Bullet 31 states:
The inventors of the ’829 patent also obtained U.S. Patent No. 4,959,472 (the“’472 patent”), which is directed to their chiral auxiliary process. The ’472 patent has expired.
I'm no lawyer but it seems to me that the suit to invalidate the NDA is valid because the isomer existed previously. Further there is no patent infringement because the patent describing how to produce it has expired. Sandoz is free to use the process in that patent - but not the proprietary process from Merck.
It sounds to me that the process from the 829 process must have some drawbacks; otherwise others would have used it by now. If those drawbacks are significant enough, Sandoz may have achieved a hollow victory here. Can someone with the requisite subject matter knowledge shed some light on the process?
The link for the verdict (posted by tin_bird1) is : wwwdotscribddotcom/doc/256408907/SPPI
On page 7 , bullet 28 the following text appears:
"The ’829 patent discloses a process for preparing a “substantially pure” diastereoisomer of a derivative of tetrahydrofolic acid e.g., purified (6S) leucovorin. The disclosed process involves: (1) attaching a chiral auxiliary group to precursors of the chosen diastereoisomers in a mixture so as to form a pair of new diastereoisomers; (2) partially separating the pair of new diastereoisomers and recovering the new diastereoisomer ((6R) or (6S)) so formed; and (3) converting the isolated, substantially pure new diastereoisomer into the corresponding desired diastereoisomer.
**************** However, none of the claims of the ’829 patent cover this process. ***************
Bullet 30 go on to say:
There is no evidence that anyone has ever used the University’s method disclosed in the ’829 patent to manufacture a commercial product. Dr. Suckling testified that none of the companies that expressed interest in the ’829 patent ever produced a commercial (6S) leucovorin using the ’829 patent’s chiral auxiliary method. Additionally, there is no evidence that Burroughs Wellcome ever used the method to make a commercial product. Not even Spectrum or its supplier uses the method. As Spectrum’s senior vice president of
pharmaceutical operations testified,
*********** how Spectrum’s Fusilev is made is “proprietary to Merck Eprova” and does not involve use of a chiral auxiliary, as in the ’829 patent. *************
to be continued..
Maybe just someone closing out a short position. Given the Fusilev decision in March, (possibly) robust Beleodaq sales and the start of the SPI-2012 phase 3 in the near future, this is becoming a risky short play.
MMs who get judged on the quality of the investments they make probably don't want to show this one on their books at report time. Also, tax loss selling to offset gains just about anywhere else in the US market (see SPY and QQQ) is likely to drive the share price lower as well.
"So, just who is going to do any of the official ousting of who?"
A consortium of major share holders. You're right to state that the BOD is useless. They do what Shrotriya tells them to do.
"Lowest compensation of all his peers".
May still be overpaid. After all the false starts and SNAFUS the burden of proof is on him.
I hear them talking about all the wonderful things to come. I'd like to see them deliver as promised - as specified, correctly and on time. So far there's a lot of sizzle and no steak. This gets old. It's time for management to deliver or get the hell out. I hope the large bag holders are coming to this conclusion. It really is time.
The company's aloofness in the face of this endless share price erosion is infuriating.
"Who is flush with cash?"
They are - unless they expect Fusilev revenue to dry up.
"they are NOT going to waste cash on manipulating PPS when they have block busters to fund"
That seems to be their position as well. I don't call it manipulation though. I prefer enhancing shareholder value - if the current price is truly too low for the value represented by the share prices.
" Do you honestly think they are working AGAINST their 25% ownership?"
No. Of course not. But I want them to give some clarity of what they are doing. Why would you not buy back a these levels when you are flush with cash. I hear the bones rattling; I want to see the skeleton (if there is one).
and no action from the company even at these prices.
Either they want to preserve cash in the event the Fusilev patent challenge goes against them, or
Belodaq revenue is not expected be enough to make up for a possible loss of Fusilev revenue, or
they expect the share price to drop even lower.
I don't like any of these alternatives. Wish someone at Spectrum would wake up long enough to explain what the #$%@ they are up to. Clearly these people have forgotten that they work for the share holders - unless of course the major share holders get information that we don't (wouldn't that be illegal?).
Hint taken. No joy. Tried to listen to the early 2013 web casts on the SPPIRX site (to May of 2013). They are no longer available. Oh well...