Wednesday, December 28, 2016
Did Mike Tyson ring a bell?
It's Mike Tyson promoting online trading platform Trade12.
What can you say? I wouldn't like to step anywhere near a ring with Iron Mike - but I would love him as a counter-party.
Trade12 is a bit of a black box. It is - and I am not exaggerating, owned and operated by an Estonian subsidiary of a Marshall Island company and regulated by a private company in Vanuatu.
And according to its literature it does not solicit and accept clients from USA and France.
Which brings me back to Iron Mike Tyson.
He is - I gather - a US citizen.
Either he trades with Trade12 (which would be illegal) or Trade12 is not "the strong choice of a champion".
I suspect the latter - in which case my fantasy of trading against Mike Tyson is - well - just a fantasy.
Friday, December 16, 2016
UCB: Lower standards in Belgium
This time it is in dispute with the US Government. And the US Government is stating there is no valid patent.
Ask other European companies how disputes with the US Government pan out.
Moreover the burden of proof has changed. UCB now has to get its patent approved under de-novo standards when the Patent Office has already rejected the patent.
Of course none of this seems to warrant any statement from UCB.
Monday, December 12, 2016
UCB's lack of candour
In Friday's post I outlined the state of play regarding UCB's important Vimpat patent. Disputes about that patent have been background for the stock for some time. When I went to visit UCB in Belgium (1 December 2015) the IR officers were straightforward about this. Third party patent challenges were the bear story on the stock.
But UCB has since then touted victories in their patent disputes and regularly touted extensions of the Vimpat franchise.
- On 14 August 2016 UCB released a press release titled U.S. District Court confirms validity of patent for UCB's Vimpat®. That press release detailed a key victory against one of two third-party challengers of the patent. The stock went up sharply.
UCB has made many press releases detailing just how important the Vimpat franchise is to them.
- When the CEO (Jean-Christophe Tellier) was appointed the press release stated: "Jean-Christophe Tellier joined the company in 2011 and was instrumental in establishing the company’s current strategy; he has played a key role in driving the growth of UCB’s three core medicines, Cimzia®, Vimpat® and Neupro®."
- UCB has been active in touting Vimpat both in the EU and the US as a monotherapy for epilepsy. (See here and here.)
- UCB has been extremely active extending labels for Vimpat in Japan. (See here for an example.)
Indeed extensions of the Vimpat franchise have been important in UCB's growth strategy.
So it was deeply surprising to us when UCB neglected to tell the market that US Patent Office had reviewed the patent (an ex-parte review) and had decided to withdraw the patent entirely. [You can find the letter that the Patent Office sent here.]
This is an unusual move. Since the ex parte examination system was introduced (35 years ago) about 13,500 ex parte requests for examination has been made just over a thousand of them have had all claims rejected. You can find statistics here. Rejected here is a term of art. A claim is "objected" for all sorts of formal reasons like the claims not being properly grouped. A "rejection" is a determination that the claim is not patentable - and is appellable to the Patent Trial and Appeal Board (a court) and then to the court system.
This is altogether a different type of threat to UCB. Past patent disputes have been with other companies wanting to release a generic - and thus far UCB has either had the case thrown out or got a significant delay. These are standard commercial disputes with commercial parties. And in every one of these disputes the court has worked on the assumption that UCB has a valid patent and the question is whether the other party is infringing on this patent.
This dispute is with the US Government. The US Government has reviewed past decisions and decided that Vimpat is simply non-patentable. That is the US Government has determined that UCB does not own a valid patent. Sure UCB has two months to try and convince a (well informed) patent examiner otherwise - but their chances of this are low. The patent examiner will be experienced in this area and it is not as if the bureaucrat was uninformed that this was a controversial and important case.
After the two months has elapsed UCB could appeal to the Patent Trial and Appeal Board. However the standard here is the de-novo patent standard. The situation is as if Vimpat had its original patent comprehensively rejected and it has to appeal to a court against the scientist/reviewers at the Patent Office. The courts are usually pretty deferential to the examiners at the Patent Office on the basis that they have the disinterested expertise to assess patents.
In this case Johnny Railey was the examiner and he is amongst the most experienced biotech patent examiners in the US. You can find his linked in CV here. You can find a very extensive list of patents in which he was the examiner here.
Appeals of this kind almost always fail. As Johnny Railey is amongst the most experienced patent examiners the chance of an appeal succeeding is even lower.
For practical purposes the Vimpat patent is almost certainly dead - and UCB's much ballyhooed growth strategy will die with it.
I am surprised at the lack of a management press release.
UCB has press released interim victories in District Court against commercial claimants on the Vimpat patent.
Their IR officers have been willing to give up-to-date reports of the (mostly) favourable commercial disputes they have.
But there is not a word here that their (new) dispute is with the US Government and the default position from here (statistically likely to be upheld) is that they will lose their patent in its entirety.
Not disclosing a business-critical dispute with the US Government is strange.
Whatever: shareholders should ask themselves how other European companies have prevailed in dispute with the US Government.
Friday, December 9, 2016
UCB's Vimpat patent
We went to visit UCB once, a cold and wet wintery day where we got modestly lost in Belgium.
The investor relations people were straightforward. We were new to the story and our notes state clearly that generic challenges to the Vimpat patent were the main bear story for the stock. Our notes also talk about Keppra - another epilepsy drug. When it went off patent revenues dropped substantially. Keppra was an famous "patent cliff" drug.
The risk to Vimpat has been reflected in the press too. Fierce Pharma - an industry rag - reports that August 15 this year was the best day for UCB in years as a Delaware District Court had rejected challenges to the Vimpat patent. Notwithstanding this, Fierce Pharma noted that the patent still faced challenges. To quote:
UCB isn’t totally out of the woods, though. In late May, New York-based generics maker Argentum Pharmaceuticals won an inter partes review of Vimpat’s patent protection by the U.S. Patent & Trademark Office (PTO)’s Patent Trial & Appeal Board (PTAB). And that decision may not be handed down until next May.
Still, court’s decision is a “long-awaited sentiment boost” for UCB, whose shares had fallen by about 17% so far this year, Citigroup analysts wrote in a Monday note seen by Bloomberg. Despite the lingering risk of patent invalidation, they wrote, “we expect market confidence to improve.”
As noted Argentum Pharmaceuticals won an inter-parties review of Vimpat's patent. Argentum's press release however noted an even more aggressive request. To quote:
Argentum also filed an ex parte reexamination request against this same patent that raises additional grounds of unpatentability than those in the IPR. A decision by the PTO on Argentum's reexamination request is due no later than July 29, 2016.This is mentioned as afterthought in the press release because it is a really aggressive claim. Argentum asked the Patent Office itself to review the patent it previously granted and presumably throw out the original patent.
Given the afterthought nature of that request I suspect even Argentum will be surprised that the ex-parte review rejected all thirteen claims of the Vimpat patent.
In other words the Patent Office has thrown out the patent.
This is all in a letter dated 5 December 2016 (that is just a few days ago). You can find that letter here. And according to that letter UCB has only two months to dispute the total rejection of the patent by the patent office.
This rejection will of course be followed by Argentum and Mylan (and probably other companies) commencing distribution of a generic for Vimpat. Mylan were behind the above-mentioned court challenge.
It is - given the significance of this to the business - perhaps a little unusual that UCB has made no press release.
Is this the beginning of a new, more aggressive patent office?
The political pressure in the US to do something to reduce drug prices is large. In the past election this was one area of near universal agreement.
I am wondering whether we are going to see this sort of action by the Patent Office more widely.
If the trend is more widespread it could be bad news for pharma investors generally.
Thursday, December 8, 2016
In praise of Donald Trump's conflicts of interest
I am obsessed too. But I want him to have more conflicts.
I want a Trump Tower paying royalties to the Donald in every country that matters, indeed in most cities. I want them in countries that do not matter. Frankly I would love them all over China, India and Pakistan.
If the Donald leaves office safely with 100 billion dollar net worth it would be just fine with me.
You see if the Donald has economic interests in some country he will not wind up on any ill-advised military adventures there. Indeed he would tend to prefer open economic relations, as much as anything so he can get his cash out.
Trump corruption is wonderful then because it preserves the open and (relatively) peaceful world I like.
So please Donald - more conflicts of interest - big international conflicts of interest. I want them yuuuge.
Make me happy.
Flotek: some new research
In plain english Flotek makes a chemical mix which makes sand-water mixes slippery so you can get more sand into fractures when you fracture an oil and gas reservoir. Their chemical mix is a surfactant.
There are many suppliers of surfactants. The product is a commodity.
However Flotek sell their product as somehow special. The claim: their surfactant is a "complex nano-fluid", but it is really a mix of d-limonene (the oil from orange peel) and isopropyl alcohol.
This blog once showed that data Flotek provided for pitching their complex nano-fluid was either (a) made up or (b) did not support the idea that their fluid was particularly effective.
We were right. Flotek put out a press release effectively admitting all of our allegations.
In other words their key claims were BS.
At the time Flotek claimed they had a software sales tool (that ran on an iPad) called FracMax which was critical to demonstrating their fluid effective - but we could not find a working copy of FracMax and could not find anyone who had ever seen one.
This was problematic. Flotek told the market that FracMax was their main selling tool.
Whatever FracMax has disappeared from Flotek's literature.
So their main selling tool was also BS.
All this should have been the death-knell for the stock. But it wasn't. Sure the stock is lower but not much (given the decline in oil and gas volumes) and somehow people still believe the "complex nano-fluid" story. I have never met a serious Flotek owner - so the stock price remains a mystery to me.
Today FourWorld Capital Management (an outfit I had never heard of) put out an updated and more thorough analysis of Flotek.
Its darn good - so go read it.
Why this stock trades above pennies I do not understand.
It will trade at pennies one day. I remain short.
The content contained in this blog represents the opinions of Mr. Hempton. You should assume Mr. Hempton and his affiliates have positions in the securities discussed in this blog, and such beneficial ownership can create a conflict of interest regarding the objectivity of this blog. Statements in the blog are not guarantees of future performance and are subject to certain risks, uncertainties and other factors. Certain information in this blog concerning economic trends and performance is based on or derived from information provided by third-party sources. Mr. Hempton does not guarantee the accuracy of such information and has not independently verified the accuracy or completeness of such information or the assumptions on which such information is based. Such information may change after it is posted and Mr. Hempton is not obligated to, and may not, update it. The commentary in this blog in no way constitutes a solicitation of business, an offer of a security or a solicitation to purchase a security, or investment advice. In fact, it should not be relied upon in making investment decisions, ever. It is intended solely for the entertainment of the reader, and the author. In particular this blog is not directed for investment purposes at US Persons.