Replies to post #9183 on Momenta Pharmaceuticals, Inc. (MNTA)

[mouton29]

 
<<The FDA can approve NVS/MNTA’s Copaxone ANDA irrespective of the patent litigation. Pursuant to Hatch-Waxman, there’s a 30-month stay on FDA approval following a Paragraph-IV challenge, but this 30-month stay for NVS/MNTA’s Copaxone ANDA expired on 1/11/11. (The clock on the 30-month stay started when the FDA accepted NVS/MNTA’s Copaxone ANDA for review on 7/11/08 [#msg-30621490] and NVS/MNTA notified Teva of their Paragraph-IV challenge, triggering the patent lawsuit by Teva.) >>

What you say makes sense, else how would generics be launched at-risk. On the other hand, TEVAs press release says they believe the ruling "should" prevent FDA approval -- see the highlighted sentence from this e crept from their press release:

The judge rejected Momenta/Sandoz and Mylan/Natco’s claims that the COPAXONE® patents are invalid and unenforceable and found that the purported generic versions of COPAXONE® for which Momenta/Sandoz and Mylan/Natco seek Food and Drug Administration (FDA) approval infringe those patents. This ruling should prevent the FDA from approving, and the defendants from selling their purported generic versions of COPAXONE® in the U.S. until the Orange Book patents expire on May 24, 2014. As a result of this ruling, Teva also believes that the defendants will be enjoined from selling their products until the process patent expires on September 1, 2015. Furthermore, any purported generic version of COPAXONE® would need to obtain FDA approval prior to being made available to the public. At this point, it is unclear what the requirements would be for approval of a purported generic synthetic peptide

.

http://finance.yahoo.com/news/teva-announces-favorable-court-ruling-062800629.html

Also, I find the last sentence of this definition of "tentative approval" from the FDA website confusing, but perhaps all it is saying is that the FDA "tentative approval" does not affect patents or other exclusivities:

 

Tentative Approval  
If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed drug product, FDA issues a tentative approval letter to the applicant. The tentative approval letter details the circumstances associated with the tentative approval. FDA delays final approval of the generic drug product until all patent or exclusivity issues have been resolved. A tentative approval does not allow the applicant to market the generic drug product.

http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=Tentative%20approval&utm_content=9

[alertmeipp]

Oops. Please pardon my mistake. I should have known better. Please blame my age.