Replies to post #309152 on Avid Bioservices Inc (CDMO)

[exwannabe]

How about lack of pursuing due to limited resources. Is that a condition for an extension?

I assume you are joking, but no.

The rule is:

. Up to 5 years past original expiration [or 14 years post approval if that is less, but that will not apply here].
. All time when FDA is "on the clock" counts.
. Sponsor time (trials and regulatory prep) counts as 50%
. "idle" time does not count at all.

In this case, they will easily hit the 5 years maximum, so it is moot.

The unknown on the original issue is which (if any) of the later patents will hold up and be able to block any competition. This is often fought out in Court, and I doubt even North would offer a certain answer either way.

Still, speed counts. That is why a cut of a program handed off to BP is likely more valuable than 100% of a program in their own hands. Also, partnering it off avoids the dillutive overhead of the development program that is needed at some point.

[Protector]

geocappy, no it is not.

You must show that the delays are due to OTHERS (FDA,FCC, etc) and that you never made any use of the patent in the period on which base you request the extension in a way that would be otherwise protected by the patent (marketing, import/export, sell, etc).

Limited resources would not be caused by a MANDATORY procedure such as a clinical trial. It would be caused by the company not correctly planning the financing of such trial which is clearly a cause of the company, hence no extension.

AIMO