Patent Issues Relative to Life Sciences R&D - Moving from Discovery in Academia to Commercialization

Discussants explore academia and corporate needs as they describe their respective patenting processes and work to improve deal flow.

Chair

Chris Fender, director, Office of Technology Management and
Industry Relations, University of Missouri-Columbia

Speakers

Cary A. Levitt, of counsel, St. Louis, Armstrong Teasdale LLP

Innovation, Inspiration, and Insulation: Practical Legal Measures to Protect Technology: The demand for new technologies is driving innovation worldwide, particularly in the fields of life sciences and biotechnology. Intellectual Property is the life blood of many life sciences and biotechnology companies. Protecting the IP is not trivial and IP protection can be a minefield.

To protect innovations and to secure the investments needed to bring innovations to market, innovators should take appropriate legal measures to protect their most valuable assets--technologies, products, and market identity. How do companies cost-effectively protect their IP assets? What can be disclosed and when? What agreements should be in place to protect the technology? When should patents be prepared and filed? Companies must identify their current intellectual property assets and put in place effective procedures to capture all of the innovations resulting from research and development efforts. The value of IP may be maximized by (a) negotiating strategic relationships, and (b) identifying and monitoring trends in important technologies. Companies must also assure their freedom to operate and the right to sell their products without infringing on the patent rights of others.

This presentation is intended to provide: (1) an overview of IP protection and key concerns of business leaders and academic researchers as they transition technologies to market globally and exploit their IP assets , and (2) a business focused review of recent developments in Intellectual Property law.

James G. Baxendale, executive director, KU Center for Technology Commercialization Inc.

The presentation will examine the challenges of the university technology transfer office in assessing new invention disclosures and the various means of doing so. The presentation will also provide information on different models for justifying the continued investment in patent prosecution while an invention is under further development.

Wynn Volkert, Curators' Professor Emeritus of radiology, biochemistry and chemistry, director of Radiopharmaceutical Sciences Institute, University of Missouri-Columbia

Presentation: This presentation will highlight successful efforts in working with the UM Office of Patents and Licensing to patent, license and commercialize radiopharmaceuticals for medical applications that emerged from collaborative research programs in which I was involved. Two FDA approved radiopharmaceuticals based on relevant patents have been commercialized and are in routine use in the U.S. and other countries. Ceretec is a diagnostic agent for imaging neurologic disorders and infectious processes in patients. Quadramet is a radiotherapeutic drug used for treatment of painful skeletal cancers. An exclusive license agreement with Amersham International was negotiated with UM for development and marketing of Ceretec while Quadramet resulted from a joint R&D program involving investigators at MU and Dow Chemical Company. A more recent patent was issued to protect the invention for use of radiolabeled bombesin peptides for diagnosis and treatment of human prostate, breast and other cancers. A license agreement was negotiated between the University and a venture capital company - Resolution Pharmaceuticals - for development of radiopharmaceuticals covered under the broad-scope US and European patents. Human clinical trials with a diagnostic agent and a therapeutic agent based on radiolabeled bombesin analogs have been performed and show promising results. It is important to recognize that the inventors of all three of these technologies worked closely with the UM Office of Patents and Licensing in identifying viable and desirable commercial partners and in negotiations of the licensing agreements. Flexibility was a key element in developing effective licensing agreements. The three examples highlighted in the presentation demonstrate three different approaches in developing corporate agreements that were successful in translating MU life sciences research into radiopharmaceuticals that are for use as diagnostic and therapeutic applications in human patients.

Robert E. Hanson, partner, Sonnenschein Nath & Rosenthal LLP, Dallas

Joseph A. Mahoney, Mayer Brown LLP, Chicago