“Cold” Plasmas — As Wound Care Agents: More Space Tech Reaches Earthly Development Stage…

December 4, 2016 - Leave a Response

life-fries-coke-ketchup-football-game-2016Okay — 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 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

December 4, 2016 - Leave a Response

life-alt-fees-gil-12-2016 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

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

December 2, 2016 - Leave a Response

crowell-biestek-12-2-16[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 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.

shkreli-biestek-crowell-12-2016 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

December 2, 2016 - Leave a Response

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. So, to quote the old adage: “We’ve established what they are — now we are simply haggling over. . . price.” [But it used to refer primarily to investment bankers.] That was uncalled for. Now stricken.

Onward.

नमस्ते

O/T Space Science, Updating: Cast Of “Hidden Figures” At “Actual” NASA — Monday, December 12, 2016

December 1, 2016 - Leave a Response

life-hiddenfigures-real-2016-2017Do see our prior post on this topic, for all the sublime background, here.

With a January 6, 2017 opening 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.

nasa-johnson-spencer-2016The 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…

December 1, 2016 - Leave a Response

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

November 30, 2016 - Leave a Response

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

The Possible Shape — Of “Medicaid Expansion 2.0” — Nationwide, In 2017-2018?

November 30, 2016 - Leave a Response

life-alt-seema-verma-hhs-2-11-2016Will 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

A Quick Peek — At The Theranos Trainwreck — Now Unfolding…

November 29, 2016 - Leave a Response

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 aftermarket — 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.]

life-theranos-holmes-12-16 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

Minor Update — In Delaware Federal District Court — On The Hep C Patent Spats…

November 28, 2016 - Leave a Response

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 dawn, and shine a beaming shaft forth — south of these parts. . . a wide, copper twisty grin, in fact. . . .

नमस्ते