There is a technology licensing discussion group somewhere on the Internet. A while ago there was an exchange of observations on tightening standards for biotech and pharmaceutical patent applications, including a comment from a former examiner. What follows is excerpts from that exchange (with names changed to protect the innocent). Greg Aharonian Internet Patent News Service (for subscription info, send 'help' to patents@world.std.com ) (for prior art search services info, send 'prior' to patents@world.std.com ) (for WWW patent searching, try http://sunsite.unc.edu/patents/intropat.html ) ==================== >Subject: Re: Patent office requiring human data > > 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. As a further comment, one may use pharmacological activity as one's "per se" patentable utility or usefulness. About ten years ago, the Court of Customs & Patent Appeals said that because knowledge of the pharmacological activity of a compound is beneficial to the public, any such activity constitutes patentable utility. Under this standard, even in vitro pharmacological activity suffices! Thus, draft a claim to pharmacological activity in your existing test data. This should be enough to give you utility sufficient to claim the compound itself. If method and pharmaceutical preparation claims are denied, your patent attorney may be able to later amend the application to include such claims. Alternatively, you can try for an entirely new patent on the new (pharmaceutical) use for the known compound. Alternatively, you may want to review your animal data to see whether you can demonstrate non-human, animal utility. Drugs need not always be shown useful in humans; perhaps you have demonstrated veterinary efficacy. If so, you may draft a claim for veterinary use, and later add a claim for human use or (as seems to be more common) for broad "mammalian, including human" use. The success of this approach depends on the nature of your animal data, but avoids the problem of having to prove the correlation of animal and human results. And as with using pharmacological activity, it will get you a compound patent, good against others who do use for human use. -------------------- Thank you for the advice. I will pass your comments along to the attorney who is prosecuting this case for us. Having spoken to the examiner several times, we have a good idea what he wants. In spite of this, it still appears that in the area of biotechnological inventions, a higher standard for utility is being applied. I was at the AIPLA Mid-Winter Meeting in Palm Springs in January and heard from several attorneys who are experiencing the same sort of utility rejections. It was my understanding at that time that many believe that the "new standard" is a by-product of the applications being filed as a result of the "Genome Project". -------------------- The discussions on the patent prosecution problems revolving around human data is certainly timely for our University. We are in the process of forming a patent strategy, after a rejection, in the area that has been referenced and discussed. I have asked him if he would be interested in participating in an AUTM panel, he is extremely interested. If any of you would be willing to contact me about suggestions for other participants on this panel, I would submit it to AUTM for the February meeting. I know I would be interested in listening to a more indepth discussion discussion. FYI, I will keep you informed on our patent prosecution in this area. We basically jumped through all the hoops that were "suggested" and we were still rejected, but it looks like we have strong grounds for the PTO appeal. -------------------- I recently left the PTO after four years as a biotech patent examiner so I feel obliged to give my $.02. This is strictly my own opinion. I believe the utility standards for biotech patents have become more stringent within the last year and a half in particular. I think the NIH gene fragments patent applications had a lot to do with it due to the negative press on the possibility of awarding patents for gene fragments when function was not known. The stringency for the utility requirement now is an overreaction to that negative press. Certain arts are under a lot of scrutiny, such as AIDS, and especially when there is no art recognized animal model for human therapy. Antibody based therapeutics is another area that seems to have a very high standard for efficacy. There really are two issues here. One is utility, 35 USC 101. Only one utility is required for patentability. This can be other uses rather than therapeutic, ie. diagnostic, research reagent, assay, etc. This is helpful for claims to a protein or gene which may have multiple uses. This is where a good biotech patent attorney or agent makes a difference. Also, be aware that the patent office can actually make the applicant delete matter from the specification for an unsubstantiated utility, though few examiners did that. The second issue is how to make and/or use the claimed invention, 35 USC 112. This is actually the issue that is more problematic for many therapeutics because that is where the applicant needs to show the detailed efficacy (how to use). In a method claim for treating some disease such as AIDS, unfortunately both rejections will apply. Prosecuting product claims (rather than the therapeutic method) will buy time while more experiments are done or a licensee is obtained that can put resources into further experiments on efficacy. If you can submit references demonstrating the acceptability of a particular animal model for extrapolating to human therapy that is very helpful and shifts the burden back to the examiner. Also, the wording of the claims is important: "treating" a disease is different that "curing" and easier to show, an "immunogenic preparation" only has to show raising of antibody while a "vaccine" requires a showing of protective antibody. Again, the patent attorney or agent is crucial. Two last thoughts: I beleive the Board (Board of Patent Appeals and Interferences) may be more conservative on this human data/utility issue than the examiners. It will probably require a decision from the CAFC ($$Better have a licensee$$). In the meantime we can submit our FDA approval data to the patent office to show utility and operability for the invention when it's ready for the market :). Second, if you can get the patent application to another Group besides Group 1800 it may have a better chance.