Over a decade ago, then Cetus Corp. Chief Executive Officer Robert Fildes shocked a roomful of investors, analysts and even his own scientific board members when he told the group he'd come up with a plan to commercialize the then brand-new technology known as PCR. In a crowded Emeryville conference room, Fildes explained he planned to offer non-exclusive licenses to all academic researchers as well as anyone else who bought automated PCR systems and they could amplify DNA to their heart's content in any research lab. But if a product eventually results from this work, Fildes told the room, Cetus would expect royalties on it.

Many in the room were floored. Cetus' own scientific advisor Joshua Lederburg of New York's Rockefeller University engaged Fildes in a heated argument. Someone else suggested it was akin to demanding royalties off a best seller when all you did was sell the writer a typewriter. While the PCR technology's use in test kits and for specific diagnostics has become a viable, protected business, the idea of following its trail to a marketed product never worked.

Since those days, the complex question of how to fairly protect the intellectual property of an inventor of a valuable, novel research tool like PCR has become even more thorny. Companies and institutions are filing to protect everything from receptor targets to transgenic mice to cell lines, monoclonal antibodies, reagents, growth factors, and combinatorial chemistry libraries. There's been growing frustration in academia and industry that basic research collaborations are being strangled by onerous, protracted negotiations over "material transfer agreements" between institutions and other contractual steps designed to ensure that what used to be the loaning of research tools from one lab to another, doesn't essentially hand over the keys to the treasure chest.

Have a strong opinion on this? An example of egregious delays in getting vital tools into researchers' hands? Fears for new tools? The National Institutes of Health wants to hear about it. NIH director Harold Varmus has opened a Director's Policy Forum on the "Intellectual Property Restrictions on Access to and Use of Research Tools in Biomedical Research."

Here's what's up:

"Over the past few years, many in the biomedical research community have expressed the view that there are ever-increasing barriers to obtaining important basic tools that enable scientists to carry out state-of-the-art research. These so-called "research tools" include materials, information and methods. As the public health agency charged with support of basic biomedical research, NIH wants to ensure that the momentum of scientific research and discoveries in the biomedical fields remains strong and unencumbered so that innovations and advances may be developed to benefit the public.

"The Director of the NIH, Dr. Harold Varmus, has appointed a special Working Group of the Advisory Committee to the Director (ACD) to study this matter and generate a report to be considered and acted upon by the ACD. The Working Group, chaired by Professor Rebecca Eisenberg, of the University of Michigan, includes Members from the academic, business and not-for-profit communities. The Working Group will
submit a preliminary report to the ACD in June, 1998.

". . . This Web Site has been established to invite people with an interest in this issue to participate in the process. Details on the goals of this forum and guidelines for participation can be found in the invitation."


Signals is planning a special report on the issue of patenting targets and other tools. Feel free to copy us on your thoughts, too! Again, the link to the NIH forum is http://www.nih.gov/welcome/forum/