In biotechnology companies, the prospect of generating sales revenue is often years away and only after completing a rigorous regulatory process.In these companies, the most important asset generally is the intellectual property portfolio, in particular, the patent portfolio which governs the products to be sold. As development proceeds or shifts, further work needs to be done to patent those developments which are not covered under the original patent umbrella. It is critical that research staffs, business executives and intellectual property counsel coordinate their efforts to determine the direction of research, the extent of coverage and the desired coverage, given the business goals involved. In developing assets, the overall business goals and an assessment of the research and patent portfolio of competitors may also be important considerations.

An intellectual property audit should be conducted at regular intervals, depending upon the size and rigors of the development projects and the business goals of the company. Coordination between the research department (in-house, in-house/university or university research which has been licensed-in), the business professionals (at an early stage, the business executives, at a later stage, the marketing professionals) and intellectual property counsel should be undertaken to best assess the strength and reliability of protection and the impact of competitor’s positions on the company’s business goals. An understanding of the dynamic between licensed-in technology and technology which is to be licensed to larger companies should also be undertaken.