Stock Doc, I think the abilities of Zovant has to do less with a "strong" anticoagulant activity, but more with a subtle early anticoagulant activity avoiding further activation of the irregular intravascular coagulation with its ability to stop the extrinsic pathway activation.
Actually, patients with protein C deficiency thrombi takes long to get rid of then (either with FFP or concentrated protein C,) weeks to months, TPA/heparin are the ones that take care of the acute situations and protein C is an add on for the long term management.
Same for Chiron's Tifacogin, at least in animal studies and not published phase II human studies encouraging enough to get Chiron/Searle into phase III especially at the microcirculatory level.
Heparin works nicely in the big clots, Tpa works nicely at both the macro and micro levels and still not out of the race, especially the new single dose SuperTpa.
But both, heparin and tpa, has propensity to excess bleeding (tpa much less so) near the effective dose range, so far it seems like rhproteinC (and tifacogin)does not share that propensity, of course,if ever, the safest one will be neuprex!!! (if ever!!!).
I still think that Pafase will be the best drug, albeit it could be combined with all the rest of them, zovant, tifacogin (and even rbpi21 if it ever makes it).
Drug combinations patents are possible, especially if the same entity owns both compounds. Even modes of action could be patentable, of course there is more risk to it in a court fight.
Vivus has patented many topical modes and drug combinations and even able to enforced the patents in dispute in Europe (against a european company!) and in the US they were able to settle with other similar patent holders and gain leverage to keep others at bay!
Schering/ICN/Biogen got to combine Interferon/ribavirin combination as new patent and new drug, nevertheless all of them agree to the terms (Biogen demanded more money, but loss in court, still keeps the original fees).
New aggreement, Merck/Schering Claritin/Singulair coming combination, but I do not think a patent is involved, and both negotiated the terms.
In my view, if ever, the combination Zovant/neuprex will end up with some agreement among the parties, of course xoma will most probably be the underdog, and Lilly the upperhanded one.
More difficult is to patent a procedure, many surgical techniques are in this category (American Medical Association opposes these patents on ethical grounds and has a big legal team working against these type of patents), and only the ones involving new equipment has been able to be enforceable via the selling of the equipment and the purposedly design multiple "non-reusable" pieces, a matter of recently big disputes (the parts companies won the battle at the FDA level).
If both drugs come to the market independtly, and clinicians combined them, Lilly could legally collect its fees, if they could track all the details, and this is difficult due to the confidential nature of medical management, but they could argue for a general fee to institution based on statistically proven combined use, which it is still a lot of work, and most hospital will then hide as much evidence of the practice as possible.
The agreements among the parties will be a better way (bax will probably be heavily involved, as per the Bluish one), to enforce the patent, and it could actually extend the life of the patent for both products. xoma obviously is theoretically better off with the patent thing (and Rk loves it).
Regarding the life of rbpi21 aka neuprex patent, it is 17 to 20 years after begining marketing, new rules that Schering is still fighting for to get claritin in, they missed by few months the new rules, and Schering wants an exception, so they could keep going another 3 years (and another $12 billions!).
xoma's neupres has "orphan drug status" it gives the drug 7 years of market exclusivity, and they already did the studies in children and these add 6 months of patent protection. The meningo studies allow for orphan drug status
protection, since the expected market is under 200,000 patients a year, not so for sepsis, so even if the meningo thing never gets trough, and neuprex, let's say with a big leap in our imaginations, gets approved for one of Gw's big indications, it is worth a lot in patent/marketing protection for xoma (at least, something is right with this xoma tacticians, although the statisticians can not do it). |
