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Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?

To: Art Vandelay AIA who wrote (2563)	4/28/1999 8:50:00 PM
From: Biomaven	Read Replies (1) \| Respond to of 10280

I saw an application at the FDA site by Knoll for a 5 year patent extension on Meridia, which would take their patent to 2007. This is based on the Waxman Hatch provision described as follows: Manufacturers of a newly approved innovator drug that contains an active ingredient never before approved by the FDA can apply for a patent-term extension that equals the sum of all the time spent in the NDA review process plus half of the time spent in the clinical testing phase. Two limitations exist. A patent-term extension cannot exceed five years, nor can it allow the period between product approval and patent expiration to exceed 14 years. The average length of patent-term extensions granted under this provision is three years. If an innovator drug is not protected by a patent, it may still benefit from certain exclusivity provisions that delay the approval or filing of an abbreviated new drug application in some cases. I believe that it is SEPR's view that this five year extension for Meridia doesn't preclude their ICE. (I assume of course that it would preclude a generic). Peter