Replies to post #9206 on Momenta Pharmaceuticals, Inc. (MNTA)

[mouton29]

<<approval will be delayed as long as there are any open patent issues, irrespective of the expiry of the 30 month exclusivity period.>>

If that were so, can you explain what happens in a generic at-risk launch? Do you think the generic is launched without FDA approval?


This article on at risk launches suggests that the best tactic for the innovator is to prevail at trial within 30 months:

An innovator’s best tactic to prevent a generic at-risk launch is to obtain a favourable trial decision before the expiration of the 30-month stay, which results in the automatic issuance of a de facto permanent injunction for the remaining life of the patents-in-suit3. As such, the innovator should consider (in addition to eg, the pharmaceutical patent experience of the court and personal jurisdiction issues) the average time to trial before bringing suit in a particular jurisdiction. This is particularly important in light of the large variation in the average times to obtain a trial decision for various district courts. For example, the average time to a nonjury trial in the District of Connecticut is 28 months, whereas a trial is typically held within 20.5 months in the Eastern District of Pennsylvania4. Reflecting the importance of the 30-month stay in these Hatch-Waxman litigations, at least one district court now requires the innovator to identify the exact date on which the 30-month stay will expire upon filing a complain

http://www.paulhastings.com/assets/publications/1877.pdf


The actual Hatch-Waxman statutory language is in subsection j(5) of the attached.

http://www.fda.gov/regulatoryinformation/legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/ucm108125.htm

[RockRat]

>>Does this affect your view?

FDA delays final approval of the generic drug product until all patent or exclusivity issues have been resolved

It seems to take the unequivocal view that approval will be delayed as long as there are any open patent issues, irrespective of the expiry of the 30 month exclusivity period.<<

No, and I gather you & others understand why by now, thanks mainly to mouton.

It is unfortunate that there is a disconnect between the glossary entry and the law as it is written, which seems to be confusing some folks who aren't looking at the latter. But it's a good lesson: glossary entries are often oversimplified, and relying on them as the final word on their subject is dangerous.

In the end, the fact that we have seen at risk launches proves the point we've been discussing, and hopefully we can put the matter to bed.

Regards, RockRat