of those times.

Recall that Idenix is the proxy for Merck, here (as Merck acquired Idenix) — and recall that the issue of which company actually first had the original idea to “invent” sofosbuvir is now (at least according to the very able US District Court Judge Beth Labson-Freeman, in the Northern District of California) probably NOT Merck (since she has effectively ruled that a Merck employee may have usurped a Gilead subsequent acquitision target’s teaching in the area). So, if Gilead can keep any additional unfortunate evidence out of the pending Delaware case, it has a pretty good shot at a win here, as well. That explains why Gilead is trying to keep the French scientists’ opinions corraled under US rules. But the Hague Convention contemplates very different ideas — making this an argument eminently worth watching. Here is a bit from Merck’s latest letter:

. . . .In effect, Gilead desires to use the provision at issue to turn the court in France into a conference room in the U.S. and turn the depositions into ones that are governed solely by U.S. laws. That is directly contrary to the legal basis by which these depositions have been sought and ordered, i.e. that they be held in a French court. There are rules in France regarding discovery of its citizens, including the French Blocking Statute. It is Idenix’s understanding that one of the roles of the French Judge will be to ensure that the rights of French citizens are respected and that its laws are properly followed. Gilead’s proposal would preclude that and strips the French Court of its power to preside over the deposition, and essentially turn the French Judge into a “potted plant.” Gilead provides no reason or basis to tie the French Court’s hands in this manner. . . .

The proposal is also directly harmful to Idenix, given the breadth of Gilead’s proposed provision — seeking to prohibit all rulings on evidence and testimony. Idenix would be prohibited from seeking any guidance or ruling from the Court since the depositions relate solely to evidence and testimony. In the event that the French judge asks the parties to weigh in on any issue that may arise during the depositions, such as to provide their respective positions as to whether certain testimony or examination is appropriate under French law, Idenix would be precluded from answering in any way that would suggest that it is seeking a ruling as to whether such evidence/testimony is appropriate under French law. In effect, the French court would be deprived of its ability to hear from both parties and to manage its affairs in accordance with French laws. . . .

So — we shall see. Do have sweet, safe and overly ripe watermelon-drenched holidays, one and all. Smiling ear to ear, as I’ll be grabbing my West Coast dwelling young man, tomorrow evening, from the airport — sweet, indeed!

Merck “Ups Its Ante” In Moderna — To $300 Million; Deepens Collaboration In Immuno-Oncology

June 29, 2016 - Leave a Response

We last reported on this longer-term R&D bet by Kenilworth in January of 2015. Back then Merck put in $100 million — it is adding $200 million today — and still there is no proof of this bioscience concept in vivo.

Even so, it is a quite exciting validation of the work Moderna is doing — and would dovetail with Merck’s pembrolizumab penetration, globally in many cancers, should it all prove out. Here’s a bit from the press release of this morning:

. . . .Moderna and Merck will develop personalized cancer vaccines that utilize Moderna’s mRNA vaccine technology to encode a patient’s specific neoantigens, unique mutations present in that specific patient’s tumor. . . .

Under the terms of the agreement, Merck will make an upfront cash payment to Moderna of $200 million, which Moderna will use to lead all research and development efforts through proof of concept. The development program will entail multiple studies in several types of cancer and include the evaluation of mRNA-based personalized cancer vaccines in combination with Merck’s Keytruda® (pembrolizumab). Moderna will also utilize the upfront payment to fund a portion of the build-out of a GMP manufacturing facility in suburban Boston for the purpose of personalized cancer vaccine manufacturing.

Following human proof of concept studies, Merck has the right to elect to make an additional undisclosed payment to Moderna. If exercised, the two companies will then equally share cost and profits under a worldwide collaboration for the development of personalized cancer vaccines. Moderna will have the right to elect to co-promote the personalized cancer vaccines in the U.S. The agreement entails exclusivity around combinations with KEYTRUDA. Moderna and Merck will each have the ability to combine mRNA-based personalized cancer vaccines with other (non-PD-1) agents. . . .

We will keep an eye in this. Onward, as we wind down for the long holiday weekend, starting tomorrow. Smiling, just the same.

Looking Ahead: Space Science — NASA Juno Mission’s Jupiter Orbit Insertion On July 4, 2016

June 27, 2016 - Leave a Response

Jupiter is plainly the giant of our system. While standing on our home planet Earth, grilling on July 4, we each absorb about one third of a rad on a sunny day. Consider that little Juno will absorb over 20 million rad from its time in Jupiter’s captive orbit.

We hope to learn much about what actually lies beneath the clouds — and those now 700 year old storms, we see from high atop Jupiter, using Hubble or Earth bound telescopes. [The storm — a tornado, several times the size of Earth — is that reddish orange dot we see.]

If, that is — if little Juno doesn’t get clobbered by debris on the way in, or so irradiated that its little circuits conk out. The folks at JPL will be all white knuckle on July 4, while we barbeque. The first dip into orbit is by far the most dangerous. It will be blogged and tweeted, in near real time, from the NASA mission page. I will peek in from time to time, with my phone — while at the grill, and later, by the pool at the club. But tomorrow, Tuesday — the craft will pressurize its fuel cells. That’s the next big event remaining, pre July 4:

. . . .On June 11, Juno began transmitting to and receiving data from Earth around the clock. This constant contact will keep the mission team informed on any developments with their spacecraft within tens of minutes of it occurring. On June 20, the protective cover that shields Juno’s main engine from micrometeorites and interstellar dust was opened, and the software program that will command the spacecraft through the all-important rocket burn was uplinked.

One of the important near-term events remaining on Juno’s pre-burn itinerary is the pressurization of its propulsion system on June 28. The following day, all instrumentation not geared toward the successful insertion of Juno into orbit around Jupiter on July 4 will be turned off. . . .

All of Juno’s instruments, including JunoCam, are scheduled to be turned back on approximately two days after achieving orbit. JunoCam images are expected to be returned from the spacecraft for processing and release to the public starting in late August or early September.

“This. . . is the start of something great,” said Bolton. “In the future we will see Jupiter’s polar auroras from a new perspective. We will see details in rolling bands of orange and white clouds like never before, and even the Great Red Spot. . . .

That JPL trailer above is only two minutes long, but summarizes well all you’ll need to know, for next Monday. This little remote-controlled craft has been sailing the inky-black frigid sea of space for just shy of five years — and is now (as I write this) exactly one week away from its mission objective achievement. That in and of itself is jaw-slacking. Do stay tuned. I do truly see you. . . . and I’m beaming, tonight, little copper-colored shepherd moonlette. . . . Pax tecum.

UPDATED: On Tuesday morning, the New York Times began running a nice, but longer form (at almost 4 minutes) video story on Juno’s Jupiter arrival. Do recall that in mythology, Juno was the only demi-god who could see through Lord Jupiter’s cloud covered deceptions — thus the name of the craft:

Click through here. Onward.

BREAKING: A 5-3 Majority Has Struck Latest Texas Abortion Restrictions Law

June 27, 2016 - Leave a Response

Texas law is struck nearly in entirety; Fifth Circuit reversed — in essence, the Court holds both provisions were designed to place an undue burden on a woman’s right to control her own body. To make a long story short, the Court struck down both provisions of Texas HB 2 — the admitting privileges requirement, and the requirement that all abortion clinics have facilities comparable to an outpatient surgical center.

Here is the opinion:

. . . .Both the admitting-privileges and the surgical-center requirements place a substantial obstacle in the path of women seeking a previability abortion, constitute an undue burden on abortion access, and thus violate the Constitution. . . .

[Justice Ginsberg, concurring:] . . . .”So long as this Court adheres to Roe v. Wade, 410 U. S. 113 (1973), and Planned Parenthood of Southeastern Pa. v. Casey, 505 U. S. 833 (1992), Targeted Regulation of Abortion Providers laws like H. B. 2 that “do little or nothing for health, but rather strew impediments to abortion,” Planned Parenthood of Wis., 806 F. 3d, at 921, cannot survive judicial inspection. . . .”

More soon — on a train. But this is the best possible outcome. Well done, SCOTUS!

UPDATING, now — as many others are opining, this likely means many of the southern states’ amended anti-abortion laws are similarly invalid. That would include Mississippi, Alabama and presumably Louisiana as well, now. The Courts of Appeals in those cases will read today’s Supreme Court case, and likely send the cases back, to the trial level courts, in each of these states — with instructions to follow the law, as announced by the Supremes today. This means most of the copy-cat laws are going to be struck, almost entirely. This is a victory for reproductive freedom everywhere.

Justice Breyer wrote “Abortions taking place in an abortion facility are safe — indeed, safer than numerous procedures that take place outside hospitals and to which Texas does not apply its surgical-center requirements. . . .” after reviewing the evidence. “Nationwide, childbirth is 14 times more likely than abortion to result in death, but Texas law allows a midwife to oversee childbirth in the patient’s own home. . . .” That is particularly telling.

Supreme Court Watch: What Happens If We See A 4-4 Deadlock Tomorrow, On The Texas Abortion Rights Case

June 26, 2016 - Leave a Response

Updated: The Supremes invalidated almost all of the Texas law, in a 5 to 3 decision, as I guessed in March of this year. Thus, with Justice Kennedy joining the liberal wing — and the death of Scalia — and the Republicans’ failure to do their job. . . it all made no difference. It would have come out the same way, even if Justice Scalia had lived on. This should be a warning to obstructionist Republicans. End, update.

Many Supreme Court observers expect to see the outcome (or perhaps, non-outcome) from the latest in the Texas state legislature’s efforts to restrict lawful abortions in state, announced tomorrow morning.

Given what we saw last week on the immigration measures case, there is a more than passing chance that we see another “your government, NOT at work” 4-4 deadlock. At issue (primarily) is whether a Texas law requiring that doctors who provide abortions in Texas must have full admitting privileges at a near-by hospital, or a surgi-center on site in the office, in order to provide abortions is constitutional after Roe v. Wade and Planned Parenthood v. Casey.

Here is where the law would then leave women seeking control over their own bodies, in Texas, were that unfortunate stalemate between Justices to occur yet again.

In plain English, the last court to rule on the case would be the binding decision. In this particular case, that was the Fifth Circuit — out of New Orleans.

That court struck parts of the Texas law, but upheld other parts of it. Here is some of that Fifth Circuit decision:

. . . .Because the Plaintiffs failed to prove that the ASC requirement imposes an undue burden on a large fraction of women for whom it is relevant, we conclude that the district court erred in striking down the ASC requirement as a whole as facially invalid. . . .

We [however] now know with certainty that the non-ASC abortion facilities have actually closed and physicians have been unable to obtain admitting privileges after diligent effort. Thus, the actual impact of the combined effect of the admitting privileges and ASC requirements on abortion facilities, abortion physicians, and women in Texas can be more concretely understood and measured. . . .

While women in the Rio Grande Valley could previously travel 150 miles or less to Corpus Christi to obtain an abortion, see Abbott II, 748 F.3d at 597 – 98, the abortion facility in Corpus Christi has now closed. The State argues that women in the Rio Grande Valley continue to be able to obtain abortions in San Antonio and Houston, where the abortion facilities now nearest to them are located. Indeed, Plaintiffs’ expert, Dr. Grossman, concluded that fifty percent of the women from the Rio Grande Valley were previously obtaining abortions somewhere other than Corpus Christi, even before that clinic closed. Nonetheless, the closure of the Corpus Christi clinic means that all women in the Rio Grande Valley will have to travel approximately 235 miles to San Antonio or farther to obtain an abortion. . . .

The Fifth Circuit went on to hold that the District Court was within bounds to find that one-third increase in distance — to 235 miles of distance — for an abortion, was an undue burden on the right of women to control their bodies under Roe, and Casey.

I am saddened, truly to even have to write about such scenarios as a possibility. Our founders would be ashamed of the Republican high-jinx here.

Even so — while much of the restrictive Texas measures would remain, the people of Texas will still be able to litigate, in new lower court cases, the issue of what constitutes an undue burden on women’s rights to an abortion, on an “as-applied” basis. Far from optimal, but not a death-knell, either. Without a USSCT opinion, new parties may effectively re-litigate these issues, as they apply to them, in new fact patterns. Highly inefficient — and a waste of judicial resources — but that is apparently what the Republicans want.

Waxing A Little Too Dramatic On A Saturday, In Forbes — On Pharma Brexit Effects

June 25, 2016 - Leave a Response

It may be that, in time (like after 2018), we see a major global contraction in pharma and bio-science spending due to Brexit — but I’d certainly not make that guess today. It is hard to know, here on day two of this news cycle — but this seems just a little overblown.

One thing almost all of the larger multinational life science companies are blessed with is. . . cash. Lots of it — conveniently sitting right there, in Europe, to boot. And very modest debt levels, relative to other very large companies, in almost all other industries. [The only notable exception to that general rule would be certain tech players, like Apple and Microsoft.] In almost all other cases, it will be pharma that will be likely to readily, and freely deploy cash (from its vast stored reserves of the stuff, in Europe, in particular) as needed — to keep growing, in all these highly-lucrative developed markets.

So I’d say that this author is a little too “Chicken Little” for my tastes.

Pharma will adjust. It always does — it always will. It may hit rough patches, for a quarter or two, as things get sorted out — but it is as sound a sector as can be found, in uncertain times — like these. Here’s a bit of the Forbes froth (do feel free to consume with a truckload of salt):

. . . .The realities of newly uncertain markets will shake every major pharmaco. Based on what I’ve seen before, one of the first casualties becomes R&D. Next less profitable operations are quick to be shuttered. Finally when even more severe actions occur it will be easy to “Blame it on Brexit” for everything that goes bad or any type of corporate reshuffling. That won’t be pretty. . . .

As I say — it could come true — IF Germany votes to leave, and France does too — while weaker economies wrestle to rope them back in. But that seems unlikely — in fact, it seems that my cousins in Ireland, and those in Scotland, may hold referenda to rejoin the EU, and leave the UK. Either way — I’m not much for the histrionics, here. I do think taxation will change among these economies — but not until after 2018.

G’night to one and all of good will.

Unintended Consequences: What Of EU-Wide VAT Systems; EMEA HQ — Now That England Is Exiting The EU?

June 24, 2016 - Leave a Response

As I write this, the continent is staggering under the weight of collateral fallout and unexpected implications from last night’s British exit vote. That is no hyperbole.

There are precious few clear answers yet, so I’ll just mention that the system of cross Europe transactional taxes may need to be reworked — and that may have profound implications for all multinational life science companies.

However, one fairly clear immediate implication is that all the regulatory expertise currently housed in London, at the headquarters of the EMEA (sort of the EU version of our FDA) will. . . depart. It is not at all clear that if (for example) EMEA HQ is relocated to Frankfurt, Germany, or Paris, France (the two most likely candidates, in my estimation) the science staffers would be willing to relocate. So multinationals may face additional hurdles (and delays at least) in clearing drugs for sale in the European Union, as the agency’s London HQ is wound down. It remains unclear however whether the UK will create a separate “whole cloth” regulatory scheme for drugs, devices and biologicals — one that might well conflict with existing EMEA frameworks. In any event, here’s a bit from Reuters, overnight:

. . . .The association of Germany’s pharmaceuticals industry said the European Union’s London-based drugs regulator, the European Medicines Agency, will have to relocate after Britain’s vote to leave the EU, posing a considerable administrative burden for drugmakers.

“The administrative hurdles that we are now facing as a result of Great Britain’s exit from the Union will require great efforts on the part of our member companies,” the association said in a statement on Friday. . . .

It is almost as though the people of Britain are awakening this morning and collectively saying. . . “Wait — I drank WHAT, last night? Sheesh.” Global equity markets are tanking as well, as they open. Yikes.

In any event, it will be sorted out in due course — but I’d not be shocked to see an undo referendum vote effort emerge, about a year from now, from the saner British quarters. Onward, on a sunny warm Friday. . .


Get every new post delivered to your Inbox.

Join 70 other followers