Replies to post #129813 on Biotech Values

[zipjet]

Cases Where a Preliminary Injunction Blocked the Launch of a Generic Drug

That is a very interesting list.

I googled each of those instances to see if the PI was unheld. Looks like they all (exclude aL) were upheld and the blocked drugs were kept off the market for years and in some cases until expiration of the patent.

I did this very quickly so I may not have this perfect. Feel free to correct me.



ij

[DewDiligence]

Housekeeping note…

A link to the latest version of the table in #msg-68490452 is kept in the iBox of this board in the section labeled Tables and Compilations.

As is the case for all items displayed in the iBox, updates may be made by any poster at any time by posting a reply to the most recent version of the item in question.

[stockbettor]

The Pulmicort reference you added includes a cite to the Federal Circuit affirmance of the DC's PI. I read the Fed. Cir's opinion and came away quite confident that the Ampha PI will be affirmed. Pulmicort did not involve infringement of a CoM patent, which is what I expected would be the issue in the cases listed in the table, but rather "kit" and methods of "kit" use claims (the kit being an inhalation device for a specified asthma drug). Interestingly, the DC ruled, and a 2/3 majority of the Fed. Cir. panel affimed, that the "kit" claims were invalid as obvious but that Apotex's use of the FDA-approved label (to titrate to the lowest effective dose) encouraged a method of use (once daily dosing) that would violate AZN's once daily method claim for the kit (Apotex received approval for twice daily dosing of its generic kit). One judge in the 3-judge appellate panel would have reversed the DC's finding as to method of use infringement.

Based on the majority opinion, it's my opinion, FWIW, that the Fed. Cir. will uphold Judge Gorton's findings as to Ampha infringement of MNTA's process claims, the validity of those claims, and the irreparable harm likely to be suffered by MNTA/Sandoz, especially MNTA. Here's a direct link to the Fed. Cir. opinion (and I welcome any contrary views as I am not a patent lawyer and may add more MNTA tomorrow based in part on my view of the case):

http://www.cafc.uscourts.gov/images/stories/opinions-orders/09-1381-1424.pdf

[DewDiligence]

Shionogi v. Lupin re Fortamet is another instance of a PI to block a US generic-drug launch:

http://finance.yahoo.com/news/Shionogi-Co-Ltd-Shionogi-Inc-bw-2093643961.html?x=0

[DewDiligence]

Cases Where a Preliminary Injunction Blocked the Launch of a Generic Drug

[Added Fortamet.]

 
 Drug       Plaintiff  Defendant      Date  iHub reference 
 Accupril   PFE        Teva/Ranbaxy   3/05  #msg-5901380 
 Evista     LLY        Teva           4/09  #msg-37243180 
 Fentora    CEPH       WPI            6/08  #msg-61335088 
 Fortamet   Shionogi   Lupin         12/11  #msg-69687048 
 Lovenox    MNTA/NVS   Amphastar/WPI 10/11  #msg-68468217 
 Mircera    AMGN       Roche          4/08  #msg-28360600 
 Oracea     Galderma   MYL            7/10  #msg-66590889 
 Plavix     SNY/BMY    Apotex         9/06  #msg-13221959 
 Pulmicort  AZN        Apotex         5/09  #msg-57400629