Patent Reform and Medical Innovation: There Are Reasons To Be Concerned

One of the constant challenges in crafting policy and law is to avoid unintentional consequences. This cannot be done by living in an ivory tower. When it comes to the business world in particular, there is a need for careful communication with small business owners and entrepreneurs to understand what they are facing and what they might face in light of proposed changes. When it comes to some of the proposals for patent reform, the need to listen to the "voice of the innovator" becomes particularly great. Unfortunately, there is sometimes a human tendency to listen to the voice of one's own staff and the voice of major contributors rather than the voice of the many who will be affected.

What will proposed patent reform legislation do for the economy? I hope there will be careful hearings and investigations into that matter, far more than the efforts so far. Consider the medical industry, an area where innovation can have tremendous impact not only on the economy but directly on human lives. Will changes in patent laws hinder innovation and weaken the industry? Whatever changes we make, let's hope they will strengthen this vital area.

The magazine Medical Innovation and Business recently devoted an entire issue to the challenges of patent reform. The lead article, "Patent Reform: Effects On Medical Innovation Businesses" by Renee Kaswan, David Boundy, and Ron Katznelson, speaks in strident tones about the scope of the problem:

We, as the 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.

Some of the many articles in the issue include:

• "Venture Capital - The Buck Stops Where?" by Gary Lauder


• "What Is A Bad Patent? 1" by Patrick Doody


• "Patent Reform's Weakened Grace Period: Its Effects On Startups, Small Companies, University Spin-Offs And Medical Innovators" by David E. Boundy and Matthew Marquardt


• "Post-Grant Review-Our Next Nightmare? VC Perspective" by John Neis


• "Patent Reforms Must Focus On The U.S. Patent Office" by Ron D. Katznelson, Ph.D.