Quick public access to sequence data remains a hallmark of the - Human Genome Project for many genome researchers in the United States and worldwide [see HGN 7(5)]. At the same time, private companies are filing applications to patent DNA sequences at unprecedented rates.

These new patent applications are challenging the capacity of the U.S. Patent and Trademark Office (PTO) to review them. Companies specializing in DNA sequencing have applied for patents on hundreds of thousands of sequences, including genes and gene fragments. PTO examines all sequence applications for fulfillment of four major patenting criteria: novelty, nonobviousness, usefulness, and enablement (i.e., detailed enough to enable one skilled in the field to use it for the stated purpose).

Earlier this year PTO held public hearings to gather ideas on streamlining the time-consuming and expensive examination process. Some possible changes include requiring more background research by applicants, setting new limits on applications, and prescreening sequences for usefulness before examining them further.