Replies to post #137696 on Biotech Values

[DewDiligence]

It was, IMO, a contradiction Dr. Sherman would have preferred to avoid (or had the opportunity to clarify), but reasonable people may disagree. Clearly, the BioCentury interviewer did not think there was anything amiss, but I doubt that he was paying close attention to the details.

[DewDiligence]

Does an indication have to appear in the Indications and Usage section of an FDA label for a “use” patent for such an indication to be enforcible under Hatch-Waxman? That’s the issue in the Yasmin case discussed at http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/02/the-yasmin-case-is-it-conceivable-or-not-that-hatch-waxman-method-patent-infringement-lawsuits-are-limited-to-information.html .

A similar question could arise vis-à-vis the 351(k) pathway for FoB’s, although there is no repository analogous to the Orange Book for that pathway.