I happened to read the 10 K which reported the following:
"""""Currently, the Company has rights to Duke’s patent for its thermo-liposome technology in the United States, which expires in 2018, ... """""
I found it interesting the the US patent, will expire in 2018, all the while the trial was apparently designed to run until 2014
Estimated Enrollment: 600
Study Start Date: February 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
I also understand they are about a year behind in enrollment, is that correct ?
So the 2014 may change to 2015.
Lets say the 2015 date is correct, and then it takes 6 months to put the trial data together, get it to the FDA, and then say 6 months for FDA approval.
Does that put this on the market in 2015 at the earliest, probably 2016, with a 2018 patent expiration ?
I hold a 48 page technology patent for a microprocessor-based
controller device. So to some extent, been there - done that.
I think that Duke has to be very "PC" (politically correct)
about their patents with regard to Celsion. Not much more to
say w/o reading everything myself. But that is my take. My
patent is largely software related. Will read and think more
on this potentially important point.
I guess if DUKE does not own the patent
if CLSN made their own patent, changed the drug, and tested the drug under their own patent
and if CLSN's patent was good for another 7 years
then CLSN should correct the 10 K
and let the investors know.
Why not contact CLSN and have them correct or add detail to the 10 K
instead of arguing with me ?
UNTIL THEN I guess I will believe what CLSN wrote in the 10 K
DUKE'S LIPOSOME TECHNOLOGY
. BTW Why Not Tell Us The Royalty CLSN will pay DUKE,
Unless of course there is none, and CLSN has their own patent.
Thanks in advance.
I usually go by what the company says
This is copy and pasted from 10 K
""""""""Currently, the Company has rights to Duke’s patent for its thermo-liposome technology in the United States, which expires in 2018, ... """"""""
As mentioned previously but discarded by your jaded ears was:
Hatch-Waxman The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) of 1984 provides patent holders on approved patented products with an extended term of protection under the patent to compensate for the delay in obtaining Food and Drug Administration (FDA) approval.
No worries on extending the patent.
However, have you checked the expiration of the Company's W/C policy? Perhaps their driver's licenses are expiring soon? I know it's hard watching the share price move up.
enough with the BS! Can you read the +????? 2018+
Current dosage form, 3-lipid, has IP protection to 2018+ with extension potential
Exclusive world-wide rights from Duke University
Orphan Drug Designation in U.S. and Europe provides 7 and 10 year exclusivity, respectively
Technology platform expandable to include additional therapeutics and indications, 4-lipid patents to 2024
4th Compound, third party funded
''Puts us in the market in 2015 or 2016''...
Wow. You are so wrong in so many ways it is truly sad . It also shows your ignorance and unwillingness to accepts facts that have been discussed before.
REPEAT AFTER ME: PFS is an accelerated approval endpoint that will allow Celsion to reach market by end of 2012/early 2013...down the road, Overall Survival will be submitted, probably in 2015ish, as a confirmatory endpoint.
I guess you want to ignore how the FDA works and what accelerated approval is, right?
See, the Patent Term Restoration part of the Hatch-Waxman Act.
In short, the Act works to restore the patent term of pioneer drug patents for 50% of the investigatory period (with a cap of 5 years), provided that the patentee is diligent in seeking restoration. I'm sure Mikey is well aware of this. But you raise a good point; hopefully, Celsion will also seek to employ trade secret protection (which has no expiration) wherever possible.