By Renee Kaswan, David Boundy and Ron Katznelson

This special issue of Medical Innovation & Business is devoted to evaluating the potential consequences of the Patent Reform Act of 2010, currently pending in the Senate as S.515 and in the House of Representatives as H.R.1260, with emphasis on university researchers, university spin-offs, emerging start-ups and small life sciences companies, especially those in the medical sciences.

We, as editors of this special issue, are deeply concerned that the Patent Reform Act will severely harm medical and small company innovation. As an academic researcher who invented a blockbuster drug, Restasis®, a patent lawyer who has helped small companies and their investors, and an inventor/entrepreneur who founded and raised investment capital for two start-up companies based on patentable inventions, we have seen how the robust American patent system enables new, innovative companies to secure investment funding and to negotiate with strategic partners. We have seen how patents enable entrepreneurs and researchers to turn raw ideas into useful products.

A strong patent system benefits patients and helps the economy grow by giving companies the competitive position and incentives they need to get new pharmaceuticals, medical devices and procedures into the technology pipeline. Innovators can invest in R&D, testing and FDA approval because patents allow investors to recoup their investments in these staggeringly expensive activities. We are very concerned that the Patent Reform Act undercuts the entire idea-to-product pipeline by weakening the investment value of patents in several ways that selectively impact the most innovative companies. If Congress gets Patent Reform wrong, products characterized by high development costs and low production costs, typical in medical innovation, will die in the lab. The capital investment necessary to get ideas to market will simply dry up, and be diverted to companies that don't need patents to attenuate risk.

In this special issue we have assembled a panel of experts, some to give a "state of the patent system" overview, some to evaluate specific effects of the Patent Reform Act. Many of the articles address Patent Reform issues that are important to classes of companies that have not been heard from, either because they don't exist yet, or because they are too small and decentralized to sponsor a major lobbying campaign: today's small companies, tomorrow's start-ups, tomorrow's university spin-offs, with a focus on medical companies.

Download to read the full text of the Guest Editors' Introduction to the Patent Reform Special Edition of Medical Innovation & Business