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Good post, recurveman. I also think wjlknew makes some good points, but I am concerned that INSM is still at a great disadvantage given the need for cash...lots of it...and that the next thing we hear may be very dilutive, either in terms of share count or a further loss of future income.
Seems to me that INSM is now at the mercy of DNA. The value to anyone else of INSM as a partner seems to be low after the deal; perhaps an Asian partner would be possible...I don't know. WHere else will INSm get support?
I question whether the bad news is over. Had INSM gotten a lot of cash, I would feel better about the deal. As it is, INSm is still in a weak and needy position and has lost negotiating power. Doesn't look good to me. regards...
zake,
"The Settlement, License and Development Agreement is in effect until the later of 2018 or the expiration of any subsequent Tercica/Genentech issued patents that cover IPLEX or its indications.
Some of these issues end in a couple of years."
the agreement is in efect until the later...the later... of 2018 or a subsequent patent...it will last at least until 2018, and maybe longer. regards...
not surprisingly, TRCA/DNA seem to have a good rebuttal to the Uraguay Round Agreements defense that INSM put forth (see page 4 of the document). Do any of our legal minds have an opinion on the worth of the TRCA/DNA rebuttal of that defense? TIA and regards...
wjlknew,
"Does that make any sense?"
yes it does, and thanks to you and DD for your thoughts. regards...
thanks wjlk, I see that I was not clear in my question. Your reply is of course accurate. I'll try again:
In post #1953, the following appears:
"(c) Continuation.—
(1) Determination.— The term of a patent that is in force on or that results from an application filed before the date that is 6 months after the date of the enactment of the Uruguay Round Agreements Act shall be the greater of the 20-year term as provided in subsection (a), or 17 years from grant, subject to any terminal disclaimers.
(2) Remedies.— The remedies of sections 283, 284, and 285 of this title shall not apply to acts which—
(A) were commenced or for which substantial investment was made before the date that is 6 months after the date of the enactment of the Uruguay Round Agreements Act; and
(B) became infringing by reason of paragraph (1). "
Section 283 applies to injuctions, but section 284 applies to damages, which of course were an issue at the trial, and were awarded. The remedy of damages seems to be excluded by this portion of the code...and if so, why was this not used as a defense during the trial?
regards...
If this is such a good legal argument, why was it not used during the trial? Its hard to believe that the legal team just recently discovered it:
• 35 U.S.C. § 154(c) provides that 35 U.S.C. § 283, the injunction section of the patent law, does not apply to patents that are in force by virtue of a patent term that is the greater of 20 years from filing or 17 years from issuance. This exclusion applies to the ’414 patent now, the ’287 patent as of March of 2008,and the ’151 patent as of February 2010;
"Why did this news not harm the stock of Habbot?"
madw,
I don't know, but maybe the injunction affected only a small part of Abbott's revenue stream. regards...
recent injunction against Abbot labs in patent dispute:
http://www.genengnews.com/news/bnitem.aspx?name=11220742
Court Permanently Halts Abbott's Sale of HCV Genotyping Products for Infringing Innogenetics' Patent
Jan 11 2007, 11:52 AM EST
GEN News Highlights
Innogenetics reported that a U.S. court entered a permanent injunction against Abbott Laboratories, prohibiting the company from selling or using products, including components, that infringe on Innogenetics' patented Hepatitis C Virus genotyping technology. The injunction also prevents Abbott from exporting components of the infringing products to foreign countries.
In September 2006 a jury unanimously found that Abbott had willfully infringed Innogenetics' U.S. patent 5,846,704 and awarded the company $7 million in damages.
The U.S. District Court for the Western District of Wisconsin made the ruling at the close of an evidentiary hearing to determine the potential public impact of a permanent injunction against Abbott. Last week, the court found that Innogenetics suffered irreparable harm from Abbott's infringement
thanks, Jellybean...regards...
rfoable,
thanks for your thorough reply...regards...
Cephalon's IGF may be a way around one of DNA's patents (the manufacturing one, which is the one of most concern, if I recall correctly) but does not make the other two go away. But the other two, if I recall correctly, expire in 2010 anyhow.
But I doubt it is a simple or quick solution. Seems likely that a new iPlex, complexed from Cephalon's yeast-derived IGF, would have to undergo some manufacturing approvals, and perhaps a trial to prove substantial equivalence.
I do think that the possibility of a new iPlex with Cephalon is a good recourse for iNSM, and might even be achievable during the 2 years it may take to go thru the appeals process. If so, there might be an uninterrupted supply.
I am curious to hear the thoughts of our more bio-knowlegeable posters have to say about this possibility...Jelly, Dr. Bio, Rfoable?
buy4,
I am no expert, but I believe accumulated deficit is simply an expression of how much the company has spent to get where it is, less any revenue. It is not the same as debt, and would not be subtracted from the sales price of the company. It is money spent, but not owed. IMHO, and no doubt someone can refine my reply. regards...
buy4,
well said! Amen!
Polite contrary views are the best way to keep reviewing one's investments.
Supacharja,
Many thanks. I always appreciate hearing your thoughts.
As for an injunction, I share your view: she shouldn't, she probably won't, but she just might anyhow. We hold our collective breath.
Allan has shown an inclination to go it alone for a number of years now, but I hope he takes a new approach at this juncture. The company has a fundamentally great drug, but is on the ropes against TRCA's cash and litiginous business model. Time to swap some future revenue for current support, IMHO.
regards...
rfoable,
You are most welcome. Its a small return for all you contribute to the board. regards...
vrtl,
Job was a guy in the old testament. To prove a point with the devil, god decided to test his faith by heaping miseries and losses on his head, even tho he was a righteous man.
Job is an image of suffering, loss, and, up to a point, patience.
Supacharja,
I'd appreciate hearing your current take on INSM, either here, at IHub, or IVillage, if you please...regards...
vrtl,
I must agree with you that insm is worth less now than before, at least over the next 6 to 12 months, if not longer.
Worth less, but not worthless.
As rstor said, this is the stock that Job would have owned.
regards...
vrtl,
yes, lazard, thanks...follow the link for their update on trca and insm...regards...
lehman says trca gets Eu approval decision late this Q...is this so?
http://www.investorshub.com/boards/read_msg.asp?message_id=15357042
marjoliein,
the jury awarded damages for sales up to now; the judge will award damages for sales to come. The judge may also increase damages already awarded by the jury due to the finding of willfull infringement of the 151 patent. The judge will also rule on INSM's plea to find the 414 patent invalid. There will be various other requests by both companies.
Then the whole thing will be appealed by INSM, and go to a court where the decision will be made by patent experts. good luck and regards...
Zake, thanks for reporting on your conversation with INSM. GIven that all 3 patents are ruled infringed (manufacture and use), how is it that this all only effects the short stature indication? regards...
Royalties for future or past sales?
The confusion around this topic is vexing, but it is interesting as well. A poster at IV claims to have replies from both trca and insm IRs saying the royalties are for past sales.
Another poster there gave a link to a Bloomberg follow-up article that said that trca's lawyer said the royalties were for past sales, and insm's lawyer said they were for past and future sales...huh? Have these guys switched roles? Or is this a case of posturing for sympathy in the post-trial judgements?
INSM's PR is actually not fully specific about this, if you read it like a weasel:
"The jury awarded damages of $7.5 million as an upfront payment and a royalty of 15% for sales below $100 million and 20% for sales above $100 million."
To assign royalties for past sales, which total maybe a million, seems trivial, and avoids the real issue of future sales. And so it seems unlikely to me that the jury meant to limit their decision to the past. But who can be sure?
For now I must assume the worst, since it seems most logical. But I wonder what is going on. regards...
rfoable,
a poster over at IV claimed it was the 151 patent that was called willfully infringed, but provided no link...regards...
rfoable,
here is a link to a court doc; I read it the same as windy does...regards...
http://www.xs4all.nl/~surg3on/2006-nov-INSMvsTRCA_trial_motions-Read_this_n0w/1006%20JURY%20VERDICT....
surf,
I'm not sure of the status with Avecia, the british manufacturer of the first several batches of Iplex, but if need be, I expect INSm could reactivate that production avenue and circumvent '414...regards...
trade,
I don't think the shelf-stable version circumvents the patent issue; anyhow it seems unlikely that management would say so publicly even if it did, not wanting to appear to validate the infringement charges.
INSM announced that they were looking into an arrangement with an outfit that may be able to produce a version from plant cells...Phyto something or other was the name...and this would likely render the patent issue moot.
Would take some time to get this done and approved, assuming it would work. But its good thinking on the part of management to look into it.
Check out the press releases maybe a year ago, or less.
regards...
hey Toonce,
I'm still around, and still long in sentiment and holdings. But I haven't much to add to the discussion these days, so I don't post much. Glad to see you here...hope you are well....regards...
io,
I believe that there has been a small P2 study already completed for burns, with good results. I guess that's not proof, but perhaps its convincing enough to prompt a contract of some sort.
regards...
drbio,
thanks for your response. I remain confused. The extreme ins resistance trial is not just kids, but adults as well "patients must be between 10-65 years of age" . Also, the population of severe ins resistance is 1mm, according to the company's statement in the october 04 R and R webcast...is severe ins res different from extreme ins resis? thanks and regards...
bladerunner,
as for supergen, I haven't followed them for several years, but back when I did, there was a high sleaze factor and a lot of empty PR. Unless there has been a big change in management, I'd tread carefully. JMHO and regards...
drbio,
"The trial will probably work and the data should be good enough to get an approval in this indication. tercica has no patents in this indication."
with an n of 10 and duration of 16 weeks, I assume this phase 2 trial would not be sufficient for approval, and that a phase 3 trial would be necessary. Is that your meaning? regards...
thanks drbio45...regards...and thanks for your response as well, dew...
drbio,
Coming from someone who obviously knows a lot about the science of medicine, this was an interesting remark:
>As I say investing in biotech has more to do with math than science<
Although I think I know what you mean, I'd be curious to hear you elaborate on this, if you'd care to.
regards...
thanks, David, for the reply, and best regards...
David,
>Understanding how these funds affect the market is, I think, one of the two or three biggest things any investor can do to make themselves a better investor. Because they exist, many of the "old" conventions in the stock market simply do not have the same impact. <
Do you have any suggestions for sources from which an investor might educate himself on this point? thanks and regards...
toys,
It is not a good thing for a company to get a "going concern" statement from the auditors. It does in fact indicate some risk about the viability of the company. Companies with plenty of cash do not get them.
But it has to be taken in context: INSM raised plenty of cash since then, so no worries there. In that sense, the market's response is ignorant.
On page 53 of the 10k the auditors stated their concern. THis press release simply points that out, along with the fact that plenty cash has since been raised. The fact that it took a PR (two weeks after the release of the 10k) to put all this on the screen of the market shows how closely the 10ks are read by most folks.
So, no worries, really...we already knew there was cash flow risk, and that the recent stock sale made it go away for now.
regards...
I find that Twinlabs, well-established purveyor of vitamins and supplements to the health-food market, sells a sublingual B12 at a dose of 5000 mcg, which I believe is 5 mg, 1.5 times the 3.3 mg dosing of cobalis. About $14 retail for 60 dots. Info available online.
According to earlier posts, clsc could force competitors off the market, if approved, by virtue of IP, or at the least block labelling for the same use. But this is a critical point, and it better be true for the sake of clsc, since the drug does exist in the market already, and inexpensively.
Perhaps the bioavailability is greater with clsc's sublingual product, but I don't know if one sublingaul is better than another.
I make no conclusions about this, and simply want to underscore the importance of this issue. regards...
urche, randy,
thanks for the replies on the iHub BV board; didn't know this one existed. I've read thru the posts here and checked out some of the usual sources. I'm tempted, but my portfolio has plenty of risk as it is, so I'm in watch mode for now. But I may get in later.
Thanks again and regards...
randychub,
I finally got around to having a look at cobalis. The story sounded pretty good til I looked at the financials, which look awful. Lots of debt, failure to pay for trials, a lawsuit for failure to pay convertibles...plus some convoluted changes of names and perhaps ownership of the company in the past.
I think I understand now why the company has a market cap less than 50m when it has what appears to be fabulous potential: they must be desparate for cash, and god knows what terms they will have to settle for.
Have I missed something to ease that concern?
regards...
From the recent 10q:
NOTE 1 2 - LITIGATION
Gryphon Master Fund, LP v. Cobalis Corp.: On November 8, 2004, the Gryphon Master Fund, LP filed a lawsuit against the Company in United States District Court, Northern District of Texas, Dallas Division. The lawsuit seeks repayment of the $600,000 convertible note payable, accrued interest on the convertible note payable, penalties for failing to register the shares underlying the conversion of the convertible note payable, attorney fees and court costs.
Lease Dispute: In March 2003, the Company vacated its office space. The landlord then filed suit against the Company in the County of Orange, Superior Court of California, for unpaid rent. The Company believes that the landlord breached the agreement and, as such, the Company does not believe it owes any unpaid rent. In January 2006, this matter was settled and the Company is to pay a total of $200,000 over the next year, of which the Company paid the first $75,000 on January 31, 2006. This leaves a total of $125,000 owing, of which $75,000 is due on July 31, 2006, and $50,000 is due on December 31, 2006.