Biotech Values

[DewDiligence]

1) don't you think patenting [a manufacturing process] has more benefits than risks esp because FDA would be anyway disclosing some details of the "sameness" criteria and methods used to prove it, when it responds to CP?

In general, the risk outweighs the benefit, IMO; the level of disclosure in an FDA response to a CP is very much less than what is required in a patent application.

2) Do you think these characterization patents would hold in patent challenge?

Some will and some won’t—the devil is in the details.