In Part I of this two part series, published in the October 2010 issue of Regulatory Focus, we discussed the importance and process of the due diligence intellectual property (IP) assessment as well as the differences in patent exclusivity in the US and EU. In Part II, we provide overviews regarding the role of the regulatory professional, patent attorney (PA) and chemistry, manufacturing and controls (CMC) professional for the IP assessment. In addition, a case study is presented to tie together the concepts discussed in Parts I and II.

Regulatory Focus 15:11:24–29, 2010.