“The first P-IV ANDA was filed in March 2007. From the Livemint report, it appears that the FDA did not accept the ANDA (this could happen if the ANDA did not meet certain technical requirements). But it did not reject it outright either. Assuming Sun is that FTF party, a back and forth discussion must have gone one between the FDA and Sun for about 3-4 months before the FDA accepted the file and assigned a number to the ANDA. The filing was publicly listed by the FDA on Aug 20, 2007.
The exact date of acceptance is not clear. Assuming again that this was around Aug 1, 2007, Sun had 20 days from the date of acceptance to notify the patent owner / NDA holder (Aug 20, 2007). The NDA holder had 45 days from the date of receipt of the notice – i.e. till about October 05, 2007 to sue, if the 30-month automatic bar on approval was to be in place. So, far, there has been no news of litigation. It is possible that Sun filed P-IV only on the later expiring polymorph patent with a non-infringement position and Novartis decided not to sue based on the information provided by Sun.
This happens many times. This would mean that Sun will have to get at least a tentative approval within 30-months of filing, or they forfeit any 180-day exclusivity that they may have. We’ll need to wait and watch.
On the story itself:
1. No one outside the FDA or the parties involved knows (or can know) for sure that the first filer is Sun. Since there is no litigation yet, this information is not public. Livemint may indeed have insider information.
2. I am not sure what this 6 month ‘surveillance’ is. There is no such thing. May be this refers to the back and forth between the FDA, referred to as an ‘appeal’ by the insider.
3. As you will know, the US patent claims both alpha and beta crystalline forms. To that extent, it is not strictly comparable to the case in India. Moreover, if the P-IV has a non-infringement argument, the difference widens. As you have said, invalidation in the US will certainly help the India case.”
We are very grateful to X for his sharp insights and for helping “spice up” this debate even more.
Readers will recollect that our earlier post had noted:
“Another possibility is that Sun is not actually challenging the ’97 patent (as being invalid) but is only claiming that it’s particular drug does not infringe this patent. As we stated in one of our earlier posts, the ’97 patent covers only one polymorphic form i.e the beta crystalline form. Therefore generics can enter the market with other forms….”
This view was reiterated by Sandeep Rathod, who’s been covering this case very well on his blog. He wrote to let me know that “Sun is arguing non-infringement for the polymorph patent since it too has an application for a polymorph form”
If this is indeed true, we may not see any legal action in the US to invalidate Novartis’ polymorph patent (at least not yet…).
However, a Novartis spokesperson has confirmed to Ed Silverman of Pharmalot that Sun has filed a Para IV certification. This is a clear indication that Sun intends to challenge the validity of the Glivec patent.
“Sun filed the Paragraph IV certification against a Gleevec patent that expires in the US in 2019. The basic compound patent, which expires in 2015 in the US, is not being challenged. So the earliest a generic could be launched – and this is only if Sun is successful in its challenge – would be after the expiry of the compound patent in 2015. We have full confidence in the integrity of these patents.”