!052594 Prosecuting biotech patents - interesting ancedotes One of the Internet discussion groups on technology transfer recently had an interesting exchange about dealing with the Patent Office during the prosecution of biotechnology patents. It was an interesting discussion which I thought you all would be interested in seeing. Greg Aharonian Internet Patent News Service ============================================================================== Dear All: I'm wondering if any of you have encountered a similar situation with the patent office and if you all have any advice. We have a compound that shows good activity against the HIV virus in vitro, but the patent office is requiring human host data in order to obtain patent protection. We have some animal data, but again the PTO is holding out for human data. It's kind of a chicken and egg thing. In order to pursue human data, a company would almost require patent protection to protect their investment. Any words of wisdom would be much appreciated. Thanks. Tom Major University of Utah TOM@TTO.UTAH.EDU ==================== We have had a similar problem with the PTO. In our case it involved extrapolation of data from animal models to humans. The PTO wanted to see data that the animal models were predictive of activity in humans. This was the case even though the application had incorporated by reference an issued patent where the same animal models had been sufficient predictors to support claims to human activity. In patent terms the issue is one of utility and its proof. It appears to many that the USPTO has raised the standards for utility on inventions in the biotechnology area. There is a paper in the April 1994 issue of the "Journal of the Patent and Trademark Office Society" entitled "Biotechnology and the Requirement for Utility in Patent Law" by Christopher A. Michaels that may be of help. David Perry Office of Technology Transfer The University of Arizona Tucson, AZ DPERRY@CCIT.ARIZONA.EDU ==================== Hi Tom, We're running into the same issues here. I have an anti-proliferative agent (anti-cancer) that has good in vitro and some animal data but the PTO wants human data. I think the issue is that they've seen a lot of non-human successes that have never translated into viable human treatments. The PTO is now wary of issuing excessively broad or unsubstantiated patents that they must later reverse themselves on, they're gun shy. >From a licensing perspective, I think the way around this is to use option agreements or provisional licenses that terminate if a patent doesn't issue. Its seemed to work for us so far. Brian Kissel Stanford University Office of Technology Licensing 900 Welch Road, Suite 350, Palo Alto, CA 94304 bkissel@leland.stanford.edu ==================== We have run up against the same utility rejections for HIV therapeutics without human data. (For cancer therapeutics we usually have to provide evidence that the animal models are accepted predictors of efficacy in humans.) When we review a new anti-HIV drug disclosure, we now look for utility other than the treatment of AIDS. This could be an in vivo utility (another biological effect that is easier to prove) or, more likely, an in vitro utility. Examples include killing HIV in blood, raising antibodies useful for a diagnostic assay such as an ELISA, etc. I also try to send these disclosures to creative attorneys who have successful experience with this sort of situation in pharmaceutical patenting. Jo Beth Dudley Thorpe Wisconsin Alumni Research Foundation (WARF) Madison, Wisconsin 53707-7365 jothorpe@macc.wisc.edu