NuvaRing® Settlement Status Conference In federal District Court In Missouri Thursday: The Agenda

July 14, 2015 - Leave a Response

The process continues to proceed apace — but we are still many months from a check mailing date, here.

I’ll attach the presently proposed form of order, for procedural matters, and proof — that will likely be required, in order to Make a non MDL claim. It is probable that some version of this six page PDF will be adopted shortly after the July 16, 2015 hearing, by the court. [The separate issues raised by opt-outs are discussed here, in my backgrounder, from August 2014.] In any event, the hearing agenda:

. . . .JOINT AGENDA FOR JULY 16, 2015 STATUS CONFERENCE

COMES NOW Counsel for Defendants and Plaintiffs’ Negotiating Counsel and hereby submit the following matters for discussion during the July16, 2015 Status Conference:

1. Status update on the completion of the claims process, and the commencement of payments from the QSF Administrator for the NuvaRing Resolution Program.

2. Status of cases pending in NuvaRing MDL No. 1964 not participating in the NuvaRing Resolution Program:

a. Proposed Order Regarding Fact Discovery for Certain Pending Cases Not Participating in the NuvaRing Resolution Program, attached as Exhibit A;

b. Proposed revised Order Regarding Preservation of Record and Prima Facie Evidence of Usage, Injury and Causation Requirements for Pending Cases Not
Participating in the NuvaRing Resolution Program and Newly Filed or Transferred Cases, attached as Exhibit B;

3. Requested Date for next Status Conference of December 17, 2015. . . .

Onward, with high res Pluto photos due into NASA by 3 pm Eastern Daylight Time, tomorrow! Woot!

Latest Skirmishes — Merck Vs. Gilead — No Multi-Billion Dollar Early “Patent Interference” Resolution: Judge Stark

July 13, 2015 - Leave a Response

For the last three weeks, Merck and Gilead have been exchanging letters, through the very able Delaware federal District Court Judge Leonard Stark’s electronic file docket. The argument at the moment has been over whether (as Gilead wished) some summary decisions might be made on so-called Sovaldi® “patent interference” proceedings, well-ahead of a trial “on the merits” — of the challenged patents (under which Merck makes its claims here), themselves.

Gilead contends that the proceedings would be more efficiently and orderly handled — if that issue were decided shortly — in some sort of a summary fashion. Merck’s contention is essentially that the same process which governs such matters inside the USPTO ought to apply here. That is, the question of interference arises only in the context of whether the disputed patent is valid, and infringed. In other words, Merck feels this question should be kicked down the road a bit, and resolved as part of the overall trial proceedings — involving questions of both law and fact.

Judge Stark agreed last Thursday in Delaware, but for a differing reason: he pointed out (quite correctly) that Gilead agreed — nearly nine months ago — to an overall scheduling order, and made no mention of this idea of running a mini pre-trial, on interference. So, he has essentially ruled that Gilead waived its right to separate and accelerate the interference issue. Here’s that oral order, from the bench:

. . . .ORAL ORDER by Judge Leonard P. Stark: Having reviewed the parties’ recent letters (D.I. 133, 135, 136, 137), IT IS HEREBY ORDERED that Gilead’s request that the Court “define the interference counts” in connection with claim construction — which the Court construes as a request to modify the scheduling order — is DENIED. Given the parties’ vastly contrasting views as to the best and most efficient manner for the interference portions of these cases to proceed, the Court deems the appropriate exercise of its discretion to be to adhere to the schedule the Court entered at the outset of the cases. Issues relating to the definition of the interference count will be resolved in connection with summary judgment, at trial, or after trial. . . .

And so it is that our summer laze and haze is fully present — we are in full-on relaxed mode now. . . consequently we forecast lighter blogging storms than might obtain in the cold winter months, by the fire.

Consumer Reports Says Most Patients Ought To “Take A Pass” — On Merck’s New Insomnia Offering

July 13, 2015 - Leave a Response

Overnight, the quite well-respected Consumer Reports franchise issued a rather downbeat assessment of Merck’s suvorexant, branded as Belsomra® in the US. To be fair, one of the independent pharmaceutical experts the magazine relied upon was a detractor who sat on the FDA Advisory panel that reviewed the candidate in 2013. However, both expert reviewers pointed to data that suggested only a scant sleep-time advantage over a placebo — coupled to a more than occasional groggy morning-after effect. So the underwhelming review is based on pretty solid independent science, in my experienced view.

More specifically, at higher doses (beyond the current FDA-approved label’s indication) Merck had (back in 2013) shown improved sleep times, to the FDA panel, during review — but the Advisory panel was very concerned about the morning after fogginess reported by some — at those higher doses. Net, net: I think Belsomra will sell only modestly for Kenilworth. I think prescribers will worry about the dangers of driving the morning after, in the wider populations of mild sleep disorder patients — and so the drug’s US market penetration will be limited.

Add to this that pharmacists must take special precautions when storing it, due to the chance of it being abused by illicit drug-seekers. Here’s a bit from the Consumer Reports reviewers — do go read it all:

. . . .[Consumer Reports] commissioned two drug safety experts — Steven Woloshin, M.D., and Lisa M. Schwartz, M.D., both at the Geisel School of Medicine at Dartmouth — to review the research and prepare a Drug Facts Box for Belsomra. Schwartz served on an FDA advisory committee of experts that looked at Belsomra in 2013.

Their analysis shows that people who took a 15 mg or 20 mg dose of Belsomra every night for 3 months fell asleep just 6 minutes faster on average than those who got a placebo pill. And the Belsomra group slept only 16 minutes longer — 6 hours and 12 minutes total vs. 5 hours and 56 minutes for the placebo group.

Those small improvements in sleep didn’t translate to people feeling more refreshed. Instead, more people who took Belsomra felt drowsy the next day compared with those who took a placebo. . . .

Onward, on a rain-soaked groggy Monday morning here — oddly apropos of this morning’s offering. Heh.

O/T — By Wednesday Night, In The Eastern USA. . .

July 12, 2015 - Leave a Response

We will see very high resolution visible light images of an icy dwarf world. One that has remained a visual mystery since its discovery — in 1930.

I for one am like a kid on December 22.

. . . .NASA Daily Press Briefings — at 10:30 AM EDT, July 12 through 16. . .

I can’t wait — literally salivating.

Mom With Kids (In Merck FMLA Case) Forced Into Bankruptcy — Merck’s $68,000 Costs Motion — As Proximate Cause?

July 11, 2015 - Leave a Response

I just take a moment here — over my Saturday coffee, banana and OJ — to note that the non-prevailing plaintiff/mom in Merck’s Spring 2015 FMLA and pregnancy discrimination case (in New Jersey federal district court), has seen all her replies and appeals stayed. That is, all efforts by Merck to collect the $68,000 — and all her efforts to appeal the adverse decisions at trial — are now on hold.

The automatic stay provisions of the federal Bankruptcy Code are the reason. She has (as of early July) sought protection from Merck (likely under Chapter 7), as an inchoate litigation creditor, there. It is now very unlikely that Kenilworth will ever collect a dime from her — unless Merck’s lawyers can show fraud or deception in the filing of the bankruptcy — or in the underlying FMLA case. Not likely, sez me.

. . . .June 2015 | Appellate Case Filing (Stayed): USCA Case No. 15-2619. . .

Personally, I think Merck ought to just let this one. . . go. This is now chasing a plainly losing cause, all Don Quixote like. At least to my eye, it is so. . . Onward — to the workout, massage, and dinner with another old college roomie! Be excellent to one another.

O/T Profound Debt Of Gratitude Owed To The Martyrs Of Mother Emanuel — 1962 to 2015 — South Carolina Edition

July 10, 2015 - Leave a Response

I’ll say no more — any text would be immensely inadequate. Only the singing will do.

Onward, now, as one nation.

O/T NASA Science Fare: About Five Days To. . . Pluto! New Horizon’s Fly-By

July 8, 2015 - Leave a Response

MRK-Pluto-07-2015 It is a tiny, frigid and largely dark place — a mini-world, only two thirds the size of our moon — made mostly of frozen chemicals, ones that would be gases at the temperature of our home planet. But way out there — almost four billion miles from the Sun — nitrogen, methane, carbon monoxide and water are all hard ices. And yet it is starkly beautiful — in its own way. The counter (at top left sidebar, on our main website) will remind you when to go check in with NASA.

This is an extraordinary moment — it may well be the last time in our lifetimes (for those of us 35 and older), that we receive the very first high res images of a distant world — the last of the “undiscovereds” — i.e., larger images of bodies in our local Solar System. And as the image at right suggests, we are already being mystified by the gradations in color, on this likely all ice mini-world. From NASA, then:

. . . .Of course, higher-resolution images in the days to come will allow mission scientists to make more accurate maps, but this map is a tantalizing preview.

“We’re at the ‘man in the moon’ stage of viewing Pluto,” said John Spencer of the Southwest Research Institute, Boulder, Colorado, deputy leader of the Geology, Geophysics and Imaging team. “It’s easy to imagine you’re seeing familiar shapes in this bizarre collection of light and dark features. However, it’s too early to know what these features really are. . . .”

And so, around midday Eastern, on July 15, we will begin to see the highest resolution images. It will be quite a show! Count on that much. Onward!

And. . . On Mars — Per our fine commenter!

Merck Sharpens Late Stage Drug Development Focus — Shedding Migraine Candidates

July 7, 2015 - Leave a Response

Kenilworth will receive $250 million — and additional revenue, if milestones are met — from Allergan, the acquirer here.

Per The Wall Street Journal reporting then:

. . . .Allergan PLC said Tuesday that it has reached a deal to buy the exclusive world-wide rights to two of Merck & Co.’s experimental migraine drugs for an upfront payment of $250 million.

Merck could also receive milestone and royalty payments based on commercialization of the two calcitonin gene-related peptide (CGRP) receptor antagonists, which are being developed for treatment and prevention of migraines. . . .

In the event that the candidate(s) clear FDA, Merck will also get a running royalty payment on each sale. But do recall that in 2009, and in 2011, Merck saw a liver toxicity signal in a Phase II trial of one of its other CGRP class candidates, so the future of these two is not entirely clear. Thus far neither of these current two harbor any class effect, thankfully though. For its part, Allergan may be able to broaden its reach — and move into larger arenas — outside of the cosmetic surgery suites, in consumer health care. Onward — on a cool cloudy but nonetheless cheerful Tuesday.

Merck (MSD India) Is Back At The Hearing Court Level — In India Sitagliptin Patent Battles Against Glenmark

July 6, 2015 - Leave a Response

The highest court in India has sent this matter back down to the trial court level, ordering that the disputed factual and legal claims be heard on a day to day basis, in between other matters. [Apparently this is what is meant when international legal experts say that there isn’t much of a smooth and well-developed practice — in India, over larger, multi-jurisdictional patent spats.]

It seems clear that the Indian judiciary would prefer that Glenmark and Merck work out an agreed settlement. I say this because while there is an order pending — to end Glenmark’s generic sales — the order has been repeatedly stayed, and now we are back at the trial court level, for factual findings. Here is a bit — from LiveMint.com:

. . . .The matter is now being considered by Justice A.K. Pathak of the Delhi high court and both the parties have been ordered to finish arguments in a fixed time frame of five days each. . . .

My earlier backgrounders are here, and here, among several that detail this four year saga. We will keep you posted. And so — onward!

Celgene Is “Under Contract” To Acquire Legacy Organon/Schering-Plough Morris Avenue Facility

July 2, 2015 - Leave a Response

MRK-Morris-Celgene-07-2015 I believe old “Fast Fred” Hassan protégé Carrie S. Cox is still a member of the board of directors of Celgene. Fascinating. But make no mistake — I think Celgene is a generally very solid public company.

In a related vein, I believe there still has been no public disclosure of the identity of the likely buyer of the pre-merger Whitehouse Station Merck HQ, now that Merck has fully transitioned over to the legacy Schering-Plough HQ digs — in Kenilworth. I suspect the final selling price — on this vast 1.3 million square foot facility — on Morris Avenue, in Summit, New Jersey, will be reduced during the scheduled due diligence period (or the contract is already subject to formulaic downward adjustments and/or credits, at closing), in order to accommodate what I hear are some at least potentially large environmental remediation expense items. In fairness, however, such remediation efforts are associated with most larger pharma manufacturing facilities — of this last half century vintage (old school — 1960s and 1970s — style chemical API waste handling standards are the drivers, there).

In any event, here is the operative bit, about the contract (terms withheld) on this Summit facility, overnight, from local New Jersey sources:

. . . .Celgene Corp. has agreed to purchase the vacant 1.3 million-square-foot Merck & Co. complex in Summit, adding to what is already a quickly growing footprint in the pharmaceutical giant’s home city.

The company announced Wednesday that it will acquire the site at 556 Morris Ave., which includes a mix of administrative and research and development space. Pending the completion of due diligence, closing is planned for September.

Terms of the deal were not disclosed. . . .

Duly noted. Have a peaceful and safe Fourth, one and all. We’re outta here.

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