More Sales Force Cuts At Merck — 1,800 Positions “Ghosted” By January 2, 2018…

October 20, 2017 - Leave a Response

This follows on the heels of similar moves at Lilly (3,500 positions), just a month ago. And two months ago, generics maker Teva announced 7,000 would be let go.

So it cannot be entirely unexpected (at least on Wall and Broad) — and even though the affected folks may “self-nom” for newly created roles (960 of them, in chronic care alone). . . and they have until New Years to find different roles inside the company — this is never easy.

FiercePharma first had the story — do go read it all. But this is about real people, losing their jobs — their careers. Whole families being dislocated, almost as effectively as Harvey or Irma both recently did. Know that our thoughts and meditations are with each of you. [Been there; done that; got that tee shirt.]

Onward. And know that soon enough, the sun will also rise, for each of you.



Even If It Is $275 Million… It Is Immaterial. Yawn.

October 20, 2017 - Leave a Response

There were some fairly breathless reports overnight — mostly third party guesses, actually — as to the potential size and scope of the mid 2017 cyber attack that struck Merck, among other multinationals. At the size reported, it would be. . . simply immaterial to Merck — and Merck need not comment at all on the matter.

It should be noted that Kenilworth has definitively said that it is still unable to estimate a range of exposure for the attack, all in. Under applicable SEC rules, the company need only provide such a guestimate if it is (i) reasonably likely to be material (i.e., more than five percent of annual revenues — or more than about $2.4 billion), and then (ii) reasonably capable of any confident estimation.

So — for my part, while I expect that the vaccine interruption may ultimately total a little more than these breathless guesses, the range would have to grow about ten-times larger, to be “material” under current SEC guidance.

And I think that possibility is vanishingly remote. Which is likely why the company’s stock rose on the NYSE yesterday, and will likely trade about even with the overall large cap pharma market today. Earlier this week, J&J reported a solid quarter (Q2 2017); I expect Merck to do much the same, in fairly short order. Its earnings call is one week away.

Now you know — as we offer a “this day in history” moment on the masthead — just. . . for fun. Perhaps of more current relevance (but since I didn’t want to take the darker historical moment, and fashion any visual allegories), it was exactly 70 years ago this morning (October 20, 1947) that the US House Un-American Activities Committee began issuing subpoenas to people in Hollywood, essentially accusing them of communism — as a way to enforce conformity.

As I say, I didn’t want to wax into negative karma, but the current occupant of 1600 Pennsylvania seems to now daily tweet decidedly pungent bits — aimed both at the NFL owners, and players — trying to enforce his own brand of conformity, upon NFL players — union members, all. As I’ve written before, not only is that antithetical to a free and just labor market — and our society of ordered liberty, it is an arguable violation of federal law.

So — instead — as dawn arrives here, luminous and clear — let us contemplate the Louisiana Purchase! Smile. . . . onward, as I say. [I think Trump is simply trying to use his seat to get even with (settle scores) related to the three decades ago failure of his USFL NJ Generals. . . he has always blamed the NFL for that.]


Now, With Another Victory For Pluralism And Economic Freedom — In Maryland, Overnight — Trump Is 0-For-15!

October 18, 2017 - Leave a Response

A 91 page opinion has issued against Trump, in the federal district courts of Maryland, overnight. It comes on the heels of Hawaii’s ruling, yesterday — and this makes him 0-for-15, on the merits. His Ban 3.0 was slated to take effect today. No more.

Two items of note, here. First, the opinion carefully addresses the US Supreme Court’s removal of the “2.0” dispute from its own docket — explaining that while the earlier Fourth Circuit opinions are no longer technically precedential, the reasoning found there remains sound, and so the trial court quotes it where appropriate, but enters its own conclusions of law, independently. It also relies on the Ninth Circuit’s holdings, since the Supremes haven’t technically vacated those yet, either.

Second, this is a preliminary injunction, nation wide — while in contrast, the Hawaii opinion is a TRO (i.e., generally of shorter duration). This, then is the next step toward a permanent shut-down of Trump’s Muslim banning schemes. Of course, 45 will appeal, but here is a bit:

. . . .At issue is whether this latest travel ban should be enjoined by this Court because it is the latest incarnation of the “Muslim ban” originally promised by President Trump as a candidate for the presidency, and thus violates the Establishment Clause of the First Amendment to the United States Constitution, or because the issuance of the travel ban exceeds the President’s delegated authority under the Immigration and Nationality Act to suspend the entry into the United States of classes of immigrants and nonimmigrants. For the reasons set forth below, the Court concludes that a preliminary injunction is warranted. . . .

In response to the injunctions against EO-1, President Trump maintained at a February 16, 2017 news conference that EO-1 was lawful but that a new Order would be issued. J.R. 91. Stephen Miller, Senior Policy Advisor to the President, described the changes being made to the Order as “mostly minor technical differences,” emphasizing that the “basic policies are still going to be in effect.” J.R. 319. White House Press Secretary Sean Spicer stated that “[t]he principles of the [second] executive order remain the same”. . . .

In [its later] ruling, the Fourth Circuit described EO-2 as one that “drips with religious intolerance, animus, and discrimination.” Id. at 572. After finding that an individual plaintiff had standing to challenge the ban and concluding that upon a showing of bad faith it could “look behind” a proffered “facially legitimate” reason for the action, the court applied standard Establishment Clause analysis to conclude that because EO-2 “cannot be divorced from the cohesive narrative linking it to the animus that inspired it . . . the reasonable observer would likely conclude that [EO-2’s] primary purpose is to exclude persons from the United States on the basis of their religious beliefs.” IRAP, 857 F.3d at 586, 590-92, 601. . . .

[Today’s injunction] is limited to barring enforcement of Section 2 against those individuals “who have a credible claim of a bona fide relationship with a person or entity in the United States.” Trump, 137 S. Ct. at 2088. For individuals, the injunction covers visa applications by individuals with immediate family members, such as parents, children, or siblings, as well as “grandparents, grandchildren, brothers-in-law, sisters-in-law, aunts, uncles, nieces, nephews, and cousins of persons in the United States. . . .”

Onward — still with glimmers of hope, for my Cubbies — and that — at 0-3 is decidedly more hope than for any chance Mr. Trump will ever do anything sensible, or lawful.

His widely corroborated remarks to Mrs. Myeshia Johnson, the young widow of Sgt. La David T. Johnson, our brave serviceman killed in the line of duty in Niger (12 days ago — i.e., a long silence from 45) are. . . simply deplorable.

Even so, we will look forward to Bobby Three Stick’s conclusions — near Christmas 2017.

[Masthead updated, in the sincerely-held hope that people representing Katherine Johnson will soon consent to her inclusion — in the “NASA STEM on Fleek” a/k/a “NASA Cool Women Lego” set. . . . smile.]


Well… Some Things Never Change — And Some Things… Do.

October 17, 2017 - Leave a Response

At least last year, the Cubbies were world champs for the first time in over 100 years. At the moment they are down 0-2 to those transplanted Brooklyn Dodgers — but coming home, to the friendly confines, tonight. So, among us faithful. . . there is hope.

Okay. Roger that. Now. . . the last time Mr. Trump won any final, on the merits decision on his Muslim Bans 1.0, 2.0 and 3.0 was. . . Oops! Never. He’s zero for something like 14 now.

On to the Ninth Circuit (on Judge Watson’s fine decision, here — even though it is only a TRO — that’s been the Administration’s prior approach: take immediate appeals, rather than await a final injunction order, as 45 well knows it is coming). And all of this, while we await a trial court level TRO ruling in Maryland — with likely the same outcome as below. [Busy deal day — so I am late with this. My apologies.]

Here’s the full 40 page PDF of the opinion, from the correct and courageous USDC Judge Derrick Watson, just now — and a bit:

. . . .On June 12, 2017, the Ninth Circuit affirmed this Court’s injunction of Sections 2 and 6 of Executive Order No. 13,780, 82 Fed. Reg. 13209 (Mar. 6, 2017), entitled “Protecting the Nation from Foreign Terrorist Entry into the United States” (“EO-2”). Hawaii v. Trump, 859 F.3d 741 (9th Cir. 2017). The Ninth Circuit did so because “the President, in issuing the Executive Order, exceeded the scope of the authority delegated to him by Congress” in 8 U.S.C. § 1182(f). Hawaii, 859 F.3d at 755. It further did so because EO-2 “runs afoul of other provisions of the [Immigration and Nationality Act (‘INA’), specifically 8 U.S.C. § 1152,] that prohibit nationality-based discrimination.” Hawaii, 859 F.3d at 756.

Enter EO-3. Ignoring the guidance afforded by the Ninth Circuit that at least this Court is obligated to follow, EO-3 suffers from precisely the same maladies as its predecessor: it lacks sufficient findings that the entry of more than 150 million nationals from six specified countries would be “detrimental to the interests of the United States,” a precondition that the Ninth Circuit determined must be satisfied before the Executive may properly invoke Section 1182(f). Hawaii, 859 F.3d at 774. And EO-3 plainly discriminates based on nationality in the manner that the Ninth Circuit has found antithetical to both Section 1152(a) and the founding principles of this Nation. Hawaii, 859 F.3d at 776–79. . . .

Accordingly, based on the record before it, the Court concludes that Plaintiffs have met their burden of establishing a strong likelihood of success on the merits of their statutory claims, that irreparable injury is likely if the requested relief is not issued, and that the balance of the equities and public interest counsel in favor of granting the requested relief. Plaintiffs’ Motion for a Temporary Restraining Order (ECF No. 368) is GRANTED. . . .

Me? I am grinning ear to ear. As is Professor Albert Einstein — likely beyond the event horizon, on the other side of the known Universe.


And Let’s Discuss The “Secret” Trump Muslim Ban 3.0 Report, Too…

October 17, 2017 - Leave a Response

Here is the latest, on that score, as well. And a bit of the filing:

. . .A basic premise of our adversarial system is that each party is permitted to view and consider documents material to the resolution of its case. Only the most extraordinary circumstances justify a departure from that practice. This case does not present such a circumstance. . . .

More, on the morrow. . . .


Let’s Discuss This Tomorrow, Shall We? Worlds Of Gold And Platinum…

October 16, 2017 - Leave a Response

The new masthead overnight is particularly fortuitous confluence of events. . . for it is Einstein’s general relativity that is more solidly proven, as a fact, by the below light bursts, and billions of tons of gold and platinum formation, from the collision of two neutron stars — to say nothing of the gravity wave observed.

And exactly 84 years ago, the man himself was among the “huddled masses, yearning to breathe free“. . . this, while Trump reviews, endorses and signs secret reports — the object of which is the banning of disfavored nationalities. . . where have we seen that behaviour, before? Hmmmm. . . . I’ll let you decide, gentle readers.

In any event, from NASA, we offer this, as we wander off to sleep:

“. . . .For the first time, NASA scientists have detected light tied to a gravitational-wave event, thanks to two merging neutron stars in the galaxy NGC 4993, located about 130 million light-years from Earth in the constellation Hydra.

Shortly after 8:41 a.m. EDT on Aug. 17, NASA’s Fermi Gamma-ray Space Telescope picked up a pulse of high-energy light from a powerful explosion, which was immediately reported to astronomers around the globe as a short gamma-ray burst. The scientists at the National Science Foundation’s Laser Interferometer Gravitational-wave Observatory (LIGO) detected gravitational waves dubbed GW170817 from a pair of smashing stars tied to the gamma-ray burst, encouraging astronomers to look for the aftermath of the explosion. Shortly thereafter, the burst was detected as part of a follow-up analysis by ESA’s (European Space Agency’s) INTEGRAL satellite. . . .

I am simply agog, with the white-hot light, and gravitational waves, of colliding neutron stars. . . . see ya’ mañana. . . .


The Able Judge Bryson (In Texas) Ultimately Reserves On The Issue Of Legitimacy… But Expresses “Serious Reservations” About It, While Leaving The Question — For IPR Proceedings

October 16, 2017 - Leave a Response

We will have to wait for the IPR proceedings to answer the question, definitively — but it sure seems that the able Judge Bryson feels Brent Saunders’ gambit, “to rent” sovereign immunity from a tribe of indigenous people. . . should be struck, as a sham transaction.

Ever employing the rule of parsimony, he did not rule exactly that, this morning — to be clear. He ruled only that many of the patents are invalid — but reserved for the IPR proceeding, the precise question of whether Mr. Saunders’ artifice of “rented immunity” will be enforceable in the federal courts. Here’s the judge’s memorandum and opinion — and a bit:

. . . .The Court has reviewed the information and briefs filed in response to the Court’s order. From that information, it is clear that Allergan’s motivation for the assignment was to attempt to avoid the IPR proceedings that are currently pending in the PTO by invoking the Tribe’s sovereign immunity as a bar to those proceedings. . . .

The Court has serious concerns about the legitimacy of the tactic that Allergan and the Tribe have employed. The essence of the matter is this: Allergan purports to have sold the patents to the Tribe, but in reality it has paid the Tribe to allow Allergan to purchase — or perhaps more precisely, to rent — the Tribe’s sovereign immunity in order to defeat the pending IPR proceedings in the PTO. This is not a situation in which the patentee was entitled to sovereign immunity in the first instance. Rather, Allergan, which does not enjoy sovereign immunity, has invoked the benefits of the patent system and has obtained valuable patent protection for its product, Restasis. But when faced with the possibility that the PTO would determine that those patents should not have been issued, Allergan has sought to prevent the PTO from reconsidering its original issuance decision. What Allergan seeks is the right to continue to enjoy the considerable benefits of the U.S. patent system without accepting the limits that Congress has placed on those benefits through the administrative mechanism for canceling invalid patents. . . .

But sovereign immunity should not be treated as a monetizable commodity that can be purchased by private entities as part of a scheme to evade their legal responsibilities. It is not an inexhaustible asset that can be sold to any party that might find it convenient to purchase immunity from suit. Because that is in essence is what the agreement between Allergan and the Tribe does, the Court has serious reservations about whether the contract between Allergan and the Tribe should be recognized as valid, rather than being held void as being contrary to public policy. . . .

While it is important to ensure that any judgment in this case will not be subject to challenge based on the omission of a necessary party, the Court is not required to decide whether the assignment of the patent rights from Allergan to the Tribe was valid in order to resolve the question whether to add the Tribe as a co-plaintiff. Instead, the Court will adopt the safer course of joining the Tribe as a co-plaintiff, while leaving the question of the validity of the assignment to be decided in the IPR proceedings, where it is directly presented. . . .

Now you know. Onward, on a lovely fall afternoon here.


As Promised: The Dueling Restasis® Memos (Public Versions) On Joinder Of The St. Regis Mohawk Tribe…

October 14, 2017 - 3 Responses

The redacted versions have been uploaded to PACER in Marshall, Texas overnight.

I will quote from the defendants’ memo opposing the addition of the Tribe to the suit, on the central grounds that the entire license transaction was a sham, to subvert the existing US patent law review process. But I will also link to Allergan’s memo setting forth its argument — as to why joinder might be proper here — to be fair.

Since Allergan has argued in favor (related to its Botox® line of products) of exactly what is now arguing against, just one year later (on its Restasis® lines) — I’d say the defendants have the better of the argument:

. . . .This transaction was not a genuine purchase of intellectual property by the Tribe. Rather, Allergan paid for the use of the Tribe’s sovereign immunity to thwart the parallel inter partes reviews (“IPRs”) before the Patent Trial and Appeal Board (“PTAB”). Allergan admitted as much in its October 10 filing with the Court conceding that the alleged “consideration” provided by the Tribe was nothing more than the Tribe’s promise not to waive its sovereign immunity in the IPR proceedings. Thus, there has been no real change in ownership — just a maneuver to derail the PTAB’s ongoing review of Allergan’s patents. . . .

The sham nature of the transaction with the Tribe is further underscored by the fact that the Tribe did not pay Allergan a cent for the patents claiming Restasis, which generated $1.4 billion in 2016 sales, or $4 million dollars a day. Instead, it was Allergan who paid the Tribe $13.75 million up-front to take faux title to the Restasis patents. . . .

Further, the illicit purpose of the transaction — to subvert the PTAB’s lawful review and not to facilitate this litigation — provides ample reason to deny joinder. It bears noting in this context that Allergan used the IPR process against a third party’s patent that was inconvenient for Allergan’s best-selling Botox franchise only one year ago. Allergan even sought a stay of parallel district court proceedings on the ground that the IPR “would save both judicial and party resources, consistent with Congress’ intent in passing the America Invents Act.” Allergan Memorandum in Support of Motion Stay, No. 1:15-cv-03372, Dkt. No. 40 at 1-2 (N.D. Ill.). It is remarkable that Allergan considered the IPR process a valid, equitable proceeding for challenging patent validity when it filed its own IPR petition just last year — yet, now that the same tribunal is scrutinizing Allergan patents, Allergan and the Tribe consider IPRs “double jeopardy” administered by a “kangaroo court.” See Ex. 4 at 3. Given its own recent, successful reliance on IPRs, Allergan’s attempt to justify its sham assignment by labeling the IPR process inequitable, harmful “double jeopardy” is pure hypocrisy. . . .

Now you know — a rainy but happy weekend here — BladeRunner 2049 is a fine piece of art, and an entertaining diversion. Do re-screen the original, before going to the theater though — the back story is critical, here. . . “sometimes to show true love, one must disappear — become a stranger, entirely — to best protect the immortal beloved. . .” Truer words were never spoken. Out.


[U X 2] A New Patent Spat To Follow, Here: Allergan’s IP Moves On Restasis® — Mohawk Tribe Gambit

October 13, 2017 - Leave a Response

UPDATED: @ 3:15 PM EDT — Well. . . all the operative motions due today have been. . . sealed. [Paging the New York Times and CNBC — time to file a formal request, down in Texas. . . these are all of our courts. The case is pending in the Eastern District of Texas — 2:15-cv-01455-WCB; Allergan, Inc. v. Teva Pharmaceuticals USA, Inc. et al.; William C. Bryson, presiding.] I gather that the defendants oppose the joinder of the Tribe — and that Allergan believes joining the Tribe will not waive the Tribe’s sovereign immunity. Beyond that, we will have to wait for the able Judge Bryson’s order — in East Texas, to learn more. [Second Update — at day’s end, Friday — by tomorrow, I will have a new post, on the defendants’ opposition (public version), to joinder of the Mohawk tribe (claiming the whole Saunders-led transaction is a sham, to thwart the US patent system). Until then.
. . Blade Runner tonight — and. . . End, updated portion; off to hit the food trucks for some red velvet cake, with cream-cheese icing!]

As several of my regular commenters have noted here, and at our other properties — this odd-ball dispute does in fact relate to the original animating narrative surrounding this site, insofar as it is all being guided by Brent Saunders — long a “Fast Fred” Hassan protégé, and confidant. It involves Allergan’s Restasis®.

So we will track it — starting today. Later today, we expect that the lawyers for Mr. Saunder’s Allergan, at Fish, Richardson will explain for the able judge why, exactly, it is that the tribe has not yet joined the suit as a party.

That explanation is due by close of business today, Friday, but is not yet on file — in the mean time, here is a six-page PDF of a background Allergan response to an order, from last week — to get you up to speed if you haven’t been following it in the newspapers (along with a pull-quote):

. . . .The Court’s October 6, 2017 Order (Dkt. 503) directed Allergan to provide the Court with “copies of those documents pertinent to the terms of the assignment of the patents-in-suit to the Tribe, including any information as to payments made or to be made either by the Tribe or by Allergan in connection with the transaction. . . .”

In its October 10 Order, the Court also directed Allergan to identify what the “good and valuable consideration” referred to in the assignment of the patents-in-suit to the Tribe “consisted of, and to provide any documentary evidence confirming the payment by the Tribe of any such consideration for the assignment of the patents.” (Dkt. 509 at 2-3.) The promises and commitments made by the Tribe in the simultaneously-executed assignment and license agreements, and the subsequent performance of those promises, provides such consideration. . . .

Now you know — this one promises to be a barn burner — with Judge Bryson highly skeptical of Mr. Saunders’ attempt to game the existing US patent law dispute-, review-, expiration- and interference- systems. Stay tuned, and have a sparkling weekend, one and all — I know I will, with a very dear adult niece in town late tonight, for a short visit — before heading out to points west, by rail. . . . Good fun!


[U] Another “Nothing Burger”: Trump’s Dubious (MEWA?) Exec. Order — On Obamacare…

October 12, 2017 - Leave a Response

We now know he’s signed it — but until we can actually read a copy of it, in full, we cannot say for certain that it violates existing federal law.

However, I strongly suspect it does, based on what he “says” it does. 45 has lied anew. It does almost nothing he claims it does.

UPDATED @ 3:30 PM EDT — I’ve now read it. It’s aspirational only. A nothing burger — to wit:

“…Sec. 2. Expanded Access to Association Health Plans. Within 60 days of the date of this order, the Secretary of Labor shall consider proposing regulations or revising guidance, consistent with law, to expand access to health coverage by allowing more employers to form AHPs. To the extent permitted by law and supported by sound policy, the Secretary should consider expanding the conditions that satisfy the commonality‑of-interest requirements under current Department of Labor advisory opinions interpreting the definition of an “employer” under section 3(5) of the Employee Retirement Income Security Act of 1974. The Secretary of Labor should also consider ways to promote AHP formation. . . .

[End, update.]

More very soon whenever 45 decides to stop being so opaque. [Under Mr. Obama, executive orders were posted to the web as he signed them.] Not so, with the adult day care center, at 1600 Pennsylvania.

And so, until then — a graphic. If all it is is an aspirational MEWA authorization, it is meaningless — like almost everything else he has written on health care. And it will not affect November 2017 enrollment periods, in any event. But now we wait for the adult day care center to declare a recess, and let us inspect and analyze. . . his scribbles. Out, for now.