is a partner with Pepper Hamilton LLP, resident in the Pittsburgh office and member of the Health Sciences Department. Ms. Stakleff also is a member of the firm’s Executive Committee. A registered patent attorney since 2002, she concentrates her practice in intellectual property law, including developing product exclusivity strategies, strategic patent prosecution and counseling, due diligence and transactional support in the pharmaceutical, biologic, nutraceutical, cosmeceutical, medical device, and other health and life sciences fields.
For More information or to contact N. Nicole, please visit her Firm Profile Page.
While part one of this two-part series on intellectual property (IP) due diligence focused on a life science company’s own IP portfolio, part two will address a company’s understanding of how it fits into the market by considering its freedom to operate, as well as its competitors’, and the interplay of patent and regulatory exclusivity as it relates to the company’s product. Patent and regulatory exclusivity—two areas that can provide the most value and protection to a life science product—are very interrelated. Simply identifying when a key patent naturally expires is not sufficient, because regulatory exclusivity could possibly extend the company’s ability to keep competitors off the market or allow competitors to speed up entry in certain situations.
The success of a life science product, and thereby the company, rests heavily upon a combination of patent protection, regulatory exclusivity and product life cycle management. A company’s ability to formulate and articulate an integrated strategy is critical to obtaining investments, strategic partnerships and market success. In this two-part series, we will discuss recent judicial developments that affect life science companies’ IP strategies and also outline the four basic principles of an integrated IP strategy on which a company’s intellectual property audit and preparation for third-party diligence should focus. These are: (1) patent prosecution and strategy, (2) rights and ownership, (3) interplay of patent and regulatory exclusivity, and (4) freedom to operate and competitors. Part one will focus on patent prosecution and strategy, as well as rights and ownership.