BLG News Spring 2002

FAQs Regarding the Licensing of Research Tools and Mouse Models

This issue of our newsletter discusses the licensing of research tools and mouse models. In general, if you have developed something to enhance your research program or you have something that gets a large number of requests from academic colleagues, chances are industry researchers would find it useful as well. Our office executes a large number of these research tool and mouse model license agreements to for-profit entities that transfer rights for internal research and development use only. A future newsletter will address licenses that cover products a company will sell or distribute.

1- What is considered a research tool?
Any item that aids in a research project is considered a research tool. This includes, but is not limited to, antibodies, cell lines, clones and mouse models (and other animal models). In the case of a research tool license, these items will not be produced, packaged or sold by the licensee, but used internally for research. Mice can be bred and propagated, but only for internal use. Most research tools are not patented.

2- Why would a company license an unpatented technology, such as a mouse model or research tool?
As you know, generating these types of research tools takes time and money. Often, it is cheaper and faster for the company to license these types of tools than to dedicate personnel, reagents and facility space to make them in-house. In addition, very often mouse models and research tools from Baylor have been validated through publications and use by academic researchers. In our efforts to make licensing these types of tools attractive to companies, we ask for reasonable license fees that are at a level where industry scientists can justify the cost of a license over that of creating it in-house.

3- What are the components of a research tool or mouse model license agreement?
The research tool and mouse model agreements are very similar. They provide for the licensee to use the research tool or mouse model on a non-exclusive basis in their internal R & D program only, and not to distribute or sell. In some cases, we will allow the licensee to distribute the research tool to collaborating companies, typically for an additional fee. The licensee can propagate mouse models and develop a colony, maintain a cell line, or use other research tools for use in long-term research projects as long as they pay the annual maintenance fee. Our licenses maintain our right to use the tool here at Baylor. They also maintain the right to transfer the research tool to other academic institutions so that you may continue to collaborate with your academic colleagues. These transfers to academic colleagues should be conducted under an MTA. MTA's are handled by the Office of Research (713-798-6970) and can be downloaded from the model contracts web page at research.bcm.tmc.edu.

4- What license fees do companies typically pay for mouse models and research tools?
Normally, fees consist of an upfront payment and maintenance fees, which are paid on each anniversary of the license agreement for as long as the research tool or mouse is used. For mouse models, a typical upfront fee is in the range of $15,000-$25,000 with an annual maintenance fee of $10,000-$15,000. Other research tools vary widely depending on what they are. Both mouse model and research tool fees are based on a number of factors.

Intended use of the tool or mouse model. Is the tool an important element required to facilitate the development of a therapeutic product, or is its utility limited to basic research applications?
Scope of use. Will the tool be employed in many varied experiments, or is it only useful for one or a few select applications?
Demand for the tool. Are companies "lining up" to get access to the research tool? If so, we may be able to command a higher price.
Availability. Is Baylor the only source of the tool in question, or does the licensee have other viable alternatives?

5- Are these research tools and mouse models covered under the Baylor Policy on Patents and Other Intellectual Property?
Yes. These items, although usually not patented, do fall under the Baylor Intellectual Property Policy. Intellectual property does not have to be patented, and in the case of research tools and mouse models, Baylor generally does not patent these items. A patent is mainly a tool to exclude others from using your invention. In the case of mouse models and research tools, the goal is to have others use the invention, and with a reasonable license fee, it is more efficient to license rather than create it in-house. These items can be disclosed to our office using the disclosure form on our web site. We will also need a brief description and perhaps, in the case of a clone, a map noting which vector backbone is used. If a paper has been published on the research tool, this can be attached as well; these make good marketing tools. When filling out the disclosure form, please be sure to indicate your funding source and if you obtained any materials under a Material Transfer Agreement (MTA) from another entity and attach any such MTAs.

6- How is income allocated under the Baylor Intellectual Property Policy?
All license income is allocated according to the following formula:

Income from license:	100%
BLG:	15%
Patent costs, if any:	Typically none in these cases
Contributors:	42.5% Distributed as per the percentages listed on the disclosure form
Department:	21.25% One or more departments represented by the contributors
BCM General Fund:	21.25%

7- What if my mouse model is being distributed by Jackson Labs?
We have an agreement with JAX in which any for-profit entity that requests a mouse model from JAX must first obtain license for use from Baylor before JAX can ship the mice. In order to include your mouse model in this agreement, please notify us when you submit the mouse to JAX for acceptance. We can also include mice that are already at JAX, so please disclose these mice and let us know they are there. Don't assume that if your mouse is disclosed to our office and you've sent it to JAX without notifying us that it has been included in the Baylor agreement with JAX.

8- What if my mouse model is made with Cre-lox?
We need to know if a mouse model was made with Cre-lox. We have an agreement with Bristol Myers-Squibb (BMS, formerly Dupont), the patent holder of the Cre-lox technology, which restricts the transfer of any mouse that is made with Cre-lox. We can still license these models, but we must work together with BMS to complete these licenses. This process takes additional time.

9- What if my mouse model was made with materials obtained from others under an MTA? Can Baylor license it?
We would need to read the terms of the MTA and contact the institution that provided the materials to determine how best to proceed. In many cases, we are able to proceed with licensing, but must share a negotiated percentage of any licensing income with the donor institution.

For additional information on research tool and mouse model licensing, please call BLG at 713-798-6821.

Recent License Deals

Transgenic Mouse Expressing the Hepatitis B virus X (HBX) Protein. Baylor College of Medicine recently non-exclusively licensed this non-patented mouse model to CTL Immunotherapies, Inc. (CTL), a Chatsworth California-based biotechnology company, for upfront and annual maintenance payments. Drs. Janet Butel, Betty Slagle, Savio Woo, Charles Madden and others developed this mouse model with the purpose of gaining additional insight regarding the function of the HBX protein on liver cells in an in vivo setting. CTL licensed the mice to augment the company's efforts in evaluating vaccine candidates.

Genetic Screens in Mammalian Cells by Enhanced Retroviral Mutagens. Baylor College of Medicine recently non-exclusively licensed this patented research tool to Tanox, Inc., a Houston-based biotechnology company, for upfront and annual maintenance payments. Drs. Sunny Songyang, Dan Liu (of Baylor) and David Baltimore (while at MIT) developed this research tool with the purpose of achieving efficient and regulated insertional mutagenesis in cultured cells. The conditionally activated endogenous genes are tagged, which aids in ease of identification.

BLG Staff

Our offices are located in Suite 600D in the Jewish Building on the main campus. We share office space with the Office of Research and Center for Comparative Medicine. Our eight-member team includes:
Lynne Schaefer is the Director of BLG. She has been with BCM Technologies, Inc., Baylor's venture development subsidiary, since 1983 and BLG since 1988. Lynne holds a B.S. degree in Marine Biology from Roger Williams College in Rhode Island and an M.B.A. from the University of Houston.
Stewart Davis is the Assistant Director of BLG. He joined BLG in 1993. Prior to this position, he worked as a research technician in Dr. Jim Lupski's lab in the Department of Molecular and Human Genetics at Baylor. Stewart received a B.S. in Zoology from Louisiana Tech University and an M.B.A. in Accounting from the University of Houston.
Lisa Beveridge joined BLG in July 2001 as Senior Licensing Manager. Her past medical experience includes positions in clinical, sales, technical support, marketing, market research and business development in various companies including BioRad Laboratories, Abbott Diagnostics Division, and Aventis Pharmaceuticals Products Inc. (formerly Rhone-Poulenc Rorer). Lisa has a B.S. in Medical Technology from the University of Delaware and has done postgraduate work at Temple University and the Medical College of Pennsylvania in hematology.
Larry Hope joined BLG in 1999 as the Technology Licensing Manager. Previously, he held market research and business development positions at several Houston-area biotechnology companies, including LifeCell Corporation and Aronex Pharmaceuticals Inc. Larry holds a B.S. in Microbiology from Texas A&M University and an M.B.A. in Finance & Entrepreneurship from Rice University.
Terese Rakow, Ph.D. also joined BLG in 1999 as a Licensing Associate. She has five years of postdoctoral training in neuroscience at the Scripps Research Institute and The University of California, San Diego. Other research experience includes molecular and cellular biology, as well as cancer biology. In addition, she has a working knowledge of the epidemiology and diagnostics of infectious viral diseases. Terese received a Ph.D. in Zoology and Genetics from Iowa State University.
Michael Dilling, Ph.D. joined BLG in January 2000 as a Licensing Associate. Michael previously worked at St. Jude Children's Research Hospital as an Associate Investigator, where he studied signal transduction pathways in rhabdomyosarcoma, a pediatric skeletal muscle tumor. He also has extensive experience working with retroviral vectors. Michael received an M.B.A. in Finance from the University of Memphis, and a Ph.D. in Genetics from Texas A&M University.