Sunday, October 09, 2011 9:28:02 AM
Basically, Section 271(e)(1) provides an exemption so a generic manufacturer can carry out activities such as bioequivalency testing to satisfy requirements by the FDA for obtaining an approval. Activities for new drug discovery or during commercialization of the product certainly are not within the scope of this Section. The language “reasonably related" leaves quite a few activities that fall in a gray area.
Given the difficulty of producing a uniform product without carefully controlling the feed-stock, the "testing" that needs to be done is inherently part of the manufacturing process, IMO.
This is the stuff of which litigation is made.
Jim
It is astonishing what foolish things one can temporarily believe if one thinks too long alone ... where it is often impossible to bring one's ideas to a conclusive test either formal or experimental. J.M. Keynes
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