Biotech Values

[DewDiligence]

Re: Teva sues MYL for Copaxone infringement

Teva says the four US patents in question pertain to Copaxone characterization and expire in Feb 2020. Based on this description and expiration date, these four non-Orange-Book patents do not include the 5,800,808 and 6,048,898 patents that are part of the litigation between Teva and NVS/MNTA (#msg-54113660). I presume (but have not verified) that some or all of these four patents are the ones Teva unsuccessfully attempted to include in the patent litigation with NVS/MNTA.

As required under Hatch-Waxman, Teva previously sued MYL for infringement of the seven Copaxone patents in the Orange Book. What’s curious about today's Teva PR is that it says Copaxone’s Orange Book patents expire in “May 2014 and September 2015,” even though the Orange Book shows May 2014 as the expiration date for all seven of these patents (http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=020622&Product_No=002&table1=OB_Rx ).

Inasmuch as MYL’s Copaxone knockoff is the drug being sold by Natco in India, I consider MYL's Copaxone ANDA a very long longshot (#msg-52598947, #msg-29902618).