Thursday, December 8, 2016

Commander John H. Glenn Catches His Last Flight -- Out...


This truly is a moment for. . . smiles -- of wonder. Senator Glenn just caught a ride -- on a moon-beam -- and he's on his way. [How does one hold a moon-beam, in one's hands. . .?]

This was a man whose life embodied every bit of what the greatest generation was all about. At the bottom, I'll add a few lines of poetry or prose, when I find something truly fitting. But for now, read his local newspaper's version of some of more prosaic events of his life. Yes, by the standards of his life -- the Friendship Seven ride was just one small part of the arc of his life. [He might well say that every moment, with his Annie, made up almost all the transcendent ones, you see.] Here's a bit:

. . . .In 1959, [Commander Glenn] was selected as one of the country's first seven astronauts, a historic group immortalized in Tom Wolfe’s 1979 book The Right Stuff, the basis for a movie of the same name.

The United States was enveloped in a cold war with the Soviet Union, and after a series of U.S. rockets had blown up, the American psyche was dealt a blow in 1961 when Russian Yuri Gagarin became the first human in space and the first to orbit Earth.

The third American in space after suborbital missions by Alan Shepard and Gus Grissom, Glenn finally equaled Gagarin’s achievement by blasting off on Feb. 20, 1962, after weather and mechanical problems caused his mission to be postponed 10 times.

Crammed into the 7-foot-wide Friendship 7 space capsule atop a 100-foot-tall Atlas rocket loaded with 250,000 pounds of explosive fuel, Glenn launched 160-miles into space, orbiting the world three times at 17,500 miles per hour.

Reflecting many years later, Glenn would say that computers were the greatest technological achievement during his life, but there were none on Friendship 7, and deep into the flight he had to take manual control of the capsule when systems malfunctioned. . . .


[More in moments -- but just as a sweet one turns one -- another rides. . . a moon-beam out. . . .] Sally Ride is known to have remarked -- of where Commander Glenn is now -- "the stars don't look bigger [in space], but they do look brighter. . . ." That I think is the perfect closer, here. Perfect. Smile with me now.

नमस्ते

Battling -- From The Sublime, To The Ridiculous: Even Verdict Form Disputed In Delaware Patents Row


As the jury trial now underway in Delaware's federal District courthouse breaks for lunch -- on its fourth day -- we see that the parties cannot even agree on which questions to ask the jury, and in what order to ask them -- when it comes time to retire, and deliberate.

Not surprisingly, Merck's version (since Merck owns Idenix) is longer, by three pages -- (at nine total in that PDF file) and puts a very specific calculation of potential damages very near the top.

Equally non-surprising is the notion that Gilead/Pharmasset leaves the damages question to near the very end of its six page PDF file. Gilead also has argued to reduce the number of matters that are even jury questions, throughout its pre-trial motions, so it asks quite a lot less, of this jury. The able Judge Stark is likely to adopt a hybrid of each form, but I have attached each of them -- for those of you interested in such minutiae. . . [as they are unlikely to come into play for a full week yet]. But now you know. [This isn't likely to be a record breaking patent damages  trial -- but it still could happen. So we now watch it, closely. Daily, in fact.]

Now, I venture ever onward, on a lovely if icy-winded December afternoon -- must. find. soup. But grinning ear to ear, here. More holiday parties await tonight. Be excellent to one another. Pax tecum.



नमस्ते

On The Virtues Of Anonymous -- But Civil, And Free -- Expression Of Ideas... Some 240 Years' Worth


I've written a fair bit about the virtues of Alexander Hamilton's thoughts, of late.

And it bears renewed mention, that almost all of his debates -- especially about immigration, with Thomas Jefferson, in particular -- were conducted in newspapers of general circulation, under various pseudonyms.

In fact, almost all of the Federalist Papers were originally printed under the name Publius. [In that sense, this medium of exchange is not so terribly different than the sort that was employed by the founders. Minus the Ju Ju Beats, of course.]

So it is that most of the central ideas that became our system of ordered liberty, and checks and balances -- were penned anonymously -- and debated in that same way, at first. As a protection from. . . yes, a tyrant. That is food for thought, as to the continuing value of anonymous public discourse, in times where a new leader may well challenge many of the core constitutional values this nation has held for going on 240 years.

So I will remain... faithfully supportive1 of anonymous public discourse -- where the idea stands, or falls, of its own merit -- and matters more than the name attached to it.

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

1. Having said all of that, the act of doxing someone who wishes to remain anonymous is. . . quite literally. . . beyond the pale -- of civil, humane behavior.

नमस्ते

Wednesday, December 7, 2016

Slightly More "Granularity": On The Pending 21st Century Cures Act -- Likely To Be Signed By President Obama


My sincere thanks go out to my (long-time) anonymous commenter, over the weekend. I will (in a future, more fulsome reply) offer a little more detail on what the Senate is likely to pass -- and the outgoing President is likely to sign into law, before he leaves office. At the moment, I'll highlight a part of it that addresses long-simmering industry grumblings about FDA hints of enforcement, on additional discussions about any item not already on the approved drug's labeling. [But in my view, that doesn't (necessarily) make it all bad -- of itself.]

I will -- as I indicated in comment replies -- withhold my section by section critique and analysis, until we have a better sense of "what else" the incoming Administration might have in mind as to FDA matters, more broadly. [And as if to specifically make my current reticence prescient, Merck and Pfizer are each off over two per cent on the NYSE this morning -- due to Trump hawkish tweets, on US drug pricing. So we will hold our fire, until an actual Administration exists, and begins to outline policy priorities.] In the mean-time, this Hogan Lovells explainer provides a nice "middle of the fairway" summary of what the bill is -- and isn't -- about:

. . . .The bill does not, however, shed light on the uncertainty that has swirled around the meaning of “competent and reliable scientific evidence”, nor does the bill instruct FDA to issue guidance to clarify this and other aspects of the safe harbor provisions. Other potential areas of ambiguity are the factors for determining whether or not HCEI “relates to” an FDA-approved indication, and whether or not there are any “material differences” between HCEI and a product’s FDA-approved labeling. Determinations of relatedness and materiality can be inherently subjective and without further guidance from FDA, manufacturers may be inclined to over-disclaim or to hold back from utilizing the expanded safe harbor until the Agency’s interpretation of these provisions becomes more clear through enforcement actions or otherwise.

Finally, these provisions do not address certain points that many stakeholders had sought. For example, the exclusion of analyses relating solely to an unapproved indication seems to foreclose the ability to engage in HCEI discussions about pipeline products prior to approval. Also, the proposed audiences for HCEI appear to preclude manufacturers from proactively discussing HCEI with certain entities (such as ACOs, IDNs, or groups developing treatment pathways or guidelines) that often factor economics into their decision-making, but do not make “coverage or reimbursement decisions” per se. . . .


Now you know. We will -- as ever -- keep a weather-eye, on the horizon here -- for additional news.

नमस्ते

Tuesday, December 6, 2016

Merck And Gilead Are Picking A Potentially Multi-Billion-Dollar Patent Jury Right Now, In Delaware Federal District Court...


With final pre-trial motions disposed of as of late yesterday -- this morning, Gilead's lawyers and Kenilworth's lawyers. . . should begin jury selection now.

While this trial is now not going to be bifurcated -- and while it holds the potential for a high-tens of billions of dollars, in patent infringement damages. . . I strongly suspect that result will not ultimately occur.

We will keep you apprised, as ever, just the same. This trial at least seeks the biggest patent damage award ever alleged in United States history -- by quite a wide margin. It is likely to run through the 15th, according to the court calendar.

Now you know -- and with the sound of one single voice. . . all is well with the Universe once more. . . smiling ear to ear, as I walk in. . . .

नमस्ते

[U] Dramatic Tete-A-Tete: Mr. Shkreli's Lawyers Re-Emerge, By Letter, Overnight -- In Reply


[Subsequent "End of Day" update, here.] UPDATED @ 3 PM EST 12.06.2016: The very capable Judge Kiyo A. Matsumoto has ruled as follows -- in Brooklyn's federal District Court, this morning:

". . .ORDER as to Martin Shkreli letter dated 12/5/16 [126] and Retrophin letter dated 12/5/16 [124]. ORDER as to [124] and [126]. The court appreciates the ongoing efforts of counsel to resolve the attorney-client privilege issues raised by Retrophin and expects that good faith negotiations will continue. The court's November 30, 2016 order is modified as follows:

(1) Katten Muchin's date for producing communications involving Mr. Shkreli between 2013 to 2014 is extended from December 6, 2016 to December 9, 2016, so that Retrophin can make necessary disclosures consistent with its contractual obligations and continue its talks with Mr. Shkreli to address its other concerns.

(2) Mr. Shkreli and Retrophin shall continue good faith discussions regarding the disclosure of documents relating to specific commercial products. Retrophin and Mr. Shkreli shall submit a joint status letter by December 10, 2016 to advise the court on the outcome of their discussions regarding communications relating to specific commercial products and remaining issues warranting the court's attention.

IT IS FURTHER ORDERED that, pursuant to Rule 502(d) of the Federal Rules of Evidence, Katten Muchin Rosenman LLPs production of its communications with Martin Shkreli to Mr. Shkreli in accordance with paragraph 3(a) of the November 30 Order [120] shall not constitute a waiver, in this or any other proceeding, of any attorney-client privilege that nonparty Retrophin, Inc. may have in such materials. As previously ordered, the court will not rule on further disclosures or on the admissibility of documents until Retrophin, MSMB and Biestek have identified and provided privilege logs regarding documents over which privileges are asserted.

Counsel for Mr. Shkreli shall serve a copy of this order on counsel for Katten Muchin, Retrophin, Mr. Biestek and the MSMB Entities by close of business on December 6, 2016 and note service on the docket. Ordered by Judge Kiyo A. Matsumoto on 12/6/2016
. . . ." [End, updated portion.]

As real life courtroom dramas go, this one has already surpassed all the over-hyped expectations -- and that hype was considerable, given that the protagonist is such an unabashedly ill-behaving odd-ball. But surpasss -- it has. Let's recap: last week we learned of one hour deadlines, half a globe away, for response to court filings.

So, that idea -- that US lawyers would find themselves "trapped in Europe" -- and thus hampered in meeting impending court filing deadlines, all while on globe-spanning flights. . . would seem plenty of good plot mill-grist.

But wait, there's more! Tonight, we learn of this bit of additional drama: it seems that spousal medical emergencies at least in part fed into the "missed signals" -- on whether Mr. Biestek was waiving client privilege (as to the MSMB materials at Katten). The Shkreli lawyer present for all the original calls was apparently drawn away by his wife's medical emergency -- for the past several days -- and thus is just now rejoining the discussions. High drama, indeed.

The upshot though -- is this latest five page letter -- filed late this evening, in Brooklyn.

I still think the able judge is likely to grant some of the argued-for (albeit belatedly-asserted) privilege to Mr. Biestek -- but we shall wait and see.

I am still puzzled that Mr. Shkreli thinks that just because he claims he "owns" a document -- he may avoid turning it over to the government, if it be unprivileged, and already covered by a subpoena. And I think it dubious that he could personally own any MSMB fund documents. He was not the fund. The fund was not. . . he. Heh.

So, that seems a stretch. But as I say, we shall see.

Now you know -- do go read it all. Fascinating.

And again -- this has been one of those nights where I've waited, mostly in vain, for sleep to find me. Even so, onward with a smile, this cold gray morning. . . .

नमस्ते

Monday, December 5, 2016

Only Slightly O/T: This Is A NYT/Hamiltonian Quite-Worthy Read...


This could well be more meaningful than the efforts in Wisconsin. This is a GOP elector -- ready to encourage a re-polling at the college meeting on December 19, 2016. Just as Alexander Hamilton had envisioned -- in times like these.

I will quote the barest part -- but do go read it all:

. . . .I am a Republican presidential elector, one of the 538 people asked to choose officially the president of the United States. . . . I do not think president-elects should be disqualified for policy disagreements. I do not think they should be disqualified because they won the Electoral College instead of the popular vote. However, now I am asked to cast a vote on Dec. 19 for someone who shows daily he is not qualified for the office. . . .

The United States was set up as a republic. Alexander Hamilton provided a blueprint for states’ votes. Federalist 68 argued that an Electoral College should determine if candidates are qualified, not engaged in demagogy, and independent from foreign influence. Mr. Trump shows us again and again that he does not meet these standards. Given his own public statements, it isn’t clear how the Electoral College can ignore these issues, and so it should reject him. . . .

Hamilton also reminded us that a president cannot be a demagogue. Mr. Trump urged violence against protesters at his rallies during the campaign. He speaks of retribution against his critics. . . .

The election of the next president is not yet a done deal. Electors of conscience can still do the right thing for the good of the country. Presidential electors have the legal right and a constitutional duty to vote their conscience. . . .

Fifteen years ago, I swore an oath to defend my country and Constitution against all enemies, foreign and domestic. On Dec. 19, I will do it again. . . .


In the end, it may not matter, but I do support this voice as one of reason -- as one that echoes Mr. Hamilton's thoughts. And those of Jefferson, Madison, Monroe and Franklin. We should all take heed -- and the electors should. . . take a pause.

नमस्ते

[U] A "Scorching" Monday Morning Missive -- From Cooley, About Mr. Shkreli...


[A later, and updating post is now up, on this topic -- here -- and even later, here.] This is turning into a regular pot-boiler: Retrophin (through Cooley) asserts that Mr. Shkreli has interfered, and is likely to continue to intentionally interfere -- with Retrophin's commercial relationships -- on its existing drug products.

It comes up (not surprisingly) in the context of the arguments about how much of the legacy Retrophin documents now held by Katten may be seen by Mr. Shkreli. The present suggestion from Cooley is that only Mr. Brafman be allowed -- i.e., "attorneys' eyes only" -- to see these documents (at least those which cover current Retrophin therapeutic products), and not Mr. Shkreli himself. This limitation is warranted, and due -- Cooley argues -- to Mr. Shkreli's prior abuse of his access to Retrophin documents. Fascinating -- and from where I sit -- that's entirely believable. Here's the bit -- from this morning's four page PDF filing:

. . . .Retrophin requests that the Court limit Mr. Shkreli’s access to communications relating to Retrophin’s existing commercial products: Sparsentan, Thiola, Chenodal, and Cholbam, because the Company is concerned that Mr. Shkreli will use the information to interfere with the Company’s ongoing business relationships, as he has in the past. Katten’s communications with Mr. Shkreli concerning these commercial products have no relationship to this case and indisputably relate to Retrophin, not MSMB or Mr. Shkreli personally.

Retrophin is not limiting Mr. Shkreli’s access to communications relating to these products. Retrophin is only asking that Mr. Shkreli’s counsel review them on an attorneys-eyes only basis to confirm that they relate to Retrophin, not MSMB or Mr. Shkreli, and should, therefore, be returned to Retrophin under paragraph (3)(c).

Mr. Shkreli’s counsel can isolate these documents by applying the following search terms to the documents they receive from Katten: Sparsentan (Sparsentan, Ligand); Thiola (Thiola, Mission, Biosolutia, Alamo, and DLSS); Chenodal (Chenodal, Manchester, and Nexgen), and Cholbam (Cholbam, Asklepion). Since the purpose of Mr. Shkreli’s review is to segregate the communications in which Katten was providing legal services to MSMB or Mr. Shkreli personally rather than Retrophin, limiting the review of communications responsive to those search terms will not prejudice Mr. Shkreli in the least, and will probably expedite the review provided for in paragraph (3)(c).

Retrophin also requests that it have the opportunity to challenge communications that Mr. Shkreli asserts were for the purpose of providing legal advice to MSMB or to him personally. Retrophin is concerned that Mr. Shkreli will be able to unilaterally determine that certain communications are covered by a privilege that he controls, when Retrophin would take a different position on those communications. In the case of communications that Shkreli contends are covered by his personal privilege, Retrophin respect fully suggests that Mr. Shkreli produce those to Retrophin for review since they are no longer covered by any privilege as a result of Mr. Shkreli’s waiver. In the case of communications that Mr. Shkreli contends are covered by MSMB’s privilege, Retrophin respectfully requests that Mr. Shkreli log them (unless Mr. Biestek waives the privilege over them). . . .


Fascinating -- and sadly hilarious, as to Mr. Shkreli's business life. Is there no bridge on the planet Mr. Shkreli has not previously. . . burned?

Now you know.

नमस्ते

Sunday, December 4, 2016

"Cold" Plasmas -- As Wound Care Agents: More Space Tech Reaches Earthly Development Stage...


Okay -- french fries are a guilty pleasure of mine (and someone else I know). And so, better french fries -- made so, by ESA-led space science -- well, that's a quiet snowy Sunday night perfecta. And it's a trifecta, when it all derives from. . . a medical application -- in this case -- wound care. Hilarious -- and prodigious!

From the ESA release, then -- a concluding bit:

. . . .Terraplasma continues to look at and develop new terrestrial applications using the cold plasma results from space. Together with German medical company Dynamify, it has formed Terraplasma Medical at ESA’s Bavarian incubator to develop systems for treating chronic and acute wounds and skin diseases. . . .


Now you know -- and whenever piping hot french fries (even minus the ice cold coke, and lots of ketchup and salt!) make it into the same article as a nascent med device -- you KNOW I am grinning. Ear to ear. . . g'night, one and all. . . g'night -- to all of good will.

नमस्ते

Gilead's Counsel Defends Its Awarded Legal Fees -- Against Merck Objections


As of Friday night, Gilead's legal team had set out its answers to Merck's objections about the amount of the fees it seeks from Kenilworth.

Here is the 13 page PDF file brief, filed Friday afternoon -- and a bit:

. . . .Merck’s argument that the Court should exclude Gilead’s fees related to summary judgment and claim construction (ECF No. 475-4 at 3-4) is wrong and unsupported. That Gilead did not prevail on specific issues raised during the course of this case is irrelevant; under established law, an award of fees for the entire case is warranted if it “bear[s] some relation to the extent of the misconduct.” Read Corp. v. Portec, Inc., 970 F.2d 816, 831 (Fed. Cir. 1992).

This Court held that Merck’s misconduct “casts a darkness on this entire case” and infected “this entire case.” [See ECF No. 422 at 60-61 (emphasis added).] Where, as here, the “litigation misconduct. . . was ‘pervasive’ enough to infect the entire litigation . . . a full award of attorney fees was proper.” Monolithic Power Sys. v. O2 Micro Int’l Ltd., 726 F.3d 1359, 1369 (Fed. Cir. 2013). An award of fees for the entire case is warranted due to Merck’s misconduct having infected “the entire case. . . .”


Onward, as the light, fluffy, flying snows approach here, on a busy-departures Sunday morning. . . [I should also have said Friday that the particulars of thy appeal are unique, in all my travels and experiences. . . truly unmatched, in all the world (a river, runs flawless warm, and silvery smooth, there). . . .] smile.

नमस्ते

Friday, December 2, 2016

In Which (It Seems) Mr. Shkreli's Criminal Defense Lawyers Are Having Trouble... Keeping All The Stories Straight.


[Yet another cross-post, from the Shkreli property.] This has to be the most fascinating cha-cha -- between some white shoe/silk stocking New York law firms I've seen in quite a while. . . .

Crowell & Moring, representing Marek Biestek (Mr. Shkreli's college friend and co-creator at MSMB, it is now claimed), says that it was (innocently of course) misquoted (in a filing prepared by the law firm of Mr. Brafman), and then filed with the court last week. It, and another letter filed this past Sunday (of Thanksgiving weekend, by Cooley) -- about Mr. Biestek's actual positions -- regarding waiver of client privilege, on the Katten MSMB documents, are in error they say.

I personally think Mr. Shkreli, and Mr. Biestek (chatting through their respective lawyers) are realizing that it is not a smart idea to say that Mr. Biestek surrenders everything (on these documents) to Mr. Shkreli -- since Mr. Shkreli has already broadly waived, here. So -- "I. Told. You. So. . ." is all I'll say. [I am guessing that -- since Mr. Biestek has not been accused of any wrongdoing in the criminal matter, in Brooklyn -- and because it is possible that the government might see evidence of crimes which might put Mr. Biestek in jeopardy of being charged -- the able Judge Matsumoto may well accept Crowell's argument (as to an error, here), and allow Mr. Biestek to at least argue for his client privilege. That is, the Judge isn't likely to penalize Mr. Biestek, in a criminal matter -- for any error or miscommunication -- by the various defense counsels, inter se.]

Just read this five page burner of a letter. More soon.

Hilarious -- but I previously told you what Mr. Shkreli's lawyers were saying. . . made absolutely no sense. Now (I conjecture) even Mr. Brafman's firm has been awakened to this fact. And when I refer to white shoe firms, or silk stocking New York firms above, I was not primarily thinking of his firm. Just to be clear, here.

As I say. . . more -- when I get some free time. Fascinating. Personally, I am not sure how one can assert an officers' "client" privilege, when one says (despite having founded the company) that one had no real day to day role in it -- nor did one own a majority/controlling stake of the equity. Me? I think this one is going to unravel -- and unravel badly -- as to Mr. Shkreli, at least.

Now -- off to dinner, with my young guy who is sitting for graduate exams in the morning. Smile. . .

नमस्ते

Just As I Said It Would -- UK Single-Payer Now Covers Pembrolizumab For Lung -- After Sharper Pencil Price Negotiations


I won't unduly belabor the point, but this is increasingly the new multi-national model for new drug pricing (Keytruda® pricing being a rather pointed example): often rather steep discounts from US list prices.

Even as to truly revolutionary treatments, the world's governmental-affiliated payers will increasingly seek -- and win -- price concessions from big pharma. And Mr. Frazier is (smartly, I think, given the incoming Administration is also likely to target drug pricing) talking peace, on price increases, more generally.

Here is the overnight item -- you may read it for yourself. But it was all easily predictable, back from June to October 2016.

Onward.

नमस्ते

Thursday, December 1, 2016

O/T Space Science, Updating: Cast Of "Hidden Figures" At "Actual" NASA -- Monday, December 12, 2016


Do see our prior post on this topic, for all the sublime background, here.

With a January 6, 2017 "launch" date looming for the likely ground-breaking film -- NASA itself will host the cast from "Hidden Figures" -- as part of its continuing celebration of these human computers of color (primarily black women from Hampton). [Once again, yes -- this is a STEM girl power historical story, on fleek.] Here is the item -- and a bit:

. . . .Media are invited to NASA’s Kennedy Space Center in Florida to participate in a news conference at 3 p.m. EST Monday, Dec. 12, with cast members from the 20th Century Fox motion picture Hidden Figures.

The film is based on the book of the same title, by Margot Lee Shetterly, and chronicles the lives of Katherine Johnson, Dorothy Vaughan and Mary Jackson -- African-American women working at NASA as “human computers,” who were critical to the success of John Glenn’s Friendship 7 mission in 1962.

The news conference will be held in the Kennedy TV Auditorium and will air on NASA Television and the agency’s website.

Media may participate by phone or in person at Kennedy. To ask questions during the news conference by phone, call 321-867-2468 no later than 2:45 p.m. Dec. 12. U.S. media must apply for accreditation by 4:30 p.m. Monday, Dec. 5. Credentialing for international media has closed. . . .


And with this post, I am at peace with the Universe, and all her wonders, once more. Also, and oddly, tonight -- not at all out of context, here -- do go see "Arrival." It is a wonderful piece of thought-provoking art. And be glorious to one another, forever backwards and forward, into Infinity. . . .





नमस्ते

And Meanwhile -- In The West Coast Version -- Of Merck Vs. Gilead Hep C (Patent Infringement Defense Legal Fees) Fight...


The very capable Judge Labson-Freeman, sitting in the federal district court for California's Northern District (San Jose) has given Merck 10 days to explain more completely why (and how) the materials related to her fee award to Gilead ought to be hidden from public view.

This will all be highly salacious, I expect, if Merck does not prevail in the reconsidered sealing motion. But we shall see -- and, bit from yesterday's order, here:

. . . .For the foregoing reasons, the sealing motion at ECF 475 is DENIED without prejudice. Merck may renew its motion to seal and serve Gilead so to provide Gilead an opportunity to submit additional declarations in support of the motion. Civil L.R. 79-5(e). The motion shall be renewed no later than 10 days from the filing of this order. If the motion is not renewed in time or if no declaration is submitted within four days of the filing of the renewed motion, Merck shall file the unredacted documents in the public record. Civil L.R. 79-5(e)(1), (2). . . .

IT IS SO ORDERED.

Dated: November 30, 2016

/S/ BETH LABSON FREEMAN

United States District Judge

Case 5:13-cv-04057-BLF Document 484 Filed 11/30/16 Page 3 of 3. . .


Now you know. We will run silently -- for an indeterminate while, here -- but hopefully, as well -- for hope is the best of all things. . . [on an entirely unrelated topic, at nearly-Christmas-time 2016. . . smile.]

नमस्ते

What The Federal Jury, In Delaware, May Be Told -- As To Infringement -- Merck Vs. Gilead


To be sure, I'll have more on this just filed five page letter briefing -- for the upcoming December 5, 2016 patent infringement trial date -- in the morning, when I am not so sleepy.

For now -- do go read it. It accurately sets out the law, and frames the issues nicely. It was written by Gilead's lawyers, though -- so do keep that in mind.

. . . .Following the Court’s direction at the pretrial conference, Gilead submits this proposal regarding what the jury can and should be told regarding infringement. Gilead believes that the issue should be handled by (a) giving the jury a short preliminary instruction that “infringement of the ’597 patent is not an issue you are deciding in this case”; (b) reading the parties’ statement of uncontested facts to the jury as part of the preliminary instructions (D.I. 452, Ex. 1), which includes a neutral statement of what the parties have agreed to; (c) preventing counsel from commenting on or eliciting testimony relating to infringement during trial; and (d) reiterating the same instruction regarding the issues that the jury is deciding (or not deciding) as part of the final instructions. . . .


And all of this matters, because Merck has made what is reliably reputed to be the largest putative patent infringement damages award request in the history of the United States federal courts system -- and by a wide margin, too. Not that Kenilworth is likely to receive it -- just that the company seeks it. That makes it. . . newsworthy.

Now do sleep soundly this night-time, one and all -- like little round river rocks. . . smile. . . .

नमस्ते

Wednesday, November 30, 2016

The Possible Shape -- Of "Medicaid Expansion 2.0" -- Nationwide, In 2017-2018?


Will Seema Verma's likely appointment signal that -- despite the "repeal and replace" campaign rhetoric -- the 45th President's administration will in fact deliver a largely intact version of Indiana's Medicaid expansion program, nationwide?

If so, that would largely be a net-positive outcome, for people of limited means in the US. Of course the version implemented in Indiana included a six-month lockout from coverage, if one was not looking for work (a provision that appeals on an "optics only" basis, to the conservatives -- but actually drives up the overall cost of care).

Even so, it makes plain that supposed HHS Secretary nominee, Dr. Price -- and his putative "repeal" will in practice actually more closely resemble many of the "continuation plan" ideas the Democratic nominee had discussed, as "ObamaCare 2.0". Sweetly ironic -- that.

In addition, this development makes for a suggestion rather broadly, I think, that Mr. Pence's pragmatism -- not Mr. Trump's idealogues -- will actually run most of the domestic policy portfolio. And that may turn out to be a limited victory, for people who believe that at least basic health care is a human right. Here's a bit from NPR's fine reporting:

. . . .Susan Jo Thomas, who heads the Indiana insurance advocacy group Covering Kids and Families, says Verma's contributions to HIP 2.0 made Medicaid expansion possible in a Republican state. "She understood that in order to get expansion in this state, it's more about what is palatable, what can get approved," she says.

Nearly 410,000 people are members of HIP 2.0, according to the latest data from the state.

Policy analyst Joan Alker, with the Georgetown Center for Children and Families, finds it worrisome. "It is a good thing that she has experience with Medicaid and it is a positive that Gov. Pence worked with Ms. Verma to advance a version of Medicaid expansion," she says. "But I think if you look at the totality of the Trump administration's picks today — Congressman Price as well as Ms. Verma — this represents potentially a very damaging and chaotic restructuring of the Medicaid program." Price has advocated severely cutting Medicaid funding, and Alker worries that cuts and more stringent requirements under Verma would mean people will lose the health insurance.

"The Healthy Indiana Plan has occurred in the context of generous federal funding," she says. "And I think some of that is on deck to go away. . . ."


Me? I am not so sure about federal funding cuts (at least in this area). I think when the dust settles, we are likely to learn that Mr. Trump is far more a "spending" government believer, than a tight-fisted conservative. What that means (assuming he can get Congress to go along) is largely a continuation of basic health care, for millions of low income Americans. Once again -- and I am not complaining here -- Mr. Trump says one thing; then does pretty much the opposite of that thing. So, I am smiling this fine morning -- be excellent to one another. . . .

नमस्ते

Tuesday, November 29, 2016

A Quick Peek -- At The Theranos Trainwreck -- Now Unfolding...


I just wrote this, overnight, for another blog property. Please forgive me. I am reposting it here, as the intersection of securities law and life science device regulation is a keen interest of mine. I hope the readership will forgive me for that, as well. Smile.

UPDATED -- 11.29.2016 @ 9:15 EST: Billy asks what form the various purchased securities took. In the case of Mr. Colman, it seems it was eventually delivered as straight voting equity (probably common) -- but perhaps only after he purchased in a "SAFE" type transaction (or a "simple agreement for future equity"). In SAFE offerings, the investor really only gets an "option" to get equity at some future date, and some future (usually "no worse than") price. In fact, most SAFEs simply kick the can of valuation/dilution (the hardest question in any early round). . . down the alley a bit -- rather than dealing with it, directly. And so, as a rule, I do not favor them. [As background, here is the original July 2010 SEC Form D (filing under Rule 506) -- disclosing that likely Colman purchase. It includes "options to buy", and $45 million of an expected $100 million had been raised -- to that point.]

Separately, in the case of Ms. Hilary Taubman-Dye, she purchased an odd-ball series of preferred (likely in the after-market -- at least nominally). I call it odd-ball, because Ms. Holmes kept an extraordinary amount of post sale control (in the form of multiple first refusal layers), on the preferred. From the complaint, then:

. . . .Plaintiff Hilary Taubman-Dye (Ms. Taubman-Dye) is a California resident. She purchased Theranos securities in August 2015 at $19.00 per share as Series B units of a SharePost affiliated fund, Celadon Technology Fund VII, LLC, whose purpose was to acquire Theranos shares of other investors or current or former personnel who held Series C Preferred shares, and hold Theranos stock. This transaction was managed and conducted by SharePost Financial Corporation (SharePost.com); a subsidiary of SharePost Inc. located in San Bruno, California, and was controlled by and occurred with the knowledge and consent of Defendants.

Ms. Taubman-Dye’s August purchase did not finalize until December 7, 2015, as Defendants imposed three separate rights of refusal on the sale. The first allowed Theranos to purchase Company stock on the same terms offered to SharePost; the second offered the same terms to Holmes; the third allowed Theranos to assign their right of first refusal to an undisclosed third party (an “Assignee”), pursuant to which such Assignee could purchase Theranos securities on the same terms previously offered to Theranos and Holmes. On August 19, 2015, SharePost successfully entered into a binding purchase agreement with a seller of Theranos securities. On August 21, 2015, the unidentified seller provided notice to Theranos of the proposed sale, triggering the relevant rights of refusal to Theranos Securities. On October 19, 2015, after the WSJ’s Theranos exposé, Ms. Taubman-Dye attempted to cancel the transaction (as did others); but SharePost informed investors that Theranos waived its right of first refusal, thereby triggering the rights of Holmes and, potentially, the Assignee. Neither Holmes nor any third party exercised their rights. Ms. Taubman-Dye’s purchase became final on or about December 1, 2015.

All aspects of this transaction took place in California as the offer to sell took place in California, and all documents were sent from and delivered in California. Ms. Taubman-Dye relied, at least in part, on Theranos’ representations herein, including that Theranos had developed a commercially ready groundbreaking blood test technology that was highly accurate, that involved drawing only a few droplets of blood, and was being successfully rolled out by Walgreens. Ms. Taubman-Dye was not aware of the material omissions alleged herein. . . .


Now, most of the above is why the usual suspects in the financial MSM are having a hard time describing the securities. The terms of Ms. Taubman-Dye's version of them were -- at best -- highly unfavorable to her, as an investor.  All investors as they invest need to see the exit -- and the bolded part above (an undisclosed parties' right to block the investors' exit -- or at least delay it, materially) is simply beyond the pale, in my experience. Ms. Holmes was (as alleged, at least) selling chunks of the pure Blue Sky. And that my friends is what led to the creation of the '34 and '34 Acts -- after the stock market crash of 1929. So the state versions were called "Blue Sky" laws. Now you know.

[End, Updated portion.]

This is -- strictly speaking -- off topic. But it is entertaining.

And Billy asked -- so here it is. A 57 page complaint at law -- just filed today, in San Francisco federal District Court. But this is no ordinary putative federal securities class action. And this is no ordinary lead plaintiff.

These are heavyweight Silicon Valley hitters -- and they are going to get Ms. Holmes. You heard it here first, Billy.

Her (alleged) deceptions look every bit as brazen as one Martin Shkreli's (in my humble opinion).

If there is anything left to take, these folks will be entitled to it.

Per Bloomberg, then a bit:

". . .Theranos Inc. was sued by a venture capital investor who claims Chief Executive Officer Elizabeth Holmes lied about its blood laboratory technology in which a pinprick of blood could be tested for hundreds of diseases.

The lawsuit, citing investigations by the U.S. Justice Department and the Securities and Exchange Commission, argues Holmes’s claims were overstated and the technology was flawed. Lead plaintiff Robert Colman, who bought shares through Menlo Park-based Lucas Venture Group XI LLC, seeks class-action status to represent investors in Theranos securities from July 29, 2013, to Oct. 2 of this year. . . ."


I will predict that while she may not ultimately see a criminal indictment -- she will be ruined, as a life science business leader of any sort, in the end. Theranos will be Turing -- and vice versa. Bank on it.

She sold sizzle -- and she allegedly knew long ago she had no steak, to back it up.

As goes Mr. Shkreli's story. . . End of story (both).

Now to walk over, on a flawless sunny morning -- expecting all the best. . . as ever.

नमस्ते

Monday, November 28, 2016

Minor Update -- In Delware Federal District Court -- On The Hep C Patent Spats...


Last week, before the holiday break, the able federal District Judge Leonard P. Stark, sitting in Wilmington, entered an order which set a small part of the Gilead-Merck patent spat for trial on December 5, 2016.

He denied a delay, on the issue of whether Gilead's subsequent work, also under a patent of its own -- facially infringes Merck's. The judge is expected to rule by next week -- about bifurcating the trial. I am guessing he will bifurcate. That would mean that the more important question -- of whether Merck has a patent that is enforceable -- may wait for another day. [The "Defendant" in the pull quotes below is. . . Gilead. Just for those of you keeping score at home -- that don't want/need to open the linked PDF.]

And to be clear, I think this portion of the trial will likely find infringement -- but that is to be expected. The question at the likely bifurcated trial, part two if you will -- will be whether that Merck/Idenix patent filing ever set forth a sufficiently precise written description -- such that Gilead should have avoided infringing on the work, as a valid "teaching the art" patent. Quoting a bit from the Memorandum Opinion and Order of last Tuesday, then:

. . . .The evidence at issue in this motion is probative of Defendant's contention that the patent-in-suit is invalid due to lack of written description. A reasonable jury could credit Defendant's evidence that in the immediate aftermath of Pharmasset's Dr. Schinazi making certain disclosures to Idenix's patent attorney, Idenix cancelled all pending original claims and added broader claims, which may be probative of Idenix's inventors not being in possession of the full scope of the ultimately-claimed inventions at the time they filed the original patent application. The Court agrees with Defendant that "the jury is entitled to consider such evidence in determining how the hypothetical person of skill in the art would view the disclosure. . . ."

It will be a contested factual issue whether Pharmasset had access to Idenix confidential information and, if so, what, if anything, Pharmasset did with it. The parties will be permitted to argue all reasonable inferences from such disputed evidence. . . .

The parties hotly contest which of them is the innovator and they will be permitted to present evidence to support their view of that controversy. To the extent Plaintiffs argue or imply that there is anything improper in merely following a competitor's published patent-related activities, the Court will be inclined to accept any reasonable jury instruction to be proposed by Defendant to clarify this point for the jury. . . .


And now we. . . wait. We wait for a clear day, and a smile to rise, and shine a beaming shaft forth -- south of these parts. . . a wide grin, in fact. . . .

नमस्ते

Sunday, November 27, 2016

The End Of A Bad Long Weekend -- For Martin Shkreli: Federal Criminal Procedure Department


UPDATED: Will this new release of the privilege, on the $900,000 note document disclosure hinted at below, lead to a new, ninth count, in the federal felony indictment? We shall see. End, updated portion.

Well, as we wind down another of our great holiday weekends -- with many, many loved ones now heading to the exits -- Retrophin's lawyers at Cooley have just now weighed in. [Recent background here.]

It is significant that the firm filed this six-page letter on a Sunday.

Mr. Shkreli's idiotic, and nearly complete, disregard for the most basic of separation-of-entities principles has hastened what may be his own undoing -- leading inexorably to up to 10 years as an orange-clad guest of a federal facility. At least three entities have been required to respond to government subpoenas -- and in each of those, Mr. Shkreli cannot seek much protection, especially since he routinely violated his own email policies, at those entities.

Now we learn that all the parties opposing Mr. Shkreli feel Mr. Biestek never held a privilege -- so it may well turn out that Mr. Shkreli's waiver of privilege only serves to bolster the government's evidence under the indictments. Here's a bit -- from the Sunday letter, from Cooley LLP:

. . . .Katten and Retrophin agree that for the period between August 2012 (when Retrophin began archiving emails) and September 30, 2014, when Mr. Shkreli was replaced as Retrophin’s CEO (and no longer had a Retrophin email account) Retrophin has a record of all of the emails between Katten and Retrophin, MSMB and Shkreli, and, therefore, Retrophin can begin its review of that segment of Katten’s files using its own email files. Retrophin has already begun searching these emails for additional documents within the scope of its existing waiver (and the $900,000 Note) and will substantially complete its production of responsive documents on December 6th. . . .

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

[Footnote No. 1]: Retrophin objects to Mr. Brafman’s proposal, which he made in his letter dated November 23 (Dkt. 116), that Katten turn over to Mr. Shkreli all of the MSMB documents. If Katten had a reliable way of identifying those documents, then Retrophin would agree to that proposal. But Katten does not believe it can do so, and all of the parties agree that culling those documents using the search term “MSMB” would identify a substantial number of Retrophin documents. Thus, Retrophin submits that the best approach is to adjudicate Mr. Biestek’s invocation of privilege first.

The Government contends that Mr. Biestek never had a privilege in MSMB’s documents. Retrophin will not weigh in on that issue at this point but contends that any such privilege was waived because, to the extent that Katten may have provided legal advice to MSMB after September 2012, Katten’s communications with Messrs. Biestek or Shkreli were sent and received on Retrophin’s email server, and certain communications prior to that period are also stored on Retrophin’s network. According to Retrophin’s E-mail Policy (Exhibit A) and its Code of Business Conduct and Ethics (Exhibit B), Messrs. Biestek’s and Shkreli’s communications with Katten on behalf of MSMB stored on Retrophin’s network belong to Retrophin. See Ex. A ¶ 3 (“[a]ll electronic data (including communications received, sent, to be sent or only partially drafted) that are transmitted through Company facilities and/or stored on a Company computer or storage media are the property of the Company.”); Ex B. at 3 (“Users should have no expectation of personal privacy in their use of Company communications systems or information sent to or from or stored in or on Company communications systems. . . . Even personal messages on the Company’s e-mail and voicemail systems are Company property.”); see also Exhibit C ¶ 18(i) (Mr. Biestek’s employment agreement, in which he committed to sign and be bound by the Code of Ethics). . . .


Clearly the able Judge Matsumoto will have to rule on these issues -- these parties are at loggerheads. Now I'm off for a series of airport drop-offs, and train station loadings-out. . . smile -- and we will do it all again in four weeks! Grinzzz. . . .

नमस्ते

Saturday, November 26, 2016

O/T Planetary Science: NASA's Cassini Begins... Its End.


We will almost undoubtedly learn much new astrophysical geological science, about the chemical composition (and various proportions -- of the icy rock-slab sizes -- from motes of dust, to perhaps car sizes) of Saturn's gorgeous rings -- in the next ten months. But we will also sacrifice the Cassini spacecraft to do so. She has enjoyed an immensely productive twelve year run, so we should not feel terribly blue. But as it is with all ends, I cannot help but feel a little sentimental -- just a little.

At right, courtesy of the CGI whizzes (in a now reduced animated GIF form) at the New York Times Science staff, we may see what the last several orbits (in gold) will look like -- compared to the earlier 12 years' worth (in blue). Dipping so close means. . . burning nearby, as opposed to freezing, at a distance. So it goes. Here is a bit from the Gray Lady:

. . . .Cassini has gradually shifted into an orbit that takes it over the planet’s north and south poles and then down into a series of increasingly vertiginous-looking dives perpendicular to the plane of its buttery glowing rings.


Starting on Wednesday, as shown here, with a gravitational nudge from the moon Titan, Cassini is set to commence a series of 20 dives just outside the outer edge of the main ring system. Along the way the spacecraft will try to sample ring particles and gases that live there in its vicinity, and pass only 56,000 miles above Saturn’s cloud tops. . . .


Eventually, in mid-September 2017, the spacecraft will make a final, forceful plunge -- disappearing into the clouds of Saturn and then -- almost immediately -- be completely incinerated by the generated friction. [Not long before that, we will have eye-witnessed a complete eclipse -- directly over the city north and east of Nashville, Tennessee.] So as I sip my Saturday morning coffee, fresh OJ, and watch the ends of a November sun slowly crest the taller buildings here, I am thinking some sentimental celestial thoughts. Thoughts of a long and fondly orbiting, if not near-by, shepherd moon -- copper in color, and ageless -- in her grace. Smile. . .



नमस्ते