AUTM Journal Volume XVII No. 2 2005

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Table of Contents

  • Bypassing Bypass Surgery and Other Success Stories from the National Institutes of Health By Ruchika Nijhara, PhD, J. Lille Tidwell, PhD, Steven Ferguson, MBA, and Krishna Balakrishnan, PhD, MBA
  • Learning from Lost Opportunities and Sharing Best Practices By Sandor G. Vari, MD, and James D. Laur, JD
  • Legalink: Rumors of the Death of Research Tool Patents Are Greatly Exaggerated By Peter G. Carroll, PhD, JD, and John S. Roberts, PhD, MBA

Editor's Preface:

Many factors indicate success in university technology transfer—products, jobs, fulfilling unmet needs, quality-of-life improvements, local and regional economic factors, licensing revenues, increases in university research monies and output, the list goes on. Further, success can be gauged technology by technology, but measuring overall success is often difficult considering the multitude of factors defining a technology transfer program’s accomplishments. However, one thing is certain: a technology transfer program’s success depends on the missions of both the technology transfer office and its institution.

This issue of the AUTM Journal tackles some of these complex ideas by examining licensing success stories.

The first article, “Bypassing Bypass Surgery and Other Success Stories from the National Institutes of Health,” by Ruchika Nijhara, PhD, J. Lille Tidwell, PhD, Steven Ferguson, MBA, and Krishna Balakrishnan, PhD, MBA, highlights four lifesaving drugs and vaccines that were produced in part through technologies licensed from the United States National Institutes of Health (NIH). The authors note the rarity of technologies that are successful and include a detailed description of the complexity of the definition of success. The first three technologies cited by the authors are products that are currently on the market and benefiting patients suffering from coronary disease, oral mucositis caused by cancer therapies, and AIDS. New applications of the technologies are under investigation.

The final technology highlighted in the NIH article is Vitravene, a therapeutic that treats AIDS-related cytomegalovirus retinitis (CMV-R). Vitravene took only eight years from development to market approval in 1998. However, as current HIV treatments have reduced the incidence of CMV-R, the market for Vitravene was eradicated. Although Vitravene is no longer a product on the market, it was the first antisense drug approved, met an unfulfilled need, and helped many patients before it was phased out, all of which qualify it as a success.

While each of the products and journeys are unique, the article points out, some common themes emerge. For example, all of them underwent contract renegotiation. NIH’s relationships with the companies extended far beyond the initial license, and NIH recognized the need for changes in the contractual relationships.

“Learning from Lost Opportunities and Sharing Best Practices,” by Sandor G. Vari, MD, and James D. Laur, JD, this issue’s second article, complements the first with a comparison of two commercially successful catheter technologies created at Cedars-Sinai, one of which was invented in 1968 and the other in 1990. The earlier technology was sold by the inventors to a company for a one-time payment. By the time the later catheter was invented, Cedars-Sinai had an invention policy and a technology transfer office. Sales of this catheter provided income to Cedars-Sinai for further research in the area.

These contrasting stories not only illustrate success, but also underscore the importance of a solid technology management program. It was this experience—coupled with the realization that some foreign research collaborators could benefit from best practices in technology transfer—that prompted Cedars-Sinai to establish a management and training program to aid Central and Eastern European institutions. The article describes its efforts to share Cedars-Sinai’s best practices in innovation management and the long, but often successful, road of an institution’s technology management program.

Finally, the AUTM Journal introduces a new section, “Legalink,” in this edition of the journal. Legalink will provide updates on legal decisions that affect technology transfer, as well as reflections on other legal issues of concern to AUTM members. Kicking off this new journal feature is “Rumors of the Death of Research Tool Patents Are Greatly Exaggerated,” which mulls the recent Merck v. Integra decision by the U. S. Supreme Court and what it could mean for university technology transfer offices. Authors Peter G. Carroll, PhD, JD, and John S. Roberts, PhD, MBA, discuss the breadth of the decision, the view on research tools outside of the United States, the applicability of research tool patents post-FDA approval, and contract language regarding research tools.

We hope you enjoy this new feature and all of the articles appearing in this issue. Each takes a significant amount of time to write, revise, review, and edit. We thank the authors and AUTM Journal Editorial Advisory Board members for undertaking the efforts needed to pull together this edition highlighting what all of us are attempting to accomplish—success.

Finally, on behalf of the AUTM board of trustees, AUTM Journal editors and Editorial Advisory Board, I extend a very special thank you to Leona Fitzmaurice, PhD, of The UAB Research Foundation for her many years of service to the AUTM Journal as editor. Her in-depth experience, gentle leadership, keen eye for detail, and steadfast insistence on excellence guided the AUTM Journal through many challenges and changes, including a transition to production on a semiannual basis and the shift to a theme-based journal. Her dedicated efforts to the AUTM Journal, too, are an exemplary illustration of success. Her presence will truly be missed.

— Kirsten Leute, Editor
Stanford University