Threshold intellectual property issues for the VP of R&D at small pharmaceutical companies

CHAL 1

Steven J. Sarussi, sarussi@mbhb.com, McDonnell Boehnen Hulbert & Berghoff LLP, 300 South Wacker Drive, Chicago, IL 60606
Before venturing too deep into a drug discovery program, small companies should address various threshold questions. Among these questions are: 1. What type of patent protection is available for compounds that the company might take into clinical trials? This requires prior art searching, the scope of which is governed by cost and other issues. 2. Will the company have freedom to operate with regard to the compounds? Are the expected target compounds covered by third party patents? Are the assays that are to be used in the program patented by third parties? These issues is of great importance because it can impact obtaining financing or finding collaborators such as large pharmaceutical companies, a critical need for some small companies. Freedom-to-operate studies also require searching, but the scope of the searching may be different from that done in prior art searches. 3. What other questions might possible investors/collaborators ask?